Applications of laser in ischemic heart disease in China

NASA Astrophysics Data System (ADS)

Chen, Mingzhe; Zhang, Yongzhen

1999-09-01

Current data demonstrate that laser coronary angioplasty is most useful in complex lesions not well suited for percutaneous transluminal coronary angioplasty (PTCA). It is not `stand-alone' procedure, and should be considered an adjunct to PTCA or stenting. To date, there are not data supporting reduction of restenosis. Direct myocardial revascularization (DMR), either transmyocardial revascularization (TMR) or percutaneous (catheter-based) myocardial revascularization (PMR), uses laser to create channels between ischemic myocardium and left ventricular cavity. Candidates include patients with chronic, severe, refractory angina and those unable to undergo angioplasty or bypass surgery because conduits or acceptable target vessels are lacking. Although the mechanisms of action of DMR have not yet been clearly elucidated, but several theories have been proposed, including channel patency, angiogenesis, and denervation. TMR, typically requiring open thoracotomy, is effective for improving myocardial perfusion and reducing angina. Pilot studies demonstrate that clinical application of PMR is feasible and safe and effective for decreasing angina. Late sequelae also remain to be determined. An ongoing randomized clinical trial is comparing PMR with conventional medical therapy in patients with severe, refractory angina and disease unamenable to angioplasty or bypass surgery.

Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: Twelve-Month Results of the DEFINITIVE AR Study.

PubMed

Zeller, Thomas; Langhoff, Ralf; Rocha-Singh, Krishna J; Jaff, Michael R; Blessing, Erwin; Amann-Vesti, Beatrice; Krzanowski, Marek; Peeters, Patrick; Scheinert, Dierk; Torsello, Giovanni; Sixt, Sebastian; Tepe, Gunnar

2017-09-01

Studies assessing drug-coated balloons (DCB) for the treatment of femoropopliteal artery disease are encouraging. However, challenging lesions, such as severely calcified, remain difficult to treat with DCB alone. Vessel preparation with directional atherectomy (DA) potentially improves outcomes of DCB. DEFINITIVE AR study (Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency-A Pilot Study of Anti-Restenosis Treatment) was a multicenter randomized trial designed to estimate the effect of DA before DCB to facilitate the development of future end point-driven randomized studies. One hundred two patients with claudication or rest pain were randomly assigned 1:1 to DA+DCB (n=48) or DCB alone (n=54), and 19 additional patients with severely calcified lesions were treated with DA+DCB. Mean lesion length was 11.2±4.0 cm for DA+DCB and 9.7±4.1 cm for DCB ( P =0.05). Predilation rate was 16.7% for DA+DCB versus 74.1% for DCB; postdilation rate was 6.3% for DA+DCB versus 33.3% for DCB. Technical success was superior for DA+DCB (89.6% versus 64.2%; P =0.004). Overall bail-out stenting rate was 3.7%, and rate of flow-limiting dissections was 19% for DCB and 2% for DA+DCB ( P =0.01). One-year primary outcome of angiographic percent diameter stenosis was 33.6±17.7% for DA+DCB versus 36.4±17.6% for DCB ( P =0.48), and clinically driven target lesion revascularization was 7.3% for DA+DCB and 8.0% for DCB ( P =0.90). Duplex ultrasound patency was 84.6% for DA+DCB, 81.3% for DCB ( P =0.78), and 68.8% for calcified lesions. Freedom from major adverse events at 1 year was 89.3% for DA+DCB and 90.0% for DCB ( P =0.86). DA+DCB treatment was effective and safe, but the study was not powered to show significant differences between the 2 methods of revascularization in 1-year follow-up. An adequately powered randomized trial is warranted. http://www.clinicaltrials.gov. Unique Identifier: NCT01366482. Copyright © 2017 The Author(s).

Effect of Ticagrelor Plus Aspirin, Ticagrelor Alone, or Aspirin Alone on Saphenous Vein Graft Patency 1 Year After Coronary Artery Bypass Grafting: A Randomized Clinical Trial.

PubMed

Zhao, Qiang; Zhu, Yunpeng; Xu, Zhiyun; Cheng, Zhaoyun; Mei, Ju; Chen, Xin; Wang, Xiaowei

2018-04-24

The effect of ticagrelor with or without aspirin on saphenous vein graft patency in patients undergoing coronary artery bypass grafting (CABG) is unknown. To compare the effect of ticagrelor + aspirin or ticagrelor alone vs aspirin alone on saphenous vein graft patency 1 year after CABG. Randomized, multicenter, open-label, clinical trial among 6 tertiary hospitals in China. Eligible patients were aged 18 to 80 years with indications for elective CABG. Patients requiring urgent revascularization, concomitant cardiac surgery, dual antiplatelet or vitamin K antagonist therapy post-CABG, and who were at risk of serious bleeding were excluded. From July 2014 until November 2015, 1256 patients were identified and 500 were enrolled. Follow-up was completed in January 2017. Patients were randomized (1:1:1) to start ticagrelor (90 mg twice daily) + aspirin (100 mg once daily) (n = 168), ticagrelor (90 mg twice daily) (n = 166), or aspirin (100 mg once daily) (n = 166) within 24 hours post-CABG. Neither patients nor treating physicians were blinded to allocation. Primary outcome was saphenous vein graft patency 1 year after CABG (FitzGibbon grade A) adjudicated independently by a committee blinded to allocation. Saphenous vein graft patency was assessed by multislice computed tomographic angiography or coronary angiography. Among 500 randomized patients (mean age, 63.6 years; women, 91 [18.2%]), 461 (92.2%) completed the trial. Saphenous vein graft patency rates 1 year post-CABG were 88.7% (432 of 487 vein grafts) with ticagrelor + aspirin; 82.8% (404 of 488 vein grafts) with ticagrelor alone; and 76.5% (371 of 485 vein grafts) with aspirin alone. The difference between ticagrelor + aspirin vs aspirin alone was statistically significant (12.2% [95% CI, 5.2% to 19.2%]; P < .001), whereas the difference between ticagrelor alone vs aspirin alone was not statistically significant (6.3% [95% CI, -1.1% to 13.7%]; P = .10). Five major bleeding episodes occurred during 1 year of follow-up (3 with ticagrelor + aspirin; 2 with ticagrelor alone). Among patients undergoing elective CABG with saphenous vein grafting, ticagrelor + aspirin significantly increased graft patency after 1 year vs aspirin alone; there was no significant difference between ticagrelor alone and aspirin alone. Further research with more patients is needed to assess comparative bleeding risks. clinicaltrials.gov Identifier: NCT02201771.

Current evidence of coronary artery bypass grafting off-pump versus on-pump: a systematic review with meta-analysis of over 16,900 patients investigated in randomized controlled trials†.

PubMed

Deppe, Antje-Christin; Arbash, Wasim; Kuhn, Elmar W; Slottosch, Ingo; Scherner, Maximilian; Liakopoulos, Oliver J; Choi, Yeong-Hoon; Wahlers, Thorsten

2016-04-01

In the present systematic review with meta-analysis, we sought to determine the current strength of evidence for or against off-pump and on-pump coronary artery bypass grafting (CABG) with regard to hard clinical end-points, graft patency and cost-effectiveness. We performed a meta-analysis of only randomized controlled trials (RCT) which reported at least one of the desired end-points including: (i) major adverse cardiac and cerebrovascular events (MACCE), (ii) all-cause mortality, (iii) myocardial infarction, (iv) cerebrovascular accident, (v) repeat revascularization, (vi) graft patency and (vii) cost-effectiveness. The pooled treatment effects [odds ratio (OR) or weighted mean difference, 95% confidence intervals (95% CIs)] were assessed using a fixed or random effects model. A total of 16 904 patients from 51 studies were identified after literature search of the major databases using a predefined keyword list. The incidence of MACCE did not differ between the groups, neither during the first 30 days (OR: 0.93; 95% CI: 0.82-1.04) nor for the longest available follow-up (OR: 1.01; 95% CI: 0.92-1.12). While the incidence of mid-term graft failure (OR: 1.37; 95% CI: 1.09-1.72) and the need for repeat revascularization (OR: 1.55; 95% CI: 1.33-1.80) was increased after off-pump surgery, on-pump surgery was associated with an increased occurrence of stroke (OR: 0.74; 95% CI: 0.58-0.95), renal impairment (OR: 0.79; 95% CI: 0.71-0.89) and mediastinitis (OR: 0.44; 95% CI: 0.31-0.62). There was no difference with regard to hard clinical end-points between on- or off-pump surgery, including myocardial infarction or mortality. The present systematic review emphasizes that both off- and on-pump surgery provide excellent and comparable results in patients requiring surgical revascularization. The choice for either strategy should take into account the individual patient profile (comorbidities, life expectancy, etc.) and importantly, the surgeon's experience in performing on- or off-pump CABG in their routine practice. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Revascularization of Left Coronary System Using a Skeletonized Left Internal Mammary Artery　- Sequential vs. Separate Grafting.

PubMed

Ji, Qiang; Shi, YunQing; Xia, LiMin; Ma, RunHua; Shen, JinQiang; Lai, Hao; Ding, WenJun; Wang, ChunSheng

2017-12-25

To evaluate in-hospital and mid-term outcomes of sequential vs. separate grafting of in situ skeletonized left internal mammary artery (LIMA) to the left coronary system in a single-center, propensity-matched study.Methods and Results:After propensity score-matching, 120 pairs of patients undergoing first scheduled isolated coronary artery bypass grafting (CABG) with in situ skeletonized LIMA grafting to the left anterior descending artery (LAD) territory were entered into a sequential group (sequential grafting of LIMA to the diagonal artery and then to the LAD) or a control group (separate grafting of LIMA to the LAD). The in-hospital and follow-up clinical outcomes and follow-up LIMA graft patency were compared. Both propensity score-matched groups had similar in-hospital and follow-up clinical outcomes. Sequential LIMA grafting was not found to be an independent predictor of adverse events. During a follow-up period of 27.0±7.3 months, 99.1% patency for the diagonal site and 98.3% for the LAD site were determined by coronary computed tomographic angiography after sequential LIMA grafting, both of which were similar with graft patency of separate grafting of in situ skeletonized LIMA to the LAD. Revascularization of the left coronary system using a skeletonized LIMA resulted in excellent in-hospital and mid-term clinical outcomes and graft patency using sequential grafting.

Design of the Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST): a randomized clinical trial.

PubMed

Malas, Mahmoud B; Qazi, Umair; Glebova, Natalia; Arhuidese, Isibor; Reifsnyder, Thomas; Black, James; Perler, Bruce A; Freischlag, Julie A

2014-12-01

To our knowledge, there is no level 1 evidence comparing open bypass with angioplasty and stenting in TransAtlantic Inter-Society Consensus (TASC II) B and C superficial femoral artery lesions. The Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST) is the first prospective randomized clinical trial comparing both treatments. To report the design of the ROBUST trial. The primary aim of the trial is to compare (1) the patency rate (primary, primary assisted, and secondary patency at 6 and 12 months), (2) improvement of quality of life, (3) clinical improvement (at least 1 Rutherford category), and (4) wound healing and limb salvage in patients presenting with critical limb ischemia; secondary aims include (1) cost-effectiveness by factoring procedure and hospital admission costs including rehabilitation, readmission, and reintervention costs, (2) amputation-free survival, (3) reintervention rate, and (4) 30-day operative mortality, morbidity, and wound and access complications. ROBUST is a prospective randomized clinical trial with the aim to enroll 320 patients with intermittent claudication that does not respond to medical management and patients with critical limb ischemia. The maximum level of medical therapy will be administered using antiplatelet agents and statins, as well as measures to control hypertension and diabetes mellitus. Patients with TASC II B or C lesions are prospectively randomized to receive either femoropopliteal bypass or percutaneous transluminal angioplasty and stenting; patients with TASC II A and D lesions are not randomized and receive percutaneous transluminal angioplasty and stenting or femoropopliteal bypass, respectively. All patients will be evaluated at 1, 6, and 12 months postoperatively with physical examination, ankle brachial index, duplex, and a quality-of-life questionnaire. The trial is actively enrolling participants. At the time of writing, 29 patients have been enrolled; most are male (60%) and white (65%). Providing level 1 evidence, ROBUST may help to establish guidelines for the treatment of superficial femoral artery lesions, eliminate unnecessary procedures, and reduce health care costs. clinicaltrials.gov Identifier: NCT01602159.

Durability of the balloon-expandable covered versus bare-metal stents in the Covered versus Balloon Expandable Stent Trial (COBEST) for the treatment of aortoiliac occlusive disease.

PubMed

Mwipatayi, Bibombe P; Sharma, Surabhi; Daneshmand, Ali; Thomas, Shannon D; Vijayan, Vikram; Altaf, Nishath; Garbowski, Marek; Jackson, Mark

2016-07-01

The Covered vs Balloon Expandable Stent Trial (COBEST) is the first multicenter trial to investigate the patency of covered stents (CSs) and bare-metal stents (BMSs) in the treatment of aortoiliac arterial disease. The short-term results demonstrated that CSs were superior to BMSs in maintaining patency for TransAtlantic Inter-Society Consensus (TASC) C and D lesions at 18 months and were equivalent to BMSs for TASC B lesions. The current study was conducted to determine if the initial patency advantage of CSs over BMSs was sustained at the 5-year follow-up. A retrospective post hoc analysis of COBEST was performed. Originally, 125 patients with 168 iliac arteries were prospectively enrolled and randomly assigned to receive a CS or BMS. In this study, 77 of the 125 patients (61.6%; 119 limbs) were assessed at 60 months for the primary and secondary end points, with particular attention paid to the outcomes stratified according to TASC lesion severity. The primary end point was the rate of binary stenosis or freedom from stent occlusion of the treated area, as determined by ultrasound imaging or quantitative visual angiography. The 5-year results of the COBEST showed that the CS had a significantly higher patency rate than the BMS at 18, 24, 48, and 60 months (95.1%, 82.1%, 79.9%, 74.7% for CS vs 73.9%, 70.9%, 63% and 62.5% for BMS; log-rank test, P = .01). On multivariate analysis, the type of stent used (hazard ratio [HR], 2.797; 95% confidence interval [CI], 1.471-5.318; P = .002) and the Rutherford classification (HR, 2.019; 95% CI, 1.278-3.191; P = .026) significantly affected the adjusted primary patency. On subgroup analysis, the CS showed significantly higher patency and a survival benefit compared with the BMS in TASC C and D lesions (HR, 8.639; 95% CI, 54.253-75.753; P = .003). Moreover, fewer patients received target limb revascularization in the CS group than in the BMS group (odds ratio, 2.32; 95% CI, 1.47-3.36; P = .02); however, there was no statistically significant difference in the rate of amputations between the groups. The 5-year results of the COBEST demonstrated that the CS has an enduring patency advantage over the BMS in both the short and long terms. Furthermore, the CS showed acceptable patency rates for the treatment of more severe TASC C and D lesions, and patients who received a CS required fewer revascularization procedures. However, the choice of stent did not affect the rate of major limb amputations. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Eight-year follow-up of the Clopidogrel After Surgery for Coronary Artery Disease (CASCADE) trial.

PubMed

Hage, Ali; Voisine, Pierre; Erthal, Fernanda; Larose, Éric; Glineur, David; Chow, Benjamin; Tremblay, Hugo; Fortier, Jacqueline; Ko, Gifferd; Une, Dai; Farkouh, Michael; Mesana, Thierry G; LeMay, Michel; Kulik, Alexander; Ruel, Marc

2018-01-01

In this 8 years' follow-up study, we evaluated the long-term outcomes of the addition of clopidogrel to aspirin during the first year after coronary artery bypass grafting, versus aspirin plus placebo, with respect to survival, major adverse cardiac, or major cerebrovascular events, including revascularization, functional status, graft patency, and native coronary artery disease progression. In the initial Clopidogrel After Surgery for Coronary Artery Disease trial, 113 patients were randomized to receive either daily clopidogrel (n = 56) or placebo (n = 57), in addition to aspirin, in a double-blind fashion for 1 year after coronary artery bypass grafting. All patients were re-evaluated to collect long-term clinical data. Surviving patients with a glomerular filtration rate > 30 mL/min were asked to undergo a coronary computed tomography angiogram to evaluate the late saphenous vein graft patency and native coronary artery disease progression. At a median follow-up of 7.6 years, survival rate was 85.5% ± 3.8% (P = .23 between the 2 groups). A trend toward enhanced freedom from all-cause death or major adverse cardiac or cerebrovascular events, including revascularization, was observed in the aspirin-clopidogrel group (P = .11). No difference in functional status or freedom from angina was observed between the 2 groups (P > .57). The long-term patency of saphenous vein graft was 89.11% in the aspirin-clopidogrel group versus 91.23% in the aspirin-placebo group (P = .79). A lower incidence of moderate to severe native disease progression was observed in the aspirin-clopidogrel group versus the aspirin-placebo group (7 out of 122 vs 13 out of 78 coronary segments that showed progression, respectively [odds ratio, 0.3 ± 0.2; 95% confidence interval, 0.1-0.8; P = .02]). At 8 years' follow-up, the addition of clopidogrel to aspirin during the first year after coronary artery bypass grafting exhibited a lower incidence of moderate to severe progression of native coronary artery disease and a trend toward higher freedom from major adverse cardiac or cerebrovascular events, including revascularization, or death in the aspirin-clopidogrel group. http://www.clinicaltrials.gov. Unique identifier: NCT00228423. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Revascularization versus medical therapy for renal-artery stenosis.

PubMed

Wheatley, Keith; Ives, Natalie; Gray, Richard; Kalra, Philip A; Moss, Jonathan G; Baigent, Colin; Carr, Susan; Chalmers, Nicholas; Eadington, David; Hamilton, George; Lipkin, Graham; Nicholson, Anthony; Scoble, John

2009-11-12

Percutaneous revascularization of the renal arteries improves patency in atherosclerotic renovascular disease, yet evidence of a clinical benefit is limited. In a randomized, unblinded trial, we assigned 806 patients with atherosclerotic renovascular disease either to undergo revascularization in addition to receiving medical therapy or to receive medical therapy alone. The primary outcome was renal function, as measured by the reciprocal of the serum creatinine level (a measure that has a linear relationship with creatinine clearance). Secondary outcomes were blood pressure, the time to renal and major cardiovascular events, and mortality. The median follow-up was 34 months. During a 5-year period, the rate of progression of renal impairment (as shown by the slope of the reciprocal of the serum creatinine level) was -0.07x10(-3) liters per micromole per year in the revascularization group, as compared with -0.13x10(-3) liters per micromole per year in the medical-therapy group, a difference favoring revascularization of 0.06x10(-3) liters per micromole per year (95% confidence interval [CI], -0.002 to 0.13; P=0.06). Over the same time, the mean serum creatinine level was 1.6 micromol per liter (95% CI, -8.4 to 5.2 [0.02 mg per deciliter; 95% CI, -0.10 to 0.06]) lower in the revascularization group than in the medical-therapy group. There was no significant between-group difference in systolic blood pressure; the decrease in diastolic blood pressure was smaller in the revascularization group than in the medical-therapy group. The two study groups had similar rates of renal events (hazard ratio in the revascularization group, 0.97; 95% CI, 0.67 to 1.40; P=0.88), major cardiovascular events (hazard ratio, 0.94; 95% CI, 0.75 to 1.19; P=0.61), and death (hazard ratio, 0.90; 95% CI, 0.69 to 1.18; P=0.46). Serious complications associated with revascularization occurred in 23 patients, including 2 deaths and 3 amputations of toes or limbs. We found substantial risks but no evidence of a worthwhile clinical benefit from revascularization in patients with atherosclerotic renovascular disease. (Current Controlled Trials number, ISRCTN59586944.) 2009 Massachusetts Medical Society

Bypass Surgery after Endovascular Therapy for Infrapopliteal Lesion Is Not a Poor Outcome Compared with Initial Bypass Surgery by Vascular Surgeons.

PubMed

Morisaki, Koichi; Yamaoka, Terutoshi; Iwasa, Kazuomi; Ohmine, Takahiro

2017-11-01

It is unclear whether prior endovascular therapy (EVT) adversely affects bypass surgery. The aim of this study is to investigate treatment outcomes between initial bypass (bypass-first) and bypass surgery after EVT (EVT-first). We conducted a retrospective analysis of critical limb ischemia patients undergoing infrapopliteal bypass between November 2006 and December 2015. Graft patency, limb salvage (LS), amputation-free survival (AFS), and overall survival (OS) were examined between bypass-first and EVT-first groups. The subjects in this study were 75 patients and 82 limbs in the bypass-first group and 24 patients and 24 limbs in the EVT-first group. The average age was higher in EVT-first group (P = 0.03). The percentage of inframalleolar bypass was higher in the EVT-first group (P = 0.002). Primary patency at 1 and 2 years was 72.0% and 67.5% for the bypass-first group and 53.1% and 47.2% for the EVT-first group, respectively (P = 0.04). Inframalleolar bypass was a risk factor for lower primary patency (hazard ratio 3.07, 95% confidence interval 1.18-8.51, P = 0.02) in multivariate analysis, while there were no differences in secondary patency, LS, AFS, and OS. Bypass surgery after EVT has lower primary patency rates in comparison with primary bypass in patients submitted to infrapopliteal revascularization. Although very heterogeneous study population with a lot of bias in the indication of the revascularization, LS, OS and AFS are not affected by previous EVT. Copyright © 2017 Elsevier Inc. All rights reserved.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Winklehner, Anna, E-mail: anna.winklehner@usz.ch; Nguyen-Kim, Thi Dan Linh, E-mail: thidanlinh.nguyen@usz.ch; Pfammatter, Thomas, E-mail: thomas.pfammatter@usz.ch

PurposeThis study was designed to evaluate retrospectively the long-term stent-graft patency after renovisceral revascularization with Viabahn Open Revascularization Technique (VORTEC) using computed tomography angiography (CTA) and magnetic resonance angiography (MRA).MethodsIn 34 patients (seven women; mean age 72 ± 8 years) with aortic aneurysm, 63 renovisceral vessels (i.e., 54 renal, nine visceral arteries) were revascularized with VORTEC between 2004 and 2009. All patients obtained a pre- and postinterventional CTA and at least one follow-up CTA or MRA after 6 or more months following intervention (median follow up: 43 months). Detection of bypass occlusion, bypass stenosis, infolding, stent-graft fractures and dislocations, and kidney shrinkage were notedmore » by two readers in consensus. Furthermore, mortality during follow-up was assessed using the medical report.ResultsDuring follow-up, 12.6 % of stent-grafts occluded. Cumulative patency rate was 95.2 ± 2.7 % at 12 months, 87.7 ± 4.4 % at 24 and 36 months, and 84.7 ± 5.2 % at 48, 60, 72, 84, and 89 months, respectively. Overall, 19 % of stent-grafts (12/63) developed bypass stenosis (<50 %, 10 stent-grafts; > 50 %, 2 stent-grafts), in one case stenosis (>70 %) was suspected to be hemodynamically significant. No secondary dislocation, no infolding of renovisceral stent-grafts, and no stent-graft fracture occurred. Kidney shrinkage occurred in nine patients, primarily in patients with an occluded Viabahn (n = 7). Eleven patients (32.3 %) died within the follow-up time period.ConclusionsIn long-term survivors after VORTEC cumulative patency rate remained high, and no stent-graft fractures or secondary dislocations occurred.« less

Expandable external support device to improve Saphenous Vein Graft Patency after CABG

PubMed Central

2013-01-01

Objectives Low patency rates of saphenous vein grafts remain a major predicament in surgical revascularization. We examined a novel expandable external support device designed to mitigate causative factors for early and late graft failure. Methods For this study, fourteen adult sheep underwent cardiac revascularization using two vein grafts for each; one to the LAD and the other to the obtuse marginal artery. One graft was supported with the device while the other served as a control. Target vessel was alternated between consecutive cases. The animals underwent immediate and late angiography and were then sacrificed for histopathologic evaluation. Results Of the fourteen animals studied, three died peri-operatively (unrelated to device implanted), and ten survived the follow-up period. Among surviving animals, three grafts were thrombosed and one was occluded, all in the control group (p = 0.043). Quantitative angiographic evaluation revealed no difference between groups in immediate level of graft uniformity, with a coefficient-of-variance (CV%) of 7.39 in control versus 5.07 in the supported grafts, p = 0.082. At 12 weeks, there was a significant non-uniformity in the control grafts versus the supported grafts (CV = 22.12 versus 3.01, p < 0.002). In histopathologic evaluation, mean intimal area of the supported grafts was significantly lower than in the control grafts (11.2 mm^2 versus 23.1 mm^2 p < 0.02). Conclusions The expandable SVG external support system was found to be efficacious in reducing SVG’s non-uniform dilatation and neointimal formation in an animal model early after CABG. This novel technology may have the potential to improve SVG patency rates after surgical myocardial revascularization. PMID:23641948

One Year Primary Patency of Infrapopliteal Angioplasty Using Drug- Eluting Balloons: Single Center Experience at King Hussein Medical Center

PubMed Central

Haddad, Sizeph Edward; Shishani, Jan Mohammad; Qtaish, Izzeddin; Rawashdeh, Mohammad Abdelmajeed; Qtaishat, Belal Saleh

2017-01-01

Objective: Conventional percutaneous transluminal angioplasty (PTA) for long lesions in the below-the-knee (BTK) arteries in patients presenting with critical limb ischemia (CLI) has high restenosis rates at 1 year. Our goal is to evaluate whether paclitaxel drug-eluting balloons (DEB) have higher 1 year primary patency rates compared to conventional PTA. Methods: This is a single-center, prospective, randomized trial that was conducted from June 2013 to December 2015. The aim of the study was to compare 1 year primary patency rates of DEB and PTA in BTK arteries in CLI patients. Inclusion criteria were patients presenting with CLI (Rutherford class 4 or greater), stenosis or occlusion ≥30 mm of at least one tibial artery, and agreement to 12-month evaluation. Exclusion criteria were life expectancy <1 year, allergy to paclitaxel, and contraindication to combined antiplatelet treatment. Follow-up was performed by clinical assessment, ankle brachial pressure index, Doppler ultrasound imaging, and conventional angiogram if indicated. Primary end point was 1 year primary patency, and secondary end points were target lesion revascularization (TLR) and major amputation. Statistical analysis was performed using Fischer's exact test. Results: Ninety-three patients with 106 lesions in the BTK arteries were enrolled in this study. One year primary patency was achieved in 26 (65%) and seven (17%) in the DEB and PTA groups (P = 0.006), respectively. TLR was performed in nine lesions (23%) and 29 lesions (71%) in DEB and PTA groups (P = 0.009), respectively. Major amputations occurred in one limb (2%) and two limbs (4%) in DEB and PTA groups (P = 0.6), respectively. Conclusion: Paclitaxel DEB has significantly higher 1 year primary patency rate associated with significantly less TLR than conventional PTA, following endovascular recanalization of BTK arteries in patients presenting with CLI. PMID:28852581

Revascularization of the internal carotid artery for isolated, stenotic, and symptomatic kinking.

PubMed

Illuminati, Giulio; Calió, Francesco G; Papaspyropoulos, Vassilios; Montesano, Giuseppe; D'Urso, Antonio

2003-02-01

The operation for isolated, stenotic, and symptomatic kinking of the internal carotid artery is safe and effective in preventing stroke and relieving the symptoms of cerebral ischemia. A consecutive sample clinical study with a mean follow-up of 44 months. The surgical department of an academic tertiary care center and an affiliated secondary care center. Fifty-four patients with a mean age of 67 years underwent 55 revascularizations of the internal carotid artery. The surgical procedures consisted of the following: shortening and reimplantation in the common carotid artery in 36 cases, bypass grafting in 15 cases, and transposition into the external carotid artery in 4 cases. Cumulative survival, primary patency, and stroke-free and neurologic symptom-free rates expressed by standard life-table analysis. No patients died in the postoperative period. The postoperative stroke rate was 1.8%. The cumulative rates (SEs) at 5 years were as follows: survival, 70% (10.2%); primary patency, 89% (7.8%); overall stroke free, 92% (6.8%); ipsilateral stroke free, 96% (5.3%); neurologic symptom free, 90% (7.5%); and ipsilateral symptom free, 93% (6.5%). Revascularization of the internal carotid artery for the treatment of isolated, stenotic, and symptomatic kinking is safe and effective in preventing stroke and relieving symptoms of cerebrovascular insufficiency.

A randomized comparison of the Saphenous Vein Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE RITA) trial: One-year angiographic results and mid-term clinical outcomes.

PubMed

Kim, Ki-Bong; Hwang, Ho Young; Hahn, Seokyung; Kim, Jun Sung; Oh, Se Jin

2014-09-01

The Saphenous Vein Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE RITA) trial was designed to evaluate the noninferiority of the saphenous vein (SV) compared with the right internal thoracic artery ([R]ITA) used as a Y-composite graft. A total of 224 patients who had undergone off-pump revascularization for multivessel coronary artery disease using the SV or RITA as a Y-composite graft based on the in situ left ITA were assigned randomly to the SV Y-composite graft (SV group, n = 112) or free RITA Y-composite graft (RITA group, n = 112). The primary endpoint was the 1-year angiographic patency rate of the second limb conduits (SV or RITA). Postoperative 1-year coronary angiograms were performed in 215 patients (SV group, 108; RITA group, 107). The overall graft patency rate was 97.4% (745 of 765) at 1 year (97.9% in the SV group vs 96.9% in the RITA group, P = .362). The primary endpoint of the study, the 1-year patency rate of the SV composite grafts, was 97.1% (238 of 245) and was noninferior to that of the RITA composite grafts (97.1% [198 of 204]) with a 95% lower confidence limit of -2.6% (P < .001 for noninferiority). The graft qualities, evaluated using the FitzGibbon patency grades, were also similar between the 2 groups (P = .948). No statistically significant differences were found in the overall survival rates between the 2 groups at 1 and 4 years (P = .998). Also, no statistically significant differences were found between the 2 groups in the freedom from major adverse cardiac and cerebrovascular event rates at 1 and 4 years (P = .597). The SV composite grafts were noninferior to the RITA composite grafts in terms of the 1-year angiographic patency rates. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Hepatic artery occlusion in liver transplantation - What counts more: Type of reconstruction or severity of recipient's disease?

PubMed

Oberkofler, Christian E; Reese, Tim; Raptis, Dimitri A; Kümmerli, Christoph; de Rougemont, Olivier; De Oliveira, Michelle L; Schlegel, Andrea; Dutkowski, Philipp; Clavien, Pierre-Alain; Petrowsky, Henrik

2018-03-01

Although the type of hepatic artery revascularization technique is known to impact on patency rates, independent perioperative risk factors on patient outcomes are poorly defined. All consecutive adult patients undergoing cadaveric liver transplantation (n=361) from July 2007 to June 2016 in a single institution were analyzed. Primary outcomes were early (<30 days) hepatic artery occlusion and primary hepatic artery patency rate. A multivariate model was used to identify independent risk factors for occlusion and the need of arterial conduit, as well as their impact on graft and patient survival. Arterial revascularization without additional reconstruction (AA) was performed in 77% (n=279), arterial reconstruction (AR) in 15% (n=53), and aorto-hepatic conduit (AHC) in 8% (n=29) of cases, respectively. AHC had the highest mean intraoperative flow (275 ml/min; p=0.024) compared to AA (250 ml/min) and AR (200 ml/min), p=0.024. 43 recipients (12%) had an occlusive event with successful revascularization in 20 recipients (47%). One-year primary patency rates of AA, AR, and AHC were 97, 88, and 74%. Aortic calcification had an impact on early occlusion. AR (OR 3.68 (1.26-10.75), p=0.017) and AHC (OR 6.21 (2.02-18.87, p=0.001) were independent risk factors for early occlusion. Dyslipidemia additionally independently contributed to early occlusion (OR 2.74 (0.96-7.87), p=0.06). One- and five-year graft survival were 83% and 70% for AA, 75% and 69% for AR, and 59% and 50% for AHC (p=0.004). Arterial patency is primarily determined by the type of vascular reconstruction rather than patient or disease characteristics. The preoperative lipid status is an independent risk factor for early occlusion, while overall occlusion is only based on the performed vascular reconstruction, which is also associated with reduced graft and patient survival. This article is protected by copyright. All rights reserved. © 2018 by the American Association for the Study of Liver Diseases.

Treating peripheral arterial disease percutaneously with atherectomy.

PubMed

Schwartz, Bryan G; Kloner, Robert A; Burstein, Steven; Economides, Christina; Mayeda, Guy S

2012-06-01

To determine clinical outcomes of patients who underwent percutaneous revascularization (PR) with multiple devices. PR cases at a private, tertiary referral hospital were reviewed retrospectively. Limb salvage and patency rates were calculated by the Kaplan Meier method. Historical and procedural factors were analyzed by multivariate Cox proportional hazards models. We identified 66 patients and 87 limbs with 261 lesions, including 38 patients with critical limb ischemia (CLI) (51 limbs, 171 lesions). PR incorporated multiple devices (2.0 ± 1.2 devices/lesion, 2.4 ± 1.6 devices/procedure), including balloon angioplasty (57%), excisional atherectomy (54%), orbital atherectomy (44%), and stenting (13%). Last imaged patency was at 18 ± 13 months and last clinical follow-up was 22 ± 12 months. Thirty-five of 87 limbs had ≥1 repeat PR. In 51 limbs with CLI, limb salvage was 75% at 3 years. Independent predictors of amputation were higher creatinine (P=.01; hazard ratio [HR], 1.4), Rutherford category (P=.03; HR, 3.5), and history of coronary artery bypass graft (CABG) (P=.03; HR, 8.9). Overall patency remained 75% through 3 years. Loss of patency or primary patency (patency without repeat PR) was predicted by higher creatinine, Rutherford category, chronic total occlusion, history of CABG, female gender, current and past smoking. Use of excisional atherectomy maintained overall patency (P=.01; HR, 0.36). An aggressive approach to PR with frequent use of atherectomy resulted in high rates of limb salvage and patency. Smoking cessation and excisional atherectomy may improve patency rates.

Long-term patency of superficial temporal artery to middle cerebral artery bypass for cerebral atherosclerotic disease: factors determining the bypass patent.

PubMed

Matano, Fumihiro; Murai, Yasuo; Tateyama, Kojiro; Tamaki, Tomonori; Mizunari, Takayuki; Matsukawa, Hideoshi; Teramoto, Akira; Morita, Akio

2016-10-01

Long-term patency of superficial temporal artery to middle cerebral artery (STA-MCA) bypass surgery for atherosclerotic disease and associated risk factors for loss of patency have rarely been discussed. We retrospectively analyzed long-term patency following STA-MCA bypass and evaluated various demographic and clinical factors to identify the ones predictive of postsurgical loss of patency using records of 84 revascularization procedures (58 patients, 45 males; mean age at surgery 63.6 years, range 31-78 years). Bypass patency was diagnosed based on magnetic resonance angiography or three-dimensional computed tomography. The mean follow-up period was 24.7 months (range 6-63 months). Decreased bypass patency was observed in 4 of 58 patients (6.9 %) who collectively underwent 6 bypasses (7.1 %) of 84. All cases of decreased bypass patency were first detected within 6 months of surgery. Bypass patency was not correlated with age, sex, number of anastomoses, postoperative cerebral infarction, or control of postoperative diabetes mellitus. We found a significant association of bypass patency with hyperperfusion (p = 0.01) and postoperative smoking (p = 0.0036). Furthermore, we found a significant association of hyperperfusion with STA diameter (p < 0.0001), location of anastomosis (p = 0.075), and preoperative cerebral blood flow (p = 0.0399). In our retrospective study, hyperperfusion and smoking after surgery may be risk factors for decreased bypass patency in cerebral atherosclerotic disease patients. Careful monitoring of patency to prevent hyperperfusion and cessation of smoking are recommended, particularly within 6 months of the surgery.

Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency

PubMed Central

Langhoff, Ralf; Rocha-Singh, Krishna J.; Jaff, Michael R.; Blessing, Erwin; Amann-Vesti, Beatrice; Krzanowski, Marek; Peeters, Patrick; Scheinert, Dierk; Torsello, Giovanni; Sixt, Sebastian; Tepe, Gunnar

2017-01-01

Background— Studies assessing drug-coated balloons (DCB) for the treatment of femoropopliteal artery disease are encouraging. However, challenging lesions, such as severely calcified, remain difficult to treat with DCB alone. Vessel preparation with directional atherectomy (DA) potentially improves outcomes of DCB. Methods and Results— DEFINITIVE AR study (Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency—A Pilot Study of Anti-Restenosis Treatment) was a multicenter randomized trial designed to estimate the effect of DA before DCB to facilitate the development of future end point-driven randomized studies. One hundred two patients with claudication or rest pain were randomly assigned 1:1 to DA+DCB (n=48) or DCB alone (n=54), and 19 additional patients with severely calcified lesions were treated with DA+DCB. Mean lesion length was 11.2±4.0 cm for DA+DCB and 9.7±4.1 cm for DCB (P=0.05). Predilation rate was 16.7% for DA+DCB versus 74.1% for DCB; postdilation rate was 6.3% for DA+DCB versus 33.3% for DCB. Technical success was superior for DA+DCB (89.6% versus 64.2%; P=0.004). Overall bail-out stenting rate was 3.7%, and rate of flow-limiting dissections was 19% for DCB and 2% for DA+DCB (P=0.01). One-year primary outcome of angiographic percent diameter stenosis was 33.6±17.7% for DA+DCB versus 36.4±17.6% for DCB (P=0.48), and clinically driven target lesion revascularization was 7.3% for DA+DCB and 8.0% for DCB (P=0.90). Duplex ultrasound patency was 84.6% for DA+DCB, 81.3% for DCB (P=0.78), and 68.8% for calcified lesions. Freedom from major adverse events at 1 year was 89.3% for DA+DCB and 90.0% for DCB (P=0.86). Conclusions— DA+DCB treatment was effective and safe, but the study was not powered to show significant differences between the 2 methods of revascularization in 1-year follow-up. An adequately powered randomized trial is warranted. Clinical Trial Registration— http://www.clinicaltrials.gov. Unique Identifier: NCT01366482. PMID:28916599

Endovascular stent-based revascularization of malignant superior vena cava syndrome with concomitant implantation of a port device using a dual venous approach.

PubMed

Anton, Susanne; Oechtering, T; Stahlberg, E; Jacob, F; Kleemann, M; Barkhausen, J; Goltz, J P

2018-06-01

The aim of this paper is to evaluate the safety and efficacy of endovascular revascularization of malignant superior vena cava syndrome (SVCS) and simultaneous implantation of a totally implantable venous access port (TIVAP) using a dual venous approach. Retrospectively, 31 patients (mean age 67 ± 8 years) with malignant CVO who had undergone revascularization by implantation of a self-expanding stent into the superior vena cava (SVC) (Sinus XL®, OptiMed, Germany; n = 11 [Group1] and Protégé ™ EverFlex, Covidien, Ireland; n = 20 [Group 2]) via a transfemoral access were identified. Simultaneously, percutaneous access via a subclavian vein was used to (a) probe the lesion from above, (b) facilitate a through-and-through maneuver, and (c) implant a TIVAP. Primary endpoints with regard to the SVC syndrome were technical (residual stenosis < 30%) and clinical (relief of symptoms) success; with regard to TIVAP implantation technical success was defined as positioning of the functional catheter within the SVC. Secondary endpoints were complications as well as stent and TIVAP patency. Technical and clinical success rate were 100% for revascularization of the SVS and 100% for implantation of the TIVAP. One access site hematoma (minor complication, day 2) and one port-catheter-associated sepsis (major complication, day 18) were identified. Mean catheter days were 313 ± 370 days. Mean imaging follow-up was 184 ± 172 days. Estimated patency rates at 3, 6, and 12 months were 100% in Group 1 and 84, 84, and 56% in Group 2 (p = 0.338). Stent-based revascularization of malignant SVCS with concomitant implantation of a port device using a dual venous approach appears to be safe and effective.

German Center Subanalysis of the LEVANT 2 Global Randomized Study of the Lutonix Drug-Coated Balloon in the Treatment of Femoropopliteal Occlusive Disease.

PubMed

Scheinert, Dierk; Schmidt, Andrej; Zeller, Thomas; Müller-Hülsbeck, Stefan; Sixt, Sebastian; Schröder, Henrik; Weiss, Norbert; Ketelsen, Dominik; Ricke, Jens; Steiner, Sabine; Rosenfield, Kenneth

2016-06-01

To report a subanalysis of the German centers enrolling patients in the prospective, global, multicenter, randomized LEVANT 2 pivotal trial (ClinicalTrials.gov identifier NCT01412541) of the Lutonix drug-coated balloon (DCB) for the treatment of femoropopliteal occlusive disease. Among the 476 patients in LEVANT 2, 126 patients (mean age 67.1±9.6 years; 79 men) were enrolled at the 8 participating German sites between August 2011 and July 2012 and were randomized 2:1 to treatment with the Lutonix DCB (n=83) vs an uncoated balloon during percutaneous transluminal angioplasty (PTA, n=43). All patients had intermittent claudication or rest pain (Rutherford categories 2-4). Average lesion length was 58 mm and average treated length was 100 mm. Severe calcification was present in 11% of lesions, and 23% were total occlusions. The efficacy outcome was primary patency at 12 months, and the safety outcome was 12-month freedom from a composite of perioperative death, index limb-related death, amputation (below or above the ankle), and index limb revascularization. Secondary endpoints included target lesion revascularization (TLR), major adverse events, and functional outcomes. Demographic, clinical, and lesion characteristics were matched between Lutonix DCB and PTA groups, as were the final percent diameter stenosis (19%) and procedure success (91%). By Kaplan-Meier analysis, the 12-month primary patency rate was 80% vs 58% (p=0.015) and the composite safety endpoint rate was 94% vs 72% (p=0.001), respectively. Freedom from TLR was higher for DCBs (96%) vs PTA (82%, p=0.012). Major adverse events were similar for both groups. The benefit favoring DCB over PTA was observed in German men and women. Compared to the non-German LEVANT 2 cohort, there was a shorter time between insertion and inflation of treatment balloons (21.8 vs 39.5 seconds, p<0.001) in the German cohort. Balloons were inflated to higher pressures (9.0 vs 7.7 atm, p<0.001) but for a shorter period of time (130 vs 167 seconds, p<0.001), and although treated lesions in the German cohort had a higher baseline stenosis, final postprocedure diameter stenosis was lower (19% vs 22%, p=0.04) than in the non-German patients. Superiority of DCB over PTA in the German cohort of LEVANT 2 was demonstrated for primary patency, composite safety, and freedom from TLR. The benefit of DCB was also consistent for both genders. Geographic or regional differences in procedural variables may account for the different outcomes between the German and non-German cohorts. © The Author(s) 2016.

Paclitaxel-Coated Balloon in Infrapopliteal Arteries: 12-Month Results From the BIOLUX P-II Randomized Trial (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries).

PubMed

Zeller, Thomas; Beschorner, Ulrich; Pilger, Ernst; Bosiers, Marc; Deloose, Koen; Peeters, Patrick; Scheinert, Dierk; Schulte, Karl-Ludwig; Rastan, Aljoscha; Brodmann, Marianne

2015-10-01

The aim of BIOLUX P-II (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries) trial was to compare the safety and efficacy of a novel paclitaxel-coated drug-eluting balloon (DEB) versus an uncoated balloon (percutaneous transluminal angioplasty [PTA]) in de novo or native restenotic lesions of the infrapopliteal arteries in patients with claudication and critical limb ischemia. DEB have shown promising results in femoropopliteal lesions, but data for infrapopliteal lesions are scarce. In this prospective, multicenter, randomized first-in-man study, 72 patients were randomized 1:1 to either a Passeo-18 Lux DEB (Biotronik AG, Buelach, Switzerland) (n = 36) or Passeo-18 PTA (n = 36). Follow-up assessments were scheduled at 1, 6, and 12 months, with angiographic assessment at 6 months. Adverse events were adjudicated by an independent clinical events committee, and angiographic parameters were assessed by an independent core laboratory. The primary safety endpoint (a composite of all-cause mortality, target extremity major amputation, target lesion thrombosis, and target vessel revascularization at 30 days) was 0% in the DEB group versus 8.3% in the PTA group (p = 0.239). The primary performance endpoint (patency loss at 6 months) was 17.1% in the DEB group versus 26.1% in the PTA group (p = 0.298), and major amputations of the target extremity occurred in 3.3% versus 5.6% of the patients at 12 months, respectively. The Passeo-18 Lux DEB has been proven to be safe and effective in infrapopliteal lesions with comparable outcomes to PTA. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Endovascular Revascularization of Chronically Thrombosed Arteriovenous Fistulas and Grafts for Hemodialysis: A Retrospective Study in 15 Patients With 18 Access Sites

DOE Office of Scientific and Technical Information (OSTI.GOV)

Weng Meijui; Chen, Matt Chiung-Yu, E-mail: jjychen@gmail.com; Chi Wenche

2011-04-15

The current study retrospectively evaluated whether endovascular revascularization of chronically thrombosed and long-discarded vascular access sites for hemodialysis was feasible. Technical and clinical success rates, postintervention primary and secondary patency rates, and complications were reported. During a 1-year period, we reviewed a total of 924 interventions performed for dysfunction and/or failed hemodialysis vascular access sites and permanent catheters in 881 patients. In patients whose vascular access-site problems were considered untreatable or were considered treatable with a high risk of failure and access-site abandonment, we attempted to revascularize (resurrect) the chronically occluded and long-discarded (mummy) vascular access sites. We attempted tomore » resurrect a total of 18 mummy access sites (mean age 46.6 {+-} 38.7 months; range 5-144) in 15 patients (8 women and 7 men; mean age 66.2 {+-} 11.5 years; age range 50-85) and had an overall technical success rate of 77.8%. Resurrection failure occurred in 3 fistulas and in 1 straight graft. The clinical success rate was 100% at 2 months after resurrection. In the 14 resurrected vascular access sites, 6 balloon-assisted maturation procedures were required in 5 fistulas; after access-site maturation, a total of 22 interventions were performed to maintain access-site patency. The mean go-through time for successful resurrection procedures was 146.6 {+-} 34.3 min (range 74-193). Postmaturation primary patency rates were 71.4 {+-} 12.1% at 30 days, 57.1 {+-} 13.2% at 60 days, 28.6 {+-} 13.4% at 90 days, and 19 {+-} 11.8% at 180 days. Postmaturation secondary patency rates were 100% at 30, 60, and 90 days and 81.8 {+-} 11.6% at 180 days. There were 2 major complications consisting of massive venous ruptures in 2 mummy access sites during balloon dilation; in both cases, prolonged balloon inflation failed to achieve hemostasis, but percutaneous N-butyl cyanoacrylate glue seal-off was performed successfully. Percutaneous resurrection of mummy vascular access sites for hemodialysis is technically feasible with high clinical success rates. In selected patients, resurrection of mummy access sites provides long-discarded access sites one more chance to be used for hemodialysis in an effort to preserve potential extremity sites for future access-site placement and to prevent long-term catheter indwelling.« less

Lasers in the treatment of ischemic heart disease in China

NASA Astrophysics Data System (ADS)

Zhang, Yongzhen; Chen, Mingzhe

2000-10-01

Myocardial revascularization by laser is a new treatment modality for chronic, severe, refractory angina in the patients with coronary heart disease that is not amenable to angioplasty (PTCA) or bypass surgery (CABG). Transmyocardial revascularization (TMR), typically requiring open thoracotomy, uses laser to create channels that would directly carry blood from left ventricular cavity into the ischemic myocardium. Current data indicate that TMR may provide these patients with improvement in angina severity, quality of life, and myocardial perfusion. The greatest potential future use of TMR is as an adjunct to CABG in patients with disease that prevents bypass grafting due to lack of distal targets or a conduit. Recently, as percutaneous (catheter-based) myocardial revascularization (PMR) has been developed with laser technology that permits the creation of channels from the endocardial surface of the left ventricle. The early results with PMR seem encouraging. Randomized clinical trial has demonstrated symptomatic improvement and increased exercise capacity. The risk: benefit ratio for PMR appears to be much more favorable than that for TMR. The mechanisms of action of them have not yet been clearly elucidated, and several theories have been proposed, including channel patency, angiogenesis, denervation, and placebo effect. The challenge of TMR/PMR is related to improvement of perioperative outcomes and long-term survival without worsening of left ventricular function. In future, it may be feasible to combine TMR/PMR with intramyocardial delivery of angiogenic growth factors to induce further new blood vessel formation.

Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease.

PubMed

Geraghty, Patrick J; Mewissen, Mark W; Jaff, Michael R; Ansel, Gary M

2013-08-01

The predominant mode of bare nitinol stent failure is diffuse in-stent restenosis, and failure rates correlate to the length and complexity of the treated lesion. Addition of an expanded polytetrafluoroethylene lining to a nitinol stent frame, as found in the VIABAHN endoprosthesis, mitigates the ingrowth of intimal hyperplasia. We compared the long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endoprosthesis to those obtained with bare nitinol stent implantation. One hundred forty-eight patients with symptomatic complex superficial femoral artery disease (TransAtlantic Inter-Society Consensus I class C and D lesions, accompanied by intermittent claudication or ischemic rest pain) were randomized to endovascular intervention using either bare nitinol stent implantation (76 patients) or nonheparin-bonded VIABAHN endoprosthesis deployment (72 patients). Patency, limb hemodynamics, and quality of life were evaluated at 1, 6, 12, 24, and 36 months following intervention. The average treated lesion measured 18 ± 8 cm in length, and 58.8% of lesions displayed segmental or complete occlusion. At 3 years, primary patency rates (defined by peak systolic velocity ratio ≤ 2.0 and no target lesion revascularization) did not significantly differ between patients treated with the VIABAHN stent graft and those who received a bare nitinol stent (24.2% vs 25.9%; P = .392). Stent fractures were significantly more common in bare nitinol stents (50.0%) than in the VIABAHN endoprostheses (2.6%). Primary-assisted patency rates were higher in those receiving bare nitinol stents than the VIABAHN stent graft (88.8% vs 69.8%; P = .04), although secondary patency rates did not differ between bare nitinol stent and stent graft recipients (89.3% vs 79.5%; P = .304). There were no instances of procedure-related mortality or amputation. The hemodynamic improvement and quality measures improved equally in both groups. The long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endograft and bare nitinol stents are similar. Although primary patency rates are low in both study arms, excellent primary-assisted and secondary patency rates were achieved, with sustained augmentation of limb perfusion and quality-of-life measures. Patency rates diminish most rapidly in the first year after device implantation. Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Endovascular treatment as a bridge to successful surgical revascularization for chronic mesenteric ischemia.

PubMed

Biebl, Matthias; Oldenburg, W Andrew; Paz-Fumagalli, Ricardo; McKinney, J Mark; Hakaim, Albert G

2004-11-01

Chronic mesenteric ischemia (CMI) can be treated with surgical revascularization or with angioplasty and stenting. As experience has been gained, endovascular treatment appears safe and effective in selected patients. Currently, surgical revascularization has better success and patency rates but also a higher short- and midterm mortality and morbidity, especially in patients at high surgical risk. A 72-year-old female with severe respiratory dysfunction presented with CMI resulting in profound malnutrition. Serial percutaneous interventions averted urgent surgery and reversed the mesenteric ischemia. Nine months later, after repeated angioplasty and stenting had failed, elective uncomplicated iliomesenteric bypass, in a medically optimized patient, resolved the ischemia. At an 18-month follow-up, the graft remained widely patent and the patient asymptomatic with a body weight corresponding to her ideal body weight. Compared to surgical revascularization, reocclusion or restenosis occurs more frequently after endovascular treatment of CMI, and reintervention may be necessary. Nevertheless, percutaneous intervention effectively provides relief from mesenteric ischemia and has lower perioperative complication rates compared to surgery in patients at high surgical risk. After initial relief of the CMI, the patient's condition may improve, allowing for more definitive secondary surgical revascularization, if needed.

Retrograde open mesenteric stenting for acute mesenteric ischemia.

PubMed

Blauw, Juliette T M; Meerwaldt, Robert; Brusse-Keizer, Marjolein; Kolkman, Jeroen J; Gerrits, Dick; Geelkerken, Robert H

2014-09-01

Acute mesenteric ischemia (AMI) encompasses the sequels of end-stage untreated chronic mesenteric ischemia and acute mesenteric artery thrombosis. Percutaneous mesenteric artery stenting (PMAS) is the preferred treatment of patients with AMI but is not always feasible. Retrograde open mesenteric stenting (ROMS) is a hybrid technique that combines the advantages of open surgical and endovascular approaches. The literature on the results of this new technique is scarce. The aim of this study was to evaluate the results of ROMS in a consecutive series of patients with AMI. All patients with emergent mesenteric revascularization for AMI between January 2007 and September 2011 were entered in our prospective registry. Technical success, mortality, patency, clinical success, and complication rate at 30 days and 6 and 12 months were assessed. Sixty-eight patients presented with AMI and 54 underwent PMAS, of which four were unsuccessful and followed by ROMS. Eleven patients were directly treated with ROMS, making a total of 15 patients (10 women and five men; median age, 66 years [interquartile range, 54-73 years]). In all patients, only the superior mesenteric artery was revascularized. In nine of the 15 patients, all three mesenteric arteries were severely stenotic or occluded. Technical success was achieved in 14 patients. At ROMS in two patients, the small bowel was severely ischemic. One of these patients needed a partial bowel resection because of irreversible transmural ischemia. At 30 days, the mortality rate was 20% and the primary patency was 92%. Ten patients underwent unplanned relaparotomy, of whom one needed resection of a large part of the small bowel. At 12 months, the mortality rate was still 20%. The primary patency was 83%. Primary assisted patency was 91%, and secondary patency was 100%. Clinical success at 30 days, 6 months, and 12 months, respectively, was 73%, 67%, and 67%. AMI is still a devastating event. If PMAS is not feasible, ROMS is a reliable alternative and is associated with a relatively low mortality and morbidity rate. Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Shifting paradigms in the treatment of lower extremity vascular disease: a report of 1000 percutaneous interventions.

PubMed

DeRubertis, Brian G; Faries, Peter L; McKinsey, James F; Chaer, Rabih A; Pierce, Matthew; Karwowski, John; Weinberg, Alan; Nowygrod, Roman; Morrissey, Nicholas J; Bush, Harry L; Kent, K Craig

2007-09-01

Catheter-based revascularization has emerged as an alternative to surgical bypass for lower extremity vascular disease and is a frequently used tool in the armamentarium of the vascular surgeon. In this study we report contemporary outcomes of 1000 percutaneous infra-inguinal interventions performed by a single vascular surgery division. We evaluated a prospectively maintained database of 1000 consecutive percutaneous infra-inguinal interventions between 2001 and 2006 performed for claudication (46.3%) or limb-threatening ischemia (52.7%; rest pain in 27.7% and tissue loss in 72.3%). Treatments included angioplasty with or without stenting, laser angioplasty, and atherectomy of the femoral, popliteal, and tibial vessels. Mean age was 71.4 years and 57.3% were male; comorbidities included hypertension (84%), coronary artery disease (51%), diabetes (58%), tobacco use (52%), and chronic renal insufficiency (39%). Overall 30-day mortality was 0.5%. Two-year primary and secondary patencies and rate of amputation were 62.4%, 79.3%, and 0.5%, respectively, for patients with claudication. Two-year primary and secondary patencies and limb salvage rates were 37.4%, 55.4%, and 79.3% for patients with limb-threatening ischemia. By multivariable Cox PH modeling, limb-threat as procedural indication (P < 0.0001), diabetes (P = 0.003), hypercholesterolemia (P = 0.001), coronary artery disease (P = 0.047), and Transatlantic Inter-Society Consensus D lesion complexity (P = 0.050) were independent predictors of recurrent disease. For patients that developed recurrent disease, 7.5% required no further intervention, 60.3% underwent successful percutaneous reintervention, 11.7% underwent bypass and 20.5% underwent amputation. Patency rates were identical for the initial procedure and subsequent reinterventions (P = 0.97). Percutaneous therapy for peripheral vascular disease is associated with minimal mortality and can achieve 2-year secondary patency rates of nearly 80% in patients with claudication. Although patency is diminished in patients with limb-threat, limb-salvage rates remain reasonable at close to 80% at 2 years. Percutaneous infra-inguinal revascularization carries a low risk of morbidity and mortality, and should be considered first-line therapy in patients with chronic lower extremity ischemia.

Drug coated balloon in peripheral artery disease.

PubMed

Shanmugasundaram, Madhan; Murugapandian, Sangeetha; Truong, Huu Tam; Lotun, Kapildeo; Banerjee, Subhash

2018-04-21

Peripheral artery disease (PAD) is highly prevalent but is often underdiagnosed and undertreated. Lower extremity PAD can often be life style limiting. Revascularization in carefully selected lower extremity PAD patients improves symptoms and functional status. Surgical revascularization used to be the only available strategy, but in the recent years, endovascular strategies have gained popularity due to faster recovery times with low morbidity and mortality rates. Endovascular procedures have increased significantly in the United States in the past few years. That being said, higher restenosis rates and low long-term patency rates have been the limiting factors for this strategy. Drug eluting stents have been introduced to help with lowering restenosis, however lower extremity PAD involves long segment where the outcomes of stents are suboptimal. Also, the disease often crosses joint line that makes it less ideal for the stents. Drug coated balloons (DCB) have been introduced to improve patency rates following endovascular intervention for lower extremity PAD. They have gained popularity among endovascular specialists due to its ease of use and the concept of "leave nothing behind". This is a review of scientific evidence supporting DCB use in PAD. Published by Elsevier Inc.

Two-year Clinical Outcomes Post Implantation of Epic™ Self-Expanding Nitinol Stents for the Aortoiliac Occlusive Disease in Patients with Peripheral Arterial Disease

PubMed Central

Tsujimura, Takuya; Iida, Osamu; Fujita, Masashi; Masuda, Masaharu; Okamoto, Shin; Ishihara, Takayuki; Nanto, Kiyonori; Kanda, Takashi; Okuno, Shota; Matsuda, Yasuhiro; Fujihara, Masahiko; Yokoi, Yoshiaki; Mano, Toshiaki

2018-01-01

Aim: We investigated 2-year clinical outcomes after implantaton of Epic™ self-expanding nitinol stents for patients with peripheral artery disease (PAD) due to the aortoiliac occlusive disease (AIOD). Methods: This study was a multicenter and retrospective study. From February 2013 through October 2014, 292 lesions (chronic total occlusion, 21%; TASC II C/D, 35%) in 217 consecutive patients (74 ± 8 years; male, 81%; diabetes mellitus, 47%; dialysis, 21%; critical limb ischemia, 29%) who had undergone endovascular therapy (EVT) with Epic™ self-expanding nitinol stents for PAD with AIOD were analyzed. The primary endpoints were 2-year primary patency and target lesion revascularization (TLR)-free rate. The primary patency and freedom from TLR were determined by Kaplan–Meier analysis. Additionally, predictors for loss of patency were estimated by Cox proportional hazard model. Results: The mean follow-up duration was 19.1 ± 8.5 months. Primary patency was 87.3% at 2 years. Freedom from TLR rate was 94.1% at 2 years. Multivariate analysis revealed that the presence of diabetes mellitus was associated with a loss of patency. Conclusion: The Epic™ self-expanding nitinol stent was demonstrated to be safe and effectivene for AIOD when tested for two years in patients with PAD. PMID:28978866

Two-year Clinical Outcomes Post Implantation of EpicTM Self-Expanding Nitinol Stents for the Aortoiliac Occlusive Disease in Patients with Peripheral Arterial Disease.

PubMed

Tsujimura, Takuya; Iida, Osamu; Fujita, Masashi; Masuda, Masaharu; Okamoto, Shin; Ishihara, Takayuki; Nanto, Kiyonori; Kanda, Takashi; Okuno, Shota; Matsuda, Yasuhiro; Fujihara, Masahiko; Yokoi, Yoshiaki; Mano, Toshiaki

2018-04-01

We investigated 2-year clinical outcomes after implantaton of Epic TM self-expanding nitinol stents for patients with peripheral artery disease (PAD) due to the aortoiliac occlusive disease (AIOD). This study was a multicenter and retrospective study. From February 2013 through October 2014, 292 lesions (chronic total occlusion, 21%; TASC Ⅱ C/D, 35%) in 217 consecutive patients (74±8 years; male, 81%; diabetes mellitus, 47%; dialysis, 21%; critical limb ischemia, 29%) who had undergone endovascular therapy (EVT) with Epic TM self-expanding nitinol stents for PAD with AIOD were analyzed. The primary endpoints were 2-year primary patency and target lesion revascularization (TLR)-free rate. The primary patency and freedom from TLR were determined by Kaplan-Meier analysis. Additionally, predictors for loss of patency were estimated by Cox proportional hazard model. The mean follow-up duration was 19.1±8.5 months. Primary patency was 87.3% at 2 years. Freedom from TLR rate was 94.1% at 2 years. Multivariate analysis revealed that the presence of diabetes mellitus was associated with a loss of patency. The Epic TM self-expanding nitinol stent was demonstrated to be safe and effectivene for AIOD when tested for two years in patients with PAD.

Evaluation of the optimal visceral branch configuration in open thoracoabdominal aortic repair by computed tomography.

PubMed

Kamohara, Keiji; Furukawa, Kojiro; Itoh, Manabu; Morokuma, Hiroyuki; Tanaka, Hideya; Hayashi, Nagi; Morita, Shigeki

2015-01-01

In thoracoabdominal aneurysm (TAAA) repair, our technical modification of visceral reconstruction using longer cut pre-sewn side branches has provided good surgical outcomes. Here, we assessed the long-term durability and patency of revascularized branches using computed tomography (CT) to confirm the validity of our approach. Early and late CT evaluations were performed in 11 TAAA patients (males: 5; mean age: 60.6 years) using the Coselli graft to evaluate the position of main graft and the diverging pattern and patency of side branches. Seven of 11 were sutured in an extra-anatomical fashion using longer cut side branches. In Anatomical (n = 4) and Extra-anatomical (n = 7) groups, the early patency of side branches was not significantly different. Although the late patency of right renal artery (RA) was 100% in both groups, the one of left RA was 60% in Extra-anatomical, while 100% in Anatomical. Furthermore, the main graft in Extra-anatomical was significantly posterior and leftward to the spine with left RA side branch diverging at an acute angle. When a pre-sewn branched graft designed for TAAA is used, the graft should be sutured in a fashion similar to normal patient anatomy to minimize the possibility of kinking of RA side branch for the patency.

Endovascular Recanalization of Chronically Occluded Native Arteries After Failed Bypass Surgery in Patients with Critical Ischemia.

PubMed

Yin, Minyi; Wang, Wei; Huang, Xintian; Hong, Biao; Liu, Xiaobing; Li, Weimin; Lu, Xinwu; Lu, Min; Jiang, Mier

2015-12-01

The study aimed to evaluate the feasibility, safety, and outcome of endovascular recanalization of native chronic total occlusions (CTO) in patients with critical limb ischemia (CLI) and lower extremities bypass graft failure. A retrospective review of CLI patients with failed lower limb grafts (>30 days after surgery) that underwent recanalization of native CTO was conducted in two institutions from January 2010 to June 2014. Twenty-eight patients (28 limbs) were included in the study, and all had limited surgical revascularization options. Demographics, procedural data, technical success, complications, vessel patency, limb salvage rates, and survival rates were analyzed. The mean follow-up period was 12.8 months. The technical success rate was 92.9% (26/28 limbs). The combined ipsilateral antegrade-retrograde approach was performed in nine limbs (32.1%). Major periprocedural (<30 days) complications included two myocardial infarctions (7.1%) and two stent thromboses (7.1%), resulting in one amputation. The ankle brachial index before discharge was significantly improved after recanalization (0.78 ± 0.08 vs. 0.31 ± 0.10, p < 0.01). The primary, assisted primary, and secondary patency rates at 12 months were 52.2, 65.8, and 82.2%, respectively. The limb salvage rate and amputation-free survival rate at 12 months were 91.6 and 87.0%, respectively. Endovascular recanalization of native CTO in patients with graft failure-related CLI is a feasible, safe, and effective procedure, with reasonable technical success, vessel patency, and limb salvage rates. The technique should be attempted before amputation in patients with limited surgical revascularization options.

Warfarin improves the outcome of infrainguinal vein bypass grafting at high risk for failure.

PubMed

Sarac, T P; Huber, T S; Back, M R; Ozaki, C K; Carlton, L M; Flynn, T C; Seeger, J M

1998-09-01

Patients with marginal venous conduit, poor arterial runoff, and prior failed bypass grafts are at high risk for infrainguinal graft occlusion and limb loss. We sought to evaluate the effects of anticoagulation therapy after autogenous vein infrainguinal revascularization on duration of patency, limb salvage rates, and complication rates in this subset of patients. This randomized prospective trial was performed in a university tertiary care hospital and in a Veterans Affairs Hospital. Fifty-six patients who were at high risk for graft failure were randomized to receive aspirin (24 patients, 27 bypass grafts) or aspirin and warfarin (WAR; 32 patients, 37 bypass grafts). All patients received 325 mg of aspirin each day, and the patients who were randomized to warfarin underwent anticoagulation therapy with heparin immediately after surgery and then were started on warfarin therapy to maintain an international normalized ratio between 2 and 3. Perioperative blood transfusions and complications were compared with the Student t test or with the chi2 test. Graft patency rates, limb salvage rates, and survival rates were compared with the Kaplan-Meier method and the log-rank test. Sixty-one of the 64 bypass grafts were performed for rest pain or tissue loss, and 3 were performed for short-distance claudication. There were no differences between the groups in ages, indications, bypass graft types, risk classifications (ie, conduit, runoff, or graft failure), or comorbid conditions (except diabetes mellitus). The cumulative 5-year survival rate was similar between the groups. The incidence rate of postoperative hematoma (32% vs 3.7%; P = .004) was greater in the WAR group, but no differences were seen between the WAR group and the aspirin group in the number of packed red blood cells transfused, in the incidence rate of overall nonhemorrhagic wound complications, or in the overall complication rate (62% vs 52%). The immediate postoperative primary graft patency rates (97.3% vs 85.2%) and limb salvage rates (100% vs 88.9%) were higher in the WAR group as compared with the aspirin group. Furthermore, the cumulative 3-year primary, primary assisted, and secondary patency rates were significantly greater in the WAR group versus the aspirin group (74% vs 51%, P = .04; 77% vs 56%, P = .05; 81% vs 56%, P = .02) and cumulative limb salvage rates were higher in the WAR group (81% vs 31%, P = .01). Perioperative anticoagulation therapy with heparin increases the incidence rate of wound hematomas, but long-term anticoagulation therapy with warfarin improves the patency rate of autogenous vein infrainguinal bypass grafts and the limb salvage rate for patients at high risk for graft failure.

Impact of angiosome- and nonangiosome-targeted peroneal bypass on limb salvage and healing in patients with chronic limb-threatening ischemia.

PubMed

Ricco, Jean-Baptiste; Gargiulo, Mauro; Stella, Andrea; Abualhin, Mohammad; Gallitto, Enrico; Desvergnes, Mathieu; Belmonte, Romain; Schneider, Fabrice

2017-11-01

Direct (DIR) or indirect (IND) revascularization of pedal angiosomes in patients with chronic limb-threatening ischemia (CLTI) has an unclear impact on limb salvage and healing. The aim of this study was to evaluate the outcomes of DIR and IND revascularization in patients with a peroneal bypass and tissue loss. We conducted a retrospective study of a prospectively maintained database in two European university centers from 2004 to 2015. We extracted from this database all patients with CLTI and tissue loss who had received a bypass to the peroneal artery. All patients underwent angiography before bypass. Revascularization was considered DIR if the wound was in a peroneal angiosome. Wounds, ischemia, and infection were categorized according to the Wound, Ischemia, and foot Infection (WIfI) classification. Limb salvage and amputation-free survival were calculated using the Kaplan-Meier method. Cox regression was used to compare the role of patient characteristics, including diabetes, peroneal runoff, pedal arch angiosome, WIfI grade, chronic kidney disease, and diabetes, in amputation-free-survival. From January 2004 through October 2015, there were 120 peroneal bypasses performed in 120 patients with CLTI and foot tissue loss. Only 55 wounds (46%) could be ascribed to a peroneal angiosome. At 3 years, amputation-free survival in patients with DIR revascularization was 54.9% ± 7.3% compared with 56.5% ± 6.3% in patients with IND revascularization (P = .44), with no significant difference in wound healing. Amputation-free survival at 3 years in patients with two patent peroneal branches was 74.8% ± 6.9% compared with 45.0% ± 6.0% in patients with one patent peroneal branch (P = .003). Amputation-free survival at 3 years in patients with a patent pedal arch (Rutherford 0-1) was 73.0% ± 7.0% vs 45.7% ± 6.0% in patients with incomplete pedal arch (Rutherford 2-3; P = .0002). Amputation-free survival at 3 years in patients with grade 1 or grade 2 WIfI was 87.4% ± 8.3% compared with 48.4% ± 5.3% in patients with grade 3 or grade 4 WIfI (P = .001). Amputation-free survival at 3 years in patients with diabetes was 43.7% ± 6.2% compared with 73.1% ± 6.7% in patients without diabetes (P = .002). Wound healing at 6 months was not significantly improved by its location within or outside a peroneal angiosome. Cox regression analysis demonstrated that diabetes, patency of both peroneal branches, patency of pedal arch, and WIfI stage but not DIR angiosome revascularization were significant predictors of amputation-free survival. Our results suggest that in patients with CLTI and tissue loss receiving a peroneal bypass, patency of both peroneal branches and pedal arch was associated with a better healing rate and a better amputation-free survival rate irrespective of wound angiosome location. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease.

PubMed

Rosenfield, Kenneth; Jaff, Michael R; White, Christopher J; Rocha-Singh, Krishna; Mena-Hurtado, Carlos; Metzger, D Christopher; Brodmann, Marianne; Pilger, Ernst; Zeller, Thomas; Krishnan, Prakash; Gammon, Roger; Müller-Hülsbeck, Stefan; Nehler, Mark R; Benenati, James F; Scheinert, Dierk

2015-07-09

The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis. In this single-blind, randomized trial conducted at 54 sites, we assigned, in a 2:1 ratio, 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty. The primary efficacy end point was primary patency of the target lesion at 12 months (defined as freedom from binary restenosis or from the need for target-lesion revascularization). The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death (i.e., death from a medical complication related to a limb), amputation, and reintervention. The two groups were well matched at baseline; 42.9% of the patients had diabetes, and 34.7% were current smokers. At 12 months, the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty (65.2% vs. 52.6%, P=0.02). The proportion of patients free from primary safety events was 83.9% with the drug-coated balloon and 79.0% with standard angioplasty (P=0.005 for noninferiority). There were no significant between-group differences in functional outcomes or in the rates of death, amputation, thrombosis, or reintervention. Among patients with symptomatic femoropopliteal peripheral artery disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon. The drug-coated balloon was noninferior to the standard balloon with respect to safety. (Funded by Lutonix-Bard; LEVANT 2 ClinicalTrials.gov number, NCT01412541.).

Occipital Artery to Middle Cerebral Artery Bypass: Operative Nuances.

PubMed

Kimura, Toshikazu; Morita, Akio

2017-12-01

Superficial temporal artery (STA)-middle cerebral artery (MCA) anastomosis is a common procedure for vascular neurosurgeons, and it is used in a variety of diseases. However, there are cases in which the STA is absent or is too hypoplastic to be used as a donor for revascularization. Occipital artery (OA)-MCA bypass may be a treatment option in these cases. We encountered 4 cases of symptomatic cerebral ischemia in which the STA was absent or unavailable. These cases were treated by revascularization from the OA to the periphery of the MCA. By meticulous dissection of the OA to the level of the superior temporal line, the OA could reach the periphery of the angular artery and be anastomosed to it in the usual fashion. The patency of the donor artery was confirmed by magnetic resonance angiography soon after the operation and 3 years later. OA-MCA bypass may be a surgical option for cerebral revascularization when the STA is not available. Copyright © 2017 Elsevier Inc. All rights reserved.

Combination Superficial Temporal Artery-Middle Cerebral Artery Bypass and M2-M2 Reanastomosis With Trapping of a Stented Distal Middle Cerebral Artery Aneurysm: 3-Dimensional Operative Video.

PubMed

Burkhardt, Jan-Karl; Yousef, Sonia; Tabani, Halima; Benet, Arnau; Rubio, Roberto Rodriguez; Lawton, Michael T

2018-05-12

Distal middle cerebral artery (MCA) aneurysms often have non-saccular morphology and cannot be clipped, requiring revascularization and trapping instead. Combination bypasses are needed when 2 arteries exit the aneurysm, and extracranial-intracranial and intracranial-intracranial bypasses can be used. This video demonstrates a combination bypass used to treat a previously stented distal MCA aneurysm with both a superficial temporal artery (STA)-to-MCA bypass and an M2-to-M2 reanastomosis. This 56-yr-old man presented with distal left-sided MCA aneurysm 2 years earlier and attempted stent-assisted coiling was aborted after the aneurysm was perforated with stenting alone. Follow-up angiography demonstrated progressive aneurysm enlargement, and he was referred for surgery. The patient consented for the procedure and a pterional craniotomy extended posteriorly exposed the distal Sylvian fissure and efferent M4-cortical arteries. After splitting the Sylvian fissure, the "flash fluorescence" technique with indocyanine green (ICG) videoangiography identified an M4 recipient artery from the deeper of 2 exiting branches for STA-MCA bypass.1 The aneurysm was then trapped, and inflow and the more superficial outflow arteries were anastomosed end to end (M2-M2 in-situ bypass). A platelet plug that developed at the reanastomosis site was broken apart with mechanical manipulation, and ICG videoangiography demonstrated patency of both bypasses. The patient recovered without any neurological deficits, and postoperative computed tomography angiography confirmed bypass patency. Combination bypasses are needed when unclippable bifurcation aneurysms require revascularization. Careful intraoperative evaluation of patency of the bypass is imperative and helps identifying and addressing any potential early bypass occlusion.

[Revascularization of left anterior descending artery area using a skeletonized left internal mammary artery: a comparison between sequential and separate grafting].

PubMed

Shen, J Q; Ji, Q; Ding, W J; Xia, L M; Wei, L; Wang, C S

2018-03-13

Objective: To evaluate in-hospital and mid-term outcomes of sequential versus separate grafting of in situ skeletonized left internal mammary artery (LIMA) to the left coronary system in a single-center, propensity-matched study. Methods: After propensity score matching, 120 pairs of patients undergoing first, scheduled, isolated coronary artery bypass grafting (CABG) with in situ skeletonized LIMA grafting to the left anterior descending artery (LAD) territory were entered into a sequential group (sequential grafting of LIMA to the diagonal artery and then to the LAD) or a control group (separate grafting of LIMA to the LAD). The in-hospital and follow-up clinical outcomes and follow-up LIMA graft patency were compared. Results: The two propensity score-matched groups had similar in-hospital and follow-up clinical outcomes. The number of bypass conduits ranged from 3 to 6 (with a mean of 3.5), and 91.3%(219/240)of the included patients received off-pump CABG surgery. No significant differences were found between the two propensity score-matched groups in the in-hospital outcomes, including in-hospital death and the incidence of complications associated with CABG (prolonged ventilation, peroperative stroke, re-operation before discharge, and deep sternal wound infection). During follow-up, 9 patients (4 patients from the sequential group and 5 patients from the control group) died, and the all-cause mortality rate was 3.9%. No significant difference was found in the all-cause mortality rate between the 2 groups[3.4% (4/116) vs 4.3% (5/115), P =0.748]. During follow-up period, 99.1% (115/116) patency for the diagonal site and 98.3% (114/116) for the LAD site were determined by coronary computed tomographic angiography after sequential LIMA grafting, both of which were similar with graft patency of separate grafting of in situ skeletonized LIMA to the LAD. Conclusions: Revascularization of the left coronary system using a skeletonized LIMA resulted in excellent in-hospital and mid-term clinical outcomes and graft patency using sequential grafting.

Percutaneous intervention for infrainguinal occlusive disease in women: equivalent outcomes despite increased severity of disease compared with men.

PubMed

DeRubertis, Brian G; Vouyouka, Angela; Rhee, Soo J; Califano, Joseph; Karwowski, John; Angle, Niren; Faries, Peter L; Kent, K Craig

2008-07-01

Experience with open surgical bypass suggests similar overall outcomes in women compared with men, but significantly increased risk of wound complications. Percutaneous treatment of lower extremity occlusive disease is therefore an attractive alternative in women, although it is not clear whether there is a difference in outcomes between women and men treated with this technique. We sought to determine the results and predictors of failure in women treated by percutaneous intervention. Percutaneous infrainguinal revascularization was performed on 309 women between 2001 and 2006. Procedures, complications, demographics, comorbidities, and follow-up data were entered into a prospective database for review. Patency was assessed primarily by duplex ultrasonography. Outcomes were expressed by Kaplan-Meier curves and compared by log-rank analysis. A total of 447 percutaneous interventions performed in 309 women were analyzed and compared with 553 interventions in men. Mean age in women was 73.2 years; comorbidities included hypertension (HTN) (86%), diabetes melitus (DM) (58%), chronic renal insufficiency (CRI) (15%), hemodialysis (7%), hypercholesterolemia (52%), coronary artery disease (CAD) (42%), and tobacco use (47%). Indications in women included claudication (38.0%), rest pain (18.8%), and tissue loss (43.2%). Overall primary & secondary patency and limb-salvage rates for women were 38% +/- 4%, 66% +/- 3%, and 80% +/- 4% at 24 months. In this patient sample, women were significantly more likely than men to present with limb-threatening ischemia (61.6% vs 47.3%, P < 0.001) and have lesions of TASC C and D severity (71.4% vs 61.7%, P < .005). However, there were no significant differences in primary and secondary patency rates or limb-salvage rates between genders. Furthermore, while women with limb-threat, diabetes, and advanced TASC severity lesions were at increased risk of failure overall, there were no differences between women and men with these characteristics. Percutaneous infrainguinal revascularization is a very effective modality in women with lower extremity occlusive disease. Although women in this sample were more likely to present with limb-threat than men, patency and limb-salvage rates were equivalent between genders, even in high-risk subsets such as diabetics or those with lesions of increased TASC severity.

The treatment of chronic intestinal ischemia.

PubMed

Illuminati, G; Caliò, F G; D'Urso, A; Papaspyropoulos, V; Mancini, P; Ceccanei, G; Vietri, F

2004-01-01

Due to the rarity of the condition, large and prospective series defining the optimal method of digestive arteries revascularization, for the treatment of chronic intestinal ischemia, are lacking. The aim of this consecutive sample clinical study was to test the hypothesis that flexible application of different revascularization methods, according to individual cases, will yield the best results in the management of chronic intestinal ischemia. Eleven patients, of a mean age of 57 years, underwent revascularization of 11 digestive arteries for symptomatic chronic mesenteric occlusive disease. Eleven superior mesenteric arteries and one celiac axis were revascularized. The revascularization techniques included retrograde bypass grafting in 7 cases, antegrade bypass grafting in 2, percutaneous arterial angioplasty in 1, and arterial reimplantation in one case. The donor axis for either reimplantation or bypass grafting was the infrarenal aorta in 4 cases, an infrarenal Dacron graft in 4, and the celiac aorta in one case. Grafting materials included 5 polytetrafluoroethylene (PTFE) and 3 Dacron grafts. Concomitant procedures included 3 aorto-ilio-femoral grafts and one renal artery revascularization. Mean follow-up length was 31 months. There was no operative mortality. Cumulative survival rate was 88.9% at 36 months (SE 12.1%). Primary patency rate was 90% at 36 months (SE 11.6%). The symptom free rate was 90% at 36 months (SE 11.6%). Direct reimplantation, antegrade and retrograde bypass grafting, all allow good mid-term results: the choice of the optimal method depends on the anatomic and general patients status. Associated infrarenal and renal arterial lesions can be safely treated in the same time of digestive revascularization. Angioplasty alone yields poor results and should be limited to patients at poor risk for surgery.

The surgical treatment of chronic intestinal ischemia: results of a recent series.

PubMed

Illuminati, G; Caliò, F G; D'Urso, A; Papaspiropoulos, V; Mancini, P; Ceccanei, G

2004-04-01

Due to the rarity of the condition, large and prospective series defining the optimal method of digestive arteries revascularization, for the treatment of chronic intestinal ischemia, are lacking. The aim of this consecutive sample clinical study was to test the hypothesis that flexible application of different revascularization methods, according to individual cases, will yield the best results in the management of chronic intestinal ischemia. Eleven patients, of a mean age of 56 years, underwent revascularization of 11 digestive arteries for symptomatic chronic mesenteric occlusive disease. Eleven superior mesenteric arteries and one celiac axis were revascularized. The revascularization techniques included retrograde bypass grafting in 7 cases, antegrade bypass grafting in 2, percutaneous arterial angioplasty in 1, and arterial reimplantation in one case. The donor axis for either reimplantation or bypass grafting was the infrarenal aorta in 4 cases, an infrarenal Dacron graft in 4, and the celiac aorta in one case. Grafting materials included 5 polytetrafluoroethylene (PTFE) and 3 Dacron grafts. Concomitant procedures included 3 aorto-ilio-femoral grafts and one renal artery revascularization. Mean follow-up duration was 31 months. There was no operative mortality. Cumulative survival rate was 88.9% at 36 months (SE 12.1%). Primary patency rate was 90% at 36 months (SE 11.6%). The symptom free rate was 90% at 36 months (SE 11.6%). Direct reimplantation, antegrade and retrograde bypass grafting, all allow good mid-term results: the choice of the optimal method depends on the anatomic and general patient's status. Associated infrarenal and renal arterial lesions can be safely treated in the same time of digestive revascularization. Angioplasty alone yields poor results and should be limited to patients at poor risk for surgery.

Percutaneous common femoral artery interventions using angioplasty, atherectomy, and stenting.

PubMed

Mehta, Manish; Zhou, Yi; Paty, Philip S K; Teymouri, Medhi; Jafree, Kamran; Bakhtawar, Humayun; Hnath, Jeffrey; Feustel, Paul

2016-08-01

This study evaluated the feasibility, safety, and effectiveness of endovascular interventions for common femoral artery (CFA) occlusive disease. Using a prospectively maintained multicenter database, we analyzed outcomes in 167 consecutive patients who underwent percutaneous CFA interventions for Rutherford class 3 to class 6 (R3-R6) disease. The standardized treatment approach included primary percutaneous transluminal angioplasty (PTA) only, atherectomy + PTA, and provisional stenting. Outcomes included technical failure rate, recurrence, complications, and major or minor amputation rate. Data were analyzed using multivariate regression analysis. During a 7-year period, 167 patients with R3 (n = 91 [54.5%]) and R4 to R6 (n = 76 [45.5%]) disease underwent CFA interventions that included PTA only (n = 114 [68.2%]), atherectomy ± PTA (n = 38 [22.8%]), and provisional stenting (n = 15 [9.0%]) for failed atherectomy ± PTA. Procedure-related complications included pseudoaneurysm (n = 1 [0.6%]), thrombosis (n = 1 [0.6%]), distal embolization (n = 1 [0.6%]), and death (R6, n = 1 [0.06%]). CFA restenosis was observed in 34 (20.4%) patents; these underwent further percutaneous (n = 18 [10.8%]) or surgical (n = 17 [10.2%]) revascularization that included CFA endarterectomy ± femoral distal bypass. Major or minor amputations were observed in none of the R3 patients and in only three (3.9%) and five (6.5%) of the R4 to R6 patients, respectively. Compared with the atherectomy + PTA group, patients in the PTA-only group had a significantly lower patency. Furthermore, during long-term mean follow-up of 42.5 months, the CFA provisional stent group had a 100% primary patency, which was significantly better than the primary patency in the CFA nonstent groups combined (77.0%; P = .0424). Data from this study to date would suggest that percutaneous CFA interventions in select patients are relatively safe and effective. In the long term, CFA stenting has significantly better primary patency than CFA atherectomy and PTA combined. CFA atherectomy + PTA has significantly better primary patency than CFA PTA-only at midterm, especially in patients with claudication. Future randomized controlled trials are warranted. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Transmyocardial revascularization on canine with Ho:YAG laser - an experimental study

NASA Astrophysics Data System (ADS)

Bao, Xiaoqing; Zhu, Jing; Zhang, Hui-Guo

2005-07-01

Background and Objective: To evaluate the efficiency of transmyocardial revascularization with Ho:YAG laser and find out adequate physical parameters of the laser. Materials and Methods: 10 dogs were studied. All the samples were divided into two groups: the laser group (5 dogs) and the control group (5 dogs). Acute myocardial ischemia was induced in all the samples, and transmyocardial laser revascularization (TMLR) was only done in the laser group. We compared the difference of improvement in myocardial perfusion between the two groups with single photon emission computed tomograph (SPECT) and observed the patency of the laser channels and heat injures in the tissue adjacent to the channels with light- and electro-scope. Results: After 4 weeks, the recovery of myocardial perfusion was significantly faster in the laser group than in the control group through SPECT (P<0.05). Most of the laser channels drilled with Ho:YAG laser were filled with fibrin. There were amount of microvessels and erythrocytes inside and around the channels. Only slight heat injures were seen in the tissue adjacent to the channels. Only 20-30 watts were needed in TMLR. Conclusions: Transmyocardial revascularization with Ho:YAG laser limits infarct expansion and reduces myocardial ischemia efficiently. TMLR with Ho:YAG laser can become a new technique to treat ischemic heart disease.

The effect of completeness of revascularization on event-free survival at one year in the ARTS trial.

PubMed

van den Brand, Marcel J B M; Rensing, Benno J W M; Morel, Marie-angèle M; Foley, David P; de Valk, Vincent; Breeman, Arno; Suryapranata, Harry; Haalebos, Maximiliaan M P; Wijns, William; Wellens, Francis; Balcon, Rafael; Magee, Patrick; Ribeiro, Expedito; Buffolo, Enio; Unger, Felix; Serruys, Patrick W

2002-02-20

We sought to assess the relationship between completeness of revascularization and adverse events at one year in the ARTS (Arterial Revascularization Therapies Study) trial. There is uncertainty to what extent degree of completeness of revascularization, using up-to-date techniques, influences medium-term outcome. After consensus between surgeon and cardiologist regarding the potential for equivalence in the completeness of revascularization, 1,205 patients with multivessel disease were randomly assigned to either bypass surgery or stent implantation. All baseline and procedural angiograms and surgical case-record forms were centrally assessed for completeness of revascularization. Of 1,205 patients randomized, 1,172 underwent the assigned treatment. Complete data for review were available in 1,143 patients (97.5%). Complete revascularization was achieved in 84.1% of the surgically treated patients and 70.5% of the angioplasty patients (p < 0.001). After one year, the stented angioplasty patients with incomplete revascularization showed a significantly lower event-free survival than stented patients with complete revascularization (i.e., freedom from death, myocardial infarction, cerebrovascular accident and repeat revascularization) (69.4% vs. 76.6%; p < 0.05). This difference was due to a higher incidence of subsequent bypass procedures (10.0% vs. 2.0%; p < 0.05). Conversely, at one year, bypass surgery patients with incomplete revascularization showed only a marginally lower event-free survival rate than those with complete revascularization (87.8% vs. 89.9%). Complete revascularization was more frequently accomplished by bypass surgery than by stent implantation. One year after bypass, there was no significant difference in event-free survival between surgically treated patients with complete revascularization and those with incomplete revascularization, but patients randomized to stenting with incomplete revascularization had a greater need for subsequent bypass surgery.

Frequency, predictors, and consequences of crossing over to revascularization within 12 months of randomization to optimal medical therapy in the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial.

PubMed

Spertus, John A; Maron, David J; Cohen, David J; Kolm, Paul; Hartigan, Pam; Weintraub, William S; Berman, Daniel S; Teo, Koon K; Shaw, Leslee J; Sedlis, Steven P; Knudtson, Merril; Aslan, Mihaela; Dada, Marcin; Boden, William E; Mancini, G B John

2013-07-01

In the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial, some patients with stable ischemic heart disease randomized to optimal medical therapy (OMT) crossed over to early revascularization. The predictors and outcomes of patients who crossed over from OMT to revascularization are unknown. We compared characteristics of OMT patients who did and did not undergo revascularization within 12 months and created a Cox regression model to identify predictors of early revascularization. Patients' health status was measured with the Seattle Angina Questionnaire. To quantify the potential consequences of initiating OMT without percutaneous coronary intervention, we compared the outcomes of crossover patients with a matched cohort randomized to immediate percutaneous coronary intervention. Among 1148 patients randomized to OMT, 185 (16.1%) underwent early revascularization. Patient characteristics independently associated with early revascularization were worse baseline Seattle Angina Questionnaire scores and healthcare system. Among 156 OMT patients undergoing early revascularization matched to 156 patients randomized to percutaneous coronary intervention, rates of mortality (hazard ratio=0.51 [0.13-2.1]) and nonfatal myocardial infarction (hazard ratio=1.9 [0.75-4.6]) were similar, as were 1-year Seattle Angina Questionnaire scores. OMT patients, however, experienced worse health status over the initial year of treatment and more unstable angina admissions (hazard ratio=2.8 [1.1-7.5]). Among COURAGE patients assigned to OMT alone, patients' angina, dissatisfaction with their current treatment, and, to a lesser extent, their health system were associated with early revascularization. Because early crossover was not associated with an increase in irreversible ischemic events or impaired 12-month health status, these findings support an initial trial of OMT in stable ischemic heart disease with close follow-up of the most symptomatic patients. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00007657.

Remote Iliac Artery Endarterectomy: A Case Series and Systematic Review.

PubMed

Bekken, Joost A; de Boer, Sanne W; van der Sluijs, Rogier; Jongsma, Hidde; de Vries, Jean-Paul P M; Fioole, Bram

2018-02-01

To evaluate the long-term results of remote iliac artery endarterectomy (RIAE) in 2 vascular referral centers and review existing literature. A retrospective analysis was conducted of 109 consecutive patients (mean age 64.2±10.7 years; 72 men) who underwent 113 RIAE procedures for lower limb ischemia from January 2004 to August 2015 at 2 vascular centers. The majority of limbs (82, 72.6%) had TASC II D lesions (31 TASC II C). Primary outcome measures were primary, assisted primary, and secondary patency. A comprehensive literature search was performed in the PubMed and EMBASE databases to identify all English-language studies published after 1990 reporting the results of RIAE. Technical success was achieved in 95 (84.1%) of the 113 procedures. The complication rate was 13.7%, and 30-day mortality was 0%. At 5 years, primary patency was 78.2%, assisted primary patency was 83.4%, and secondary patency was 86.7%. Hemodynamic success was obtained in 91.7% of patients, and clinical improvement was observed in 95.2%. Freedom from major amputation was 94.7% at 5 years. The systematic review comprised 6 studies including 419 RIAEs, and pooled data showed results similar to the current study. For external iliac artery occlusions extending into the common femoral artery, RIAE appears to be a valuable hybrid treatment option. It combines acceptable morbidity and low mortality with good long-term patency. It has some advantages over an open surgical iliofemoral bypass or complete endovascular revascularization and could be the best treatment option in selected cases.

The influence of polymorbidity, revascularization, and wound therapy on the healing of arterial ulceration.

PubMed

Tautenhahn, Joerg; Lobmann, Ralf; Koenig, Brigitte; Halloul, Zuhir; Lippert, Hans; Buerger, Thomas

2008-01-01

An ulcer categorized as Fontaine's stage IV represents a chronic wound, risk factor of arteriosclerosis, and co-morbidities which disturb wound healing. Our objective was to analyze wound healing and to assess potential factors affecting the healing process. 199 patients were included in this 5-year study. The significance levels were determined by chi-squared and log-rank tests. The calculation of patency rate followed the Kaplan-Meier method. Mean age and co-morbidities did not differ from those in current epidemiological studies. Of the patients with ulcer latency of more than 13 weeks (up to one year), 40% required vascular surgery. Vascular surgery was not possible for 53 patients and they were treated conservatively. The amputation rate in the conservatively treated group was 37%, whereas in the revascularizated group it was only 16%. Ulcers in patients with revascularization healed in 92% of cases after 24 weeks. In contrast, we found a healing rate of only 40% in the conservatively treated group (p<0.001). Revascularization appeared more often in diabetic patients (n=110; p<0.01) and the wound size and number of infections were elevated (p=0.03). Among those treated conservatively, wound healing was decelerated (p=0.01/0.02; chi(2) test). The success of revascularization, presence of diabetes mellitus, and wound treatment proved to be prognostic factors for wound healing in arterial ulcers.

Endovascular Repair of Acute Symptomatic Pararenal Aortic Aneurysm With Three Chimney and One Periscope Graft for Complete Visceral Artery Revascularization

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brechtel, Klaus, E-mail: klaus.brechtel@med.uni-tuebingen.de; Ketelsen, Dominik; Endisch, Andrea

2012-04-15

PurposeTo describe a modified endovascular technique for complete revascularization of visceral and renal arteries in symptomatic pararenal aortic aneurysm (PRAA).TechniqueArterial access was surgically established in both common femoral arteries (CFAs) and the left subclavian artery (LSA). Revascularization of the left renal artery, the celiac trunk, and the superior mesenteric artery was performed through one single sheath via the LSA. Suitable covered stents were put in the aortic branches but not deployed. The right renal artery was accessed over the left CFA. Due to the longitudinal extension of the presented aneurysm two stent-grafts were introduced via the right CFA. After deployingmore » the aortic stent-grafts, all covered stents in the side branches were deployed consecutively with a minimum overlap of 5 mm over the cranial and caudal stent-graft edges. Simultaneous ballooning was performed to fully expand all stent-grafts and warranty patency. Conclusion: This is the first report in the literature of chimney grafting in PRAA for complete revascularization of visceral and renal branches by using more than two covered stents introduced from one side through one single sheath. However this technique is modified, it should be used only in bailout situations when branched stent-grafts are not available and/or surgery is not suitable.« less

Endovascular reconstruction of popliteal and infrapopliteal arteries for limb salvage and wound healing in patients with critical limb ischemia – A retrospective analysis

PubMed Central

Khanolkar, Uday B.; Ephrem, Biju

2016-01-01

Background Advancement in endovascular techniques has led to rapid growth in endovascular revascularization, and it has emerged as a treatment for critical limb ischemia (CLI). Clinical effectiveness of revascularization has been frequently judged by vessel patency and limb salvage, but there is paucity of reports on outcomes of the wound. We present a retrospective analysis of immediate angiographic and 3-month clinical outcome of patients who underwent endovascular reconstruction of popliteal and infrapopliteal arteries for CLI. Methods All patients who underwent endovascular reconstruction of popliteal and/or infrapopliteal arteries for CLI and >70% stenosis on digital subtraction angiography between March 2010 and November 2014 and had a clinical follow-up of at least 3 months were selected for analysis. Results 34 patients underwent endovascular reconstruction. 9 patients (26%) underwent only POBA and remaining 25 (74%) underwent additional stenting. 13 patients (38%) had multiple segmental revascularization. 24 patients (71%) had successful vessel recanalization. Linear flow to foot in at least one artery could be achieved in 20 patients (59%) post revascularization. Successful wound healing occurred in 11 (35%) patients with an additional 7 (21%) patients showing clinical improvement in their wounds. Limb salvage was achieved in 33 patients (97%) at 3-month follow-up. Conclusion Endovascular revascularization of popliteal and infrapopliteal arteries is a feasible, safe, and effective procedure for the treatment of CLI. Normal inflow and outflow with at least one of the three infrapopliteal vessels being patent is essential for adequate healing of chronic ulcers and prevention of major amputation. PMID:26896272

Long-term Durability of Infrainguinal Endovascular and Open Revascularization for Disabling Claudication.

PubMed

Khan, Sikandar Z; Rivero, Mariel; Cherr, Gregory S; Harris, Linda M; Dryjski, Maciej L; Dosluoglu, Hasan H

2018-05-15

Infrainguinal revascularization for disabling claudication (DC) is frequently performed, but long-term results are still unknown. In this study, we compared clinical outcomes of infrainguinal endovascular (EV) and open interventions for DC after the failure of medical management. One hundred ninety-four patients with DC (Rutherford category 3) who had open (n = 53) or EV (n = 141) interventions were grouped as open-great saphenous vein (GSV) (n = 21), open-prosthetic (n = 32), EV-Trans-Atlantic Inter-Society Consensus II (TASC II) A and B (AB) (n = 48), and EV-TASC II C and D (CD) (n = 93). Patency, primary clinical success (PCS; sustained improvement in symptoms without reintervention), and secondary clinical success (SCS; sustained improvement in symptoms with reintervention) rates were compared. Mean follow-up was 57 ± 33 months. Five-year primary patency was 58% in open-GSV, 40% in open-prosthetic, 72% in EV-AB, and 38% in EV-CD (P < 0.001). Five-year secondary patency was 77% in open-GSV, 50% in open-prosthetic, 96% in EV-AB, and 61% in EV-CD (P < 0.001). Freedom from major adverse limb events was 73% in open-GSV, 77% in EV-AB, 70% in EV-CD, and 67% in open-prosthetic (P = 0.279). Five-year PCS was 46% in open-GSV, 40% in open-prosthetic, 57% in EV-AB, and 44% in EV-CD (P = 0.02). Five-year SCS was 78% in open-GSV, 78% in open-prosthetic, 85% in EV-AB, and 84% in EV-CD (P = 0.732). A total of 116 reinterventions were performed, 10 in 6 limbs (27%) in open-GSV, 18 in 12 limbs (36%) in open-prosthetic, 26 in 15 limbs (24%) in EV-AB, and 62 in 39 limbs (36%) in EV-CD. Reinterventions included 71 (61%) EV and 45 (39%) open procedures. Durability of infrainguinal interventions in claudicants depends mainly on anatomic complexity of disease. Good long-term clinical success can be achieved with both open and EV interventions, albeit with high reintervention rates, especially in patients with TASC II C and D disease. A considerable subset of EV patients will eventually require surgical revascularization to maintain clinical benefit. In this study, almost 20% of patients undergoing EV for TASC II C and D disease eventually required surgical bypass. Copyright © 2018 Elsevier Inc. All rights reserved.

Sustained Benefit at 2 Years for Covered Stents Versus Bare-Metal Stents in Long SFA Lesions: The VIASTAR Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lammer, Johannes, E-mail: jlammer@gmx.at, E-mail: johannes.lammer@meduniwien.ac.at; Zeller, Thomas, E-mail: thomas.zeller@universitaets-herzzentrum.de; Hausegger, Klaus A., E-mail: klaus.hausegger@lkh-klu.at

PurposeThe hypothesis that covered stents are superior to bare-metal stents (BMS) in long femoropopliteal artery disease was tested. The one-year results of the VIASTAR trial revealed a patency benefit of covered stents in the treatment-per-protocol (TPP) analysis only.MethodsA prospective, randomized, single-blind, multicenter study evaluated 141 patients with symptomatic peripheral arterial disease (PAD) after treatment with heparin-bonded covered stents (VIABAHN{sup ®} Endoprosthesis) or BMS. Clinical outcomes and patency rates were assessed at 1, 6, 12, and 24 months. Mean lesion length was 19.0 ± 6.3 cm in the VIABAHN{sup ®} versus 17.3 ± 6.6 cm in the BMS group.ResultsThe 24-month primary patency rates in the VIABAHN{sup ®} andmore » BMS group were: intention-to-treat 63.1 (95 % CI 0.52–0.76) versus 41.2 % (95 % CI 0.29–0.57; log rank p = 0.04) and TPP 69.4 (95 % CI 0.58–0.83) versus 40.0 % (95 % CI 0.28–0.56; log rank p = 0.004). Freedom from target-lesion-revascularization (TLR) was 79.4 (95 % CI 0.70–0.90) versus 73.0 % (95 % CI 0.63–0.85) for VIABAHN{sup ®} versus BMS (log rank p = 0.37). For the TPP group in lesions ≥20 cm, the 24-month patency rates were 65.2 (95 % CI 0.50–0.85) versus 26.7 % (95 % CI 0.12–0.59; log rank p = 0.004) for VIABAHN{sup ®} versus BMS, and freedom from TLR was 80.0 (95 % CI 0.68–0.94) versus 61.9 % (95 % CI 0.44–0.87; log rank p = 0.13). The ankle brachial index was 0.89 ± 0.18 versus 0.91 ± 0.17 (p = 0.76) at 24-month in the VIABAHN{sup ®} versus the BMS group, respectively.ConclusionAt 24-month, this trial in PAD patients with long femoropopliteal lesions demonstrated a significantly improved primary patency rate for heparin-bonded covered stents compared to BMS, however, without a significant impact on clinical outcomes and TLR rate (Reg. Nr. ISRCTN48164244)« less

Endovascular Revascularization of Hemodialysis Thrombosed Grafts with the Hydrodynamic Thrombectomy Catheter. Our 7-Year Experience

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bermudez, Patrícia, E-mail: pbermude@clinic.ub.es; Fontseré, Nestor, E-mail: fontsere@clinic.ub.es; Mestres, Gaspar, E-mail: gmestres@clinic.ub.es

2017-02-15

PurposeTo evaluate the efficacy and safety of the hydrodynamic thrombectomy catheter (AngioJet DVX) in the salvage of thrombosed hemodialysis vascular grafts.Materials and MethodsA retrospective study was designed, including all patients with occluded arteriovenous grafts treated with the AngioJet system between 2007 and 2014 in our institution. Outcomes included technical success, clinical success, complications, and primary and secondary patencies. Procedural success was defined as angiographic confirmation of flow restoration, the presence of a pulsatile thrill along the graft, and successful resumption of at least one hemodialysis session. Primary and secondary patencies after first AVG thrombectomy were calculated with Kaplan–Meier curves. Coxmore » regression was used to determine prognostic factors of primary patency after every thrombectomy episode.ResultsA total of 149 thrombectomies were performed in 68 grafts. After thrombectomy, endovascular treatment of one or more stenosis was performed in all cases. Technical success was 93% and clinical success was 86%. Complications occurred in 7 thrombectomies, most of them were minor except for one anastomosis rupture requiring surgery. Primary and secondary patencies were 52, 41, and 23 and 76, 68, and 57% at 3, 6 and 12 months, respectively. Independent prognostic factors of poor patency after every thrombectomy episode were the presence of residual thrombus (OR 1.831, P = 0.008) and time from last thrombosis (less than 1 month; and OR 7.116, P < 0.001).ConclusionPercutaneous mechanical thrombectomy with AngioJet is a safe technique with a high-clinical success rate. The presence of residual thrombus after thrombectomy and early re-occlusions are related to poorer results.« less

Endovascular revascularization for aortoiliac atherosclerotic disease

PubMed Central

Aggarwal, Vikas; Waldo, Stephen W; Armstrong, Ehrin J

2016-01-01

Atherosclerotic iliac artery disease is increasingly being treated with endovascular techniques. A number of new stent technologies can be utilized with high long-term patency, including self-expanding stents, balloon-expandable stents, and covered stents, but comparative data on these stent types and in more complex lesions are lacking. This article provides a review of currently available iliac stent technologies, as well as complex procedural aspects of iliac artery interventions, including approaches to the treatment of iliac bifurcation disease, long segment occlusions, choice of stent type, and treatment of iliac artery in-stent restenosis. PMID:27099509

Evolution of patency rates of self-expandable bare metal stents for endovascular treatment of femoro-popliteal arterial occlusive disease: Does stent design matter?

PubMed

Treitl, Karla Maria; Woerner, Benedikt; Schinner, Regina; Czihal, Michael; Notohamiprodjo, Susan; Hoffmann, Ulrich; Treitl, Marcus

2017-09-01

To analyse the patency rates of femoro-popliteal stenting with different self-expandable Nitinol stent-designs. Two hundred and twenty-two patients (142 (64%) male; age 72.4 ± 11.6 years) with symptomatic femoro-popliteal peripheral arterial occlusive disease (PAOD) underwent percutaneous transluminal angioplasty (PTA) and stenting with three different Nitinol stents (interwoven IW: n = 70; closed-cell CC: n = 85; open-cell OC: n = 67). One-year post-procedural target lesion revascularization (TLR_12M) rates were investigated with regard to co-morbidities: diabetes (DBM), hyperlipidaemia (HLP), hypertension (RR), coronary artery disease (CAD) and degree of calcification. Twelve-month follow-up data were available for 60, 69 and 50 patients in the IW, OC and CC groups (179 patients in total). The cumulative patency (IW: 52 (86.7%); OC: 50 (72.5%); CC: 23 (46.0%); P < 0.001) and the TLR_12M rates (IW: 8 (13.3%); OC: 19 (27.5%); CC: 27 (54.0%); P < 0.001) differed significantly, as did the subgroup analyses (DBM: P = 0.05; RR: P = 0.003; HLP: P = 0.005; CAD: P = 0.02; localization: P < 0.001; calcification: P < 0.001), with the best patency for the IW stent and the highest TLR_12M for the CC stent. The interwoven stent-design was superior to the standard open- and closed-cell stent-designs in endovascular treatment of femoro-popliteal PAOD in a follow-up period of 12 months. • Results of femoro-popliteal stenting are still unsatisfactory. • Comparative studies for currently available different Nitinol stent-designs are lacking. • This is a first comparative study on long-term patency of different Nitinol stent-designs. • Interwoven stent-design leads to improved long-term patency. • Interwoven stent-design leads to lower TLR than other stent-designs.

Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease).

PubMed

Lammer, Johannes; Zeller, Thomas; Hausegger, Klaus A; Schaefer, Philipp J; Gschwendtner, Manfred; Mueller-Huelsbeck, Stefan; Rand, Thomas; Funovics, Martin; Wolf, Florian; Rastan, Aljoscha; Gschwandtner, Michael; Puchner, Stefan; Ristl, Robin; Schoder, Maria

2013-10-08

The hypothesis that endovascular treatment with covered stents has equal risks but higher efficacy than bare-metal stents (BMS) in long femoropopliteal artery disease was tested. Although endovascular treatment of short superficial femoral artery lesions revealed excellent results, efficacy in long lesions remains unsatisfactory. In a prospective, randomized, single-blind, multicenter study, 141 patients with symptomatic peripheral arterial disease were assigned to treatment with heparin-bonded, covered stents (Viabahn 72 patients) or BMS (69 patients). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months. Mean ± SD lesion length was 19.0 ± 6.3 cm in the Viabahn group and 17.3 ± 6.6 cm in the BMS group. Major complications within 30 days were observed in 1.4%. The 12-month primary patency rates in the Viabahn and BMS groups were: intention-to-treat (ITT) 70.9% (95% confidence interval [CI]: 0.58 to 0.80) and 55.1% (95% CI: 0.41 to 0.67) (log-rank test p = 0.11); treatment per-protocol (TPP) 78.1% (95% CI: 0.65 to 0.86) and 53.5% (95% CI: 0.39 to 0.65) (hazard ratio: 2.23 [95% CI: 1.14 to 4.34) (log-rank test p = 0.009). In lesions ≥20 cm, (TransAtlantic Inter-Society Consensus class D), the 12-month patency rate was significantly longer in VIA patients in the ITT analysis (VIA 71.3% vs. BMS 36.8%; p = 0.01) and the TPP analysis (VIA 73.3% vs. BMS 33.3%; p = 0.004). Freedom from target lesion revascularization was 84.6% for Viabahn (95% CI: 0.72 to 0.91) versus 77.0% for BMS (95% CI: 0.63 to 0.85; p = 0.37). The ankle-brachial index in the Viabahn group significantly increased to 0.94 ± 0.23 compared with the BMS group (0.85 ± 0.23; p < 0.05) at 12 months. This randomized trial in symptomatic patients with peripheral arterial disease who underwent endovascular treatment for long femoropopliteal lesions demonstrated significant clinical and patency benefits for heparin-bonded covered stents compared with BMS in lesions ≥20 cm and for all lesions in the TPP analysis. In the ITT analysis for all lesions, which was flawed by major protocol deviations in 8.5% of the patients, the difference was not significant. (GORE VIABAHN® endoprosthesis with bioactive propaten surface versus bare nitinol stent in the treatment of TASC B, C and D lesions in superficial femoral artery occlusive disease; ISRCTN48164244). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Systematic Review of Infrapopliteal Drug-Eluting Stents: A Meta-Analysis of Randomized Controlled Trials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr; Spiliopoulos, Stavros; Diamantopoulos, Athanasios

2013-06-15

IntroductionDrug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES.Materials and MethodsPubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Primary endpoint was primary patency defined as absencemore » of {>=}50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford-Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel-Haenszel fixed effects model, and number-needed-to-treat values are reported.ResultsThree RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18-1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford-Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002-1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28-0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02-1.62, p = 0.04; NNT = 5.9), and better overall event-free survival (72.2 vs. 57.3 %; pooled RR = 1.26, 95 % CI = 1.10-1.44, p = 0.0006; NNT = 6.7). Conclusion. DES for focal infrapopliteal lesions significantly inhibit vascular restenosis and thereby improve primary patency, decrease repeat procedures, improve wound healing, and prolong overall event-free survival.« less

Paclitaxel-Eluting Balloon Versus Standard Balloon Angioplasty in In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Artery: 1-Year Results of the PACUBA Trial.

PubMed

Kinstner, Christian M; Lammer, Johannes; Willfort-Ehringer, Andrea; Matzek, Wolfgang; Gschwandtner, Michael; Javor, Domagoj; Funovics, Martin; Schoder, Maria; Koppensteiner, Renate; Loewe, Christian; Ristl, Robin; Wolf, Florian

2016-07-11

The hypothesis that paclitaxel-eluting balloon angioplasty provides higher 1-year patency rates in femoropopliteal artery in-stent restenosis compared with standard percutaneous transluminal angioplasty (PTA) was tested. Several trials have demonstrated that paclitaxel-eluting balloon angioplasty reduces late luminal loss in comparison with PTA. In a prospective, randomized, single-blind, dual-center study, 74 patients with symptomatic peripheral artery disease due to in-stent restenosis were treated with either paclitaxel-based drug-eluting balloon (DEB) angioplasty (n = 35) or standard PTA (n = 39). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months. The mean lesion length was 17.3 ± 11.3 cm in the DEB group and 18.4 ± 8.8 cm in the PTA group. A single major complication (bleeding) was observed once (1.4%). The mean ankle-brachial index before endovascular treatment was 0.65 ± 0.16 in both groups and 0.79 ± 0.2 versus 0.84 ± 0.3 (p = 0.70, Student t test) in the DEB versus PTA group at 12 months. The 12-month primary patency rates were 40.7% (95% confidence interval [CI]: 0.26 to 0.64) versus 13.4% (95% CI: 0.05 to 0.36) (log-rank p = 0.02) in the DEB versus PTA group. The odds ratio for PTA over DEB angioplasty for experiencing an event was estimated at 2.8 (95% CI: 1.2 to 6.6). Freedom from clinically driven target lesion revascularization was 49.0% (95% CI: 0.32 to 0.75) versus 22.1% (95% CI: 0.10 to 0.48) (log-rank p = 0.11) in the DEB versus PTA group. Clinical improvement by ≥1 Rutherford-Becker category was 68.8% versus 54.5% (p = 0.87) in the DEB versus PTA group at 12 months. When treating peripheral artery disease in patients with in-stent restenosis in the femoropopliteal artery, paclitaxel-eluting balloon angioplasty provides significantly higher patency rates than standard PTA. (Paclitaxel Balloon Versus Standard Balloon in In-Stent Restenoses of the Superficial Femoral Artery [PACUBA I Trial] [PACUBA 1]; NCT01247402). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Early Outcomes following Endovascular, Open Surgical, and Hybrid Revascularization for Lower Extremity Acute Limb Ischemia.

PubMed

Davis, Frank M; Albright, Jeremy; Gallagher, Katherine A; Gurm, Hitinder S; Koenig, Gerald C; Schreiber, Theodore; Grossman, P Michael; Henke, Peter K

2018-03-05

Acute limb ischemia (ALI) of the lower extremity is a potentially devastating condition that requires urgent and definitive management. This challenging scenario is often treated with endovascular, open surgical, or hybrid revascularization (HyR) in an urgent basis, but the comparative effects of such therapies remain poorly defined. The purpose of this study was to compare the outcomes of endovascular, open surgical, and HyR for ALI in the contemporary era. A large statewide cardiovascular consortium of 45 hospitals was queried for patients between January 2012 and June 2015 who underwent an endovascular, open surgical, or HyR for ALI deemed at high risk of limb loss if not treated within 24 hr (Rutherford class IIA or IIB). A propensity score weighted analysis was performed controlling for demographics, medical history, and procedure type for patients. The primary outcomes were 30-day morbidity and mortality. A total of 1,480 patients underwent endovascular revascularization (ER; n = 818), open surgical revascularization (OSR; n = 195), or hybrid revascularization (HyR; n = 467) for ALI. The mean age was similar across revascularization technique with an increased predominance of male gender in open surgery cohort. Comorbidities for all groups were consistent with peripheral arterial disease. The most common endovascular procedures were angioplasty (93%) and thrombolysis (49.8%), whereas the most common surgical revascularization was femoral to popliteal bypass (32.8%), femoral to tibial bypass (28.2%), and thrombectomy (19.0%); ER as compared with OSR and HyR procedures was associated with less transfusion (OSR versus ER, odds ratio [OR] 2.7; HyR versus ER, OR 2.8; P < 0.001) and major amputation (OSR versus ER, OR 3.4; HyR versus ER, OR 4.0; P < 0.001) within 30 days of intervention. There was no difference in 30-day freedom from reintervention, myocardial infarction (MI), or mortality. Among patients requiring urgent revascularization for Rutherford grade IIA and IIB ischemia, ER has lower 30-day morbidity but similar mortality and rates of reintervention. Although long-term patency rates were not compared, ER may offer superior short-term outcomes compared with open surgery and hybrid revascularization. Copyright © 2018 Elsevier Inc. All rights reserved.

Independence and mobility after infrainguinal lower limb bypass surgery for critical limb ischemia.

PubMed

Ambler, Graeme K; Dapaah, Andrew; Al Zuhir, Naail; Hayes, Paul D; Gohel, Manjit S; Boyle, Jonathan R; Varty, Kevin; Coughlin, Patrick A

2014-04-01

Critical limb ischemia (CLI) is a common condition associated with high levels of morbidity and mortality. Most work to date has focused on surgeon-oriented outcomes such as patency, but there is increasing interest in patient-oriented outcomes such as mobility and independence. This study was conducted to determine the effect of infrainguinal lower limb bypass surgery (LLBS) on postoperative mobility in a United Kingdom tertiary vascular surgery unit and to investigate causes and consequences of poor postoperative mobility. We collected data on all patients undergoing LLBS for CLI at our institution during a 3-year period and analyzed potential factors that correlated with poor postoperative mobility. During the study period, 93 index LLBS procedures were performed for patients with CLI. Median length of stay was 11 days (interquartile range, 11 days). The 12-month rates of graft patency, major amputation, and mortality were 75%, 9%, and 6%, respectively. Rates of dependence increased fourfold during the first postoperative year, from 5% preoperatively to 21% at 12 months. Predictors of poor postoperative mobility were female sex (P = .04) and poor postoperative mobility (P < .001), initially and at the 12-month follow-up. Patients with poor postoperative mobility had significantly prolonged hospital length of stay (15 vs 8 days; P < .001). Patients undergoing LLBS for CLI suffer significantly impaired postoperative mobility, and this is associated with prolonged hospital stay, irrespective of successful revascularization. Further work is needed to better predict patients who will benefit from revascularization and in whom a nonoperative strategy is optimal. Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Paclitaxel Drug-Eluting Stents in Peripheral Arterial Disease: A Health Technology Assessment

PubMed Central

2015-01-01

Background Peripheral arterial disease is a condition in which atherosclerotic plaques partially or completely block blood flow to the legs. Although percutaneous transluminal angioplasty and metallic stenting have high immediate success rates in treating peripheral arterial disease, long-term patency and restenosis rates in long and complex lesions remain unsatisfactory. Objective The objective of this analysis was to evaluate the clinical effectiveness, safety, cost-effectiveness and budget impact of Zilver paclitaxel self-expanding drug-eluting stents for the treatment of de novo or restenotic lesions in above-the-knee peripheral arterial disease. Data Sources Literature searches were performed using Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid Embase, EBSCO Cumulative Index to Nursing & Allied Health Literature (CINAHL), and EBM Reviews. For the economic review, a search filter was applied to limit search results to economics-related literature. Data sources for the budget impact analysis included expert opinion, published literature, and Ontario administrative data. Review Methods Systematic reviews, meta-analyses, randomized controlled trials, and observational studies were included in the clinical effectiveness review, and full economic evaluations were included in the economic literature review. Studies were included if they examined the effect of Zilver paclitaxel drug-eluting stents in de novo or restenotic lesions in above-the-knee arteries. For the budget impact analysis, 3 scenarios were constructed based on different assumptions. Results One randomized controlled trial reported a significantly higher patency rate with Zilver paclitaxel drug-eluting stents for lesions ≤ 14 cm than with angioplasty or bare metal stents. One observational study showed no difference in patency rates between Zilver paclitaxel drug-eluting stents and paclitaxel drug-coated balloons. Zilver paclitaxel drug-eluting stents were associated with a significantly higher event-free survival rate than angioplasty, but the event-free survival rate was similar for Zilver paclitaxel drug-eluting stents and paclitaxel drug-coated balloons. No economic evaluations compared Zilver paclitaxel drug-eluting stents with bare metal stents or angioplasty for peripheral arterial disease. A budget impact analysis showed that the cost savings associated with funding of Zilver paclitaxel drug-eluting stents would be $470,000 to $640,000 per year, assuming that the use of the Zilver paclitaxel drug-eluting stent was associated with a lower risk of subsequent revascularization. Conclusions Based on evidence of low to moderate quality, Zilver paclitaxel drug-eluting stents were associated with a higher patency rate than angioplasty or bare metal stents, and with fewer adverse events than angioplasty. The effectiveness and safety of Zilver paclitaxel drug-eluting stents and paclitaxel drug-coated balloons were similar. PMID:26719778

PEACE I all-comers registry: patency evaluation after implantation of the 4-French Pulsar-18 self-expanding nitinol stent in femoropopliteal lesions.

PubMed

Lichtenberg, Michael; Kolks, Oliver; Hailer, Birgit; Stahlhoff, Wilhelm-Friedrich; Tiefenbacher, Christiane; Nolte-Ernsting, Claus; Arjumand, Jawed; Wittenberg, Guenther

2014-06-01

To evaluate the 1-year patency of the 4-F Pulsar-18 self-expanding nitinol stent for treatment of femoropopliteal occlusive disease in a national, prospective, multicenter, all-comers registry. Between January and June 2012, the German PEACE I all-comers prospective registry enrolled 148 patients with symptomatic femoropopliteal lesions (Rutherford category 2-5) undergoing recanalization and implantation of the Pulsar-18 SE nitinol stent at 6 clinical centers. Thirty patients did not have the 12-month follow-up visit (18 declined reevaluation, 5 withdrew consent, and 7 died), leaving 118 patients (64 men; mean 71.9±9.6 age years) for the 1-year evaluation. The average lesion length was 111.5±71.4 mm, and 38 of the 118 lesions were classified as TASC II D. More than half the lesions (67, 56.7%) were chronic total occlusions (CTO). The popliteal segment was involved in 22 (18.7%) lesions. The mean stented length was 122.7±64.5 mm. Routine follow-up included duplex ultrasound at 6 and 12 months. Outcome measures were primary patency and no clinically driven target lesion revascularization (TLR) within 12 months. The overall primary patency rates after 6 and 12 months were 87.4% and 79.5%, respectively; in the popliteal segments, the rate was 71.4% after 12 months. The overall freedom from TLR was 93.2% after 6 months and 81% after 12 months. Ankle-brachial index, pain-free walking distance, and Rutherford category all improved significantly (p<0.0001) after 6 and 12 months. The primary patency rates in patients with diabetes (p=1.0) and those with renal insufficiency (p=0.8) were not significantly lower compared to the overall rate. There was no significant difference (p=0.67) in restenosis rate for recanalization of CTOs compared to non-CTO lesions. In this all-comers registry, the use of the Pulsar-18 self-expanding nitinol stent in femoropopliteal lesions averaging 111.5 mm long showed promising primary patency and freedom from TLR after 6 and 12 months. Diabetes had no negative impact on patency. Primary patency in the popliteal segments was acceptable at 12 months.

Randomized Trial of Complete Versus Lesion-Only Revascularization in Patients Undergoing Primary Percutaneous Coronary Intervention for STEMI and Multivessel Disease

PubMed Central

Gershlick, Anthony H.; Khan, Jamal Nasir; Kelly, Damian J.; Greenwood, John P.; Sasikaran, Thiagarajah; Curzen, Nick; Blackman, Daniel J.; Dalby, Miles; Fairbrother, Kathryn L.; Banya, Winston; Wang, Duolao; Flather, Marcus; Hetherington, Simon L.; Kelion, Andrew D.; Talwar, Suneel; Gunning, Mark; Hall, Roger; Swanton, Howard; McCann, Gerry P.

2015-01-01

Background The optimal management of patients found to have multivessel disease while undergoing primary percutaneous coronary intervention (P-PCI) for ST-segment elevation myocardial infarction is uncertain. Objectives CvLPRIT (Complete versus Lesion-only Primary PCI trial) is a U.K. open-label randomized study comparing complete revascularization at index admission with treatment of the infarct-related artery (IRA) only. Methods After they provided verbal assent and underwent coronary angiography, 296 patients in 7 U.K. centers were randomized through an interactive voice-response program to either in-hospital complete revascularization (n = 150) or IRA-only revascularization (n = 146). Complete revascularization was performed either at the time of P-PCI or before hospital discharge. Randomization was stratified by infarct location (anterior/nonanterior) and symptom onset (≤3 h or >3 h). The primary endpoint was a composite of all-cause death, recurrent myocardial infarction (MI), heart failure, and ischemia-driven revascularization within 12 months. Results Patient groups were well matched for baseline clinical characteristics. The primary endpoint occurred in 10.0% of the complete revascularization group versus 21.2% in the IRA-only revascularization group (hazard ratio: 0.45; 95% confidence interval: 0.24 to 0.84; p = 0.009). A trend toward benefit was seen early after complete revascularization (p = 0.055 at 30 days). Although there was no significant reduction in death or MI, a nonsignificant reduction in all primary endpoint components was seen. There was no reduction in ischemic burden on myocardial perfusion scintigraphy or in the safety endpoints of major bleeding, contrast-induced nephropathy, or stroke between the groups. Conclusions In patients presenting for P-PCI with multivessel disease, index admission complete revascularization significantly lowered the rate of the composite primary endpoint at 12 months compared with treating only the IRA. In such patients, inpatient total revascularization may be considered, but larger clinical trials are required to confirm this result and specifically address whether this strategy is associated with improved survival. (Complete Versus Lesion-only Primary PCI Pilot Study [CvLPRIT]; ISRCTN70913605) PMID:25766941

Extra-Anatomic Revascularization of Extensive Coral Reef Aorta.

PubMed

Gaggiano, Andrea; Kasemi, Holta; Monti, Andrea; Laurito, Antonella; Maselli, Mauro; Manzo, Paola; Quaglino, Simone; Tavolini, Valeria

2017-10-01

Coral reef aorta (CRA) is a rare, potential lethal disease of the visceral aorta as it can cause visceral and renal infarction. Various surgical approaches have been proposed for the CRA treatment. The purpose of this article is to report different extensive extra-anatomic CRA treatment modalities tailored on the patients' clinical and anatomic presentation. From April 2006 to October 2012, 4 symptomatic patients with extensive CRA were treated at our department. Extra-anatomic aortic revascularization with selective visceral vessels clamping was performed in all cases. Technical success was 100%. No perioperative death was registered. All patients remained asymptomatic during the follow-up period (62, 49, 25, and 94 months, respectively), with bypasses and target vessels patency. The extra-anatomic bypass with selective visceral vessels clamping reduces the aortic occlusion time and the risk of organ ischemia. All approaches available should be considered on a case-by-case basis and in high-volume centers. Copyright © 2017 Elsevier Inc. All rights reserved.

Impact of percutaneous coronary intervention on biomarker levels in patients in the subacute phase following myocardial infarction: the Occluded Artery Trial (OAT) biomarker ancillary study

PubMed Central

2013-01-01

Background The purpose of the Occluded Artery Trial (OAT) Biomarker substudy was to evaluate the impact of infarct related artery (IRA) revascularization on serial levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) and dynamics of other biomarkers related to left ventricular remodeling, fibrosis and angiogenesis. Methods Patients were eligible for OAT-Biomarker based on the main OAT criteria. Of 70 patients (age 60.8 ± 8.8, 25% women) enrolled in the substudy, 37 were randomized to percutaneous coronary intervention (PCI) and 33 to optimal medical therapy alone. Baseline serum samples were obtained prior to OAT randomization with follow up samples taken at one year. The primary outcome was percent change of NT-proBNP from baseline to 1 year. The secondary outcomes were respective changes of matrix metalloproteinases (MMP) 2 and 9, tissue inhibitor of matrix metalloproteinase 2 (TIMP-2), Vascular Endothelial Growth Factor (VEGF), and Galectin-3. Results Paired (baseline and one-year) serum samples were obtained in 62 subjects. Baseline median NT-proBNP level was 944.8 (455.3, 1533) ng/L and decreased by 69% during follow-up (p < 0.0001). Baseline MMP-2 and TIMP-2 levels increased significantly from baseline to follow-up (p = 0.034, and p = 0.027 respectively), while MMP-9 level decreased from baseline (p = 0.038). Levels of VEGF and Galectin-3 remained stable at one year (p = NS for both). No impact of IRA revascularization on any biomarker dynamics were noted. Conclusions There were significant changes in measured biomarkers related to LV remodeling, stress, and fibrosis following MI between 0 and 12 month. Establishing infarct vessel patency utilizing stenting 24 hours-28 days post MI did not however influence the biomarkers’ release. PMID:24156746

Antireflux Versus Conventional Plastic Stent in Malignant Biliary Obstruction: A Prospective Randomized Study.

PubMed

Vihervaara, Hanna; Grönroos, Juha M; Hurme, Saija; Gullichsen, Risto; Salminen, Paulina

2017-01-01

Endoscopic stents are used to relieve obstructive jaundice. The purpose of this prospective randomized study was to compare the patency of antireflux and conventional plastic biliary stent in relieving distal malignant biliary obstruction. All jaundiced patients admitted to hospital with suspected unresectable malignant distal biliary stricture between October 2009 and September 2010 were evaluated for the study. Eligible patients were randomized either to antireflux or conventional plastic stent arms. The primary endpoint was stent patency and the follow-up was continued either until the stent was occluded or until 6 months after the stent placement. At an interim analysis, antireflux stents (ARSs; n = 6) had a significantly shorter median patency of 34 (8-49) days compared with the conventional stent (n = 7) patency of 167 (38-214) days (P = .0003). Based on these results, the study was terminated due to ethical concerns. According to these results, the use of this ARS is not recommended.

Effect of maintaining apical patency on endodontic pain in posterior teeth with pulp necrosis and apical periodontitis: a randomized controlled trial.

PubMed

Arora, M; Sangwan, P; Tewari, S; Duhan, J

2016-04-01

To evaluate the association between apical patency and post-operative pain in posterior teeth with pulp necrosis and apical periodontitis. Sixty-eight patients requiring primary root canal treatment in mandibular first molars with necrotic pulps and apical periodontitis were included. The patients were randomly allocated to one of two groups: patency (n = 34) and nonpatency (n = 34). After administering local anaesthesia, root canal preparation was completed using ProTaper rotary instruments. A size 10 K-file was used as a patency file and carried 1 mm beyond the working length (WL) between each instrument change in the patency group, while it was carried up to WL in the nonpatency group. Patients were asked to record their pain experience on a pain chart daily for 7 days. Three patients (two in the patency group, one in the nonpatency group) did not return with completed pain charts on the subsequent visit, resulting in a total of 65 patients for the final analysis (patency, n = 32; nonpatency, n = 33). Data was analysed using Chi Square test, t-test, Mann-Whitney test and Wilcoxon Signed Ranks test. Overall, 43% of the patients experienced post-operative pain. The patency group had less incidence of pain (34%) as compared to the nonpatency group (52%), but the difference was not significant (P = 0.163). Maintenance of apical patency during chemomechanical preparation had no significant influence on post-operative pain in posterior teeth with necrotic pulps and apical periodontitis. © 2015 International Endodontic Journal. Published by John Wiley & Sons Ltd.

FFR-guided multivessel stenting reduces urgent revascularization compared with infarct-related artery only stenting in ST-elevation myocardial infarction: A meta-analysis of randomized controlled trials.

PubMed

Gupta, Ankur; Bajaj, Navkaranbir S; Arora, Pankaj; Arora, Garima; Qamar, Arman; Bhatt, Deepak L

2018-02-01

Randomized controlled trials (RCTs) have shown fractional flow reserve-guided (FFR) multivessel stenting to be superior to infarct-related artery (IRA) only stenting in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease. This effect was mainly driven by a reduction in overall repeat revascularization. However, the ability to assess the effect of this strategy on urgent revascularization or reinfarction was underpowered in individual trials. We searched Pubmed, EMBASE, Cochrane CENTRAL, and Web of Science for RCTs of FFR-guided multivessel stenting versus IRA-only stenting in STEMI with multivessel disease. The outcomes of interest were death, reinfarction, urgent, and non-urgent repeat revascularization. Risk ratios (RR) were pooled using the DerSimonian and Laird random-effects model. After review of 786 citations, 2 RCTs were included. The pooled results demonstrated a significant reduction in the composite of death, reinfarction, or revascularization in the FFR-guided multivessel stenting group versus IRA-only stenting group (RR [95%, Confidence Interval]: 0.49 [0.33-0.72], p<0.001). This risk reduction was driven mainly by a reduction in repeat revascularization, both urgent (0.41 [0.24-0.71], p=0.002) and non-urgent revascularization (0.31 [0.19-0.50], p<0.001). Pooled RR for reinfarction was lower in the FFR-guided strategy, but was not statistically significant (0.71[0.39-1.31], p=0.28). This systematic review and meta-analysis suggests that a strategy of FFR-guided multivessel stenting in STEMI patients reduces not only overall repeat revascularization but also urgent revascularization. The effect on reinfarction needs to be evaluated in larger trials. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Comparison of TR Band™ and VasoStat™ Hemostasis Devices following Transpedal Catheterization for Lower Extremity Revascularization for Peripheral Arterial Disease.

PubMed

Kwan, Tak W; Patel, Apurva; Parikh, Roosha; Auguste, Uschi; Rosero, Hugo; Huang, Yili; Liou, Michael; Ratcliffe, Justin; Puma, Joseph

2016-08-01

Transpedal access is increasingly utilized for peripheral vascular catheterization. There is a paucity of data on the use of radial hemostasis devices as an alternative to manual compression for achievement of hemostasis after this approach. To compare safety and efficacy of two hemostasis devices following transpedal catheterization for lower extremity revascularization for peripheral arterial disease. A consecutive cohort of patients with bilateral Rutherford 2-5 disease who underwent transpedal catheterization for peripheral vascular interventions were retrospectively analyzed. In each patient, retrograde tibial artery access was obtained, a 4 French sheath was placed, and all revascularization was performed via tibial access. In all patients, a TR Band™ (Terumo Medical, n = 215) and/or VasoStat™ (Forge Medical, n = 99) were used to apply puncture site compression, following removal of the tibial sheath until hemostasis was achieved. Safety and efficacy of each device was compared. Puncture site hemostasis was achieved in all patients within 2 hours of sheath removal facilitating early discharge. Two access site pseudoaneurysms occurred within 30 days of revascularization, one of which followed TR Band™ placement and the other following VasoStat™ placement (P = 0.53). Each patient was successfully treated with ultrasound-guided thrombin injection. Loss of access site patency by duplex ultrasound occurred in 2 patients following the TR Band™ and a single patient following the VasoStat™ (P = 1.0). Both the TR Band™ and the VasoStat™ were effective in achieving hemostasis following transpedal catheterization with low rates of complications. © 2016, Wiley Periodicals, Inc.

Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Isolated Popliteal Artery Lesions.

PubMed

Stavroulakis, Konstantinos; Schwindt, Arne; Torsello, Giovanni; Stachmann, Arne; Hericks, Christiane; Bosiers, Michel J; Beropoulis, Efthymios; Stahlhoff, Stefan; Bisdas, Theodosios

2017-04-01

To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery. Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR). The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99). In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively.

Factors affecting primary patency of stenting for TransAtlantic Inter-Society (TASC II) type B, C, and D iliac occlusive disease.

PubMed

Kavaliauskienė, Zana; Benetis, Rimantas; Inčiūra, Donatas; Aleksynas, Nerijus; Kaupas, Rytis Stasys; Antuševas, Aleksandras

2014-01-01

The purpose of our study was to evaluate 1- and 2-year results and the influence of risk factors on the outcome in the patients undergoing iliac artery stenting for TASC II type B, C, and D iliac lesions. In this prospective nonrandomized study conducted between April 15, 2011, and April 15, 2013, 316 patients underwent angiography with a diagnosis of aortoiliac atherosclerotic disease. Of these, 62 iliac endovascular procedures (87 stents) were performed in 54 patients. The indications for revascularization were disabling claudication (Rutherford 2, 5.9%; Rutherford 3, 35.2%), rest pain (Rutherford 4, 22.2%), and gangrene (Rutherford 5, 16.7%). The overall complication rate was 9.2%. The cumulative primary stent patency at 1 and 2 years was 83.0%±5.2% and 79.9%±5.8%, respectively. Early stent thrombosis in ≤30 days was detected in two patients (3.7%). The primary patency rates for the stents ≤61mm at 12 and 24 months were 90.6%±4.5% and 86.6%±5.8%, respectively; those for the stents >61mm were 67.7%±10.9% and 60.2%±12.0%, respectively (P=0.016). The multivariate Cox regression analysis enabled the localization of a stent in both the CIA and the EIA (hazard ratio [HR], 3.3; 95% confidence interval [CI], 1.1-9.5; P=0.021) and poor runoff (HR, 3.2; 95%, CI 1.0-10.0; P=0.047) as independent predictors of decreased stent primary patency. The localization of a stent in both iliac (CIA and EIA) arteries and poor runoff significantly reduce the primary stent patency. Patients with stents >61mm have a higher risk of stent thrombosis or in-stent restenosis development. Copyright © 2014 Lithuanian University of Health Sciences. Production and hosting by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

Gender related Long-term Differences after Open Infrainguinal Surgery for Critical Limb Ischemia.

PubMed

Lejay, A; Schaeffer, M; Georg, Y; Lucereau, B; Roussin, M; Girsowicz, E; Delay, C; Schwein, A; Thaveau, F; Geny, B; Chakfe, N

2015-10-01

The role of gender on long-term infrainguinal open surgery outcomes still remains uncertain in critical limb ischemia patients. The aim of this study is to evaluate the gender-specific differences in patient characteristics and long-term clinical outcomes in terms of survival, primary patency and limb salvage among patients undergoing infrainguinal open surgery for CLI. All consecutive patients undergoing infrainguinal open surgery for critical limb ischemia between 2003 and 2012 were included. Survival, limb salvage and primary patency rates were assessed. Independent outcome determinants were identified by the Cox proportional hazard ratio using age and gender as adjustment factors. 584 patients (269 women and 315 men, mean age 76 and 71 years respectively) underwent 658 infrainguinal open surgery (313 in women and 345 in men). Survival rate at 6 years was lower among women compared to men with 53.5% vs 70.9% (p < 0.001). The same applied to primary patency (35.9% vs 52.4%, p < 0.001) and limb salvage (54.3% vs 81.1%, p < 0.001) at 6 years. Female-gender was an independent factor predicting death (hazard ratio 1.50), thrombosis (hazard ratio 2.37) and limb loss (hazard ratio 7.05) in age and gender-adjusted analysis. Gender-related disparity in critical limb ischemia open surgical revascularization outcomes still remains. Copyright © 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Hybrid Therapy in Patients with Complex Peripheral Multifocal Steno-obstructive Vascular Disease: Two-Year Results

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cotroneo, Antonio Raffaele; Iezzi, Roberto; Marano, Giuseppe

2007-06-15

Purpose. To report the 2-year results after hybrid (combined surgical-endovascular) therapy in patients with complex peripheral multifocal steno-obstructive vascular disease. Methods. From September 2001 through April 2003, 47 combined surgical-endovascular procedures were performed in a single session in 44 patients with peripheral occlusive artery disease. Although the common femoral artery is usually treated with open surgery, endoluminal procedures were performed upward in 23 patients (group A), distally in 18 patients (group B), and both upward and downward of the area treated with open surgery in 3 patients (group C). Patients underwent clinical assessment and color duplex ultrasonography examination at 1,more » 3, 6, 12, 18, and 24 months after the procedure. Results. The technical success rate was 100%. Two patients died, at 2 and 19 months after treatment, respectively, both from myocardial infarction. Primary and primary-assisted patency rates were 86.2% and 90.8% at 6 months and 79.1% and 86.1% at 24 months, respectively. Thirty-three patients remained free of symptoms, without any secondary interventions, which corresponded to a primary patency rate of 78.6% (33 of 42). Conclusion. Combined therapy simplifies and allows the one-step treatment of patients with complex peripheral multifocal steno-obstructive vascular disease that has indications for revascularization, and it provides excellent long-term patency rates.« less

Results of Infrageniculate Bypasses Using the Profunda Femoris Artery as Inflow Source.

PubMed

Illuminati, Giulio; Calio', Francesco G; Pizzardi, Giulia; Pasqua, Rocco; Masci, Federica; Frezzotti, Francesca; Palumbo, Piergaspare; Vietri, Francesco

2018-02-01

When the common femoral artery is not accessible for infrainguinal bypass grafting, the profunda femoris artery (PFA) can be a valuable alternative inflow source for distal arterial revascularization. The purpose of this retrospective study was to evaluate the results of infrageniculate bypass grafting via the PFA as inflow source for critical limb ischemia. Between 1994 and 2016, 68 patients, 51 men of a mean age of 74 years, underwent an infrageniculate arterial bypass grafting for critical limb ischemia, using the PFA as inflow site. PFA was exposed at the Scarpa's triangle in 38 patients (56%) and at its medio-crural segment in 30 patients (44%). The distal anastomosis was performed on the infragenicular popliteal artery in 33 patients (48%), the peroneal artery in 14 patients (20%), the tibioperoneal trunk in 8 patients (12%), the posterior tibial artery in 8 patients (12%), and the dorsalis pedis artery in 5 patients (8%). The graft material consisted of a reversed great saphenous vein (GSV) in 62 patients (91%) and a 6-mm polytetrafluoroethylene graft in 6 patients (9%). The median duration of follow-up was 51 months (range, 6-72 months). As main results, postoperative mortality and morbidity, overall late patients' survival, primary grafts' patency, and limb salvage rate were considered. Operative mortality and morbidity were 3% and 4%, respectively. Overall patients' survival, primary patency and limb salvage rate, at 36 and 60 months were, respectively, 62% and 53%, 66% and 59%, and 92% and 77%. The PFA, both exposed at the Scarpa's triangle and at mid-thigh, is an excellent inflow source for infrageniculate revascularizations. It should remain an important part of the technical armamentarium of vascular surgeons, even in the endovascular era. Copyright © 2017 Elsevier Inc. All rights reserved.

Coronary bypass graft patency in patients with diabetes in the Bypass Angioplasty Revascularization Investigation (BARI).

PubMed

Schwartz, Leonard; Kip, Kevin E; Frye, Robert L; Alderman, Edwin L; Schaff, Hartzell V; Detre, Katherine M

2002-11-19

Few studies have compared long-term status of bypass grafts between patients with and without diabetes, and uncertainty exists as to whether diabetes independently predicts poor clinical outcome after CABG. Among 1526 patients in BARI who underwent CABG as initial revascularization, 99 of 292 (34%) with treated diabetes mellitus (TDM) (those on insulin or oral hypoglycemic agents) and 469 of 1234 (38%) without TDM had follow-up angiography. Angiograms with the longest interval from initial surgery and before any percutaneous graft intervention (mean 3.9 years) were reviewed. An average of 3.0 grafts were placed at initial CABG for patients with TDM (n=297; internal mammary artery [IMA], 33%) and 2.9 grafts for patients without TDM (n=1347; IMA, 34%). Patients with TDM were more likely than those without to have small (<1.5 mm) grafted distal vessels (29% versus 22%) and vessels of poor quality (9% versus 6%). On follow-up angiography, 89% of IMA grafts were free of stenoses > or =50% among patients with TDM versus 85% among patients without TDM (P=0.23). For vein grafts, the corresponding percentages were 71% versus 75% (P=0.40). After statistical adjustment, TDM was unrelated to having a graft stenosis > or =50% (adjusted odds ratio, 0.87; 95% CI, 0.58 to 1.32). Despite diabetic patients' having smaller distal vessels and vessels judged to be of poorer quality, diabetes does not appear to adversely affect patency of IMA or vein grafts over an average of 4-year follow-up. Previously observed differences in survival between CABG-treated patients with and without diabetes may be largely a result of differential risk of mortality from noncardiac causes.

Initial Experience with the E-liac® Iliac Branch Device for the Endovascular Aortic Repair of Aorto-iliac Aneurysm.

PubMed

Anton, Susanne; Wiedner, Marcus; Stahlberg, Erik; Jacob, Fabian; Barkhausen, Jörg; Goltz, Jan Peter

2018-05-01

Occlusion of internal iliac arteries during endovascular treatment (EVAR) of abdominal aortic (AAA) and common iliac artery aneurysms might be associated with ischemic pelvic complications. This study evaluates technical and clinical success, safety and mid-term results of a novel iliac branch device (IBD) for revascularization of the internal iliac artery (IIA) during EVAR. Retrospectively, we identified 21 men (mean age 73.3 ± 6.2 years) treated for aorto-iliac aneurysms by use of a novel IBD (E-liac ® , Jotec Hechingen, Germany). We analyzed safety (30-day survival), technical (no type I and III endoleaks, "EL"), clinical (no ischemic complications) success, mid-term patency of this IBD, peri-procedural complications, occurrence of type II ELs, rate of re-interventions and additional treatment of the revascularized IIA for landing zone preparation. Twenty-three IBDs were implanted. Aneurysms of the ipsilateral IIA were present in 6/23 IIAs (26.1%). Super-selective branch embolization was performed in these patients and the landing zone for the iliac sidebranch stent-graft was within the superior gluteal artery. Mean follow-up was 341 days (range 4-1103 days). Technical success and 30-day survival were 100%. Clinical success was 95.2%. Primary patency of the IBDs was 100% at 12 months. Peri-procedural complications occurred in 3/21 patients (14.3%), none of them related to the IBD. AAA-related type II ELs were found in 6 patients (28.6%), IBD-related ELs in 4/23 IBDs (17.4%) (two type Ib, two type II endoleaks). Overall re-intervention rate was 23.8%, IBD-related 8.7%. Utilization of the E-liac ® IBD is safe and effective for the treatment of aorto-iliac aneurysms.

Angiographic flow grading and graft arrangement of arterial conduits.

PubMed

Nakajima, Hiroyuki; Kobayashi, Junjiro; Tagusari, Osamu; Niwaya, Kazuo; Funatsu, Toshihiro; Kawamura, Atsushi; Yagihara, Toshikatsu; Kitamura, Soichiro

2006-11-01

We sought to delineate the effects of competitive and reverse flow on the intermediate-term patency of arterial conduits and examined graft arrangements for maximizing antegrade bypass flow. The angiograms of 2083 bypass grafts in 570 patients who underwent off-pump total arterial revascularization without aortic manipulation since December 2000 were reviewed. The blood flow in the bypass grafts were graded A (antegrade), B (competitive), C (reverse), or O (occlusion). The mean number of distal anastomoses was 3.65 +/- 0.94 per patient. In the early angiography 91.3% (1901/2083) of the bypasses were grade A. Thirty (1.4%) bypasses were grade O, whereas 2.9% (61/2083) were grade B, and 4.4%(91/2083) were grade C. In the multivariate analysis the end-to-side anastomosis (P < .0001), 4 or more distal anastomoses of the conduit (P = .01), native coronary stenosis of less than 75% (P < .0001), and target branch location of the right coronary artery territory (P < .0001) and left circumflex artery territory (P = .02) significantly correlated with grade non-A. The patency rate in the late angiography of the bypasses graded B or C in the early angiography was 7 (28.0%) of 25, whereas that of the bypasses graded A was 164 (89.1%) of 184 (P < .0001). The actuarial graft patency rate of the bypasses graded A was 72.3% at 3 years and was significantly higher than that of the bypasses graded B or C (28.6% at 3 years after surgical intervention, P < .0001). The sufficient antegrade bypass flow had a favorable effect on the graft patency of arterial conduits. The graft arrangement should be adjusted for each patient so as to maximize the antegrade bypass flow and to confirm the advantage of arterial grafts.

A Comparison of Clinical Outcomes for Diabetic and Nondiabetic Patients Following Directional Atherectomy in the DEFINITIVE LE Claudicant Cohort.

PubMed

Garcia, Lawrence A; Jaff, Michael R; Rocha-Singh, Krishna J; Zeller, Thomas; Bosarge, Christopher; Kamat, Suraj; McKinsey, James F

2015-10-01

To report a subset analysis that evaluated the hypothesis that directional atherectomy for peripheral artery disease in diabetic claudicants has noninferior primary patency at 12 months compared with nondiabetic claudicants. DEFINITIVE LE, a US/European multicenter study, assessed the effectiveness of directional atherectomy using SilverHawk/TurboHawk systems for treatment of peripheral artery disease in the superficial femoral, popliteal, and infrapopliteal arteries. Of the 800 patients enrolled in the study, only the 598 claudicant patients (mean age 69.5±10.4 years; 336 men) who were classified at baseline as Rutherford category 1-3 were eligible for this subset analysis. Of these, 46.8% (280/598) had diabetes. Follow-up to 12 months included duplex ultrasound examination, functional assessments, and adverse event evaluations. Independent angiographic and duplex ultrasound core laboratories assessed primary patency and secondary endpoints; a clinical events committee adjudicated adverse events. Although diabetics had significantly more baseline comorbidities, 12-month primary patency (77.0%) was no different than for nondiabetics (77.9%; superiority p=0.98; noninferiority p<0.001) across all anatomic territories treated. Freedom from clinically driven target lesion revascularization was no different between diabetics (83.8%) and nondiabetics (87.5%) overall (p=0.19) or by lesion locations. Secondary clinical outcomes (Rutherford category, ankle-brachial index, and walking impairment) improved at 12 months for both diabetics and nondiabetics. Noninferior 12-month patency rates demonstrate that directional atherectomy is an effective treatment in diabetic as well as nondiabetic claudicants. Directional atherectomy remains an attractive treatment option, improving luminal diameters without stents, which preserves future treatment options for both diabetic and nondiabetic patients with progressive, diffuse vascular disease. © The Author(s) 2015.

Robotic-assisted coronary artery bypass surgery: an 18-year single-centre experience.

PubMed

Giambruno, Vincenzo; Chu, Michael W; Fox, Stephanie; Swinamer, Stuart A; Rayman, Reiza; Markova, Zarina; Barnfield, Rebecca; Cooper, Mitchell; Boyd, Douglas W; Menkis, Alan; Kiaii, Bob

2018-06-01

Minimally invasive robot-assisted direct coronary artery bypass (RADCAB) has emerged as a feasible minimally invasive surgical technique for revascularization that might offer several potential advantages over conventional approaches. We present our 18-year experience in RADCAB. Between February 1998 and February 2016, 605 patients underwent RADCAB. Patients underwent post-procedural selective graft patency assessment using cardiac catheterization. The mortality rate was 0.3%. The rate of conversion to sternotomy for any cause was reduced from 16.0% of the first 200 cases to 6.9% of the last 405 patients. The patency rate of the LITA-to-LAD anastomosis was 97.4%. Surgical re-exploration for bleeding occurred in 1.8% of patients, and the transfusion rate was 9.2%. Average ICU stay was 1.2 ± 1.4 days, and average hospital stay was 4.8 ± 2.9 days. Robot-assisted coronary artery bypass grafting is safe, feasible and it seems to represent an effective alternative to traditional coronary artery bypass grafting in selected patients. Copyright © 2018 John Wiley & Sons, Ltd.

Stent revascularization restores cortical blood flow and reverses tissue hypoxia in atherosclerotic renal artery stenosis but fails to reverse inflammatory pathways or glomerular filtration rate.

PubMed

Saad, Ahmed; Herrmann, Sandra M S; Crane, John; Glockner, James F; McKusick, Michael A; Misra, Sanjay; Eirin, Alfonso; Ebrahimi, Behzad; Lerman, Lilach O; Textor, Stephen C

2013-08-01

Atherosclerotic renal artery stenosis (ARAS) is known to reduce renal blood flow, glomerular filtration rate (GFR) and amplify kidney hypoxia, but the relationships between these factors and tubulointerstitial injury in the poststenotic kidney are poorly understood. The purpose of this study was to examine the effect of renal revascularization in ARAS on renal tissue hypoxia and renal injury. Inpatient studies were performed in patients with ARAS (n=17; >60% occlusion) before and 3 months after stent revascularization, or in patients with essential hypertension (n=32), during fixed Na(+) intake and angiotensin converting enzyme/angiotensin receptors blockers Rx. Single kidney cortical, medullary perfusion, and renal blood flow were measured using multidetector computed tomography, and GFR by iothalamate clearance. Tissue deoxyhemoglobin levels (R(2)*) were measured by blood oxygen level-dependent MRI at 3T, as was fractional kidney hypoxia (percentage of axial area with R(2)*>30/s). In addition, we measured renal vein levels of neutrophil gelatinase-associated lipocalin, monocyte chemoattractant protein-1, and tumor necrosis factor-α. Pre-stent single kidney renal blood flow, perfusion, and GFR were reduced in the poststenotic kidney. Renal vein neutrophil gelatinase-associated lipocalin, tumor necrosis factor-α, monocyte chemoattractant protein-1, and fractional hypoxia were higher in untreated ARAS than in essential hypertension. After stent revascularization, fractional hypoxia fell (P<0.002) with increased cortical perfusion and blood flow, whereas GFR and neutrophil gelatinase-associated lipocalin, monocyte chemoattractant protein-1, and tumor necrosis factor-α remained unchanged. These data demonstrate that despite reversal of renal hypoxia and partial restoration of renal blood flow after revascularization, inflammatory cytokines and injury biomarkers remained elevated and GFR failed to recover in ARAS. Restoration of vessel patency alone failed to reverse tubulointerstitial damage and partly explains the limited clinical benefit of renal stenting. These results identify potential therapeutic targets for recovery of kidney function in renovascular disease.

[Supra-aortic trunks occlusive disease: three different treatment approaches].

PubMed

Dias, P; Almeida, P; Sampaio, S; Silva, A; Leite-Moreira, A; Pinho, P; Roncon de Albuquerque, R

2010-01-01

Unlike carotid bifurcation atherosclerotic stenosis, supra-aortic trunks (SAT) occlusive disease is rare and its revascularization uncommon, accouting for less than 10% of the operations performed on the extracranial brain-irrigating arteries. There are three different treatment approaches: transthoracic, extra-anatomic cervical and endovascular. Endovascular repair is gaining popularity as first-line therapy for proximal lesions with favorable anatomy because of its low morbidity and rare mortality. Extra-anatomic bypass is a safe and durable reconstruction and should be considered in patients with single vessel disease, with cardiopulmonary high-risk or with limited life expectancy. If cardiac surgery is needed, central transthoracic reconstruction is preferable, and the two procedures should be combined. The long-term patency of bypasses with aortic origin, specially when multiple vessels are involved, is superior to other repair techniques. We present three clinical cases that illustrate each of these therapeutic strategies: central brachiocephalic revascularization and synchronous cardiac surgery in a patient with complex SAT atherosclerosis disease; subclavian-carotid transposition for disabling upper limb claudication; and subclavian artery stenting for subclavian-steal syndrome. Surgical approach selection should be based on the individual patient's anatomy and operative risk.

Pathfinding to an optimal strategy of revascularization in primary coronary intervention in patients with multivessel disease: a network meta-analysis of randomized trials.

PubMed

Komócsi, András; Kehl, Dániel; d'Ascenso, Fabrizio; DiNicolantonio, James; Vorobcsuk, András

2017-03-01

In ST-segment elevation myocardial infarction (STEMI), current guidelines discourage treatment of the non-culprit lesions at the time of the primary intervention. Latest trials have challenged this strategy suggesting benefit of early complete revascularization. We performed a Bayesian multiple treatment network meta-analysis of randomized clinical trials (RCTs) in STEMI on culprit-only intervention (CO) versus different timing multivessel revascularization, including immediate (IM), same hospitalization (SH) or later staged (ST). Outcome parameters were pooled with a random-effects model. For multiple-treatment meta-analysis, a Bayesian Markov chain Monte Carlo method was used. Eight RCTs involving 2077 patients were identified. ST and IM revascularization was associated with a decrease in major adverse cardiac events (MACEs) compared to culprit-only approach (risk ratio [RR]: 0.43 credible interval [CrI]: 0.22-0.77 and RR: 0.36 CrI: 0.24-0.54, respectively). IM was superior to SH (RR: 0.49 CrI: 0.29-0.80). With regards to myocardial infarction IM was superior to SH (RR: 0.18 CrI: 0.02-0.99). The posterior probability of being the best choice of treatment regarding the frequency of MACEs was 71.2% for IM, 28.5% for ST, 0.3% for SH and 0.05% for culprit-only approach. Results from RCTs indicate that immediate or staged revascularization of non-culprit lesions reduces major adverse events in patients after primary percutaneous coronary intervention. Differences in MACEs suggest superiority of the immediate or staged intervention; however, further randomized trials are needed to determine the optimal timing of revascularization of the non-culprit lesions.

A Structured Review of Antithrombotic Therapy in Peripheral Artery Disease With a Focus on Revascularization: A TASC (InterSociety Consensus for the Management of Peripheral Artery Disease) Initiative.

PubMed

Hess, Connie N; Norgren, Lars; Ansel, Gary M; Capell, Warren H; Fletcher, John P; Fowkes, F Gerry R; Gottsäter, Anders; Hitos, Kerry; Jaff, Michael R; Nordanstig, Joakim; Hiatt, William R

2017-06-20

Peripheral artery disease affects >200 million people worldwide and is associated with significant limb and cardiovascular morbidity and mortality. Limb revascularization is recommended to improve function and quality of life for symptomatic patients with peripheral artery disease with intermittent claudication who have not responded to medical treatment. For patients with critical limb ischemia, the goals of revascularization are to relieve pain, help wound healing, and prevent limb loss. The baseline risk of cardiovascular and limb-related events demonstrated among patients with stable peripheral artery disease is elevated after revascularization and related to atherothrombosis and restenosis. Both of these processes involve platelet activation and the coagulation cascade, forming the basis for the use of antiplatelet and anticoagulant therapies to optimize procedural success and reduce postprocedural cardiovascular risk. Unfortunately, few high-quality, randomized data to support use of these therapies after peripheral artery disease revascularization exist, and much of the rationale for the use of antiplatelet agents after endovascular peripheral revascularization is extrapolated from percutaneous coronary intervention literature. Consequently, guideline recommendations for antithrombotic therapy after lower limb revascularization are inconsistent and not always evidence-based. In this context, the purpose of this structured review is to assess the available randomized data for antithrombotic therapy after peripheral arterial revascularization, with a focus on clinical trial design issues that may affect interpretation of study results, and highlight areas that require further investigation. © 2017 American Heart Association, Inc.

Randomized clinical trial of cutting balloon angioplasty versus high-pressure balloon angioplasty in hemodialysis arteriovenous fistula stenoses resistant to conventional balloon angioplasty.

PubMed

Aftab, Syed Arafat; Tay, Kiang Hiong; Irani, Farah G; Gong Lo, Richard Hoau; Gogna, Apoorva; Haaland, Benjamin; Tan, Seck Guan; Chng, Siew Png; Pasupathy, Shanker; Choong, Hui Lin; Tan, Bien Soo

2014-02-01

To compare the efficacy and safety of cutting balloon angioplasty (CBA) versus high-pressure balloon angioplasty (HPBA) for the treatment of hemodialysis autogenous fistula stenoses resistant to conventional percutaneous transluminal angioplasty (PTA). In a prospective, randomized clinical trial involving patients with dysfunctional, stenotic hemodialysis arteriovenous fistulas (AVFs), patients were randomized to receive CBA or HPBA if conventional PTA had suboptimal results (ie, residual stenosis > 30%). A total of 516 patients consented to participate in the study from October 2008 to September 2011, 85% of whom (n = 439) had technically successful conventional PTA. The remaining 71 patients (mean age, 60 y; 49 men) with suboptimal PTA results were eventually randomized: 36 to the CBA arm and 35 to the HPBA arm. Primary and secondary target lesion patencies were determined by Kaplan-Meier analysis. Clinical success rates were 100% in both arms. Primary target lesion patency rates at 6 months were 66.4% and 39.9% for CBA and HPBA, respectively (P = .01). Secondary target lesion patency rates at 6 months were 96.5% for CBA and 80.0% for HPBA (P = .03). There was a single major complication of venous perforation following CBA. The 30-day mortality rate was 1.4%, with one non-procedure-related death in the HPBA group. Primary and secondary target lesion patency rates of CBA were statistically superior to those of HPBA following suboptimal conventional PTA. For AVF stenoses resistant to conventional PTA, CBA may be a better second-line treatment given its superior patency rates. © 2014 SIR Published by SIR All rights reserved.

Coronary Endarterectomy: Recent Trends.

PubMed

Ghatanatti, Ravi; Teli, Anita

2017-08-01

Coronary Endarterectomy (CE) assures complete revascularization of the myocardium in case of diffusely diseased vessels and prevents residual ischemia. Recently cardiac surgeons are performing increasing number of coronary endarterectomy and it has evolved as an important adjuvant procedure in Coronary Artery Bypass Grafting (CABG). There are controversies regarding the efficiency of CE. CE is criticised for its higher rates of morbidity and mortality. At present the available evidence supports CE in Off Pump Coronary Artery Bypass surgery (OPCAB) and along with valvular procedures. Graft patency is better with open technique. Postoperative anticoagulation regimen though not uniform, the overall outcome remains the same. Therefore, it is important to focus on the current results to accept CE as a routine procedure like CABG.

Intraoperative Evaluation of Reverse Bypass Using a Naturally Formed "Bonnet" Superficial Temporal Artery: Technical Note.

PubMed

Nagm, Alhusain; Horiuchi, Tetsuyoshi; Hasegawa, Takatoshi; Hongo, Kazuhiro

2016-04-01

In reverse bypass that used a naturally formed "bonnet" superficial temporal artery, intraoperative volume flow measurement quantifies flow augmentation after revascularization, confirms flow preservation, and identifies inadvertent vessel compromise. A 75-year-old man presented with transient ischemic attacks attributed to right internal carotid artery stenosis. He underwent successful reverse bypass via a naturally formed "bonnet" superficial temporal artery middle cerebral artery bypass. As the result of proper intraoperative volume flow evaluation, a successful reverse bypass was achieved. Modification of the intraoperative stroke risk and prediction of the long-term patency after reverse bypass can be achieved by meticulous intraoperative blood flow evaluation. Copyright © 2016 Elsevier Inc. All rights reserved.

Long-Term Patency of Posterior Auricular Artery-Middle Cerebral Artery Bypass for Adult-Onset Moyamoya Disease: Case Report and Review of Literature.

PubMed

Torazawa, Seiei; Hasegawa, Hirotaka; Kin, Taichi; Sato, Hiroaki; Sora, Shigeo

2017-12-01

Direct extracranial-intracranial (EC-IC) bypass is one of the fundamental techniques to prevent recurrent stroke in patients with adult-onset ischemic moyamoya disease. When the standard superficial temporal artery (STA) cannot be used for a graft, the posterior auricular artery (PAA) can be a potential surrogate graft. In this article, the authors reported a 34-year-old female patient suffering from ischemic moyamoya disease. To widely revascularize the anterior half of the hemisphere, direct double EC-IC bypass was considered beneficial; however, she had only a single-branched STA but had a prominent branch of the PAA. After discussion, a direct double surgical revascularization was successfully performed using a combination of the STA-middle cerebral artery (MCA) and the PAA-MCA bypass. The authors herein reported the detailed surgical technique of the PAA-MCA bypass with an informative video of the actual procedure. To clearly define the feasibility of PAA-MCA bypass, the authors also conducted a literature review, yielding 3 previous articles describing the bypass. In conclusion, the PAA becomes a potential donor for EC-IC bypass as long as its diameter is approximately 1.0 mm. Even though the PAA-MCA bypass is not primarily considered in the initial revascularization, it can be useful as a combination bypass with other grafts or as a rescue for recurrent ischemia. Copyright © 2017 Elsevier Inc. All rights reserved.

Conservative versus invasive stable ischemic heart disease management strategies: what do we plan to learn from the ISCHEMIA trial?

PubMed

Cheng-Torres, Kathleen A; Desai, Karan P; Sidhu, Mandeep S; Maron, David J; Boden, William E

2016-01-01

Over the past decade, landmark randomized clinical trials comparing initial management strategies in stable ischemic heart disease (SIHD) have demonstrated no significant reduction in 'hard' end points (all-cause mortality, cardiac death or myocardial infarction) with one strategy versus another. The main advantage derived from early revascularization is improved short-term quality of life. Nonetheless, questions remain regarding how best to manage SIHD patients, such as whether a high-risk subgroup can be identified that may experience a survival or myocardial infarction benefit from early revascularization, and if not, when should diagnostic catheterization and revascularization be performed. The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches trial is designed to address these questions by randomizing SIHD patients with at least moderate ischemia to an initial conservative strategy of optimal medical therapy or an initial invasive strategy of optimal medical therapy plus cardiac catheterization and revascularization.

Current outcomes of off-pump versus on-pump coronary artery bypass grafting: evidence from randomized controlled trials

PubMed Central

Benedetto, Umberto; Pecchinenda, Gustavo Guida; Chivasso, Pierpaolo; Bruno, Vito Domenico; Rapetto, Filippo; Bryan, Alan; Angelini, Gianni Davide

2016-01-01

Coronary artery bypass grafting remains the standard treatment for patients with extensive coronary artery disease. Coronary surgery without use of cardiopulmonary bypass avoids the deleterious systemic inflammatory effects of the extracorporeal circuit. However there is an ongoing debate surrounding the clinical outcomes after on-pump versus off-pump coronary artery bypass (ONCAB versus OPCAB) surgery. The current review is based on evidence from randomized controlled trials (RCTs) and meta-analyses of randomized studies. It focuses on operative mortality, mid- and long-term survival, graft patency, completeness of revascularisation, neurologic and neurophysiologic outcomes, perioperative complications and outcomes in the high risk groups. Early and late survival rates for both OPCAB and ONCAB grafting are similar. Some studies suggest early poorer vein graft patency with off-pump when compared with on-pump, comparable midterm arterial conduit patency with no difference in long term venous and arterial graft patency. A recent, pooled analysis of randomised trials shows a reduction in stroke rates with use off-pump techniques. Furthermore, OPCAB grafting seems to reduce postoperative renal dysfunction, bleeding, transfusion requirement and respiratory complications while perioperative myocardial infarction rates are similar to ONCAB grafting. The high risk patient groups seem to benefit from off-pump coronary surgery. PMID:27942394

Intraoperative IR imaging in the cardiac operating room

NASA Astrophysics Data System (ADS)

Szabo, Tamas; Fazekas, Levente; Horkay, Ferenc; Geller, Laslu; Gyongy, Tibor; Juhasz-Nagy, Alexander

1999-07-01

The high blood flow rate and the considerable metabolic activity render the myocardium a possible candidate for IR imaging. The study was aimed to test cardiothermography in evaluating arterial bypass graft patency and in assessing myocardial protection during open-heart surgery. Ten patients underwent arterial bypass grafting. Thermograms were obtained immediately before and after opening the grafts. As the bypasses were opened in hypothermia the warmer blood coming from the extracorporeal circulation readily delineated graft and coronary anatomy. By the end of the 5 min observation period, the revascularized area exhibited a temperature increase of 5.9 +/- 0.7 degrees C. The affectivity of antegrade cardioplegia was monitored in 38 patients undergoing either valve implantations or aorto- coronary bypass surgery. Thermographic imags were taken after sternotomy, before aortic cross-clamping and after administrating the 4 degrees C cardioplegic solution. Most of the patients displayed adequate myocardial cooling, moreover the bypass-group exhibited a more profound temperature-decrease. In conclusion, cardiothermography can visualize arterial grafts, recipient coronaries and collaterals seconds after opening by bypass, thus it properly evaluated arterial bypass graft patency. The obtained images could easily be analyzed for qualitative flow- and quantitative temperature changes. Myocardial protection could also be safely assessed with thermography.

Effect of dipyridamole plus aspirin on hemodialysis graft patency.

PubMed

Dixon, Bradley S; Beck, Gerald J; Vazquez, Miguel A; Greenberg, Arthur; Delmez, James A; Allon, Michael; Dember, Laura M; Himmelfarb, Jonathan; Gassman, Jennifer J; Greene, Tom; Radeva, Milena K; Davidson, Ingemar J; Ikizler, T Alp; Braden, Gregory L; Fenves, Andrew Z; Kaufman, James S; Cotton, James R; Martin, Kevin J; McNeil, James W; Rahman, Asif; Lawson, Jeffery H; Whiting, James F; Hu, Bo; Meyers, Catherine M; Kusek, John W; Feldman, Harold I

2009-05-21

Arteriovenous graft stenosis leading to thrombosis is a major cause of complications in patients undergoing hemodialysis. Procedural interventions may restore patency but are costly. Although there is no proven pharmacologic therapy, dipyridamole may be promising because of its known vascular antiproliferative activity. We conducted a randomized, double-blind, placebo-controlled trial of extended-release dipyridamole, at a dose of 200 mg, and aspirin, at a dose of 25 mg, given twice daily after the placement of a new arteriovenous graft until the primary outcome, loss of primary unassisted patency (i.e., patency without thrombosis or requirement for intervention), was reached. Secondary outcomes were cumulative graft failure and death. Primary and secondary outcomes were analyzed with the use of a Cox proportional-hazards regression with adjustment for prespecified covariates. At 13 centers in the United States, 649 patients were randomly assigned to receive dipyridamole plus aspirin (321 patients) or placebo (328 patients) over a period of 4.5 years, with 6 additional months of follow-up. The incidence of primary unassisted patency at 1 year was 23% (95% confidence interval [CI], 18 to 28) in the placebo group and 28% (95% CI, 23 to 34) in the dipyridamole-aspirin group, an absolute difference of 5 percentage points. Treatment with dipyridamole plus aspirin significantly prolonged the duration of primary unassisted patency (hazard ratio, 0.82; 95% CI, 0.68 to 0.98; P=0.03) and inhibited stenosis. The incidences of cumulative graft failure, death, the composite of graft failure or death, and serious adverse events (including bleeding) did not differ significantly between study groups. Treatment with dipyridamole plus aspirin had a significant but modest effect in reducing the risk of stenosis and improving the duration of primary unassisted patency of newly created grafts. (ClinicalTrials.gov number, NCT00067119.) 2009 Massachusetts Medical Society

Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: An intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy.

PubMed

Bradbury, Andrew W; Adam, Donald J; Bell, Jocelyn; Forbes, John F; Fowkes, F Gerry R; Gillespie, Ian; Ruckley, Charles Vaughan; Raab, Gillian M

2010-05-01

A 2005 interim analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI; rest pain, ulceration, gangrene) due to infrainguinal disease, bypass surgery (BSX)-first and balloon angioplasty (BAP)-first revascularization strategies led to similar short-term clinical outcomes, although BSX was about one-third more expensive and morbidity was higher. We have monitored patients for a further 2.5 years and now report a final intention-to-treat (ITT) analysis of amputation-free survival (AFS) and overall survival (OS). Of 452 enrolled patients in 27 United Kingdom hospitals, 228 were randomized to a BSX-first and 224 to a BAP-first revascularization strategy. All patients were monitored for 3 years and more than half for >5 years. At the end of follow-up, 250 patients were dead (56%), 168 (38%) were alive without amputation, and 30 (7%) were alive with amputation. Four were lost to follow-up. AFS and OS did not differ between randomized treatments during the follow-up. For those patients surviving 2 years from randomization, however, BSX-first revascularization was associated with a reduced hazard ratio (HR) for subsequent AFS of 0.85 (95% confidence interval [CI], 0.5-1.07; P = .108) and for subsequent OS of 0.61 (95% CI, 0.50-0.75; P = .009) in an adjusted, time-dependent Cox proportional hazards model. For those patients who survived for 2 years after randomization, initial randomization to a BSX-first revascularization strategy was associated with an increase in subsequent restricted mean overall survival of 7.3 months (95% CI, 1.2-13.4 months, P = .02) and an increase in restricted mean AFS of 5.9 months (95% CI, 0.2-12.0 months, P = .06) during the subsequent mean follow-up of 3.1 years (range, 1-5.7 years). Overall, there was no significant difference in AFS or OS between the two strategies. However, for those patients who survived for at least 2 years after randomization, a BSX-first revascularization strategy was associated with a significant increase in subsequent OS and a trend towards improved AFS. Crown Copyright (c) 2010. Published by Mosby, Inc. All rights reserved.

Nine-Month Outcomes of the DURABILITY Iliac Study on Self-Expanding Stents for Symptomatic Peripheral Artery Disease.

PubMed

Faries, Peter; Jaff, Michael; Peeters, Patrick; Khatib, Yazan; Roberts, David; Bosiers, Marc; Malik, Rajesh; Ravin, Reid; Rundback, John

2018-04-17

The DURABILITY Iliac clinical study evaluated the safety and effectiveness of two nitinol self-expanding stents for the treatment of atherosclerotic common and external iliac artery lesions up to 10 cm in length and >50% stenosis in subjects with Rutherford Classification peripheral arterial disease stages 2-4. DURABILITY Iliac was a prospective, multicenter, core lab adjudicated, nonrandomized clinical study enrolling 75 subjects from 15 sites in the United States and Europe. Clinical follow-up visits were at 30 days, 9 months, and 1, 2, and 3 years post procedure. The primary outcome measured was the major adverse event rate (MAE) at 9 months, defined as a composite of periprocedural death, in-hospital myocardial infarction (MI), clinically-driven target lesion revascularization (CD-TLR), and amputation of the treated limb through 9 months post-procedure. Secondary outcomes included primary patency rate at 9 months, clinically-driven target vessel revascularization (CD-TVR), change in ankle-brachial index, and change in Walking Impairment Questionnaire score at 30 days and 9 months. Device success was defined as the ability to deploy the stent as intended at the treatment site. The MAE rate at 9 months was 1.3% (1/75), with 1 subject experiencing a CD-TLR. No periprocedural deaths, myocardial infarctions, or amputations were reported. Primacy patency at 9 months was 95.8%. Freedom from CD-TVR was 98.6% at 9 months. Subjects improved in Walking Impairment Questionnaire scores for all categories (walking impairment, walking speed, walking distance, and stair climbing) at the 30-day and 9-month visit. Device success was 100%. The 9-month results of the DURABILITY Iliac study demonstrate the safety and effectiveness of 2 nitinol self-expanding stents for the treatment of atherosclerotic lesions of the common and external iliac arteries. Copyright © 2018. Published by Elsevier Inc.

Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months.

PubMed

Rundback, John H; Peeters, Patrick; George, Jon C; Jaff, Michael R; Faries, Peter L

2017-06-01

To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions. Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2-4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed. Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender. Nine-month results of the VISIBILITY Iliac stent study ( ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts.

Highly flexible nitinol mesh to encase aortocoronary saphenous vein grafts: first clinical experiences and angiographic results nine months postoperatively.

PubMed

Schoettler, Jan; Jussli-Melchers, Jill; Grothusen, Christina; Stracke, Lars; Schoeneich, Felix; Stohn, Simon; Hoffmann, Grischa; Cremer, Jochen

2011-10-01

Saphenous vein graft patency is frequently limited by degeneration. Experimental studies have indicated that rigid external support of venous grafts by a flexible, tubular nitinol mesh may improve graft patency. The study presented was part of a prospective, randomized, multicenter first-in-man trial investigating the safety and effectiveness of nitinol-supported venous grafts in coronary artery bypass graft (CABG) surgery. From our clinic, 25 subjects with multivessel coronary artery disease requiring saphenous vein graft CABG of the right coronary artery (RCA) and the circumflex artery were entered into the trial. Subjects were randomized to receive a mesh-supported graft on one of these arteries; the other vessel received an untreated vein graft. Graft patency was assessed by coronary angiography nine months after surgery. The implantation of mesh grafts was simple and safe. In 10 cases, a nitinol mesh-supported venous graft was anastomosed to the circumflex artery and in 15 cases to the RCA. All patients survived the observation period. A total of 72% of the patients underwent control coronary angiography. The patency rate of mesh-supported grafts was 27.8% nine months postoperatively. Conventional vein grafts showed an 85.7% patency, and arterial grafts had a 100% patency. No complications directly related to the implantation of mesh-supported grafts were observed. The promising experimental results of mesh-supported venous grafts could not be reproduced in the study presented. A critical item seems to be correct selection of nitinol mesh diameter, the anastomotic method and fixation of the mesh tube to the venous graft.

Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 12-Month Results.

PubMed

Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Snyder, Scott A; Dake, Michael D

2016-02-08

This multicenter, prospective, post-market surveillance study in Japan evaluates the paclitaxel-coated Zilver PTX stent in real-world patients with complex lesions. The Zilver PTX stent is the first drug-eluting stent (DES) approved for the superficial femoral artery. Previously, results from a large randomized study and a complementary, large single-arm study supported the safety and effectiveness of the DES. There were no exclusion criteria, and consecutive patients with symptomatic peripheral artery disease (PAD) treated with the DES were enrolled in the study. Clinically driven target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms of PAD. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. In this study, 907 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including high incidences of diabetes (58.8%), chronic kidney disease (43.8%), and critical limb ischemia (21.5%). Lesions were also complex, with an average length of 14.7 cm, 41.6% total occlusions, and 18.6% in-stent restenosis. In total, 1,861 DES were placed in 1,075 lesions. Twelve-month follow-up was obtained for >95% of eligible patients. Freedom from TLR was 91.0%, and clinical benefit was 87.7% through 12 months. The 12-month primary patency rate was 86.4%. Despite more challenging lesions, results from the current study are similar to outcomes from the previous Zilver PTX studies, confirming the benefit of the Zilver PTX DES in a real-world patient population. (Zilver PTX Post-Market Study in Japan; NCT02254837). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

A next-generation bioresorbable coronary scaffold system: from bench to first clinical evaluation: 6- and 12-month clinical and multimodality imaging results.

PubMed

Verheye, Stefan; Ormiston, John A; Stewart, James; Webster, Mark; Sanidas, Elias; Costa, Ricardo; Costa, J Ribamar; Chamie, Daniel; Abizaid, Andrea S; Pinto, Ibraim; Morrison, Lynn; Toyloy, Sara; Bhat, Vinayak; Yan, John; Abizaid, Alexandre

2014-01-01

This study sought to perform clinical and imaging assessments of the DESolve Bioresorbable Coronary Scaffold (BCS). BCS, which is drug eluting, may have potential advantages compared with conventional metallic drug-eluting stents. The DESolve system, designed to provide vessel support and neointimal suppression, combines a poly-l-lactic acid-based scaffold with the antiproliferative myolimus. The DESolve First-in-Man (a non-randomized, consecutive enrollment evaluation of the DESolve myolimus eluting bioresorbable coronary stent in the treatment of patients with de novo native coronary artery lesions) trial was a prospective multicenter study enrolling 16 patients eligible for treatment. The principal safety endpoint was a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization. The principal imaging endpoint was in-scaffold late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 6 months. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging was performed at baseline and 6 months; multislice computed tomography (MSCT) was performed at 12 months. Acute procedural success was achieved in 15 of 15 patients receiving a study scaffold. At 12 months, there was no scaffold thrombosis and no major adverse cardiac events directly attributable to the scaffold. At 6 months, in-scaffold LLL (by QCA) was 0.19 ± 0.19 mm; neointimal volume (by IVUS) was 7.19 ± 3.56%, with no evidence of scaffold recoil or late malapposition. Findings were confirmed with OCT and showed uniform, thin neointimal coverage (0.12 ± 0.04 mm). At 12 months, MSCT demonstrated excellent vessel patency. This study demonstrated the feasibility and efficacy of the DESolve BCS. Results showing low in-scaffold LLL, low % neointimal volume at 6 months, no chronic recoil, and maintenance of lumen patency at 12 months prompt further study. (DESolve First-in-Man; EudraCT number 2011-000027-32). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Failure and Success of Percutaneous Angioplasty in a Hypertensive Child with Bilateral Renal Artery Stenosis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Giavroglou, Constantinos; Tsifountoudis, Ioannis, E-mail: jtsif@mycosmos.g; Boutzetis, Theodoros

2009-01-15

We describe the clinical course of a 5-year-old girl with severe arterial hypertension that was uncontrollable with antihypertensive medication. Renal angiography revealed bilateral renal artery stenoses. Because percutaneous transluminal renal angioplasty (PTRA) failed to dilate the stenotic lesions, a renal artery bypass grafting in both renal arteries was performed. The patient remained normotensive for 7 months, and after that the arterial pressure increased again. Digital subtraction angiography demonstrated stenosis at the peripheral and central anastomosis of the vein graft that was used for revascularization of the left kidney. PTRA was decided on and successful patency was achieved. The patient hasmore » now been normotensive for a period of 5 years.« less

Clinical efficacy of concomitant tibial interventions associated with superficial femoral artery interventions in critical limb ischemia.

PubMed

Smolock, Christopher J; Anaya-Ayala, Javier E; El-Sayed, Hosam F; Naoum, Joseph J; Lumsden, Alan B; Davies, Mark G

2013-01-01

Combined superficial femoral artery (SFA) and tibial angioplasty (TA) are a common treatment for critical limb ischemia. Poor tibial runoff significantly compromises durability and clinical effectiveness of SFA interventions. The aim of this study is to determine clinical and anatomic outcomes of SFA interventions in patients with equally compromised runoff, with and without concomitant TA. The database of patients undergoing endovascular treatment of SFA (1999-2009) was retrospectively queried. Patients with poor runoff, scored>10 by modified Society for Vascular Surgery criteria, were selected. Preoperative angiograms were reviewed to assess distal popliteal and tibial runoff. Kaplan-Meier analyses were performed to assess time-dependent outcomes. Factor analyses were performed for time-dependent variables. A total of 162 limbs with a runoff score>10 (56% men; average age, 69 years) underwent endovascular intervention for symptomatic SFA disease: 61 (54% men) underwent TA but the remaining 101 (57% men) did not. The groups were matched for age, sex, and SFA anatomy (Trans-Atlantic Inter-Society Consensus II C/D lesions: 56% no TA vs 62% TA; P=.5). Presenting symptoms were similar between no TA and TA groups (rest pain: 40% vs 32%; tissue loss: 60% vs 68%; P=.3). Three-year survival favored the TA group (79%±5%) vs no TA (68%±5%; P=.06). Three-year anatomic outcomes in no TA vs TA group, including primary patency (45%±6% vs 63%±8%; P=.04), assisted primary patency (55%±6% vs 75%±7%; P=.03), and secondary patency (57%±6% vs 77%±7%; P=.03) were all superior in the TA group. Target vessel revascularization in no TA vs TA (61%±6% vs 74%±8%; P=.002) and target extremity revascularization (42%±6% vs 59%±8%; P=.06) also favored the TA group. However the comparison of no TA vs TA for clinical success (39%±6% vs 47%±8%; P=.6), freedom from recurrent symptoms (59%±6% vs 60%±9%; P=.1), amputation-free survival (46%±5% vs 63%±7%; P=.06), and limb salvage at 3 years (63%±6% vs 74%±7%; P=.6) were similar. TA in patients with poor runoff has a positive effect on SFA anatomic outcomes. However, clinical success was not affected. Concomitant TA appears not to add clinical benefit to SFA intervention in critical limb ischemia. Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

A prospective, randomized study of the patency period of the plastic antireflux biliary stent: an interim analysis.

PubMed

Leong, Quan Wai; Shen, Mira L; Au, Kim W; Luo, Derek; Lau, James Y; Wu, Justin C; Chan, Francis K; Sung, Joseph J

2016-02-01

There is as yet no ideal design of a plastic biliary stent with the longest patency period. To study the safety and effective patency period of a new plastic antireflux biliary stent in the clinical setting. We conducted a prospective, randomized trial to compare the patency of 2 similar plastic biliary stents, one of which has an antiduodenobiliary reflux property. The study was conducted at 2 separate tertiary centers in 2 countries. Patients with inoperable distal malignant biliary obstruction were recruited. One of the 2 types of plastic stents under study was randomly chosen and inserted in the common bile duct of the study subjects. The subjects were followed until the end of study or occlusion occurrence. Our primary endpoint was the time to stent occlusion in days, with stent-related adverse events and all-cause mortality the secondary endpoints. A total of 16 subjects were recruited for the study; 7 were allocated to group A (ordinary Tannenbaum stent) and 9 to group B (antireflux biliary stent). Five of 7 subjects (71%) in group B had stent occlusion within 8 days, and the primary end point was reached in all 7 subjects within 30 days, whereas the primary endpoint was not reached within 30 days in any of the subjects in group A. Our data showed a significantly shorter stent patency period in group B compared with group A (P < .003). Small sample size. Routine use of antireflux plastic biliary stents in the palliative management of malignant biliary obstructions cannot be recommended at present. (Clinical trial registration number: NCT01142921.). Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

The Effects of Intra-Aortic Balloon Pumps on Mortality in Patients Undergoing High-Risk Coronary Revascularization: A Meta-Analysis of Randomized Controlled Trials of Coronary Artery Bypass Grafting and Stenting Era

PubMed Central

Wan, You-Dong; Sun, Tong-Wen; Kan, Quan-Cheng; Guan, Fang-Xia; Liu, Zi-Qi; Zhang, Shu-Guang

2016-01-01

Background Intra-aortic balloon pumps (IABP) have generally been used for patients undergoing high-risk mechanical coronary revascularization. However, there is still insufficient evidence to determine whether they can improve outcomes in reperfusion therapy patients, mainly by percutaneous coronary intervention (PCI) with stenting or coronary artery bypass graft (CABG). This study was designed to determine the difference between high-risk mechanical coronary revascularization with and without IABPs on mortality, by performing a meta-analysis on randomized controlled trials of the current era. Methods Pubmed and Embase databases were searched from inception to May 2015. Unpublished data were obtained from the investigators. Randomized clinical trials of IABP and non-IABP in high-risk coronary revascularization procedures (PCI or CABG) were included. In the case of PCI procedures, stents should be used in more than 80% of patients. Numbers of events at the short-term and long-term follow-up were extracted. Results A total of 12 randomized trials enrolling 2155 patients were included. IABPs did not significantly decrease short-term mortality (relative risk (RR) 0.66; 95% CI, 0.42–1.01), or long-term mortality (RR 0.79; 95% CI, 0.47–1.35), with low heterogeneity across the studies. The findings remained stable in patients with acute myocardial infarction with or without cardiogenic shock. But in high-risk CABG patients, IABP was associated with reduced mortality (71 events in 846 patients; RR 0.40; 95%CI 0.25–0.67). Conclusion In patients undergoing high-risk coronary revascularization, IABP did not significantly decrease mortality. But high-risk CABG patients may be benefit from IABP. Rigorous criteria should be applied to the use of IABPs. PMID:26784578

Dacron® vs. PTFE as bypass materials in peripheral vascular surgery – systematic review and meta-analysis

PubMed Central

Roll, Stephanie; Müller-Nordhorn, Jacqueline; Keil, Thomas; Scholz, Hans; Eidt, Daniela; Greiner, Wolfgang; Willich, Stefan N

2008-01-01

Background In peripheral vascular bypass surgery different synthetic materials are available for bypass grafting. It is unclear which of the two commonly used materials, polytetrafluoroethylene (PTFE) or polyester (Dacron®) grafts, is to be preferred. Thus, the aim of this meta-analysis and systematic review was to compare the effectiveness of these two prosthetic bypass materials (Dacron® and PTFE). Methods We performed a systematic literature search in MEDLINE, Cochrane-Library – CENTRAL, EMBASE and other databases for relevant publications in English and German published between 1999 and 2008. Only randomized controlled trials were considered for inclusion. We assessed the methodological quality by means of standardized checklists. Primary patency was used as the main endpoint. Random-effect meta-analysis as well as pooling data in life table format was performed to combine study results. Results Nine randomized controlled trials (RCT) were included. Two trials showed statistically significant differences in primary patency, one favouring Dacron® and one favouring PTFE grafts, while 7 trials did not show statistically significant differences between the two materials. Meta-analysis on the comparison of PTFE vs. Dacron® grafts yielded no differences with regard to primary patency rates (hazard ratio 1.04 (95% confidence interval [0.85;1.28]), no significant heterogeneity (p = 0.32, I2 = 14%)). Similarly, there were no significant differences with regard to secondary patency rates. Conclusion Systematic evaluation and meta-analysis of randomized controlled trials comparing Dacron® and PTFE as bypass materials for peripheral vascular surgery showed no evidence of an advantage of one synthetic material over the other. PMID:19099583

Effect of Dipyridamole plus Aspirin on Hemodialysis Graft Patency

PubMed Central

Dixon, Bradley S.; Beck, Gerald J.; Vazquez, Miguel A.; Greenberg, Arthur; Delmez, James A.; Allon, Michael; Dember, Laura M.; Himmelfarb, Jonathan; Gassman, Jennifer J.; Greene, Tom; Radeva, Milena K.; Davidson, Ingemar J.; Ikizler, T. Alp; Braden, Gregory L.; Fenves, Andrew Z.; Kaufman, James S.; Cotton, James R.; Martin, Kevin J.; McNeil, James W.; Rahman, Asif; Lawson, Jeffery H.; Whiting, James F.; Hu, Bo; Meyers, Catherine M.; Kusek, John W.; Feldman, Harold I.

2014-01-01

BACKGROUND Arteriovenous graft stenosis leading to thrombosis is a major cause of complications in patients undergoing hemodialysis. Procedural interventions may restore patency but are costly. Although there is no proven pharmacologic therapy, dipyridamole may be promising because of its known vascular antiproliferative activity. METHODS We conducted a randomized, double-blind, placebo-controlled trial of extended-release dipyridamole, at a dose of 200 mg, and aspirin, at a dose of 25 mg, given twice daily after the placement of a new arteriovenous graft until the primary outcome, loss of primary unassisted patency (i.e., patency without thrombosis or requirement for intervention), was reached. Secondary outcomes were cumulative graft failure and death. Primary and secondary outcomes were analyzed with the use of a Cox proportional-hazards regression with adjustment for prespecified covariates. RESULTS At 13 centers in the United States, 649 patients were randomly assigned to receive dipyridamole plus aspirin (321 patients) or placebo (328 patients) over a period of 4.5 years, with 6 additional months of follow-up. The incidence of primary unassisted patency at 1 year was 23% (95% confidence interval [CI], 18 to 28) in the placebo group and 28% (95% CI, 23 to 34) in the dipyridamole–aspirin group, an absolute difference of 5 percentage points. Treatment with dipyridamole plus aspirin significantly prolonged the duration of primary unassisted patency (hazard ratio, 0.82; 95% CI, 0.68 to 0.98; P = 0.03) and inhibited stenosis. The incidences of cumulative graft failure, death, the composite of graft failure or death, and serious adverse events (including bleeding) did not differ significantly between study groups. CONCLUSIONS Treatment with dipyridamole plus aspirin had a significant but modest effect in reducing the risk of stenosis and improving the duration of primary unassisted patency of newly created grafts. (ClinicalTrials.gov number, NCT00067119.) PMID:19458364

Covered Metallic Stents With an Anti-Migration Design vs. Uncovered Stents for the Palliation of Malignant Gastric Outlet Obstruction: A Multicenter, Randomized Trial

PubMed Central

Lee, Hyuk; Min, Byung-Hoon; Lee, Jeong Hoon; Shin, Cheol Min; Kim, Younjoo; Chung, Hyunsoo; Lee, Sang Hyub

2015-01-01

OBJECTIVES: Previous studies reported comparable stent patency between covered self-expandable metallic stents (SEMS) and uncovered SEMS (UCS) for palliation of malignant gastric outlet obstruction (GOO). The aim of this study was to evaluate the efficacy and safety of the newly developed WAVE-covered SEMS (WCS), which has an anti-migration design, compared with UCS in gastric cancer patients with symptomatic GOO. METHODS: A total of 102 inoperable gastric cancer patients with symptomatic GOO were prospectively enrolled from five referral centers and randomized to undergo UCS or WCS placement. Stent patency and recurrence of obstructive symptoms were assessed at 8 weeks and 16 weeks after stent placement. RESULTS: At the 8-week follow-up, both stent patency rates (72.5% vs. 62.7%) and re-intervention rates (19.6% vs. 19.6%) were comparable between the WCS and the UCS groups. Both stent stenosis (2.4% vs. 8.1%) and migration rates (9.5% vs. 5.4%) were comparable between WCS and UCS groups. At the 16-week follow-up, however, the WCS group had a significantly higher stent patency rate than the UCS group (68.6% vs. 41.2%). Re-intervention rates in the WCS and UCS groups were 23.5% and 39.2%, respectively. Compared with the UCS group, the WCS group had a significantly lower stent restenosis rate (7.1% vs. 37.8%) and a comparable migration rate (9.5% vs. 5.4%). Overall stent patency was significantly longer in the WCS group than in the UCS group. No stent-associated significant adverse events occurred in either the WCS or UCS groups. In the multivariate analysis, WCS placement and chemotherapy were identified as independent predictors of 16-week stent patency. CONCLUSIONS: WCS group showed comparable migration rate and significantly more durable long-term stent patency compared with UCS group for the palliation of GOO in patients with inoperable gastric cancer. PMID:26372507

Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs.

PubMed

Kayssi, Ahmed; Al-Atassi, Talal; Oreopoulos, George; Roche-Nagle, Graham; Tan, Kong Teng; Rajan, Dheeraj K

2016-08-04

Atherosclerotic peripheral arterial disease (PAD) can lead to disabling ischemia and limb loss. Treatment modalities have included risk factor optimization through life-style modifications and medications, or operative approaches using both open and minimally invasive techniques, such as balloon angioplasty. Drug-eluting balloon (DEB) angioplasty has emerged as a promising alternative to uncoated balloon angioplasty for the treatment of this difficult disease process. By ballooning and coating the inside of atherosclerotic vessels with cytotoxic agents, such as paclitaxel, cellular mechanisms responsible for atherosclerosis and neointimal hyperplasia are inhibited and its devastating complications are prevented or postponed. DEBs are considerably more expensive than uncoated balloons, and their efficacy in improving patient outcomes is unclear. To assess the efficacy of drug-eluting balloons (DEBs) compared with uncoated, nonstenting balloon angioplasty in people with symptomatic lower-limb peripheral arterial disease (PAD). The Cochrane Vascular Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched December 2015) and Cochrane Register of Studies (CRS) (2015, Issue 11). The TSC searched trial databases for details of ongoing and unpublished studies. We included all randomized controlled trials that compared DEBs with uncoated, nonstenting balloon angioplasty for intermittent claudication (IC) or critical limb ischemia (CLI). Two review authors (AK, TA) independently selected the appropriate trials and performed data extraction, assessment of trial quality, and data analysis. The senior review author (DKR) adjudicated any disagreements. Eleven trials that randomized 1838 participants met the study inclusion criteria. Seven of the trials included femoropopliteal arterial lesions, three included tibial arterial lesions, and one included both. The trials were carried out in Europe and in the USA and all used the taxane drug paclitaxel in the DEB arm. Nine of the 11 trials were industry-sponsored. Four companies manufactured the DEB devices (Bard, Bavaria Medizin, Biotronik, and Medtronic). The trials examined both anatomic and clinical endpoints. There was heterogeneity in the frequency of stent deployment and the type and duration of antiplatelet therapy between trials. Using GRADE assessment criteria, the quality of the evidence presented was moderate for the outcomes of target lesion revascularization and change in Rutherford category, and high for amputation, primary vessel patency, binary restenosis, death, and change in ankle-brachial index (ABI). Most participants were followed up for 12 months, but one trial reported outcomes at five years.There were better outcomes for DEBs for up to two years in primary vessel patency (odds ratio (OR) 1.47, 95% confidence interval (CI) 0.22 to 9.57 at six months; OR 1.92, 95% CI 1.45 to 2.56 at 12 months; OR 3.51, 95% CI 2.26 to 5.46 at two years) and at six months and two years for late lumen loss (mean difference (MD) -0.64 mm, 95% CI -1.00 to -0.28 at six months; MD -0.80 mm, 95% CI -1.44 to -0.16 at two years). DEB were also superior to uncoated balloon angioplasty for up to five years in target lesion revascularization (OR 0.28, 95% CI 0.17 to 0.47 at six months; OR 0.40, 95% CI 0.31 to 0.51 at 12 months; OR 0.28, 95% CI 0.18 to 0.44 at two years; OR 0.21, 95% CI 0.09 to 0.51 at five years) and binary restenosis rate (OR 0.44, 95% CI 0.29 to 0.67 at six months; OR 0.38, 95% CI 0.15 to 0.98 at 12 months; OR 0.26, 95% CI 0.10 to 0.66 at two years; OR 0.12, 95% CI 0.05 to 0.30 at five years). There was no significant difference between DEB and uncoated angioplasty in amputation, death, change in ABI, change in Rutherford category and quality of life (QoL) scores, or functional walking ability, although none of the trials were powered to detect a significant difference in these clinical endpoints. We carried out two subgroup analyses to examine outcomes in femoropopliteal and tibial interventions as well as in people with CLI (4 or greater Rutherford class), and showed no advantage for DEBs in tibial vessels at six and 12 months compared with uncoated balloon angioplasty. There was also no advantage for DEBs in CLI compared with uncoated balloon angioplasty at 12 months. Based on a meta-analysis of 11 trials with 1838 participants, there is evidence of an advantage for DEBs compared with uncoated balloon angioplasty in several anatomic endpoints such as primary vessel patency (high-quality evidence), binary restenosis rate (moderate-quality evidence), and target lesion revascularization (low-quality evidence) for up to 12 months. Conversely, there is no evidence of an advantage for DEBs in clinical endpoints such as amputation, death, or change in ABI, or change in Rutherford category during 12 months' follow-up. Well-designed randomized trials with long-term follow-up are needed to compare DEBs with uncoated balloon angioplasties adequately for both anatomic and clinical study endpoints before the widespread use of this expensive technology can be justified.

A prospective, multi-center study of the chocolate balloon in femoropopliteal peripheral artery disease: The Chocolate BAR registry.

PubMed

Mustapha, Jihad A; Lansky, Alexandra; Shishehbor, Mehdi; Miles McClure, John; Johnson, Sarah; Davis, Thomas; Makam, Prakash; Crowder, William; Konstantino, Eitan; Attaran, Robert R

2018-05-01

The Chocolate BAR study is a prospective multicenter post-market registry designed to evaluate the safety and performance of the Chocolate percutaneous transluminal angioplasty balloon catheter in a broad population with symptomatic peripheral arterial disease. The primary endpoint is acute procedural success (defined as ≤30% residual stenosis without flow-limiting dissection); secondary long-term outcomes include freedom from target lesion revascularization (TLR), major unplanned amputation, survival, and patency. A total of 262 patients (290 femoropopliteal lesions) were enrolled at 30 US centers between 2012 and 2014. The primary endpoint of procedure success was achieved in 85.1% of cases, and freedom from stenting occurred in 93.1%. Bail out stenting by independent adjudication occurred in 1.6% of cases and there were no flow limiting dissections. There was mean improvement of 2.1 Rutherford classes (±1.5) at 12-months, with 78.5% freedom from TLR, 97.2% freedom from major amputation, and 93.3% freedom from all-cause mortality. Core Lab adjudicated patency was 64.1% at 12 months. Use of the Chocolate balloon in an "all-comers" population achieved excellent procedural outcomes with low dissection rates and bailout stent use. © 2018 Wiley Periodicals, Inc.

Atherosclerotic renovascular disease – epidemiology, treatment and current challenges

PubMed Central

Vassallo, Diana

2017-01-01

The neutral results of recent large randomized controlled trials comparing renal revascularization with optimal medical therapy in patients with atherosclerotic renovascular disease (ARVD) have cast doubt on the role of revascularization in the management of unselected patients with this condition. However, these studies have strengthened the evidence base for the role of contemporary intensive medical vascular protection therapy and aggressive risk factor control in improving clinical outcomes in ARVD. Patients presenting with ‘high-risk’ clinical features such as uncontrolled hypertension, rapidly declining renal function or flash pulmonary oedema are underrepresented in these studies; hence these results may not be applicable to all patients with ARVD. In this ‘high-risk’ subgroup, conservative management may not be sufficient in preventing adverse events, and indeed, observational evidence suggests that this specific patient subgroup may gain benefit from timely renal revascularization. Current challenges include the development of novel diagnostic techniques to establish haemodynamic significance of a stenosis, patient risk stratification and prediction of post-revascularization outcomes to ultimately facilitate patient selection for revascularization. In this paper we describe the epidemiology of this condition and discuss treatment recommendations for this condition in light of the results of recent randomized controlled trials while highlighting important clinical unmet needs and challenges faced by clinicians managing this condition. PMID:29056991

Drug-Eluting Nitinol Stent Treatment of the Superficial Femoral Artery and Above-the-Knee Popliteal Artery (The Zilver PTX Single-Arm Clinical Study): A Comparison Between Diabetic and Nondiabetic Patients

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fanelli, Fabrizio, E-mail: fabrizio.fanelli@uniroma1.it; Primo, Massimiliano Di; Boatta, Emanuele

2013-10-15

Purpose: To describe the 1-year results of drug-eluting nitinol stent placement in the femoropopliteal artery of diabetic and nondiabetic patients. Materials and Methods: All patients enrolled in this prospective, multicenter study underwent paclitaxel-eluting stent placement for de novo or restenotic lesions of the superficial femoral and/or popliteal artery. Baseline and follow-up walking impairment questionnaire (WIQ) scores, Rutherford classifications, and ankle-brachial index (ABI) measurements were obtained. Follow-up was completed at 1, 6, and 12 months. Results: There were 285 diabetic patients and 502 nondiabetic patients treated. There were no significant differences in mean lesion length or lesion calcification between patient groups.more » Procedural success in both treatment groups was >97 %. There were no significant differences between diabetic and nondiabetic groups in Kaplan-Meier estimates of patency, event-free survival (EFS), or freedom from target lesion revascularization (TLR) at 6 and 12 months. Both groups experienced a significant increase in ABI and WIQ values after treatment, and these improvements were sustained to 12-month follow-up; however, nondiabetic patients had significantly greater 6- and 12-month WIQ scores compared with diabetic patients. Based on covariate analysis, the only factors shown to be significant and to negatively influence patency were longer lesion length (p = 0.009), higher Rutherford classification (p = 0.02), and lack of hypertension (p = 0.02); diabetic status was not found to be a significant factor. Conclusion: Diabetic and nondiabetic patients had similar estimates of primary patency, EFS, and freedom from TLR; however, diabetic patients showed less improvement in WIQ scores compared with nondiabetic patients.« less

Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries: Twelve-Month Results of the SUPERB Trial.

PubMed

Garcia, Lawrence; Jaff, Michael R; Metzger, Christopher; Sedillo, Gino; Pershad, Ashish; Zidar, Frank; Patlola, Raghotham; Wilkins, Robert G; Espinoza, Andrey; Iskander, Ayman; Khammar, George S; Khatib, Yazan; Beasley, Robert; Makam, Satyaprakash; Kovach, Richard; Kamat, Suraj; Leon, Luis R; Eaves, William Britton; Popma, Jeffrey J; Mauri, Laura; Donohoe, Dennis; Base, Carol C; Rosenfield, Kenneth

2015-05-01

Stent-based therapy in the superficial femoral and popliteal arteries in patients with peripheral artery disease is compromised by restenosis and risk of stent fracture or distortion. A novel self-expanding nitinol stent was developed that incorporates an interwoven-wire design (Supera stent, IDEV Technologies, Inc, Webster, TX) to confer greater radial strength, flexibility, and fracture resistance. This prospective, multicenter, investigational device exemption, single-arm trial enrolled 264 patients with symptomatic peripheral artery disease undergoing percutaneous treatment of de novo or restenotic lesions of the superficial femoral or proximal popliteal (femoropopliteal) artery. Freedom from death, target lesion revascularization, or any amputation of the index limb at 30 days (+ 7 days) postprocedure was achieved in 99.2% (258/260) of patients (P < 0.001). Primary patency at 12 months (360 ± 30 days) was achieved in 78.9% (180/228) of the population (P < 0.001). Primary patency by Kaplan-Meier analysis at 12 months (360 days) was 86.3%. No stent fracture was observed by independent core laboratory analysis in the 243 stents (228 patients) evaluated at 12 months. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford-Becker category in 88.7% of patients. The SUPERB Trial, an investigational device exemption study using an interwoven nitinol wire stent in the femoropopliteal artery, achieved the efficacy and safety performance goals predesignated by the Food and Drug Administration. On the basis of the high primary patency rate, absence of stent fracture, and significant improvements in functional and quality-of-life measures, the Supera stent provides safe and effective treatment of femoropopliteal lesions in symptomatic patients with peripheral artery disease. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00933270. © 2015 American Heart Association, Inc.

Impact of Chronic Renal Failure on Safety and Effectiveness of Paclitaxel-Eluting Stents for Femoropopliteal Artery Disease: Subgroup Analysis from Zilver PTX Post-Market Surveillance Study in Japan.

PubMed

Ogawa, Yukihisa; Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Saunders, Alan T; Dake, Michael D

2017-11-01

Favorable long-term outcomes of the Zilver PTX drug-eluting stent (DES) in femoropopliteal lesions have been demonstrated. Chronic renal failure (CRF) has been shown to be a risk factor for restenosis and decreased limb salvage. The results of the DES in patients with CRF have not previously been reported. This study compares the results with the DES in patients with CRF and those without CRF. This retrospective analysis from the Zilver PTX Japan Post-Market Surveillance Study included 321 patients with CRF and 584 patients without CRF. Outcomes included freedom from target lesion revascularization (TLR) and patency. Of the patients included in this subgroup analysis, 2-year data were available for 209 patients in the CRF group and 453 patients in the non-CRF group. The two groups were similar in terms of lesion length and the frequency of in-stent restenosis. Critical limb ischemia, severe calcification, and diabetes were more common in patients with CRF, whereas total occlusion was more common in patients without CRF. Freedom from TLR rates were 81.4 versus 84.9% (p = 0.24), and patency rates were 70.7 versus 70.3% (p = 0.95) in patients with and without CRF at 2 years, respectively. This is the first comparative study of the DES in femoropopliteal artery lesions in patients with and without CRF. These results indicate that the DES placed in femoropopliteal artery lesions of CRF patients is safe and effective with similar patency and TLR rates to patients without CRF. Level 3, Post-Market Surveillance Study.

Analysis by early angiography of right internal thoracic artery grafting via the transverse sinus : predictors of graft failure.

PubMed

Ura, M; Sakata, R; Nakayama, Y; Arai, Y; Oshima, S; Noda, K

2000-02-15

There has been debate regarding whether technically demanding right internal thoracic artery (RITA) grafting via the transverse sinus can be extensively applied to patients in high-risk groups, such as patients with a small body size, elderly patients, and woman with relatively smaller coronary artery and internal thoracic artery (ITA) diameters. Of the 1456 patients who underwent isolated coronary artery bypass grafting between January 1989 and December 1998 at Kumamoto Central Hospital, 393 patients (mean age, 62.4+/-9.0 years) with the RITA anastomosed to the major branches of the circumflex artery were studied. Left ITA grafting was performed in 384 patients, and in 369, the in situ left ITA was anastomosed to the left anterior descending coronary artery using standard methods. Early postoperative angiography was performed in 381 patients. The RITA was occluded in 4 patients, and string-like artery and significant stenosis were present in 11 and 7 patients, respectively; RITA graft patency was thus 94.1%. Of the preoperative variables and angiographic data, simple and multiple logistic regression analyses identified decreased severity of native stenosis, diffuse sclerosis of native vessels, and residual side branches of the ITA as independent predictors of nonfunctional grafts. The method of ITA grafting did not influence the patency of the graft. The excellent patency rate demonstrated by this study, the largest angiographic study to date of RITA grafting via the transverse sinus, indicates that this technique can provide reliable revascularization of the left ventricle and that it has the potential to be applied to a wide variety of patients with diseased circumflex arteries.

Safety, dose, and timing of reteplase in treating occluded central venous catheters in children with cancer.

PubMed

Terrill, Kelly R; Lemons, Richard S; Goldsby, Robert E

2003-11-01

Recombinant tissue plasminogen activator, alteplase, began to be commonly used to restore the patency of occluded central venous catheters (CVCs) as urokinase production was halted in the late 1990s. However, alteplase often requires an extended dwell time to restore patency to occluded CVCs. In adults, reteplase, a newer thrombolytic agent, has been reported to restore patency to CVCs in 30 minutes. The authors prospectively evaluated the safety and efficacy of reteplase in restoring patency to occluded CVCs in children with cancer. This was a dose escalation trial. The dose of reteplase was initiated at 0.1 units and increased by increments of 0.1 units to a maximum dose of 0.4 units. Each dose was tested on at least three participants. Time to patency after reteplase administration was recorded by nurses caring for the patients. Attempts to access the line occurred every 15 minutes for 1 hour. CVCs that remained occluded after 1 hour were treated with alteplase. Reteplase was administered to 15 clotted CVCs. Twelve of the 15 were cleared with an average dwell time of 38 minutes. The time to patency did not appear to correlate with the dose. No adverse events were reported. Reteplase can restore patency to occluded CVCs in a pediatric population. Reteplase appears to have comparable efficacy with alteplase, but reteplase may require shorter dwell times. A prospective, randomized, clinical trial is warranted to determine whether reteplase is as effective as alteplase in restoring patency to occluded CVCs.

Meta-Analysis Comparing Complete Revascularization Versus Infarct-Related Only Strategies for Patients With ST-Segment Elevation Myocardial Infarction and Multivessel Coronary Artery Disease.

PubMed

Shah, Rahman; Berzingi, Chalak; Mumtaz, Mubashir; Jasper, John B; Goswami, Rohan; Morsy, Mohamed S; Ramanathan, Kodangudi B; Rao, Sunil V

2016-11-15

Several recent randomized controlled trials (RCTs) demonstrated better outcomes with multivessel complete revascularization (CR) than with infarct-related artery-only revascularization (IRA-OR) in patients with ST-segment elevation myocardial infarction. It is unclear whether CR should be performed during the index procedure (IP) at the time of primary percutaneous coronary intervention (PCI) or as a staged procedure (SP). Therefore, we performed a pairwise meta-analysis using a random-effects model and network meta-analysis using mixed-treatment comparison models to compare the efficacies of 3 revascularization strategies (IRA-OR, CR-IP, and CR-SP). Scientific databases and websites were searched to find RCTs. Data from 9 RCTs involving 2,176 patients were included. In mixed-comparison models, CR-IP decreased the risk of major adverse cardiac events (MACEs; odds ratio [OR] 0.36, 95% CI 0.25 to 0.54), recurrent myocardial infarction (MI; OR 0.50, 95% CI 0.24 to 0.91), revascularization (OR 0.24, 95% CI 0.15 to 0.38), and cardiovascular (CV) mortality (OR 0.44, 95% CI 0.20 to 0.87). However, only the rates of MACEs, MI, and CV mortality were lower with CR-SP than with IRA-OR. Similarly, in direct-comparison meta-analysis, the risk of MI was 66% lower with CR-IP than with IRA-OR, but this advantage was not seen with CR-SP. There were no differences in all-cause mortality between the 3 revascularization strategies. In conclusion, this meta-analysis shows that in patients with ST-segment elevation myocardial infarction and multivessel coronary artery disease, CR either during primary PCI or as an SP results in lower occurrences of MACE, revascularization, and CV mortality than IRA-OR. CR performed during primary PCI also results in lower rates of recurrent MI and seems the most efficacious revascularization strategy of the 3. Published by Elsevier Inc.

Costs of revascularization over eight years in the randomized and eligible patients in the Emory Angioplasty versus Surgery Trial (EAST).

PubMed

Weintraub, W S; Becker, E R; Mauldin, P D; Culler, S; Kosinski, A S; King, S B

2000-10-01

The Emory Angioplasty versus Surgery Trial (EAST) was a randomized trial that compared, by intention to treat, the clinical outcome and costs of percutaneous transluminal coronary angioplasty (PTCA) and coronary bypass grafting (CABG) for multivessel coronary artery disease. We present the findings of the economic analysis of EAST through 8 years of follow-up and compare the cost and outcomes of patients randomized in EAST versus patients eligible but not randomized (registry patients). Charges were assessed from hospital UB82 and UB92 bills and professional charges from the Emory Clinic. Hospital charges were reduced to cost through step-down accounting methods. All costs and charges were inflated to 1997 dollars. Costs were assessed for initial hospitalization and for cumulative costs of the initial hospitalization and additional revascularization procedures up to 8 years. Total 8-year costs were $46,548 for CABG and $44,491 for PTCA (p = 0.37). Cost of CABG in the eligible registry group showed a pattern similar to that for randomized patients, but total cost of PTCA was lower for registry patients than for randomized patients. Thus, the primary procedural costs of CABG are more than those for PTCA; this cost advantage, given the limits of measurement, is largely or even completely lost for randomized patients over the course of 8 years because of additional procedures after a first revascularization by PTCA.

Atherectomy in complex infrainguinal lesions: a review.

PubMed

Engelberger, S; van den Berg, J C

2015-02-01

In the femoropopliteal segment, endovascular revascularization techniques have gained the role as a first line treatment strategy. Nitinol stent placement has improved the short- and mid-term primary patency rates in most lesion types and is therefore widely applied. Stenting has several shortcomings as in-stent restenosis, stent fractures and foreign material being left behind in the vessel. The concept of atherectomy is plaque debulking. This results in a potential reduction of inflation pressure requirements in angioplasty. Stent placement and consecutive in-stent restenosis may be avoided. In this non systematic literature review, the performance of different atherectomy techniques, such as direct atherectomy, orbital atherectomy, laser debulking and rotational atherectomy in the treatment of complex femoropopliteal lesions, including long lesions, moderately to heavily calcified lesions as well as occlusions and in-stent restenosis, has been analyzed.

Adolescent External Iliac Artery Trauma: Recurrent Aneurysmal Dilatation of an Iliofemoral Saphenous Vein Graft Treated by Stent-Grafting

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lenton, James, E-mail: jlenton@doctors.org.u; Davies, John; Homer-Vanniasinkam, S.

An adolescent male sustained a severe penetrating injury to the external iliac artery. Emergency surgical revascularization was with a reversed long saphenous vein interposition graft. The primary graft and the subsequent revision graft both became aneurysmal. The second graft aneurysm was successfully excluded by endovascular stent-grafts with medium-term primary patency. A venous graft was used initially rather than a synthetic graft to reduce the risk of infection and the potential problems from future growth. Aneurysmal dilatation of venous grafts in children and adolescents is a rare but recognized complication. To the best of our knowledge, exclusion of these aneurysms withmore » stent-grafts has not been previously reported in the adolescent population.« less

Revascularization as a treatment to improve renal function

PubMed Central

Alderson, Helen V; Ritchie, James P; Kalra, Philip A

2014-01-01

An aging atherosclerosis-prone population has led to an increase in the prevalence of atherosclerotic renovascular disease (ARVD). Medical management of this disease, as with other atherosclerotic conditions, has improved over the past decade. Despite the widespread availability of endovascular revascularization procedures, there is inconsistent evidence of benefit in ARVD and no clear consensus of opinion as to the best way to select suitable patients for revascularization. Several published randomized controlled trials have attempted to provide clearer evidence for best practice in ARVD, but they have done so with varying clarity and success. In this review, we provide an overview of ARVD and its effect on renal function. We present the currently available evidence for best practice in the management of patients with ARVD with a particular focus on revascularization as a treatment to improve renal function. We provide a brief overview of the evidence for revascularization in other causes of renal artery stenosis. PMID:24600242

Comparison of coronary bypass surgery with drug-eluting stenting for the treatment of left main and/or three-vessel disease: 3-year follow-up of the SYNTAX trial.

PubMed

Kappetein, Arie Pieter; Feldman, Ted E; Mack, Michael J; Morice, Marie-Claude; Holmes, David R; Ståhle, Elisabeth; Dawkins, Keith D; Mohr, Friedrich W; Serruys, Patrick W; Colombo, Antonio

2011-09-01

Long-term randomized comparisons of percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in left main coronary (LM) disease and/or three-vessel disease (3VD) patients have been limited. This analysis compares 3-year outcomes in LM and/or 3VD patients treated with CABG or PCI with TAXUS Express stents. SYNTAX is an 85-centre randomized clinical trial (n= 1800). Prospectively screened, consecutive LM and/or 3VD patients were randomized if amenable to equivalent revascularization using either technique; if not, they were entered into a registry. Patients in the randomized cohort will continue to be followed for 5 years. At 3 years, major adverse cardiac and cerebrovascular events [MACCE: death, stroke, myocardial infarction (MI), and repeat revascularization; CABG 20.2% vs. PCI 28.0%, P< 0.001], repeat revascularization (10.7 vs. 19.7%, P< 0.001), and MI (3.6 vs. 7.1%, P= 0.002) were elevated in the PCI arm. Rates of the composite safety endpoint (death/stroke/MI 12.0 vs. 14.1%, P= 0.21) and stroke alone (3.4 vs. 2.0%, P= 0.07) were not significantly different between treatment groups. Major adverse cardiac and cerebrovascular event rates were not significantly different between arms in the LM subgroup (22.3 vs. 26.8%, P= 0.20) but were higher with PCI in the 3VD subgroup (18.8 vs. 28.8%, P< 0.001). At 3 years, MACCE was significantly higher in PCI- compared with CABG-treated patients. In patients with less complex disease (low SYNTAX scores for 3VD or low/intermediate terciles for LM patients), PCI is an acceptable revascularization, although longer follow-up is needed to evaluate these two revascularization strategies.

Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter Randomized Controlled Trial.

PubMed

Mejía, Omar Asdrúbal Vilca; Sá, Michel Pompeu Barros Oliveira; Deininger, Maurilio Onofre; Dallan, Luís Roberto Palma; Segalote, Rodrigo Coelho; Oliveira, Marco Antonio Praça de; Atik, Fernando Antibas; Santos, Magaly Arrais Dos; Silva, Pedro Gabriel Melo de Barros E; Milani, Rodrigo Mussi; Hueb, Alexandre Ciappina; Monteiro, Rosangela; Lima, Ricardo Carvalho; Lisboa, Luiz Augusto Ferreira; Dallan, Luís Alberto Oliveira; Puskas, John; Jatene, Fabio Biscegli

2017-01-01

Advances in modern medicine have led to people living longer and healthier lives. Frailty is an emerging concept in medicine yet to be explored as a risk factor in cardiac surgery. When it comes to CABG surgery, randomized controlled clinical trials have primarily focused on low-risk (ROOBY, CORONARY), elevated-risk (GOPCABE) or high-risk patients (BBS), but not on frail patients. Therefore, we believe that off-pump CABG could be an important technique in patients with limited functional capacity to respond to surgical stress. In this study, the authors introduce the new national, multicenter, randomized, controlled trial "FRAGILE", to be developed in the main cardiac surgery centers of Brazil, to clarify the potential benefit of off-pump CABG in frail patients. FRAGILE is a two-arm, parallel-group, multicentre, individually randomized (1:1) controlled trial which will enroll 630 patients with blinded outcome assessment (at 30 days, 6 months, 1 year, 2 years and 3 years), which aims to compare adverse cardiac and cerebrovascular events after off-pump versus on-pump CABG in pre-frail and frail patients. Primary outcomes will be all-cause mortality, acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome/cardiogenic shock, stroke, and coronary reintervention. Secondary outcomes will be major adverse cardiac and cerebrovascular events, operative time, mechanical ventilation time, hyperdynamic shock, new onset of atrial fibrillation, renal replacement therapy, reoperation for bleeding, pneumonia, length of stay in intensive care unit, length of stay in hospital, number of units of blood transfused, graft patency, rate of complete revascularization, neurobehavioral outcomes after cardiac surgery, quality of life after cardiac surgery and costs. FRAGILE trial will determine whether off-pump CABG is superior to conventional on-pump CABG in the surgical treatment of pre-frail and frail patients. ClinicalTrials.gov, ID: NCT02338947. Registered on August 29th 2014; last updated on March 21st 2016.

Culprit versus multivessel coronary intervention in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials.

PubMed

Vaidya, Satyanarayana R; Qamar, Arman; Arora, Sameer; Devarapally, Santhosh R; Kondur, Ashok; Kaul, Prashant

2018-03-01

The 2015 American College of Cardiology/American Heart Association update on primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) recommended PCI of the non-infarct-related artery at the time of primary PCI (class IIb recommendation). Despite evidence supporting complete revascularization in STEMI, its benefit on mortality rates is uncertain. We searched all available databases for randomized controlled trials comparing complete multivessel percutaneous coronary intervention (CMV PCI) with infarct-artery-only revascularization in patients with STEMI. Summary risk ratios and 95% confidence intervals (CIs) were calculated for both the efficacy and safety outcomes. Nine randomized controlled trials fulfilled the inclusion criteria, yielding 2991 patients. Follow-up periods ranged from 6 to 36 months. Compared with infarct-related artery-only PCI, CMV PCI was associated with significantly lower rates of major adverse cardiac events [relative risk (RR)=0.54, 95% CI=0.41-0.71; P<0.00001], cardiovascular mortality (RR=0.48, 95% CI=0.28-0.80; P=0.005), and repeat revascularization (RR=0.38, 95% CI=0.30-0.47; P<0.00001). Although, contrast-induced nephropathy and major bleed rates were comparable between both groups, CMV PCI failed to show any reduction in all-cause mortality (RR=0.75, 95% CI=0.53-1.07; P=0.11) and nonfatal myocardial infarction (RR=0.69, 95% CI=0.43-1.10; P=0.12). Our results suggest that in patients with STEMI and multivessel disease, complete revascularization is safe, and is associated with reduced risks of major adverse cardiac events and cardiac death along with a reduced need for repeat revascularization. However, it showed no beneficial effect on all-cause mortality and nonfatal myocardial infarction.

Less is more: as less as reasonably achievable stenting (ALARAS) strategy in the femoropopliteal area.

PubMed

Deloose, Koen; Callaert, Joren

2018-05-23

Although evidence supports that the performance of drug coated balloons seems to be lesion complexity independent, it is quite clear that in long lesions, severe calcified lesions and chronic total occlusions, the bail out stent ratio is very high and that the "leaving nothing behind" strategy remains a dream in a lot of our daily cases. On the other side of the spectrum, "full metal jackets" of nitinol stents are creating even more problems. Stent fractures, intimal hyperplasia and reintervention difficulties complicate the recurrent vascular disease treatment. The go-between with the "As Less As Reasonably Achievable Stenting"-strategy (ALARAS), earlier named with a bad name "spot" stenting, seems the most attractive one. Scaffolding where needed and allowing freedom of vessel motion will lead to reduction of TLR rates. New technologies like the Tack Endovascular System and the Vascuflex MultiLOC MSD are responding very well tot this idea. Animal tests and pivotal trials (like TOBA and LOCOMOTIVE trials) already showed with both devices good results in terms of patencies and freedom from target lesion revascularizations, and... with less metallic implants. Primary patency at 12 months was 76.4% and 85.7% in the TOBA and LOCOMOTIVE trial respectively. Target lesion revascularization at 12 months was 10.5% and 9.3% respectively. In an era of "leaving nothing behind", post-angioplasty dissections are more frequent than ever. With a direct link between lesion complexity, dissections and increase of TLR rates, scaffolding solutions remains essential. The "As Less As Reasonably Achievable Stenting" (ALARAS) strategy tries to leave as little metal behind as possible, minimizing the risk of stent fractures, allowing freedom of vessel motion and reducing TLR rates. However, the lack of clear strategies and guidelines in where to scaffold which kind of dissections is the biggest issue at the moment. More objective classifications based on newer types of imaging like intra-operative ultrasound, IVUS, OCT and/or FFR pressure wire gradient measurements will potentially offer more solutions in this interesting field.

Treatment of hand ischemia following angioaccess surgery using the distal revascularization interval-ligation technique with preservation of vascular access: description of an 18-case series.

PubMed

Sessa, Carmine; Riehl, Gregory; Porcu, Paolo; Pichot, Olivier; Palacin, Pedro; Maghlaoua, Mohamed; Magne, Jean-Luc

2004-11-01

Hand ischemia is a rare complication of angioaccess surgery for hemodialysis. Management usually requires ligation of the arteriovenous fistula (AVF). The purpose of this report is to describe our experience with the use of the distal revascularization interval-ligation (DRIL) technique for treatment of ischemia without ligation of the AVF. From January 1999 to September 2002, the DRIL technique was used to treat 18 patients (10 men, 8 women, 10 diabetic patients) with severe paresthesia of the hand (n = 9) and finger necrosis (n = 10). The AVF was located at the elbow in 16 patients and at the wrist in 2 patients. Mean flow distal to the AVF was less than 10 mL in 5 patients, less than 5 mL in 10, and unmeasurable in 3. The conduit used for all DRIL arterial bypasses, including 15 brachiobrachial bypasses, 1 axillobrachial bypass, 1 brachioradial bypass, and 1 radioradial bypass, was the great saphenous vein graft. Trophic manifestations required finger amputation in five patients, pulpar necrosis resection in four, and transmetacarpal amputation of the index finger in one patient. Symptoms disappeared in 13 patients (73%) and improved in 5 (27%). The time required for healing of finger amputations and trophic manifestations ranged from 15 days to 2 months. Mean arterial flow through the DRIL bypass was 50 mL/min (range, 20-90 mL/min). With a mean follow-up interval of 16 months (range, 5-48 months), primary patency of the DRIL artery bypass and AVF was 94% and the limb salvage rate was 100%. The DRIL technique is the most effective procedure for treatment of angioaccess-induced hand ischemia. This technique can be used to achieve persistent relief of symptoms with continued access patency. The DRIL artery bypass improves vacularization of the hand, and ligature of the artery stops the vascular steal without affecting hemodialysis access. The DRIL technique should be proposed as first-line treatment for hand ischemia due to AVF for hemodialysis.

Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty.

PubMed

Bosiers, Marc; Scheinert, Dierk; Hendriks, Jeroen M H; Wissgott, Christian; Peeters, Patrick; Zeller, Thomas; Brodmann, Marianne; Staffa, Robert

2016-07-01

The mechanism of angioplasty is disruption of atherosclerotic plaque, which often results in dissections. Dissection after percutaneous transluminal angioplasty (PTA) remains a significant clinical problem and untreated may cause acute occlusion or later restenosis. Stents are used to manage dissections, which is often followed by in-stent restenosis and occasionally stent fracture. Tack (Intact Vascular, Wayne, Pa) implants have minimal metal and low radial force and are specifically designed for dissection repair. This study evaluated Tack implants for treatment of dissections resulting from standard balloon PTA for femoral-popliteal arterial disease. Twelve-month outcomes after Tack treatment of post-PTA dissections are described. This prospective, single-arm study evaluated patients with ischemia (Rutherford clinical category 2-4) caused by lesions of the superficial femoral and popliteal arteries. Patients were treated with standard balloon angioplasty, and post-PTA dissections were treated with Tacks. The primary end points were core laboratory-adjudicated device technical success, defined as the ability of the Tack implants to resolve post-PTA dissection, and device safety, defined as the absence of new-onset major adverse events. Patients were followed up to 12 months after implantation. Tacks were used in 130 patients with post-PTA dissections (74.0% ≥ grade C). Technical success was achieved in 128 (98.5%) patients with no major adverse events at 30 days. The 12-month patency was 76.4%, and freedom from target lesion revascularization was 89.5%. Significant improvement from baseline was observed in Rutherford clinical category (82.8% with grade ≤1) and ankle-brachial index (0.68 ± 0.18 to 0.94 ± 0.15; P < .0001). Tack implant treatment of post-PTA dissection was safe, produced reasonable patency, and resulted in low rates of target lesion revascularization. Tack treatment represents a new, minimal metal paradigm for dissection repair that can safely improve the clinical results associated with PTA. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months

PubMed Central

Rundback, John H.; Peeters, Patrick; George, Jon C.; Jaff, Michael R.; Faries, Peter L.

2017-01-01

Purpose: To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions. Methods: Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2–4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed. Results: Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender. Conclusion: Nine-month results of the VISIBILITY Iliac stent study (ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts. PMID:28351204

Barriers to the universal adoption of bilateral internal mammary artery grafting.

PubMed

Umakanthan, Jeremiah; Jeyakumar, Panch; Umakanthan, Branavan; Jeyakumar, Nikeshan; Senthilkumar, Nadarajah; Saraswathy, Mathioli R; Umakanthan, Padminidevi; Umakanthan, Janani; Sial, Tamoor; Abrina, Sofia; Buendia, Frances M; Pan, Irene; Kamath, Ramadas K; Pathmarajah, Canagaratnam; Sivalingam, Kanagaratnam; Nathan, Shan A; Sunder, Shun K; Mahendra, Tom; Umakanthan, Ramanan

2015-04-01

The left internal mammary artery (LIMA) graft is considered the "gold standard" of coronary artery bypass grafting (CABG). This conduit provides increased survival, symptomatic relief, increased freedom from myocardial infarction, and increased freedom from re-intervention when compared to saphenous venous grafting. It has a remarkable long term patency rate with clinical and angiographic outcomes that are unmatched by other conduits. Given the fact that patients often require more than one graft during a coronary revascularization procedure, the prospect of bilateral internal mammary artery (BIMA) grafting has been very appealing to some surgeons. BIMA grafting has been extensively studied via multiple retrospective and prospective cohort studies and findings have indicated that BIMA grafting can have an increased survival benefit when compared to LIMA grafting alone. As a result, this technique has accrued increasing popularity over the course of the last decade. Yet, questions still remain on whether BIMA grafting is the optimal treatment modality for patients in terms of long-term prognosis. There is limited data at the present time from randomized controlled trials and only 4-12% of CABGs performed today utilize BIMA grafting. Concerns regarding perioperative complications, which patient subsets are at higher risks for complications from the technique, and the technical challenges involved in utilizing and teaching the technique have limited its widespread use. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

Randomized comparison of percutaneous coronary intervention with coronary artery bypass grafting in diabetic patients. 1-year results of the CARDia (Coronary Artery Revascularization in Diabetes) trial.

PubMed

Kapur, Akhil; Hall, Roger J; Malik, Iqbal S; Qureshi, Ayesha C; Butts, Jeremy; de Belder, Mark; Baumbach, Andreas; Angelini, Gianni; de Belder, Adam; Oldroyd, Keith G; Flather, Marcus; Roughton, Michael; Nihoyannopoulos, Petros; Bagger, Jens Peder; Morgan, Kenneth; Beatt, Kevin J

2010-02-02

The purpose of this study was to compare the safety and efficacy of percutaneous coronary intervention (PCI) with stenting against coronary artery bypass grafting (CABG) in patients with diabetes and symptomatic multivessel coronary artery disease. CABG is the established method of revascularization in patients with diabetes and multivessel coronary disease, but with advances in PCI, there is uncertainty whether CABG remains the preferred method of revascularization. The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), and stroke, and the main secondary outcome included the addition of repeat revascularization to the primary outcome events. A total of 510 diabetic patients with multivessel or complex single-vessel coronary disease from 24 centers were randomized to PCI plus stenting (and routine abciximab) or CABG. The primary comparison used a noninferiority method with the upper boundary of the 95% confidence interval (CI) not to exceed 1.3 to declare PCI noninferior. Bare-metal stents were used initially, but a switch to Cypher (sirolimus drug-eluting) stents (Cordis, Johnson & Johnson, Bridgewater, New Jersey) was made when these became available. At 1 year of follow-up, the composite rate of death, MI, and stroke was 10.5% in the CABG group and 13.0% in the PCI group (hazard ratio [HR]: 1.25, 95% CI: 0.75 to 2.09; p=0.39), all-cause mortality rates were 3.2% and 3.2%, and the rates of death, MI, stroke, or repeat revascularization were 11.3% and 19.3% (HR: 1.77, 95% CI: 1.11 to 2.82; p=0.02), respectively. When the patients who underwent CABG were compared with the subset of patients who received drug-eluting stents (69% of patients), the primary outcome rates were 12.4% and 11.6% (HR: 0.93, 95% CI: 0.51 to 1.71; p=0.82), respectively. The CARDia (Coronary Artery Revascularization in Diabetes) trial is the first randomized trial of coronary revascularization in diabetic patients, but the 1-year results did not show that PCI is noninferior to CABG. However, the CARDia trial did show that multivessel PCI is feasible in patients with diabetes, but longer-term follow-up and data from other trials will be needed to provide a more precise comparison of the efficacy of these 2 revascularization strategies. (The Coronary Artery Revascularisation in Diabetes trial; ISRCTN19872154). Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Design of the multicenter standardized supervised exercise training intervention for the claudication: exercise vs endoluminal revascularization (CLEVER) study.

PubMed

Bronas, Ulf G; Hirsch, Alan T; Murphy, Timothy; Badenhop, Dalynn; Collins, Tracie C; Ehrman, Jonathan K; Ershow, Abby G; Lewis, Beth; Treat-Jacobson, Diane J; Walsh, M Eileen; Oldenburg, Niki; Regensteiner, Judith G

2009-11-01

The CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study is the first randomized, controlled, clinical, multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication. In this report, the methods and dissemination techniques of the supervised exercise training intervention are described. A total of 217 participants are being recruited and randomized to one of three arms: (1) optimal medical care; (2) aortoiliac revascularization with stent; or (3) supervised exercise training. Of the enrolled patients, 84 will receive supervised exercise therapy. Supervised exercise will be administered according to a protocol designed by a central CLEVER exercise training committee based on validated methods previously used in single center randomized control trials. The protocol will be implemented at each site by an exercise committee member using training methods developed and standardized by the exercise training committee. The exercise training committee reviews progress and compliance with the protocol of each participant weekly. In conclusion, a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy, safety and cost-effectiveness for patients with claudication due to peripheral arterial disease (PAD) is being evaluated for the first time in CLEVER. The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication resulting from PAD and provide standardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice.

A randomized trial of therapies for type 2 diabetes and coronary artery disease.

PubMed

Frye, Robert L; August, Phyllis; Brooks, Maria Mori; Hardison, Regina M; Kelsey, Sheryl F; MacGregor, Joan M; Orchard, Trevor J; Chaitman, Bernard R; Genuth, Saul M; Goldberg, Suzanne H; Hlatky, Mark A; Jones, Teresa L Z; Molitch, Mark E; Nesto, Richard W; Sako, Edward Y; Sobel, Burton E

2009-06-11

Optimal treatment for patients with both type 2 diabetes mellitus and stable ischemic heart disease has not been established. We randomly assigned 2368 patients with both type 2 diabetes and heart disease to undergo either prompt revascularization with intensive medical therapy or intensive medical therapy alone and to undergo either insulin-sensitization or insulin-provision therapy. Primary end points were the rate of death and a composite of death, myocardial infarction, or stroke (major cardiovascular events). Randomization was stratified according to the choice of percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) as the more appropriate intervention. At 5 years, rates of survival did not differ significantly between the revascularization group (88.3%) and the medical-therapy group (87.8%, P=0.97) or between the insulin-sensitization group (88.2%) and the insulin-provision group (87.9%, P=0.89). The rates of freedom from major cardiovascular events also did not differ significantly among the groups: 77.2% in the revascularization group and 75.9% in the medical-treatment group (P=0.70) and 77.7% in the insulin-sensitization group and 75.4% in the insulin-provision group (P=0.13). In the PCI stratum, there was no significant difference in primary end points between the revascularization group and the medical-therapy group. In the CABG stratum, the rate of major cardiovascular events was significantly lower in the revascularization group (22.4%) than in the medical-therapy group (30.5%, P=0.01; P=0.002 for interaction between stratum and study group). Adverse events and serious adverse events were generally similar among the groups, although severe hypoglycemia was more frequent in the insulin-provision group (9.2%) than in the insulin-sensitization group (5.9%, P=0.003). Overall, there was no significant difference in the rates of death and major cardiovascular events between patients undergoing prompt revascularization and those undergoing medical therapy or between strategies of insulin sensitization and insulin provision. (ClinicalTrials.gov number, NCT00006305.) 2009 Massachusetts Medical Society

Negative pressure wound therapy for high-risk wounds in lower extremity revascularization: study protocol for a randomized controlled trial.

PubMed

Murphy, Patrick; Lee, Kevin; Dubois, Luc; DeRose, Guy; Forbes, Thomas; Power, Adam

2015-11-04

Rates of surgical site infections (SSIs) following groin incision for femoral artery exposure are much higher than expected of a clean operation. The morbidity and mortality is high, particularly with the use of prosthetic grafts. The vascular surgery population is at an increased risk of SSIs related to peripheral vascular disease (PVD), diabetes, obesity, previous surgery and presence of tissue loss. Negative pressure wound therapy (NPWT) dressings have been used on primarily closed incisions to reduce surgical site infections in other surgical disciplines. We have not come across any randomized controlled trials to support the prophylactic use of negative pressure wound therapy in high-risk vascular patients undergoing lower limb revascularization. In this single-center, prospective randomized controlled trial, patients scheduled for a lower limb revascularization requiring open femoral artery exposure who are at a high risk (BMI > 30 kg/m(2), previous femoral cutdown or Rutherford V or VI category for chronic limb ischemia) will be eligible for the study. A total of 108 groin incisions will be randomized to the use of a negative pressure wound device or standard adhesive gauze dressing. Patients will be followed in hospital and reassessed within the first 30 days postoperatively. The primary outcome is SSI within the first 30 days of surgery and will be determined using the intention-to-treat principle. Secondary outcomes include length of stay, emergency room visits, reoperation, amputation and mortality. A cost analysis will be performed. The trial is expected to define the role of NPWT in SSI prophylaxis for lower limb revascularization in high-risk vascular patients. The results of the study will be used to inform current best practice for perioperative care and the minimization of SSIs. NCT02084017 , March 2014.

Impact of Clinical Trial Results on the Temporal Trends of Carotid Endarterectomy and Stenting From 2002 to 2014

PubMed Central

Hussain, Mohamad A.; Mamdani, Muhammad; Tu, Jack V.; Saposnik, Gustavo; Khoushhal, Zeyad; Aljabri, Badr; Verma, Subdoh

2016-01-01

Background and Purpose— Randomized trials provide conflicting data for the efficacy of carotid-artery stenting compared with endarterectomy. The purpose of this study was to examine the impact of conflicting clinical trial publications on the utilization rates of carotid revascularization procedures. Methods— We conducted a population-level time-series analysis of all individuals who underwent carotid endarterectomy and stenting in Ontario, Canada (2002–2014). The primary analysis examined temporal changes in the rates of carotid revascularization procedures after publications of major randomized trials. Secondary analyses examined changes in overall and age, sex, carotid-artery symptom, and operator specialty–specific procedure rates. Results— A total of 16 772 patients were studied (14 394 endarterectomy [86%]; 2378 stenting [14%]). The overall rate of carotid revascularization decreased from 6.0 procedures per 100 000 individuals ≥40 years old in April 2002 to 4.3 procedures in the first quarter of 2014 (29% decrease; P<0.001). The rate of endarterectomy decreased by 36% (P<0.001), whereas the rate of carotid-artery stenting increased by 72% (P=0.006). We observed a marked increase (P=0.01) in stenting after publication of the SAPPHIRE trial (Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy) in 2004, whereas stenting remained relatively unchanged after subsequent randomized trials published in 2006 (P=0.11) and 2010 (P=0.34). In contrast, endarterectomy decreased after trials published in 2006 (P=0.04) and 2010 (P=0.005). Conclusions— Although the overall rates of carotid revascularization and endarterectomy have fallen since 2002, the rate of carotid-artery stenting has risen since the publication of stenting-favorable SAPPHIRE trial. Subsequent conflicting randomized trials were associated with a decreasing rate of carotid endarterectomy. PMID:27834754

The transmyocardial laser revascularization international registry report.

PubMed

Burns, S M; Sharples, L D; Tait, S; Caine, N; Wallwork, J; Schofield, P M

1999-01-01

This report aimed to provide an analysis of the data submitted from Europe and Asia on transmyocardial laser revascularization. Prospective data was recorded on 967 patients with intractable angina not amenable to conventional revascularization in 21 European and Asian centres performing transmyocardial laser revascularization using the PLC Medical Systems CO2 laser. Patient characteristics, operative details and early complications following transmyocardial laser revascularization were recorded. The in-hospital death rate was 9.7% (95% confidence interval 7.8% to 11.6%). Other early complications were consistent with similar cardiothoracic surgical procedures. There was a decrease of two or more Canadian Cardiovascular Score angina classes in 47.3%, 45.4% and 34.0% of survivors at 3, 6 and 12 months follow-up, respectively (P=0.001 for each). Treadmill exercise time increased by 42 s at 3 months (P=0.008), 1 min 43 s at 6 months (P<0.001) and 1 min 50 s at 12 months (P<0.001) against pre-operative times of 6 min. Uncontrolled registry data suggest that transmyocardial laser revascularization may lead to a decrease in angina and improved exercise tolerance. It does, however, have a risk of peri-operative morbidity and mortality. Definitive results from randomized controlled trials are awaited.

The FOAM study: is Hysterosalpingo foam sonography (HyFoSy) a cost-effective alternative for hysterosalpingography (HSG) in assessing tubal patency in subfertile women? Study protocol for a randomized controlled trial.

PubMed

van Rijswijk, Joukje; van Welie, Nienke; Dreyer, Kim; van Hooff, Machiel H A; de Bruin, Jan Peter; Verhoeve, Harold R; Mol, Femke; Kleiman-Broeze, Kimiko A; Traas, Maaike A F; Muijsers, Guido J J M; Manger, Arentje P; Gianotten, Judith; de Koning, Cornelia H; Koning, Aafke M H; Bayram, Neriman; van der Ham, David P; Vrouenraets, Francisca P J M; Kalafusova, Michaela; van de Laar, Bob I G; Kaijser, Jeroen; van Oostwaard, Miriam F; Meijer, Wouter J; Broekmans, Frank J M; Valkenburg, Olivier; van der Voet, Lucy F; van Disseldorp, Jeroen; Lambers, Marieke J; Peters, Henrike E; Lier, Marit C I; Lambalk, Cornelis B; van Wely, Madelon; Bossuyt, Patrick M M; Stoker, Jaap; van der Veen, Fulco; Mol, Ben W J; Mijatovic, Velja

2018-05-09

Tubal pathology is a causative factor in 20% of subfertile couples. Traditionally, tubal testing during fertility work-up is performed by hysterosalpingography (HSG). Hysterosalpingo-foam sonography (HyFoSy) is a new technique that is thought to have comparable accuracy as HSG, while it is less expensive and more patient friendly. HyFoSy would be an acceptable alternative for HSG, provided it has similar effectiveness in terms of patient outcomes. We aim to compare the effectiveness and costs of management guided by HyFoSy or by HSG. Consenting women will undergo tubal testing by both HyFoSy and HSG in a randomized order during fertility work-up. The study group will consist of 1163 subfertile women between 18 and 41 years old who are scheduled for tubal patency testing during their fertility work-up. Women with anovulatory cycles not responding to ovulation induction, endometriosis, severe male subfertility or a known contrast (iodine) allergy will be excluded. We anticipate that 7 % (N = 82) of the participants will have discordant test results for HyFoSy and HSG. These participants will be randomly allocated to either a management strategy based on HyFoSy or a management strategy based on HSG, resulting in either a diagnostic laparoscopy with chromopertubation or a strategy that assumes tubal patency (intrauterine insemination or expectant management). The primary outcome is ongoing pregnancy leading to live birth within 12 months after randomization. Secondary outcomes are patient pain scores, time to pregnancy, clinical pregnancy, miscarriage rate, multiple pregnancy rate, preterm birth rate and number of additional treatments. Costs will be estimated by counting resource use and calculating unit prices. This trial will compare the effectiveness and costs of HyFoSy versus HSG in assessing tubal patency in subfertile women. Dutch Trial Register (NTR 4746, http://www.trialregister.nl ). Date of registration: 19 August 2014.

Randomized clinical trial of negative pressure wound therapy for high-risk groin wounds in lower extremity revascularization.

PubMed

Lee, Kevin; Murphy, Patrick B; Ingves, Matthew V; Duncan, Audra; DeRose, Guy; Dubois, Luc; Forbes, Thomas L; Power, Adam

2017-12-01

The surgical site infection (SSI) rate in vascular surgery after groin incision for lower extremity revascularization can lead to significant morbidity and mortality. This trial was designed to study the effect of negative pressure wound therapy (NPWT) on SSI in closed groin wounds after lower extremity revascularization in patients at high risk for SSI. A single-center, randomized, controlled trial was performed at an academic tertiary medical center. Patients with previous femoral artery surgical exposure, body mass index of >30 kg/m 2 or the presence of ischemic tissue loss were classified as a high-risk patient for SSI. All wounds were closed primarily and patients were randomized to either NPWT or standard dressing. The primary outcome of the trial was postoperative 30-day SSI in the groin wound. The secondary outcomes included 90-day SSI, hospital duration of stay, readmissions or reoperations for SSI, and mortality. A total of 102 patients were randomized between August 2014 and December 2015. Patients were classified as at high risk owing to the presence of previous femoral artery cut down (29%), body mass index of >30 kg/m 2 (39%) or presence of ischemic tissue loss (32%). Revascularization procedures performed included femoral to distal artery bypass (57%), femoral endarterectomy (18%), femoral to femoral artery crossover (17%), and other procedures (8%). The primary outcome of 30-day SSI was 11% in NPWT group versus 19% in standard dressing group (P = .24). There was a statistically significant shorter mean duration of hospital stay in the NPWT group (6.4 days) compared with the standard group (8.9 days; P = .01). There was no difference in readmission or reoperation for SSI or mortality between the two groups. This study demonstrated a nonsignificant lower rate of groin SSI in high-risk revascularization patients with NPWT compared with standard dressing. Owing to a lower than expected infection rate, the study was underpowered to detect a difference at the prespecified level. The NPWT group did show significantly shorter mean hospital duration of stay compared with the standard dressing group. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Outcomes after coronary computed tomography angiography in the emergency department: a systematic review and meta-analysis of randomized, controlled trials.

PubMed

Hulten, Edward; Pickett, Christopher; Bittencourt, Marcio Sommer; Villines, Todd C; Petrillo, Sara; Di Carli, Marcelo F; Blankstein, Ron

2013-02-26

The aim of the study was to systematically review and perform a meta-analysis of randomized, controlled trials of coronary computed tomography angiography (CCTA) versus usual care (UC) triage of acute chest pain in the emergency department (ED). CCTA allows rapid evaluation of patients presenting to the ED with acute chest pain syndromes; however, the impact of such testing on patient management and downstream testing has emerged as a concern. We systematically searched for randomized, controlled trials of CCTA in the ED and performed a meta-analysis of clinical outcomes. Four randomized, controlled trials were included, with 1,869 patients undergoing CCTA and 1,397 undergoing UC. There were no deaths and no difference in the incidence of myocardial infarction, post-discharge ED visits, or rehospitalizations. Four studies reported decreased length of stay with CCTA and 3 reported cost savings; 8.4% of patients undergoing CCTA versus 6.3% of those receiving UC underwent invasive coronary angiography (ICA), whereas 4.6% of patients undergoing CCTA versus 2.6% of those receiving UC underwent coronary revascularization. The odds ratio of ICA for CCTA patients versus UC patients was 1.36 (95% confidence interval [CI]: 1.03 to 1.80, p = 0.030), and for revascularization, it was 1.81 (95% CI: 1.20 to 2.72, p = 0.004). The absolute increase in ICA after CCTA was 21 per 1,000 CCTA patients (95% CI: 1.8 to 44.9), and the number needed to scan was 48. The absolute increase in revascularization after CCTA was 20 per 1,000 patients (95% CI: 5.0 to 41.4); the number needed to scan was 50. Both percutaneous coronary intervention and coronary artery bypass graft surgery independently contributed to the significant increase in revascularization. Compared with UC, the use of CCTA in the ED is associated with decreased ED cost and length of stay but increased ICA and revascularization. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Re-OPCAB vs. Re-CABG for myocardial revascularization.

PubMed

Schütz, A; Mair, H; Wildhirt, S M; Gillrath, G; Lamm, P; Kilger, E; Reichart, B

2001-06-01

The present study compared redo coronary artery bypass grafting (Re-OPCAB) techniques with conventional redo coronary artery bypass grafting (Re-CABG) with particular focus on myocardial damage and clinical outcome parameters. Redo OPCAB (Re-OPCAB) was performed on 20 consecutive patients (15 males, mean age 63.2 +/- 9.3 years) using either the anterolateral approach for minimally invasive direct coronary artery bypass (n = 4) or the Octopus technique with regular sternotomy (n = 16). The Re-CABG group consisted of 20 consecutive patients (18 males, mean age 67.1 +/- 6.6 years). Groups did not differ in the number of atherosclerotic risk factors, or left ventricular, renal or liver function. Duration of surgery, number of bypass grafts and amount of transfused red blood cells did not differ significantly between both groups. Requirement of epinephrine (mg/h) within the first 24 h was lower in the Re-OPCAB group (Re-OPCAB: 0.14 +/- 0.22 vs. CABG: 0.88 +/- 0.97; p<0.01). In addition, CKMB levels at 24 h after operation were lower in the Re-OPCAB group (Re-OPCAB: 10.0 +/- 10.1 vs. Re-CABG: 38.7 +/- 28.1 U/l, p<0.001). There were no acute myocardial infarctions or deaths in the perioperative period. In the CABG group, there was a longer time period to extubation (hours) (Re-OPCAB: 9.8 +/- 3.9 vs. Re-CABG: 28.7 +/- 25.5; p<0.001), and the length of ICU stay was significantly prolonged (OPCAB: 1.3 +/- 0.5 versus Re-CABG: 4.4 +/- 8.7; p<0.001). The graft patency rate at follow-up was 95% in the Re-OPCAB group. Re-OPCAB results in decreased cardiac specific enzyme release, reduced requirement of inotropes and comparable clinical outcome in the early postoperative period. It is an appropriate alternative to conventional Re-CABG in selected patients awaiting reoperation for myocardial revascularization. Larger prospective and randomized trials are required to select the appropriate patient who benefits most from one or the other treatment regime.

Vein Graft Preservation Solutions, Patency, and Outcomes After Coronary Artery Bypass Graft Surgery

PubMed Central

Harskamp, Ralf E.; Alexander, John H.; Schulte, Phillip J.; Brophy, Colleen M.; Mack, Michael J.; Peterson, Eric D.; Williams, Judson B.; Gibson, C. Michael; Califf, Robert M.; Kouchoukos, Nicholas T.; Harrington, Robert A.; Ferguson, T. Bruce; Lopes, Renato D.

2015-01-01

IMPORTANCE In vitro and animal model data suggest that intraoperative preservation solutions may influence endothelial function and vein graft failure (VGF) after coronary artery bypass graft (CABG) surgery. Clinical studies to validate these findings are lacking. OBJECTIVE To evaluate the effect of vein graft preservation solutions on VGF and clinical outcomes in patients undergoing CABG surgery. DESIGN, SETTING, AND PARTICIPANTS Data from the Project of Ex-Vivo Vein Graft Engineering via Transfection IV (PREVENT IV) study, a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that enrolled 3014 patients at 107 US sites from August 1, 2002, through October 22, 2003, were used. Eligibility criteria for the trial included CABG surgery for coronary artery disease with at least 2 planned vein grafts. INTERVENTIONS Preservation of vein grafts in saline, blood, or buffered saline solutions. MAIN OUTCOMES AND MEASURES One-year angiographic VGF and 5-year rates of death, myocardial infarction, and subsequent revascularization. RESULTS Most patients had grafts preserved in saline (1339 [44.4%]), followed by blood (971 [32.2%]) and buffered saline (507 [16.8%]). Baseline characteristics were similar among groups. One-year VGF rates were much lower in the buffered saline group than in the saline group (patient-level odds ratio [OR], 0.59 [95% CI, 0.45-0.78; P < .001]; graft-level OR, 0.63 [95% CI, 0.49-0.79; P < .001]) or the blood group (patient-level OR, 0.62 [95% CI, 0.46-0.83; P = .001]; graft-level OR, 0.63 [95% CI, 0.48-0.81; P < .001]). Use of buffered saline solution also tended to be associated with a lower 5-year risk for death, myocardial infarction, or subsequent revascularization compared with saline (hazard ratio, 0.81 [95% CI, 0.64-1.02; P = .08]) and blood (0.81 [0.63-1.03; P = .09]) solutions. CONCLUSIONS AND RELEVANCE Patients undergoing CABG whose vein grafts were preserved in a buffered saline solution had lower VGF rates and trends toward better long-term clinical outcomes compared with patients whose grafts were preserved in saline- or blood-based solutions. PMID:25073921

Effects of a platelet gel on early graft revascularization after anterior cruciate ligament reconstruction: a prospective, randomized, double-blind, clinical trial.

PubMed

Vogrin, M; Rupreht, M; Dinevski, D; Hašpl, M; Kuhta, M; Jevsek, M; Knežević, M; Rožman, P

2010-01-01

Slow graft healing in bone tunnels and a slow graft ligamentization process after anterior cruciate ligament (ACL) reconstruction are some of the reasons for prolonged rehabilitation. The purpose of this study was to determine if the use of platelet gel (PG) accelerates early graft revascularization after ACL reconstruction. PG was produced from autologous platelet-rich plasma and applied locally. We quantitatively evaluated the revascularization process in the osteoligamentous interface zone in the bone tunnels and in the intra-articular part of the graft by means of contrast-enhanced magnetic resonance imaging (MRI). After 4-6 weeks, the PG-treated group demonstrated a significantly higher level of vascularization in the osteoligamentous interface (0.33 ± 0.09) than the control group (0.16 ± 0.09, p < 0.001). In the intra-articular part of the graft, we found no evidence of revascularization in either group. Locally applied PG enhanced early revascularization of the graft in the osteoligamentous interface zone after ACL reconstruction. Copyright © 2010 S. Karger AG, Basel.

Outcomes of spot stenting versus long stenting after intentional subintimal approach for long chronic total occlusions of the femoropopliteal artery.

PubMed

Hong, Sung-Jin; Ko, Young-Guk; Shin, Dong-Ho; Kim, Jung-Sun; Kim, Byeong-Keuk; Choi, Donghoon; Hong, Myeong-Ki; Jang, Yangsoo

2015-03-01

This study sought to compare the outcomes of spot stenting versus long stenting after intentional subintimal approach for long femoropopliteal chronic total occlusions (CTO). The optimal stenting strategy following the subintimal recanalization of long femoropopliteal chronic total occlusions has not been investigated. A total of 196 limbs in 163 patients, implanted with bare nitinol stents after subintimal approach in long femoropopliteal occlusions (lesion length 25 ± 8 cm), were retrospectively analyzed. The primary patency was compared between spot stenting (n = 129) and long stenting (n = 67). Baseline characteristics and immediate procedural results were similar between groups. Adjusted-primary patency (47% vs. 77%, p < 0.001) and adjusted-freedom from target lesion revascularization (52% vs. 84%, p < 0.001) at 2 years were significantly lower in the long stenting group than in the spot stenting group. The incidence of stent fracture, fracture type, and restenosis pattern did not differ between groups. Long stenting was an independent predictor of restenosis (hazard ratio [HR]: 2.0) along with other risk factors such as nonuse of clopidogrel (HR: 3.3) or cilostazol (HR: 2.2), small stent diameter (HR: 0.6), poor run-off (HR: 1.9), and post-procedural ankle-brachial index (HR: 0.1). Compared with spot stenting after adjustment using inverse probability of treatment weighting, long stenting, especially involving the P2 or P3 segment of the popliteal artery, was independently associated with 7.5-fold increases in restenosis risk (p < 0.001). The primary patency was significantly higher with spot stenting than with long stenting following subintimal approach for long femoropopliteal chronic total occlusions. The risk of restenosis was especially higher when long stenting was extended to the distal popliteal artery. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Below-the-ankle Angioplasty and Stenting for Limb Salvage: Anatomical Considerations and Long-term Outcomes

DOE Office of Scientific and Technical Information (OSTI.GOV)

Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr; Diamantopoulos, Athanasios; Spiliopoulos, Stavros

2013-08-01

PurposeTo report the long-term angiographic and clinical results in a series of below-the-ankle (BTA) angioplasty procedures and to present some biomechanical issues related to the unique anatomical geometry of the ankle.MethodsWe performed a retrospective analysis of BTA angioplasty procedures. Clinical end points included technical success, patient mortality, salvage of the treated foot, and repeat target lesion revascularization. Imaging end points included primary patency, binary restenosis of the target lesion at the 50 % threshold, and stent integrity (stent fracture, deformation, or collapse). Univariate subgroup analysis was performed.ResultsIn total, 40 limbs in 37 patients (age 73.5 {+-} 8.2 years) with criticalmore » limb ischemia were included and 42 inframalleolar lesions (4.2 {+-} 1.4 cm) were analyzed. Technical success was achieved in 95.2 % (40 of 42). Provisional stent placement was performed in 45.2 % (19 of 42). Two patients died, and two major amputations occurred up to 3 years. At 1 year, overall primary vessel patency was 50.4 {+-} 9.1 %, lesion binary restenosis rate was 64.1 {+-} 8.3 %, and repeat intervention-free survival was 93.6 {+-} 4.3 % according to life table analysis of all treated lesions. Pairwise subgroup analysis showed that BTA self-expanding stents were associated with significantly higher restenosis and poorer primary patency compared to plain balloon angioplasty or sirolimus-eluting balloon-expandable stents. Significant deformation and/or fracture of balloon-expandable stents placed BTA were identified in five of 11. Dynamic imaging showed that the dorsalis pedis artery is kinked during foot dorsiflexion, whereas the distal posterior tibial artery is kinked during plantar flexion of the foot.ConclusionBTA angioplasty for critical limb ischemia treatment is safe and feasible with satisfactory long-term results. BTA stent placement must be reserved for bailout indications.« less

Edge Stenosis After Covered Stenting for Long Superficial Femoral Artery Occlusive Disease: Risk Factor Analysis and Prevention With Drug-Coated Balloon Angioplasty.

PubMed

Lin, Ting-Chao; Huang, Chun-Yang; Chen, Po-Lin; Lee, Chiu-Yang; Shih, Chun-Che; Chen, I-Ming

2018-06-01

To report a retrospective analysis of risk factors for edge restenosis after Viabahn stent-graft treatment of superficial femoral artery (SFA) occlusive disease and determine any protective effect of drug-coated balloons (DCBs) used at the time of stent-graft implantation. Between October 2011 and July 2016, 110 patients (mean age 73.3±7.6 years; 78 men) were treated with the Viabahn stent-graft for long SFA occlusions. Thirty-eight (34.5%) patients had DCB reinforcement at the distal edge of the stent-graft. For analysis, the population was divided into groups of no edge stenosis patients (n=88; mean lesion length 22.4±4.2 cm) and edge stenosis patients (n=22; mean lesion length 23.5±5.7 cm). The clinical outcomes, ankle-brachial indices, computed tomography angiography findings, and patency were compared at a minimum of 12 months. Logistic regression analysis was employed to determine risk factors for edge stenosis; the results are presented as the odds ratio (OR) and 95% confidence interval. No differences in clinical or procedural characteristics were identified except the higher incidence of diabetes (p=0.008) and greater need for retrograde access (p=0.033) in the edge stenosis group. DCB reinforcement reduced the incidence of edge stenosis (p=0.021) and target lesion revascularization (TLR; p=0.010) and resulted in a significantly higher 1-year primary patency rate (92.1% vs 76.4%, p=0.042). However, multivariate analysis revealed only poor distal runoff (OR 0.31, 95% CI 0.11 to 0.83, p=0.020) as a predictor of edge stenosis. The risk of edge stenosis after Viabahn implantation was higher in patients with poor distal runoff. DCB reinforcement over the distal edge reduced edge stenosis, decreased 1-year TLR, and improved 1-year primary patency.

Sequential vs simultaneous revascularization in patients undergoing liver transplantation: A meta-analysis.

PubMed

Wang, Jia-Zhong; Liu, Yang; Wang, Jin-Long; Lu, Le; Zhang, Ya-Fei; Lu, Hong-Wei; Li, Yi-Ming

2015-06-14

We undertook this meta-analysis to investigate the relationship between revascularization and outcomes after liver transplantation. A literature search was performed using MeSH and key words. The quality of the included studies was assessed using the Jadad Score and the Newcastle-Ottawa Scale. Heterogeneity was evaluated by the χ(2) and I (2) tests. The risk of publication bias was assessed using a funnel plot and Egger's test, and the risk of bias was assessed using a domain-based assessment tool. A sensitivity analysis was conducted by reanalyzing the data using different statistical approaches. Six studies with a total of 467 patients were included. Ischemic-type biliary lesions were significantly reduced in the simultaneous revascularization group compared with the sequential revascularization group (OR = 4.97, 95%CI: 2.45-10.07; P < 0.00001), and intensive care unit (ICU) days were decreased (MD = 2.00, 95%CI: 0.55-3.45; P = 0.007) in the simultaneous revascularization group. Although warm ischemia time was prolonged in simultaneous revascularization group (MD = -25.84, 95%CI: -29.28-22.40; P < 0.00001), there were no significant differences in other outcomes between sequential and simultaneous revascularization groups. Assessment of the risk of bias showed that the methods of random sequence generation and blinding might have been a source of bias. The sensitivity analysis strengthened the reliability of the results of this meta-analysis. The results of this study indicate that simultaneous revascularization in liver transplantation may reduce the incidence of ischemic-type biliary lesions and length of stay of patients in the ICU.

Comparing the 12-month patency of low- versus high-pressure dilation in failing arteriovenous fistulae: A prospective multicenter trial (YOROI study).

PubMed

Wakamoto, Koki; Doi, Shigehiro; Nakashima, Ayumu; Kawai, Toru; Kyuden, Yasufumi; Naito, Takayuki; Asai, Mariko; Takahashi, Shunsuke; Murakami, Masaaki; Masaki, Takao

2018-03-01

This study was performed to investigate the effect of the balloon dilation pressure on the 12-month patency rate in patients with failed arteriovenous fistulas undergoing hemodialysis. In this multicenter, prospective, randomized trial, the 4-mm-diameter YOROI balloon was used for dilation of stenotic lesions. The balloons were inflated to a pressure of 8 atm (low-pressure group) or 30 atm to achieve complete expansion (high-pressure group). The 12-month patency rate after balloon angioplasty was analyzed by the Kaplan-Meier method and log-rank test and/or a Cox proportional hazard model. We also investigated the dilation pressure required to achieve complete expansion in the high-pressure group. In total, 71 patients were enrolled and allocated to either the low-pressure group (n = 34) or the high-pressure group (n = 37). The 12-month patency rates showed no significant difference between the low- and high-pressure groups (47% and 49%, respectively; p = 0.87). In the low-pressure group, the patency rate was not different between patients with complete dilation and residual stenosis (44% and 50%, respectively; p = 0.87). The Cox proportional hazard model revealed that the 12-month patency rate was associated with the stenosis diameter (hazard ratio 0.36; p = 0.001) and the presence of diabetes (hazard ratio 0.33; p = 0.018). Finally, the pressure required to achieve complete dilation was ≤20 atm in 76% of patients and ≤30 atm in 97% of patients. One patient required a dilation pressure of >30 atm. The patency rate does not differ between low-pressure dilation and high-pressure dilation.

A Meta-analysis of Randomized Trials Comparing Surgery versus Endovascular Therapy for Thrombosed Arteriovenous Fistulas and Grafts in Hemodialysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kuhan, G., E-mail: gkuhan@nhs.net; Antoniou, G. A.; Nikam, M.

Purpose. To carry out a systematic review of randomized trials comparing surgery vs. endovascular therapy for occluded fistulas and grafts. Methods. All randomized trials which compared surgery and endovascular therapy for occluded fistulas and grafts were retrieved from 1990 onwards. The following search terms were used: 'haemodialysis,' 'thrombosis,' 'arteriovenous fistula,' 'arteriovenous shunt,' 'end stage renal failure' on Medline and PubMed. The results of the pooled data were analysed by a fixed-effect model. Results. There were no randomized trials comparing surgery vs. endovascular therapy for native fistulas and vein grafts. Six randomized studies reporting on 573 occluded grafts were identified. Technicalmore » success, need for access line and primary patency at 30 days were similar between the two groups (odds ratio [OR] 1.40, 95 % confidence interval [CI] 0.91-2.14; OR 0.77, 95 % CI 0.44-1.34; and OR 1.15, 95 % CI 0.79-1.68, respectively). There was no significant difference in morbidity at 30 days between groups (OR 1.12, 95 % CI 0.67-1.86). There were no statistical difference between the two groups for 1 year primary patency (OR 2.08, 95 % CI 0.97-4.45). Primary assisted patency at 1 year was better with surgery (OR 3.03, 95 % CI 1.12-8.18) in a single study. Conclusion. Comparable results to surgery have been achieved with endovascular techniques for occluded prosthetic grafts for dialysis access. Long-term data comparing the two groups were lacking. Further trials designed to encompass variation in methods are warranted in order to obtain the best available evidence particularly for native fistulas.« less

Sharp Dissection versus Electrocautery for Radial Artery Harvesting

PubMed Central

Marzban, Mehrab; Arya, Reza; Mandegar, Mohammad Hossein; Karimi, Abbas Ali; Abbasi, Kiomars; Movahed, Namvar; Abbasi, Seyed Hesameddin

2006-01-01

Radial arteries have been increasingly used during the last decade as conduits for coronary artery revascularization. Although various harvesting techniques have been described, there has been little comparative study of arterial damage and patency. A radial artery graft was used in 44 consecutive patients, who were randomly divided into 2 groups. In the 1st group, the radial artery was harvested by sharp dissection and in the 2nd, by electrocautery. These groups were compared with regard to radial artery free flow, harvest time, number of clips used, complications, and endothelial damage. Radial artery free flow before and after intraluminal administration of papaverine was significantly greater in the electrocautery group (84.3 ± 50.7 mL/min and 109.7 ± 68.5 mL/min) than in the sharp-dissection group (52.9 ± 18.3 mL/min and 69.6 ± 28.2 mL/ min) (P =0.003). Harvesting time by electrocautery was significantly shorter (25.4 ± 4.3 min vs 34.4 ± 5.9 min) (P =0.0001). Electrocautery consumed an average of 9.76 clips, versus 22.45 clips consumed by sharp dissection. The 2 groups were not different regarding postoperative complications, except for 3 cases of temporary paresthesia of the thumb in the electrocautery group; histopathologic examination found no endothelial damage. We conclude that radial artery harvesting by electrocautery is faster and more economical than harvesting by sharp dissection and is associated with better intraoperative flow and good preservation of endothelial integrity. PMID:16572861

Troponin and Cardiac Events in Stable Ischemic Heart Disease and Diabetes.

PubMed

Everett, Brendan M; Brooks, Maria Mori; Vlachos, Helen E A; Chaitman, Bernard R; Frye, Robert L; Bhatt, Deepak L

2015-08-13

Cardiac troponin concentrations are used to identify patients who would benefit from urgent revascularization for acute coronary syndromes. We hypothesized that they might be used in patients with stable ischemic heart disease to identify those at high risk for cardiovascular events who might also benefit from prompt coronary revascularization. We measured the cardiac troponin T concentration at baseline with a high-sensitivity assay in 2285 patients who had both type 2 diabetes and stable ischemic heart disease and were enrolled in the Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes trial. We tested for an association between the troponin T concentration and a composite end point of death from cardiovascular causes, myocardial infarction, or stroke; we then evaluated whether random assignment to prompt revascularization reduced the rate of the composite end point in patients with an abnormal troponin T concentration (≥14 ng per liter) as compared with those with a normal troponin T concentration (<14 ng per liter). Of the 2285 patients, 2277 (99.6%) had detectable (≥3 ng per liter) troponin T concentrations and 897 (39.3%) had abnormal troponin T concentrations at baseline. The 5-year rate of the composite end point was 27.1% among the patients who had had abnormal troponin T concentrations at baseline, as compared with 12.9% among those who had had normal baseline troponin T concentrations. In models that were adjusted for cardiovascular risk factors, severity of diabetes, electrocardiographic abnormalities, and coronary anatomy, the hazard ratio for the composite end point among patients with abnormal troponin T concentrations was 1.85 (95% confidence interval [CI], 1.48 to 2.32; P<0.001). Among patients with abnormal troponin T concentrations, random assignment to prompt revascularization, as compared with medical therapy alone, did not result in a significant reduction in the rate of the composite end point (hazard ratio, 0.96; 95% CI, 0.74 to 1.25). The cardiac troponin T concentration was an independent predictor of death from cardiovascular causes, myocardial infarction, or stroke in patients who had both type 2 diabetes and stable ischemic heart disease. An abnormal troponin T value of 14 ng per liter or higher did not identify a subgroup of patients who benefited from random assignment to prompt coronary revascularization. (Funded by the National Institutes of Health and Roche Diagnostics; BARI 2D ClinicalTrials.gov number, NCT00006305.).

Clinical outcome, pain perception and activities of daily life after minimally invasive coronary artery bypass grafting.

PubMed

Uymaz, Barış; Sezer, Gül; Köksal Coşkun, Pınar; Tarcan, Onurcan; Ozleme, Seyhan; Aybek, Tayfun

2014-03-01

Minimally invasive direct coronary artery bypass (MIDCAB) for revascularization of the left anterior descending artery has become a routine operation. We present our clinical experiences with beating heart MIDCAB surgery performed through partial lower sternotomy (PLS) and retrospectively compare the results of pain perception as well as activities of daily life (ADL) with the conventional full sternotomy. From January 2009 to August 2012, 197 patients underwent MIDCAB using modified PLS at our hospital. Their mean age was 58.5±10.5 years. 54 (28%) had previous myocardial infarction, 38 (19%) had diabetes mellitus. The visual analog scale (VAS) for pain one, two and three, the ADL score for mobilization were obtained within four days after surgery. 98% of patients were followed-up with both direct visits and questionnaires to assess the major adverse cardiac events (MACE). We performed t-test for comperative data and Kaplan-Meier curves for survival analysis. There was one postoperative death (0.5%) and three conversions to full sternotomy (1.5%). Postoperative angiography was performed in 34 (17.2%) patients, who had some symptoms during the follow-up period of 45 months. The graft patency rate was 96.5% (190 of 197). At follow-up (24.1±11.7 months), survival free of MACE was 91.8±3.1% at 3.5 years. Both the Visual Analog Scale (35.1±9.6 vs. 57.1±7.8) and the ADL score (80.4±11.8 vs. 36.2±8.6) were significantly higher after the operation in comparison to the matched group of beating heart revascularizations with full sternotomy (p<0.001). This study demonstrates that the MIDCAB using PLS can achieve an effective intermediate-term revascularization and an acceptable clinical outcome. Patients who undergo this procedure are free of major complications and enjoy good quality of life after surgery.

Ablation velocity and thermal damage of myocardial tissue using a CO2 laser for transmyocardial laser revascularization

NASA Astrophysics Data System (ADS)

Sachinopoulou, Anna; Beek, Johan F.; van Leeuwen, Ton G. J. M.; Beek, W. J.

1999-02-01

Transmyocardial Laser Revascularization (TMLR) is a new experimental method for relief of angina pectoris in patients with severe coronary artery disease. TMLR aims at revascularizing chronic hibernating myocardium by creating transmural channels. One of the working mechanism hypotheses is that the endocardial side of the channels remains open, enabling perfusion of the hibernating myocardium directly from the left ventricle. Although the working mechanism of TMLR is still unknown (perfusion through patent channels, induction of angiogenesis, relief of angina through destruction of sympatic innervation, others?), first clinical studies are successful. Currently, the Heart LaserTM and other CO2 lasers, XeCl Excimer laser and Ho:YAG laser are under investigation for TMLR. The initial attempts of TMR with needles were soon replaced by laser induced channels. Efforts were focused on developing a CO2 laser that could penetrate a beating heart during its relaxation phase. Later, the position of the beam could be fixed in the myocardial wall using lasers with fiber delivery systems and perforation was achieved within multiple cycles. Various researchers reported on both patent and non-patent channels after TMLR. Our belief is that the extent of laser induced thermal damage is one of the factors that determine the clinical outcome and the extent of angiogenesis (and, possibly, the patency of the channel). The purpose of this study is to present a simple theoretical model to predict the extent of thermal damage around a transmyocardial channel. In vitro experiments were performed on myocardial bovine tissue and damage was assessed. The results were used to determine the final parameters of the approximating theoretical equation. To evaluate our results, we compared our results to in vitro data using the Heart LaserTM from the literature. Ablation velocities were also measured and the results were compared to ablation velocity calculations using a model described by Ostegar et al.

Thrombelastographic haemostatic status and antiplatelet therapy after coronary artery bypass surgery (TEG-CABG trial): assessing and monitoring the antithrombotic effect of clopidogrel and aspirin versus aspirin alone in hypercoagulable patients: study protocol for a randomized controlled trial.

PubMed

Rafiq, Sulman; Johansson, Pär Ingemar; Zacho, Mette; Stissing, Trine; Kofoed, Klaus; Lilleør, Nikolaj Bang; Steinbrüchel, Daniel Andreas

2012-04-27

Hypercoagulability, assessed by the thrombelastography (TEG) assay, has in several observational studies been associated with an increased risk of post-procedural thromboembolic complications. We hypothesize that intensified antiplatelet therapy with clopidogrel and aspirin, as compared to aspirin alone, will improve saphenous vein graft patency in preoperatively TEG-Hypercoagulable coronary artery bypass surgery (CABG) patients and reduce their risk for thromboembolic complications and death postoperatively. This is a prospective randomized clinical trial, with an open-label design with blinded evaluation of graft patency. TEG-Hypercoagulability is defined as a TEG maximum amplitude above 69 mm. Two hundred and fifty TEG-Hypercoagulable patients will be randomized to either an interventional group receiving clopidogrel 75 mg daily for three months (after initial oral bolus of 300 mg) together with aspirin 75 mg or a control group receiving aspirin 75 mg daily alone. Monitoring of antiplatelet efficacy and on-treatment platelet reactivity to clopidogrel and aspirin will be conducted with Multiplate aggregometry. Graft patency will be assessed with Multislice computed tomography (MSCT) at three months after surgery. The present trial is the first randomized clinical trial to evaluate whether TEG-Hypercoagulable CABG patients will benefit from intensified antiplatelet therapy after surgery. Monitoring of platelet inhibition from instituted antithrombotic therapy will elucidate platelet resistance patterns after CABG surgery. The results could be helpful in redefining how clinicians can evaluate patients preoperatively for their postoperative thromboembolic risk and tailor individualized postoperative antiplatelet therapy. Clinicaltrials.gov Identifier NCT01046942.

Infrarenal aorta as the donor site for bypasses to the superior mesenteric artery for chronic mesenteric ischemia: A prospective clinical series of 24 patients.

PubMed

Illuminati, Giulio; Pizzardi, Giulia; Calio', Francesco G; Pasqua, Rocco; Masci, Federica; Vietri, Francesco

2017-11-01

Treatment of symptomatic, chronic mesenteric ischemia is indicated to relieve symptoms and prevent acute ischemia and death. Current therapeutic options include endovascular and open surgery. The purpose of this prospective study was to evaluate the results of bypasses to the superior mesenteric artery arising from the infrarenal aorta or infrarenal aortic grafts. From January 1999 to December 2016, 24 consecutive patients with a mean age of 61 years underwent a prosthetic bypass to the superior mesenteric artery. Nine patients (37%) presented with an associated clinically important stenosis of the celiac artery and 10 (42%) of the inferior mesenteric artery. Five patients (21%) received preoperative parenteral nutrition. Four patients (17%) underwent dual antiplatelet treatment. The donor site was the infrarenal aorta in 19 patients (79%) and an infrarenal, Dacron graft was used in 5 (21%). The origin of the bypass was from the distal infrarenal aorta or Dacron graft in 19 patients (79%) and from the proximal infrarenal aorta in 5 patients (21%). The graft material consisted of 7 mm polytetrafluoroethylene in 19 cases (79%) and 7 mm Dacron in 5 cases (21%). A concomitant bypass to the inferior mesenteric artery was performed in 4 patients (17%). The primary end points were postoperative mortality, morbidity, graft infection, late survival, primary patency, and symptom-free rate. The secondary end point was postoperative hemorrhagic complications. No postoperative mortality occurred. Postoperative morbidity included a prolonged postoperative ileus in 4 patients (17%), transitory postoperative increases in serum creatinine concentrations in 3 patients (12%), and myocardial ischemia in 2 patients (8%). No postoperative hemorrhagic complications or graft infection were observed. Overall, the cumulative survival rate was 77% at 60 months. The overall late-patency rate and freedom from recurrence of symptoms were both 87% at 60 months. Infrarenal aorta and infrarenal aortic grafts are an excellent source for the revascularization of the superior mesenteric artery. Bypasses to the superior mesenteric artery from the infrarenal aorta, either isolated or associated with adjunctive bypass to the inferior mesenteric artery, yield results that are comparable with those obtained with complete digestive artery revascularization using other donor sources. Copyright © 2017 Elsevier Inc. All rights reserved.

Surgical internal iliac artery preservation associated with endovascular repair of infrarenal aortoiliac aneurysms to avoid buttock claudication and distal type I endoleaks.

PubMed

Gaudric, Julien; Tresson, Philippe; Derycke, Lucie; Tezenas Du Montcel, Sophie; Couture, Thibault; Davaine, Jean-Michel; Kashi, Mahine; Lawton, James; Chiche, Laurent; Koskas, Fabien

2018-06-21

The objective of this study was to assess outcomes of a hybrid technique for treatment of abdominal aortic aneurysm (AAA) associated with iliac aneurysm without distal neck by combining an AAA endovascular repair approach with open surgery for preservation of the internal iliac artery (IIA). The files of 51 patients operated on between 1998 and 2017 in a single vascular surgery department were retrospectively analyzed. Inclusion criteria were patients with AAA associated with uni-iliac or bi-iliac aneurysm without suitable distal sealing zone. Surgery consisted of deployment of an aortouni-iliac stent graft combined with an extra-anatomic crossover prosthetic bypass. With use of a limited retroperitoneal approach, the contralateral proximal common iliac aneurysm was surgically excluded and the IIA revascularized by direct ilioiliac anastomosis or terminal common iliac suture, preserving the iliac bifurcation. The patients' mean age was 74 years (58-88 years), and 92% were men. The mean follow-up was 5.8 years (0.1-18 years). Twenty-nine patients (57%) had one or more high-risk criteria for open surgery. Nineteen patients (37.3%) had aortouni-iliac aneurysms, 19 (37.3%) aortobi-iliac aneurysms, 5 (10%) isolated iliac aneurysms, and 8 (15.7%) bi-iliac aneurysms without aortic location. Four patients (7.8%) also had IIA aneurysms. Surgery was successful in all cases. Two patients (4%) died during the 30 days after surgery. One surgically preserved IIA occluded within the first month, resulting in buttock claudication. The 5-year IIA primary patency rate was 96%. Type I proximal endoleaks occurred in two patients, requiring additional surgery 3 years and 13 years after the initial surgery, respectively. This hybrid technique, consisting of AAA endovascular exclusion combined with open IIA revascularization, is safe and effective for preservation of pelvic vascularization. It is associated with long-term patency and low morbidity rates. We have been using this technique since before the advent of branched dedicated devices, allowing preservation of the IIA with good results. This technique should continue to be proposed, especially in patients not eligible for endovascular iliac branch repair because of anatomic contraindications, to avoid pelvic ischemia if the IIA has to be sacrificed. Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Sequential vs simultaneous revascularization in patients undergoing liver transplantation: A meta-analysis

PubMed Central

Wang, Jia-Zhong; Liu, Yang; Wang, Jin-Long; Lu, Le; Zhang, Ya-Fei; Lu, Hong-Wei; Li, Yi-Ming

2015-01-01

AIM: We undertook this meta-analysis to investigate the relationship between revascularization and outcomes after liver transplantation. METHODS: A literature search was performed using MeSH and key words. The quality of the included studies was assessed using the Jadad Score and the Newcastle-Ottawa Scale. Heterogeneity was evaluated by the χ2 and I2 tests. The risk of publication bias was assessed using a funnel plot and Egger’s test, and the risk of bias was assessed using a domain-based assessment tool. A sensitivity analysis was conducted by reanalyzing the data using different statistical approaches. RESULTS: Six studies with a total of 467 patients were included. Ischemic-type biliary lesions were significantly reduced in the simultaneous revascularization group compared with the sequential revascularization group (OR = 4.97, 95%CI: 2.45-10.07; P < 0.00001), and intensive care unit (ICU) days were decreased (MD = 2.00, 95%CI: 0.55-3.45; P = 0.007) in the simultaneous revascularization group. Although warm ischemia time was prolonged in simultaneous revascularization group (MD = -25.84, 95%CI: -29.28-22.40; P < 0.00001), there were no significant differences in other outcomes between sequential and simultaneous revascularization groups. Assessment of the risk of bias showed that the methods of random sequence generation and blinding might have been a source of bias. The sensitivity analysis strengthened the reliability of the results of this meta-analysis. CONCLUSION: The results of this study indicate that simultaneous revascularization in liver transplantation may reduce the incidence of ischemic-type biliary lesions and length of stay of patients in the ICU. PMID:26078582

Coronary revascularization vs. medical therapy following coronary-computed tomographic angiography in patients with low-, intermediate- and high-risk coronary artery disease: results from the CONFIRM long-term registry

PubMed Central

Schulman-Marcus, Joshua; Lin, Fay Y.; Gransar, Heidi; Berman, Daniel; Callister, Tracy; DeLago, Augustin; Hadamitzky, Martin; Hausleiter, Joerg; Al-Mallah, Mouaz; Budoff, Matthew; Kaufmann, Philipp; Achenbach, Stephan; Raff, Gilbert; Chinnaiyan, Kavitha; Cademartiri, Filippo; Maffei, Erica; Villines, Todd; Kim, Yong-Jin; Leipsic, Jonathon; Feuchtner, Gudrun; Rubinshtein, Ronen; Pontone, Gianluca; Andreini, Daniele; Marques, Hugo; Chang, Hyuk-Jae; Chow, Benjamin J.W.; Cury, Ricardo C.; Dunning, Allison; Shaw, Leslee; Min, James K.

2017-01-01

Abstract Aims To identify the effect of early revascularization on 5-year survival in patients with CAD diagnosed by coronary-computed tomographic angiography (CCTA). Methods and results We examined 5544 stable patients with suspected CAD undergoing CCTA who were followed a median of 5.5 years in a large international registry. Patients were categorized as having low-, intermediate-, or high-risk CAD based on CCTA findings. Two treatment groups were defined: early revascularization within 90 days of CCTA (n = 1171) and medical therapy (n = 4373). To account for the non-randomized referral to revascularization, we developed a propensity score by logistic regression. This score was incorporated into Cox proportional hazard models to calculate the effect of revascularization on all-cause mortality. Death occurred in 363 (6.6%) patients and was more frequent in medical therapy. In multivariable models, when compared with medical therapy, the mortality benefit of revascularization varied significantly over time and by CAD risk (P for interaction 0.04). In high-risk CAD, revascularization was significantly associated with lower mortality at 1 year (hazard ratio [HR] 0.22, 95% confidence interval [CI] 0.11–0.47) and 5 years (HR 0.31, 95% CI 0.18–0.54). For intermediate-risk CAD, revascularization was associated with reduced mortality at 1 year (HR 0.45, 95% CI 0.22–0.93) but not 5 years (HR 0.63, 95% CI 0.33–1.20). For low-risk CAD, there was no survival benefit at either time point. Conclusions Early revascularization was associated with reduced 1-year mortality in intermediate- and high-risk CAD detected by CCTA, but this association only persisted for 5-year mortality in high-risk CAD. PMID:28329294

National trends in carotid artery revascularization surgery.

PubMed

Dumont, Travis M; Rughani, Anand I

2012-06-01

Several randomized trials have emerged with conflicting data on the overall safety of carotid artery stenting (CAS) in comparison with carotid endarterectomy (CEA). The authors hypothesize that changes in national trends correspond to publication of randomized trials, including an increase in utilization of CAS after publication of trials favorable to CAS (for example, Carotid and Vertebral Artery Transluminal Angioplasty Study [CAVATAS] and Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy [SAPPHIRE]) and decrease in utilization of CAS after publication of trials favorable to CEA (for example, Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis [EVA3-S] and Stent-Supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy [SPACE]). The Nationwide Inpatient Sample was obtained for the years 1998-2008. Individual cases were isolated for principal diagnosis of unilateral or bilateral carotid artery stenosis or occlusion undergoing CEA or CAS. The percentage of CAS for all carotid revascularization procedures was calculated for each year. Perioperative inpatient morbidity, including stroke or death, were calculated and compared. The percentage of patients undergoing CAS increased yearly from the start of the observed period to the end, with the exception of a decrease in 2007. The peak utilization of CAS for carotid artery revascularization procedures was 15% of all cases in 2006. The stroke or death rate was consistent at 5% among all patients undergoing CEA for all years, while the incidence of stroke or death decreased among patients undergoing CAS from 9% in 1998 to 5% in 2008. The practice of CAS in the US is expanding, from less than 3% of all carotid artery revascularization procedures to 13% in 2008. The utilization of CAS was seen to correlate with publication of randomized trials. Utilization nearly doubled in 2005 after publication of the CAS-favorable SAPPHIRE in 2004, and decreased by 22% after publication of the CEA-favorable EVA-3S and SPACE in 2007. With the publication of Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), the authors predict a resultant increase in the rate of CAS for carotid artery disease in the upcoming years.

Some old drugs improve late primary patency rate of native arteriovenous fistulas in hemodialysis patients.

PubMed

Righetti, Marco; Ferrario, GianMichele; Serbelloni, Paola; Milani, Silvana; Tommasi, Adalberto

2009-01-01

Vascular access failure causes 20% of all hospitalizations of dialysis patients. Native arteriovenous fistulas, the best type of dialysis vascular access, have a 1-year primary patency rate that is extremely variable, ranging 40-80%. Neointimal hyperplasia is the most important cause of arteriovenous fistula late primary dysfunction. In recent years the arteriovenous fistula late primary patency rate has not improved because of the increase of old uremic patients with a high number of comorbidities and the lack of new therapeutic interventions. Therefore, we performed a long-term case-control study to analyze which factors or drugs may affect native arteriovenous fistula late primary patency rate in 60 incident hemodialysis patients. The arteriovenous fistula late primary patency rate was 75.1% after 12 months, 58.5% after 24 months, and 50% after 987 days. Homocysteine levels during follow-up had a significant direct association with vascular access failure (event vs. event-free 28.5+/-1.9 vs. 22.3+/-1.2 micromol/L, p<0.01). Folate values had a trend toward an inverse relationship with arteriovenous fistula failure (event vs. event-free 11.5+/-1.2 vs. 14.6 vs. 1.1 ng/mL, p=0.06). Patients treated with folic acid and/or statin had an arteriovenous fistula late primary patency rate significantly higher than patients without folic acid and statin therapy, respectively, 81.7% vs. 66% after 1 year and 71.5% vs. 39.1% after 2 years (p=0.02). Many other factors were not associated with vascular access failure. Statin and homocysteine-lowering folic acid therapy is associated with prolonged arteriovenous fistula survival. It is important to perform randomized trials to verify our observation.

Comparison of heparinized saline and 0.9% sodium chloride for maintaining peripheral intravenous catheter patency in dogs.

PubMed

Ueda, Yu; Odunayo, Adesola; Mann, F A

2013-01-01

To determine whether heparinized saline would be more effective in maintaining the patency of peripheral IV catheters in dogs compared to 0.9% sodium chloride. Prospective blinded randomized study. University Veterinary Teaching Hospital. Thirty healthy purpose bred dogs, intended for use in the junior surgery laboratory, were utilized. The dogs were randomized into 1 of 3 groups, 2 treatment groups and a control group. An 18-Ga cephalic catheter was placed in the cephalic vein of each dog. Each dog in the treatment group had their catheter flushed with either 10 IU/mL heparinized saline or 0.9% sodium chloride every 6 hours for 42 hours. The dogs in the control group did not have their catheters flushed until the end of the study period. Immediately prior to flushing catheters, each catheter was evaluated for patency by aspiration of blood and the catheter site was evaluated for phlebitis. All dogs in the heparinized saline and 0.9% sodium chloride group had catheters that flushed easily at each evaluation point. More dogs in the saline group had catheters from which blood could not be aspirated, but there was no significant difference between these groups. All dogs in the control group had catheters that flushed easily at the end of the assigned 6 hour interval except in 1 dog. Phlebitis was not detected in any dog. Flushes of 0.9% sodium chloride were found to be as effective as 10 IU/mL heparinized saline flushes in maintaining patency of 18-Ga peripheral venous catheters in dogs for up to 42 hours. For peripheral catheters placed with the intention of performing serial blood draws, heparinized flushes may be warranted. © Veterinary Emergency and Critical Care Society 2013.

Impact of cardiac hybrid imaging-guided patient management on clinical long-term outcome.

PubMed

Benz, Dominik C; Gaemperli, Lara; Gräni, Christoph; von Felten, Elia; Giannopoulos, Andreas A; Messerli, Michael; Buechel, Ronny R; Gaemperli, Oliver; Pazhenkottil, Aju P; Kaufmann, Philipp A

2018-06-15

Although randomized trials have provided evidence for invasive fractional flow reserve to guide revascularization, evidence for non-invasive imaging is less well established. The present study investigated whether hybrid coronary computed tomography (CCTA)/single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) can identify patients who benefit from early revascularization compared to medical therapy. This retrospective study consists of 414 patients referred for evaluation of known or suspected coronary artery disease (CAD) with CCTA/SPECT hybrid imaging. CCTA categorized patients into no CAD, non-high-risk CAD and high-risk CAD. In patients with CAD (n = 329), a matched finding (n = 75) was defined as a reversible perfusion defect in a territory subtended by a coronary artery with CAD. All other combinations of pathologic findings were classified as unmatched (n = 254). Death, myocardial infarction, unstable angina requiring hospitalization, and late coronary revascularization were defined as major adverse cardiac events (MACE). Cox hazards models included covariates age, male gender, more than two risk factors, previous CABG, high-risk CAD and early revascularization. During median follow-up of 6.0 years, 112 patients experienced a MACE (27%). Early revascularization (n = 50) was independently associated with improved outcome among patients with a matched finding (p < 0.001). There was no benefit among patients with an unmatched finding (p = 0.787), irrespective of presence (p = 0.505) or absence of high-risk CAD (p = 0.631). Early revascularization is associated with an outcome benefit in CAD patients with a matched finding documented by cardiac hybrid imaging while no benefit of revascularization was observed in patients with an unmatched finding. Copyright © 2018 Elsevier B.V. All rights reserved.

Effectiveness of revascularization of the ulcerated foot in patients with diabetes and peripheral artery disease: a systematic review.

PubMed

Hinchliffe, R J; Brownrigg, J R W; Andros, G; Apelqvist, J; Boyko, E J; Fitridge, R; Mills, J L; Reekers, J; Shearman, C P; Zierler, R E; Schaper, N C

2016-01-01

Symptoms or signs of peripheral artery disease (PAD) can be observed in up to 50% of the patients with a diabetic foot ulcer and is a risk factor for poor healing and amputation. In 2012, a multidisciplinary working group of the International Working Group on the Diabetic Foot published a systematic review on the effectiveness of revascularization of the ulcerated foot in patients with diabetes and PAD. This publication is an update of this review and now includes the results of a systematic search for therapies to revascularize the ulcerated foot in patients with diabetes and PAD from 1980 to June 2014. Only clinically relevant outcomes were assessed. The research conformed to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, and Scottish Intercollegiate Guidelines Network methodological scores were assigned. A total of 56 articles were eligible for full-text review. There were no randomized controlled trials, but there were four nonrandomized studies with a control group. The major outcomes following endovascular or open bypass surgery were broadly similar among the studies. Following open surgery, the 1-year limb salvage rates were a median of 85% (interquartile range of 80-90%), and following endovascular revascularization, these rates were 78% (70-89%). At 1-year follow-up, 60% or more of ulcers had healed following revascularization with either open bypass surgery or endovascular techniques. Studies appeared to demonstrate improved rates of limb salvage associated with revascularization compared with the results of conservatively treated patients in the literature. There were insufficient data to recommend one method of revascularization over another. There is a real need for standardized reporting of baseline demographic data, severity of disease and outcome reporting in this group of patients. Copyright © 2015 John Wiley & Sons, Ltd.

[Meta-analysis of percutaneous transluminal atherectomy in the treatment for in-stent restenosis of lower extremity peripheral artery disease].

PubMed

Li, Weihao; Zhang, Tao; Liu, Yunfeng; Zhang, Yongbao; Li, Qingle; Zhang, Xiaoming; Shen, Chenyang

2015-11-24

To evaluate the clinical safety and efficacy of percutaneous transluminal atherectomy for in-stent restenosis (ISR) in patients with low extremity peripheral arterial diseases (PAD). PubMed, Elsevier, EBSCO, Spring databases and Cochrane Library were searched for relevant articles. Based on the different mechanisms of atherectomy, the patients were divided into mechanic atherectomy group and laser atherectomy group. The safety end points included the rate of distal embolism and severe arterial wall injuries. And the efficacy end points included primary patency rate and freedom from target vessel revascularization (TVR-free) 6 months and 12 months after surgery. A total of 9 studies and 620 patients (published between 2006 and 2014) were accepted. The rate of distal embolism was 4.2% (95% confidence interval (CI): 1.7%-6.7%), while that of severe arterial wall injuries was 1.9% (95%CI: 0.9%-3.0%), respectively. Laser atherectomy was responsible for more distal embolism (6.8%) compared to mechanic atherectomy (2.0%), which was significantly different (Q=21.66, P=0.010). At 6-month follow-up, primary patency rate and rate of TVR-free were 63.0% (95% CI: 55.5%-70.6%) and 80.4% (95% CI: 70.5%-90.3%), while at 12-month follow-up were 43.5% (95%CI: 32.2%-54.9%) and 58.0% (95% CI: 52.1%-63.9%), respectively. The free-TVR rate at 6 months follow-up in mechanical atherectomy group was 77.9%, and was inferior to that in laser atherectomy group (80.8%, Q=13.49, P=0.009). Published bias was discovered at the analysis of 12-month TVR-free rate by means of Begg Test (P=0.039). Meta analysis concerned about the 3 randomized controlled trials demonstrated that there was no significant improvement using atherectomy for ISR comparing to standard balloon at 6-month TVR-free rate (OR=1.34, 95% CI: 0.86-2.07, P=0.196). To treat ISR lesion in lower extremities, laser atherectomy has a lower free-TVR rate in the middle term follow-up.A higher rate of distal embolism is noted though. On balance, percutaneous transluminal atherectomy demonstrates no significant improvement compared to plain balloon angioplasty for ISR lesions.

Effect of Aspirin in Postoperative Management of Adult Ischemic Moyamoya Disease.

PubMed

Zhao, Yahui; Zhang, Qian; Zhang, Dong; Zhao, Yuanli

2017-09-01

Aspirin has been implicated in the postoperative management of moyamoya disease (MMD) in order to avoid bypass failure and decrease the incidence of subsequent stroke. However, its effect has not been completely determined yet. In this study, we retrospectively reviewed data of 184 adult patients (197 hemispheres) presented with ischemic-onset MMD who had undergone direct or combined revascularization in our hospital, to clarify the effect of postoperative aspirin therapy in the management of moyamoya disease. Fifty-nine hemispheres that had been administered with aspirin (100 mg/day) after bypass surgery were defined as the "aspirin group," whereas 138 that hadn't been given aspirin postoperatively were defined as the "control group". Among 197 hemispheres, the mortality rate was 0. The incidence of postoperative newly developed infarction, transient ischemic attack, and hemorrhage were not significantly different between the aspirin and control groups. The patency rate of bypass graft was not significantly different between the groups, either. Notably, more patients experienced major stroke in the control group (9/138) than the aspirin group (1/59), but no statistical difference was found (P > 0.05). In the aspirin group, more patients had improved outcome than the control group (P = 0.04). Our findings showed that aspirin might not decrease the incidence of postoperative ischemic stroke or increase patency rate of bypass graft, but it does not increase the risk of hemorrhages, either. Also, postoperative aspirin therapy might improve outcome. More studies are needed to provide evidence for postoperative antiplatelet therapy in MMD management. Copyright © 2017 Elsevier Inc. All rights reserved.

Direct Stenting in Patients with Acute Lower Limb Arterial Occlusions: Immediate and Long-Term Results

DOE Office of Scientific and Technical Information (OSTI.GOV)

Galanakis, Nikolaos; Kontopodis, Nikolaos; Peteinarakis, Ioannis

PurposeThe purpose of this study is to accentuate the efficacy of direct stenting (stent placement without predilatation of the lesion) in patients with acute lower limb arterial ischemia (ALLI).Materials and MethodsBetween January 2010 and September 2015, 16 patients (11 men and 5 women) underwent direct stenting of acute arterial occlusions. All patients had contraindication for surgical revascularization or catheter-directed thrombolysis. According to SVS/ISCVS Classification, six patients had IIa and ten patients IIb ALLI. The occlusions were located in CIA, EIA, SFA, or popliteal artery. Mean follow-up time with clinical examination and color Duplex ultrasonography was 37.6 months (range 1–72). We analyzedmore » the technical and clinical outcomes of the procedures, as well the complications and patency rates.ResultsTechnical success was achieved in all patients (16/16) and there was significant clinical improvement in 15 patients. There was neither distal embolization nor procedure-related complications. During the 6 years of follow-up, four patients died due to non-procedure-related causes and there were two minor and one major amputations. The primary patency rates and the amputation-free survival rates were 93.7 and 87% at 1 year, 75.2 and 71.2% at 3 years, and 75.2 and 62.3%, respectively, at 6 years.ConclusionsDirect stenting may be a valuable alternative procedure for acute arterial occlusions in selected cases with high technical success and significant clinical improvement.Level of EvidenceLevel 4, Case Series.« less

Economic Evaluation of Complete Revascularization for Patients with Multivessel Disease Undergoing Primary Percutaneous Coronary Intervention.

PubMed

Barton, Garry R; Irvine, Lisa; Flather, Marcus; McCann, Gerry P; Curzen, Nick; Gershlick, Anthony H

2017-06-01

To determine the cost-effectiveness of complete revascularization at index admission compared with infarct-related artery (IRA) treatment only, in patients with multivessel disease undergoing primary percutaneous coronary intervention (P-PCI) for ST-segment elevation myocardial infarction. An economic evaluation of a multicenter randomized trial was conducted, comparing complete revascularization at index admission to IRA-only P-PCI in patients with multivessel disease (12-month follow-up). Overall hospital costs (costs for P-PCI procedure(s), hospital length of stay, and any subsequent re-admissions) were estimated. Outcomes were major adverse cardiac events (MACEs, a composite of all-cause death, recurrent myocardial infarction, heart failure, and ischemia-driven revascularization) and quality-adjusted life-years (QALYs) derived from the three-level EuroQol five-dimensional questionnaire. Multiple imputation was undertaken. The mean incremental cost and effect, with associated 95% confidence intervals, the incremental cost-effectiveness ratio, and the cost-effectiveness acceptability curve were estimated. On the basis of 296 patients, the mean incremental overall hospital cost for complete revascularization was estimated to be -£215.96 (-£1390.20 to £958.29), compared with IRA-only, with a per-patient mean reduction in MACEs of 0.170 (0.044 to 0.296) and a QALY gain of 0.011 (-0.019 to 0.041). According to the cost-effectiveness acceptability curve, the probability of complete revascularization being cost-effective was estimated to be 72.0% at a willingness-to-pay threshold value of £20,000 per QALY. Complete revascularization at index admission was estimated to be more effective (in terms of MACEs and QALYs) and cost-effective (overall costs were estimated to be lower and complete revascularization thereby dominated IRA-only). There was, however, some uncertainty associated with this decision. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Renal autotransplantation for vascular disease: late outcome according to etiology.

PubMed

Chiche, Laurent; Kieffer, Edouard; Sabatier, Jean; Colau, Alexandre; Koskas, Fabien; Bahnini, Amine

2003-02-01

The purpose of this study was to evaluate the early and late outcomes of renal autotransplantation (RAT) according to the etiology of the underlying renal artery disease. Between January 1985 and April 2001, we performed 68 RAT procedures in 57 patients. The surgical indications were fibromuscular dysplasia (FMD) for 34 RAT procedures in 30 patients (11 men, 19 women; mean age, 41.3 +/- 14.6 years), Takayasu's disease (TD) for 26 RAT procedures in 19 patients (five men, 14 women; mean age, 33.0 +/- 12.3 years), and atherosclerosis for eight RAT procedures in eight patients (seven men, one woman; mean age, 66.5 +/- 7.9 years). The incidence rate of hypertension was 87% in patients with FMD and 100% in patients with TD and atherosclerosis. The incidence rate of renal dysfunction was 75% in patients with atherosclerosis, 27% in patients with FMD, and 16% in patients with TD. Autotransplantation was isolated in 31 cases and was associated with another vascular procedure in 37 cases, including 22 thoracoabdominal aorta repairs and 11 abdominal aorta or iliac artery repairs. The technique used to achieve renal revascularization was direct reimplantation in 17 cases and indirect reimplantation in 51 cases. The conduit used for indirect reimplantation was an arterial autograft in 42 cases, a vein autograft in seven cases, and a prosthetic graft in two cases. Simultaneous revascularization of the contralateral kidney was performed in 21 patients and included nine RAT procedures. Contralateral nephrectomy was performed in five patients. In the FMD group, early segmental infarction was observed in four cases. Secondary nephrectomy was necessary in one case (at 88 months). Actuarial survival rates were 96.2% +/- 0.03% at 5 years and 84.1% +/- 0.11% at 10 years. Secondary patency rates were 100% at 5 years and 92% +/- 0.07% at 10 years. Hypertension normalized or improved in 96% of patients. Renal function improved in 50% of patients. In the TD group, one patient died of multiple organ failure 4 days after the procedure. Nephrectomy was necessary in one case. The actuarial survival rate was 94.7% +/- 0.05% and the secondary patency rate was 91.3% +/- 0.05% at both 5 and 10 years. Hypertension normalized or improved in 89% of the cases, and kidney function improved in all cases. In the atherosclerosis group, nephrectomy was necessary during the early postoperative period in three cases and during late follow-up in two cases (at 9 months and at 68 months, respectively). Actuarial survival rates were 54.7% +/- 0.2% at 5 years and 18.2% +/- 0.16% at 10 years. The secondary patency rates were 50.0% +/- 0.17% at 5 years and 33.3% +/- 0.18% at 10 years. Hypertension normalized or improved in 50% of cases, and kidney function improved in 33% of cases. RAT is highly effective for treatment of complex renovascular lesions related to FMD and TD. Although RAT is less effective for atherosclerosis, it may be the only alternative in cases involving extensive renovascular disease.

Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study.

PubMed

McKinsey, James F; Zeller, Thomas; Rocha-Singh, Krishna J; Jaff, Michael R; Garcia, Lawrence A

2014-08-01

The aim of this study was to assess the safety and effectiveness of directional atherectomy (DA) for endovascular treatment of peripheral arterial disease (PAD) in infrainguinal arteries in patients with claudication or critical limb ischemia. To date, no prospective, multicenter, independently-adjudicated study has evaluated the effectiveness and durability of DA in the treatment of PAD. Previous DA studies have not been prospectively powered to evaluate any differences in outcomes in patients with and without diabetes. DEFINITIVE LE (Determination of EFfectiveness of the SilverHawk(®) PerIpheral Plaque ExcisioN System (SIlverHawk Device) for the Treatment of Infrainguinal VEssels / Lower Extremities) prospectively enrolled subjects at 47 multinational centers with an infrainguinal lesion length up to 20 cm. Primary endpoints were defined as primary patency at 12 months for claudicants and freedom from major unplanned amputation for critical limb ischemia (CLI) subjects. A pre-specified statistical hypothesis evaluated noninferiority of primary patency in diabetic versus nondiabetic claudicants. Independent angiographic and sonographic core laboratories assessed outcomes, and events were adjudicated by a clinical events committee. A total of 800 subjects were enrolled. The 12-month primary patency was 78% (95% confidence interval: 74.0% to 80.6%) in claudicants, with a 77% rate in the diabetic subgroup versus 78% in the nondiabetic subgroup (noninferior, p < 0.001). The rate of freedom from major unplanned amputation of the target limb at 12 months in CLI subjects was 95% (95% confidence interval: 90.7% to 97.4%). Periprocedural adverse events included embolization (3.8%), perforation (5.3%), and abrupt closure (2.0%). The bail-out stent rate was 3.2%. The DEFINITIVE LE study demonstrated that DA is a safe and effective treatment modality at 12 months for a diverse patient population with either claudication or CLI. Furthermore, DA was shown to be noninferior for treating PAD in patients with diabetes compared with those without diabetes. (Study of SilverHawk/TurboHawk in Lower Extremity Vessels [DEFINITIVE LE]; NCT00883246). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Sustained Thromboresistant Bioactivity with Reduced Intimal Hyperplasia of Heparin-Bonded Polytetrafluoroethylene Propaten Graft in a Chronic Canine Femoral Artery Bypass Model.

PubMed

Freeman, John; Chen, Aaron; Weinberg, Roy J; Okada, Tamuru; Chen, Changyi; Lin, Peter H

2018-05-01

Bypass graft thrombosis remains a significant mode of failure in prosthetic graft revascularization. The purpose of this investigation was to evaluate the long-term thromboresistant effect of heparin-bonded expanded polytetrafluoroethylene (ePTFE) graft using Carmeda BioActive Surface technology in a canine model. Bilateral femorofemoral artery bypass grafts with ePTFE grafts were performed in 25 adult grayhound dogs. In each animal, a heparin-bonded ePTFE graft (Propaten, WL Gore) was placed on one side, whereas a control nonheparin graft was placed on the contralateral side. The graft patency was assessed at 1, 6, 12, 18, and 24 months (n = 5 per group) following the bypass. Heparin bioactivity of the graft material was analyzed. The effect of intimal hyperplasia was also assessed. All bypass grafts were patent at 1 month. Significantly greater patency rates were noted in the Propaten group compared to the control group at 12, 18, and 24 months, which were 84%, 80%, and 80% vs. 55%, 35%, and 20%, respectively (P < 0.02). There was a significant reduction in the anastomotic neointimal area and neointimal cell proliferation in Propaten grafts compared with control grafts at all groups between 6 and 24 months (P < 0.05). Heparin bioactivity as measured by antithrombin binding assay was demonstrated in the Propaten graft between 1 and 24 months. Mean heparin activities on Propaten grafts ranged from 26.3 ± 6.4 pmol/cm 2 to 18.4 ± 8.7 pmol/cm 2 between 1 and 24 months, which were significantly greater than the control group (P < 0.001). Differences between mean heparin activities of explanted Propaten graft samples at the various time points were nonsignificant (P > 0.05). Heparin-bonded ePTFE graft provides a thromboresistant surface and reduced anastomotic intimal hyperplasia at 2 years. The stable heparin bioactivity of the Propaten graft confers an advantage in long-term graft patency. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Fractional Flow Reserve-Guided Complete Revascularization Improves the Prognosis in Patients With ST-Segment-Elevation Myocardial Infarction and Severe Nonculprit Disease: A DANAMI 3-PRIMULTI Substudy (Primary PCI in Patients With ST-Elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization).

PubMed

Lønborg, Jacob; Engstrøm, Thomas; Kelbæk, Henning; Helqvist, Steffen; Kløvgaard, Lene; Holmvang, Lene; Pedersen, Frants; Jørgensen, Erik; Saunamäki, Kari; Clemmensen, Peter; De Backer, Ole; Ravkilde, Jan; Tilsted, Hans-Henrik; Villadsen, Anton Boel; Aarøe, Jens; Jensen, Svend Eggert; Raungaard, Bent; Køber, Lars; Høfsten, Dan Eik

2017-04-01

The impact of disease severity on the outcome after complete revascularization in patients with ST-segment-elevation myocardial infarction and multivessel disease is uncertain. The objective of this post hoc study was to evaluate the impact of number of diseased vessel, lesion location, and severity of the noninfarct-related stenosis on the effect of fractional flow reserve-guided complete revascularization. In the DANAMI-3-PRIMULTI study (Primary PCI in Patients With ST-Elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization), we randomized 627 ST-segment-elevation myocardial infarction patients to fractional flow reserve-guided complete revascularization or infarct-related percutaneous coronary intervention only. In patients with 3-vessel disease, fractional flow reserve-guided complete revascularization reduced the primary end point (all-cause mortality, reinfarction, and ischemia-driven revascularization; hazard ratio [HR], 0.33; 95% confidence interval [CI], 0.17-0.64; P =0.001), with no significant effect in patients with 2-vessel disease (HR, 0.77; 95% CI, 0.47-1.26; P =0.29; P for interaction =0.046). A similar effect was observed in patients with diameter stenosis ≥90% of noninfarct-related arteries (HR, 0.32; 95% CI, 0.18-0.62; P =0.001), but not in patients with less severe lesions (HR, 0.72; 95% CI, 0.44-1.19; P =0.21; P for interaction =0.06). The effect was most pronounced in patients with 3-vessel disease and noninfarct-related stenoses ≥90%, and in this subgroup, there was a nonsignificant reduction in the end point of mortality and reinfarction (HR, 0.32; 95% CI, 0.08-1.32; P =0.09). Proximal versus distal location did not influence the benefit from complete revascularization. The benefit from fractional flow reserve-guided complete revascularization in ST-segment-elevation myocardial infarction patients with multivessel disease was dependent on the presence of 3-vessel disease and noninfarct diameter stenosis ≥90% and was particularly pronounced in patients with both of these angiographic characteristics. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01960933. © 2017 American Heart Association, Inc.

Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study.

PubMed

Micari, Antonio; Brodmann, Marianne; Keirse, Koen; Peeters, Patrick; Tepe, Gunnar; Frost, Martin; Wang, Hong; Zeller, Thomas

2018-05-28

The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. The IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296). Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Coronary artery bypass surgery compared with percutaneous coronary interventions in patients with insulin-treated type 2 diabetes mellitus: a systematic review and meta-analysis of 6 randomized controlled trials.

PubMed

Bundhun, Pravesh Kumar; Wu, Zi Jia; Chen, Meng-Hua

2016-01-06

Data regarding the long-term clinical outcomes in patients with insulin-treated type 2 diabetes mellitus (ITDM) revascularized by either coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI) are still controversial. We sought to compare the long-term (≥1 year) adverse clinical outcomes in patients with ITDM who underwent revascularization by either CABG or PCI. Randomized Controlled Trials (RCTs) comparing the long-term clinical outcomes in patients with ITDM and non-ITDM revascularized by either CABG or PCI were searched from electronic databases. Data for patients with ITDM were carefully retrieved. Odd Ratio (OR) with 95 % confidence interval (CI) was used to express the pooled effect on discontinuous variables and the pooled analyses were performed with RevMan 5.3. Six RCTs involving 10 studies, with a total of 1297 patients with ITDM were analyzed (639 patients from the CABG group and 658 patients from the PCI group). CABG was associated with a significantly lower mortality rate compared to PCI with OR: 0.59, 95 % CI 0.42-0.85; P = 0.004. Major adverse cardiovascular and cerebrovascular events as well as repeated revascularization were also significantly lower in the CABG group with OR: 0.51, 95 % CI 0.27-0.99; P = 0.03 and OR 0.34, 95 % CI 0.24-0.49; P < 0.00001 respectively. However, compared to PCI, the rate of stroke was higher in the CABG group with OR: 1.41, 95 % CI 0.64-3.09; P = 0.40, but this result was not statistically significant. CABG was associated with significantly lower long-term adverse clinical outcomes compared to PCI in patients with ITDM. However, due to an insignificantly higher rate of stroke in the CABG group, further researches with a larger number of randomized patients are required to completely solve this issue.

Heparin or 0.9% sodium chloride to maintain central venous catheter patency: a randomized trial.

PubMed

Schallom, Marilyn E; Prentice, Donna; Sona, Carrie; Micek, Scott T; Skrupky, Lee P

2012-06-01

To compare heparin (3 mL, 10 units/mL) and 0.9% sodium chloride (NaCl, 10 mL) flush solutions with respect to central venous catheter lumen patency. Single-center, randomized, open label trial. Medical intensive care unit and Surgical/Burn/Trauma intensive care unit at Barnes-Jewish Hospital, St. Louis, MO. Three hundred forty-one patients with multilumen central venous catheters. Patients with at least one lumen with a minimum of two flushes were included in the analysis. Patients were randomly assigned within 12 hrs of central venous catheter insertion to receive either heparin or 0.9% sodium chloride flush. The primary outcome was lumen nonpatency. Secondary outcomes included the rates of loss of blood return, inability to infuse or flush through the lumen (flush failure), heparin-induced thrombocytopenia, and catheter-related blood stream infection. Assessment for patency was performed every 8 hrs in lumens without continuous infusions for the duration of catheter placement or discharge from intensive care unit. Three hundred twenty-six central venous catheters were studied yielding 709 lumens for analysis. The nonpatency rate was 3.8% in the heparin group (n = 314) and 6.3% in the 0.9% sodium chloride group (n = 395) (relative risk 1.66, 95% confidence interval 0.86-3.22, p = .136). The Kaplan-Meier analysis for time to first patency loss was not significantly different (log rank = 0.093) between groups. The rates of loss of blood return and flush failure were similar between the heparin and 0.9% sodium chloride groups. Pressure-injectable central venous catheters had significantly greater rates of nonpatency (10.6% vs. 4.3%, p = .001) and loss of blood return (37.0% vs. 18.8%, p <.001) compared to nonpressure-injectable catheters. The frequencies of heparin-induced thrombocytopenia and catheter-related blood stream infection were similar between groups. 0.9% sodium chloride and heparin flushing solutions have similar rates of lumen nonpatency. Given potential safety concerns with the use of heparin, 0.9% sodium chloride may be the preferred flushing solution for short-term use central venous catheter maintenance.

Efficacy of a Multiplex Paclitaxel Emission Stent Using a Pluronic® Mixture Membrane versus a Covered Metal Stent in Malignant Biliary Obstruction: A Prospective Randomized Comparative Study.

PubMed

Jang, Sung Ill; Lee, Se Joon; Jeong, Seok; Lee, Don Haeng; Kim, Myung-Hwan; Yoon, Hong Jin; Lee, Dong Ki

2017-07-15

A drug-eluting stent for unresectable malignant biliary obstruction was developed to increase stent patency by preventing tumor ingrowth. The safety and efficacy of a new generation of metallic stents covered with a paclitaxel-incorporated membrane using a Pluronic ® mixture (MSCPM-II) were compared prospectively with those of covered metal stents (CMSs) in patients with malignant biliary obstructions. This study was initially designed as a prospective randomized trial but was closed early because of a high incidence of early occlusion. Therefore, the data were analyzed using the intent-to-treat method. A total of 72 patients with unresectable distal malignant biliary obstructions were prospectively enrolled. The two groups did not differ significantly in basic characteristics and mean follow-up period (MSCPM-II 194 days vs CMS 277 days, p=0.063). Stent occlusion occurred in 14 patients (35%) who received MSCPM-II and in seven patients (21.9%) who received CMSs. Stent patency and survival time did not significantly differ between the two groups (p=0.355 and p=0.570). The complications were mild and resolved by conservative management in both groups. There were no significant differences in stent patency or patient survival in MSCPM-II and CMS patients with malignant biliary obstructions.

Challenges with Evidence-Based Management of Stable Ischemic Heart Disease.

PubMed

Patel, Amit V; Bangalore, Sripal

2017-02-01

Stable ischemic heart disease (SIHD) is a highly prevalent condition associated with increased costs, morbidity, and mortality. Management goals of SIHD can broadly be thought of in terms of improving prognosis and/or improving symptoms. Treatment options include medical therapy as well as revascularization, either with percutaneous coronary intervention or coronary artery bypass grafting. Herein, we will review the current evidence base for treatment of SIHD as well as its challenges and discuss ongoing studies to help address some of these knowledge gaps. There has been no consistent reduction in death or myocardial infarction (MI) with revascularization vs. medical therapy in patients with SIHD in contemporary trials. Angina and quality of life have been shown to be relieved more rapidly with revascularization vs. optimal medical therapy; however, the durability of these results is uncertain. There have been challenges and limitations in several of the trials addressing the optimal treatment strategy for SIHD due to potential selection bias (due to knowledge of coronary anatomy prior to randomization), patient crossover, and advances in medical therapy and revascularization strategies since trial completion. The challenges inherent to prior trials addressing the optimal management strategy for SIHD have impacted the generalizability of results to real-world cohorts. Until the results of additional ongoing trials are available, the decision for revascularization or medical therapy should be based on patients' symptoms, weighing the risks and benefits of each approach, and patient preference.

Aspirin resistance in patients with hemodynamic cerebral ischemia undergoing extracranial-intracranial bypass surgery.

PubMed

Jussen, Daniel; Horn, Peter; Vajkoczy, Peter

2013-01-01

Aspirin (acetylsalicylic acid, ASA) is the treatment of choice for prevention of vascular events in symptomatic steno-occlusive cerebrovascular disease (CVD). Cerebral revascularization using standard extracranial-intracranial (EC-IC) bypass surgery may be used to revert hemodynamic compromise. Aspirin is prescribed as standard medication in order to avoid bypass failure. Accumulating evidence of an increased risk of major adverse clinical events led to this study, in which we aimed to assess the prevalence of aspirin resistance and prothrombotic disorders among patients scheduled for EC-IC bypass surgery, and the effectiveness of aspirin dose escalation. We prospectively screened patients with circumscribed high-grade stenosis or occlusion of brain-supplying vessels fulfilling the hemodynamic criteria for EC-IC bypass surgery for aspirin resistance using a platelet function analyzer (PFA-100®) test. We also determined their smoking habits and screened for prothrombotic disorders and comorbidities. The patients were divided into 2 major groups: group A had atherosclerotic steno-occlusive CVD and group B consisted of patients with nonatherosclerotic steno-occlusive CVD (moyamoya disease) and a subgroup of pediatric moyamoya patients (pediatric subgroup). Bypass patency was documented via digital subtraction angiography. Standard initial ASA dose applied was 100 mg/day. In cases of aspirin resistance, doses were increased and the PFA-100 test was repeated. A total of 56 patients were included over a time period of 6 months. In group A (n = 25), we found a ratio of 40% of patients with primary resistance to aspirin 100 mg/day. In contrast, in group B (n = 25), only 20% of the patients were resistant to aspirin 100 mg/day; in the pediatric population (n = 6), there was no primary aspirin resistance. After a dose escalation to 300 mg/day, the ratio of aspirin resistance was reduced to 20% in group A and to 0% in group B. Altogether 5 patients with atherosclerotic steno-occlusive CVD remained aspirin-resistant despite the dose escalation; 2 of them suffered an early bypass failure. Smoking habits and diabetes mellitus were positively correlated with aspirin resistance. Moreover, 25% of all patients had laboratory signs of a prothrombotic disorder, but this had no influence on aspirin response or bypass patency. Aspirin resistance is common in the population of patients with hemodynamic cerebral ischemia scheduled for cerebral revascularization. It may have an adverse impact on the outcome of surgery. Screening and treatment via dose escalation of aspirin is a straightforward and sensible routine for patients undergoing EC-IC bypass surgery. Copyright © 2013 S. Karger AG, Basel.

Immediate outcomes of eptifibatide therapy during intracoronary stent implantation.

PubMed

Shariati, Hooman; Sanei, Hamid; Pourmoghadas, Ali; Salehizadeh, Leila; Amirpour, Afshin

2016-01-01

The objective of the present study was to assess the major immediate outcomes of eptifibatide therapy during intracoronary stent implantation. In an interventional study, patients undergoing percutaneous coronary intervention (PCI) were randomized into either the eptifibatide ( n = 100) or the control ( n = 107) group. In each group, demographic and clinical characteristics such as cardiac death, stent thrombosis (ST), myocardial infarction (MI), rates of target lesion and vessel revascularization, cerebral vascular accident (CVA), and emergency coronary artery bypass grafting (CABG) were recorded. The overall rates of major adverse events such as mortality, Stent thrombosis (ST), Myocardial Infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), CVA, and emergency CABG within 24 h after stent implantation were low and comparable between the two groups; P > 0.05 considered significant for all comparisons. There were no statistical differences between the clinical outcomes of groups administered with single-dose intracoronary eptifibatide and control groups among patients undergoing PCI during stent implantation.

The Carotid Revascularization Endarterectomy vs. Stenting Trial completes randomization: lessons learned and anticipated results.

PubMed

Lal, Brajesh K; Brott, Thomas G

2009-11-01

The Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) completed randomization on July 18, 2008. Sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), the trial has enrolled 2,522 participants across North America and is the largest randomized clinical trial (RCT) comparing the efficacy of carotid artery stenting (CAS) to carotid endarterectomy (CEA). It is also the largest RCT to assess carotid revascularization in both symptomatic and asymptomatic patients with carotid artery stenosis. Conventional-risk patients with symptomatic carotid stenosis (> or =50% by angiography, > or =70% by ultrasound) or asymptomatic carotid stenosis (> or =60% by angiography, > or =70% by ultrasound) were randomized to both treatment arms in a 1:1 ratio. Eligibility criteria for CREST were similar to those of the previous NINDS-sponsored CEA RCTs. The investigational devices used in the CAS arm of the study are the RX Acculink stent and the RX Accunet embolic protection system, (Abbott Vascular, Santa Clara, Calif). The primary aim is to contrast the efficacy of CAS versus CEA in preventing stroke, myocardial infarction, and all-cause mortality during a 30-day peri-procedural period, and ipsilateral stroke over the follow-up period (extending up to four years). The secondary aims are to contrast the efficacy of CAS and CEA in men and women, the restenosis rates of the two procedures, health-related quality of life, and cost effectiveness of CAS and CEA. The conclusion of enrollment in CREST marks the end of a long recruitment period from 117 community and academic hospital centers across the United States and Canada. Each surgeon and interventionalist underwent a rigorous credentialing process that included performance-assessment of prior CEA and CAS procedures. Credentialing of interventionalists also included a review of additional CAS procedures enrolled into a CREST lead-in phase prior to entering patients into the randomized trial; 1564 patients were enrolled in the lead-in, the final pathway for the largest credentialing effort to date for any clinical trial. CREST will provide long-term follow-up after carotid revascularization based on systematic ultrasonographic and neurologic surveillance, and on quality of life and cost-effectiveness comparisons between CAS and CEA in the setting of a RCT. We present a brief description of the CREST protocol, impediments that were overcome during the trial, salient results from the lead-in phase of the trial, a summary of enrollment activities and characteristics of the final cohort, and a timeline for anticipated results from the randomized phase.

Baseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.

PubMed

2008-09-01

The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial was undertaken to determine whether early revascularization intervention is superior to deferred intervention in the presence of aggressive medical therapy and whether antidiabetes regimens targeting insulin sensitivity are more or less effective than regimens targeting insulin provision in reducing cardiovascular events among patients with type 2 diabetes mellitus and stable coronary artery disease (CAD). The BARI 2D trial is a National Institutes of Health-sponsored randomized clinical trial with a 2 x 2 factorial design. Between 2001 and 2005, 49 clinical sites in North America, South America, and Europe randomized 2,368 patients. At baseline, the trial collected data on clinical history, symptoms, and medications along with centralized evaluations of angiograms, electrocardiograms, and blood and urine specimens. Most of the BARI 2D patients were referred from the cardiac catheterization laboratory (54%) or cardiology clinic (27%). Of the randomized participants, 30% were women, 34% were minorities, 61% had angina, and 67% had multiregion CAD. Moreover, 29% had been treated with insulin, 58% had hemoglobin A(1c) >7.0%, 41% had low-density lipoprotein cholesterol >or=100 mg/dL, 52% had blood pressure >130/80 mm Hg, and 56% had body mass index >or=30 kg/m(2). Baseline characteristics in BARI 2D are well balanced between the randomized treatment groups, and the clinical profile of the study cohort is representative of the target population. As a result, the BARI 2D clinical trial is in an excellent position to evaluate alternative treatment approaches for diabetes and CAD.

Study design and rationale of the 'Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial': study protocol for a randomized controlled trial.

PubMed

Choi, Woong Gil; Rha, Seung Woon; Choi, Cheol Ung; Kim, Eung Ju; Oh, Dong Joo; Cho, Yoon Hyung; Park, Sang Ho; Lee, Seung Jin; Hur, Ae Yong; Ko, Young Guk; Park, Sang Min; Kim, Ki Chang; Kim, Joo Han; Kim, Min Woong; Kim, Sang Min; Bae, Jang Ho; Bong, Jung Min; Kang, Won Yu; Seo, Jae Bin; Jung, Woo Yong; Cho, Jang Hyun; Kim, Do Hoi; Ahn, Ji Hoon; Kim, Soo Hyun; Jang, Ji Yong

2016-06-25

The self-expandable COMPLETE™ stent (Medtronic) has greater elasticity, allowing it to regain its shape after the compression force reduces, and has higher trackability, thus is easier to maneuver through tortuous vessels, whereas the balloon-expandable SCUBA™ stent (Medtronic) has higher radial stiffness and can afford more accurate placement without geographic miss, which is important in aortoiliac bifurcation lesions. To date, there have been no randomized control trials comparing efficacy and safety between the self-expanding stent and balloon-expandable stent in advanced atherosclerotic iliac artery disease. The purpose of our study is to examine primary patency (efficacy) and incidence of stent fracture and geographic miss (safety) between two different major representative stents, the self-expanding nitinol stent (COMPLETE-SE™) and the balloon-expanding cobalt-chromium stent (SCUBA™), in stenotic or occlusive iliac arterial lesions. This trial is designed as a prospective, randomized, multicenter trial to demonstrate a noninferiority of SCUBA™ stent to COMPLETE-SE™ stent following balloon angioplasty in iliac arterial lesions, and a total of 280 patients will be enrolled. The primary end point of this study is the rate of primary patency in the treated segment at 12 months after intervention as determined by catheter angiography, computed tomography angiography, or duplex ultrasound. The SENS-ILIAC trial will give powerful insight into whether the stent choice according to deployment mechanics would impact stent patency, geographic miss, or stent fracture in patients undergoing stent implantation in iliac artery lesions. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT01834495 ), registration date: May 8, 2012.

Sodium bicarbonate does not prevent postoperative acute kidney injury after off-pump coronary revascularization: a double-blinded randomized controlled trial.

PubMed

Soh, S; Song, J W; Shim, J K; Kim, J H; Kwak, Y L

2016-10-01

Acute kidney injury (AKI) is a common morbidity after off-pump coronary revascularization. We investigated whether perioperative administration of sodium bicarbonate, which might reduce renal injury by alleviating oxidative stress in renal tubules, prevents postoperative AKI in off-pump coronary revascularization patients having renal risk factors. Patients (n=162) having at least one of the following AKI risk factors were enrolled: (i) age >70 yr; (ii) diabetes mellitus; (iii) chronic renal disease; (iv) congestive heart failure or left ventricular ejection fraction <35%; and (v) reoperation or emergency. Patients were evenly randomized to receive either sodium bicarbonate (0.5 mmol kg -1 for 1 h upon induction of anaesthesia followed by 0.15 mmol kg -1 h -1 for 23 h) or 0.9% saline. Acute kidney injury within 48 h after surgery was assessed using the Acute Kidney Injury Network criteria. The incidences of AKI were 21 and 26% in the bicarbonate and control groups, respectively (P=0.458). Serially measured serum creatinine concentrations and perioperative fluid balance were also comparable between the groups. The length of postoperative hospitalization and incidence of morbidity end points were similar between the groups, whereas significantly more patients in the bicarbonate group required prolonged mechanical ventilation (>24 h) relative to the control group (20 vs 6, P=0.003). Perioperative sodium bicarbonate administration did not decrease the incidence of AKI after off-pump coronary revascularization in high-risk patients and might even be associated with a need for prolonged ventilatory care. NCT01840241. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Comparison of cost-effectiveness of oral rapamycin plus bare-metal stents versus first generation of drug-eluting stents (from the Randomized Oral Rapamycin in Argentina [ORAR] 3 trial).

PubMed

Rodriguez, Alfredo E; Palacios, Igor; Rodriguez-Granillo, Alfredo M; Mieres, Juan R; Tarragona, Sonia; Fernandez-Pereira, Carlos; Solorzano, Leonardo; Pauletto, Ricardo; Serruys, Patrick W; Antoniucci, David

2014-03-01

The aim of this study was to compare 5-year cost-effectiveness and clinical outcomes of patients with oral rapamycin (OR) plus bare-metal stent versus the drug-eluting stent (DES) strategy. During 2006 to 2007, a total of 200 patients were randomized to OR (n = 100) and DES (n = 100). Primary end point was to compare costs of initial procedure and cost-effectiveness of both revascularization strategies. Safety was evaluated by the composite of death, myocardial infarction, and cerebrovascular accident. Efficacy was assessed by target vessel and target lesion revascularizations. The 2 groups had similar baseline demographic, clinical, and angiographic characteristics. In the DES group, paclitaxel-, zotarolimus-, and sirolimus-eluting stents were used. Five-year clinical follow-up was accomplished in 99% patients. The DES group had significantly higher procedural (p <0.001), discharge to first-year (p = 0.02), and 1- to 5-year costs (p <0.001) compared with the OR group. At 5 years, the composite end point of death, myocardial infarction, and cerebrovascular accident (12% in the OR group vs 25% in the DES group, p = 0.01) was significantly less in the OR group. Target vessel revascularization (14.5% in the OR group vs 21% in the DES group, p = 0.16) and target lesion revascularization (10% in the OR group vs 17.6% in the DES group, p = 0.05) were not significantly different. In conclusion, a strategy of OR plus bare-metal stent was cost saving than a first-generation DES. Copyright © 2014 Elsevier Inc. All rights reserved.

A UK trial-based cost--utility analysis of transmyocardial laser revascularization compared to continued medical therapy for treatment of refractory angina pectoris.

PubMed

Campbell, H E; Tait, S; Buxton, M J; Sharples, L D; Caine, N; Schofield, P M; Wallwork, J

2001-08-01

Transmyocardial laser revascularization (TMLR) is used to treat patients with refractory angina considered unsuitable for conventional forms of revascularization. Using patient specific data from a single centre UK randomised-controlled trial, we aimed to determine whether, from a UK National Health Service (NHS) perspective, TMLR plus standard medical management is cost-effective when compared with standard medical management alone. One hundred and eighty-eight patients assessed as having refractory angina, and not suitable for conventional forms of revascularization were randomized to receive TMLR and medical management (94) or medical management alone (94). Costs to the UK NHS of TMLR (where appropriate), and all secondary sector health care contacts and cardiac-related medication in the 12 months following randomization, were collected. Patient utility as measured using the EuroQol EQ-5D questionnaire was combined with 12-month survival data to generate quality adjusted life years (QALYs). The mean cost per patient over the year from hospitalization for TMLR was 11,470 pounds sterling and for medical management alone was 2586 pounds sterling, giving a cost difference of 8901 pounds sterling (95% confidence interval (CI) 7502 pounds sterling--10,008 pounds sterling: P < 0.0001). The mean QALY difference, in favour of TMLR was 0.039 (95% CI -0.033 to 0.113: P = 0.268). This gives an incremental cost per QALY of over 228,000 pounds sterling. Analysis of stochastic uncertainty and of sensitivity to gross changes in key parameters consistently produces very high costs per QALY. The policy implications are clear: for such patients TMLR is an inefficient use of UK health service resources. This conclusion would not be changed by considerable improvements in effectiveness or reductions in cost.

Outcomes of the single-stent versus kissing-stents technique in asymmetric complex aortoiliac bifurcation lesions.

PubMed

Suh, Yongsung; Ko, Young-Guk; Shin, Dong-Ho; Kim, Jung-Sun; Kim, Byeong-Keuk; Choi, Donghoon; Hong, Myeong-Ki; Jang, Yangsoo

2015-07-01

This study investigated the outcomes of single-stent vs kissing-stents techniques in asymmetric complex aortoiliac bifurcation (ACAB) lesions. We retrospectively investigated 80 consecutive patients (69 males, 66.6 ± 8.7 years) treated with a single stent and 30 patients (26 males, 67.1 ± 7.7 years) treated with kissing stents for ACAB between January 2005 and December 2012 from a single-center cohort. A ACAB lesion was defined as a symptomatic unilateral common iliac artery stenosis (>50%) combined with intermediate stenosis (30%-50%) in the contralateral common iliac artery ostium. The primary end point was the primary patency of the ACAB. The baseline clinical characteristics did not differ significantly between the single-stent and the kissing-stents group. Technical success was achieved in all patients. The single-stent group required fewer stents (1.3 ± 0.5 vs 2.3 ± 0.8; P < .001) and less bilateral femoral access (55% vs 100%; P < .001). Two patients in the single-stent group (3%) required bailout kissing stents because of plaque shift to the contralateral side. The major complication rates were 8% in single-stent vs 13% in the kissing-stent group, which was similar (P = .399). At 3 years, the single-stent and kissing-stents group had similar rates of primary patency (89% vs 87%; P = .916) and target lesion revascularization-free survival (93% vs 87%; P = .462). The single-stent technique in ACAB was safe and showed midterm outcomes comparable with those of kissing stents. Considering the benefits, such as fewer stents, less bilateral femoral access, and the availability of contralateral access for future intervention, the single-stent technique may be an advantageous treatment option in ACAB. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Natural History of Moderate Coronary Artery Stenosis After Surgical Revascularization.

PubMed

Raza, Sajjad; Blackstone, Eugene H; Houghtaling, Penny L; Olivares, Gabriel; Ravichandren, Kirthi; Koprivanac, Marijan; Bakaeen, Faisal G; Sabik, Joseph F

2018-03-01

It remains controversial whether grafting moderately stenosed coronary arteries (MSCAs) influences native-vessel disease progression and whether grafting may protect against late myocardial ischemia. From 1972 to 2011, 55,567 patients underwent primary isolated coronary artery bypass grafting (CABG); 1,902 had a single coronary artery with angiographically moderate (50% to 69%) stenosis and ≥1 postoperative angiogram. Disease progression was studied in 489 nongrafted, 371 internal thoracic artery (ITA)-grafted, and 957 saphenous vein (SV)-grafted MSCAs, as well as patency of 376 ITA and 1,016 SV grafts to these MSCAs. At 1, 5, 10, and 15 years, native-vessel disease progressed from moderate to severe stenosis/occlusion in 32%, 52%, 66%, and 72% of nongrafted MSCAs; 55%, 73%, 84%, and 87% of ITA-grafted MSCAs; and 67%, 82%, 90%, and 92% of SV-grafted MSCAs. After adjusting for patient characteristics, MSCA disease progressed 3.6 times faster with ITA and 10 times faster with SV grafting compared with nongrafting. At these same time points, occlusion of ITA grafts to MSCAs was 8%, 9%, 11%, and 15% and for SV grafts, 13%, 32%, 46%, and 56%; protection from myocardial ischemia by ITA-grafted versus nongrafted MSCAs was 29%, 47%, 59%, and 61%. Most MSCAs progress to severe stenosis or occlusion in the long term. Progression is faster in grafted than nongrafted MSCAs, more so with SV than ITA grafts. However, ITA grafts to such arteries have excellent patency, providing long-term protection from myocardial ischemia. Therefore, ITA grafting of MSCAs should be considered. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Long-Term Effectiveness of the Zilver PTX Drug-Eluting Stent for Femoropopliteal Peripheral Artery Disease in Patients with No Patent Tibial Runoff Vessels-Results from the Zilver PTX Japan Post-Market Surveillance Study.

PubMed

Cipollari, Stefano; Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Saunders, Alan T; Dake, Michael D

2018-01-01

To evaluate 2-year results of the Zilver PTX (Cook Medical, Bloomington, Indiana) drug-eluting stent (DES) for femoropopliteal peripheral artery disease (PAD) in patients with no continuous patent infrapopliteal runoff arteries compared with patients with ≥ 1 continuous patent runoff vessels. A retrospective analysis of patients with femoropopliteal PAD enrolled in the Zilver PTX Post-Market Surveillance Study in Japan was performed. There were no exclusion criteria. Outcomes, including freedom from target lesion revascularization (TLR), patency, and clinical benefit, for the no-runoff group (n = 54) were compared with the runoff group (n = 846). The 2 groups were similar in terms of demographics, lesion characteristics, and comorbidities (P > .05). There was a higher incidence of critical limb ischemia in the no-runoff group compared with the runoff group (44.8% vs 19.7%; P < .01). There were 3 amputations (5.6%) in the no-runoff group versus 7 amputations (0.8%) in the runoff group (P = .02). At 2 years, freedom from TLR rates were 81.3% versus 83.8% (P = .87), patency rates were 68.4% versus 70.7% (P = .95), and clinical benefit rates were 73.7% versus 80.0% (P = .16) in the no-runoff versus runoff group, respectively. Results in patients with no continuous patent tibial runoff were favorable through 2 years and similar to results for patients with ≥ 1 continuous patent runoff vessels, indicating that the Zilver PTX DES may be a valid treatment option for patients with these difficult-to-treat lesions. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

Is the mid-term outcome of free right internal thoracic artery with a proximal anastomosis modification inferior to in situ right internal thoracic artery?

PubMed

Yoshizumi, Tomo; Ito, Toshiaki; Maekawa, Atsuo; Sunada, Masatoshi; Wakai, Kenii; Usui, Akihiko; Ueda, Yuichi

2012-08-01

We investigated the mid-term results of free right internal thoracic artery (RITA) grafts used in an aorto-coronary fashion with a modified proximal anastomosis. The subjects were 214 patients who underwent coronary artery bypass grafting with anastomosis to the left circumflex arteries using the RITA as a free graft (Group A: 158 patients) or an in situ graft (Group B: 56 patients). In Group A, the proximal end of the free RITA was anastomosed onto the ascending aorta interposing free graft tissue or to part of its own tissue as a cuff. The number of RITA anastomoses was 1.38 ± 0.50 in Group A and 1.04 ± 0.19 in Group B (P < 0.001). The relationship between perioperative variables and mid-term outcomes was assessed using Cox proportional hazard models. Survival was not associated with the way the RITA graft was performed (Hazard Ratio 5.26, 95 % CI 0.52-53.1, P = 0.159), however, the number of cardiac events was decreased in Group A (Hazard Ratio 2.55, 95 % CI 1.03-6.33, P = 0.043). The graft patency was evaluated in 187 of 214 patients, and at 1, 3 and 5 years was 97.0, 97.0 and 97.0 % in Group A, and 97.9, 92.5 and 80.5 % in Group B (P = 0.378), respectively. By modifying the proximal anastomosis of the free RITA, cardiac events may be decreased, while survival and graft patency comparable with in situ RITA can be obtained, and a significantly larger number of targets can be revascularized.

AMS INSIGHT--absorbable metal stent implantation for treatment of below-the-knee critical limb ischemia: 6-month analysis.

PubMed

Bosiers, Marc; Peeters, Patrick; D'Archambeau, Olivier; Hendriks, Jeroen; Pilger, Ernst; Düber, Christoph; Zeller, Thomas; Gussmann, Andreas; Lohle, Paul N M; Minar, Erich; Scheinert, Dierk; Hausegger, Klaus; Schulte, Karl-Ludwig; Verbist, Jürgen; Deloose, Koen; Lammer, J

2009-05-01

Endoluminal treatment of infrapopliteal artery lesions is a matter of controversy. Bioabsorbable stents are discussed as a means to combine mechanical prevention of vessel recoil with the advantages of long-term perspectives. The possibility of not having a permanent metallic implant could permit the occurrence of positive remodeling with lumen enlargement to compensate for the development of new lesions. The present study was designed to investigate the safety of absorbable metal stents (AMSs) in the infrapopliteal arteries based on 1- and 6-month clinical follow-up and efficacy based on 6-month angiographic patency. One hundred seventeen patients with 149 lesions with chronic limb ischemia (CLI) were randomized to implantation of an AMS (60 patients, 74 lesions) or stand-alone percutaneous transluminal angioplasty (PTA; 57 patients, 75 lesions). Seven PTA-group patients "crossed over" to AMS stenting. The study population consisted of patients with symptomatic CLI (Rutherford categories 4 and 5) and de novo stenotic (>50%) or occlusive atherosclerotic disease of the infrapopliteal arteries who presented with a reference diameter of between 3.0 and 3.5 mm and a lesion length of <15 mm. The primary safety endpoint was defined as absence of major amputation and/or death within 30 days after index intervention and the primary efficacy endpoint was the 6-month angiographic patency rate as confirmed by core-lab quantitative vessel analysis. The 30-day complication rate was 5.3% (3/57) and 5.0% (3/60) in patients randomized for PTA alone and PTA followed by AMS implantation, respectively. On an intention-to-treat basis, the 6-month angiographic patency rate for lesions treated with AMS (31.8%) was significantly lower (p = 0.013) than the rate for those treated with PTA (58.0%). Although the present study indicates that the AMS technology can be safely applied, it did not demonstrate efficacy in long-term patency over standard PTA in the infrapopliteal vessels.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Krokidis, Miltiadis, E-mail: mkrokidis@hotmail.com; Fanelli, Fabrizio; Orgera, Gianluigi

The purpose of this study was to compare the clinical effectiveness of expanded polytetrafluoroethylene/fluorinated-ethylene-propylene (ePTFE/FEP)-covered stents with that of uncovered nitinol stents for the palliation of malignant jaundice caused by inoperable pancreatic head cancer. Eighty patients were enrolled in a prospective randomized study. Bare nitinol stents were used in half of the patients, and ePTFE/FEP-covered stents were used in the remaining patients. Patency, survival, complications, and mean cost were calculated in both groups. Mean patency was 166.0 {+-} 13.11 days for the bare-stent group and 234.0 {+-} 20.87 days for the covered-stent group (p = 0.007). Primary patency rates atmore » 3, 6, and 12 months were 77.5, 69.8, and 69.8% for the bare-stent group and 97.5, 92.2, and 87.6% for the covered-stent group, respectively. Mean secondary patency was 123.7 {+-} 22.5 days for the bare-stent group and 130.3 {+-} 21.4 days for the covered-stent group. Tumour ingrowth occurred exclusively in the bare-stent group in 27.5% of cases (p = 0.002). Median survival was 203.2 {+-} 11.8 days for the bare-stent group and 247.0 {+-} 20 days for the covered-stent group (p = 0.06). Complications and mean cost were similar in both groups. Regarding primary patency and ingrowth rate, ePTFE/FEP-covered stents have shown to be significantly superior to bare nitinol stents for the palliation of malignant jaundice caused by inoperable pancreatic head cancer and pose comparable cost and complications. Use of a covered stent does not significantly influence overall survival rate; nevertheless, the covered endoprosthesis seems to offer result in fewer reinterventions and better quality of patient life.« less

Percutaneous Coronary Intervention of Left Main Disease: Pre- and Post-EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic-Baltic-British Left Main Revascularization Study) Era.

PubMed

Park, Duk-Woo; Park, Seung-Jung

2017-06-01

For nearly half a century, coronary artery bypass grafting has been the standard treatment for patients with obstructive left main coronary artery (LMCA) disease. However, there has been considerable evolution in the field of percutaneous coronary intervention, and especially, percutaneous coronary intervention for LMCA disease has been rapidly expanded with adoption of drug-eluting stents. Some, but not all randomized trials, have shown that percutaneous coronary intervention with drug-eluting stents might be a suitable alternative for selected patients with LMCA disease instead of bypass surgery. However, none of previous trials involving early-generation drug-eluting stents was sufficiently powered and comparative trials using contemporary drug-eluting stents were limited. Recently, primary results of 2 new trials of EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic-Baltic-British Left Main Revascularization Study) were reported. However, these trials showed conflicting results, which might pose uncertainty on the optimal revascularization strategy for LMCA disease. In this article, with the incorporation of a key review on evolution of LMCA treatment, we summarize the similarity or disparity of the EXCEL and NOBLE trials, focus on how they relate to previous trials in the field, and finally speculate on how the treatment strategy may be changed or recommended for LMCA treatment. © 2017 American Heart Association, Inc.

A comparison of the efficacy of heparinized and nonheparinized solutions for maintenance of perioperative radial arterial catheter patency and subsequent occlusion.

PubMed

Tuncali, Binnur E; Kuvaki, Buhar; Tuncali, Bahattin; Capar, Emine

2005-04-01

In a randomized, double-blind, controlled study, we compared heparinized and nonheparinized infusions for the maintenance of perioperative arterial catheter patency and the incidence of subsequent radial arterial occlusion. Two-hundred patients were randomized into 2 groups to receive heparinized (group H, n = 100) or nonheparinized (group S, n = 100) flush solutions. Radial and ulnar blood flows were assessed using Doppler probe and pulse oximetry before, just after, and 24 h after decannulation by the same investigator. The cannulation site was examined for complications such as hematoma, nerve injury, and infection. The mean duration of cannulations was 378 +/- 159.0 min in group H and 332 +/- 154.6 min in group S. The mean number of corrective interventions caused by dampening of the pressure wave (mean number of positional changes [group S, 1.5 +/- 2.0; group H, 1.4 +/- 3.8] and mean number of manual flushes [group S, 1.3 +/- 1.7; group H, 1.2 +/- 1.2]) was not significantly different in both groups. After decannulation, partial or total occlusion developed in 20 group H patients and 16 group S patients (not significant). The incidence of occlusion was correlated to the presence of hematoma at the puncture site after decannulation (P = 0.013), long duration of cannulation (P = 0.04), and age <65 yr (P = 0.009). In conclusion, there is no significant difference between heparinized and nonheparinized flush solutions for the maintenance of perioperative radial artery catheter patency.

A randomized controlled comparison of flushing protocols in home care patients with peripherally inserted central catheters.

PubMed

Lyons, Margaret G; Phalen, Ann G

2014-01-01

Research has failed to demonstrate an optimal flushing solution or frequency for central catheters. In a 2002 study of 50 000 home care patients, catheter dysfunction with loss of patency was the most common complication and occurred in 29% of the peripherally inserted central catheters (PICCs) tracked. With the advent of the Affordable Care Act and the promise of expanded home care services, this study offers evidence as to a preferred flushing protocol to prevent catheter patency complications for home infusion patients with PICCs. This prospective, randomized, 1-way, single-blinded posttest with control group study was performed to compare 3 commonly used flushing protocols in home infusion patients with PICCs. The independent variable was the flushing protocol, and dependent variables included the development of patency-related complications and other significant issues such as sluggishness, occlusion, missed medication doses, catheter replacement, additional nursing visits, and the use of alteplase (Cathflo Activase). Each of the study groups had patients who experienced 1 or more patency-related complications. Additional factors that may affect catheter function, including patient age, gender, diagnosis, therapy type, frequency of catheter use, catheter brand/size/number of lumens, concomitant use of anticoagulant medications, and whether PICCs were used for routine lab testing, were analyzed, and no statistical significance was determined. Catheter dwell time (catheter days) was statistically significant (p = .003, confidence interval = 95%; assuming equal variance) and confirmed the assumption that the longer a home care patient's catheter was in place, the more complications occurred. There were no cases of heparin allergy, heparin-induced thrombocytopenia, or line infection. The data provide some evidence to support the elimination of heparin flushing in home care patients with PICCs, although data in the saline-only group that related to additional registered nurse visits to assess PICC patency and the use of alteplase (Cathflo Activase) were trending toward significance because this group experienced a higher incidence of these complications than both the heparin groups. These findings should not be translated to home care patients with cancer or pregnancy diagnoses because these populations were excluded from this study. More studies of this topic area should be initiated. Please see video abstract, Supplemental Digital Content 1, for more information (http://links.lww.com/JIN/A3).

3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents.

PubMed

Alfonso, Fernando; Pérez-Vizcayno, María José; Cuesta, Javier; García Del Blanco, Bruno; García-Touchard, Arturo; López-Mínguez, José Ramón; Masotti, Mónica; Zueco, Javier; Cequier, Angel; Velázquez, Maite; Moreno, Raúl; Mainar, Vicente; Domínguez, Antonio; Moris, Cesar; Molina, Eduardo; Rivero, Fernando; Jiménez-Quevedo, Pilar; Gonzalo, Nieves; Fernández-Pérez, Cristina

2018-05-28

This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). Treatment of patients with DES-ISR remains a challenge. The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01). Three-year clinical follow-up was obtained in all enrolled patients (100%). The combined clinical outcome measure of cardiac death, myocardial infarction and target lesion revascularization was significantly reduced in the EES arm (19 [12.3%] vs. 31 [20.1%]; p = 0.04; hazard ratio: 0.57 [95% confidence interval: 0.34 to 0.96]), driven by a lower need for target lesion revascularization (11 [7.1%] vs. 24 [15.6%]; p = 0.015; hazard ratio: 0.43 [95% confidence interval: 0.21 to 0.87]). The need for "late" (>1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940). Published by Elsevier Inc.

Surgical Treatment of Large or Giant Fusiform Middle Cerebral Artery Aneurysms: A Case Series.

PubMed

Xu, Feng; Xu, Bin; Huang, Lei; Xiong, Ji; Gu, Yuxiang; Lawton, Michael T

2018-04-14

Management of large or giant fusiform middle cerebral artery (MCA) aneurysms represents a significant challenge. To describe the authors' experience in the treatment of large or giant fusiform MCA aneurysm by using various surgical techniques. We retrospectively reviewed a database of aneurysms treated at our division between 2015 and 2017. Overall, 20 patients (11 males, 9 females) were identified, with a mean age of 40.7 years (range, 13-65 years; median, 43 years). Six patients (30%) had ruptured aneurysms and 14 (70%) had unruptured aneurysms. The mean aneurysm size was 19 mm (range, 10-35 mm). The aneurysms involved the prebifurcation in 5 cases, bifurcation in 4 cases, and postbifurcation in 11 cases. The aneurysms were treated by clip reconstruction (n = 5), clip wrapping (n = 1), proximal occlusion or trapping (n = 4), and bypass revascularization (n = 10). Bypasses included 7 low-flow superficial temporal artery-MCA bypasses, 2 high-flow extracranial-intracranial bypasses, and 1 intracranial-intracranial bypass (reanastomosis). Bypass patency was 90%. Nineteen aneurysms (95%) were completely obliterated, and no rehemorrhage occurred during follow-up. There was no procedural-related mortality. Clinical outcomes were good (modified Rankin Scale score ≤2) in 18 of 20 patients (90%) at the last follow-up. Surgical treatment strategy for large or giant fusiform MCA aneurysms should be determined on an individual basis, based on aneurysm morphology, location, size, and clinical status. Favorable outcomes can be achieved by various surgical techniques, including clip reconstruction, wrap clipping, aneurysm trapping, aneurysm excision followed by reanastomosis, and partial trapping with bypass revascularization. Copyright © 2018 Elsevier Inc. All rights reserved.

Mid-Term Outcomes of Endovascular Treatment for TASC-II D Femoropopliteal Occlusive Disease with Critical Limb Ischemia

DOE Office of Scientific and Technical Information (OSTI.GOV)

Torres-Blanco, Álvaro, E-mail: atorres658@yahoo.es; Edo-Fleta, Gemma; Gómez-Palonés, Francisco

2016-03-15

PurposeThe purpose of the study was to assess the safety and midterm effectiveness of endovascular treatment in Trans-Atlantic Inter-Society Consensus II (TASC-II) D femoropopliteal occlusions in patients with critical limb ischemia (CLI).MethodsPatients with CLI who underwent endovascular treatment for TASC-D de novo femoropopliteal occlusive disease between September 2008 and December 2013 were selected. Data included anatomic features, pre- and postprocedure ankle-brachial index, duplex ultrasound, and periprocedural complications. Sustained clinical improvement, limb salvage rate, freedom from target lesion revascularization (TLR), and freedom from target extremity revascularization (TER) were assessed by Kaplan–Meier estimation and predictors of restenosis/occlusion with Cox analysis.ResultsThirty-two patients underwentmore » treatment of 35 TASC-D occlusions. Mean age was 76 ± 9. Mean lesion length was 23 ± 5 cm. Twenty-eight limbs (80 %) presented tissue loss. Seventeen limbs underwent treatment by stent, 13 by stent-graft, and 5 by angioplasty. Mean follow-up was 29 ± 20 months. Seven patients required major amputation and six patients died during follow-up. Eighteen endovascular and three surgical TLR procedures were performed due to restenosis or occlusion. Estimated freedom from TLR and TER rates at 2 years were 41 and 76 %, whereas estimated primary and secondary patency rates were 41 and 79 %, respectively.ConclusionsEndovascular treatment for TASC II D lesions is safe and offers satisfying outcomes. This patient subset would benefit from a minimally invasive approach. Follow-up is advisable due to a high rate of restenosis. Further follow-up is necessary to know the long-term efficacy of these procedures.« less

Bioresorbable Everolimus-Eluting Vascular Scaffold for Patients With Peripheral Artery Disease (ESPRIT I): 2-Year Clinical and Imaging Results.

PubMed

Lammer, Johannes; Bosiers, Marc; Deloose, Koen; Schmidt, Andrej; Zeller, Thomas; Wolf, Florian; Lansink, Wouter; Sauguet, Antoine; Vermassen, Frank; Lauwers, Geert; Scheinert, Dierk; Popma, Jeffrey J; McGreevy, Robert; Rapoza, Richard; Schwartz, Lewis B; Jaff, Michael R

2016-06-13

This is the first-in-human study of a drug-eluting bioresorbable vascular scaffold (BVS) for treatment of peripheral artery disease (PAD) involving the external iliac artery (EIA) and superficial femoral artery (SFA). Drug-eluting BVS has shown promise in coronary arteries. The ESPRIT BVS system is a device-drug combination consisting of an everolimus-eluting poly-l-lactide scaffold. Safety and performance were evaluated in 35 subjects with symptomatic claudication. Lesions were located in the SFA (88.6%) and EIA (11.4%). Mean lesion length was 35.7 ± 16.0 mm. The study device was successfully deployed in 100% of cases, without recoil. Procedure-related minor complications were observed in 3 patients (groin hematoma, dissection). Within 2 years there was 1 unrelated death, but no patients in this cohort had an amputation. At 1 and 2 years, the binary restenosis rates were 12.1% and 16.1%, respectively, and target lesion revascularization was performed in 3 of 34 patients (8.8%) and 4 of 32 patients (11.8%), respectively. The ankle brachial index 0.75 ± 0.14 improved from pre-procedure to 0.96 ± 0.16 at 2 years' follow-up. At 2 years, 71.0% of the patients were Rutherford-Becker 0, and 93.5% achieved a maximum walking distance of 1,500 feet. The safety of the ESPRIT BVS was demonstrated with no procedure or device-related deaths or amputations within 2 years. The low occurrence of revascularizations was consistent with duplex-ultrasonography showing sustained patency at 2-years. (A Clinical Evaluation of the Abbott Vascular ESPRIT BVS [Bioresorbable Vascular Scaffold] System [ESPRIT I]; NCT01468974). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design.

PubMed

Maron, David J; Hochman, Judith S; O'Brien, Sean M; Reynolds, Harmony R; Boden, William E; Stone, Gregg W; Bangalore, Sripal; Spertus, John A; Mark, Daniel B; Alexander, Karen P; Shaw, Leslee; Berger, Jeffrey S; Ferguson, T Bruce; Williams, David O; Harrington, Robert A; Rosenberg, Yves

2018-07-01

Prior trials comparing a strategy of optimal medical therapy with or without revascularization have not shown that revascularization reduces cardiovascular events in patients with stable ischemic heart disease (SIHD). However, those trials only included participants in whom coronary anatomy was known prior to randomization and did not include sufficient numbers of participants with significant ischemia. It remains unknown whether a routine invasive approach offers incremental value over a conservative approach with catheterization reserved for failure of medical therapy in patients with moderate or severe ischemia. The ISCHEMIA trial is a National Heart, Lung, and Blood Institute supported trial, designed to compare an initial invasive or conservative treatment strategy for managing SIHD patients with moderate or severe ischemia on stress testing. Five thousand one-hundred seventy-nine participants have been randomized. Key exclusion criteria included estimated glomerular filtration rate (eGFR) <30 mL/min, recent myocardial infarction (MI), left ventricular ejection fraction <35%, left main stenosis >50%, or unacceptable angina at baseline. Most enrolled participants with normal renal function first underwent blinded coronary computed tomography angiography (CCTA) to exclude those with left main coronary artery disease (CAD) and without obstructive CAD. All randomized participants receive secondary prevention that includes lifestyle advice and pharmacologic interventions referred to as optimal medical therapy (OMT). Participants randomized to the invasive strategy underwent routine cardiac catheterization followed by revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery, when feasible, as selected by the local Heart Team to achieve optimal revascularization. Participants randomized to the conservative strategy undergo cardiac catheterization only for failure of OMT. The primary endpoint is a composite of cardiovascular (CV) death, nonfatal myocardial infarction (MI), hospitalization for unstable angina, hospitalization for heart failure, or resuscitated cardiac arrest. Assuming the primary endpoint will occur in 16% of the conservative group within 4 years, estimated power exceeds 80% to detect an 18.5% reduction in the primary endpoint. Major secondary endpoints include the composite of CV death and nonfatal MI, net clinical benefit (primary and secondary endpoints combined with stroke), angina-related symptoms and disease-specific quality of life, as well as a cost-effectiveness assessment in North American participants. Ancillary studies of patients with advanced chronic kidney disease and those with documented ischemia and non-obstructive coronary artery disease are being conducted concurrently. ISCHEMIA will provide new scientific evidence regarding whether an invasive management strategy improves clinical outcomes when added to optimal medical therapy in patients with SIHD and moderate or severe ischemia. Copyright © 2018 Elsevier Inc. All rights reserved.

[Carotid Stenting in France after the EVA 3S and SPACE publications].

PubMed

Beyssen, B; Rousseau, H; Bracard, S; Sapoval, M; Gaux, J-C

2007-01-01

Angioplasty of stenoses of the carotid bifurcation is a revascularization procedure that is used successfully in many patients. With more than 10 years of experience now, the feasibility of carotid stenting has been demonstrated. Its distribution is highly variable depending on the country, with a mean penetration rate in Europe of 15% of the number of carotid revascularizations. However, the complication rate is highly variable from one series to another and depends on the type of patient treated and the operator's learning curve. The results of the first two randomized studies comparing endarterectomy and carotid stenting, EVA 3S in France and SPACE in Germany, have just been published. The conclusions of these studies only relate to symptomatic patients, who make up a small proportion of revascularized patients. At 30 days, the French study concluded that surgery was better, and the German study showed no advantage to stenting. The analysis of these results compared to other publications should make it possible to best define the current indications for carotid stenting.

Best way to revascularize patients with main stem and three vessel lesions: patients should undergo PCI!

PubMed

Schächinger, Volker; Herdeg, Christian; Scheller, Bruno

2010-09-01

The optimal revascularization strategy for multivessel disease is under controversial discussion for long time. Until now, technical innovations have been faster than performance of clinical trials, making results of randomized studies outdated at the time of appearance. Recently, the SYNTAX trial has been published, which compared drug elutings stents (DES) implantation with Coronary artery bypass graft (CABG) patients with multivessel or left main disease in a clinically stable population. Overall, CABG was superior with respect to the clinical endpoint of death, myocardial infarction, stroke, or revascularization. However, the difference is driven by the "weakest" end point, namely repeated revascularization, whereas combined "hard" events did not demonstrate a difference. More detailed analysis demonstrates that only patients with most complex coronary anatomy gain definite benefit from CABG. In addition, SYNTAX demonstrated that left main disease is no longer a domain of CABG, since DES implantation revealed comparable results, as long as there is no concomitant multivessel disease. Regardless the results of SYNTAX, one should not forget that SYNTAX represents only a minority of daily patients in a catheterization laboratory, excluding patients with one- or two-vessel disease and those with an acute coronary syndrome. Especially in the latter, percutaneous coronary intervention has demonstrated to improve prognosis.

Endovascular treatment of atherosclerotic popliteal artery disease based on dynamic angiography findings.

PubMed

Cui, Chaoyi; Huang, Xintian; Liu, Xiaobing; Li, Weimin; Lu, Xinwu; Lu, Min; Jiang, Mier; Yin, Minyi

2017-01-01

To evaluate efficacy, safety, and midterm patency of endovascular treatment of obstructive popliteal artery (PA) disease. A retrospective evaluation of patients with atherosclerotic PA disease who underwent percutaneous transluminal balloon angioplasty and provisional stent, based on both conventional and dynamic angiographies, was conducted from June 2011 to June 2014. Forty-three patients were included in the study, and most patients had limited surgical revascularization options. Demographic characteristics, angiographic findings, interventional data, complications, vessel patency, limb salvage rates, and survival rates were analyzed. The median lesion length was 5 cm with 72.1% having total occlusions. The second popliteal segment (P2) was involved most frequently (60.5%, n = 26). Critical limb ischemia was present in 69.8%. The technical success rate was 92.9% (42/43 limbs), with 29 cases requiring adjunctive nitinol stents after balloon angioplasty (47.6% based on conventional angiography, 21.4% based on dynamic angiography, and 4.8% additional stents based on dynamic angiography). Complications included thromboembolism (2.3%), perforation (2.3%), pseudoaneurysm (2.3%), and myocardial infarction (2.3%). Stent fracture was present in three cases (7.1%) during the mean follow-up period of 18.3 months. The baseline ankle-brachial index significantly improved after the intervention, from 0.49 ± 0.11 to 0.92 ± 0.14 (P < .01). The Rutherford-Becker class decreased from 3.95 ± 0.76 to 1.76 ± 0.95 (P < .01) at 12 months. The 1-year primary, primary-assisted, and secondary patency rates were 75.2% ± 6.8%, 82.4% ± 6.0%, and 89.9% ± 4.8%, respectively. The limb salvage and amputation-free survival rates at 12 months were 91.6% and 87.0%, respectively. Balloon angioplasty with a provisional stent based on dynamic angiography is a feasible, safe, and effective therapy for patients with obstructive PA disease. Although the occurrence of stent fracture is still inevitable, patients with critical limb ischemia who have limited surgical options may get more benefits from the endovascular treatment of PA obstructive diseases. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Effects of tooth-brushing force with a desensitising dentifrice on dentine tubule patency and surface roughness.

PubMed

Mullan, F; Paraskar, S; Bartlett, D W; Olley, R C

2017-05-01

To investigate the effects of a 5% NovaMin containing dentifrice on dentine tubule patency and surface roughness at 100g and 400g tooth brush abrasion forces. 75 polished human dentine samples were prepared and randomly allocated into one of five groups; control (1), Na 2 PFO 3 100g abrasion force (2), NovaMin 100g (3), Na 2 PFO 3 400g (4) and NovaMin 400g (5). The control group underwent two 2-min cycles of artificial saliva (AS), one 2-min erosion cycle; the rest underwent two toothbrush abrasion cycles in an AS/dentifrice slurry and one 2-min erosion cycle. All samples were imaged at baseline and post intervention using Tandem Scanning Microscopy and Profilometry to analyse tubule patency and roughness. Mean tubule patency increased significantly between baseline and post intervention in groups 1,2 and 4 and decreased significantly post intervention in groups 3 and 5 (p<0.01). Post intervention, there were statistically significant differences in mean patent tubules between NovaMin and the Na 2 PFO 3 and control groups (p<0.001). Surface roughness increased for all groups between baseline and post interventions (P<0.001); mean (SD) roughness increases for groups 1, 2, 3, 4 and 5 were 0.14 (0.05) μm, 0.18 (0.04) μm, 0.16 (0.06) μm, 0.19 (0.07) μm and 0.21 (0.02) μm respectively. Differences between group 1 and 5 were significant (p<0.01). Brushing with NovaMin resulted in significant dentine tubule occlusion at 100g and 400g, but brushing with Na 2 PFO 3 resulted in increased tubule patency. Surface roughness increased significantly at 400g brushing with NovaMin. There was no correlation between tubule patency and surface roughness. A NovaMin desensitising dentifrice resulted in tubule occlusion even at high brushing forces. There was minimal increase in surface roughness at the lower (100g) brushing force. Copyright © 2017 Elsevier Ltd. All rights reserved.

Enhanced recovery after elective coronary revascularization surgery with minimal versus conventional extracorporeal circulation: a prospective randomized study.

PubMed

Anastasiadis, Kyriakos; Asteriou, Christos; Antonitsis, Polychronis; Argiriadou, Helena; Grosomanidis, Vassilios; Kyparissa, Magdalena; Deliopoulos, Apostolos; Konstantinou, Dimitrios; Tossios, Paschalis

2013-10-01

A minimal extracorporeal circulation (MECC) circuit integrates the advances in cardiopulmonary bypass (CPB) technology into a single circuit and is associated with improved short-term outcome. The aim of this study was to prospectively evaluate MECC compared with conventional CPB in facilitating fast-track recovery after elective coronary revascularization procedures. Prospective randomized study. All patients scheduled for elective coronary artery surgery were evaluated, excluding those considered particularly high risk for fast-track failure. The fast-track protocol included careful preoperative patient selection, a fast-track anesthetic technique based on minimal administration of fentanyl, surgery at normothermia, early postoperative extubation in the cardiac recovery unit, and admission to the cardiothoracic ward within the first 24 hours postoperatively. One hundred twenty patients were assigned randomly into 2 groups (60 in each group). Group A included patients who were operated on using the MECC circuit, whereas patients in Group B underwent surgery on conventional CPB. Incidence of fast-track recovery was significantly higher in patients undergoing MECC (25% v 6.7%, p = 0.006). MECC also was recognized as a strong independent predictor of early recovery, with an odds ratio of 3.8 (p = 0.011). Duration of mechanical ventilation and cardiac recovery unit stay were significantly lower in patients undergoing MECC together with the need for blood transfusion, duration of inotropic support, need for an intra-aortic balloon pump, and development of postoperative atrial fibrillation and renal failure. MECC promotes successful early recovery after elective coronary revascularization procedures, even in a nondedicated cardiac intensive care unit setting. Copyright © 2013 Elsevier Inc. All rights reserved.

Percutaneous Intervention in ST-Elevation Myocardial Infarction: Culprit-only or Complete Revascularization?

PubMed Central

Osório, Ana Paula Susin; de Quadros, Alexandre Schaan; Vieira, José Luiz da Costa; Portal, Vera Lucia

2017-01-01

The best approach of multivessel coronary artery disease in the context of acute myocardial infarction with ST segment elevation and primary percutaneous coronary intervention is one of the main reasons for controversy in cardiology. Although the main global guidelines do not recommend routine complete revascularization in these patients, recent randomized clinical trials have demonstrated benefit of this approach in reducing cardiovascular outcomes. For this reason, an adequate review of this evidence is essential in order to establish scientifically based strategy and achieve better outcomes for these patients who present with acute myocardial infarction. This review aims to present objectively the most recent evidence available on this topic. PMID:29185617

Does off-pump coronary artery bypass graft surgery have a beneficial effect on long-term mortality and morbidity compared with on-pump coronary artery bypass graft surgery?

PubMed

Chaudhry, Umar A R; Rao, Christopher; Harling, Leanne; Athanasiou, Thanos

2014-07-01

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether off-pump coronary artery bypass grafting (CABG) surgery offered superior long-term outcomes compared with on-pump CABG surgery. Best evidence papers were considered to be those that had a follow-up period of ≥5 years, had >50 patients in either cohort, did not utilize concomitant interventions nor comprised low-risk, high-risk or sub-population groups. Where potential duplicate data sets from the same institution were likely, the more credible and recently published study was included. Two hundred and fifty-six papers were found as a result of the reported search, of which 16 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. The 16 studies comprised 4 prospective randomized controlled trials (RCTs), with the remaining 12 retrospective, of which 8 were propensity-score matched. All 4 RCTs contained fewer than 450 participants. Two studies concluded with a survival advantage towards on-pump CABG: one, a large registry-based study, the Veterans Affairs, with >25 000 patients, and another, a propensity-matched retrospective study involving almost 8000 patients. The remaining 14 studies all provided evidence to suggest comparable long-term survival. In addition, all other long-term outcomes mentioned within these studies including angina recurrence, myocardial infarction heart failure, need for revascularization, stroke, graft patency, cognitive and quality of life showed similar results between the two groups. We conclude that off-pump CABG surgery may have similar or slightly reduced long-term survival compared with on-pump CABG surgery. Other long-term indicators such as cardiovascular or cerebrovascular events or neuro-psychological outcomes were similar between the two groups. Despite these conclusions, the evidence is limited by substantial variability in patient selection and study methods. The CORONARY (coronary artery bypass surgery off- or on-pump revascularization study) trial recently presented results, which showed no significant differences in composite outcomes at 1 year; it will be interesting to observe whether these comparable outcomes are maintained for a much longer time frame. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Maintaining Apical Patency Does Not Increase Postoperative Pain in Molars with Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.

PubMed

Yaylali, Ibrahim Ethem; Kurnaz, Safa; Tunca, Yasar Meric

2018-03-01

This prospective, single-center, single-blind, randomized controlled trial aimed to evaluate whether maintaining apical patency (AP) during endodontic treatment increases postoperative pain in molar teeth with necrotic pulp and apical periodontitis. Three hundred twenty qualified patients between 21 and 45 years of age were randomized into 1 of 2 groups (the AP group and the nonapical patency [NAP] group) using a series of random numbers in a 1:1 ratio. Qualified patients were selected from patients who had necrotic pulp and apical periodontitis in the maxillary or mandibular molar teeth. The primary outcome was to assess postoperative pain severity, and the secondary outcome was to evaluate analgesic consumption during the 7-day follow-up period using the visual analog scale (VAS). The VAS consisted of a 100-mm line. Pain severity was evaluated as no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). The Student t test was used to identify statistically significant differences between the study groups (P < .05). The mean VAS scores were significantly lower in the AP group in the first 5 postoperative days (P < .05); after which, it was nonsignificant. In the NAP group, the postoperative pain increased between 12 and 24 hours, whereas the postoperative pain decreased in the AP group during that period. At 12 and 24 hours, the mean VAS scores for the AP group were 42.90 and 37.78 mm, respectively. The mean VAS scores for the NAP group were 64.46 and 65.74 mm, respectively. None of the patients had severe postoperative pain during the follow-up period. No significant difference was found in analgesic consumption (P > .05) between the groups. The maintenance of AP in molar teeth with necrotic pulp and apical periodontitis was associated with less postoperative pain when compared with NAP. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Quality-of-Life After Everolimus-Eluting Stents or Bypass Surgery for Left-Main Disease: Results From the EXCEL Trial.

PubMed

Baron, Suzanne J; Chinnakondepalli, Khaja; Magnuson, Elizabeth A; Kandzari, David E; Puskas, John D; Ben-Yehuda, Ori; van Es, Gerrit-Anne; Taggart, David P; Morice, Marie-Claude; Lembo, Nicholas J; Brown, W Morris; Banning, Adrian; Simonton, Charles A; Kappetein, A Pieter; Sabik, Joseph F; Serruys, Patrick W; Stone, Gregg W; Cohen, David J

2017-12-26

The EXCEL (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial compared outcomes in patients with unprotected left main coronary artery disease (LMCAD) treated with coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) using everolimus-eluting stents. Whereas rates of death, stroke, and myocardial infarction were similar at 36 months, event timing and repeat revascularization rates differed by treatment group. To understand the effects of revascularization strategy from the patient's perspective, a prospective quality of life (QoL) substudy was performed alongside the EXCEL trial. Between September 2010 and March 2014, 1,905 patients with LMCAD were randomized to undergo CABG or PCI, of whom 1,788 participated in the QoL substudy. QoL was assessed at baseline and 1, 12, and 36 months using the Seattle Angina Questionnaire, the 12-Item Short Form Health Survey, the Rose Dyspnea Scale, the Patient Health Questionnaire-8, and the EQ-5D. Differences between PCI and CABG were assessed using longitudinal random-effect growth curve models. Over 36 months, both PCI and CABG were associated with significant improvements in QoL compared with baseline. At 1 month, PCI was associated with better QoL than CABG. By 12 months though, these differences were largely attenuated, and by 36 months, there were no significant QoL differences between PCI and CABG. Among selected patients with LMCAD, both PCI and CABG result in similar QoL improvement through 36 months, although a greater early benefit is seen with PCI. Taken together with the 3-year clinical results of EXCEL, these findings suggest that PCI and CABG provide similar intermediate-term outcomes for patients with LMCAD. (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Percutaneous intervention versus coronary artery bypass graft surgery in left main coronary artery stenosis: a systematic review and meta-analysis.

PubMed

Zhang, Xin-Lin; Zhu, Qing-Qing; Yang, Jing-Jing; Chen, Yu-Han; Li, Yang; Zhu, Su-Hui; Xie, Jun; Wang, Lian; Kang, Li-Na; Xu, Biao

2017-04-21

The optimal revascularization technique in patients with left main coronary artery disease (CAD) remains controversial. We aimed to compare the long-term performance of percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) surgery in treatment of left main CAD. PubMed, EMBASE, and the Cochrane Library were searched until November 16, 2016. Six randomized controlled trials and 22 matched observational studies including 22,487 patients and 90,167 patient-years of follow-up were included. PCI was associated with an overall higher risk for the major adverse cardiac and cerebrovascular events (hazard ratio (HR), 1.42; 95% confidence interval (CI), 1.14-1.77), mainly driven by higher rates of myocardial infarction (HR, 1.69; 95% CI, 1.22-2.34) and revascularization (HR, 2.80; 95% CI, 1.86-4.22). The overall risks for all-cause death (HR, 1.05; 95% CI, 0.93-1.20), cardiac death (HR, 1.05; 95% CI, 0.69-1.59), stroke (HR, 0.64; 95% CI, 0.33-1.24), and the composite safety endpoint of death, myocardial infarction, or stroke (HR, 1.06; 95% CI, 0.97-1.16) were similar between PCI and CABG. Stratified analysis based on stent types showed that the increased risk for myocardial infarction associated with PCI was only evident in patients with bare-metal stents or early-generation drug-eluting stents (DES), but not newer-generation DES. Stratified analyses based on study designs showed largely similar findings with the overall analyses, except for a significantly higher incidence of myocardial infarction in adjusted studies (HR, 2.01; 95% CI, 1.64-2.45) but a trend toward higher incidence in randomized trials (HR, 1.39; 95% CI, 0.85-2.27) associated with PCI. Compared with CABG, PCI with newer-generation DES might be a safe alternative revascularization strategy for treatment of left main CAD, but is associated with more repeat revascularization.

Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: Analysis of amputation free and overall survival by treatment received.

PubMed

Bradbury, Andrew W; Adam, Donald J; Bell, Jocelyn; Forbes, John F; Fowkes, F Gerry R; Gillespie, Ian; Ruckley, Charles Vaughan; Raab, Gillian M

2010-05-01

An intention-to-treat analysis of randomized Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial data showed that initial randomization to a bypass surgery (BSX)-first strategy was associated with improvements in subsequent overall survival (OS) and amputation-free survival (AFS) of about 7 and 6 months, respectively. We describe the nature and timing of first, crossover, and reinterventions and examine AFS and OS by first treatment received. We also compare vein with prosthetic BSX and transluminal with subintimal balloon angioplasty (BAP) and examine outcomes from BSX after failed BAP. We randomly assigned 452 patients with SLI due to infrainguinal disease in 27 United Kingdom hospitals to a BSX first (n = 228) or a BAP first (n = 224) revascularization strategy. All patients have been monitored for 3 years and more than half for >5 years. We prospectively collected data on every procedure, major amputation, and death. Patients randomized to BAP were more likely to have their assigned treatment first (94% vs 85%, P = .01, chi(2)test). BAP had a higher immediate technical failure rate of 20% vs 2.6% (P = .01, chi(2)test). By 12 weeks after randomization 9 BAP (4%) vs 23 BSX (10%) patients had not undergone revascularization; 3 BAP (1.3%) vs 13 BSX (5.8%) had undergone the opposite treatment first; and 35 BAP (15.6%) and 2 (0.9%) BSX had received the assigned treatment and then undergone the opposite treatment. BSX distal anastomoses were divided approximately equally between the above and below knee popliteal and crural arteries; most originated from the common femoral artery. About 25% of the grafts were prosthetic and >90% of vein BSX used ipsilateral great saphenous vein. Most (80%) BAP patients underwent treatment of the SFA alone (38%) or combined with the popliteal artery (42%) and crural arteries (20%). Outcome of vein BSX was better for AFS (P = 0.003) but not OS (P = 0.38, log-rank tests) than prosthetic BSX. There were no differences in outcome between approximately equal numbers of transluminal and subintimal BAP. AFS (P = 0.006) but not OS (P = 0.06, log rank test) survival was significantly worse after BSX after failed BAP than after BSX as a first revascularization attempt. BAP was associated with a significantly higher early failure rate than BSX. Most BAP patients ultimately required surgery. BSX outcomes after failed BAP are significantly worse than for BSX performed as a first revascularization attempt. BSX with vein offers the best long term AFS and OS and, overall, BAP appears superior to prosthetic BSX. Crown Copyright (c) 2010. Published by Mosby, Inc. All rights reserved.

[Assessment of the course of ischemic heart disease after placement of stents with drug covering and uncovered metal stents: data of 3 years follow-up].

PubMed

Buza, V V; Karpov, Iu A; Samko, A N; Deev, A D; Lopukhova, V V; Levitskiĭ, I V; Sozykin, A V

2009-01-01

The placement of sirolimus-eluting stents decreases the frequency of repeat revascularization procedures in patients undergoing percutaneous coronary intervention (PCI) in randomized clinical trials. However, there is uncertainty about the effectiveness of sirolimus-eluting stents, and increasing concern about their safety in routine clinical practice. From the prof. Samko PCI laboratory in Moscow, Russia, we identified 426 patients, who received either bare-metal stents alone or sirolimus-eluting stents alone during an index PCI procedure between March 1, 2002, and September 31, 2004.The primary outcomes of the study were the rates of target-lesion revascularization, myocardial infarction, death, late stent thrombosis. The 3-year rate of target-lesion revascularization was significantly lower among patients who received sirolimus-eluting stents than among those who received bare-metal stents (3.1% vs. 19 %, p=0.001). The 3-year mortality rate was not different between the bare-metal stent group and the sirolimus eluting stent group (5.9% vs. 7.2%, p=0.68), the 3-year rate of all ARC late stent thrombosis was similar in the two groups (5.9% and 7.2%, respectively; p=0.95). Sirolimus-eluting stents are effective in reducing the need for target-vessel revascularization without significantly increased rates of death, late stent thrombosis, myocardial infarction.

Necessity of heparin for maintaining peripheral venous catheters: A systematic review and meta-analysis

PubMed Central

You, Tao; Jiang, Jianliang; Chen, Jianchang; Xu, Weiting; Xiang, Li; Jiao, Yang

2017-01-01

Heparin has typically been used as a flushing or infusion solution for vascular lines in daily practice. However, several clinical trials have yielded controversial results about the benefits of heparin in maintaining peripheral venous catheters. The present meta-analysis was conducted to evaluate the efficacy of heparin on the patency profiles and complications in peripheral intravenous catheters. PubMed, Embase and Cochrane Central Register of Controlled Trials were searched up to February 2016 for randomized controlled trials comparing heparin with placebo in maintaining peripheral intravenous catheters. Additional studies were retrieved from the reference lists of identified articles. In total 32 eligible studies were included, from which the pooled standard mean difference (SMD), relative risk (RR) and corresponding 95% confidence interval (CI) were calculated. The use of heparin as a continuous infusion significantly prolonged the duration of patency (SMD, 0.90; 95% CI, 0.48–1.32; P<0.001), reduced rates of infusion failure (RR, 0.83; 95% CI, 0.76–0.92; P<0.001) and occlusion (RR, 0.82; 95% CI, 0.69–0.98; P<0.05) in a peripheral intravenous catheter. However, there were no significant changes in the duration of patency and infusion failure when heparin was used intermittently as a flushing solution, although a significantly decreased risk of occlusion was observed in this setting (RR, 0.80; 95% CI, 0.66–0.98; P<0.05). Furthermore, the risk of phlebitis was significantly decreased by both continuous infusion (RR, 0.66; 95% CI, 0.58–0.75; P<0.01) and intermittent flushing (RR, 0.70; 95% CI, 0.56–0.86; P<0.01) of heparin in peripheral venous catheters. In conclusion, the use of heparin as continuous infusion in peripheral intravenous catheters improved the duration of patency, reduced infusion failure and phlebitis, whereas heparin as intermittent flushing showed more benefits in ameliorating phlebitis rather than in patency profiles. PMID:28810636

Transmyocardial Laser Revascularization as an Adjunct to Coronary Artery Bypass Grafting

PubMed Central

Frazier, O. H.; Tuzun, Egemen; Eichstadt, Harald; Boyce, Steven W.; Lansing, Allan M.; March, Robet J.; Satori, Michele; Kadipasaoglu, Kamuran A.

2004-01-01

We evaluated transmyocardial laser revascularization (TMLR) with coronary artery bypass grafting (CABG) versus CABG alone for severe coronary artery disease involving ≥1 myocardial region unsuited for CABG. At 4 centers, 44 consecutive patients were randomized for CABG+TMLR (n = 23) or CABG alone (n = 21). Operative and in-hospital mortality and morbidity rates were monitored. Clinical status was evaluated at hospital discharge, 1 year, and 4 years. Success was characterized by relief of angina and freedom from repeat revascularization and death. Preoperatively, 20 patients (47%) were at high risk. The CABG technique, number of grafts, and target vessels were similar in both groups. Patients undergoing CABG+ TMLR received 25 ± 11 laser channels. Their ≤30-day mortality was 13% (3/23) compared with 28% (6/21) after CABG alone (P = 0.21). There were no significant intergroup differences in the number of intraoperative or in-hospital adverse events. The follow-up period was 50.3 ± 17.8 months for CABG alone and 48.1 ± 16.8 months for CABG+TMLR. Both groups had substantially improved angina and functional status at 1 and 4 years, with no significant differences in cumulative 4-year mortality. The incidence of repeat revascularization was 24% after CABG alone versus none after CABG+ TMLR (P < 0.05). The 4-year event-free survival rate was 14% versus 39%, respectively (P < 0.064). In conclusion, CABG+TMLR appears safe and poses no additional threat for high-risk patients. Improved overall success and repeat revascularization rates may be due to better perfusion of ischemic areas not amenable to bypass. Further studies are warranted to determine whether these trends are indeed significant. PMID:15562842

Long term outcomes of new generation drug eluting stents versus coronary artery bypass grafting for multivessel and/or left main coronary artery disease. A Bayesian network meta-analysis of randomized controlled trials.

PubMed

Mina, George S; Watti, Hussam; Soliman, Demiana; Shewale, Anand; Atkins, Jessica; Reddy, Pratap; Dominic, Paari

2018-01-05

Most data guiding revascularization of multivessel disease (MVD) and/or left main disease (LMD) favor coronary artery bypass grafting (CABG) over percutaneous coronary intervention (PCI). However, those data are based on trials comparing CABG to bare metal stents (BMS) or old generation drug eluting stents (OG-DES). Hence, it is essential to outcomes of CABG to those of new generation drug eluting stents (NG-DES). We searched PUBMED and Cochrane database for trials evaluating revascularization of MVD and/or LMD with CABG and/or PCI. A Bayesian network meta-analysis was performed to calculate odds ratios (OR) and 95% credible intervals (CrI). Primary outcome was major adverse cardiovascular events (MACE) at 3-5 years. Secondary outcomes were mortality, cerebrovascular accidents (CVA), myocardial infarction (MI) and repeat revascularization. We included 10 trials with a total of 9287 patients. CABG was associated with lower MACE when compared to BMS or OG-DES. However, MACE was not significantly different between CABG and NG-DES (OR 0.79, CrI 0.45-1.40). Moreover, there were no significant differences between CABG and NG-DES in mortality (OR 0.78, CrI 0.45-1.37), CVA (OR 0.93 CrI 0.35-2.2) or MI (OR 0.6, CrI 0.17-2.0). On the other hand, CABG was associated with lower repeat revascularization (OR 0.55, CrI 0.36-0.84). Our study suggests that NG-DES is an acceptable alternative to CABG in patients with MVD and/or LMD. However, repeat revascularization remains to be lower with CABG than with PCI. Copyright © 2018. Published by Elsevier Inc.

Implantable Defibrillators for Secondary Prevention of Sudden Cardiac Death in Cardiac Surgery Patients With Perioperative Ventricular Arrhythmias

PubMed Central

Nageh, Maged F.; Kim, John J.; Chen, Lie‐Hong; Yao, Janis F.

2014-01-01

Background Randomized studies of implantable cardioverter defibrillators (ICD) have excluded sudden cardiac death survivors who had revascularization before or after an arrhythmic event. To evaluate the role of ICD and the effects of clinical variables including degree of revascularization, we studied cardiac surgery patients who had an ICD implanted for sustained perioperative ventricular arrhythmias. Methods and Results The electronic database for Southern California Kaiser Foundation hospitals was searched for patients who had cardiac surgery between 1999 and 2005 and an ICD implanted within 3 months of surgery. One hundred sixty‐four patients were identified; 93/164 had an ICD for sustained pre‐ or postoperative ventricular tachycardia or fibrillation requiring resuscitation. Records were reviewed for the following: presenting arrhythmia, ejection fraction, and degree of revascularization. The primary end point was total mortality (TM) and/or appropriate ICD therapy (ICD‐T), and secondary end points are TM and ICD‐T. During the mean follow up of 49 months, the primary endpoint of TM+ICD‐T and individual end points of TM and ICD‐T were observed in 52 (56%), 35 (38%), and 28 (30%) patients, respectively, with 55% of TM, and 23% of ICD‐T occurring within 2 years of implant. In multivariate risk analysis, none of the following was associated with any of the end points: incomplete revascularization, presenting ventricular arrhythmia, and timing of arrhythmias. Conclusion Our data supports the recent guidelines for ICD in this cohort of patients, as the presence of irreversible substrate and triggers of ventricular arrhythmias, cannot be reliably excluded even with complete revascularization. Further studies are needed to understand this complex group of patients. PMID:25146702

Effectiveness and safety of drug-eluting stents in Ontario.

PubMed

Tu, Jack V; Bowen, James; Chiu, Maria; Ko, Dennis T; Austin, Peter C; He, Yaohua; Hopkins, Robert; Tarride, Jean-Eric; Blackhouse, Gord; Lazzam, Charles; Cohen, Eric A; Goeree, Ron

2007-10-04

The placement of drug-eluting stents decreases the frequency of repeat revascularization procedures in patients undergoing percutaneous coronary intervention (PCI) in randomized clinical trials. However, there is uncertainty about the effectiveness of drug-eluting stents, and increasing concern about their safety, in routine clinical practice. From the Cardiac Care Network of Ontario's population-based clinical registry of all patients undergoing PCI in Ontario, Canada, we identified a well-balanced cohort of 3751 pairs of patients, matched on the basis of propensity score, who received either bare-metal stents alone or drug-eluting stents alone during an index PCI procedure between December 1, 2003, and March 31, 2005. The primary outcomes of the study were the rates of target-vessel revascularization, myocardial infarction, and death. The 2-year rate of target-vessel revascularization was significantly lower among patients who received drug-eluting stents than among those who received bare-metal stents (7.4% vs. 10.7%, P<0.001). Drug-eluting stents were associated with significant reductions in the rate of target-vessel revascularization among patients with two or three risk factors for restenosis (i.e., presence of diabetes, small vessels [<3 mm in diameter], and long lesions [> or =20 mm]) but not among lower-risk patients. The 3-year mortality rate was significantly higher in the bare-metal-stent group than in the drug-eluting-stent group (7.8% vs. 5.5%, P<0.001), whereas the 2-year rate of myocardial infarction was similar in the two groups (5.2% and 5.7%, respectively; P=0.95). Drug-eluting stents are effective in reducing the need for target-vessel revascularization in patients at highest risk for restenosis, without a significantly increased rate of death or myocardial infarction. Copyright 2007 Massachusetts Medical Society.

Percutaneous intraductal radiofrequency ablation for treatment of biliary stent occlusion: A preliminary result.

PubMed

Xia, Ning; Gong, Ju; Lu, Jian; Chen, Zhi-Jin; Zhang, Li-Yun; Wang, Zhong-Min

2017-03-14

To assess the feasibility and effectiveness of a novel application of percutaneous intraductal radiofrequency (RF) for the treatment of biliary stent obstruction. We specifically report a retrospective study presenting the results of percutaneous intraductal RF in patients with biliary stent occlusion. A total of 43 cases involving biliary stent obstruction were treated by placing an EndoHPB catheter and percutaneous intraductal RF was performed to clean stents. The stent patency was evaluated by cholangiography and follow-up by contrast enhanced computed tomography or ultrasound after the removal of the drainage catheter. Following the procedures, of the 43 patients, 40 survived and 3 died with a median survival of 80.5 (range: 30-243) d. One patient was lost to follow-up. One patient had the stent patent at the time of last follow-up. Two patients with stent blockage at 35 d and 44 d after procedure underwent percutaneous transhepatic drain insertion only. The levels of bilirubin before and after the procedure were 128 ± 65 μmol/L and 63 ± 29 μmol/L, respectively. There were no related complications (haemorrhage, bile duct perforation, bile leak or pancreatitis) and all patients' stent patency was confirmed by cholangiography after the procedure, with a median patency time of 107 (range: 12-180) d. This preliminary clinical study demonstrated that percutaneous intraductal RF is safe and effective for the treatment of biliary stent obstruction, increasing the duration of stent patency, although randomized controlled trials are needed to confirm the effectiveness of this approach.

Percutaneous intraductal radiofrequency ablation for treatment of biliary stent occlusion: A preliminary result

PubMed Central

Xia, Ning; Gong, Ju; Lu, Jian; Chen, Zhi-Jin; Zhang, Li-Yun; Wang, Zhong-Min

2017-01-01

AIM To assess the feasibility and effectiveness of a novel application of percutaneous intraductal radiofrequency (RF) for the treatment of biliary stent obstruction. METHODS We specifically report a retrospective study presenting the results of percutaneous intraductal RF in patients with biliary stent occlusion. A total of 43 cases involving biliary stent obstruction were treated by placing an EndoHPB catheter and percutaneous intraductal RF was performed to clean stents. The stent patency was evaluated by cholangiography and follow-up by contrast enhanced computed tomography or ultrasound after the removal of the drainage catheter. RESULTS Following the procedures, of the 43 patients, 40 survived and 3 died with a median survival of 80.5 (range: 30-243) d. One patient was lost to follow-up. One patient had the stent patent at the time of last follow-up. Two patients with stent blockage at 35 d and 44 d after procedure underwent percutaneous transhepatic drain insertion only. The levels of bilirubin before and after the procedure were 128 ± 65 μmol/L and 63 ± 29 μmol/L, respectively. There were no related complications (haemorrhage, bile duct perforation, bile leak or pancreatitis) and all patients’ stent patency was confirmed by cholangiography after the procedure, with a median patency time of 107 (range: 12-180) d. CONCLUSION This preliminary clinical study demonstrated that percutaneous intraductal RF is safe and effective for the treatment of biliary stent obstruction, increasing the duration of stent patency, although randomized controlled trials are needed to confirm the effectiveness of this approach. PMID:28348491

Photoplethysmography using a smartphone application for assessment of ulnar artery patency: a randomized clinical trial

PubMed Central

Di Santo, Pietro; Harnett, David T.; Simard, Trevor; Ramirez, F. Daniel; Pourdjabbar, Ali; Yousef, Altayyeb; Moreland, Robert; Bernick, Jordan; Wells, George; Dick, Alexander; Le May, Michel; Labinaz, Marino; So, Derek; Motazedian, Pouya; Jung, Richard G.; Chandrasekhar, Jaya; Mehran, Roxana; Chong, Aun-Yeong

2018-01-01

BACKGROUND: Radial artery access is commonly performed for coronary angiography and invasive hemodynamic monitoring. Despite limitations in diagnostic accuracy, the modified Allen test (manual occlusion of radial and ulnar arteries followed by release of the latter and assessment of palmar blush) is used routinely to evaluate the collateral circulation to the hand and, therefore, to determine patient eligibility for radial artery access. We sought to evaluate whether a smartphone application may provide a superior alternative to the modified Allen test. METHODS: We compared the modified Allen test with a smartphone heart rate–monitoring application (photoplethysmography readings detected using a smartphone camera lens placed on the patient’s index finger) in patients undergoing a planned cardiac catheterization. Test order was randomly assigned in a 1:1 fashion. All patients then underwent conventional plethysmography of the index finger, followed by Doppler ultrasonography of the radial and ulnar arteries (the diagnostic standard). The primary outcome was diagnostic accuracy of the heart rate–monitoring application. RESULTS: Among 438 patients who were included in the study, we found that the heart rate–monitoring application had a superior diagnostic accuracy compared with the modified Allen test (91.8% v. 81.7%, p = 0.002), attributable to its greater specificity (93.0% v. 82.8%, p = 0.001). We also found that this application had greater diagnostic accuracy for assessment of radial or ulnar artery patency in the ipsilateral and contralateral wrist (94.0% v. 84.0%, p < 0.001). INTERPRETATION: A smartphone application used at the bedside was diagnostically superior to traditional physical examination for confirming ulnar patency before radial artery access. This study highlights the potential for smartphone-based diagnostics to aid in clinical decision-making at the patient’s bedside. Trial registration: Clinicaltrials.gov, no. NCT02519491. PMID:29615421

Mid-term outcome of endovascular treatment for acute lower extremity deep venous thrombosis.

PubMed

Jiang, Kun; Li, Xiao-Qiang; Sang, Hong-Fei; Qian, Ai-Min; Rong, Jian-Jie; Li, Cheng-Long

2017-04-01

Purposes of the study To evaluate the benefit of stenting the iliac vein in patients with residual iliac vein stenosis treated with catheter-directed thrombolysis for acute iliofemoral deep venous thrombosis. Procedures In this randomized prospective study, patients with a first-time acute lower extremity deep venous thrombosis that had persisted <14 days were treated with catheter-directed thrombolysis. After catheter-directed thrombolysis, patients with >50% residual iliac vein stenosis were randomly divided into two groups: catheter-directed thrombolysis + Stent Group and catheter-directed thrombolysis Alone Group. Patients received urokinase thrombolysis and low-molecular-weight heparin/oral warfarin during the hospitalization period and were administrated oral warfarin after discharge. Cumulative deep vein patency, the Clinical Etiology Anatomic Pathophysiologic classification system, the Venous Clinical Severity Score and the Chronic Venous Insufficiency Questionnaire score were evaluated. Findings The cumulative deep vein patency rate was 74.07% in the catheter-directed thrombolysis + Stent Group and 46.59% in the catheter-directed thrombolysis Alone Group. The mean postoperative Clinical Etiology Anatomic Pathophysiologic classification and Venous Clinical Severity Score was significantly lower in the catheter-directed thrombolysis + Stent Group than in the catheter-directed thrombolysis Alone Group. The mean postoperative Chronic Venous Insufficiency Questionnaire score was significantly higher in the catheter-directed thrombolysis + Stent Group than the catheter-directed thrombolysis Alone Group. Conclusions Placement of an iliac vein stent in patients with residual iliac vein stenosis after catheter-directed thrombolysis for acute lower extremity deep venous thrombosis increases iliac vein patency and improves clinical symptoms and health-related quality of life at mid-term follow-up compared to patients treated with catheter-directed thrombolysis alone.

Photoplethysmography using a smartphone application for assessment of ulnar artery patency: a randomized clinical trial.

PubMed

Di Santo, Pietro; Harnett, David T; Simard, Trevor; Ramirez, F Daniel; Pourdjabbar, Ali; Yousef, Altayyeb; Moreland, Robert; Bernick, Jordan; Wells, George; Dick, Alexander; Le May, Michel; Labinaz, Marino; So, Derek; Motazedian, Pouya; Jung, Richard G; Chandrasekhar, Jaya; Mehran, Roxana; Chong, Aun-Yeong; Hibbert, Benjamin

2018-04-03

Radial artery access is commonly performed for coronary angiography and invasive hemodynamic monitoring. Despite limitations in diagnostic accuracy, the modified Allen test (manual occlusion of radial and ulnar arteries followed by release of the latter and assessment of palmar blush) is used routinely to evaluate the collateral circulation to the hand and, therefore, to determine patient eligibility for radial artery access. We sought to evaluate whether a smartphone application may provide a superior alternative to the modified Allen test. We compared the modified Allen test with a smartphone heart rate-monitoring application (photoplethysmography readings detected using a smartphone camera lens placed on the patient's index finger) in patients undergoing a planned cardiac catheterization. Test order was randomly assigned in a 1:1 fashion. All patients then underwent conventional plethysmography of the index finger, followed by Doppler ultrasonography of the radial and ulnar arteries (the diagnostic standard). The primary outcome was diagnostic accuracy of the heart rate-monitoring application. Among 438 patients who were included in the study, we found that the heart rate-monitoring application had a superior diagnostic accuracy compared with the modified Allen test (91.8% v. 81.7%, p = 0.002), attributable to its greater specificity (93.0% v. 82.8%, p = 0.001). We also found that this application had greater diagnostic accuracy for assessment of radial or ulnar artery patency in the ipsilateral and contralateral wrist (94.0% v. 84.0%, p < 0.001). A smartphone application used at the bedside was diagnostically superior to traditional physical examination for confirming ulnar patency before radial artery access. This study highlights the potential for smartphone-based diagnostics to aid in clinical decision-making at the patient's bedside. Trial registration: Clinicaltrials.gov, no. NCT02519491. © 2018 Joule Inc. or its licensors.

Diabetic and nondiabetic patients with left main and/or 3-vessel coronary artery disease: comparison of outcomes with cardiac surgery and paclitaxel-eluting stents.

PubMed

Banning, Adrian P; Westaby, Stephen; Morice, Marie-Claude; Kappetein, A Pieter; Mohr, Friedrich W; Berti, Sergio; Glauber, Mattia; Kellett, Mirle A; Kramer, Robert S; Leadley, Katrin; Dawkins, Keith D; Serruys, Patrick W

2010-03-16

This study was designed to compare contemporary surgical revascularization (coronary artery bypass graft surgery [CABG]) versus TAXUS Express (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stents (PES) in diabetic and nondiabetic patients with left main and/or 3-vessel disease. Although the prevalence of diabetes mellitus is increasing, the optimal coronary revascularization strategy in diabetic patients with complex multivessel disease remains controversial. The SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) study randomly assigned 1,800 patients (452 with medically treated diabetes) to receive PES or CABG. The overall 1-year major adverse cardiac and cerebrovascular event rate was higher among diabetic patients treated with PES compared with CABG, but the revascularization method did not impact the death/stroke/myocardial infarction rate for nondiabetic patients (6.8% CABG vs. 6.8% PES, p = 0.97) or for diabetic patients (10.3% CABG vs. 10.1% PES, p = 0.96). The presence of diabetes was associated with significantly increased mortality after either revascularization treatment. The incidence of stroke was higher among nondiabetic patients after CABG (2.2% vs. PES 0.5%, p = 0.006). Compared with CABG, mortality was higher after PES use for diabetic patients with highly complex lesions (4.1% vs. 13.5%, p = 0.04). Revascularization with PES resulted in higher repeat revascularization for nondiabetic patients (5.7% vs. 11.1%, p < 0.001) and diabetic patients (6.4% vs. 20.3%, p < 0.001). Subgroup analyses suggest that the 1-year major adverse cardiac and cerebrovascular event rate is higher among diabetic patients with left main and/or 3-vessel disease treated with PES compared with CABG, driven by an increase in repeat revascularization. However, the composite safety end point (death/stroke/myocardial infarction) is comparable between the 2 treatment options for diabetic and nondiabetic patients. Although further study is needed, these exploratory results may extend the evidence for PES use in selected patients with less complex left main and/or 3-vessel lesions. (SYNergy Between PCI With TAXus and Cardiac Surgery [SYNTAX]; NCT00114972). Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Resistance within hemodialysis shunts predicts patency.

PubMed

Bui, Trung D; Gordon, Ian L; Parashar, Amish; Vo, David; Wilson, Samuel E

2006-01-01

The authors examined the relationship between patency after thrombectomy of clotted dialysis grafts and intraoperative measurements of flow (Q), pressure gradient (PGR), and longitudinal resistance (RL). Eighteen thrombosed arteriovenous (AV) grafts underwent 21 thrombectomies. Pressures at arterial (P1) and venous (P2) ends of the AV grafts were determined with 22-gauge catheters and standard transducers; flow was measured with transit-time probes; arithmetic averaging of waveforms was used to compute mean Q, PGR, and RL. Kaplan-Meier patency curves were analyzed by using log rank methods. Mean patency for all grafts was 164 +/-152 days. For each variable, the 21 measurements were split and the patency curve for the grafts with the 11 lowest value grafts was compared to the curve representing the 10 highest value grafts. The difference between high RL versus low RL patency curves was significant with high-resistance grafts having a median patency of 55 days and low-resistance grafts having a median patency greater than 151 days (p = 0.0089). In contrast, the high Q group median patency was 151 days versus 174 days for the low Q group (p = 0.86). Median patency for the low PGR group was 115 days compared to 62 days for the high PGR group (p = 0.162). Longitudinal resistance within AV grafts, but not flow or pressure gradient, showed a significant correlation with patency after thrombectomy. Increased resistance to flow within AV grafts appears to be an important factor affecting the propensity of dialysis grafts to thrombose.

Endovascular Treatment of Severely Calcified Femoropopliteal Lesions Using the "Pave-and-Crack" Technique: Technical Description and 12-Month Results.

PubMed

Dias-Neto, Marina; Matschuck, Manuela; Bausback, Yvonne; Banning-Eichenseher, Ursula; Steiner, Sabine; Branzan, Daniela; Staab, Holger; Varcoe, Ramon L; Scheinert, Dierk; Schmidt, Andrej

2018-06-01

To report midterm results of the "pave-and-crack" technique to facilitate safe and effective scaffolding of heavily calcified femoropopliteal lesions in preparation for delivery of a Supera interwoven stent. Data were collected retrospectively on 67 consecutive patients (mean age 71±8 years; 54 men) treated with this technique between November 2011 and February 2017 at a single center. A third (22/64, 34%) of the patients had critical limb ischemia (CLI). Most lesions were TASC D (52/67, 78%), and the majority were occlusions (61/66, 92%). The mean lesion length was 26.9±11.2 cm. Nearly two-thirds (40/64, 62%) had grade 4 calcification (Peripheral Arterial Calcium Scoring System). To prepare for Supera stenting, the most heavily calcified segments of the lesion were predilated aggressively to obliterate recoil. A Viabahn stent-graft was then implanted to "pave" the lesion and protect from vessel rupture as aggressive predilation continued until the calcified plaque was "cracked" before lining the entire lesion with a Supera stent. Patency and target lesion revascularization (TLR) rates were estimated using the Kaplan-Meier method. Procedural success was achieved in 100% and technical success (residual stenosis <30%) in 98% (66/67). The mean cumulative stent lengths were 16±9 cm for the Viabahn and 23±12 cm for the Supera. Only 2 complications occurred (distal embolization and access-site pseudoaneurysm). Two CLI patients died within 30 days, and 3 patients (all claudicants) underwent a TLR. Patients were followed for a mean 19±18 months, during which another 2 CLI patients died and 1 patient had a major amputation. One-year primary and secondary patency estimates were 79% and 91%, respectively; freedom from TLR was 85%. Despite severe lesion calcification, patients experienced high technical success and a safe and durable therapy at midterm follow-up with the femoropopliteal "pave-and-crack" technique.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Parthipun, Aneeta; Diamantopoulos, Athanasios; Kitrou, Panagiotis

PurposeTo report the immediate and mid-term clinical and anatomical outcomes of a novel, hybrid, heparin-bonded, nitinol ring stent (TIGRIS; Gore Medical) when used for the treatment of lesions located in the popliteal artery.Materials and MethodsThis was a prospective single-centre registry. Patients eligible for inclusion were individuals suffering from symptomatic popliteal arterial occlusive disease (Rutherford–Becker stage 3–6; P1–P3 segments) and treated with placement of the TIGRIS stent(s). Patients were prospectively scheduled for clinical review and duplex ultrasound follow-up after 6 and 12 months. Outcome measures included immediate technical success, primary vessel patency, in-stent binary restenosis (evaluable by Duplex at 50 % threshold; PSVRmore » > 2.0), freedom from target lesion revascularization (TLR) and amputation-free survival (AFS) estimated by Kaplan–Meier (K–M) survival analysis. Cox proportional-hazards regression analysis was also performed to adjust for confounders and search for independent predictors of outcomes.ResultsFrom August 2012 to March 2014, a total of 54 popliteal TIGRIS stents were implanted in 50 limbs of 48 patients (27 men and 21 women; mean age 76.0 ± 1.7 years). Median Rutherford–Becker stage was five at baseline and 37/50 (74.0 %) were chronic total occlusions. Technical success was achieved in all cases (100 %). Stented lesion length was 114.2 ± 36.9 mm (range 6–20 cm). Median follow-up was 11.8 ± 0.8 months. After 12 months, primary patency of the TIGRIS stent was 69.5 ± 10.2 % with an 86.1 ± 5.9 % freedom from TLR and 87 ± 5.0 % AFS (K–M estimates).ConclusionThe TIGRIS hybrid heparin-bonded nitinol ring stent is a safe and effective endovascular option for complex occlusive disease of the popliteal artery.« less

Effects of testosterone supplementation on clinical and rehabilitative outcomes in older men undergoing on-pump CABG.

PubMed

Maggio, Marcello; Nicolini, Francesco; Cattabiani, Chiara; Beghi, Cesare; Gherli, Tiziano; Schwartz, Robert S; Valenti, Giorgio; Ceda, Gian Paolo

2012-07-01

Testosterone levels decrease with age. This decline is steeper during "critical illnesses". Cardiac surgery is a particular representative model of major clinical condition producing stress responses similar to those observed during severe nonsurgical illness. Cardiac revascularization with extracorporeal circulation is characterized by marked postoperative complications such as insulin resistance, a pro-inflammatory state, acute anemia and renal dysfunction. These phenomena are more evident in older subjects, who are particularly vulnerable in the post-operative state, a condition that has been recently termed as "acute postoperative frailty". We recently showed that in older men with low ejection fraction undergoing cardiac revascularization with extracorporeal circulation, there is a profound decline in anabolic hormones, including testosterone. After surgery testosterone concentration frequently declines to less than 200 ng/dl, a situation suggestive of overt hypogonadism. Since men with low testosterone levels have a high probability of developing mobility limitations, we considered this a rationale for the perioperative use of testosterone treatment in older men undergoing cardiac revasularization surgery. We hypothesized that testosterone supplementation at this time might attenuate the impressive post-surgical catabolic hormonal milieu. The aim of this manuscript is to elucidate an ongoing randomized clinical trial in older men (70+ years old) undergoing elective cardiovascular revascularization with extracorporeal circulation. This randomized clinical trial will evaluate the effects of intramuscular testosterone administration on clinical and functional outcomes in this population. The study will also address potential mechanisms underlying the expected beneficial effects of testosterone supplementation including improvement of insulin sensitivity, markers of inflammatory status and improved hemoglobin levels. Copyright © 2012 Elsevier Inc. All rights reserved.

Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial.

PubMed

Kitano, Masayuki; Yamashita, Yukitaka; Tanaka, Kiyohito; Konishi, Hideyuki; Yazumi, Shujiro; Nakai, Yoshitaka; Nishiyama, Osamu; Uehara, Hiroyuki; Mitoro, Akira; Sanuki, Tsuyoshi; Takaoka, Makoto; Koshitani, Tatsuya; Arisaka, Yoshifumi; Shiba, Masatsugu; Hoki, Noriyuki; Sato, Hideki; Sasaki, Yuichi; Sato, Masako; Hasegawa, Kazunori; Kawabata, Hideaki; Okabe, Yoshihiro; Mukai, Hidekazu

2013-11-01

The requirements of biliary stents used in the palliation of malignant biliary obstruction are a long duration of patency and minimal adverse effects. Covered self-expandable metal stents (SEMSs) have been shown to prevent tumor ingrowth, which is the most frequent complication of uncovered SEMSs. However, because they are prone to migration, the superiority of covered SEMS has yet to be convincingly demonstrated. The aim of this study was to evaluate the superiority of covered over uncovered SEMSs in the palliation of distal biliary obstruction due to unresectable pancreatic carcinoma, using both stent types with relatively low axial force and uncovered flared ends to prevent their migration. From April 2009 to December 2010, 120 patients who were admitted to 22 tertiary-care centers because of distal biliary obstruction from unresectable pancreatic carcinomas were enrolled in this prospective randomized multicenter study. Patients were randomly assigned to receive a covered or uncovered SEMS deployed at the site of the biliary stricture during endoscopic retrograde cholangiopancreatography. Stent patency time, patient survival time, patient survival time without stent dysfunction (time to stent dysfunction or patient death), cause of stent dysfunction (ingrowth, overgrowth, migration, or sludge formation), and serious adverse events were compared between covered and uncovered SEMS groups. Patient survival time in the two groups did not significantly differ (median: 285 and 223 days, respectively; P=0.68). Patient survival time without stent dysfunction was significantly longer in the covered than in the uncovered SEMS group (median: 187 vs. 132 days; P=0.043). Stent patency was also significantly longer in the covered than in the uncovered SEMS group (mean±s.d.: 219.3±159.1 vs. 166.9±124.9 days; P=0.047). Reintervention for stent dysfunction was performed in 14 of 60 patients with covered SEMSs (23%) and in 22 of 60 patients with uncovered SEMSs (37%; P=0.08). Stent dysfunction was caused by tumor ingrowth, tumor overgrowth, and sludge formation in 0 (0%), 3 (5%), and 11 (18%) patients in the covered SEMSs group, and in 15 (25%), 2 (3%), and 6 (10%) patients in the uncovered SEMSs group, respectively. Stent migration was not observed in either group. Rates of tumor overgrowth and sludge formation did not significantly differ between the two groups, whereas the rate of tumor ingrowth was significantly lower in the covered than in the uncovered SEMS group (P<0.01). Acute pancreatitis occurred in only one patient in the covered SEMS group. Acute cholecystitis occurred in one patient in the covered SEMS group and in two patients in the uncovered SEMS group. There was no significant difference between the two groups in the incidence of serious adverse events. By preventing tumor ingrowth and migration, covered SEMSs with an anti-migration system had a longer duration of patency than uncovered SEMSs, which recommends their use in the palliative treatment of patients with biliary obstruction due to pancreatic carcinomas.

Topical Rapamycin Suppresses the Angiogenesis Pathways Induced by Pulsed Dye Laser: Molecular Mechanisms of Inhibition of Regeneration and Revascularization of Photocoagulated Cutaneous Blood Vessels

PubMed Central

Tan, Wenbin; Jia, Wangcun; Sun, Victor; Mihm, Martin C.; Nelson, J. Stuart

2014-01-01

Background and Objectives Pulsed dye laser (PDL) is the most effective treatment for port wine stain (PWS) birthmarks. However, regeneration and revascularization of photocoagulated blood vessels may result in poor therapeutic outcome. We have recently shown that rapamycin (RPM), an angiogenesis inhibitor, can reduce the regeneration and revascularization of photocoagulated blood vessels. Herein, we attempt to further elucidate the molecular pathophysiology on the inhibition of the regeneration and revascularization of photocoagulated blood vessels by topical RPM in an animal model. Materials and Methods Two separate skin areas on each hamster were irradiated by PDL. After PDL exposure, topical RPM was applied daily to one of the randomly selected test sites. PDL, PDL + RPM and normal skin test sites were biopsied on day 3 after PDL exposure. The total ribonucleic acid (RNA) and protein were extracted from biopsied skin samples and quantified. Real-time reverse transcription-polymerase chain reaction (RT-PCR) and immunoblot were subsequently performed to quantify the mRNA and protein levels of hypoxia-inducible factor-1alpha (HIF-1α), vascular endothelial growth factor (VEGF) and ribosomal protein S6 kinase (S6). The phosphorylation levels of S6 and AKT were also evaluated by immunoblot. Results The mRNA and protein levels of HIF-1α, VEGF, and S6 significantly increased after PDL exposure as compared to the normal hamster skin. Topical application of 1% RPM suppressed the PDL-induced increase in mRNA and protein levels of those genes on day 3 post-PDL exposure. The phosphorylation levels of S6 and AKT increased after PDL exposure but the increases were suppressed by the topical application of RPM. Conclusion The increase in expression of HIF-1α, VEGF, and S6 after PDL-exposure suggests that angiogenesis pathways play very active roles in the process of skin blood vessel regeneration and revascularization. Topical application of 1% RPM can suppress the angiogenesis pathways and, therefore, reduce the regeneration and revascularization of photocoagulated blood vessels. PMID:23213008

Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials.

PubMed

Planer, David; Smits, Pieter C; Kereiakes, Dean J; Kedhi, Elvin; Fahy, Martin; Xu, Ke; Serruys, Patrick W; Stone, Gregg W

2011-10-01

This study sought to compare the clinical outcomes of everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES) in patients with acute coronary syndromes (ACS) and stable coronary artery disease (CAD). Although randomized trials have shown superiority of EES to PES, the safety and efficacy of EES in ACS is unknown. We performed a patient-level pooled analysis from the prospective, randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV, and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) trials in which 2,381 patients with ACS and 4,404 patients with stable CAD were randomized to EES or to PES. Kaplan-Meier estimates of death, myocardial infarction (MI), ischemia-driven target lesion revascularization, and stent thrombosis were assessed at 2 years and stratified by clinical presentation (ACS vs. stable CAD). At 2 years, patients with ACS compared with stable CAD had higher rates of death (3.2% vs. 2.4%, hazard ratio [HR]: 1.37 [95% confidence interval (CI): 1.02 to 1.85], p = 0.04) and MI (4.9% vs. 3.4%, HR: 1.45 [95% CI: 1.14 to 1.85], p = 0.02). In patients with ACS, EES versus PES reduced the rate of death or MI (6.6% vs. 9.3%, HR: 0.70 [95% CI: 0.52 to 0.94], p = 0.02), stent thrombosis (0.7% vs. 2.9%, HR: 0.25 [95% CI: 0.12 to 0.52], p = 0.0002), and ischemia-driven target lesion revascularization (4.7% vs. 6.2%, HR: 0.69 [95% CI: 0.48 to 0.99], p = 0.04). In patients with stable CAD, EES reduced the rate of death or MI (4.5% vs. 7.1%, HR: 0.62 [95% CI: 0.48 to 0.80], p = 0.0002), stent thrombosis (0.7% vs. 1.8%, HR: 0.34 [95% CI: 0.19 to 0.62], p = 0.0002), and ischemia-driven target lesion revascularization (3.9% vs. 6.9%, HR: 0.55 [95% CI: 0.42 to 0.73], p < 0.0001). Treatment with EES versus PES provides enhanced safety and efficacy regardless of the acuity of the clinical syndrome being treated and appears to mitigate the increased risk of stent thrombosis associated with ACS. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions [SPIRIT II]; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions [SPIRIT III]; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions [SPIRIT IV]; NCT00307047; A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice: the COMPARE Trial [COMPARE]; NCT01016041). Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Percutaneous Intraductal Radiofrequency Ablation for Extrahepatic Distal Cholangiocarcinoma: A Method for Prolonging Stent Patency and Achieving Better Functional Status and Quality of Life

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wu, Tian-tian, E-mail: matthewwu1979@hotmail.com; Li, Wei-min, E-mail: weimin-li-surgery@126.com; Li, Hu-cheng, E-mail: hucheng-li-surgery@126.com

PurposeThe clinical efficacy of intraductal radiofrequency ablation (RFA) with Habib™ EndoHPB catheter, a newly developed intervention for malignant extrahepatic biliary obstruction, remains uncertain. The aim of this study was to investigate the clinical efficacy of intraductal RFA.MethodsData from 71 patients with extrahepatic distal cholangiocarcinoma were retrospectively analyzed. The study patients were divided into RFA and control groups. The RFA group had undergone percutaneous transhepatic intraductal RFA with a Habib™ EndoHPB catheter, followed by placement of covered or uncovered biliary self-expandable metallic stents (SEMs) whereas the control group had undergone percutaneous transhepatic covered or uncovered SEMs placement. Procedure-related complications, stent patency,more » patient survival, and postoperative serum bilirubin concentrations were compared between the two groups. The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire was administered to evaluate functional status, improvement in clinical manifestations, and quality of life.ResultsThe RFA group had a longer median stent patency than the control group (p = 0.001 for uncovered SEMs placement). Higher functional well-being, hepatobiliary-specific cancer subscale, Trial Outcome Index, and total FACT-Hep scores were observed during post-procedure follow-up in the RFA group. However, median survival did not differ significantly between the two groups (p > 0.05).ConclusionsProlongation of stent patency and better functional status and quality of life, which are all important clinical endpoints, were observed in patients treated with intraductal RFA. Prospective randomized controlled clinical trials are necessary to further investigate the clinical efficacy and long-term benefits of intraductal RFA.« less

Technique and results of femoral bifurcation endarterectomy by eversion.

PubMed

Dufranc, Julie; Palcau, Laura; Heyndrickx, Maxime; Gouicem, Djelloul; Coffin, Olivier; Felisaz, Aurélien; Berger, Ludovic

2015-03-01

This study evaluated, in a contemporary prospective series, the safety and efficacy of femoral endarterectomy using the eversion technique and compared our results with results obtained in the literature for the standard endarterectomy with patch closure. Between 2010 and 2012, 121 patients (76% male; mean age, 68.7 years; diabetes, 28%; renal insufficiency, 20%) underwent 147 consecutive femoral bifurcation endarterectomies using the eversion technique, associating or not inflow or outflow concomitant revascularization. The indications were claudication in 89 procedures (60%) and critical limb ischemia in 58 (40%). Primary, primary assisted, and secondary patency of the femoral bifurcation, clinical improvement, limb salvage, and survival were assessed using Kaplan-Meier life-table analysis. Factors associated with those primary end-points were evaluated with univariate analysis. The technical success of eversion was of 93.2%. The 30-day mortality was 0%, and the complication rate was 8.2%; of which, half were local and benign. Median follow-up was 16 months (range, 1.6-31.2 months). Primary, primary assisted, and secondary patencies were, respectively, 93.2%, 97.2%, and 98.6% at 2 years. Primary, primary assisted, and secondary maintenance of clinical improvement were, respectively, 79.9%, 94.6%, and 98.6% at 2 years. The predictive factors for clinical degradation were clinical stage (Rutherford category 5 or 6, P = .024), platelet aggregation inhibitor treatment other than clopidogrel (P = .005), malnutrition (P = .025), and bad tibial runoff (P = .0016). A reintervention was necessary in 18.3% of limbs at 2 years: 2% involving femoral bifurcation, 6.1% inflow improvement, and 9.5% outflow improvement. The risk factors of reintervention were platelet aggregation inhibitor (other than clopidogrel, P = .049) and cancer (P = .011). Limb preservation at 2 years was 100% in the claudicant population. Limb salvage was 88.6% in the critical limb ischemia population, with a statistically higher rate for patients with malnutrition (P = .029), preoperative platelet count >450 ×10(9)/L (P = .0071), platelet aggregation inhibitor treatment other than clopidogrel (P = .022), preoperative deep femoral artery occlusion or stenosis >75% (P = .0064), and poor tibial runoff (P = .00042). Eversion femoral bifurcation endarterectomy is a safe, efficient, and reproducible technique for the treatment of atherosclerotic femoral lesions. Advantages are notable, especially the lack of need for prosthetic angioplasty, eliminating the risk of patch infection or pseudoaneurysms and permitting direct puncture if endovascular procedures are needed for assisted patency. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Supera self-expanding stents for endovascular treatment of femoropopliteal disease: a review of the clinical evidence

PubMed Central

Bishu, Kalkidan; Armstrong, Ehrin J

2015-01-01

Femoropopliteal lesions account for a significant proportion of endovascular interventions for peripheral artery disease in patients with disabling claudication or chronic limb ischemia. The femoropopliteal artery crosses two joint structures (hip and knee joints) and courses through the muscular adductor canal in the thigh, which places the artery at increased biomechanical stress. There is a critical need for stent platforms with a reduced risk of stent fracture while maintaining patency during long-term follow-up. The Supera peripheral stent system has a braided nickel–titanium alloy stent designed to withstand the unique stressors along the course of the femoropopliteal artery. This design may be associated with improved patency in association with reduced stent fracture rates on short- and medium-term follow-up. Further studies, including randomized controlled studies, comparing the Supera interwoven nickel–titanium alloy stent system with other stent platforms and angioplasty alone are needed. PMID:26203255

Solitaire™ with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) trial: protocol for a randomized, controlled, multicenter study comparing the Solitaire revascularization device with IV tPA with IV tPA alone in acute ischemic stroke.

PubMed

Saver, Jeffrey L; Goyal, Mayank; Bonafe, Alain; Diener, Hans-Christoph; Levy, Elad I; Pereira, Vitor M; Albers, Gregory W; Cognard, Christophe; Cohen, David J; Hacke, Werner; Jansen, Olav; Jovin, Tudor G; Mattle, Heinrich P; Nogueira, Raul G; Siddiqui, Adnan H; Yavagal, Dileep R; Devlin, Thomas G; Lopes, Demetrius K; Reddy, Vivek; du Mesnil de Rochemont, Richard; Jahan, Reza

2015-04-01

Early reperfusion in patients experiencing acute ischemic stroke is critical, especially for patients with large vessel occlusion who have poor prognosis without revascularization. Solitaire™ stent retriever devices have been shown to immediately restore vascular perfusion safely, rapidly, and effectively in acute ischemic stroke patients with large vessel occlusions. The aim of the study was to demonstrate that, among patients with large vessel, anterior circulation occlusion who have received intravenous tissue plasminogen activator, treatment with Solitaire revascularization devices reduces degree of disability 3 months post stroke. The study is a global multicenter, two-arm, prospective, randomized, open, blinded end-point trial comparing functional outcomes in acute ischemic stroke patients who are treated with either intravenous tissue plasminogen activator alone or intravenous tissue plasminogen activator in combination with the Solitaire device. Up to 833 patients will be enrolled. Patients who have received intravenous tissue plasminogen activator are randomized to either continue with intravenous tissue plasminogen activator alone or additionally proceed to neurothrombectomy using the Solitaire device within six-hours of symptom onset. The primary end-point is 90-day global disability, assessed with the modified Rankin Scale (mRS). Secondary outcomes include mortality at 90 days, functional independence (mRS ≤ 2) at 90 days, change in National Institutes of Health Stroke Scale at 27 h, reperfusion at 27 h, and thrombolysis in cerebral infarction 2b/3 flow at the end of the procedure. Statistical analysis will be conducted using simultaneous success criteria on the overall distribution of modified Rankin Scale (Rankin shift) and proportions of subjects achieving functional independence (mRS 0-2). © 2015 The Authors. International Journal of Stroke published by John Wiley & Sons Ltd on behalf of World Stroke Organization.

Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS–NSTEMI randomized trial

PubMed Central

Layland, Jamie; Oldroyd, Keith G.; Curzen, Nick; Sood, Arvind; Balachandran, Kanarath; Das, Raj; Junejo, Shahid; Ahmed, Nadeem; Lee, Matthew M.Y.; Shaukat, Aadil; O'Donnell, Anna; Nam, Julian; Briggs, Andrew; Henderson, Robert; McConnachie, Alex; Berry, Colin; Hannah, Andrew; Stewart, Andrew; Metcalfe, Malcolm; Norrie, John; Chowdhary, Saqib; Clark, Andrew; Henderson, Robert; Balachandran, Kanarath; Berry, Colin; Baird, Gordon; O'Donnell, Anna; Sood, Arvind; Curzen, Nick; Das, Raj; Ford, Ian; Layland, Jamie; Junejo, Shahid; Oldroyd, Keith

2015-01-01

Aim We assessed the management and outcomes of non-ST segment elevation myocardial infarction (NSTEMI) patients randomly assigned to fractional flow reserve (FFR)-guided management or angiography-guided standard care. Methods and results We conducted a prospective, multicentre, parallel group, 1 : 1 randomized, controlled trial in 350 NSTEMI patients with ≥1 coronary stenosis ≥30% of the lumen diameter assessed visually (threshold for FFR measurement) (NCT01764334). Enrolment took place in six UK hospitals from October 2011 to May 2013. Fractional flow reserve was disclosed to the operator in the FFR-guided group (n = 176). Fractional flow reserve was measured but not disclosed in the angiography-guided group (n = 174). Fractional flow reserve ≤0.80 was an indication for revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). The median (IQR) time from the index episode of myocardial ischaemia to angiography was 3 (2, 5) days. For the primary outcome, the proportion of patients treated initially by medical therapy was higher in the FFR-guided group than in the angiography-guided group [40 (22.7%) vs. 23 (13.2%), difference 95% (95% CI: 1.4%, 17.7%), P = 0.022]. Fractional flow reserve disclosure resulted in a change in treatment between medical therapy, PCI or CABG in 38 (21.6%) patients. At 12 months, revascularization remained lower in the FFR-guided group [79.0 vs. 86.8%, difference 7.8% (−0.2%, 15.8%), P = 0.054]. There were no statistically significant differences in health outcomes and quality of life between the groups. Conclusion In NSTEMI patients, angiography-guided management was associated with higher rates of coronary revascularization compared with FFR-guided management. A larger trial is necessary to assess health outcomes and cost-effectiveness. PMID:25179764

Effects of preoperative aspirin in coronary artery bypass grafting: a double-blind, placebo-controlled, randomized trial.

PubMed

Deja, Marek A; Kargul, Tomasz; Domaradzki, Wojciech; Stącel, Tomasz; Mazur, Witold; Wojakowski, Wojciech; Gocoł, Radosław; Gaszewska-Żurek, Ewa; Żurek, Paweł; Pytel, Agata; Woś, Stanisław

2012-07-01

This trial was undertaken to determine the safety and efficacy of preoperative aspirin administration in a contemporary cardiac surgical practice setting. This randomized, double-blind, parallel-group, single-center trial involved patients with stable coronary artery disease who were assigned to receive either 300 mg of aspirin or placebo the night before coronary bypass surgery. Using a random digit table, patients were allocated to receive the tablet from 1 of the 40 coded bottles containing either aspirin or placebo. Patients, surgeons, anesthetists, and investigators were all masked to treatment allocation. The primary safety end points were as follows: more than 750 mL of bleeding during the first postoperative 12 hours and more than 1000 mL of total discharge from the chest drains. The secondary efficacy end point was a composite of cardiovascular death, myocardial infarction, or repeat revascularization. A total of 390 patients were allocated to aspirin (387 analyzed) and 399 to placebo (396 analyzed). The follow-up median was 53 months. Fifty-four placebo recipients and 86 aspirin recipients bled more than 750 mL in the first 12 hours (odds ratio [OR], 1.81; 95% confidence interval [CI], 1.25-2.63), while total chest drain discharge was above 1000 mL in 96 placebo and 131 aspirin recipients (OR, 1.60; 95% CI, 1.17-2.18). Preoperative aspirin decreased the long-term hazard of nonfatal coronary event (infarction or repeat revascularization)-hazard ratio (HR), 0.58 (95% CI, 0.33-0.99)--and tended to decrease the hazard of a major cardiac event (cardiovascular death, infarction, or repeat revascularization--HR, 0.65 [95% CI, 0.41-1.03]). Performing coronary grafts on aspirin is associated with increased postoperative bleeding but may decrease the long-term hazard of coronary events. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Screening asymptomatic patients with diabetes for unknown coronary artery disease: does it reduce risk? An open-label randomized trial comparing a strategy based on exercise testing aimed at revascularization with management based on pharmacological/behavioural treatment of traditional risk factors. DADDY-D Trial (Does coronary Atherosclerosis Deserve to be Diagnosed and treated early in Diabetics?).

PubMed

Turrini, Fabrizio; Messora, Roberto; Giovanardi, Paolo; Tondi, Stefano; Magnavacchi, Paolo; Cavani, Rita; Tosoni, Giandomenico; Cappelli, Carlo; Pellegrini, Elisa; Romano, Stefania; Baldini, Augusto; Zennaro, Romeo Giulietto; Bondi, Marco

2009-12-23

Coronary artery disease is the leading cause of morbidity and mortality in patients with type 2 diabetes. Screening for asymptomatic coronary artery disease with treatment by means of revascularization seems to be an appealing option for prevention. The utility of such a strategy has never been challenged in a randomized trial. In the present study a cohort of diabetic patients without any symptoms and without known coronary artery disease will be screened at two diabetes outpatients services. Those with intermediate or high risk (equal or greater than 10% according to the Italian risk chart) will be asked to participate and enrolled. They will be seen and followed in order to provide the best adherence to medical therapy. Half of the patients will be randomized to undergo an exercise tolerance testing while the other group will continue to be regularly seen at diabetes outpatients services. Best medical/behavioral therapy will be offered to both groups. Those patients with a positive exercise tolerance testing will be studied by coronary angiography and treated according to the severity of coronary lesions by percutaneous stenting or surgery.The objective of the study is to evaluate the efficacy of the screening strategy aimed at revascularization. A cost-effectiveness analysis will be performed at the end of the follow up. The study will provide useful information about prevention and treatment of diabetic patients at high risk of coronary events. It will be made clearer if detection of silent coronary artery disease has to be recommended and followed by treatment. Given the simplicity of the study protocol, it will be easily transferable to the real world. (ClinicalTrials.gov): NCT00547872.

Screening asymptomatic patients with diabetes for unknown coronary artery disease: Does it reduce risk? An open-label randomized trial comparing a strategy based on exercise testing aimed at revascularization with management based on pharmacological/behavioural treatment of traditional risk factors. DADDY-D Trial (Does coronary Atherosclerosis Deserve to be Diagnosed and treated early in Diabetics?)

PubMed Central

2009-01-01

Background Coronary artery disease is the leading cause of morbidity and mortality in patients with type 2 diabetes. Screening for asymptomatic coronary artery disease with treatment by means of revascularization seems to be an appealing option for prevention. The utility of such a strategy has never been challenged in a randomized trial. Methods/Design In the present study a cohort of diabetic patients without any symptoms and without known coronary artery disease will be screened at two diabetes outpatients services. Those with intermediate or high risk (equal or greater than 10% according to the Italian risk chart) will be asked to participate and enrolled. They will be seen and followed in order to provide the best adherence to medical therapy. Half of the patients will be randomized to undergo an exercise tolerance testing while the other group will continue to be regularly seen at diabetes outpatients services. Best medical/behavioral therapy will be offered to both groups. Those patients with a positive exercise tolerance testing will be studied by coronary angiography and treated according to the severity of coronary lesions by percutaneous stenting or surgery. The objective of the study is to evaluate the efficacy of the screening strategy aimed at revascularization. A cost-effectiveness analysis will be performed at the end of the follow up. Discussion The study will provide useful information about prevention and treatment of diabetic patients at high risk of coronary events. It will be made clearer if detection of silent coronary artery disease has to be recommended and followed by treatment. Given the simplicity of the study protocol, it will be easily transferable to the real world. Trial registration (ClinicalTrials.gov): NCT00547872 PMID:20030830

Outcome in adult patients with hemorrhagic moyamoya disease after combined extracranial-intracranial bypass.

PubMed

Jiang, Hanqiang; Ni, Wei; Xu, Bin; Lei, Yu; Tian, Yanlong; Xu, Feng; Gu, Yuxiang; Mao, Ying

2014-11-01

The outcome of patients with hemorrhagic moyamoya disease (MMD) after cerebral revascularization is uncertain. The purpose of this study was to delineate the efficacy of this surgical method in the treatment of hemorrhagic MMD. Between January 2007 and August 2011, a consecutive cohort of 113 patients with hemorrhagic MMD was enrolled into this prospective single-center cohort study. The surgical method was combined direct and indirect bypass. The cumulative probability of the primary end point (all stroke and deaths from surgery through 30 days after surgery and ipsilateral recurrent hemorrhage afterward) was analyzed. The angiographic outcome was measured by the following parameters: bypass patency, reduction of basal MMD vessels, improved degree of dilation, and branch extension of the anterior choroidal and posterior communicating arteries (AChA-PCoA). Of the 113 enrolled cases, CT scans revealed pure intraventricular hemorrhage (IVH) in 63 cases (55.7%), pure intracranial hemorrhage (ICH) in 14 cases (12.4%), and ICH with IVH in 36 cases (31.9%). In 74 of 113 hemorrhagic hemispheres (65.5%), the AChA-PCoA was extremely dilated with extensive branches beyond the choroidal fissure. A total of 114 surgeries were performed. No patient suffered ischemic or hemorrhagic stroke through 30 days after surgery. Ipsilateral rebleeding occurred in 5 patients, 4 of whom died of the rebleeding event. The cumulative probability of the primary end point was 0% at 1 year and 1.9% at 2 years. The annual rebleeding rate was 1.87%/person/year. The improvement in AChA-PCoA extension was observed in 75 of 107 operated hemispheres (70.1%), which was higher than that in 7 of 105 unoperated hemispheres (35.2%). Revascularization may provide a benefit over conservative therapy for hemorrhagic MMD patients. The improvement of dilation and branch extension of AChA-PCoA might be correlated with the low rebleeding rate.

Improving the Prediction of Spontaneous and Post-thrombolytic Recanalization in Ischemic Stroke Patients.

PubMed

Vanacker, Peter; Lambrou, Dimitris; Eskandari, Ashraf; Ntaios, George; Cras, Patrick; Maeder, Philippe; Meuli, Reto; Michel, Patrik

2015-08-01

Endovascular treatment for acute ischemic stroke patients was recently shown to improve recanalization rates and clinical outcome in a well-defined study population. Intravenous thrombolysis (IVT) alone is insufficiently effective to recanalize in certain patients or of little value in others. Accordingly, we aimed at identifying predictors of recanalization in patients treated with or without IVT. In the observational Acute Stroke Registry and Analysis of Lausanne (ASTRAL) registry, we selected those stroke patients (1) with an arterial occlusion on computed tomography angiography (CTA) imaging, (2) who had an arterial patency assessment at 24 hours (CTA/magnetic resonance angiography/transcranial Doppler), and (3) who were treated with IVT or had no revascularization treatment. Based on 2 separate logistic regression analyses, predictors of spontaneous and post-thrombolytic recanalization were generated. Partial or complete recanalization was achieved in 121 of 210 (58%) thrombolyzed patients. Recanalization was associated with atrial fibrillation (odds ratio , 1.6; 95% confidence interval, 1.2-3.0) and absence of early ischemic changes on CT (1.1, 1.1-1.2) and inversely correlated with the presence of a significant extracranial (EC) stenosis or occlusion (.6, .3-.9). In nonthrombolyzed patients, partial or complete recanalization was significantly less frequent (37%, P < .01). The recanalization was independently associated with a history of hypercholesterolemia (2.6, 1.2-5.6) and the proximal site of the intracranial occlusion (2.5, 1.2-5.4), and inversely correlated with a decreased level of consciousness (.3, .1-.8), and EC (.3, .1-.6) and basilar artery pathology (.1, .0-.6). Various clinical findings, cardiovascular risk factors, and arterial pathology on acute CTA-based imaging are moderately associated with spontaneous and post-thrombolytic arterial recanalization at 24 hours. If confirmed in other studies, this information may influence patient selection toward the most appropriate revascularization strategy. Copyright © 2015 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Percutaneous Endovascular Treatment of Hepatic Artery Stenosis in Adult and Pediatric Patients After Liver Transplantation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Maruzzelli, Luigi; Miraglia, Roberto, E-mail: rmiraglia@ismett.edu; Caruso, Settimo

2010-12-15

The purpose of this study was to evaluate the efficacy of percutaneous endovascular techniques for the treatment of hepatic artery stenosis (HAS) occurring after liver transplantation (LT) in adult and pediatrics patients. From February 2003 to March 2009, 25 patients (15 adults and 10 children) whose developed HAS after LT were referred to our interventional radiology unit. Technical success was achieved in 96% (24 of 25) of patients. Percutaneous transluminal angioplasty (PTA) was performed in 13 patients (7 children), and stenting was performed in 11 patients (2 children). After the procedure, all patients were followed-up with liver function tests, Dopplermore » ultrasound, and/or computed tomography. Mean follow-up was 15.8 months (range 5 days to 58 months). Acute hepatic artery thrombosis occurred immediately after stent deployment in 2 patients and was successfully treated with local thrombolysis. One patient developed severe HA spasm, which reverted after 24 h. After the procedure, mean trans-stenotic pressure gradient decreased from 30.5 to 6.2 mmHg. Kaplan-Meyer curve of HA primary patency was 77% at 1 and 2 years. During the follow-up period, 5 patients (20%) had recurrent stenosis, and 2 patients (8.3%) had late thrombosis. Two of 7 patients with stenosis/thrombosis underwent surgical revascularization (n = 1) and liver retransplantation (n = 1). Six (25%) patients died during follow-up, but overall mortality was not significantly different when comparing patients having patent hepatic arteries with those having recurrent stenosis/thrombosis. There were no significant differences in recurrent stenosis/thrombosis and mortality comparing patients treated by PTA versus stenting and comparing adult versus pediatric status. Percutaneous interventional treatment of HAS in LT recipients is safe and effective and decreases the need for surgical revascularization and liver retransplantation. However, the beneficial effects for survival are not clear, probably because the clinical complexity of many of these cases.« less

Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: A survival prediction model to facilitate clinical decision making.

PubMed

Bradbury, Andrew W; Adam, Donald J; Bell, Jocelyn; Forbes, John F; Fowkes, F Gerry R; Gillespie, Ian; Ruckley, Charles Vaughan; Raab, Gillian M

2010-05-01

An intention-to-treat analysis of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial showed that in patients with severe lower limb ischemia (SLI) due to infrainguinal disease who survived for 2 years after intervention, initial randomization to a bypass surgery (BSX)-first vs balloon angioplasty (BAP)-first revascularization strategy was associated with improvements in subsequent overall survival (OS) and amputation-free survival (AFS) of about 7 and 6 months, respectively. This study explored the value of baseline factors to estimate the likelihood of survival to 2 years for the trial cohort (Cox model) and for individual BASIL trial patients (Weibull model) as an aid to clinical decision making. Of 452 patients presenting to 27 United Kingdom hospitals, 228 were randomly assigned to a BSX-first and 224 to a BAP-first revascularization strategy. Patients were monitored for at least 3 years. Baseline factors affecting the survival of the entire cohort were examined with a multivariate Cox model. The chances of survival at 1 and 2 years for patients with given baseline characteristics were estimated with a Weibull parametric model. At the end of follow-up, 172 patients (38%) were alive without major limb amputation of the trial leg, and 202 (45%) were alive. Baseline factors that were significant in the Cox model were BASIL randomization stratification group, below knee Bollinger angiogram score, body mass index, age, diabetes, creatinine level, and smoking status. Using these factors to define five equally sized groups, we identified patients with 2-year survival rates of 50% to 90%. The factors that contributed to the Weibull predictive model were age, presence of tissue loss, serum creatinine, number of ankle pressure measurements detectable, maximum ankle pressure measured, a history of myocardial infarction or angina, a history of stroke or transient ischemia attack, below knee Bollinger angiogram score, body mass index, and smoking status. Patients in the BASIL trial were at high risk of amputation and death regardless of revascularization strategy. However, baseline factors can be used to stratify those risks. Furthermore, within a parametric Weibull model, certain of these factors can be used to help predict outcomes for individuals. It may thus be possible to define the clinical and anatomic (angiographic) characteristics of SLI patients who are likely-and not likely-to live for >2 years after intervention. Used appropriately in the context of the BASIL trial outcomes, this may aid clinical decision making regarding a BSX- or BAP-first revascularization strategy in SLI patients like those randomized in BASIL. Copyright (c) 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Bicanalicular Silicone Stents in Endonasal Dacryocystorhinostomy: Results of a Randomized Clinical Trial.

PubMed

Fayers, Tessa; Dolman, Peter J

2016-10-01

To assess whether the use of silicone lacrimal stents affects the long-term success of endonasal dacryocystorhinostomy (EN-DCR). Prospective, randomized, controlled, interventional trial. The subjects were adult patients older than 16 years undergoing primary EN-DCR for nasolacrimal duct obstruction who gave fully informed consent and who had no lid malpositions or canalicular pathology. In cases with bilateral surgery, only the right eyes were studied. Participants were randomized to receive stents (control group) or not (study group). Standardized nonendoscopic EN-DCR was performed by the senior author in all cases. When the ostium was completed, the randomization code was revealed as to whether a lacrimal stent was placed or not. Follow-up assessments were made at 3, 6, 9, and 12 months. Stents were removed at 3 months. The primary end point was symptoms of epiphora at 12 months, reported to the surgical booking clerk as (a) resolved, (b) significantly improved, (c) partially improved, or (d) no change or worse. The secondary end point was anatomic patency based on nasolacrimal syringing and categorized as (a) fully patent, minimal, or no reflux; (b) >50% patent but some reflux; (c) some patency but >50% reflux; or (d) nonpatent, 100% reflux. Complete success was defined as having resolved or significantly improved symptoms of watering and minimal or no reflux on nasolacrimal syringing. Partial success was defined as symptoms partially improved with a combination of patency and reflux on syringing. Failure was categorized as no change or worse symptoms of watering and 50% to 100% reflux on syringing. A total of 300 patients completed 12 months of follow-up. A total of 152 patients received tubes, and 148 patients did not. Overall success both subjectively and objectively was 94.7% in the stented group and 87.8% in the nonstented group (P = 0.034, Pearson chi-square 1-tailed test). The most common complications of stents included canalicular cheese-wiring and tube prolapse in approximately 4% each. There is a statistically significantly higher success rate in EN-DCR surgery with tubes compared with no tubes. The failure rate in this study was more than twice as high when tubes were not used (12.2% vs. 5.3%). Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis

PubMed Central

Toklu, Bora; Amoroso, Nicholas; Fusaro, Mario; Kumar, Sunil; Hannan, Edward L; Faxon, David P; Feit, Frederick

2013-01-01

Objective To compare the efficacy and safety of biodegradable polymer drug eluting stents with those of bare metal stents and durable polymer drug eluting stents. Design Mixed treatment comparison meta-analysis of 258 544 patient years of follow-up from randomized trials. Data sources and study selection PubMed, Embase, and Central were searched for randomized trials comparing any of the Food and Drug Administration approved durable polymer drug eluting stents (sirolimus eluting, paclitaxel eluting, cobalt chromium everolimus eluting, platinum chromium everolimus eluting, zotarolimus eluting-Endeavor, and zotarolimus eluting-Resolute) or biodegradable polymer drug eluting stents, with each other or against bare metal stents. Outcomes Long term efficacy (target vessel revascularization, target lesion revascularization) and safety (death, myocardial infarction, stent thrombosis). Landmark analysis at more than one year was evaluated to assess the potential late benefit of biodegradable polymer drug eluting stents. Results From 126 randomized trials and 258 544 patient years of follow-up, for long term efficacy (target vessel revascularization), biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.66, 95% credibility interval 0.57 to 0.78) and zotarolimus eluting stent-Endeavor (0.69, 0.56 to 0.84) but not to newer generation durable polymer drug eluting stents (for example: 1.03, 0.89 to 1.21 versus cobalt chromium everolimus eluting stents). Similarly, biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.61, 0.37 to 0.89) but inferior to cobalt chromium everolimus eluting stents (2.04, 1.27 to 3.35) for long term safety (definite stent thrombosis). In the landmark analysis after one year, biodegradable polymer drug eluting stents were superior to sirolimus eluting stents for definite stent thrombosis (rate ratio 0.29, 0.10 to 0.82) but were associated with increased mortality compared with cobalt chromium everolimus eluting stents (1.52, 1.02 to 2.22). Overall, among all stent types, the newer generation durable polymer drug eluting stents (zotarolimus eluting stent-Resolute, cobalt chromium everolimus eluting stents, and platinum chromium everolimus eluting stents) were the most efficacious (lowest target vessel revascularization rate) stents, and cobalt chromium everolimus eluting stents were the safest with significant reductions in definite stent thrombosis (rate ratio 0.35, 0.21 to 0.53), myocardial infarction (0.65, 0.55 to 0.75), and death (0.72, 0.58 to 0.90) compared with bare metal stents. Conclusions Biodegradable polymer drug eluting stents are superior to first generation durable polymer drug eluting stents but not to newer generation durable polymer stents in reducing target vessel revascularization. Newer generation durable polymer stents, and especially cobalt chromium everolimus eluting stents, have the best combination of efficacy and safety. The utility of biodegradable polymer stents in the context of excellent clinical outcomes with newer generation durable polymer stents needs to be proven. PMID:24212107

Perceiving nasal patency through mucosal cooling rather than air temperature or nasal resistance.

PubMed

Zhao, Kai; Blacker, Kara; Luo, Yuehao; Bryant, Bruce; Jiang, Jianbo

2011-01-01

Adequate perception of nasal airflow (i.e., nasal patency) is an important consideration for patients with nasal sinus diseases. The perception of a lack of nasal patency becomes the primary symptom that drives these patients to seek medical treatment. However, clinical assessment of nasal patency remains a challenge because we lack objective measurements that correlate well with what patients perceive. The current study examined factors that may influence perceived patency, including air temperature, humidity, mucosal cooling, nasal resistance, and trigeminal sensitivity. Forty-four healthy subjects rated nasal patency while sampling air from three facial exposure boxes that were ventilated with untreated room air, cold air, and dry air, respectively. In all conditions, air temperature and relative humidity inside each box were recorded with sensors connected to a computer. Nasal resistance and minimum airway cross-sectional area (MCA) were measured using rhinomanometry and acoustic rhinometry, respectively. General trigeminal sensitivity was assessed through lateralization thresholds to butanol. No significant correlation was found between perceived patency and nasal resistance or MCA. In contrast, air temperature, humidity, and butanol threshold combined significantly contributed to the ratings of patency, with mucosal cooling (heat loss) being the most heavily weighted predictor. Air humidity significantly influences perceived patency, suggesting that mucosal cooling rather than air temperature alone provides the trigeminal sensation that results in perception of patency. The dynamic cooling between the airstream and the mucosal wall may be quantified experimentally or computationally and could potentially lead to a new clinical evaluation tool.

Perceiving Nasal Patency through Mucosal Cooling Rather than Air Temperature or Nasal Resistance

PubMed Central

Zhao, Kai; Blacker, Kara; Luo, Yuehao; Bryant, Bruce; Jiang, Jianbo

2011-01-01

Adequate perception of nasal airflow (i.e., nasal patency) is an important consideration for patients with nasal sinus diseases. The perception of a lack of nasal patency becomes the primary symptom that drives these patients to seek medical treatment. However, clinical assessment of nasal patency remains a challenge because we lack objective measurements that correlate well with what patients perceive.The current study examined factors that may influence perceived patency, including air temperature, humidity, mucosal cooling, nasal resistance, and trigeminal sensitivity. Forty-four healthy subjects rated nasal patency while sampling air from three facial exposure boxes that were ventilated with untreated room air, cold air, and dry air, respectively. In all conditions, air temperature and relative humidity inside each box were recorded with sensors connected to a computer. Nasal resistance and minimum airway cross-sectional area (MCA) were measured using rhinomanometry and acoustic rhinometry, respectively. General trigeminal sensitivity was assessed through lateralization thresholds to butanol. No significant correlation was found between perceived patency and nasal resistance or MCA. In contrast, air temperature, humidity, and butanol threshold combined significantly contributed to the ratings of patency, with mucosal cooling (heat loss) being the most heavily weighted predictor. Air humidity significantly influences perceived patency, suggesting that mucosal cooling rather than air temperature alone provides the trigeminal sensation that results in perception of patency. The dynamic cooling between the airstream and the mucosal wall may be quantified experimentally or computationally and could potentially lead to a new clinical evaluation tool. PMID:22022361

Proximal Tubal Patency Demonstrated Through Air Infusion During Flexible Office Hysteroscopy Is Predictive of Whole Tubal Patency.

PubMed

Parry, J Preston; Riche, Daniel; Aldred, Justin; Isaacs, John; Lutz, Elizabeth; Butler, Vicki; Shwayder, James

To determine whether air bubbles infused into saline during flexible office hysteroscopy can accurately predict tubal patency. Diagnostic accuracy study (Canadian Task Force classification II-1). An academic hospital. Women undergoing office hysteroscopy and ultrasound. Air infusion into saline during office hysteroscopy. The primary outcome measures were whether air bubbles traverse the ostia at hysteroscopy, whether there is patency at abdominal surgery, and the rate of cul-de-sac (CDS) fluid accumulation from office hysteroscopy. Four hundred thirty-five patients underwent office hysteroscopy with air infusion, 89 of whom also had abdominal surgery. Depending on interpretation, sensitivity to tubal occlusion was 98.3% to 100%, and specificity was 83.7% with standard chromopertubation pressures; 95.3% to 100% of the time proximal patency was observed, whole tubal patency was observed through chromopertubation for patients with surgical data. Changes in CDS fluid volume from before to after office hysteroscopy were also used as an indirect proxy for tubal patency. Patients with risk factors for occlusion such as known or suspected tubal disease, known or suspected adhesions, and sonographic identification of adhesions through the sliding sign were all less likely to demonstrate a change in CDS fluid volume after hysteroscopy than women without these risk factors (p < .0001). Bilateral dispersion of air bubbles during hysteroscopy better predicted shifts in CDS volume than these risk factors and demonstrated shifts comparable with bilateral patency at laparoscopy (p < .001). Air-infused saline at office hysteroscopy can accurately assess tubal patency. Additionally, bilateral patency identified through office hysteroscopy may predict bilateral patency at surgery better than several commonly used historic and sonographic variables. Published by Elsevier Inc.

Long-term outcomes of coronary artery bypass grafting versus stent-PCI for unprotected left main disease: a meta-analysis.

PubMed

De Rosa, Salvatore; Polimeni, Alberto; Sabatino, Jolanda; Indolfi, Ciro

2017-09-06

Coronary artery bypass graft (CABG) surgery has traditionally represented the standard of care for left main coronary artery (LMCA) disease. However, percutaneous coronary intervention with stent implantation (PCI) has more recently emerged as a valuable alternative. The long-time awaited results of the largest randomized trials on the long-term impact of PCI versus CABG in LMCA disease, the newly published NOBLE and EXCEL studies, revealed contrasting results. Thus, aim of the present meta-analysis was to review the most robust evidence from randomized comparisons of CABG versus PCI for revascularization of LMCA. Randomized studies comparing long-term clinical outcomes of CABG or Stent-PCI for the treatment of LMCA disease were searched for in PubMed, the Chochrane Library and Scopus electronic databases. A total of 5 randomized studies were selected, including 4499 patients. No significant difference between CABG and PCI was found in the primary analysis on the composite endpoint of death, stroke and myocardial infarction (OR = 1·06 95% CI 0·80-1·40; p = 0·70). Similarly, no differences were observed between CABG and PCI for all-cause death (OR = 1·03 95% CI 0·81-1·32; p = 0·81). Although not statistically significant, a lower rate of stroke was registered in the PCI arm (OR = 0·86; p = 0·67), while a lower rate of myocardial infarction was found in the CABG arm (OR = 1·43; p = 0·17). On the contrary, a significantly higher rate of repeat revascularization was registered in the PCI arm (OR = 1·76 95% CI 1·45-2·13; p < 0·001). The present meta-analysis, the most comprehensive and updated to date, including 5 randomized studies and 4499 patients, demonstrates no difference between Stent-PCI and CABG for the treatment of LMCA disease in the composite endpoint of death, stroke and myocardial infarction. Hence, a large part of patients with unprotected left main coronary artery disease can be managed equally well by means of both these revascularization strategies.

Ticagrelor Compared With Clopidogrel in Patients With Prior Lower Extremity Revascularization for Peripheral Artery Disease.

PubMed

Jones, W Schuyler; Baumgartner, Iris; Hiatt, William R; Heizer, Gretchen; Conte, Michael S; White, Christopher J; Berger, Jeffrey S; Held, Peter; Katona, Brian G; Mahaffey, Kenneth W; Norgren, Lars; Blomster, Juuso; Millegård, Marcus; Reist, Craig; Patel, Manesh R; Fowkes, F Gerry R

2017-01-17

In patients with symptomatic peripheral artery disease with a history of limb revascularization, the optimal antithrombotic regimen for long-term management is unknown. The EUCLID trial (Examining Use of Ticagrelor In PAD) randomized 13 885 patients with peripheral artery disease to treatment with ticagrelor 90 mg twice daily or clopidogrel 75 mg daily. Patients were enrolled based on an abnormal ankle-brachial index ≤0.80 or a previous lower extremity revascularization. This analysis focuses on the 7875 (57%) patients enrolled based on the previous lower extremity revascularization criterion. Patients could not be enrolled within 30 days of most recent revascularization, and patients with an indication for dual antiplatelet therapy were excluded. The primary efficacy end point was a composite of cardiovascular death, myocardial infarction, or ischemic stroke. The primary safety end point was major bleeding. Patients with a previous revascularization had a mean age of 66 years, 73% were male, and the median baseline ankle-brachial index was 0.78. After adjustment for baseline characteristics, patients enrolled based on previous revascularization had similar rates of the primary composite end point (hazard ratio [HR] 1.10, 95% confidence interval [CI] 0.98-1.23, P=0.12) and statistically significantly higher rates of myocardial infarction (HR 1.29, 95% CI 1.08-1.55, P=0.005) and acute limb ischemia (HR 4.23, 95% CI 2.86-6.25, P<0.001) when compared with patients enrolled based on ankle-brachial index criteria. No differences in ticagrelor- versus clopidogrel-treated patients were found for the primary efficacy end point (11.4% vs 11.3%; HR 1.01, 95% CI 0.88-1.15; P=0.90), all-cause mortality (9.2% vs 9.2%; HR 0.99, 95% CI 0.86-1.15; P=0.93), acute limb ischemia (2.5% vs 2.5%; HR 1.03, 95% CI 0.78-1.36; P=0.84), or major bleeding (1.9% vs 1.8%; HR 1.15, 95% CI 0.83-1.59; P=0.41). The median duration of follow-up was ≈30 months. After adjustment for baseline characteristics, patients enrolled based on previous revascularization for peripheral artery disease had higher rates of myocardial infarction and acute limb ischemia, with similar composite rates of cardiovascular death, myocardial infarction, and stroke when compared with patients enrolled based on the ankle-brachial index criterion. No significant differences were found between ticagrelor and clopidogrel for reduction of cardiovascular or acute limb events. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01732822. © 2016 American Heart Association, Inc.

Comparison of a priori versus provisional heparin therapy on radial artery occlusion after transradial coronary angiography and patent hemostasis (from the PHARAOH Study).

PubMed

Pancholy, Samir B; Bertrand, Olivier F; Patel, Tejas

2012-07-15

Systemic anticoagulation decreases the risk of radial artery occlusion (RAO) after transradial catheterization and standard occlusive hemostasis. We compared the efficacy and safety of provisional heparin use only when the technique of patent hemostasis was not achievable to standard a priori heparin administration after radial sheath introduction. Patients referred for coronary angiography were randomized in 2 groups. In the a priori group, 200 patients received intravenous heparin (50 IU/kg) immediately after sheath insertion. In the provisional group, 200 patients did not receive heparin during the procedure. After sheath removal, hemostasis was obtained using a TR band (Terumo corporation, Tokyo, Japan) with a plethysmography-guided patent hemostasis technique. In the provisional group, no heparin was given if radial artery patency could be obtained and maintained. If radial patency was not achieved, a bolus of heparin (50 IU/kg) was given. Radial artery patency was evaluated at 24 hours (early RAO) and 30 days after the procedure (late RAO) by plethysmography. Patent hemostasis was obtained in 67% in the a priori group and 74% in the provisional group (p = 0.10). Incidence of RAO remained similar in the 2 groups at the early (7.5% vs 7.0%, p = 0.84) and late (4.5% vs 5.0%, p = 0.83) evaluations. Women, patients with diabetes, patients having not received heparin, and patients without radial artery patency during hemostasis had more RAO. By multivariate analysis, patent radial artery during hemostasis (odds ratio [OR] 0.03, 95% confidence interval [CI] 0.004 to 0.28, p = 0.002) and diabetes (OR 11, 95% CI 3 to 38,p <0.0001) were independent predictors of late RAO, whereas heparin was not (OR 0.45 95% CI 0.13 to 1.54, p = 0.20). In conclusion, our results suggest that maintenance of radial artery patency during hemostasis is the most important parameter to decrease the risk of RAO. In selected cases, provisional use of heparin appears feasible and safe when patent hemostasis is maintained. Copyright © 2012 Elsevier Inc. All rights reserved.

Edifoligide and long-term outcomes after coronary artery bypass grafting: PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT IV) 5-year results.

PubMed

Lopes, Renato D; Williams, Judson B; Mehta, Rajendra H; Reyes, Eric M; Hafley, Gail E; Allen, Keith B; Mack, Michael J; Peterson, Eric D; Harrington, Robert A; Gibson, C Michael; Califf, Robert M; Kouchoukos, Nicholas T; Ferguson, T Bruce; Lorenz, Todd J; Alexander, John H

2012-09-01

Edifoligide, an E2F transcription factor decoy, does not prevent vein graft failure or adverse clinical outcomes at 1 year in patients undergoing coronary artery bypass grafting (CABG). We compared the 5-year clinical outcomes of patients in PREVENT IV treated with edifoligide and placebo to identify predictors of long-term clinical outcomes. A total of 3,014 patients undergoing CABG with at least 2 planned vein grafts were enrolled. Kaplan-Meier curves were generated to compare the long-term effects of edifoligide and placebo. A Cox proportional hazards model was constructed to identify factors associated with 5-year post-CABG outcomes. The main outcome measures were death, myocardial infarction (MI), repeat revascularization, and rehospitalization through 5 years. Five-year follow-up was complete in 2,865 patients (95.1%). At 5 years, patients randomized to edifoligide and placebo had similar rates of death (11.7% and 10.7%, respectively), MI (2.3% and 3.2%), revascularization (14.1% and 13.9%), and rehospitalization (61.6% and 62.5%). The composite outcome of death, MI, or revascularization occurred at similar frequency in patients assigned to edifoligide and placebo (26.3% and 25.5%, respectively; hazard ratio 1.03 [95% CI 0.89-1.18], P = .721). Factors associated with death, MI, or revascularization at 5 years included peripheral and/or cerebrovascular disease, time on cardiopulmonary bypass, lung disease, diabetes mellitus, and congestive heart failure. Up to a quarter of patients undergoing CABG will have a major cardiac event or repeat revascularization procedure within 5 years of surgery. Edifoligide does not affect outcomes after CABG; however, common identifiable baseline and procedural risk factors are associated with long-term outcomes after CABG. Copyright © 2012 Mosby, Inc. All rights reserved.

Single-Staged Compared With Multi-Staged PCI in Multivessel NSTEMI Patients: The SMILE Trial.

PubMed

Sardella, Gennaro; Lucisano, Luigi; Garbo, Roberto; Pennacchi, Mauro; Cavallo, Erika; Stio, Rocco Edoardo; Calcagno, Simone; Ugo, Fabrizio; Boccuzzi, Giacomo; Fedele, Francesco; Mancone, Massimo

2016-01-26

A lack of clarity exists about the role of complete coronary revascularization in patients presenting with non-ST-segment elevation myocardial infarction. The aim of our study was to compare long-term outcomes in terms of major adverse cardiovascular and cerebrovascular events of 2 different complete coronary revascularization strategies in patients with non-ST-segment elevation myocardial infarction and multivessel coronary artery disease: 1-stage percutaneous coronary intervention (1S-PCI) during the index procedure versus multistage percutaneous coronary intervention (MS-PCI) complete coronary revascularization during the index hospitalization. In the SMILE (Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention) trial, 584 patients were randomly assigned in a 1:1 manner to 1S-PCI or MS-PCI. The primary study endpoint was the incidence of major adverse cardiovascular and cerebrovascular events, which were defined as cardiac death, death, reinfarction, rehospitalization for unstable angina, repeat coronary revascularization (target vessel revascularization), and stroke at 1 year. The occurrence of the primary endpoint was significantly lower in the 1-stage group (1S-PCI: n = 36 [13.63%] vs. MS-PCI: n = 61 [23.19%]; hazard ratio [HR]: 0.549 [95% confidence interval (CI): 0.363 to 0.828]; p = 0.004). The 1-year rate of target vessel revascularization was significantly higher in the MS-PCI group (1S-PCI: n = 22 [8.33%] vs. MS-PCI: n = 40 [15.20%]; HR: 0.522 [95% CI: 0.310 to 0.878]; p = 0.01; p log-rank = 0.013). When the analyses were limited to cardiac death (1S-PCI: n = 9 [3.41%] vs. MS-PCI: n = 14 [5.32%]; HR: 0.624 [95% CI: 0.270 to 1.441]; p = 0.27) and myocardial infarction (1S-PCI: n = 7 [2.65%] vs. MS-PCI: n = 10 [3.80%]; HR: 0.678 [95% CI: 0.156 to 2.657]; p = 0.46), no significant differences were observed between groups. In multivessel non-ST-segment elevation myocardial infarction patients, complete 1-stage coronary revascularization is superior to multistage PCI in terms of major adverse cardiovascular and cerebrovascular events. (Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction [NSTEMI] One Stage Versus Multistaged Percutaneous Coronary Intervention [PCI] [SMILE]: NCT01478984). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Minimally invasive direct coronary artery bypass grafting: a meta-analysis.

PubMed

Kettering, K

2008-12-01

Recently minimally invasive direct coronary artery bypass (MIDCAB) grafting has become an interesting alternative to conventional coronary artery bypass grafting, especially in patients with a high-grade left anterior descending coronary artery (LAD) stenosis unsuitable for balloon angioplasty. Although MIDCAB offers several advantages such as the avoidance of sternotomy and cardiopulmonary bypass, concerns have been raised about the technical accuracy of the anastomoses that can be performed on a beating heart. Therefore, clinical and angiographic outcomes after MIDCAB are the subject of current controversy. A literature search for all published outcome studies of MIDCAB grafting was performed for the period from January 1995 through October 2007. Seventeen articles were enrolled in this meta-analysis. The data presented in the studies was analyzed with regard to clinical and angiographic results. Early and late (>30 days after MIDCAB) death rates were 1.3% (51/4081 patients) and 3.2% (130/4081 patients), respectively. The infarct rate was 0.8% (32/4081 patients; non-fatal myocardial infarction). Other minor or major complications (e.g. reoperation for management of bleeding, chest wound problems, arrhythmias, cerebrovascular accident, pericardial effusion, pulmonary complications) were reported in 781 cases. The conversion rate to sternotomy/cardiopulmonary bypass was 1.8% (74/4081 patients). A re-intervention due to graft failure was necessary in 134/4081 patients (3.3%). A total of 2556 grafts were studied angiographically immediately after surgery. One hundred and six grafts (4.2%) were occluded and 169 grafts (6.6 %) had a significant stenosis (50-99%). At 6-month follow-up, 445 grafts were studied angiographically. Sixteen grafts (3.6%) were occluded and 32 grafts (7.2%) had a significant stenosis. Clinical outcomes and immediate graft patency after MIDCAB are acceptable. However, long-term follow-up results and further randomized prospective clinical trials comparing this new technique with standard revascularization procedures in large patient cohorts are needed.

Evaluation of Revascularization Subtypes in Octogenarians Undergoing Coronary Artery Bypass Grafting

PubMed Central

Aziz, Abdulhameed; Lee, Anson M.; Pasque, Michael K.; Lawton, Jennifer S.; Moazami, Nader; Damiano, Ralph J.; Moon, Marc R.

2009-01-01

Background Recent data suggest that octogenarians’ long-term survival after complete CABG revascularization is superior to incomplete revascularization. Discriminating between variable definitions of “complete” complicates interpretation of survival data. We aimed to clarify octogenarian long-term survival rates by stratifying revascularization subtypes. Methods and Results From 1986 to 2007, 580 patients 80 to 94 years of age underwent CABG. Functional complete revascularization was defined as at least one graft to all diseased coronary vessels with greater than 50% stenosis. Traditional complete revascularization was defined as one graft to each major arterial system with at least 50% stenosis. Incomplete revascularization was defined as leaving diseased, ungrafted regions. Revascularization was functional in 279 (48%), traditional in 181 (31%), and incomplete in 120 (21%). Long-term survival was evaluated by Kaplan-Meier analysis. Of 537 operative survivors, there were 402 late deaths. Cumulative long-term survival totaled 2,890 patient-years. Late survival (Kaplan-Meier) was similar between functional (6.8 years, mean) and traditional (6.7 years) groups (p=0.51), but diminished with incomplete (4.2 years) revascularization (p=0.007). Survival by group at 5 years was: 59±3% functional, 57±4% traditional, and 45±5% incomplete. Survival at 8 years was: 40±3% functional, 37±4% traditional, and 26±5% incomplete. To minimize selection bias in patients with limited life expectancy, Kaplan-Meier analysis was repeated including only patients with survival greater than 12 months. Survival was again impaired with incomplete revascularization (p=0.04), and there was no difference between functional and traditional complete revascularization (p=0.73). Conclusions Bypassing all diseased arterial vessels after revascularization does not afford significant long-term survival advantage compared to a traditional approach. Incomplete revascularization, related to more extensive disease, is associated with an 18% decline in survival. These data suggest that it is important to avoid incomplete revascularization in octogenarians, but the supplementary endeavor required to perform functional complete revascularization does not improve survival. PMID:19752388

Use of cardiopulmonary pump support during coronary artery bypass grafting in the high-risk: a meta-analysis.

PubMed

Yousif, A; Addison, D; Lakkis, N; Rosengart, T; Virani, S S; Birnbaum, Y; Alam, M

2018-05-01

Data from randomized trials evaluating the efficacy of on- versus off-pump coronary artery bypass grafting remain inconclusive, particularly in high-risk populations. The aim of this study is to compare the outcomes associated with on- versus off-pump coronary artery bypass grafting among high-risk patients. We performed a meta-analysis of randomized control trials comparing on- versus off-pump coronary artery bypass grafting, focusing on high-risk populations. Studies focusing on "high-risk" features: European System of Cardiac Operative Risk Evaluation (EuroSCORE) ≥ 5, age > 70 years, preexisting renal insufficiency, history of stroke(s), and the presence of left ventricular dysfunction were included. MEDLINE, Scopus, and Embase were searched for all publications between January 1, 2000 and August 1, 2016, using the following terms: on-pump, off-pump, coronary artery bypass, high-risk, left ventricular dysfunction, elderly, aged, and renal insufficiency. Endpoints included cardiovascular and all-cause mortality, non-fatal myocardial infarction, stroke, need for revascularization, renal failure, and length of hospital stay. Nine studies incorporating 11,374 patients with a mean age of 70 years were selected. There was no statistical difference in cardiovascular mortality, all-cause mortality, non-fatal myocardial infarction, and renal failure between the two groups. There was a decrease in further revascularization at 1 year with on-pump (OR 0.67 (0.50-0.89)). However, there was an increase in length of hospital stay by 2.24 days (p = 0.03) among the on-pump group with no difference in stroke (OR 1.34 (1.00-1.80)). On-pump is associated with a decreased risk of additional revascularization by 1 year. However, this appears to be a cost of longer hospitalization.

Strategies for multivessel revascularization in patients with diabetes.

PubMed

Farkouh, Michael E; Domanski, Michael; Sleeper, Lynn A; Siami, Flora S; Dangas, George; Mack, Michael; Yang, May; Cohen, David J; Rosenberg, Yves; Solomon, Scott D; Desai, Akshay S; Gersh, Bernard J; Magnuson, Elizabeth A; Lansky, Alexandra; Boineau, Robin; Weinberger, Jesse; Ramanathan, Krishnan; Sousa, J Eduardo; Rankin, Jamie; Bhargava, Balram; Buse, John; Hueb, Whady; Smith, Craig R; Muratov, Victoria; Bansilal, Sameer; King, Spencer; Bertrand, Michel; Fuster, Valentin

2012-12-20

In some randomized trials comparing revascularization strategies for patients with diabetes, coronary-artery bypass grafting (CABG) has had a better outcome than percutaneous coronary intervention (PCI). We sought to discover whether aggressive medical therapy and the use of drug-eluting stents could alter the revascularization approach for patients with diabetes and multivessel coronary artery disease. In this randomized trial, we assigned patients with diabetes and multivessel coronary artery disease to undergo either PCI with drug-eluting stents or CABG. The patients were followed for a minimum of 2 years (median among survivors, 3.8 years). All patients were prescribed currently recommended medical therapies for the control of low-density lipoprotein cholesterol, systolic blood pressure, and glycated hemoglobin. The primary outcome measure was a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke. From 2005 through 2010, we enrolled 1900 patients at 140 international centers. The patients' mean age was 63.1±9.1 years, 29% were women, and 83% had three-vessel disease. The primary outcome occurred more frequently in the PCI group (P=0.005), with 5-year rates of 26.6% in the PCI group and 18.7% in the CABG group. The benefit of CABG was driven by differences in rates of both myocardial infarction (P<0.001) and death from any cause (P=0.049). Stroke was more frequent in the CABG group, with 5-year rates of 2.4% in the PCI group and 5.2% in the CABG group (P=0.03). For patients with diabetes and advanced coronary artery disease, CABG was superior to PCI in that it significantly reduced rates of death and myocardial infarction, with a higher rate of stroke. (Funded by the National Heart, Lung, and Blood Institute and others; FREEDOM ClinicalTrials.gov number, NCT00086450.).

Favorable effects of insulin sensitizers pertinent to peripheral arterial disease in type 2 diabetes: results from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.

PubMed

Althouse, Andrew D; Abbott, J Dawn; Sutton-Tyrrell, Kim; Forker, Alan D; Lombardero, Manuel S; Buitrón, L Virginia; Pena-Sing, Ivan; Tardif, Jean-Claude; Brooks, Maria Mori

2013-10-01

The aim of this manuscript was to report the risk of incident peripheral arterial disease (PAD) in a large randomized clinical trial that enrolled participants with stable coronary artery disease and type 2 diabetes and compare the risk between assigned treatment arms. The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial randomly assigned participants to insulin sensitization (IS) therapy versus insulin-providing (IP) therapy for glycemic control. Results showed similar 5-year mortality in the two glycemic treatment arms. In secondary analyses reported here, we examine the effects of treatment assignment on the incidence of PAD. A total of 1,479 BARI 2D participants with normal ankle-brachial index (ABI) (0.91-1.30) were eligible for analysis. The following PAD-related outcomes are evaluated in this article: new low ABI≤0.9, a lower-extremity revascularization, lower-extremity amputation, and a composite of the three outcomes. During an average 4.6 years of follow-up, 303 participants experienced one or more of the outcomes listed above. Incidence of the composite outcome was significantly lower among participants assigned to IS therapy than those assigned to IP therapy (16.9 vs. 24.1%; P<0.001). The difference was significant in time-to-event analysis (hazard ratio 0.66 [95% CI 0.51-0.83], P<0.001) and remained significant after adjustment for in-trial HbA1c (0.76 [0.59-0.96], P=0.02). In participants with type 2 diabetes who are free from PAD, a glycemic control strategy of insulin sensitization may be the preferred therapeutic strategy to reduce the incidence of PAD and subsequent outcomes.

The Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study: rationale and methods.

PubMed

Murphy, Timothy P; Hirsch, Alan T; Ricotta, John J; Cutlip, Donald E; Mohler, Emile; Regensteiner, Judith G; Comerota, Anthony J; Cohen, David J

2008-06-01

Intermittent claudication is the primary symptom of peripheral arterial disease, affecting between 1 and 3 million Americans. Symptomatic improvement can be achieved by endovascular revascularization, but such procedures are invasive, expensive, and may be associated with procedural adverse events. Medical treatment options, including claudication medications and supervised exercise training, are also known to be effective, albeit also with associated limitations. The CLEVER (Claudication: Exercise Vs. Endoluminal Revascularization) study, funded by the Heart, Lung, and Blood Institute of the National Institutes of Health, is a prospective, multicenter, randomized, controlled clinical trial evaluating the relative efficacy, safety, and health economic impact of four treatment strategies for people with aortoiliac peripheral arterial disease and claudication. The treatment arms are: (1) optimal medical care (claudication pharmacotherapy); (2) primary stent placement; (3) supervised exercise rehabilitation; and (4) combined stenting with supervised exercise rehabilitation. The CLEVER study is a 5-year randomized, controlled clinical trial to be conducted at approximately 25 centers in the United States that will monitor 252 patients and their responses to treatment during an 18-month follow-up period. The primary end point is change in maximum walking duration on a graded treadmill test. Secondary end points include the change at 18 months in maximum walking duration from baseline, comparisons of free-living daily activity levels assessed by pedometer, health-related quality of life, and cost-effectiveness. Other analyses include the effect of these treatment strategies on anthropomorphic and physiologic variables, including body mass index, waist circumference, blood pressure, pulse pressure, and resting pulse as well as biochemical markers of cardiovascular health, including fasting lipids, fibrinogen, C-reactive protein, and hemoglobin A 1c values.

gender-specific outcome after paclitaxel-eluting stent implantation in japanese patients with coronary artery disease--sub-analysis of the Japan TAXUS Express2 post-marketing survey.

PubMed

Okura, Hiroyuki; Nakamura, Masato; Kotani, Jun-Ichi; Kozuma, Ken

2013-01-01

 Although previous randomized and non-randomized studies have demonstrated the safety and efficacy of paclitaxel-eluting stents (PES), a higher revascularization rate has been reported in women than in men. A sub-analysis of the TAXUS Japan Post-market Surveillance Study (TAXUS-PMS) was done to assess the influence of gender on clinical outcome.  A total of 2,132 PES-treated Japanese patients (women, n=551) from this registry were analyzed. Subjects were stratified by gender to compare 1-year clinical outcome. PES-treated women were older and more likely to have insulin-treated diabetes and hypertension. In contrast, PES-treated men were more likely to be smokers, have a previous history of myocardial infarction, and lower ejection fraction. While cardiac death, myocardial infarction and stent thrombosis were similar between men and women, major cardiac events tended to be lower in women than in men (6.4% vs. 8.8%, P=0.08). Although women had significantly smaller reference vessel size (2.46±0.53 mm vs. 2.59±0.60 mm, P<0.0001), the restenosis rate tended to be lower in women than in men (11.5% vs. 14.8%, P=0.11). Subsequently, the target lesion revascularization rate was significantly lower in women than in men (4.2% vs. 6.5%, P<0.05).  Despite a higher risk profile, Japanese women treated with PES did not have a higher rate of repeat revascularization or major adverse clinical outcome than PES-treated men at 1 year. 

Stent patency in patients with distal malignant biliary obstruction receiving chemo(radio)therapy.

PubMed

Haal, Sylke; van Hooft, Jeanin E; Rauws, Erik A J; Fockens, Paul; Voermans, Rogier P

2017-11-01

 Recent literature suggests that chemo(radio)therapy might reduce the patency of plastic stents in patients with malignant biliary obstruction. Whether this might also be valid for other types of stents is unknown. The aim of this study was to determine the influence of chemo(radio)therapy on the patency of fully-covered self-expandable metal stents (FCSEMSs) and plastic stents.  We retrospectively reviewed the electronic medical records of patients with distal malignant biliary obstruction who underwent biliary stent placement between April 2001 and July 2015. Primary outcome was duration of stent patency. Secondary outcome was stent patency at 3 and 6 months. We used Kaplan-Meier survival analyses to compare stent patency rates between patients who received chemo(radio)therapy and patients who did not.  A total of 291 biliary stents (151 metal and 140 plastic) were identified. The median cumulative stent patency of FCSEMSs did not differ between patients receiving chemo(radio)therapy (n = 51) and those (n = 100) who did not ( P  = 0.70, log-rank test). The estimated cumulative stent patency of plastic stents was also comparable in 99 patients without and 41 patients with chemo(radio)therapy ( P  = 0.73, log-rank test). At 3 and 6 months, FCSEMS patency rates were 87 % and 83 % in patients without chemo(radio)therapy and 96 % and 83 % in patients with therapy, respectively. Plastic patency rates were 69 % and 55 % in patients without and 85 % and 39 % in patients with therapy, respectively. After 1 year, 78 % of the FCSEMSs were still patent in patients without chemo(radio)therapy and 69 % of the FCSEMSs were still patent in patients with therapy.  Our data indicate that chemo(radio)therapy does not reduce the patency of biliary fully-covered metal and plastic stents.

The Relationship Between Neutrophil–Lymphocyte Ratio and Primary Patency of Percutaneous Transluminal Angioplasty in Hemodialysis Arteriovenous Fistula Stenosis When Using Conventional and Drug-Eluting Balloons

DOE Office of Scientific and Technical Information (OSTI.GOV)

Çildağ, Mehmet Burak, E-mail: mbcildag@yahoo.com; Çildağ, Songül, E-mail: songulcildag@yahoo.com; Köseoğlu, Ömer Faruk Kutsi, E-mail: kutsikoseoglu@yahoo.com

ObjectiveThe aim of this study is to investigate the potential association of neutrophil–lymphocyte ratio (NLR) between primary patency of percutaneous transluminal angioplasty (PTA) in hemodialysis arteriovenous fistula stenosis and type (Conventional and Drug-Eluting) of balloons used in PTA.Material-MethodThis retrospective study consists of 78 patients with significant arteriovenous fistulas stenosis who were treated with PTA by using Drug-Eluting Balloon (DEB) (n = 29) or Conventional Balloon (CB) (n = 49). NLR was calculated from preinterventional blood samples. All patients were classified into two groups. Group A; primary patency <12 months (43/78), Group B; primary patency ≥12 months (35/78). Cox regression analysis and Kaplan–Meier method were used to determine respectivelymore » independent factors affecting the primary patency and to compare the primary patency for the two balloon types.ResultsNLR ratio and balloon type of the two groups were significantly different (p = 0.002, p = 0.010). The cut-off value of NLR was 3.18 for determination of primary patency, with sensitivity of 81.4 % and specificity of 51.4 %. Primary patency rates between PTA with DEB and CB displayed statistically significant differences (p < 0.05). The cut-off value was 3.28 for determination of 12-month primary patency with the conventional balloon group; sensitivity was 81.8 % and specificity was 81.3 %. There was no statistical relation between NLR levels and the drug-eluting balloon group in 12-month primary patency (p = 0.927).ConclusionIncreased level of NLR may be a risk factor in the development of early AVF restenosis after successful PTA. Preferring Drug-Eluting Balloon at an increased level of NLR can be beneficial to prolong patency.« less

Stent patency in patients with distal malignant biliary obstruction receiving chemo(radio)therapy

PubMed Central

Haal, Sylke; van Hooft, Jeanin E.; Rauws, Erik A. J.; Fockens, Paul; Voermans, Rogier P.

2017-01-01

Background and study aims  Recent literature suggests that chemo(radio)therapy might reduce the patency of plastic stents in patients with malignant biliary obstruction. Whether this might also be valid for other types of stents is unknown. The aim of this study was to determine the influence of chemo(radio)therapy on the patency of fully-covered self-expandable metal stents (FCSEMSs) and plastic stents. Patients and methods  We retrospectively reviewed the electronic medical records of patients with distal malignant biliary obstruction who underwent biliary stent placement between April 2001 and July 2015. Primary outcome was duration of stent patency. Secondary outcome was stent patency at 3 and 6 months. We used Kaplan–Meier survival analyses to compare stent patency rates between patients who received chemo(radio)therapy and patients who did not. Results  A total of 291 biliary stents (151 metal and 140 plastic) were identified. The median cumulative stent patency of FCSEMSs did not differ between patients receiving chemo(radio)therapy (n = 51) and those (n = 100) who did not ( P  = 0.70, log-rank test). The estimated cumulative stent patency of plastic stents was also comparable in 99 patients without and 41 patients with chemo(radio)therapy ( P  = 0.73, log-rank test). At 3 and 6 months, FCSEMS patency rates were 87 % and 83 % in patients without chemo(radio)therapy and 96 % and 83 % in patients with therapy, respectively. Plastic patency rates were 69 % and 55 % in patients without and 85 % and 39 % in patients with therapy, respectively. After 1 year, 78 % of the FCSEMSs were still patent in patients without chemo(radio)therapy and 69 % of the FCSEMSs were still patent in patients with therapy. Conclusion  Our data indicate that chemo(radio)therapy does not reduce the patency of biliary fully-covered metal and plastic stents. PMID:29090242

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mizandari, Malkhaz; Pai, Madhava, E-mail: madhava.pai@imperial.ac.uk; Xi Feng

Purpose. Previous clinical studies have shown the safety and efficacy of this novel radiofrequency ablation catheter when used for endoscopic palliative procedures. We report a retrospective study with the results of first in man percutaneous intraductal radiofrequency ablation in patients with malignant biliary obstruction. Methods. Thirty-nine patients with inoperable malignant biliary obstruction were included. These patients underwent intraductal biliary radiofrequency ablation of their malignant biliary strictures following external biliary decompression with an internal-external biliary drainage. Following ablation, they had a metal stent inserted. Results. Following this intervention, there were no 30-day mortality, hemorrhage, bile duct perforation, bile leak, or pancreatitis.more » Of the 39 patients, 28 are alive and 10 patients are dead with a median survival of 89.5 (range 14-260) days and median stent patency of 84.5 (range 14-260) days. One patient was lost to follow-up. All but one patient had their stent patent at the time of last follow-up or death. One patient with stent blockage at 42 days postprocedure underwent percutaneous transhepatic drain insertion and restenting. Among the patients who are alive (n = 28) the median stent patency was 92 (range 14-260) days, whereas the patients who died (n = 10) had a median stent patency of 62.5 (range 38-210) days. Conclusions. In this group of patients, it appears that this new approach is feasible and safe. Efficacy remains to be proven in future, randomized, prospective studies.« less

Establishing Apical Patency: To be or not to be?

PubMed

Mohammadi, Zahed; Jafarzadeh, Hamid; Shalavi, Sousan; Kinoshita, Jun-Ichiro

2017-04-01

The apical portion of the root canal is very complex and challenging during endodontic treatment. Root canal preparation and obturation to the apical constriction may provide the best prognosis. Incomplete debridement, foramen transportation, and inadequate seal in the apical portion are considered to be responsible for treatment failure. The technique "apical patency" is considered as a way for maintaining the apical part the free of the debris by recapitulation, using a small K-file through the area of the apical foramen. This term was firstly proposed by Buchanan. In this technique, the smallest diameter file is set 1 mm longer than working length and recapitulated after each instrument to prevent packing of debris in the apical part. Apical patency has been found to be effective in achieving an apical seal with gutta-percha. Teeth prepared with a step back method and with maintained apical patency may show less leakage when obturated with cold lateral condensation technique. Data regarding the effect of apical patency on the healing of periapical tissue are very scarce, and it has been shown that the patency file has detrimental effect on the healing of periapical tissues in animal studies. However, using patency file in endodontic treatment is controversial and further studies are needed. The purpose of this article is to review the effect of using a patency file on the extrusion of root canal contents, the apical seal, postoperative pain, and healing of periapical tissues. Furthermore, the effect of establishing patency on reaching irrigation solutions to the apical portion of the canal and prognosis of root canal treatment are discussed. Keywords: Apical patency, Apical seal, Apical transportation, Postoperative pain, Prognosis.

A novel diagnostic tool for detecting functional patency of the small bowel: the Given patency capsule.

PubMed

Spada, C; Spera, G; Riccioni, M; Biancone, L; Petruzziello, L; Tringali, A; Familiari, P; Marchese, M; Onder, G; Mutignani, M; Perri, V; Petruzziello, C; Pallone, F; Costamagna, G

2005-09-01

The current visualization of small-bowel strictures using traditional radiological methods is associated with high radiation doses and false-negative results. These methods do not always reveal small-bowel patency for solids. The aim is to assess the safety of the Given patency system and its ability to detect intestinal strictures in patients with strictures that are known or suspected radiologically. The Given patency capsule is composed of lactose, remains intact in the gastrointestinal tract for 40-100 hours post ingestion, and disintegrates thereafter. A total of 34 patients with small-bowel stricture were prospectively enrolled; 30 had a previous diagnosis of Crohn's disease, three had adhesion syndrome and in one ischemic enteritis was suspected. Of the patients, 15 (44.1 %) had previously undergone surgery. Following ingestion, the capsule was monitored for integrity and transit time, using a specially designed Given scanner and also radiologically. Seventeen patients had been enrolled with the intent of using the patency capsule as a preliminary test in patients with small-bowel strictures before undergoing video capsule endoscopy. 30 patients (88.2 %) retrieved the capsule in the stool; it was intact in 20 (median transit time 22 hours), and disintegrated in 10 patients (median transit time 53 hours). Six patients complained of abdominal pain which disappeared within 24 hours. The scanner successfully indicated the presence of the capsule in 94 % of cases. Ten patients underwent video capsule endoscopy following the patency capsule examination; in all of these the video capsule passed through the small-bowel stricture. This feasibility study has shown that the Given patency capsule is a safe, effective, and convenient tool for assessment of functional patency of the small bowel. It can indicate functional patency even in cases where traditional radiology indicates stricture.

Incidence and clinical implications of intraoperative bilateral internal thoracic artery graft conversion: Insights from the Arterial Revascularization Trial.

PubMed

Benedetto, Umberto; Altman, Douglas G; Flather, Marcus; Gerry, Stephen; Gray, Alastair; Lees, Belinda; Taggart, David P

2018-06-01

The Arterial Revascularization Trial has been designed to answer the question whether the use of bilateral internal thoracic arteries can improve 10-year outcomes when compared with single internal thoracic arteries. In the Arterial Revascularization Trial, a significant proportion of patients initially allocated to bilateral internal thoracic arteries received other conduit strategies. We sought to investigate the incidence and clinical implication of bilateral internal thoracic artery graft conversion in the Arterial Revascularization Trial. Among patients enrolled in the Arterial Revascularization Trial (n = 3102), we excluded those allocated to single internal thoracic arteries (n = 1554), those who did not undergo surgery (n = 16), and those who underwent operation but withdrew after randomization (n = 7). Propensity score matching was used to compare converted versus nonconverted bilateral internal thoracic artery groups. A total of 1525 patients were operated with the intention to receive bilateral internal thoracic artery grafting. Of those, 233 (15.3%) were converted to other conduit selection strategies. Incidence of conversion largely varied across 131 participating surgeons (from 0% to 100%). The most common reason for bilateral internal thoracic artery graft conversion was the evidence of at least 1 internal thoracic artery that was not suitable, which was reported in 77 cases. Patients with intraoperative bilateral internal thoracic artery graft conversion received a lower number of grafts (2.95 ± 0.84 vs 3.21 ± 0.74; P < .001). However, the hospital mortality rate was comparable to that of those who did not require bilateral internal thoracic artery graft conversion (0% vs 1.6%; P = .1), as well as the incidence of major complications. At 5 years, we found a nonsignificant excess of deaths (11.9% vs 8.4%; P = .1) and major adverse events (17.1% 13.2%; P = .1) mainly driven by an excess of revascularization in patients requiring conversion. The incidence of intraoperative bilateral internal thoracic artery graft conversion is not infrequent. Bilateral internal thoracic artery graft conversion is not associated with increased operative morbidity, but its effect on late outcomes remains uncertain. Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Endovascular interventions for central vein stenosis.

PubMed

Agarwal, Anil K

2015-12-01

Central vein stenosis is common because of the placement of venous access and cardiac intravascular devices and compromises vascular access for dialysis. Endovascular intervention with angioplasty and/or stent placement is the preferred approach, but the results are suboptimal and limited. Primary patency after angioplasty alone is poor, but secondary patency can be maintained with repeated angioplasty. Stent placement is recommended for quick recurrence or elastic recoil of stenosis. Primary patency of stents is also poor, though covered stents have recently shown better patency than bare metal stents. Secondary patency requires repeated intervention. Recanalization of occluded central veins is tedious and not always successful. Placement of hybrid graft-catheter with a combined endovascular surgical approach can maintain patency in many cases. In the presence of debilitating symptoms, palliative approach with endovascular banding or occlusion of the access may be necessary. Prevention of central vein stenosis is the most desirable strategy.

Revascularization heart team recommendations as an adjunct to appropriate use criteria for coronary revascularization in patients with complex coronary artery disease.

PubMed

Sanchez, Carlos E; Dota, Anthony; Badhwar, Vinay; Kliner, Dustin; Smith, A J Conrad; Chu, Danny; Toma, Catalin; Wei, Lawrence; Marroquin, Oscar C; Schindler, John; Lee, Joon S; Mulukutla, Suresh R

2016-10-01

To evaluate how a comprehensive evidence-based clinical review by a multidisciplinary revascularization heart team on treatment decisions for revascularization in patients with complex coronary artery disease using SYNTAX scores combined with Society of Thoracic Surgeons-derived clinical variables can be additive to the utilization of Appropriate Use Criteria for coronary revascularization. Decision-making regarding the use of revascularization for coronary artery disease has come under major scrutiny due to inappropriate overuse of revascularization. There is little data in routine clinical practice evaluating how a structured, multidisciplinary heart team approach may be used in combination with the Appropriate Use Criteria for revascularization. From May 1, 2012 to January 1, 2015, multidisciplinary revascularization heart team meetings were convened to discuss evidence-based management of 301 patients with complex coronary artery disease. Heart team recommendations were adjudicated with the Appropriate Use Criteria for coronary revascularization for each clinical scenario using the Society for Cardiovascular Angiography and Interventions' Quality Improvement Toolkit (SCAI-QIT) Appropriate Use Criteria App. Concordance of the Heart Team to Appropriate Use Criteria had a 99.3% appropriate primary indication for coronary revascularization. Among patients who underwent percutaneous revascularization, 34.9% had an inappropriate or uncertain indication as recommended by the Heart Team. Patients with uncertain or inappropriate percutaneous coronary interventions had significantly higher SYNTAX score (27.3 ± 6.6; 28.5 ± 5.5; 19.2 ± 6; P < 0.0001) and Society of Thoracic Surgeons-Predicted Risk of Mortality (6.1% ± 4.7%; 8.1% ± 6.3%; 3.7% ± 4.1%; P < 0.0081) compared to appropriate indications, frequently had concomitant forms of advanced comorbidities and frailty in the setting of symptomatic coronary artery disease. A formal, multidisciplinary revascularization heart team can provide proper validation for clinical decisions and should be considered in combination with the Appropriate Use Criteria for coronary revascularization to formulate revascularization strategies for individuals in a patient-centered fashion. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Predictors of radio-cephalic arteriovenous fistulae patency in an Asian population.

PubMed

Joseph Lo, Zhiwen; Tay, Wee Ming; Lee, Qinyi; Chua, Jia Long; Tan, Glenn Wei Leong; Chandrasekar, Sadhana; Narayanan, Sriram

2016-09-21

To identify predictors of arteriovenous fistula (AVF) patency in Asian patients with autogenous radio-cephalic arteriovenous fistula (RCAVF). Retrospective review of 436 RCAVFs created between 2009 and 2013. Predictors of patency were identified with univariate and multivariate analysis. Kaplan-Meier survival analysis and log-rank test were used to calculate patency rates. Overall secondary patency rate was 72% at 12 months, 69% at 24 months, 58% at 36 months, 57% at 48 months, 56% at 60 months and 54% at 72 months. Univariate analysis showed that factors which predict for patency include male gender (p = 0.003), good diabetic control (p = 0.025), aspirin use (p = 0.031), pre-dialysis status (p = 0.037), radial artery diameter (p = 0.029) and non-calcified radial arteries (p = 0.002). Age (p = 0.866), cephalic vein diameter (p = 0.630) and surgeon grade (p = 0.472) did not predict for primary AVF failure. Multivariate analysis revealed the male gender to be an independent predictor for patency (odds ratio 1.99, p = 0.01). Subset analysis showed a significantly larger average radial artery diameter of 2.3 mm amongst males, as compared to 1.9 mm amongst females (p = 0.001) and no statistical difference in the average cephalic vein diameter. Within our Asian study population, 12-month patency rate of RCAVF is 72%, 69% at 24 months, 58% at 36 months, 57% at 48 months, 56% at 60 months and 54% at 72 months. Male gender is an independent predictor for RCAVF patency. In females or patients with calcified radial arteries, a more proximal AVF should be considered.

Influence of Diabetes on Long-Term Coronary Artery Bypass Graft Patency.

PubMed

Raza, Sajjad; Blackstone, Eugene H; Houghtaling, Penny L; Rajeswaran, Jeevanantham; Riaz, Haris; Bakaeen, Faisal G; Lincoff, A Michael; Sabik, Joseph F

2017-08-01

Nearly 50% of patients undergoing coronary artery bypass grafting have diabetes. However, little is known about the influence of diabetes on long-term patency of bypass grafts. Because patients with diabetes have more severe coronary artery stenosis, we hypothesized that graft patency is worse in patients with than without diabetes. This study sought to examine the influence of diabetes on long-term patency of bypass grafts. From 1972 to 2011, 57,961 patients underwent primary isolated coronary artery bypass grafting. Of these, 1,372 pharmacologically treated patients with diabetes and 10,147 patients without diabetes had 15,887 postoperative angiograms; stenosis was quantified for 7,903 internal thoracic artery (ITA) grafts and 20,066 saphenous vein grafts. Status of graft patency across time was analyzed by longitudinal nonlinear mixed-effects modeling. ITA graft patency was stable over time and similar in patients with and without diabetes: at 1, 5, 10, and 20 years, 97%, 97%, 96%, and 96% in patients with diabetes, and 96%, 96%, 95%, and 93% in patients without diabetes, respectively (early p = 0.20; late p = 0.30). In contrast, saphenous vein graft patency declined over time and similarly in patients with and without diabetes: at 1, 5, 10, and 20 years, 78%, 70%, 57%, and 42% in patients with diabetes, and 82%, 72%, 58%, and 41% in patients without diabetes, respectively (early p < 0.002; late p = 0.60). After adjusting for patient characteristics, diabetes was associated with higher early patency of ITA grafts (odds ratio: 0.63; 95% confidence limits: 0.43 to 0.91; p = 0.013), but late patency of ITA grafts was similar in patients with and without diabetes (p = 0.80). Early and late patency of saphenous vein grafts were similar in patients with and without diabetes (early p = 0.90; late p = 0.80). Contrary to our hypothesis, diabetes did not influence long-term patency of bypass grafts. Use of ITA grafts should be maximized in patients undergoing coronary artery bypass grafting because they have excellent patency in patients with and without diabetes even after 20 years. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Primary patency rate of native AV fistula: long term follow up

PubMed Central

GH, Kazemzadeh; MHS, Modaghegh; H, Ravari; M, Daliri; L, Hoseini; M, Nateghi

2012-01-01

The number of end stage of renal disease patients that need dialysis or renal transplantation increased in the world. Insertion and maintenance functional vascular access remain the challenging problem. Arteriovenous fistula is the common access for dialysis but complication and its failure is the main problem. The aim of this study is to evaluate patients with arteriovenous fistula during 4 years and describe the probable influenced factors on fistula patency. In this analytical descriptive study, we fallowed 245 patients during 4 years and evaluated them for primary failures and effective factors on vascular patency. The patients were asked about demographic data, how to caring condition arteriovenous fistula, dialysis and complications. The mean age of the patients was 47.77 years. The underline diseases were hypertension (43.3%), hypertension and diabetes mellitus (21.2%) and diabetes mellitus (4.5%). According Log rank test there were meaningful results between arteriovenous patency with sex and dialysis (P < 0.05). Our result of primary patency at 6 months, 1, 2, 3 and 4 years for all patients were 79.5%, 70%, 65%, 60.5% and 48%. Our study showed dialysis could increase the fistula patency rate. Other factors were not associated with primary patency. It seems ESRD patients undergoing dialysis have better fistula patency, may be due to homeostasis abnormalities induced by their particular conditions. PMID:22567178

Safety and Efficacy of Percutaneous Biliary Covered Stent Placement in Patients with Malignant Biliary Hilar Obstruction; Correlation with Liver Function.

PubMed

Hyun, Hyeran; Choi, Sun Young; Kim, Kyung Ah; Ko, Soo Bin

2016-09-01

To estimate the safety and efficacy of percutaneous ePTFE-covered biliary stent placement and the relationship between underlying liver function and stent patency in patients with malignant hilar obstruction. From March 2012 to June 2015, 41 patients [22 females, 19 males; mean age 69.8 (range 34-94) years] with malignant biliary obstruction underwent percutaneous biliary stent placement (31 patients with unilateral, 10 patients with bilateral side-by-side). Cumulative patient survival and stent patency rate curves were derived using the Kaplan-Meier method. A Cox model was used to explore the relationship between liver function and patient survival, and also biliary stent patency. Pearson correlation coefficient was used to analyze the relationship between patient survival and stent patency. Technical success rate was 100 % and clinical success rate was 95 %. During follow-up, four complications occurred (two bilomas and two cases of acute cholecystitis) and were treated successfully with percutaneous drainage. No other complication occurred. Mean serum bilirubin level was 11.34 ± 7.35 mg/dL before drainage and 5.00 ± 4.83 mg/dL 2 weeks after stent placement. The median patent survival duration was 147 days (95 % CI, 69.6-224.4 days). The median stent patency duration was 101 days (95 % CI, 70.0-132.0 days). The cumulative stent patency rates at 1, 3, 6, and 12 months were 97, 57.6, 30.3, and 17.0 %, respectively. Child-Pugh score was correlated significantly with patient survival (P = 0.011) and stent patency (P = 0.007). MELD score was correlated significantly with stent patency (P = 0.044). There was a correlation between patient survival and stent patency (r = 0.778, P < 0.001). Percutaneous placement of ePTFE-covered biliary stent was a safe and an effective method for malignant biliary obstruction. Underlying liver function seemed to be one of the important factors affecting patient survival and stent patency, and stent patency showed statistically significant correlation with patient survival.

A randomized two-by-two comparison of high-dose bolus tirofiban versus abciximab and unfractionated heparin versus bivalirudin during percutaneous coronary revascularization and stent placement: the tirofiban evaluation of novel dosing versus abciximab with clopidogrel and inhibition of thrombin (TENACITY) study trial.

PubMed

Moliterno, David J

2011-06-01

In the absence of high-dose thienopyridines, placebo-controlled trials have demonstrated a reduction in ischemic events with intravenous glycoprotein IIb/IIIa antagonists during percutaneous coronary intervention (PCI). One head-to-head trial comparing abciximab and tirofiban among PCI patients found tirofiban to be inferior, and laboratory evidence confirmed that the bolus dose of tirofiban tested in that trial to be less effective than abciximab. Whether a higher bolus dose of tirofiban would be as efficacious as abciximab during PCI is uncertain. Patients undergoing PCI were randomized equally to abciximab or to tirofiban, given as high-dose bolus (25 μg/kg) plus 12-hr infusion (0.15 μg/kg/min). All patients received aspirin and clopidogrel and were additionally randomized to unfractionated heparin or bivalirudin. Approximately 8,000 patients were to be studied, but after 383 were enrolled, the study sponsor discontinued the trial for financial reasons. The primary endpoint of 30-day death, myocardial infarction, or urgent target vessel revascularization occurred in 8.8% of patients randomized to abciximab and 6.9% of those randomized to tirofiban. The respective rates of major bleeding were 1.5 and 1.6%. Additionally, the primary endpoint occurred in 8.1% of patients randomized to unfractionated heparin and 7.6% of those randomized to bivalirudin. The respective rates of major bleeding were 2.5% and 0.5%. With limited assessment, this direct comparison of high-dose bolus tirofiban versus abciximab produced encouraging results and suggests that further study of this tirofiban dose regimen is warranted. The limited assessments comparing heparin and bivalirudin are consistent with prior observations. Copyright © 2010 Wiley-Liss, Inc.

Current Readings: Single Versus Bilateral Internal Mammary Artery in Coronary Artery Bypass Grafting.

PubMed

Ejiofor, Julius I; Kaneko, Tsuyoshi; Aranki, Sary F

2018-06-24

There is strong retrospective data demonstrating that BIMA grafting leads to better long-term survival as compared to LIMA grafting. However, this survival advantage was not corroborated by the interim results of the Arterial Revascularization Trial(ART). Today, there are barriers to widespread adoption of BIMA grafting. One of the main disadvantages of the use of BIMA grafts is the higher risk of DSWI. Deep sternal wound infections can be minimized by skeletonized harvesting of the IMA grafts, which preserves blood flow to the sternum. Also, utilizing the BIMA graft as a "Y" graft may lead to more complete revascularization compared to its in-situ use. BIMA grafting on average takes 25 minutes longer operating time with a higher in-hospital costs. We eagerly await the 10-year results of the ART trial to determine the truly unbiased randomized long-term effectiveness of BIMA grafting. Copyright © 2018 Elsevier Ltd. All rights reserved.

Organizational structure and communication strategies of the bypass angioplasty revascularization investigation: a multicenter clinical trial.

PubMed

Naydeck, B L; Sutton-Tyrrell, K; Burek, K; Sopko, G S

1996-06-01

Efficient communication is a challenge for the many operating components of a multicenter randomized clinical trial. Traditional management theory states that communications generally flow along a path established by a hierarchical organizational structure. A multicenter clinical trial does not fit traditional organizational models well and requires modification of traditional communication techniques. While the scientific community typically views a clinical trial as one large and cohesive enterprise, at each site the trial may actually be conducted as a small project related to the medical specialty of the investigator. Therefore overall trial management must be accomplished through collaboration rather than through direct management. In the Bypass Angioplasty Revascularization Investigation (BARI), the BARI clinical coordinating center has designed and utilized several mechanisms that facilitate effective communication and administrative control of a multicenter clinical trial. These mechanisms provide a framework of communication techniques that accommodate the specific needs of a complex organization.

Chronic Mesenteric Ischemia: A Rare Cause of Chronic Abdominal Pain.

PubMed

Barret, Maximilien; Martineau, Chloé; Rahmi, Gabriel; Pellerin, Olivier; Sapoval, Marc; Alsac, Jean-Marc; Fabiani, Jean-Noël; Malamut, Georgia; Samaha, Elia; Cellier, Christophe

2015-12-01

Chronic mesenteric ischemia is a rare disease with nonspecific clinical symptoms, such as chronic postprandial abdominal pain and weight loss. Diagnostic modalities and revascularization techniques have evolved during the past 20 years. The significance of stenosis in a single splanchnic vessel remains unclear. Our aims were to assess the outcomes of 2 revascularization techniques and report on the diagnostic modalities of splanchnic vessel stenoses. The demographic data, medical history, technical characteristics, and outcomes of the revascularization procedures were recorded for all of the patients admitted for endovascular revascularization or open surgical revascularization of the splanchnic vessels as treatment for chronic mesenteric ischemia in our tertiary referral center since 2000. Fifty-four patients were included in this study: 43 received endovascular revascularization, and 11 had open surgical revascularization. The symptoms were abdominal pain, weight loss, and diarrhea in 98%, 53%, and 25% of the cases, respectively. Computed tomography angiography was the key diagnostic tool for 60% of the patients. A single-vessel stenosis was found in one-third of the patients. Endovascular and open revascularization had similar early and late outcomes, and no 30-day mortality was observed. However, we did observe higher morbidity in the open revascularization group (73% vs 19%, P <.03). Chronic mesenteric ischemia may be diagnosed in the presence of a splanchnic syndrome and stenosis of a single splanchnic vessel, typically assessed using computed tomography angiography. In selected patients, endovascular revascularization had similar efficacy as, and lower complication rates than open revascularization. Copyright © 2015 Elsevier Inc. All rights reserved.

The Effect of Previous Coronary Artery Revascularization on the Adverse Cardiac Events Ninety days After Total Joint Arthroplasty.

PubMed

Feng, Bin; Lin, Jin; Jin, Jin; Qian, Wenwei; Cao, Shiliang; Weng, Xisheng

2018-01-01

Although coronary artery revascularization therapies are effective for treating coronary artery disease (CAD), these patients may be more susceptible to adverse cardiac events during later non-cardiac surgeries. The purpose of this study is to evaluate post-operative 90-day complications of total joint arthroplasty (TJA) in CAD patients with a history of CAD and to study the risk factors for cardiac complications. We performed a retrospective analysis of TJA patients between 2005 and 2015 at our institute by summarizing the history of CAD, cardiac revascularization, and cardiac complications within 90 days after the operation. Multivariate logistic regression was performed to identify the factors that predicted cardiac complications within 90 days after the operation. A total of 4414 patients were included; of these, 64 underwent cardiac revascularization and 201 CAD patients underwent medical therapy other than revascularization. All the revascularization had history of myocardial infarction (MI). The rate of cardiac complications within 90 days for the CAD with revascularization was 18.7%, 18.4% for the CAD without revascularization, and 2.0% for the non-CAD group. A history of CAD and revascularization, bilateral TJA, general anesthesia, body mass index ≥30 kg/m 2 , and history of MI were associated with a higher risk of cardiac complications. Patients who underwent TJA within 2 years after cardiac revascularization had a significantly higher cardiac complication rate, and the risk decreased with time. There is an increased risk of cardiac complications within 90 days after the operation among TJA patients with a history of CAD. Revascularization cannot significantly reduce the risk of cardiac complications after TJA for CAD patients. However, the risk decreased as the interval between revascularization and TJA increased. Copyright © 2017 Elsevier Inc. All rights reserved.

Optimal percutaneous coronary intervention in patients with ST-elevation myocardial infarction and multivessel disease: An updated, large-scale systematic review and meta-analysis.

PubMed

Nguyen, An Vu; Thanh, Le Van; Kamel, Mohamed Gomaa; Abdelrahman, Sara Attia Mahmoud; El-Mekawy, Mohamed; Mokhtar, Mohamed Ashraf; Ali, Aya Ashraf; Hoang, Nam Nguyen Nho; Vuong, Nguyen Lam; Abd-Elhay, Fatma Abd-Elshahed; Omer, Omer Abdelbagi; Mohamed, Ahmed Abdou; Hirayama, Kenji; Huy, Nguyen Tien

2017-10-01

Our study aimed to compare three different percutaneous coronary intervention (PCI) approaches: culprit-only (COR) and complete (CR) revascularization - categorizing into immediate (ICR) or staged (SCR). We searched 13 databases for randomized controlled trials. Articles were included if they compared at least two strategies. To have more studies in each analysis, an adjusted analysis was performed using person-years to incorporate follow-up durations and obtain pooled rate ratios (RR), with their corresponding 95% confidence interval. Thirteen trials were included with a population of 2830 patients. COR significantly increased major adverse cardiac event (MACE) (adjusted RR 1.67, 95% CI: 1.27-2.19) and repeat revascularization (2.12, 1.67-2.69), which was driven by repeat PCI, without any difference in all-cause mortality and myocardial infarction (MI) compared to CR. When categorizing CR into SCR and ICR, the trend repeated with COR increased MACE (1.99, 1.53-2.6 for ICR), cardiovascular mortality (2.06, 1.07-3.96 for ICR), MI for ICR (1.72, 1.04-2.86), repeat revascularization and repeat PCI for both ICR and SCR. Non-cardiovascular mortality, stroke, nephropathy, re-hospitalization, stent thrombosis and bleeding were similar among all approaches. In MVD-STEMI patients, CR is better than COR in terms of MACE, cardiovascular mortality, repeat revascularization with no difference in safety outcomes. There was a trend towards to a reduction of cardiovascular mortality and MI in ICR compared to SCR when each matched with COR; even though there is no statistically significant difference between ICR and SCR when compared together. Copyright © 2017 Elsevier B.V. All rights reserved.

Gender-Specific Differences in All-Cause Mortality Between Incomplete and Complete Revascularization in Patients With ST-Elevation Myocardial Infarction and Multi-Vessel Coronary Artery Disease.

PubMed

Dimitriu-Leen, Aukelien C; Hermans, Maaike P J; van Rosendael, Alexander R; van Zwet, Erik W; van der Hoeven, Bas L; Bax, Jeroen J; Scholte, Arthur J H A

2018-03-01

The best revascularization strategy (complete vs incomplete revascularization) in patients with ST-elevation myocardial infarction (STEMI) is still debated. The interaction between gender and revascularization strategy in patients with STEMI on all-cause mortality is uncertain. The aim of the present study was to evaluate gender-specific difference in all-cause mortality between incomplete and complete revascularization in patients with STEMI and multi-vessel coronary artery disease. The study population consisted of 375 men and 115 women with a first STEMI and multi-vessel coronary artery disease without cardiogenic shock at admission or left main stenosis. The 30-day and 5-year all-cause mortality was examined in patients categorized according to gender and revascularization strategy (incomplete and complete revascularization). Within the first 30 days, men and women with incomplete revascularization were associated with higher mortality rates compared with men with complete revascularization. However, the gender-strategy interaction variable was not independently associated with 30-day mortality after STEMI when corrected for baseline characteristics and angiographic features. Within the survivors of the first 30 days, men with incomplete revascularization (compared with men with complete revascularization) were independently associated with all-cause mortality during 5 years of follow-up (hazard ratios 3.07, 95% confidence interval 1.24;7.61, p = 0.016). In contrast, women with incomplete revascularization were not independently associated with 5-year all-cause mortality (hazard ratios 0.60, 95% confidence interval 0.14;2.51, p = 0.48). In conclusion, no gender-strategy differences occurred in all-cause mortality within 30 days after STEMI. However, in the survivors of the first 30 days, incomplete revascularization in men was independently associated with all-cause mortality during 5-year follow-up, but this was not the case in women. Copyright © 2017 Elsevier Inc. All rights reserved.

1.9-μm diode-laser-assisted anastomoses (LAMA) in reconstructive microsurgery: results of the preliminary clinical study

NASA Astrophysics Data System (ADS)

Mordon, Serge R.; Schoofs, Michel; Martinot, Veronique L.; Capon, Alexandre; Buys, Bruno; Patenotre, Philippe; Pellerin, P. N.

2001-05-01

The authors report an original 1.9-micrometers diode laser assisted microvascular anastomosis (LAMA) in human. This technique has been applied in 20 patients during reconstructive surgery for digital replantations (nequals6), for digital revascularizations (nequals4) and for free flap transfers (nequals10). LAMA were always performed on vessel (16 arteries and 6 veins) which did not impede the chance of success of the surgical procedure in case of thrombosis. LAMA was performed with a 1.9-micrometers diode laser after placement of 2 equidistant stitches at 180 degrees. The diode spot was obtained by means of a 300-micrometers optic fiber transmitted to the vessel wall via a pencil size hand piece. The following parameters were used: spot size equals 500 micrometers , power equals 70 to 220 mW, pulse duration equals 0.7 to 3 seconds. Ten to 15 spots were applied on each face. The mechanism involved is a thermal effect on the collagen of the adventitia and media leading to a phenomenon which the authors have termed 'heliofusion'. Immediate assessment consisted in evaluating the permeability by patency test (O'Brien) and water tightness. Secondary assessment consisted in evaluating the clinical success, confirmed by Doppler at one month.

[Application of Silicone Rubber Stents in Intracranial Arterial Microanastomosis for Vessels with Intimal Dissection:A Technical Note].

PubMed

Funatsu, Takayuki; Kawashima, Akitsugu; Mochizuki, Yuichi; Kikuta, Yoshichika; Imanaka, Kousuke; Okada, Yoshikazu

2015-10-01

Intracranial arterial microanastomosis remains an important neurosurgical technique. Intimal dissection of donor or recipient arteries can cause bypass failure. We used a silicone rubber stent while performing arterial microanastomoses, and achieved an excellent postoperative patency rate. In this study, we evaluated the efficacy of the stent in cases of extensive intimal dissection. In 5 cases involving extensive intimal dissection of vessels out of a total of 856 microanastomoses that were performed between November 2000 and August 2014, we placed a silicone rubber stent in the lumen of the recipient artery for donor to recipient suturing. Surgery was performed in 3 cases of cerebrovascular atherosclerotic disease and in 2 cases requiring cerebral revascularization for the treatment of aneurysm recurrence. In one of the 5 cases in which arterial microanastomosis was performed in the spasm period after subarachnoid hemorrhage, a patent anastomosis could not be confirmed. We observed the following advantages of silicone stent use: clear visualization of the orifice created in the vessel, avoidance of suturing or damaging the contralateral side vessel edges, and maintenance of the shape of the anastomosed vessel segment. These advantages made it easier to visualize the intima and to achieve fixation by using tacking sutures.

Pharmacological treatment and perceived health status during 1-year follow up in patients diagnosed with coronary artery disease, but ineligible for revascularization. Results from the Euro Heart Survey on Coronary Revascularization.

PubMed

Lenzen, Mattie; Scholte op Reimer, Wilma; Norekvål, Tone M; De Geest, Sabina; Fridlund, Bengt; Heikkilä, Johanna; Jaarsma, Tiny; Mårtensson, Jan; Moons, Philip; Smith, Karen; Stewart, Simon; Strömberg, Anna; Thompson, David R; Wijns, William

2006-06-01

It has been recognized that a clinically significant portion of patients with coronary artery disease (CAD) continue to experience anginal and other related symptoms that are refractory to the combination of medical therapy and revascularization. The Euro Heart Survey on Revascularization (EHSCR) provided an opportunity to assess pharmacological treatment and outcome in patients with proven CAD who were ineligible for revascularization. We performed a secondary analysis of EHS-CR data. After excluding patients with ST-elevation myocardial infarction and those in whom revascularization was not indicated, 4409 patients remained in the analyses. We selected two groups: (1) patients in whom revascularization was the preferred treatment option (n = 3777, 86%), and (2) patients who were considered ineligible for revascularization (n = 632, 14%). Patient ineligible for revascularization had a worse risk profile, more often had a total occlusion (59% vs. 37%, p < 0.001), were treated more often with ACE-inhibitors (65% vs. 55%, p < 0.001) but less likely with aspirin (83% vs. 88%, p < 0.001). Overall, they had higher case-fatality at 1-year (7.0% vs. 3.7%, p < 0.001). Regarding self-perceived health status, measured via the EuroQol 5D (EQ-5D) questionnaire, these same patients reported more problems on all dimensions of the EQ-5D. Furthermore, in the revascularization group we observed an increase between discharge and 1-year follow up (utility score from 0.85 to 1.00) whereas patients ineligible for revascularization did not improve over time (utility score remained 0.80) In this large cohort of European patients with CAD, those considered ineligible for revascularization had more co-morbidities and risk factors, and scored worse on self-perceived health status as compared to revascularized patients in the revascularization group. With the exception of ACE-inhibitors and aspirin, there were no major differences regarding drug treatment between the two groups. Given these clinically significant observations, there appears to be a role for nurse-led, multidisciplinary, rehabilitation teams that target clinically vulnerable patients whose symptoms remain refractory to standard medical care.

The PARAGON stent study: a randomized trial of a new martensitic nitinol stent versus the Palmaz-Schatz stent for treatment of complex native coronary arterial lesions.

PubMed

Holmes, D R; Lansky, A; Kuntz, R; Bell, M R; Buchbinder, M; Fortuna, R; O'Shaughnessy, C D; Popma, J

2000-11-15

A new martensitic nitinol stent with improved flexibility and radiopacity was tested to evaluate whether these differences improve initial or long-term outcome. Patients who underwent percutaneous revascularization of a discrete native coronary lesion were randomly assigned to the new stent (PARAGON, n = 349) or to the first-generation Palmaz-Schatz (PS) stent (n = 339). The primary end point was target vessel failure at 6 months (a composite of cardiac or noncardiac death, any infarction in the distribution of the treated vessel, or clinically indicated target vessel revascularization). Secondary end points were, among others, device and procedural success and angiographic restenosis. Mean age was 62 years; diabetes was present in 21% of patients, prior bypass surgery in 6%, and recent infarction in 22% (p = NS for comparison between the 2 randomized arms). The PARAGON stent group had smaller reference vessels (2.97 vs 3.05 mm, p = 0.05), more prior restenosis (8.0% vs 4.5%, p = 0.07), and a longer average stent length (21.3 vs 19.4 mm, p < 0.05). Device success was significantly higher in the PARAGON arm (99.1% vs 94.3%, p < 0.05). Death and infarction at 6-month follow-up were infrequent in both groups. There was no significant difference in death (2.0% vs 1.2%, p = 0.546), but a higher rate of infarction for the PARAGON cohort (9.2% vs 4.7%, p = 0.025). Although target vessel failure (20.3% vs 12.4%, p = 0.005) and target lesion revascularization (12.0% vs 5.9%, p = 0.005) were higher in the PARAGON group, there was no significant difference in 6-month follow-up in in-stent minimal lumen diameter or in the rate of binary angiographic restenosis. Both PARAGON and PS stents are safe and associated with infrequent adverse events. The PARAGON stent can be delivered more frequently than the first-generation PS stent. Although there was no significant difference in in-stent minimal lumen diameter or the frequency of angiographic restenosis, clinical restenosis was more frequent in the PARAGON group.

Pain Intensity During Ultrasound Assessment of Uterine Cavity and Tubal Patency With and Without Painkillers: Prospective Observational Study.

PubMed

Ludwin, Inga; Martins, Wellington P; Nastri, Carolina O; Ludwin, Artur

To determine the pain intensity and incidence of mild to severe pain during the ultrasound assessment of the uterine cavity and tubal patency using saline, air and saline, and foam as contrasts with and without painkiller. Prospective observational study (Canadian Task Force classification II-1). Private clinic. Three hundred infertile women who were consecutively submitted to uterine cavity and tubal patency assessment by ultrasound using saline, air, and foam in single exam between October 2012 and November 2013. No painkillers were used until March 2013 when we started offering an effervescent codeine tablet containing paracetamol 500 mg and codeine phosphate 30 mg approximately 1 hour before the procedure. Pain intensity measured with an 11-point (0-10) numerical rating scale and incidence of moderate/severe levels of pain (numerical rating scale > 3) during the main components of the procedure (speculum insertion, catheter insertion, saline infusion, air and saline infusion, foam infusion, and after the procedure [0 minutes, 15 minutes, 30 minutes, and 24 hours]) were assessed. The incidence of moderatesevere pain was significantly lower in women using painkillers considering any moment of the procedure: 49 of 175 (28%) versus 65 of 125 (52%); relative risk, .54; 95% confidence interval, .40-.72; p < .001; number needed to treat, 4. Less women presented with moderate/severe pain during air and saline compared with foam infusion: 31 of 300 (10%) versus 75 of 300 (25%); p < .001; relative risk, .41, 95% confidence interval, .28-.61. The incidence of moderate/severe pain during the ultrasound assessment of the uterine cavity and tubal patency is common. Our results suggest that using paracetamol + codeine before the procedure reduces the pain level, but randomized controlled trials are required. Copyright © 2017 AAGL. Published by Elsevier Inc. All rights reserved.

Graft patency is associated with higher health-related quality of life after coronary artery bypass surgery.

PubMed

Samano, Ninos; Bodin, Lennart; Karlsson, Jan; Geijer, Håkan; Arbeus, Mikael; Souza, Domingos

2017-03-01

The objective of this study was to investigate whether graft patency was associated with higher health-related quality of life in coronary artery bypass grafting patients and to compare this study with the general Swedish population. Patients were included from 3 randomized trials and 1 prospective cohort trial. The generic health-related quality of life instrument, EQ-5D (VAS and index) was used. Graft patency was assessed with computed tomography angiography. Patients were divided into 2 groups according to the number of occluded distal anastomosis: Group I with no to 1 occlusion ( n  = 209) and Group II with 2 to 4 occlusions ( n  = 24). Two hundred and thirty-three patients underwent computed tomography angiography at a mean of 7.5 (1-18) years post-operatively. The mean difference in EQ-VAS and EQ-5D index between Groups II and I after model adjustment was -19.8 (95% CI -25.3 to -14.3; P  < 0.001) and -0.13 (95% CI -0.19 to -0.08; P  < 0.001), respectively. The EQ-5D index for the study population was similar compared with the Swedish population, 0.851 and 0.832, respectively, with an effect-size of 0.112 (trivial). The EQ-5D index of the study population was higher compared with the ischemic heart disease group in the Swedish population, 0.851 vs 0.60, with an effect-size of 0.999 (large). Graft patency was associated with higher health-related quality of life in coronary artery bypass patients. This patient group reported similar function and wellbeing compared to the general Swedish population and better health status than those in the same disease group in the general population. Clinicaltrials.gov: NCT02547194 and the Research and Development registry in Sweden: 167861. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Patency© and agile© capsules

PubMed Central

Caunedo-Álvarez, Ángel; Romero-Vazquez, Javier; Herrerias-Gutierrez, Juan M

2008-01-01

Small bowel strictures can be missed by current diagnostic methods. The Patency capsule is a new non-endoscopic dissolvable capsule which has as an objective of checking the patency of digestive tract, in a non-invasive manner. The available clinical trials have demonstrated that the Patency© capsule is a good tool for assessment of the functional patency of the small bowel, and it allows identification of those patients who can safely undergo a capsule endoscopy, despite clinical and radiographic evidence of small-bowel obstruction. Some cases of intestinal occlusion have been reported with the Patency© capsule, four of them needed surgery. So, a new capsule with two timer plugs (Agile© capsule) has been recently developed in order to minimize the risk of occlusion. This new device stars its dissolution process earlier (30 h after ingestion) and its two timer plugs have been designed to begin the disintegration even when the device is blocked in a tight stricture. PMID:18785278

Correlation between Patient-Reported Symptoms and Ankle-Brachial Index after Revascularization for Peripheral Arterial Disease.

PubMed

Je, Hyung Gon; Kim, Bo Hyun; Cho, Kyoung Im; Jang, Jae Sik; Park, Yong Hyun; Spertus, John

2015-05-18

Improvement in quality of life (QoL) is a primary treatment goal for patients with peripheral arterial disease (PAD). The current study aimed to quantify improvement in the health status of PAD patients following peripheral revascularization using the peripheral artery questionnaire (PAQ) and ankle-brachial index (ABI), and to evaluate possible correlation between the two methods. The PAQ and ABI were assessed in 149 symptomatic PAD patients before, and three months after peripheral revascularization. Mean PAQ summary scores improved significantly three months after revascularization (+49.3 ± 15 points, p < 0.001). PAQ scores relating to patient symptoms showed the largest improvement following revascularization. The smallest increases were seen in reported treatment satisfaction (all p's < 0.001). As expected the ABI of treated limbs showed significant improvement post-revascularization (p < 0.001). ABI after revascularization correlated with patient-reported changes in the physical function and QoL domains of the PAQ. Twenty-two percent of PAD patients were identified as having a poor response to revascularization (increase in ABI < 0.15). Interestingly, poor responders reported improvement in symptoms on the PAQ, although this was less marked than in patients with an increase in ABI > 0.15 following revascularization. In conclusion, data from the current study suggest a significant correlation between improvement in patient-reported outcomes assessed by PAQ and ABI in symptomatic PAD patients undergoing peripheral revascularization.

Correlation between Patient-Reported Symptoms and Ankle-Brachial Index after Revascularization for Peripheral Arterial Disease

PubMed Central

Je, Hyung Gon; Kim, Bo Hyun; Cho, Kyoung Im; Jang, Jae Sik; Park, Yong Hyun; Spertus, John

2015-01-01

Improvement in quality of life (QoL) is a primary treatment goal for patients with peripheral arterial disease (PAD). The current study aimed to quantify improvement in the health status of PAD patients following peripheral revascularization using the peripheral artery questionnaire (PAQ) and ankle-brachial index (ABI), and to evaluate possible correlation between the two methods. The PAQ and ABI were assessed in 149 symptomatic PAD patients before, and three months after peripheral revascularization. Mean PAQ summary scores improved significantly three months after revascularization (+49.3 ± 15 points, p < 0.001). PAQ scores relating to patient symptoms showed the largest improvement following revascularization. The smallest increases were seen in reported treatment satisfaction (all p’s < 0.001). As expected the ABI of treated limbs showed significant improvement post-revascularization (p < 0.001). ABI after revascularization correlated with patient-reported changes in the physical function and QoL domains of the PAQ. Twenty-two percent of PAD patients were identified as having a poor response to revascularization (increase in ABI < 0.15). Interestingly, poor responders reported improvement in symptoms on the PAQ, although this was less marked than in patients with an increase in ABI > 0.15 following revascularization. In conclusion, data from the current study suggest a significant correlation between improvement in patient-reported outcomes assessed by PAQ and ABI in symptomatic PAD patients undergoing peripheral revascularization. PMID:25993299

Nitinol versus steel partially covered self-expandable metal stent for malignant distal biliary obstruction: a randomized trial.

PubMed

Soderlund, Claes; Linder, Stefan; Bergenzaun, Per E; Grape, Tomas; Hakansson, Hans-Olof; Kilander, Anders; Lindell, Gert; Ljungman, Martin; Ohlin, Bo; Nielsen, Jorgen; Rudberg, Claes; Stotzer, Per-Ove; Svartholm, Erik; Toth, Ervin; Frozanpor, Farshad

2014-11-01

Covered nitinol alloy self-expandable metal stents (SEMSs) have been developed to overcome the shortcomings of steel SEMS in patients with malignant biliary obstruction. In a randomized, multicenter trial, we compared stent patency, patient survival, and adverse events in patients with partly covered stents made from steel or nitinol. A total of 400 patients with unresectable distal malignant biliary obstruction were randomized at endoscopic retrograde cholangiopancreatography (ERCP) to insertion of a steel or nitinol partially covered SEMS, with 200 patients in each group. The primary outcome was confirmed stent failure during 300 days of follow-up.  At 300 days, the proportion of patients with patent stents was 77 % in the steel group, compared with 89 % in the nitinol group (P = 0.01). Confirmed stent failure occurred more often in the steel SEMS group compared with the nitinol SEMS group, in 30 versus 14 patients (P = 0.02). Stent migration occurred in 13 patients in the steel group and in 3 patients in the nitinol group (P = 0.01). Median patient survival (secondary outcome) was 137 days and 120 days in the steel SEMS and nitinol SEMS groups, respectively (P = 0.59). The nitinol SEMS showed longer patency time, and the nitinol group had fewer patients with stent failure, compared with the steel SEMS group. We could not detect any differences between the two groups regarding survival time, and regarding adverse event rate.Clinical trial registration : NCT 00980889. © Georg Thieme Verlag KG Stuttgart · New York.

Durability of renal artery stents in patients with transrenal abdominal aortic endografts.

PubMed

Baril, Donald T; Lookstein, Robert A; Jacobs, Tikva S; Won, Jamie; Marin, Michael L

2007-05-01

The management of renal artery stenosis in patients with abdominal aortic aneurysms continues to be complex and technically challenging despite advances in endovascular therapy. There is growing concern about the durability of renal artery stents in the setting of transrenal abdominal aortic endografts. This study reports a single-center experience of renal artery stenting with transrenal abdominal aortic endografts for patients with renal artery stenosis. All patients undergoing endovascular abdominal aortic aneurysm repair preceded or followed by renal artery stent placement between January 1999 and December 2005 were retrospectively reviewed from a prospectively gathered endovascular database. Patients were surveyed after renal stent procedures with multidetector computed tomography angiography or duplex sonography. The surveillance data were analyzed for primary patency of the renal artery stent at 6 months, incidence of complications, need for secondary interventions, and changes in creatinine clearance (CrCl). Sixty-two renal artery stents were placed in 56 patients (44 men, 12 women) with a mean age of 77.3 years (range, 61 to 94 years). Forty-one were placed before the endograft procedure, eight were placed during the endograft procedure, and 13 were placed postoperatively. There were no major or minor complications related to the renal artery stent procedures. Transrenal aortic endografts were used in 44 of the 56 patients, and 12 had devices with infrarenal fixation. The mean follow-up was 18.5 months (range, 1 to 73 months). The 6-month primary patency, which could be evaluated for 51 renal artery stents, was 97.4% (37/38) in patients with transrenal fixation and 84.6% (11/13) in patients with infrarenal fixation. The overall rate of in-stent restenosis was 8.5% (4/47) in the transrenal fixation group and 20.0% (3/15) in the infrarenal fixation group. The overall occlusion rate was 2.1% (1/47) in the transrenal fixation group and 0% (0/15) in infrarenal fixation group. Five (83.3%) of six patients underwent successful treatment of in-stent restenosis with placement of a new stent in all five cases. CrCl decreased in the total group by 4.2 +/- 11.8 mL/min, by 4.7 +/- 12.0 mL/min in patients with transrenal fixation, and by 2.2 +/- 11.0 mL/min in patients with infrarenal fixation. The presence of a transrenal aortic endograft did not affect the outcome of the renal artery revascularization procedure in this cohort. Renal artery stenting in the presence of transrenal abdominal aortic endografts appears to be a safe procedure without adverse effect on renal artery stent patency or renal function.

Prospective, multicenter study of endovascular repair of aortoiliac and iliac aneurysms using the Gore Iliac Branch Endoprosthesis.

PubMed

Schneider, Darren B; Matsumura, Jon S; Lee, Jason T; Peterson, Brian G; Chaer, Rabih A; Oderich, Gustavo S

2017-09-01

The GORE EXCLUDER Iliac Branch Endoprosthesis (IBE; W. L. Gore and Associates, Flagstaff, Ariz) is an iliac branch stent graft system designed to preserve internal iliac artery perfusion during endovascular repair of aortoiliac aneurysms (AIAs) and common iliac artery (CIA) aneurysms (CIAAs). We report the 6-month primary end point results of the IBE 12-04 United States pivotal trial for endovascular treatment of AIAs and CIAAs using the IBE device. The trial prospectively enrolled 63 patients with AIA or CIAA who underwent implantation of the IBE device at 28 centers in the United States from 2013 to 2015. All patients underwent placement of a single IBE device. Twenty-two patients (34.9%) with bilateral CIAs were enrolled after undergoing staged coil or plug embolization (21 of 22) or surgical revascularization (1 of 22) of the contralateral internal iliac artery. Follow-up at 30 days and 6 months included clinical assessment and computed tomography angiography evaluation as assessed by an independent core laboratory. The primary effectiveness end point was freedom from IBE limb occlusion and reintervention for type I or III endoleak and ≥60% stenosis at 6 months, and the secondary effectiveness end point was freedom from new onset of buttock claudication on the IBE side at 6 months. Mean CIA diameter on the IBE side was 41.0 ± 11.4 mm (range, 25.2-76.3 mm). There were no procedural deaths, and technical success, defined as successful deployment and patency of all IBE components and freedom from type I or III endoleak, was 95.2% (60 of 63). Data for 61 patients were available for primary and secondary effectiveness end point analysis. Internal iliac limb patency was 95.1% (58 of 61), and no new type I or III endoleaks or device migrations were observed at 6 months. The three patients with loss of internal iliac limb patency were asymptomatic, and freedom from new-onset buttock claudication on the IBE side was 100% at 6 months. New-onset buttock claudication occurred on the non-IBE treatment side in six of 21 patients (28.6%) who underwent staged internal iliac artery coil embolization. These results confirm that the IBE device is effective at treating CIAAs and AIAs, maintaining blood flow into the internal iliac artery, and avoiding complications associated with internal iliac artery sacrifice. Follow-up will be continued for 5 years to establish the long-term durability of iliac aneurysm repair with the IBE device. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Meta-analysis of posterior versus medial approach for popliteal artery aneurysm repair.

PubMed

Phair, Alison; Hajibandeh, Shahin; Hajibandeh, Shahab; Kelleher, Damian; Ibrahim, Riza; Antoniou, George A

2016-10-01

Popliteal artery aneurysm is an uncommon vascular disease but one that can cause significant morbidity, the most severe being limb loss reported in 20% to 59% of cases. Two approaches to repair are described in the literature, the posterior and the medial; however, the "gold standard" method of repair remains controversial. A systematic review of electronic information sources was undertaken to identify papers comparing outcomes of posterior repair vs medial repair. The methodologic quality of the papers was assessed using the Newcastle-Ottawa Scale. Fixed-effect or random-effects models were applied to synthesize data. The search yielded seven articles eligible for inclusion. The total population comprised 1427 patients; 338 had posterior repair and 1089 had medial repair. There was no difference in the two groups in terms of postoperative nerve damage (odds ratio [OR], 1.01; 95% confidence interval [CI], 0.24-4.2) and 30-day postoperative complications (OR, 0.87; 95% CI, 0.43-1.77). Limb loss at 30 days occurred more frequently in the medial approach group, but the difference was not statistically significant (risk difference [RD], 0.02; 95% CI, -0.04 to 0.00). Thirty-day primary patency was not statistically different between groups (RD, -0.01; 95% CI, -0.04 to 0.02), but the 30-day secondary patency suggested superiority of the posterior approach (RD, 0.05; 95% CI, 0.02-0.07). Long-term primary and secondary patency both favored the posterior approach (OR, 1.61 [95% CI, 1.06-2.43] and OR, 1.73 [95% CI, 0.91-3.30], respectively). Aneurysm exclusion was also superior with the posterior approach (OR, 4.20; 95% CI, 1.40-12.60). The rate of reoperation favored the posterior approach (OR, 0.26; 95% CI, 0.09-0.72). Long-term risk of limb loss favored posterior repair, but no statistically significant difference was found (OR, 0.32; 95% CI, 0.43-1.77). High-level comparative data comparing posterior and medial repair for popliteal artery aneurysms are not available. Within the parameters of this review, however, superiority of the posterior approach for primary and secondary patency, aneurysm exclusion, and need for reoperation was noted. High-level evidence from randomized clinical trials is required to define the relative benefits of the posterior approach over the medial approach in selected patients. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

[Small-caliber polyurethane arterial prosthesis: clinical and angiomorphological follow-up of 20 patients in a prospective study].

PubMed

Gloor, B; Wehrli, E; Rotzer, A; Brunner, D; Wilms, C; Largiadèr, J

1996-01-01

The five year patency rate for femoropopliteal vein bypass grafts is around 70% according to the literature. Patency rates for synthetic grafts (eg PTFE, Dacron) range between 43 and 57%. If a vein is not available there is a new polyurethane 6 mm artery substitute on the market, that has shown in vitro promising physical characteristics and good long term results after implantation in dogs. In a prospective, randomized trial the results of the new polyurethane graft (PUR) were compared with those of a Dacron graft of the same diameter. Included in the study were 20 patients with lower limb ischemia stage Fontaine II B, III and IV, 10 in each group. Patency rates, handling of the graft and complications were analysed. During the one year follow up 7 PUR grafts had to be changed due to recurrent bypass occlusion within the first 3 months. At the end of the year there were only one PUR-bypass but 8 Dacron grafts open. 5 PUR grafts were examined histologically and no morphological reason for the occlusion, especially no myointimal hyperplasia, was found. A special regard was brought to the arterial run-off in both groups. It was confirmed to be comparable with only slightly better data for the PUR group. The exact reasons for the astonishing bad results of the PUR graft for femoropopliteal above knee bypass cannot be explained in our study. Due to the unexpected high occlusion rate the study was stopped earlier then planned.

Rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: Two-year clinical outcome of the randomized ROTAXUS trial.

PubMed

de Waha, Suzanne; Allali, Abdelhakim; Büttner, Heinz-Joachim; Toelg, Ralph; Geist, Volker; Neumann, Franz-Josef; Khattab, Ahmed A; Richardt, Gert; Abdel-Wahab, Mohamed

2016-03-01

In the randomized ROTAXUS trial, routine lesion preparation of complex calcified coronary lesions using rotational atherectomy (RA) prior to paclitaxel-eluting stent implantation did not reduce the primary endpoint of angiographic late lumen loss at 9 months compared to stenting without RA. So far, no long-term data of prospective head-to-head comparisons between both treatment strategies have been reported. ROTAXUS randomly assigned patients with complex calcified coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events (MACE) at 2-year follow-up defined as the composite of death, myocardial infarction, and target vessel revascularization (TVR). At 2 years, MACE occurred in 32 patients in the RA group and 37 patients in the standard therapy group (29.4% vs. 34.3%, P = 0.47). The rates of death (8.3% vs. 7.4%, P = 1.00), myocardial infarction (8.3% vs. 6.5%, P = 0.80), target lesion revascularization (TLR, 13.8% vs. 16.7%, P = 0.58), and TVR (19.3% vs. 22.2%, P = 0.62) were similar in both groups. Despite high rates of initial angiographic success, nearly one third of patients enrolled in ROTAXUS experienced MACE within 2-year follow-up, with no differences between patients treated with or without RA. © 2015 Wiley Periodicals, Inc.

Agreement between hysterosalpingography and laparoscopic chromopertubation in assessment of tubal patency.

PubMed

Matorras, R; Rodriguez, F; Pêrez, C; Pijoan, J I; Echanojauregui, A; Rodriguez-Escudero, F J

1998-01-01

To assess the agreement between tubal patency assessed by laparoscopy with chromopertubation and by hysterosalpingography using contrast media. University Medical School. 314 consecutive women subjected to laparoscopy and hysterosalpingography for an infertility study. Prospective study. Chromopertubation using Methylen blue dye, performed on days 20-24. Hysterosalpingography performed on days 7-10 with water soluble contrast. Kappa coefficient calculation. Kappa coefficient ranged from 0.40 to 0.36, depending on the categories analyzed, corresponding to a fair agreement. The diagnosis of tubal factor requires that both tubal patency tests (Hysterosalpingography and laparoscopy) show an abnormal patency. When one of the aforementioned tests is normal, performing the second one has little clinical advantage. However, it is suggested that when there is a discordant patency the pregnancy rates could be somewhat reduced.

Inflation-deflation test as a predictor of aditus patency in patients with chronic suppurative otitis media.

PubMed

Kurien, Regi; Chrisolyte, Shipra; Rupa, V

2009-09-01

To assess eustachian tubal function (ETF) preoperatively in patients with chronic suppurative otitis media (CSOM) with central perforation by performing the inflation-deflation test. To correlate the results of the inflation-deflation test with the finding of aditus patency or block in patients with CSOM STUDY DESIGN: Prospective, cohort Tertiary care hospital Eighty adult patients with chronic suppurative otitis media and central perforation were recruited into the study. There were 45 males and 35 females. All patients underwent preoperative inflation-deflation test followed by cortical mastoidectomy and tympanoplasty. The patency of the aditus was assessed intraoperatively. Equalization of pressure on inflation-deflation test and intraoperative assessment of aditus patency Of a total of 80 patients, 49 patients were found to have discharging ears and 31 had dry ears at the time of surgery. In dry ears the inflation-deflation test had a sensitivity of 93% in predicting aditus patency although the specificity was lower at 67%. In discharging ears the sensitivity in predicting aditus patency was 72% and the specificity was 67%. The eustachian tube inflation-deflation test is a sensitive test for predicting aditus patency in patients with dry ears but less so in patients with discharging ears. Hence, it could be used in the former to avoid unnecessary exploration of the mastoid.

Safety and Efficacy of Percutaneous Biliary Covered Stent Placement in Patients with Malignant Biliary Hilar Obstruction; Correlation with Liver Function

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hyun, Hyeran; Choi, Sun Young, E-mail: medmath@hanmail.net; Kim, Kyung Ah

PurposeTo estimate the safety and efficacy of percutaneous ePTFE-covered biliary stent placement and the relationship between underlying liver function and stent patency in patients with malignant hilar obstruction.Materials and MethodsFrom March 2012 to June 2015, 41 patients [22 females, 19 males; mean age 69.8 (range 34–94) years] with malignant biliary obstruction underwent percutaneous biliary stent placement (31 patients with unilateral, 10 patients with bilateral side-by-side). Cumulative patient survival and stent patency rate curves were derived using the Kaplan–Meier method. A Cox model was used to explore the relationship between liver function and patient survival, and also biliary stent patency. Pearsonmore » correlation coefficient was used to analyze the relationship between patient survival and stent patency.ResultsTechnical success rate was 100 % and clinical success rate was 95 %. During follow-up, four complications occurred (two bilomas and two cases of acute cholecystitis) and were treated successfully with percutaneous drainage. No other complication occurred. Mean serum bilirubin level was 11.34 ± 7.35 mg/dL before drainage and 5.00 ± 4.83 mg/dL 2 weeks after stent placement. The median patent survival duration was 147 days (95 % CI, 69.6–224.4 days). The median stent patency duration was 101 days (95 % CI, 70.0–132.0 days). The cumulative stent patency rates at 1, 3, 6, and 12 months were 97, 57.6, 30.3, and 17.0 %, respectively. Child–Pugh score was correlated significantly with patient survival (P = 0.011) and stent patency (P = 0.007). MELD score was correlated significantly with stent patency (P = 0.044). There was a correlation between patient survival and stent patency (r = 0.778, P < 0.001).ConclusionPercutaneous placement of ePTFE-covered biliary stent was a safe and an effective method for malignant biliary obstruction. Underlying liver function seemed to be one of the important factors affecting patient survival and stent patency, and stent patency showed statistically significant correlation with patient survival.« less

Immediate and intermediate-term results of optical coherence tomography guided atherectomy in the treatment of peripheral arterial disease: Initial results from the VISION trial.

PubMed

Cawich, Ian; Paixao, Andre R M; Marmagkiolis, Konstantinos; Lendel, Vasili; Rodriguez-Araujo, Gerardo; Rollefson, William A; Mego, David M; Cilingiroglu, Mehmet

Long-term patency rates for percutaneous peripheral arterial interventions are suboptimal. Optical coherence tomography (OCT) guided atherectomy may yield superior patency by optimizing plaque removal while preserving the tunica media and adventitia. The VISION study is a multicenter prospective study of patients with peripheral arterial disease undergoing OCT guided atherectomy with the Pantheris™ device. In 11 patients enrolled in a single center, we report procedural and clinical outcomes, at 30days and 6months. The mean age was 63±11years and 73% (n=8) were men. The target lesion was in the superficial femoral artery in 82% (n=9) of the patients. Mean stenosis severity was 87%±10% and mean lesion length was 39±31mm. Procedural success was observed in all patients with no device related complications. Mean post-atherectomy stenosis was 18%±15%. Almost all excised tissue consisted of intimal plaque (94%). At 30days, significant improvements in Rutherford class, VascuQoL scores and ABI were observed, 0.9±0.8 vs. 3.1±0.7 (p=0.01), 4.9±1.9 vs. 3.6±1.5 (p=0.03) and 1.04±0.19 vs. 0.80±0.19 (p<0.01) respectively. At 6months, there were significant improvements in Rutherford class (1.0±1.0 vs. 3.1±0.7, p=0.01) and ABI (0.93±0.19 versus 0.80±0.19, p=0.02) but not in VascuQoL scores (3.7±1.4 versus 3.6±1.5, p=0.48). Target lesion revascularization occurred in 18% (n=2) of the patients. OCT guided atherectomy resulted in high procedural success, no device related complications and encouraging results up to 6months. Histological analysis suggested little injury to the media and adventitia. Larger studies are needed to confirm the efficacy of this approach. Copyright © 2016 Elsevier Inc. All rights reserved.

Mid-term outcomes of orbital atherectomy combined with drug-coated balloon angioplasty for treatment of femoropopliteal disease.

PubMed

Foley, T Raymond; Cotter, Ryan P; Kokkinidis, Damianos G; Nguyen, Daniel D; Waldo, Stephen W; Armstrong, Ehrin J

2017-05-01

To assess the intraprocedural and mid-term outcomes of orbital atherectomy (OA) combined with drug-coated balloon (DCB) angioplasty for the treatment of calcified femoropopliteal disease. In this single-center cohort, 89 patients (139 lesions) were treated with DCB angioplasty for claudication or critical limb ischemia (CLI). Angiographic characteristics and procedural outcomes were reviewed for patients treated with or without adjunctive OA. Lesion calcification was graded using two previously published scoring systems, the angiographic calcium score (ACS) and the peripheral artery calcification scoring system (PACSS). Among 139 lesions, 40 (29%) were treated with OA + DCB. Mean lesion length was 135 ± 100 mm for lesions treated with OA + DCB and 139 ± 100 mm for DCB alone (P = 0.9). Moderate to severe calcification was present in 83% of patients treated with OA, compared to 42% of patients treated with DCB alone (P < 0.001). Lesions treated with OA + DCB were less likely to require bailout stenting (18% vs. 39%, P =0.01). Rates of embolization (0% in OA + DCB vs. 2% in DCB only, P = 0.4), dissection (13% vs. 14%, P = 0.8), and perforation (0%) did not differ significantly between groups. The freedom from TLR at 1 year was 82% in both groups (P = 0.6) while primary patency was 81% in-patients treated with DCB alone and 77% in-patients treated with DCB with concomitant OA (P = 0.8). In this single-center analysis of patients undergoing DCB angioplasty for claudication or CLI, OA was most often used for the treatment of severely calcified lesions. These lesions were more likely to be treated with scoring balloons and less likely to require bailout stenting. At 1 year, target lesion revascularization and primary patency was similar in patients treated with and without adjunctive OA, despite the higher lesion complexity among those receiving the combination procedure. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Determinants of variations in initial treatment strategies for stable ischemic heart disease

PubMed Central

Bennell, Maria C.; Qiu, Feng; Kingsbury, Kori J.; Austin, Peter C.; Wijeysundera, Harindra C.

2015-01-01

Background: The ratio of revascularization to medical therapy (referred to herein as the revascularization ratio) for the initial treatment of stable ischemic heart disease varies considerably across hospitals. We conducted a comprehensive study to identify patient, physician and hospital factors associated with variations in the revascularization ratio across 18 cardiac centres in the province of Ontario. We also explored whether clinical outcomes differed between hospitals with high, medium and low ratios. Methods: We identified all patients in Ontario who had stable ischemic heart disease documented by index angiography performed between Oct. 1, 2008, and Sept. 30, 2011, at any of the 18 cardiac centres in the province. We classified patients by initial treatment strategy (medical therapy or revascularization). Hospitals were classified into equal tertiles based on their revascularization ratio. The primary outcome was all-cause mortality. Patient follow-up was until Dec. 31, 2012. Hierarchical logistic regression models identified predictors of revascularization. Multivariable Cox proportional hazards models, with a time-varying covariate for actual treatment received, were used to evaluate the impact of the revascularization ratio on clinical outcomes. Results: Variation in revascularization ratios was twofold across the hospitals. Patient factors accounted for 67.4% of the variation in revascularization ratios. Physician and hospital factors were not significantly associated with the variation. Significant patient-level predictors of revascularization were history of smoking, multivessel disease, high-risk findings on noninvasive stress testing and more severe symptoms of angina (v. no symptoms). Treatment at hospitals with a high revascularization ratio was associated with increased mortality compared with treatment at hospitals with a low ratio (hazard ratio 1.12, 95% confidence interval 1.03–1.21). Interpretation: Most of the variation in revascularization ratios across hospitals was warranted, in that it was driven by patient factors. Nonetheless, the variation was associated with potentially important differences in mortality. PMID:25991840

Long-term patency of complex bilobular, bisaccular, and broad-neck aneurysms in the rabbit microsurgical venous pouch bifurcation model.

PubMed

Marbacher, Serge; Tastan, Ilhan; Neuschmelting, Volker; Erhardt, Salome; Coluccia, Daniel; Sherif, Camillo; Remonda, Luca; Fandino, Javier

2012-07-01

In experimental aneurysm models, long-term patency without spontaneous thrombosis is the most important precondition for analyses of embolization devices. We recently reported the feasibility of creating complex venous pouch bifurcation aneurysms in the rabbit with low morbidity, low mortality, and high short-term aneurysm patency. In order to further evaluate our model, we examined the long-term patency rate. Various sizes of complex bilobular, bisaccular, and broad-neck venous pouch aneurysms were surgically formed at an artificially created bifurcation of both common carotid arteries in 17 rabbits. Early aggressive anticoagulation was continued for 1 month. The rabbits were followed up using contrast-enhanced three-dimensional 1.5-T magnetic resonance angiography (CE-3D-MRA) at 1 month and up to 1 year after creation of the bifurcation. At 1-month follow-up, all but one of the created aneurysms and all parent vessels proved to be patent. Three animals (18%) were lost during follow-up for reasons unrelated to aneurysm surgery. At 1-year follow-up, one animal showed partial and one complete spontaneous aneurysm thrombosis (aneurysm patency rate: 86%). Six out of 42 parent vessels were occluded at that time (vessel patency rate: 86%). Complex bilobular, bisaccular, and broad-neck microsurgical aneurysm formation in the rabbit bifurcation model demonstrates a high long-term patency rate but is complicated by high rates of unrelated procedural mortality and morbidity. There is no need for prolonged (>4 weeks) anticoagulation to achieve good long-term patency in complex venous pouch bifurcation aneurysms.

The short- and long-term outcomes of percutaneous intervention with drug-eluting stent vs bare-metal stent in saphenous vein graft disease: An updated meta-analysis of all randomized clinical trials.

PubMed

Kheiri, Babikir; Osman, Mohammed; Abdalla, Ahmed; Ahmed, Sahar; Bachuwa, Ghassan; Hassan, Mustafa

2018-05-11

The use of drug-eluting stents (DES) vs bare-metal stents (BMS) in saphenous vein graft (SVG) lesions remains controversial. We conducted a meta-analysis of all randomized clinical trials comparing the outcomes of DES with BMS in SVG percutaneous coronary interventions. A search of PubMed, Embase, the Cochrane Register of Controlled Trials, and Clinicaltrials.gov was performed for all randomized clinical trials. We evaluated the short- and long-term clinical outcomes of the following: all-cause mortality, major adverse cardiovascular events (MACE), definite/probable stent thrombosis, target lesion revascularization (TLR), and target-vessel revascularization (TVR). From a total of 1582 patients in 6 randomized clinical trials, 797 had DES and 785 had BMS. Patients with DES had lower short-term MACE, TLR, and TVR in comparison with BMS (odds ratio [OR]: 0.56, 95% confidence interval [CI]: 0.35-0.91, P = 0.02; OR: 0.43, 95% CI: 0.19-0.99, P = 0.05; and OR: 0.45, 95% CI: 0.22-0.95, P = 0.04, respectively). However, there were no different outcomes for all-cause mortality (P = 0.63) or stent thrombosis (P = 0.21). With long-term follow-up, there were no significant reductions of MACE (P = 0.20), TLR (P = 0.57), TVR (P = 0.07), all-cause mortality (P = 0.29), and stent thrombosis (P = 0.76). The use of DES in SVG lesions was associated with lower short-term MACE, TLR, and TVR in comparison with BMS. However, there were no significant differences with long-term follow-up. © 2018 Wiley Periodicals, Inc.

Tissue removal by ultrasound evaluation (the TRUE study): the Jetstream G2 system post-market peripheral vascular IVUS study.

PubMed

Singh, Tejwant; Koul, Deepak; Szpunar, Susanna; Torey, James; Dhabuwala, Jigishu; Saigh, Lisa; Pires, Luis A; Davis, Thomas

2011-07-01

Balloon angioplasty and stenting of infra-inguinal lesions is limited by poor long-term patency rates. Atherectomy decreases plaque burden and provides an alternative means of revascularizing patients with peripheral arterial disease. The Jetstream G2™ (Pathway Medical Technologies, Inc., Kirkland, Washington) is a newer rotational aspiration atherectomy device, uniquely combining rotablation with aspiration capability. We evaluated the debulking properties of this device by analyzing changes in the plaque volume and composition and vessel size using intravascular ultrasound (IVUS) and virtual histology (VH). Freedom from target lesion revascularization (TLR) at 6 and 12 months was also evaluated. Eighteen patients with peripheral arterial disease requiring intervention (severe claudication despite optimal medical treatment or critical limb ischemia) were treated with rotational atherectomy. The mean age was 69.6 ± 11 years, 66.7% were male, and 44.4% had diabetes. The mean total plaque volume decreased by 56.6 mm³ (479.8 ± 172.5 mm³ to 423.2 ± 156.6 mm³; p < 0.0001), which resulted in a mean luminal volume increase of 64.3 mm³ (148.4 ± 84.1 mm³ to 212.7 ± 72.1 mm³; p < 0.0001). This was achieved without significant Dotter effect with either technique, as evidenced by the virtually unchanged vessel volume before and after treatment (628.3 ± 158.5 mm³ and 635.9 ± 169.0 mm³, respectively; p = 0.22). There was a significant reduction in fibrotic and fibro-fatty plaque volume, with no appreciable effect on necrotic core and dense calcium. There were no reported procedure-related complications and the 6- and 12-month TLR rate was 11% (2/18). Atherectomy with the Jetstream G2 system results in substantial plaque volume reduction by removing fibrotic and fibro-fatty plaque. This resulted in substantial luminal volume expansion without concomitant vessel expansion. There were no major procedure-related complications, along with a relatively low 6- and 12-month rate of TLR. Future studies involving a larger number of patients are warranted to examine the potential clinical benefits of this promising technology.

Interhospital Transfers among Medicare Beneficiaries Admitted for Acute Myocardial Infarction at Non-Revascularization Hospitals

PubMed Central

Iwashyna, Theodore J.; Kahn, Jeremy M.; Hayward, Rodney A.; Nallamothu, Brahmajee K.

2011-01-01

Background Patients with acute myocardial infarctions (AMI) who are admitted to hospitals without coronary revascularization are frequently transferred to hospitals with this capability, yet we know little about the basis for how such revascularization hospitals are selected. Methods and Results We examined interhospital transfer patterns in 71,336 AMI patients admitted to hospitals without revascularization capabilities in the 2006 Medicare claims using network analysis and regression models. A total of 31,607 (44.3%) AMI patients were transferred from 1,684 non-revascularization hospitals to 1,104 revascularization hospitals. Median time to transfer was 2 days. Median transfer distance was 26.7 miles, with 96.1% within 100 miles. In 45.8% of cases, patients bypassed a closer hospital to go to farther hospital that had a better 30-day risk standardized mortality rates. However, in 36.8% of cases, another revascularization hospital with lower 30-day risk-standardized mortality was actually closer to the original admitting non-revascularization hospital than the observed transfer destination. Adjusted regression models demonstrated that shorter transfer distances were more common than transfers to the hospitals with lowest 30-day mortality rates. Simulations suggest that an optimized system that prioritized the transfer of AMI patients to a nearby hospital with the lowest 30-day mortality rate might produce clinically meaningful reduction in mortality. Conclusions Over 40% of AMI patients admitted to non-revascularization hospitals are transferred to revascularization hospitals. Many patients are not directed to nearby hospitals with the lowest 30-day risk-standardized mortality, and this may represent an opportunity for improvement. PMID:20682917

[State of duodenal patency in patients with postgastrectomy syndromes].

PubMed

Nazarenko, P M; Bilichenko, V B; Nazarenko, D P; Samgina, T A

2014-01-01

It was analyzed the examination and treatment results of 100 patients who underwent resection of stomach by Billroth-I in case of peptic ulcer. Chronic disorders of duodenal patency were diagnosed in 86% of patients. The main role of chronic disorders of duodenal patency in postgastrectomy syndromes development was proved. There were a combination of reflux gastritis with dumping syndrome in 66.3% of patients, a combination of reflux gastritis with recurrent ulcer in 8.1% of patients. Correction of chronic disorders of duodenal patency is necessary stage in conservative and surgical treatment of postgastrectomy syndromes.

Rationale of a novel study design for the BIOFLOW V study, a prospective, randomized multicenter study to assess the safety and efficacy of the Orsiro sirolimus-eluting coronary stent system using a Bayesian approach.

PubMed

Doros, Gheorghe; Massaro, Joseph M; Kandzari, David E; Waksman, Ron; Koolen, Jacques J; Cutlip, Donald E; Mauri, Laura

2017-11-01

Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design using the Bayesian approach. This design was proposed for testing DES with bioresorbable polymer compared with DES most commonly in use today that use durable polymers for drug elution. This prospective, multicenter, randomized, controlled trial is designed to assess the safety and efficacy of the Orsiro bioresorbable polymer sirolimus-eluting stent (BP SES). Up to 1,334 subjects with up to 3 de novo or restenotic coronary artery lesions who qualify for percutaneous coronary intervention with stenting will be randomized 2:1 to the BP SES versus the Xience durable polymer everolimus-eluting stent (DP EES). Data from this trial will be combined with data from 2 similarly designed trials that also randomize subjects to BP SES and DP EES (BIOFLOW II, N=452 and BIOFLOW IV, N=579) by using a Bayesian approach. The primary end point is target lesion failure at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a test of noninferiority of the BP SES versus DP EES on the primary end point according to a noninferiority delta of 3.85%. Secondary end points include stent thrombosis and the individual components of target lesion failure. Subjects will be followed for 5 years after randomization. The BIOFLOW V trial offers an opportunity to assess clinical outcomes in patients treated with coronary revascularization using the Orsiro BP SES relative to a commonly used DP EES. The use of a Bayesian analysis combines a large randomized cohort of patients 2 two smaller contributing randomized trials to augment the efficiency of the comparison. Copyright © 2017 Elsevier Inc. All rights reserved.

Histologic study of a human immature permanent premolar with chronic apical abscess after revascularization/revitalization.

PubMed

Becerra, Patricia; Ricucci, Domenico; Loghin, Simona; Gibbs, Jennifer L; Lin, Louis M

2014-01-01

Histologic studies of teeth from animal models of revascularization/revitalization are available; however, specimens from human studies are lacking. The nature of tissues formed in the canal of human revascularized/revitalized teeth was not well established. An immature mandibular premolar with infected necrotic pulp and a chronic apical abscess was treated with revascularization/revitalization procedures. At both the 18-month and 2-year follow-up visits, radiographic examination showed complete resolution of the periapical lesion, narrowing of the root apex without root lengthening, and minimal thickening of the canal walls. The revascularized/revitalized tooth was removed because of orthodontic treatment and processed for histologic examination. The large canal space of revascularized/revitalized tooth was not empty and filled with fibrous connective tissue. The apical closure was caused by cementum deposition without dentin. Some cementum-like tissue was formed on the canal dentin walls. Inflammatory cells were observed in the coronal and middle third of revascularized/revitalized tissue. In the present case, the tissue formed in the canal of a human revascularized/revitalized tooth was soft connective tissue similar to that in the periodontal ligament and cementum-like or bone-like hard tissue, which is comparable with the histology observed in the canals of teeth from animal models of revascularization/revitalization. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Capsule Endoscope Aspiration after Repeated Attempts for Ingesting a Patency Capsule

PubMed Central

Mannami, Tomohiko; Ikeda, Genyo; Seno, Satoru; Sonobe, Hiroshi; Fujiwara, Nobukiyo; Komoda, Minori; Edahiro, Satoru; Ohtawa, Yasuyuki; Fujimoto, Yoshimi; Sato, Naohiro; Kambara, Takeshi; Waku, Toshihiko

2015-01-01

Capsule endoscope aspiration into the respiratory tract is a rare complication of capsule endoscopy. Despite the potential seriousness of this complication, no accepted methods exist to accurately predict and therefore prevent it. We describe the case of an 85-year-old male who presented for evaluation of iron deficiency anemia. He complained of dysphagia while ingesting a patency capsule, with several attempts over a period of 5 min before he was successful. Five days later, he underwent capsule endoscopy, where he experienced similar symptoms in swallowing the capsule. The rest of the examination proceeded uneventfully. On reviewing the captured images, the capsule endoscope was revealed to be aspirated, remaining in the respiratory tract for approximately 220 s before images of the esophagus and stomach appeared. To our knowledge, this is the first documented case of a patient who experienced capsule endoscope aspiration after ingestion of a patency capsule. This case suggests that repeated attempts required for ingesting the patency capsule can predict capsule endoscope aspiration. We presume that paying sufficient attention to the symptoms of a patient who ingests a patency capsule could help us prevent serious complications such as aspiration of the capsule endoscope. In addition, this experience implies the potential risk for ingesting the patency capsule. We must be aware that the patency capsule could also be aspirated and there may be more unrecognized aspiration cases. PMID:26600772

Capsule Endoscope Aspiration after Repeated Attempts for Ingesting a Patency Capsule.

PubMed

Mannami, Tomohiko; Ikeda, Genyo; Seno, Satoru; Sonobe, Hiroshi; Fujiwara, Nobukiyo; Komoda, Minori; Edahiro, Satoru; Ohtawa, Yasuyuki; Fujimoto, Yoshimi; Sato, Naohiro; Kambara, Takeshi; Waku, Toshihiko

2015-01-01

Capsule endoscope aspiration into the respiratory tract is a rare complication of capsule endoscopy. Despite the potential seriousness of this complication, no accepted methods exist to accurately predict and therefore prevent it. We describe the case of an 85-year-old male who presented for evaluation of iron deficiency anemia. He complained of dysphagia while ingesting a patency capsule, with several attempts over a period of 5 min before he was successful. Five days later, he underwent capsule endoscopy, where he experienced similar symptoms in swallowing the capsule. The rest of the examination proceeded uneventfully. On reviewing the captured images, the capsule endoscope was revealed to be aspirated, remaining in the respiratory tract for approximately 220 s before images of the esophagus and stomach appeared. To our knowledge, this is the first documented case of a patient who experienced capsule endoscope aspiration after ingestion of a patency capsule. This case suggests that repeated attempts required for ingesting the patency capsule can predict capsule endoscope aspiration. We presume that paying sufficient attention to the symptoms of a patient who ingests a patency capsule could help us prevent serious complications such as aspiration of the capsule endoscope. In addition, this experience implies the potential risk for ingesting the patency capsule. We must be aware that the patency capsule could also be aspirated and there may be more unrecognized aspiration cases.

Prospective randomized comparison of coronary bypass grafting with minimal extracorporeal circulation system (MECC) versus off-pump coronary surgery.

PubMed

Mazzei, Valerio; Nasso, Giuseppe; Salamone, Giovanni; Castorino, Filippo; Tommasini, Antonello; Anselmi, Amedeo

2007-10-16

We aimed to evaluate the clinical results and biocompatibility of the minimal extracorporeal circulation system (MECC) compared with off-pump coronary revascularization (OPCABG). In a prospective randomized study, 150 patients underwent coronary surgery with the use of MECC and 150 underwent OPCABG. End points were (1) circulating markers of inflammation and organ injury, (2) operative results, and (3) outcome at 1-year follow-up. Operative mortality and morbidity were comparable between the groups. Release of inflammatory markers was similar between groups at all time points (peak interleukin-6 167.2+/-13.5 versus 181+/-6.5 pg/mL, P=0.14, OPCABG versus MECC group, respectively). Peak creatine kinase was 419.3+/-103.5 versus 326+/-84.2 mg/dL (P=0.28), and peak S-100 protein was 0.13+/-0.08 versus 0.29+/-0.1 pg/mL (P=0.058, OPCABG versus MECC group, respectively). Length of hospital stay and use of blood products were similar between groups. Two cases of angina recurrence at 1 year in the MECC group were observed versus 5 cases observed in the OPCABG group (P=0.44). A residual perfusion defect at myocardial nuclear scan was less frequent among patients in the MECC group (3 versus 9 cases, P=0.14; odds ratio 0.32, 95% confidence interval 0.07 to 1.32). Six (OPCABG group) versus 3 (MECC group) coronary grafts were occluded or severely stenotic at 1 year (P=0.33, odds ratio 0.47, 95% confidence interval 0.09 to 2.14). Clinical results of coronary revascularization with MECC are optimal when this procedure is performed by experienced teams. Postoperative morbidity is comparable to that with OPCABG. MECC is associated with little pump-related systemic and organ injury. It may achieve the benefits of OPCABG (less morbidity in high-risk patients) while facilitating complete revascularization in the case of complex lesions unsuitable for OPCABG.

A randomized study to compare bioactive titanium stents and everolimus-eluting stents in diabetic patients (TITANIC XV): 1-year results.

PubMed

López-Mínguez, José R; Nogales-Asensio, Juan M; Doncel-Vecino, Luis J; Merchán-Herrera, Antonio; Pomar-Domingo, Francisco; Martínez-Romero, Pedro; Fernández-Díaz, José A; Valdesuso-Aguilar, Raúl; Moreu-Burgos, José; Díaz-Fernández, José

2014-07-01

Up to 25% of patients who undergo a percutaneous coronary intervention show some limitation in the use of drug-eluting stents. The aim of this study was to evaluate if titanium-nitride-oxide-coated stents could be a good alternative to everolimus-eluting stents in diabetic patients. A total of 173 diabetic patients with lesions at moderate risk of restenosis (exclusion criteria: diameter < 2.5 mm or length > 28 mm in vessels < 3mm, chronic occlusion) were randomized to a titanium group (83 patients) or an everolimus group (90 patients). Baseline characteristics were well balanced; 28.3% of patients were insulin dependent. At 1 year, the incidence of major adverse cardiac events (death, nonfatal myocardial infarction, stroke, or repeat target vessel revascularization) was significantly higher in the titanium group than in the everolimus group (total, 14.5% vs 4.4%; P = .02; noninsulin-dependent subgroup, 9.7% vs 3.2%; P = .14; insulin-dependent subgroup, 28.6% vs 7.1%; P = .04). The incidence of death, nonfatal myocardial infarction, stroke, or any revascularization was 16.9% in the titanium group and 7.8% in the everolimus group (P = .06). Target lesion and vessel revascularizations occurred in 8.4% compared with 3.3% (P = .15) and in 13.3% compared with 3.3% (P = .01) in the titanium and everolimus groups, respectively. Angiographic follow-up at 9 months showed significantly less late lumen loss in the everolimus group (in-segment, 0.52 [standard deviation, 0.58) mm vs -0.05 [0.32] mm; in-stent, 0.76 [0.54] mm vs 0.13 [0.31] mm; P < .0001). The everolimus-eluting stent is superior to the titanium stent for clinical and angiographic end points in diabetic patients with lesions at moderate risk of restenosis. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes.

PubMed

Valgimigli, Marco; Frigoli, Enrico; Leonardi, Sergio; Rothenbühler, Martina; Gagnor, Andrea; Calabrò, Paolo; Garducci, Stefano; Rubartelli, Paolo; Briguori, Carlo; Andò, Giuseppe; Repetto, Alessandra; Limbruno, Ugo; Garbo, Roberto; Sganzerla, Paolo; Russo, Filippo; Lupi, Alessandro; Cortese, Bernardo; Ausiello, Arturo; Ierna, Salvatore; Esposito, Giovanni; Presbitero, Patrizia; Santarelli, Andrea; Sardella, Gennaro; Varbella, Ferdinando; Tresoldi, Simone; de Cesare, Nicoletta; Rigattieri, Stefano; Zingarelli, Antonio; Tosi, Paolo; van 't Hof, Arnoud; Boccuzzi, Giacomo; Omerovic, Elmir; Sabaté, Manel; Heg, Dik; Jüni, Peter; Vranckx, Pascal

2015-09-10

Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome. We randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events. The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P=0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P=0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P=0.34). In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.).

Fondaparinux with UnfracTionated heparin dUring Revascularization in Acute coronary syndromes (FUTURA/OASIS 8): a randomized trial of intravenous unfractionated heparin during percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes initially treated with fondaparinux.

PubMed

Steg, Philippe Gabriel; Mehta, Shamir; Jolly, Sanjit; Xavier, Denis; Rupprecht, Hans-Juergen; Lopez-Sendon, Jose Luis; Chrolavicius, Susan; Rao, Sunil V; Granger, Christopher B; Pogue, Janice; Laing, Shiona; Yusuf, Salim

2010-12-01

There is uncertainty regarding the optimal adjunctive unfractionated heparin (UFH) regimen for percutaneous coronary intervention (PCI) in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) treated with fondaparinux. The aim of this study is to evaluate the safety of 2 dose regimens of adjunctive intravenous UFH during PCI in high-risk patients with NSTE-ACS initially treated with fondaparinux and referred for early coronary angiography. This is an international prospective cohort study of approximately 4,000 high-risk patients presenting to hospital with unstable angina or non-ST-segment elevation myocardial infarction, treated with fondaparinux as initial medical therapy, and referred for early coronary angiography with a view to revascularization. Within this cohort, 2,000 patients undergoing PCI will be eligible for enrollment into a double-blind international randomized parallel-group trial evaluating standard activated clotting time (ACT)-guided doses of intravenous UFH versus a non-ACT-guided weight-adjusted low dose. The standard regimen uses an 85-U/kg bolus of UFH if there is no platelet glycoprotein IIb/IIIa (GpIIb-IIIa) inhibitor or 60 U/kg if GpIIb-IIIa inhibitor use is planned, with additional bolus guided by blinded ACT measurements. The low-dose regimen uses a 50 U/kg UFH bolus, irrespective of planned GpIIb-IIIa use. The primary outcome is the composite of peri-PCI major bleeding, minor bleeding, or major vascular access site complications. The assessment of net clinical benefit is a key secondary outcome: it addresses the composite of peri-PCI major bleeding with death, myocardial infarction, or target vessel revascularization at day 30. FUTURA/OASIS 8 will help define the optimal UFH regimen as adjunct to PCI in high-risk NSTE-ACS patients treated with fondaparinux. Copyright © 2010 Mosby, Inc. All rights reserved.

Long-term clinical follow-up of the multicentre, randomized study to test immunosuppressive therapy with oral prednisone for the prevention of restenosis after percutaneous coronary interventions: Cortisone plus BMS or DES veRsus BMS alone to EliminAte Restenosis (CEREA-DES).

PubMed

Ribichini, Flavio; Tomai, Fabrizio; Pesarini, Gabriele; Zivelonghi, Carlo; Rognoni, Andrea; De Luca, Giuseppe; Boccuzzi, Giacomo; Presbitero, Patrizia; Ferrero, Valeria; Ghini, Anna S; Marino, Paolo; Vassanelli, Corrado

2013-06-01

To analyse the clinical outcome at 4 years in patients with coronary artery disease treated with bare metal stents (BMS) vs. BMS and oral prednisone, or drug-eluting stents (DES), all assuming similar adjunctive medical treatment. Five Italian hospitals enrolled 375 non-diabetic, ischaemic patients without contraindications to dual anti-platelet treatment or corticosteroid therapy in a randomized controlled study. The primary endpoint was the event-free survival of cardiovascular death, myocardial infarction, and recurrence of ischaemia needing repeated target vessel revascularization at 1 year, and this was significantly lower in the BMS group (80.8%) compared with the prednisone (88.0%) and DES group (88.8%, P = 0.04 and 0.006, respectively). The long-term analysis of the primary endpoint was a pre-specified aim of the trial, and was performed at 1447 days (median, IQ range = 1210-1641). Patients receiving BMS alone had significantly lower event-free survival (75.3%) compared with 84.1% in the prednisone group (HR: 0.447; 95% CI: 0.25-0.80, P = 0.007) and 80.6% in DES patients (HR: 0.519; 95% CI: 0.29-0.93, P = 0.03). Prednisone-treated patients did not develop new treatment-related clinical problems. Drug-eluting stents patients suffered more very late stent thrombosis as a cause of spontaneous myocardial infarction. The need for target vessel revascularization remained lower in the prednisone and DES groups (13.6 and 15.2%, respectively), compared with BMS (23.2%). The clinical benefits of prednisone compared with BMS only persisted almost unchanged at 4 years. Drug-eluting stents performed better than BMS at long-term, although the advantages observed at 1 year were in part attenuated because of the occurrence of very late stent thrombosis and late revascularizations. Clinical Trial NCT 00369356.

Intravascular Ultrasound to Guide Percutaneous Coronary Interventions

PubMed Central

2006-01-01

Executive Summary Objective The objective of this health technology policy assessment was to determine the effectiveness and cost-effectiveness of using intravascular ultrasound (IVUS) as an adjunctive imaging tool to coronary angiography for guiding percutaneous coronary interventions. Background Intravascular Ultrasound Intravascular ultrasound is a procedure that uses high frequency sound waves to acquire 3-dimensional images from the lumen of a blood vessel. The equipment for performing IVUS consists of a percutaneous transducer catheter and a console for reconstructing images. IVUS has been used to study the structure of the arterial wall and nature of atherosclerotic plaques, and obtain measurements of the vessel lumen. Its role in guiding stent placement is also being investigated. IVUS is presently not an insured health service in Ontario. Clinical Need Coronary artery disease accounts for approximately 55% of cardiovascular deaths, the leading cause of death in Canada. In Ontario, the annual mortality rate due to ischemic heart disease was 141.8 per 100,000 population between 1995 and 1997. Percutaneous coronary intervention (PCI), a less invasive approach to treating coronary artery disease, is used more frequently than coronary bypass surgery in Ontario. The number of percutaneous coronary intervention procedures funded by the Ontario Ministry of Health and Long-term Care is expected to increase from approximately 17, 780 in 2004/2005 to 22,355 in 2006/2007 (an increase of 26%), with about 95% requiring the placement of one or more stents. Restenosis following percutaneous coronary interventions involving bare metal stents occurs in 15% to 30% of the cases, mainly because of smooth muscle proliferation and migration, and production of extracellular matrix. In-stent restenosis has been linked to suboptimal stent expansion and inadequate lesion coverage, while stent thrombosis has been attributed to incomplete stent-to-vessel wall apposition. Since coronary angiography (the imaging tool used to guide stent placement) has been shown to be inaccurate in assessing optimal stent placement, and IVUS can provide better views of the vessel lumen, the clinical utility of IVUS as an imaging tool adjunctive to coronary angiography in coronary intervention procedures has been explored in clinical studies. Method A systematic review was conducted to answer the following questions: What are the procedure-related complications associated with IVUS? Does IVUS used in conjunction with angiography to guide percutaneous interventions improve patient outcomes compared to angiographic guidance without IVUS? Who would benefit most in terms of clinical outcomes from the use of IVUS adjunctive to coronary angiography in guiding PCIs? What is the effectiveness of IVUS guidance in the context of drug-eluting stents? What is the cost-effectiveness ratio and budget impact of adjunctive IVUS in PCIs in Ontario? A systematic search of databases OVID MEDLINE, EMBASE, MEDLINE In-Process & Other Non-Indexed Citations, The Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) database for the period beginning in May 2001 until the day of the search, November 4, 2005 yielded 2 systematic reviews, 1 meta-analysis, 6 randomized controlled trials, and 2 non-randomized studies on left main coronary arteries. The quality of the studies ranged from moderate to high. These reports were combined with reports from a previous systematic review for analysis. In addition to qualitative synthesis, pooled analyses of data from randomized controlled studies using a random effect model in the Cochrane Review Manager 4.2 software were conducted when possible. Findings of Literature Review & Analysis Safety Intravascular ultrasound appears to be a safe tool when used in coronary interventions. Periprocedural complications associated with the use of IVUS in coronary interventions ranged from 0.5% in the largest study to 4%. Coronary rupture was reported in 1 study (1/54). Other complications included prolonged spasms of the artery after stenting, dissection, and femoral aneurysm. Effectiveness Based on pooled analyses of data from randomized controlled studies, the use of intravascular ultrasound adjunctive to coronary intervention in percutaneous coronary interventions using bare metal stents yielded the following findings: For lesions predominantly at low risk of restenosis: There were no significant differences in preintervention angiographic minimal lumen diameter between the IVUS-guided and angiography-guided groups. IVUS guidance resulted in a significantly larger mean postintervention angiographic minimal lumen diameter (weighted mean difference of 0.11 mm, P = .0003) compared to angiographic guidance alone. The benefit in angiographic minimal lumen diameter from IVUS guidance was not maintained at 6-month follow-up, when no significant difference in angiographic minimal lumen diameter could be detected between the two arms (weighted mean difference 0.08, P = .13). There were no statistically significant differences in angiographic binary restenosis rates between IVUS-guidance and no IVUS guidance (Odds ratio [OR] 0.87 in favour of IVUS, 95% Confidence Interval [CI] [0.64–1.18], P = 0.37). IVUS guidance resulted in a reduction in the odds of target lesion revascularization (repeat percutaneous coronary intervention or coronary bypass graft) compared to angiographic guidance alone. The reduction was statistically significant at a follow-up period of 6 months to 1 year, and at a follow-up period of 18 month to 2 years (OR 0.52 in favour of IVUS, 95% CI [0.33–0.81], P = .004). Total revascularization rate (either target lesion or target vessel revascularization) was significantly lower for IVUS-guided patients at 18 months to 2.5 years after intervention (OR 0.43 in favour of IVUS, 95% CI [0.29–0.63], p < .0001). There were no statistically significant differences in the odds of death (OR 1.36 in favour of no IVUS, P =0.65) or myocardial infarction (OR 0.95 in favour of IVUS, P = 0.93) between IVUS-guidance and angiographic guidance alone at up to 2.5 years of follow-up The odds of having a major cardiac event (defined as death, myocardial infarction, and target lesion or target vessel revascularization) were significantly lower for patients with IVUS guidance compared to angiographic guidance alone during follow-up periods of up to 2.5 years (OR 0.53, 95% CI [0.36–0.78], P = 0.001). Since there were no significant reductions in the odds of death or myocardial infarction, the reduction in the odds of combined events reflected mainly the reduction in revascularization rates. For lesions at High Risk of Restenosis: There is evidence from one small, randomized controlled trial (n=150) that IVUS-guided percutaneous coronary intervention in long de novo lesions (>20 mm) of native coronary arteries resulted in statistically significant larger minimal lumen Diameter, and statistically significant lower 6-month angiographic binary restenosis rate. Target vessel revascularization rate and the rate of combined events were also significantly reduced at 12 months. A small subgroup analysis of a randomized controlled trial reported no benefit in clinical or angiographic outcomes for IVUS-guided percutaneous coronary interventions in patients with diabetes compared to those guided by angiography. However, due to the nature and size of the analysis, no firm conclusions could be reached. Based on 2 small, prospective, non-randomized controlled studies, IVUS guidance in percutaneous coronary interventions of left main coronary lesions using bare metal stents or drug-eluting stents did not result in any benefits in angiographic or clinical outcomes. These findings need to be confirmed. Interventions Using Drug-Eluting Stents There is presently no evidence on whether the addition of IVUS guidance during the implantation of drug-eluting stents would reduce incomplete stent apposition, or improve the angiographic or clinical outcomes of patients. Ontario-Based Economic Analysis Cost-effectiveness analysis showed that PCIs using IVUS guidance would likely be less costly and more effective than PCIs without IVUS guidance. The upfront cost of adjunctive use of IVUS in PCIs ranged from $1.56 million at 6% uptake to $13.04 million at 50% uptake. Taking into consideration cost avoidance from reduction in revascularization associated with the use of IVUS, a net saving of $0.63 million to $5.2 million is expected. However, since it is uncertain whether the reduction in revascularization rate resulting from the use of IVUS can be generalized to clinical settings in Ontario, further analysis on the budget impact and cost-effectiveness need to be conducted once Ontario-specific revascularization rates are verified. Factors to be Considered in the Ontario Context Applicability of Findings to Ontario The interim analysis of an Ontario field evaluation that compared drug-eluting stents to bare metal stents showed that the revascularization rates in low-risk patients with bare metal stents were much lower in Ontario compared to rates reported in randomized controlled trials (7.2% vs >17 %). Even though IVUS is presently not routinely used in the stenting of low-risk patients in Ontario, the revascularization rates in these patients in Ontario were shown to be lower than those reported for the IVUS groups reported in published studies. Based on this information and previous findings from the Ontario field evaluation on stenting, it is uncertain whether the reduction in revascularization rates from IVUS guidance can be generalized to Ontario. In light of the above findings, it is advisable to validate the reported benefits of IVUS guidance in percutaneous coronary interventions involving bare metal stents in the Ontario context. Licensing Status As of January 16, 2006, Health Canada has licensed 10 intravascular ultrasound imaging systems/catheters for transluminal intervention procedures, most as class 4 medical devices. Current Funding IVUS is presently not an insured procedure under the Ontario Health Insurance Plan and there are no professional fees for this procedure. All costs related to the use of IVUS are covered within hospitals’ global budgets. A single use IVUS catheter costs approximately $900CDN and the procedure adds approximately 20 minutes to 30 minutes to a percutaneous coronary intervention procedure. Diffusion According to an expert consultant, current use of IVUS in coronary interventions in Ontario is probably limited to high-risk cases such as interventions in long lesions, small vessels, and bifurcated lesions for which images from coronary angiography are indeterminate. It was estimated that IVUS is being used in about 6% of all percutaneous coronary interventions at a large Ontario cardiac centre. Expert Opinion IVUS greatly enhances the cardiac interventionists’ ability to visualize and assess high-risk lesions such as long lesions, narrow lesions, and bifurcated lesions that may have indeterminate angiographic images. Information from IVUS in these cases facilitates the choice of the most appropriate approach for the intervention. Conclusion The use of adjunctive IVUS in PCIs using bare metal stents in lesions predominantly at low risk for restenosis had no significant impact on survival, myocardial infarction, or angiographic restenosis rates up to 2.5 years after intervention. The use of IVUS adjunctive to coronary angiography in percutaneous coronary interventions using bare metal stents in lesions predominantly at low risk for restenosis significantly reduced the target lesion and target vessel revascularization at a follow-up period of 18 months to 2.5 years. One small study suggests that adjunctive IVUS in PCIs using bare metal stents in long lesions (>20 mm) significantly improved the 6-month angiographic restenosis rate and one-year target lesion revascularization rate. These results need to be confirmed with large randomized controlled trials. Based on information from the Ontario field evaluation on stenting, it is uncertain whether the reduction in revascularization rate resulting from the use of IVUS in the placement of bare metal stents can be generalized to clinical settings in Ontario. There is presently insufficient evidence available to determine the impact of adjunctive IVUS in percutaneous interventions in high-risk lesions (other than long lesions) or in PCIs using drug-eluting stents. PMID:23074482

The Stent Patency and Migration Rate of Different Shaped Plastic Stents in Bile Flow Phantom Model and In Vivo Animal Bile Duct Dilation Model.

PubMed

Kwon, Chang-Il; Kim, Gwangil; Jeong, Seok; Lee, Don Haeng; Kim, Kyoung Ah; Ko, Kwang Hyun; Cho, Joo Young; Hong, Sung Pyo

2017-05-01

In research and development of biliary plastic stents (PS), continuous efforts have been made to overcome short patency time and high rate of migration. The aim of this study was to evaluate the patency and migration rate of different PS shapes for a given period of time. Using an in vitro bile phantom model, we compared the patency among different shapes of PS (three straight PS, four double-pigtail PS, and a new screw-shaped PS). We performed an analysis of the degree of luminal narrowing by light microscopic examination. Using an in vivo swine model, we compared the patency and migration rate among the three different types of PS. Eight weeks after the bile exposure in the bile flow phantom model, 80 PS were retrieved and analyzed. The straight PS showed less biofilm formation and luminal narrowing than other types of PS (p < 0.05). Forty-nine PS were inserted into the dilated bile ducts of 10 swine models, and 39 PS were successfully retrieved 8 weeks later. The stent migration occurred less frequently in the double-pigtail PS and the screw-shaped PS than it did in the straight PS (11.1, 10, and 27.3%, respectively). However, there was no statistical difference in stent patency among the different shapes. Stent patency may not be significantly different depending on the shape of PS for 8 weeks. The screw-shaped PS showed similar patency and migration rate to the double-pigtail PS. These results may help guiding future PS development and clinical decisions.

Agile patency system eliminates risk of capsule retention in patients with known intestinal strictures who undergo capsule endoscopy.

PubMed

Herrerias, Juan M; Leighton, Jonathan A; Costamagna, Guido; Infantolino, Anthony; Eliakim, Rami; Fischer, Doron; Rubin, David T; Manten, Howard D; Scapa, Eitan; Morgan, Douglas R; Bergwerk, Ari J; Koslowsky, Binyamin; Adler, Samuel N

2008-05-01

Capsule endoscopy (CE) of the small bowel has become a standard diagnostic tool, but there have been concerns regarding the risk of capsule retention in certain high-risk groups. The Agile patency system, an ingestible and dissolvable capsule with an external scanner, was developed to allow physicians to perform CE with greater confidence that the capsule will be safely excreted in patients at risk for capsule retention. Our purpose was to assess the ability of the device to help physicians identify which patients with known strictures may safely undergo CE. Patients with known strictures ingested the new patency capsule and underwent periodic scanning until it was excreted. The intestinal tract was considered to be sufficiently patent if the capsule was excreted intact or if the capsule was not detected by the scanner at 30 hours after ingestion. If patency was established, then standard CE was performed. International multicenter study. A total of 106 patients with known strictures. Agile patency system. Performance and safety of Agile patency system. A total of 106 patients ingested the patency capsule. Fifty-nine (56%) excreted it intact and subsequently underwent CE. There were no cases of capsule retention. Significant findings on CE were found in 24 (41%). There were 3 severe adverse events. These results suggest that the Agile patency system is a useful tool for physicians to use before CE in patients with strictures to avoid retention. This group of patients may have a high yield of clinically significant findings at CE. This capsule may determine whether patients who have a contraindication to CE may safely undergo CE and obtain useful diagnostic information.

Endovascular Treatment of Haemodialysis Arteriovenous Fistula with Drug-Coated Balloon Angioplasty: A Single-Centre Study.

PubMed

Lučev, Jernej; Breznik, Silva; Dinevski, Dejan; Ekart, Robert; Rupreht, Mitja

2018-06-01

To evaluate the effect of percutaneous transluminal angioplasty (PTA) on haemodialysis fistulas utilising drug-coated balloons with plain balloon vessel preparation (DCB). In the study group, 31 patients (16 men; mean age 62.8 ± 17.2 years) with failing arteriovenous fistulas were treated, with DCB, and compared with a control group (31 patients; 15 men; mean age 67.0 ± 8.44 years), in which only plain balloon PTA was performed. All stenoses were dilated with regular PTA balloons. After achieving haemodynamic success (< 30% residual stenosis), drug-coated balloons were used for drug administration in the study group. The follow-up intervals were 6, 12 and 24 months. Target lesion primary patency, primary assisted patency and secondary patency were compared. The statistical significance was set at 0.05. Target lesion primary patency was compared in both groups and was significantly higher in the study group (DCB) at 6 months (90.3 vs. 61.3%; p = 0.016), 12 months (77.4 vs. 29%; p = 0.0004) as well as 24 months (45.2 vs. 16.1%; p = 0.026). Kaplan-Meier survival curves also showed a significant difference for target lesion primary patency (534.2 vs. 315.7 days; p = 0.0004). There were no significant differences in target lesion primary assisted patency and in secondary patency. However, only 38.7% of patients in the study group were treated twice or more versus 80.6% in the control group (p = 0.002). DCB increases target lesion primary patency during the first 24 months and decreases the rate of reinterventions.

Influence of reproductive tract obstruction on expression of epididymal proteins and their restoration after patency.

PubMed

Li, Bing-Kun; Wang, Xiang; Liu, Chun-Xiao; Zheng, Shao-Bo; Li, Hu-Lin; Li, Li-Ping; Xu, A-Bai

2013-01-01

Vasectomy is a simple and reliable method of male contraception. A growing number of men after vasectomy request vasectomy reversal due to various reasons. The pregnancy rate is lower than the patency rate after vasovasostomy and the pregnancy rate is time dependent. In this study, we evaluated the influence of reproductive tract obstruction on expression of epididymal proteins and their restoration after patency. Adult male Wistar rats were studied 30, 60 and 120 days after vasectomy, 30 days after vasovasostomy or after sham operations. Two-dimensional gel electrophoresis, mass-spectrometric technique, multidatabase search, Western blotting and real-time PCR were used to analyze the expression regulation of epididymal proteins. Total integrated intensity and total spot area of autoradiograms showed a consistent downward trend with time after obstruction, and this trend remained after patency. The intensity of the autoradiographic spots in three patency groups showed three trends: a downward trend, similar intensity and an upward trend compared with the correspondent obstruction group, respectively. Further verified experiments on human epididymis 2 (HE2), fertilization antigen-1 (FA-1), clusterin and PH20 demonstrated that compared with the correspondent obstruction group, the translation levels of HE2 and the mRNA transcription levels of HE2 showed an upward trend in patency groups, especially in the groups of obstruction for 60 days where the expression levels of HE2 were significantly upregulated after patency (P<0.05). Reproductive tract obstruction provokes a disregulation of gene expression in the epididymis and this disregulation remained after patency. Successful reversal may recover some proteins and the recovery is time dependent. Obstruction differentially alters mRNA transcription of different proteins and the content of proteins seemed to be easier to be influenced than the gene transcription.

Does Technical Success of Angioplasty in Dysfunctional Hemodialysis Accesses Correlate with Access Patency?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sidhu, Arshdeep; Tan, Kong T.; Noel-Lamy, Maxime

2016-10-15

PurposeTo study if <30 % residual stenosis post angioplasty (PTA) correlates with primary access circuit patency, and if any variables predict technical success.Materials and MethodsA prospective observational study was performed between January 2009 and December 2012, wherein 76 patients underwent 154 PTA events in 56 prosthetic grafts (AVG) and 98 autogenous fistulas (AVF). Data collected included patient age, gender, lesion location and laterality, access type and location, number of prior interventions, and transonic flow rates pre- and postintervention. Impact of technical outcome on access patency was assessed. Univariate logistic regression was used to assess the impact of variables on technical success withmore » significant factors assessed with a multiple variable model.ResultsTechnical success rates of PTA in AVFs and AVGs were 79.6 and 76.7 %, respectively. Technical failures of PTA were associated with an increased risk of patency loss among circuits with AVFs (p < 0.05), but not with AVGs (p = 0.7). In AVFs, primary access patency rates between technical successes and failures at three and 6 months were 74.4 versus 61.9 % (p = 0.3) and 53.8 versus 23.8 % (p < 0.05), respectively. In AVGs, primary access patency rates between technical successes and failures at three and six months were 72.1 versus 53.9 % (p = 0.5) and 33.6 versus 38.5 % (p = 0.8), respectively. Transonic flow rates did not significantly differ among technically successful or failed outcomes at one or three months.ConclusionTechnical failures of PTA had a significant impact on access patency among AVFs with a trend toward poorer access patency within AVGs.« less

Does Technical Success of Angioplasty in Dysfunctional Hemodialysis Accesses Correlate with Access Patency?

PubMed

Sidhu, Arshdeep; Tan, Kong T; Noel-Lamy, Maxime; Simons, Martin E; Rajan, Dheeraj K

2016-10-01

To study if <30 % residual stenosis post angioplasty (PTA) correlates with primary access circuit patency, and if any variables predict technical success. A prospective observational study was performed between January 2009 and December 2012, wherein 76 patients underwent 154 PTA events in 56 prosthetic grafts (AVG) and 98 autogenous fistulas (AVF). Data collected included patient age, gender, lesion location and laterality, access type and location, number of prior interventions, and transonic flow rates pre- and postintervention. Impact of technical outcome on access patency was assessed. Univariate logistic regression was used to assess the impact of variables on technical success with significant factors assessed with a multiple variable model. Technical success rates of PTA in AVFs and AVGs were 79.6 and 76.7 %, respectively. Technical failures of PTA were associated with an increased risk of patency loss among circuits with AVFs (p < 0.05), but not with AVGs (p = 0.7). In AVFs, primary access patency rates between technical successes and failures at three and 6 months were 74.4 versus 61.9 % (p = 0.3) and 53.8 versus 23.8 % (p < 0.05), respectively. In AVGs, primary access patency rates between technical successes and failures at three and six months were 72.1 versus 53.9 % (p = 0.5) and 33.6 versus 38.5 % (p = 0.8), respectively. Transonic flow rates did not significantly differ among technically successful or failed outcomes at one or three months. Technical failures of PTA had a significant impact on access patency among AVFs with a trend toward poorer access patency within AVGs.

Applying the payoff time framework to carotid artery disease management.

PubMed

Yuo, Theodore H; Roberts, Mark S; Braithwaite, R Scott; Chang, Chung-Chou H; Kraemer, Kevin L

2013-11-01

and Asymptomatic stenosis of the carotid arteries is associated with stroke. Carotid revascularization can reduce the future risk of stroke but can also trigger an immediate stroke. The objective was to model the generic relationship between immediate risk, long-term benefit, and life expectancy for any one-time prophylactic treatment and then apply the model to the use of revascularization in the management of asymptomatic carotid disease. In the "payoff time" framework, the possibility of losing quality-adjusted life-years (QALYs) because of revascularization failure is conceptualized as an "investment" that is eventually recouped over time, on average. Using this framework, we developed simple mathematical forms that define relationships between the following: perioperative probability of stroke (P); annual stroke rate without revascularization (r0); annual stroke rate after revascularization, conditional on not having suffered perioperative stroke (r1); utility levels assigned to the asymptomatic state (ua) and stroke state (us); and mortality rates (λ). In patients whose life expectancy is below a critical life expectancy (CLE = P/(1-P)r0-r1, the "investment" will never pay off, and revascularization will lead to loss of QALYs, on average. CLE is independent of utilities assigned to the health states if a rank ordering exists in which ua > us. For clinically relevant values (P = 3%, r0 = 1%, r1 = 0.5%), the CLE is approximately 6.4 years, which is longer than published guidelines regarding patient selection for revascularization. In managing asymptomatic carotid disease, the payoff time framework specifies a CLE beneath which patients, on average, will not benefit from revascularization. This formula is suitable for clinical use at the patient's bedside and can account for patient variability, the ability of clinicians who perform revascularization, and the particular revascularization technology that is chosen.

Revascularization Treatment of Emergency Patients with Acute ST-Segment Elevation Myocardial Infarction in Switzerland: Results from a Nationwide, Cross-Sectional Study in Switzerland for 2010-2011.

PubMed

Berlin, Claudia; Jüni, Peter; Endrich, Olga; Zwahlen, Marcel

2016-01-01

Cardiovascular diseases are the leading cause of death worldwide and in Switzerland. When applied, treatment guidelines for patients with acute ST-segment elevation myocardial infarction (STEMI) improve the clinical outcome and should eliminate treatment differences by sex and age for patients whose clinical situations are identical. In Switzerland, the rate at which STEMI patients receive revascularization may vary by patient and hospital characteristics. To examine all hospitalizations in Switzerland from 2010-2011 to determine if patient or hospital characteristics affected the rate of revascularization (receiving either a percutaneous coronary intervention or a coronary artery bypass grafting) in acute STEMI patients. We used national data sets on hospital stays, and on hospital infrastructure and operating characteristics, for the years 2010 and 2011, to identify all emergency patients admitted with the main diagnosis of acute STEMI. We then calculated the proportion of patients who were treated with revascularization. We used multivariable multilevel Poisson regression to determine if receipt of revascularization varied by patient and hospital characteristics. Of the 9,696 cases we identified, 71.6% received revascularization. Patients were less likely to receive revascularization if they were female, and 80 years or older. In the multivariable multilevel Poisson regression analysis, there was a trend for small-volume hospitals performing fewer revascularizations but this was not statistically significant while being female (Relative Proportion = 0.91, 95% CI: 0.86 to 0.97) and being older than 80 years was still associated with less frequent revascularization. Female and older patients were less likely to receive revascularization. Further research needs to clarify whether this reflects differential application of treatment guidelines or limitations in this kind of routine data.

A prospective randomized study for efficacy of an uncovered double bare metal stent compared to a single bare metal stent in malignant biliary obstruction.

PubMed

Lee, Hyun Jik; Chung, Moon Jae; Park, Jeong Yup; Park, Seung Woo; Nam, Chung Mo; Song, Si Young; Bang, Seungmin

2017-08-01

A biliary self-expandable metal stent (SEMS) is commonly used to relieve malignant biliary obstruction. The aim of this study was to compare the efficacy of a conventional uncovered SEMS with that of a newly developed uncovered double bare metal stent in reducing the risk of stent occlusion caused by tumor ingrowth. We performed a prospective, open-labeled, randomized trial in 71 patients at Severance Hospital, Yonsei University College of Medicine from June 2013 to June 2014. Patients with inoperable malignant biliary obstruction were included and randomized to receive an uncovered single bare metal stent (SBSs; S&G Biotech Inc.), an uncovered single bare metal stent (SBSt; Taewoong Medical), or an uncovered double bare metal stent (DBS; S&G Biotech Inc.). The mean age was 66.6 years (range, 35-83), and 42 (59.2%) were male. The mean duration of stent patency was 212 days (±152) in the DBS group (n = 24) compared with 124 days (±98) in the SBSs group (n = 23; P = 0.022 for noninferiority) and 116 days (±79) in the SBSt group (n = 24; P = 0.010 for noninferiority). There were no differences in the incidences of early and delayed complications or migration. The newly developed DBS is noninferior to the conventional uncovered SEMSs on duration of stent patency and tumor ingrowth occurred less frequently in the DBS group. This might decrease the need for reintervention and offer a better quality of life. The trial is registered with Clinicaltrials.gov no: NCT01869894.

Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study.

PubMed

Schmidt, Arthur; Riecken, Bettina; Rische, Susanne; Klinger, Christoph; Jakobs, Ralf; Bechtler, Matthias; Kähler, Georg; Dormann, Arno; Caca, Karel

2015-05-01

Previous studies have shown superior patency rates for self-expandable metal stents (SEMS) compared with plastic stents in patients with malignant biliary obstruction. The aim of this study was to compare stent patency, patient survival, and complication rates between a newly designed, wing-shaped, plastic stent and SEMSs in patients with unresectable, malignant, distal, biliary obstruction. A randomized, multicenter trial was conducted at four tertiary care centers in Germany. A total of 37 patients underwent randomization between March 2010 and January 2013. Patients underwent endoscopic retrograde cholangiography with insertion of either a wing-shaped, plastic stent without lumen or an SEMS.  Stent failure occurred in 10/16 patients (62.5 %) in the winged-stent group vs. 4/18 patients (22.2 %) in the SEMS group (P = 0.034). The median time to stent failure was 51 days (range 2 - 92 days) for the winged stent and 80 days (range 28 - 266 days) for the SEMS (P = 0.002). Early stent failure (< 8 weeks after placement) occurred in 8 patients (50 %) vs. 2 patients (11.1 %), respectively (P = 0.022). After obtaining the results from this interim analysis, the study was discontinued because of safety concerns. The frequency of stent failure was significantly higher in the winged-stent group compared with the SEMS group. A high incidence of early stent failure within 8 weeks was observed in the winged-stent group. Thus, the winged, plastic stent without central lumen may not be appropriate for mid or long term drainage of malignant biliary obstruction. Study registration ClinicalTrials.gov (NCT01063634). © Georg Thieme Verlag KG Stuttgart · New York.

Predictors of the patency of self-expandable metallic stents in malignant gastroduodenal obstruction.

PubMed

Kim, Seung Han; Chun, Hoon Jai; Yoo, In Kyung; Lee, Jae Min; Nam, Seung Joo; Choi, Hyuk Soon; Kim, Eun Sun; Keum, Bora; Seo, Yeon Seok; Jeen, Yoon Tae; Lee, Hong Sik; Um, Soon Ho; Kim, Chang Duck

2015-08-14

To investigate the predictive factors of self-expandable metallic stent patency after stent placement in patients with inoperable malignant gastroduodenal obstruction. A total of 116 patients underwent stent placements for inoperable malignant gastroduodenal obstruction at a tertiary academic center. Clinical success was defined as acceptable decompression of the obstructive lesion within the malignant gastroduodenal neoplasm. We evaluated patient comorbidities and clinical statuses using the World Health Organization's scoring system and categorized patient responses to chemotherapy using the Response Evaluation Criteria in Solid Tumors criteria. We analyzed the relationships between possible predictive factors and stent patency. Self-expandable metallic stent placement was technically successful in all patients (100%), and the clinical success rate was 84.2%. In a multivariate Cox proportional hazards model, carcinoembryonic antigen (CEA) levels were correlated with a reduction in stent patency [P = 0.006; adjusted hazard ratio (aHR) = 2.92, 95%CI: 1.36-6.25]. Palliative chemotherapy was statistically associated with an increase in stent patency (P = 0.009; aHR = 0.27, 95%CI: 0.10-0.72). CEA levels can easily be measured at the time of stent placement and may help clinicians to predict stent patency and determine the appropriate stent procedure.

Patency of cavopulmonary connection studied by single phase electron beam computed tomography.

PubMed

Choi, Byoung Wook; Park, Young Hwan; Lee, Jong Kyun; Kim, Dong Joon; Kim, Min Jung; Choe, Kyu Ok

2003-10-01

The shunt patency and anatomic alteration of central PA after cavopulmonary connection was assessed by one phase electron-beam computed tomography (EBCT) METHODS: Thirteen patients that received a bi-directional cavo-pulmonary shunt (BCPS, n = 7) or total cavo-pulmonary connection (TCPC, n = 6) were included. The patency of the shunt and the anatomy of intra-pericardial PA were evaluated by EBCT, and compared by angiography and echocardiography. EBCT accurately evaluated shunt patency and the anatomy of the intra-pericardial PA, except for the incorrect diagnosis of SVC-PA shunt patency and peripheral pulmonary stenosis in two TCPC patients. Both of these patients had bilateral SVC and received either bilateral BCPS or ligation of the left SVC respectively. The baffle between the IVC and PA was partly opacified through a fenestration of the baffle, but was not opacified in two patients without fenestration. EBCT accurately evaluated shunt patency and the anatomy of central PA, however, the accuracy was limited in two cases with bilateral SVC. The opacification of the intra-atrial baffle was insufficient in TCPC cases. Multi-phase CT angiography may overcome this limitation in this patient subset.

One step pulp revascularization treatment of an immature permanent tooth with chronic apical abscess: a case report.

PubMed

Shin, S Y; Albert, J S; Mortman, R E

2009-12-01

To describe a case in which a mandibular right second premolar with a necrotic pulp, sinus tract, periradicular radiolucency and an immature apex underwent revascularization via a single treatment approach. Revascularization procedures have the potential to heal a partially necrotic pulp, which can be beneficial for the continued root development of immature teeth. However, it is not clear which revascularization protocols are the most effective. This case report details the outcome of a successful revascularization procedure on tooth 45 (FDI) in a 12-year-old patient, eliminating the associated periapical pathosis within 19 months. The tooth was treated using coronal root irrigation with 6% NaOCl and 2% chlorhexidine without instrumentation in a single visit. The successful outcome of this case report suggests that this conservative revascularization treatment approach can preserve the vitality of the dental pulp stem cells and create a suitable environment for pulp regeneration, resulting in the completion of root maturation. The noninstrumentation procedure using 6% NaOCl and 2% chlorhexidine coronal irrigation may help preserve the remaining vital dental pulp stem cells believed to be critical for pulp revascularization. A single visit pulp revascularization protocol can be a favourable treatment option for an immature permanent tooth with a partially necrotic pulp.

Role of Stress Myocardial Scintigraphy in the Evaluation of Incompletely Revascularized Post-PCI Patients

PubMed Central

Galassi, Alfredo R.; Marzá, Francesco; Azzarelli, Salvatore; Tomasello, Salvatore D.

2011-01-01

Percutaneous coronary intervention (PCI) is actually the most used method of revascularization. Although complete revascularization remains a desirable goal, it may not be possible or not easy to plan in many patients. Thus, incomplete revascularization might be a preferred treatment strategy in selected patient categories. Stress myocardial scintigraphy, because of its high diagnostic accuracy and prognostic value and its ability to assess location and extent of myocardial ischemia regardless of symptoms as well as to evaluate patients who are unable to exercise or who have uninterpretable electrocardiogram, is of paramount importance for clinical decision making in patients with multivessel disease and incomplete revascularization. PMID:21941646

Influence of apical patency and filling material on healing process of dogs' teeth with vital pulp after root canal therapy.

PubMed

Holland, Roberto; Sant'Anna Júnior, Arnaldo; Souza, Valdir de; Dezan Junior, Eloi; Otoboni Filho, José Arlindo; Bernabé, Pedro Felício Estrada; Nery, Mauro Juvenal; Murata, Sueli Satomi

2005-01-01

The purpose of this study was to investigate the periapical healing process of dogs' teeth with or without apical patency and after root canal filling with two types of sealers. Forty roots of premolars and incisors were utilized. The root canals were over-instrumented and dressed with a corticosteroid-antibiotic solution for 7 days to obtain ingrowth of periapical connective tissue into the canals. After this period, the tissue was removed in half of the specimens (groups with patency) and preserved in the other half (groups without patency). Canals were filled by lateral condensation technique with gutta-percha points and either a calcium hydroxide-based sealer (Sealer Plus) or a Grossman's cement (Fill Canal). The animals were killed by anesthetic overdose 60 days after the endodontic treatment and anatomic pieces were obtained and prepared for histologic examination. Data were evaluated in a blind analysis on the basis of several histomorphologic parameters. The groups without patency had better results (p=0.01) than those in which the ingrown connective tissue was removed. Comparing the sealers, Sealer Plus had significantly better results (p=0.01) than Fill Canal. In conclusion, both the apical patency (presence or absence) and the type of root canal filling material influenced the periapical healing process in dogs' teeth with vital pulp after root canal treatment. The use of a calcium hydroxide-based sealer in teeth without apical patency yielded the best results among the experimental conditions proposed.

Impact of revascularization and factors associated with limb salvage in patients with diabetic foot.

PubMed

Hinojosa, Carlos A; Boyer-Duck, Estefanía; Anaya-Ayala, Javier E; Núñez-Salgado, Ana E; Laparra-Escareno, Hugo; Lizola, René

2018-01-01

Diabetic foot is a common cause of hospitalization. To examine the impact of revascularization on lower limb salvage. Retrospective study of diabetic patients with foot ulcers. The extent of tissue loss was assessed according to the PEDIS and Wagner classifications, and revascularization indications and techniques were evaluated. Factors involved with major amputation and limb salvage were assessed with Fisher's and chi-square tests. A total of 307 patients with a mean age of 61 years were included in the study; 198 (64%) were males; 53 (17%) underwent limb revascularization, 26 (8%) with endovascular techniques and 27 (9%) with open surgery; 27 belonged to PEDIS grade 3 (51%) and 21 (41%) to Wagner's classification grade 4; 52% of revascularized patients required major amputation versus 25% of those without revascularization. Comorbidities, demographic variables, complications and mortality showed no differences when patients who required major amputation were compared with those who didn't. Despite revascularization, the limb was preserved in less than 50% of patients. Early referral to vascular surgery and appropriate patient-selection criteria might increase limb salvage. Copyright: © 2018 SecretarÍa de Salud.

Left subclavian artery revascularization in zone 2 thoracic endovascular aortic repair is associated with lower stroke risk across all aortic diseases.

PubMed

Bradshaw, Rhiannon J; Ahanchi, S Sadie; Powell, Obie; Larion, Sebastian; Brandt, Colin; Soult, Michael C; Panneton, Jean M

2017-05-01

The best management strategy for the left subclavian artery (LSA) in pathologic processes of the aorta requiring zone 2 thoracic endovascular aortic repair (TEVAR) remains controversial. We compared LSA coverage with or without revascularization as well as the different means of LSA revascularization. A retrospective chart review was conducted of patients with any aortic diseases who underwent zone 2 TEVAR deployment from 2007 to 2014. Primary end points included 30-day stroke and 30-day spinal cord injury (SCI). Secondary end points were 30-day procedure-related reintervention, freedom from aorta-related reintervention, aorta-related mortality, and all-cause mortality. We identified 96 patients with zone 2 TEVAR who met our inclusion criteria. The mean age of the patients was 62 years, with 61.5% male. Diseases included acute aortic dissections (n = 25), chronic aortic dissection with aneurysmal degeneration (n = 22), primary aortic aneurysms (n = 21), penetrating aortic ulcers/intramural hematomas (n = 17), and traumatic aortic injuries (n = 11). Strategies for the LSA included coverage with revascularization (n = 54) or without revascularization (n = 42). Methods of LSA revascularization included laser fenestration with stenting (n = 33) and surgical revascularization: transposition (n = 10) or bypass (n = 11). Of the 54 patients with LSA revascularization, 44 (81.5%) underwent LSA intervention at the time of TEVAR and 10 (18.5%) at a mean time of 33 days before TEVAR (range, 4-63 days). For the entire cohort, the overall incidence of 30-day stroke was 7.3%; of 30-day SCI, 2.1%; and of procedure-related reintervention, 5.2%. At a mean follow-up of 24 months (range, 1-79 months), aorta-related reintervention was 15.6%, aorta-related mortality was 12.5%, and all-cause mortality was 29.2%. The 30-day stroke rate was highest for LSA coverage without revascularization (6/42 [14.3%]) compared with any form of LSA revascularization (1/54 [1.9%]; P = .020), with no difference between LSA interventions done synchronously with TEVAR (1/44 [2.3%]) vs metachronously with TEVAR (0/10 [0%]; P = .63). There was no significant difference in 30-day SCI in LSA coverage without revascularization (2/42 [4.8%]) vs with revascularization (0/54 [0%]; P = .11). There was no difference in aorta-related reintervention, aorta-related mortality, or all-cause mortality in coverage without revascularization (5/42 [11.9%], 6/42 [14.3%], and 14/42 [33.3%]) vs with revascularization (10/54 [18.5%; P = .376], 6/54 [11.1%; P = .641], and 14/54 [25.9%; P = .43], respectively). After univariate and multivariable analysis, we identified LSA coverage without revascularization as associated with a higher rate of 30-day stroke (hazard ratio, 17.2; 95% confidence interval, 1.3-220.4; P = .029). Our study suggests that coverage of the LSA without revascularization increases the risk of stroke and possibly SCI. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Current guidelines recommend thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI); however, there are insufficient data to unequivocally support thrombectomy in patients with non-STEMI (NSTEMI). Methods/Design The TATORT-NSTEMI (Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction) trial is a prospective, controlled, multicenter, randomized, open-label trial enrolling 460 patients. The hypothesis is that, against a background of early revascularization, adjunctive thrombectomy leads to less microvascular obstruction (MO) compared with conventional percutaneous coronary intervention (PCI) alone, as assessed by cardiac magnetic resonance imaging (CMR) in patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary endpoint is the extent of late MO assessed by CMR. Secondary endpoints include early MO, infarct size, and myocardial salvage assessed by CMR as well as enzymatic infarct size and angiographic parameters, such as thrombolysis in myocardial infarction flow post-PCI and myocardial blush grade. Furthermore, clinical endpoints including death, myocardial re-infarction, target vessel revascularization, and new congestive heart failure will be recorded at 6 and 12 months. Safety will be assessed by the incidence of bleeding and stroke. Summary The TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit vessel reperfused by early PCI. Trial registration The trial is registered under http://www.clinicaltrials.gov: NCT01612312. PMID:23782681

Establishing Apical Patency and its Effect on Endodontic Outcomes

DTIC Science & Technology

2012-06-01

canal space and periodontal ligament. Establishing apical patency is controversial with only 50% of dental programs in the United States teaching the... periodontal ligament (PDL) (1) where a small file can passively continue through the apical foramen (2). Establishing apical patency is...teeth with apical periodontitis that will eventually heal demonstrate signs of healing at 1 year follow-up, and almost 50% are completely healed

Acute mesenteric ischemia of arterial origin: importance of early revascularization.

PubMed

Plumereau, F; Mucci, S; Le Naoures, P; Finel, J B; Hamy, A

2015-02-01

The goal of our study was to show that survival was better when early revascularization was performed rather than gastrointestinal resection in the management of acute mesenteric ischemia of arterial origin. The reports of patients managed in our center between January 2005 and May 2012 for acute mesenteric ischemia of arterial origin were analyzed retrospectively. Data on clinical, laboratory and radiologic findings, the interval before treatment, the operative findings and the surgical procedures were collected. Follow-up information included the postoperative course, and mortality at 48 h, 30 days and 1 year, the latter being compared between patients undergoing revascularization versus gastrointestinal resection. Of 43 patients treated during this period, 20 had gastrointestinal lesions deemed to be beyond all therapeutic resources, 13 were treated with gastrointestinal resection without revascularization, while 10 underwent early revascularization. There were no statistically significant differences found in the extent of involvement between the two groups (P=0.22). Mortality at 48 h, 30 days and 1 year was 8% (n=1), 30% (n=4) and 68% (n=8) in patients who underwent enterectomy vs. 0% (n=0), 0% (n=0) and 10% (n=1) in patients who underwent revascularization procedures. The difference at 1 year was statistically significant (P=0.02). At 1 year, two patients in the revascularized group had a short bowel syndrome vs. one in the non-revascularized group. Acute mesenteric ischemia of arterial origin is associated with high morbidity and mortality. Optimal management should include early revascularization. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Radiographic and Clinical Outcomes of the Treatment of Immature Permanent Teeth by Revascularization or Apexification: A Pilot Retrospective Cohort Study

PubMed Central

Alobaid, Adel S.; Cortes, Lina M.; Lo, Jeffery; Nguyen, Thuan T.; Albert, Jeffery; Abu-Melha, Abdulaziz S; Lin, Louis M.; Gibbs, Jennifer L.

2014-01-01

Introduction This retrospective cohort study compared clinical and radiographic outcomes of endodontic treatment performed in immature non-vital permanent teeth, by apexification (calcium hydroxide or apical barrier with Mineral Trioxide Aggregate (MTA)), versus revascularization. Methods A comprehensive chart review was performed to obtain a cohort of sequential previously completed cases with recalls. Clinical and radiographic data were collected for 31 treated teeth (19 revascularization and 12 apexification) with an average follow up time of 17 months and a recall rate of 63%. Tooth survival, success rate, and adverse events were analyzed. Changes in radiographic root length, width and area were quantified. Results The majority of treated teeth survived throughout the study period with 30/31 (97%) teeth surviving (18/19 (95%) revascularization, 12/12 apexification). Most cases were also clinically successful with 27/31 (87%) meeting criteria for success, (15/19 (78%) revascularization and 12/12 apexification; non-significant difference). A greater incidence of adverse events was observed in the revascularization group (8/19 (42%) versus 1/12 (11%) in apexification (Risk Ratio= 5.1, p=0.04, 95%CI (0.719, 35.48)). Although more revascularization cases than apexification cases demonstrated an increase in radiographic root area and width, the effect was not statistically significant. Conclusion In this study, revascularization was not superior to other apexification techniques in either clinical or radiographic outcomes. Studies with large subject cohorts, and long follow up periods are needed to evaluate outcomes of revascularization and apexification, while accounting for important co-variants relevant to clinical success. PMID:25069909

Should we consider off-pump coronary artery bypass grafting in patients with acute coronary syndrome?

PubMed

Moscarelli, Marco; Harling, Leanne; Ashrafian, Hutan; Athanasiou, Thanos

2013-03-01

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether off-pump coronary artery bypass (OPCAB) grafting should be considered as an alternative to the conventional on-pump surgery (ONCAB) in patients presenting with acute coronary syndrome (ACS) requiring emergency revascularization. Eighty-two papers were identified by a systematic search, of which nine were judged to best answer the clinical question. Of these, one was a randomized controlled trial and the remaining eight were retrospective observational studies. The author, journal, date, patient group, country of publication, relevant outcomes, results and study weaknesses were tabulated. In total, these nine studies included 3001 patients (n = 817 OPCAB, 2184 ONCAB) undergoing emergency revascularization in the setting of ACS. The timing between the onset of ACS and operative intervention ranged from 6 to 72 h. All cases were categorized as urgent/emergent according to the National confidential enquiry into patient outcome and death classification of intervention. Six studies included patients with preoperative cardiogenic shock; however the majority of patients were haemodynamically stable at the time of surgery. Three out of nine studies showed an improvement in 30-day mortality with OPCAB although the remaining six reveal no significant mortality benefit. No difference in long-term mortality was observed between the two techniques. OPCAB was associated with significantly fewer grafts per patient (six studies) and less complete revascularization (two studies). We conclude that whilst OPCAB may have a beneficial effect on 30-day mortality in haemodynamically stable patients undergoing emergency revascularization, there is a lack of high-quality data with clearly defined patient demographics. Future studies must ensure adequate preoperative matching between OPCAB and ONCAB groups and clearly categorize haemodynamic status, disease pattern and time to surgery in order to determine the patients in whom OPCAB may confer the greatest benefit.

The Impact of Apical Patency in the Success of Endodontic Treatment of Necrotic Teeth with Apical Periodontitis: A Brief Review.

PubMed

Machado, Ricardo; Ferrari, Carlos Henrique; Back, Eduardo; Comparin, Daniel; Tomazinho, Luiz Fernando; Vansan, Luiz Pascoal

2016-01-01

Accumulation of soft tissue or dentinal remnants in the apical region is a common event that can cause blockage of root canals. This event can be avoided if apical patency is performed during the root canal shaping procedures. However, there is no consensus on the role of apical patency in relation to the success of endodontic treatment of necrotic teeth with apical periodontitis. Therefore, the purpose of this paper was to conduct a brief review on the role of apical patency in guaranteeing the success of endodontic treatments of necrotic teeth with apical periodontitis considering two other key points; the root canal anatomy and microbiology.

Omega-3 Polyunsaturated Fatty Acid Supplementation to Prevent Arteriovenous Fistula and Graft Failure: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

PubMed

Viecelli, Andrea K; Irish, Ashley B; Polkinghorne, Kevan R; Hawley, Carmel M; Johnson, David W; Mori, Trevor A; Pascoe, Elaine M; Strippoli, Giovanni F M; Lok, Charmaine E; Palmer, Suetonia C

2018-07-01

Arteriovenous access failure frequently occurs in people on hemodialysis and is associated with morbidity, mortality and large healthcare expenditures. Omega-3 polyunsaturated fatty acids (omega-3 PUFA) may improve access outcomes via pleiotropic effects on access maturation and function, but may cause bleeding complications. Systematic review with meta-analysis. Adults requiring hemodialysis via arteriovenous fistula or graft. Trials evaluating omega-3 PUFA for arteriovenous access outcomes identified by searches in CENTRAL, MEDLINE, and Embase to 24 January 2017. Omega-3 PUFA. Primary patency loss, dialysis suitability failure, access abandonment, interventions to maintain patency or assist maturation, bleeding, gastrointestinal side-effects, all-cause and cardiovascular mortality, hospitalization, and treatment adherence. Treatment effects were summarized as relative risks (RR) and 95% confidence intervals (CI). Evidence was assessed using GRADE. Five eligible trials (833 participants) with a median follow-up of 12 months compared peri-operative omega-3 PUFA supplementation with placebo. One trial (n=567) evaluated treatment for fistulae and four (n=266) for grafts. Omega-3 PUFA supplementation prevented primary patency loss with moderate certainty (761 participants, RR 0.81, CI 0.68-0.98). Low quality evidence suggested, that omega-3 PUFA may have had little or no effect on dialysis suitability failure (536 participants, RR 0.95, CI 0.73-1.23), access abandonment (732 participants, RR 0.78, CI 0.59-1.03), need for interventions (732 participants, RR 0.82, CI 0.64-1.04), or all-cause mortality (799 participants, RR 0.99, CI 0.51-1.92). Bleeding risk (793 participants, RR 1.40, CI 0.78-2.49) or gastrointestinal side-effects (816 participants, RR 1.22, CI 0.64-2.34) from treatment were uncertain. There was no evidence of different treatment effects for grafts and fistulae. Small number and methodological limitations of included trials. Omega-3 PUFA supplementation probably protects against primary loss of arteriovenous access patency, but may have little or no effect on dialysis suitability failure, access interventions or access abandonment. Potential treatment harms are uncertain. Copyright © 2018 National Kidney Foundation, Inc. All rights reserved.

B-Type Natriuretic Peptide Assessment in Patients Undergoing Revascularization for Left Main Coronary Artery Disease: Analysis from the EXCEL Trial.

PubMed

Redfors, Björn; Chen, Shmuel; Crowley, Aaron; Ben-Yehuda, Ori; Gersh, Bernard J; Lembo, Nicholas J; Brown, W Morris; Banning, Adrian P; Taggart, David P; Serruys, Patrick W; Kappetein, Arie Pieter; Sabik, Joseph F; Stone, Gregg W

2018-04-17

Background -Elevated B-type natriuretic peptide (BNP) is reflective of impaired cardiac function and is associated with worse prognosis among patients with coronary artery disease (CAD). We sought to assess the association between baseline BNP, adverse outcomes, and the relative efficacy of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) in patients with left main (LM) CAD. Methods -The EXCEL trial randomized patients with LMCAD and low or intermediate SYNTAX scores to PCI with everolimus-eluting stents versus CABG. The primary endpoint was the composite of all-cause death, myocardial infarction (MI) or stroke. We used multivariable Cox proportional hazards regression to assess the associations between normal versus elevated BNP (≥100 pg/mL), randomized treatment, and the 3-year risk of adverse events. Results -BNP at baseline was elevated in 410 of 1037 (39.5%) patients enrolled in EXCEL. Patients with elevated BNP levels were older and more frequently had additional cardiovascular risk factors and lower LVEF than those with normal BNP, but had similar SYNTAX scores. Patients with elevated BNP had significantly higher 3-year rates of the primary endpoint (18.6% vs. 11.7%, adjusted HR 1.62, 95% CI 1.16-2.28, P=0.005), and higher mortality (11.5% vs. 3.9%, adjusted HR 2.49, 95% CI 1.48-4.19, P=0.0006), both from cardiovascular and non-cardiovascular causes. In contrast, there were no significant differences in the risks of MI, stroke, ischemia-driven revascularization, stent thrombosis, graft occlusion, or major bleeding. A significant interaction (P interaction =0.03) was present between elevated versus normal BNP and treatment with PCI versus CABG for the adjusted risk of the primary composite endpoint at 3 years among patients with elevated BNP (adjusted HR for PCI versus CABG 1.54, 95% CI 0.96-2.47) versus normal BNP (adjusted HR 0.74, 95% CI 0.46-1.20). This interaction was stronger when log(BNP) was modeled as a continuous variable (P interaction =0.002). Conclusions -In the EXCEL trial, elevated baseline BNP levels in patients with LMCAD undergoing revascularization were independently associated with long-term mortality but not non-fatal adverse ischemic or bleeding events. The relative long-term outcomes after PCI vs. CABG for revascularization of LMCAD may be conditioned by the baseline BNP level. Clinical Trial Registration -URL: http://www.clinicaltrials.gov. Unique identifier: NCT01205776.

Clinical results of carotid artery stenting versus carotid endarterectomy

PubMed Central

Akinci, Tuba; Derle, Eda; Kibaroğlu, Seda; Harman, Ali; Kural, Feride; Cınar, Pınar; Kilinc, Munire; Akay, Hakki T.; Can, Ufuk; Benli, Ulku S.

2016-01-01

Objective: To review our results of carotid artery stenting (CAS) and carotid endarterectomy (CEA). Methods: We evaluated the medical records of patients undergoing carotid artery revascularization procedure, between 2001 and 2013 in Baskent University Hospital, Ankara, Turkey. Carotid artery stenting or CEA procedures were performed in patients with asymptomatic carotid stenosis (≥70%) or symptomatic stenosis (≥50%). Demographic data, procedural details, and clinical outcomes were recorded. Primary outcome measures were in 30-day stroke/transient ischemic attacks (TIA)/amaurosis fugax or death. Secondary outcome measures were nerve injury, bleeding complications, length of stay in hospital, stroke, restenosis (ICA patency), and all-cause death during long-term follow-up. Results: One hundred ninety-four CEA and 115 CAS procedures were performed for symptomatic and/or asymptomatic carotid artery stenosis. There is no significant differences 30-day mortality and neurologic morbidity between CAS (13%) and CEA procedures (7.7%). Length of stay in hospital were significantly longer in CEA group (p=0.001). In the post-procedural follow up, only in symptomatic patients, restenosis rate was higher in the CEA group (p=.045). The other endpoints did not differ significantly. Conclusions: Endovascular stent treatment of carotid artery atherosclerotic disease is an alternative for vascular surgery, especially for patients that are high risk for standard CEA. The increasing experience, development of cerebral protection systems and new treatment protocols increases CAS feasibility. PMID:27744460

Drug-coated balloon angioplasty for de novo small vessel disease including chronic total occlusion and bifurcation in real-world clinical practice.

PubMed

Onishi, Takayuki; Onishi, Yuko; Kobayashi, Isshi; Umezawa, Shigeo; Niwa, Akihiro

2018-06-18

The aim of this study is to validate the efficacy of drug-coated balloons (DCBs) for real-world de novo small vessel diseases including chronic total occlusion and bifurcation. DCB angioplasty has been reported to be effective in the treatment of de novo small vessel disease. However, the number of reports that have focused on complex lesions is limited. This observational study comprised consecutive patients who underwent DCB angioplasty for de novo small vessel disease with a reference diameter of less than 2.5 mm by visual estimation. Outcome parameters included late lumen loss, restenosis rate, and major adverse cardiac events, such as cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). Fifty-two patients underwent DCB angioplasty for 59 lesions with a reference vessel diameter of 1.93 ± 0.63 mm. Thirty-eight of the lesions (69%) were classified as type B2/C, including chronic total occlusions (20%) and bifurcations (33%). At the 8-month follow-up, late lumen loss was - 0.01 ± 0.44 mm with a restenosis rate of 20%. No cardiac deaths or myocardial infarctions were reported and only 5 (9%) angiographically driven TLRs were reported. DCB angioplasty offered an acceptable 8-month lumen patency and a stable clinical outcome for real-world complex de novo coronary diseases.

Impact of Body Mass Index on Outcomes after Mesenteric Revascularization for Chronic Mesenteric Ischemia.

PubMed

Mansukhani, Neel A; Hekman, Katherine E; Yoon, Dustin Y; Helenowski, Irene B; Hoel, Andrew W; Rodriguez, Heron E; Pearce, William H; Eskandari, Mark K; Tomita, Tadaki M

2018-04-01

Historically, patients with chronic mesenteric ischemia (CMI) are underweight with a low body mass index (BMI). However, with the recent obesity epidemic many of these patients now are overweight with a high BMI. We evaluated the impact of BMI on outcomes after mesenteric revascularization for CMI. A retrospective chart review of patients undergoing open or endovascular mesenteric revascularization for CMI between January 2000 and June 2015 was performed. Demographics, comorbidities, BMI, Society for Vascular Surgery-combined comorbidity score, treatment modality, postoperative complications, reintervention, and all-cause mortality were analyzed. The primary end point for the study was all-cause mortality at 5 years. Patients were stratified using the World Health Organization BMI criteria. Univariate, Kaplan-Meier survival, and multivariate analyses were performed. In the study period, 104 unique patients underwent mesenteric revascularization for CMI, for 77 of whom BMI information was available. Of these 77, 30 patients were treated by endovascular revascularization, and 47 patients were treated by open revascularization. Overall, 27 (35.1%) were overweight or obese with a BMI ≥25. Median follow-up time was 41 months. High BMI patients were less likely to have weight loss at the time of surgery (P = 0.004). Stratified by BMI <25 versus BMI ≥25, 5-year survival for patients treated by open revascularization was 90% versus 50% (P = 0.02); survival for patients treated by endovascular revascularization was 27% vs. 53% (P = 0.37). Multivariate survival analysis identified active smoking, hypertensive chronic kidney disease, open repair with the use of venous conduit instead of prosthetic conduit (P < 0.001), and history of peripheral arterial disease (PAD) (P = 0.002), as independent predictors of increased all-cause mortality. BMI needs to be considered in assessing and counseling patients on outcomes of mesenteric revascularization for CMI, as a BMI over 25 is associated with poorer long-term survival after open revascularization. Smoking, hypertensive chronic kidney disease, PAD, and open repair with the use of venous conduit are independent predictors of long-term mortality after mesenteric revascularization independent of BMI. Copyright © 2017 Elsevier Inc. All rights reserved.

The SPIRIT V study: a clinical evaluation of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery lesions.

PubMed

Grube, Eberhard; Chevalier, Bernard; Smits, Peter; Džavík, Vladimir; Patel, Tejas M; Mullasari, Ajit S; Wöhrle, Jochen; Stuteville, Marrianne; Dorange, Cécile; Kaul, Upendra

2011-02-01

The SPIRIT V (A Clinical Evaluation of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With De Novo Coronary Artery Lesions) study is a post-market surveillance experience of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) in patients with higher-risk coronary anatomy. Previous pre-approval studies have shown the safety and efficacy of EES in highly selected groups of patients. The SPIRIT V trial is a prospective, open label, single arm, multicenter study. Two thousand seven hundred patients with multiple de novo coronary artery lesions suitable for treatment with a planned maximum of 4 EES were enrolled at 93 centers in Europe, Asia Pacific, Canada, and South Africa. Lesions had a reference vessel diameter between 2.25 and 4.0 mm and a length of ≤ 28 mm by visual estimation. An independent clinical events committee adjudicated all end point-related events. The primary end point was the composite rate of all death, myocardial infarction (MI), and target vessel revascularization at 30 days. Secondary end points included stent thrombosis and acute success (clinical device and procedure success). At 30 days, the primary composite end point of all death, MI, and target vessel revascularization was 2.7%. At 1 year, rates of cardiac death, overall MI, and target lesion revascularization were 1.1%, 3.5%, and 1.8%, respectively. The cumulative rate of definite and probable stent thrombosis was low at 0.66% at 1 year. Use of EES in patients with multiple, complex de novo lesions yielded 1-year major adverse cardiac events, stent thrombosis, and target lesion revascularization rates that are comparable to those of the more controlled SPIRIT II and SPIRIT III trials-which included patients with restricted inclusion/exclusion criteria-and other all-comer population, physician-initiated studies like the X-SEARCH (Xience Stent Evaluated At Rotterdam Cardiology Hospital) and COMPARE (A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice) trials. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Treatment of complex coronary artery disease in patients with diabetes: 5-year results comparing outcomes of bypass surgery and percutaneous coronary intervention in the SYNTAX trial.

PubMed

Kappetein, Arie Pieter; Head, Stuart J; Morice, Marie-Claude; Banning, Adrian P; Serruys, Patrick W; Mohr, Friedrich-Wilhelm; Dawkins, Keith D; Mack, Michael J

2013-05-01

This prespecified subgroup analysis examined the effect of diabetes on left main coronary disease (LM) and/or three-vessel disease (3VD) in patients treated with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in the SYNTAX trial. Patients (n = 1800) with LM and/or 3VD were randomized to receive either PCI with TAXUS Express paclitaxel-eluting stents or CABG. Five-year outcomes in subgroups with (n = 452) or without (n = 1348) diabetes were examined: major adverse cardiac or cerebrovascular events (MACCE), the composite safety end-point of all-cause death/stroke/myocardial infarction (MI) and individual MACCE components death, stroke, MI and repeat revascularization. Event rates were estimated with Kaplan-Meier analyses. In diabetic patients, 5-year rates were significantly higher for PCI vs CABG for MACCE (PCI: 46.5% vs CABG: 29.0%; P < 0.001) and repeat revascularization (PCI: 35.3% vs CABG: 14.6%; P < 0.001). There was no difference in the composite of all-cause death/stroke/MI (PCI: 23.9% vs CABG: 19.1%; P = 0.26) or individual components all-cause death (PCI: 19.5% vs CABG: 12.9%; P = 0.065), stroke (PCI: 3.0% vs CABG: 4.7%; P = 0.34) or MI (PCI: 9.0% vs CABG: 5.4%; P = 0.20). In non-diabetic patients, rates with PCI were also higher for MACCE (PCI: 34.1% vs CABG: 26.3%; P = 0.002) and repeat revascularization (PCI: 22.8% vs CABG: 13.4%; P < 0.001), but not for the composite end-point of all-cause death/stroke/MI (PCI: 19.8% vs CABG: 15.9%; P = 0.069). There were no differences in all-cause death (PCI: 12.0% vs CABG: 10.9%; P = 0.48) or stroke (PCI: 2.2% vs CABG: 3.5%; P = 0.15), but rates of MI (PCI: 9.9% vs CABG: 3.4%; P < 0.001) were significantly increased in the PCI arm in non-diabetic patients. In both diabetic and non-diabetic patients, PCI resulted in higher rates of MACCE and repeat revascularization at 5 years. Although PCI is a potential treatment option in patients with less-complex lesions, CABG should be the revascularization option of choice for patients with more-complex anatomic disease, especially with concurrent diabetes.

The Combination of Sonography and Physical Examination Improves the Patency and Suitability of Hemodialysis Arteriovenous Fistula in Vascular Access.

PubMed

Mat Said, Normawati; Musa, Kamarul Imran; Mohamed Daud, Mohamed Ashraf; Haron, Juhara

2016-07-01

We compared the patency and the suitability of arteriovenous fistula (AVF) created for vascular access by two approaches: (a) physical examination with preoperative vascular mapping and (b) physical examination alone. We compared the patency and the suitability of AVF created in patients for dialysis. There were two cohorts of patients of 79 patients each: (a) patients with AVF created based on the combination of physical examination and preoperative vascular mapping (PE+VM) and (b) patients with AVF created based on physical examination (PE) alone. Fistula patency is defined as clinical detection of thrill (or auscultation) of murmur over the fistula and coded as having thrills (patent) versus not having thrills (not patent). Suitability of fistula is defined as functioning AVF (AVF can be adequately used via 2-needle cannulation for dialysis) and coded as suitable versus not suitable. AVF created after the preoperative vascular mapping (PE+VM) has 5.70 (at six weeks) and 3.76 (at three months) times higher chance for patency, and 3.08 times higher chance for suitable AVF for dialysis than AVF created after the physical examination (PE) alone. Physical examination with preoperative ultrasound mapping (PE+VM) significantly improves the short term patency and the suitability of AVF for dialysis.

Effect of Patency File on Transportation and Curve Straightening in Canal Preparation with ProTaper System

PubMed Central

Hasheminia, Seyed Mohsen

2013-01-01

The aim of this ex vivo study was to evaluate the effect of using a patency file on apical transportation and curve straightening during canal instrumentation with the ProTaper rotary system. Seventy permanent mandibular first molars with mesiobuccal canals, measuring 18–23 mm in length and with a 25–40° curvature (according to the Schneider method), were selected. The working lengths were determined and the teeth were mounted and divided into two experimental groups: (A) prepared by the ProTaper system without using a patency file (n = 35) and (B) prepared by the ProTaper system using a patency file (n = 35). Radiographs taken before and after the preparation were imported into Photoshop software and the apical transportation, and curve straightening were measured. Data were analyzed using independent t-test. Partial correlation analysis was performed to evaluate the relationship between the initial curvature, transportation, and curve straightening (α = 0.05). Using a patency file during canal preparation significantly decreased both apical transportation and curve straightening (P < 0.001). There were significant relationships between the angle of curvature, transportation and curve straightening in pairs (P < 0.001). Apical patency is recommended during root canal preparation with the ProTaper rotary system. PMID:24159390

Predictors of the patency of self-expandable metallic stents in malignant gastroduodenal obstruction

PubMed Central

Kim, Seung Han; Chun, Hoon Jai; Yoo, In Kyung; Lee, Jae Min; Nam, Seung Joo; Choi, Hyuk Soon; Kim, Eun Sun; Keum, Bora; Seo, Yeon Seok; Jeen, Yoon Tae; Lee, Hong Sik; Um, Soon Ho; Kim, Chang Duck

2015-01-01

AIM: To investigate the predictive factors of self-expandable metallic stent patency after stent placement in patients with inoperable malignant gastroduodenal obstruction. METHODS: A total of 116 patients underwent stent placements for inoperable malignant gastroduodenal obstruction at a tertiary academic center. Clinical success was defined as acceptable decompression of the obstructive lesion within the malignant gastroduodenal neoplasm. We evaluated patient comorbidities and clinical statuses using the World Health Organization’s scoring system and categorized patient responses to chemotherapy using the Response Evaluation Criteria in Solid Tumors criteria. We analyzed the relationships between possible predictive factors and stent patency. RESULTS: Self-expandable metallic stent placement was technically successful in all patients (100%), and the clinical success rate was 84.2%. In a multivariate Cox proportional hazards model, carcinoembryonic antigen (CEA) levels were correlated with a reduction in stent patency [P = 0.006; adjusted hazard ratio (aHR) = 2.92, 95%CI: 1.36-6.25]. Palliative chemotherapy was statistically associated with an increase in stent patency (P = 0.009; aHR = 0.27, 95%CI: 0.10-0.72). CONCLUSION: CEA levels can easily be measured at the time of stent placement and may help clinicians to predict stent patency and determine the appropriate stent procedure. PMID:26290640

Association between patency of the circle of Willis and diabetes mellitus in patients with cerebral ischaemic stroke

PubMed Central

Chi, Ying

2017-01-01

Objective To examine patency of the cerebral anterior and posterior communicating arteries in patients with ischaemic stroke with or without diabetes mellitus. Methods This retrospective study included patients with acute ischaemic stroke treated between July 2011 and May 2016. Cerebral infarction was evaluated by magnetic resonance imaging. Anterior and posterior communicating-artery patency was determined using magnetic resonance angiography. Vessels were defined as patent or occluded. Results Out of 1 406 patients, incidence of vertebral basilar artery brain infarction and posterior cerebral artery brain infarction were significantly higher in patients with diabetes versus those without diabetes (35.5% versus 22.3% and 11.7% versus 6.8%, respectively). Among patients with posterior cerebral artery brain infarction, anterior and posterior communicating-artery patency rates were higher in patients with diabetes versus those without diabetes (66.7 versus 23.5% and 33.3% versus 5.9% [bilateral], respectively). Among patients with vertebral basilar artery infarction and posterior cerebral artery P1 segment infarction, patency rate of the anterior communicating artery was higher in patients with diabetes versus those without diabetes (55.7% versus 45.9%). Conclusion Among patients with ischaemic stroke, patency rate of the circle of Willis may be higher in patients with diabetes than those without diabetes. PMID:28173711

Effect of Patency File on Transportation and Curve Straightening in Canal Preparation with ProTaper System.

PubMed

Hasheminia, Seyed Mohsen; Farhadi, Nastaran; Shokraneh, Ali

2013-01-01

The aim of this ex vivo study was to evaluate the effect of using a patency file on apical transportation and curve straightening during canal instrumentation with the ProTaper rotary system. Seventy permanent mandibular first molars with mesiobuccal canals, measuring 18-23 mm in length and with a 25-40° curvature (according to the Schneider method), were selected. The working lengths were determined and the teeth were mounted and divided into two experimental groups: (A) prepared by the ProTaper system without using a patency file (n = 35) and (B) prepared by the ProTaper system using a patency file (n = 35). Radiographs taken before and after the preparation were imported into Photoshop software and the apical transportation, and curve straightening were measured. Data were analyzed using independent t-test. Partial correlation analysis was performed to evaluate the relationship between the initial curvature, transportation, and curve straightening (α = 0.05). Using a patency file during canal preparation significantly decreased both apical transportation and curve straightening (P < 0.001). There were significant relationships between the angle of curvature, transportation and curve straightening in pairs (P < 0.001). Apical patency is recommended during root canal preparation with the ProTaper rotary system.

Provisional vs. two-stent technique for unprotected left main coronary artery disease after ten years follow up: A propensity matched analysis.

PubMed

D'Ascenzo, Fabrizio; Iannaccone, Mario; Giordana, Francesca; Chieffo, Alaide; Connor, Stephen O; Napp, L Christian; Chandran, SujaySubash; de la Torre Hernández, José María; Chen, Shao-Liang; Varbella, Ferdinando; Omedè, Pierluigi; Taha, Salma; Meliga, Emanuele; Kawamoto, Hiroyoshi; Montefusco, Antonio; Chong, Mervyn; Garot, Philippe; Sin, Lin; Gasparetto, Valeria; Abdirashid, Mohamed; Cerrato, Enrico; Biondi-Zoccai, Giuseppe; Gaita, Fiorenzo; Escaned, Javier; Hiddick Smith, David; Lefèvre, Thierry; Colombo, Antonio; Sheiban, Imad; Moretti, Claudio

2016-05-15

There is uncertainty on which stenting approach confers the best long-term outlook for unprotected left main (ULM) bifurcation disease. This is a non-randomized, retrospective study including all consecutive patients with 50% stenosis of the left main involving at least 1 of the arteries stemming from the left main treated with drug-eluting stents (DES) in 9 European centers between 2002 and 2004. Patients were divided into two groups: those treated with provisional stentings vs. those treated with two stent strategy. The outcomes of interest were 10-year rates of target lesion revascularization (TLR), major adverse cardiac events (MACE), and their components (cardiovascular death, myocardial infarction [MI], or repeat revascularization), along with stent thrombosis (ST). A total of 285 patients were included, 178 (62.5%) in the provisional stenting group and 87 (37.5%) in the two stent group. After 10 years, no differences in TLR were found at unadjusted analysis (19% vs 25%, p>0.05) nor after propensity score matching (25% vs 28%, p>0.05). Similar rates of MACE (60% vs 66%, p>0.05), death (34% vs 43%, p>0.05), MI (9% vs 14%, p>0.05) and ST were also disclosed at propensity-based analysis. Even after 10 year follow-up, patients treated with provisional stenting on left main showed comparable rates of target lesion revascularization compared to two stent strategy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Treatment of central venous in-stent restenosis with repeat stent deployment in hemodialysis patients.

PubMed

Ronald, James; Davis, Bradley; Guevara, Carlos J; Pabon-Ramos, Waleska M; Smith, Tony P; Kim, Charles Y

2017-05-15

To report patency rates for stent deployment for treatment of in-stent stenosis of the central veins of the chest in hemodialysis patients. A retrospective analysis was performed on 29 patients who underwent 35 secondary percutaneous transluminal stent (PTS) deployments for in-stent stenosis within the central veins that were refractory to angioplasty and ipsilateral to a functioning hemodialysis access (in-stent PTS group). For comparison, patency data were acquired for 47 patients who underwent 78 successful percutaneous transluminal angioplasty (PTA) procedures for in-stent stenosis (in-stent PTA group) and 55 patients who underwent 55 stent deployments within native central vein stenosis refractory to angioplasty (native vein PTS group). The 3-, 6-, and 12-month primary lesion patency for the in-stent PTS group was 73%, 57%, and 32%, respectively. The 3-, 6-, and 12-month primary patency for the in-stent PTA group was 70%, 38%, and 17% and for the native vein PTS group was 78%, 57%, and 26%, which were similar to the in-stent PTS group (p = 0.20 and 0.41, respectively). The 3-, 6-, and 12-month secondary access patency was 91%, 73%, and 65% for the in-stent PTS group. Sub-analysis of the in-stent PTS group revealed no difference in primary (p = 0.93) or secondary patency rates (p = 0.27) of bare metal stents (n = 23) compared with stent grafts (n = 12). Stent deployment for central vein in-stent stenosis refractory to angioplasty was associated with reasonable patency rates, which were similar to in-stent PTA and native vein PTS.

Variation in Management of Patients With Obstructive Coronary Artery Disease: Insights From the Veterans Affairs Clinical Assessment and Reporting Tool (VA CART) Program.

PubMed

Sandhu, Amneet; Stanislawski, Maggie A; Grunwald, Gary K; Guinn, Kathryn; Valle, Javier; Matlock, Daniel; Ho, P Michael; Maddox, Thomas M; Bradley, Steven M

2017-09-12

Little is known about facility-level variation in the use of revascularization procedures for the management of stable obstructive coronary artery disease. Furthermore, it is unknown if variation in the use of coronary revascularization is associated with use of other cardiovascular procedures. We evaluated all elective coronary angiograms performed in the Veterans Affairs system between September 1, 2007, and December 31, 2011, using the Clinical Assessment and Reporting Tool and identified patients with obstructive coronary artery disease. Patients were considered managed with revascularization if they received percutaneous coronary intervention (PCI) or coronary artery bypass grafting within 30 days of diagnosis. We calculated risk-adjusted facility-level rates of overall revascularization, PCI, and coronary artery bypass grafting. In addition, we determined the association between facility-level rates of revascularization and post-PCI stress testing. Among 15 650 patients at 51 Veterans Affairs sites who met inclusion criteria, the median rate of revascularization was 59.6% (interquartile range, 55.7%-66.7%). Across all facilities, risk-adjusted rates of overall revascularization varied from 41.5% to 88.1%, rate of PCI varied from 23.2% to 80.6%, and rate of coronary artery bypass graftingvariedfrom 7.5% to 36.5%. Of 6179 patients who underwent elective PCI, the median rate of stress testing in the 2 years after PCI was 33.7% (interquartile range, 30.7%-47.1%). There was no evidence of correlation between facility-level rate of revascularization and follow-up stress testing. Within the Veterans Affairs system, we observed large facility-level variation in rates of revascularization for obstructive coronary artery disease, with variation driven primarily by PCI. There was no association between facility-level use of revascularization and follow-up stress testing, suggesting use rates are specific to a particular procedure and not a marker of overall facility-level use. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

The no-touch saphenous vein graft in elderly coronary bypass patients with multiple comorbidities is a promising conduit to substitute the left internal thoracic artery.

PubMed

Samano, Ninos; Geijer, Håkan; Bodin, Lennart; Arbeus, Mikael; Mannion, John D; Dashwood, Michael; Souza, Domingos

2017-08-01

We investigated the patency rates of no-touch saphenous vein grafts anastomosed to the left anterior descending artery compared with the left internal thoracic artery. Further, we compared the patency of no-touch vein grafts to the left anterior descending artery with the patency of no-touch vein grafts to other coronary arteries. Of 2635 consecutive patients undergoing coronary artery bypass grafting between 2003 and 2008, 168 (6.3%) were given at least a saphenous vein graft to the left anterior descending artery to avoid harvesting complications in high-risk patients or in response to a left internal thoracic artery injury. A total of 97 patients were consecutively included after informed consent. A clinical examination and computed tomography angiography were performed on 91 patients at a mean of 6 (4-9) years. The mean age of patients was 75.6 ± 8.5 years. Postoperatively, 88.7% of patients (86/97) were free of angina. The 91 examined patients had 163 grafts with 286 distal anastomoses. Crude patency, according to distal anastomoses, was 94.4% (270/286). The patency of single versus sequential no-touch vein grafts to the left anterior descending artery was 98% (50/51) versus 92.5% (37/40). The total patency rate was 95.6% (87/91), similar to the reported patency rate for the left internal thoracic artery. The no-touch grafts to the left anterior descending artery versus other coronaries had a patency of 95.6% (87/91) versus 93.8% (183/195), a high similarity confirmed by an equivalence analysis. In elderly coronary bypass patients with multiple comorbidities, a no-touch saphenous vein graft is a promising substitute for the left internal thoracic artery. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Bioengineered human acellular vessels for dialysis access in patients with end-stage renal disease: two phase 2 single-arm trials

PubMed Central

Lawson, Jeffrey H; Glickman, Marc H; Ilzecki, Marek; Jakimowicz, Tomasz; Jaroszynski, Andrzej; Peden, Eric K; Pilgrim, Alison J; Prichard, Heather L; Guziewicz, Malgorzata; Przywara, Stanisław; Szmidt, Jacek; Turek, Jakub; Witkiewicz, Wojciech; Zapotoczny, Norbert; Zubilewicz, Tomasz; Niklason, Laura E

2016-01-01

Summary Background For patients with end-stage renal disease who are not candidates for fistula, dialysis access grafts are the best option for chronic haemodialysis. However, polytetrafluoroethylene arteriovenous grafts are prone to thrombosis, infection, and intimal hyperplasia at the venous anastomosis. We developed and tested a bioengineered human acellular vessel as a potential solution to these limitations in dialysis access. Methods We did two single-arm phase 2 trials at six centres in the USA and Poland. We enrolled adults with end-stage renal disease. A novel bioengineered human acellular vessel was implanted into the arms of patients for haemodialysis access. Primary endpoints were safety (freedom from immune response or infection, aneurysm, or mechanical failure, and incidence of adverse events), and efficacy as assessed by primary, primary assisted, and secondary patencies at 6 months. All patients were followed up for at least 1 year, or had a censoring event. These trials are registered with ClinicalTrials.gov, NCT01744418 and NCT01840956. Findings Human acellular vessels were implanted into 60 patients. Mean follow-up was 16 months (SD 7·6). One vessel became infected during 82 patient-years of follow-up. The vessels had no dilatation and rarely had post-cannulation bleeding. At 6 months, 63% (95% CI 47–72) of patients had primary patency, 73% (57–81) had primary assisted patency, and 97% (85–98) had secondary patency, with most loss of primary patency because of thrombosis. At 12 months, 28% (17–40) had primary patency, 38% (26–51) had primary assisted patency, and 89% (74–93) had secondary patency. Interpretation Bioengineered human acellular vessels seem to provide safe and functional haemodialysis access, and warrant further study in randomised controlled trials. Funding Humacyte and US National Institutes of Health. PMID:27203778

Do catheter washouts extend patency time in long-term indwelling urethral catheters? A randomized controlled trial of acidic washout solution, normal saline washout, or standard care.

PubMed

Moore, Katherine N; Hunter, Kathleen F; McGinnis, Rosemary; Bacsu, Chasta; Fader, Mandy; Gray, Mikel; Getliffe, Kathy; Chobanuk, Janice; Puttagunta, Lakshmi; Voaklander, Donald C

2009-01-01

Blockage of long-term indwelling catheters with mineral deposit is an ongoing management issue, but evidence on optimal management is lacking. Our purpose was to examine whether catheter washouts prevent or reduce catheter blockage. A multisite randomized controlled trial. Adults with long-term indwelling catheters that required changing every 3 weeks or less, living in the community, and requiring supportive or continuing care were recruited. Participants were randomly assigned to 1 of 3 groups: control (usual care, no washout), saline washout, or commercially available acidic washout solution (Contisol Maelor Pharmaceuticals Ltd, Wrexham, UK). At baseline visit, the catheter was changed and participants were followed weekly for 8 weeks, with checks for catheter patency and urine pH. Participants randomized to saline or commercial solution had a weekly washout with the appropriate solution. Endpoints were 8 weeks (completion data), 3 or more catheter changes in the 8-week period, or symptomatic urinary tract infection (UTI) requiring antibiotics. The study hypothesis was that catheter life would be extended by 25% in the commercial solution group. It was not possible to blind participants or research nurses to washout versus no intervention, but participants in the saline and washout solution groups were blinded to solution type. One hundred twelve potential participants were screened; 73 were enrolled, randomized, and included in the final analysis. Of these, 53 completed the full 8 weeks of data collection; 16 terminated early because of 3 catheter changes or self-reported 'UTI'. Other reasons for termination were hematuria, latex sensitivity, deceased/severe illness, or personal choice. Analysis of variance was used to analyze mean differences on demographic variables and mean number of weeks in study. Kaplan-Meier survival curve analysis showed no statistical difference between the groups in time to first catheter change. At this time, the evidence is insufficient to state whether catheter washout with saline or Contisol is more effective than usual care with no washout in preventing blocking. No increased risk of UTI was associated with washout regimes.

Association of left subclavian artery coverage without revascularization and spinal cord ischemia in patients undergoing thoracic endovascular aortic repair: A Vascular Quality Initiative® analysis.

PubMed

Teixeira, Pedro Gr; Woo, Karen; Beck, Adam W; Scali, Salvatore T; Weaver, Fred A

2017-12-01

Objectives Investigate the impact of left subclavian artery coverage without revascularization on spinal cord ischemia development in patients undergoing thoracic endovascular aortic repair. Methods The Vascular Quality Initiative thoracic endovascular aortic repair module (April 2011-July 2014) was analyzed. Patients undergoing left subclavian artery coverage were divided into two groups according to revascularization status. The association between left subclavian artery revascularization with the primary outcome of spinal cord ischemia and the secondary outcome of stroke was assessed with multivariable analysis adjusting for between-group baseline differences. Results The left subclavian artery was covered in 508 (24.6%) of the 2063 thoracic endovascular aortic repairs performed. Among patients with left subclavian artery coverage, 58.9% underwent revascularization. Spinal cord ischemia incidence was 12.1% in the group without revascularization compared to 8.5% in the group undergoing left subclavian artery revascularization (odds ratio (95%CI): 1.48(0.82-2.68), P = 0.189). Multivariable analysis adjustment identified an independent association between left subclavian artery coverage without revascularization and the incidence of spinal cord ischemia (adjusted odds ratio (95%CI): 2.29(1.03-5.14), P = 0.043). Although the incidence of stroke was also higher for the group with a covered and nonrevascularized left subclavian artery (12.1% versus 8.5%), this difference was not statistically significant after multivariable analysis (adjusted odds ratio (95%CI): 1.55(0.74-3.26), P = 0.244). Conclusion For patients undergoing left subclavian artery coverage during thoracic endovascular aortic repair, the addition of a revascularization procedure was associated with a significantly lower incidence of spinal cord ischemia.

Global Positioning System Use in the Community to Evaluate Improvements in Walking After Revascularization

PubMed Central

Gernigon, Marie; Le Faucheur, Alexis; Fradin, Dominique; Noury-Desvaux, Bénédicte; Landron, Cédric; Mahe, Guillaume; Abraham, Pierre

2015-01-01

Abstract Revascularization aims at improving walking ability in patients with arterial claudication. The highest measured distance between 2 stops (highest-MDCW), the average walking speed (average-WSCW), and the average stop duration (average-DSCW) can be measured by global positioning system, but their evolution after revascularization is unknown. We included 251 peripheral artery diseased patients with self-reported limiting claudication. The patients performed a 1-hour stroll, recorded by a global positioning system receiver. Patients (n = 172) with confirmed limitation (highest-MDCW <2000m) at inclusion were reevaluated after 6 months. Patients revascularized during the follow-up period were compared with reference patients (ie, with unchanged lifestyle medical or surgical status). Other patients (lost to follow-up or treatment change) were excluded (n = 89). We studied 44 revascularized and 39 reference patients. Changes in highest-MDCW (+442 vs. +13 m) and average-WSCW (+0.3 vs. −0.2 km h−1) were greater in revascularized than in reference patients (both P < 0.01). In contrast, no significant difference in average-DSCW changes was found between the groups. Among the revascularized patients, 13 (29.5%) had a change in average-WSCW, but not in highest-MDCW, greater than the mean + 1 standard deviation of the change observed for reference patients. Revascularization may improve highest-MDCW and/or average-WSCW. This first report of changes in community walking ability in revascularized patients suggests that, beyond measuring walking distances, average-WSCW measurement is essential to monitor these changes. Applicability to other surgical populations remains to be evaluated. Registration: http://www.clinicaltrials.gov/ct2/show/NCT01141361 PMID:25950694

Global positioning system use in the community to evaluate improvements in walking after revascularization: a prospective multicenter study with 6-month follow-up in patients with peripheral arterial disease.

PubMed

Gernigon, Marie; Le Faucheur, Alexis; Fradin, Dominique; Noury-Desvaux, Bénédicte; Landron, Cédric; Mahe, Guillaume; Abraham, Pierre

2015-05-01

Revascularization aims at improving walking ability in patients with arterial claudication. The highest measured distance between 2 stops (highest-MDCW), the average walking speed (average-WSCW), and the average stop duration (average-DSCW) can be measured by global positioning system, but their evolution after revascularization is unknown.We included 251 peripheral artery diseased patients with self-reported limiting claudication. The patients performed a 1-hour stroll, recorded by a global positioning system receiver. Patients (n = 172) with confirmed limitation (highest-MDCW <2000m) at inclusion were reevaluated after 6 months. Patients revascularized during the follow-up period were compared with reference patients (ie, with unchanged lifestyle medical or surgical status). Other patients (lost to follow-up or treatment change) were excluded (n = 89).We studied 44 revascularized and 39 reference patients. Changes in highest-MDCW (+442 vs. +13 m) and average-WSCW (+0.3 vs. -0.2 km h) were greater in revascularized than in reference patients (both P < 0.01). In contrast, no significant difference in average-DSCW changes was found between the groups. Among the revascularized patients, 13 (29.5%) had a change in average-WSCW, but not in highest-MDCW, greater than the mean + 1 standard deviation of the change observed for reference patients.Revascularization may improve highest-MDCW and/or average-WSCW. This first report of changes in community walking ability in revascularized patients suggests that, beyond measuring walking distances, average-WSCW measurement is essential to monitor these changes. Applicability to other surgical populations remains to be evaluated. http://www.clinicaltrials.gov/ct2/show/NCT01141361.

Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: The TACT Randomized Trial

PubMed Central

Lamas, Gervasio A.; Goertz, Christine; Boineau, Robin; Mark, Daniel B.; Rozema, Theodore; Nahin, Richard L.; Lindblad, Lauren; Lewis, Eldrin F.; Drisko, Jeanne; Lee, Kerry L.

2014-01-01

Context Chelation therapy with disodium ethylene diamine tetraacetic acid (EDTA) has been used for over 50 years to treat atherosclerosis without proof of efficacy. Objective To determine if an EDTA-based chelation regimen reduces cardiovascular events. Design and Setting Double-blind placebo-controlled 2×2 factorial multicenter randomized trial. NIH Funding was approved in August 2002. The first patient was enrolled in September 2003, and the last follow-up took place in October 2011. Median follow-up was 55 months. Participants were recruited from 134 US and Canadian clinical sites. Participants 1708 patients, age 50 or older and at least 6 weeks post myocardial infarction, with a serum creatinine <2.0 mg/dL. 289 patients (17% of total; 115 in the EDTA group and 174 in the placebo group) withdrew consent for continued follow-up over the course of the trial. Interventions Patients were randomized to receive 40 infusions of a 500 mL chelation solution (containing 3 grams of disodium EDTA, 7 grams of ascorbate, B-vitamins, electrolytes, procaine, and heparin) versus placebo, and to an oral vitamin and mineral regimen or an oral placebo. Infusions were administered weekly for 30 weeks, followed by 10 infusions 2 to 8 weeks apart. Patients received 55,222 infusions. 15% discontinued infusions for adverse events. Main outcome measure The pre-specified primary endpoint was a composite of total mortality, recurrent myocardial infarction, stroke, coronary revascularization, or hospitalization for angina. Followup for clinical events began upon randomization. This report describes the intent-to-treat comparison of EDTA chelation versus placebo. To account for multiple interim analyses, the significance threshold required at the final analysis was p=0.036. Results The qualifying myocardial infarction occurred a median of 4.6 years before enrollment. Median age was 65 years, 18% were female, 9% were nonwhite, 31% were diabetic. 83% had prior coronary revascularization, and 73% were on statins. The primary endpoint occurred in 222 (26%) of the chelation group and 261 (30%) of the placebo group (hazard ratio 0.82, 95% confidence interval 0.69–0.99, p=0.035). There was no effect on total mortality (chelation: 87 deaths (10%) placebo 93 (11%): hazard ratio (HR) 0.93, 95% confidence interval 0.70–1.25, p=0.64), but the study was not powered for this comparison. The effect of EDTA chelation on the components of the primary endpoint other than death was of similar magnitude as its overall effect (myocardial infarction HR 0.77 95% confidence interval (0.54,1.11); stroke HR 0.77 95% confidence interval (0.34, 1.76); coronary revascularization HR 0.81 95% confidence interval (0.64, 1.02); hospitalization for angina HR 0.72 95% confidence interval (0.35, 1.47). Extensive sensitivity analyses examining the effect of patient drop out and varying treatment compliance did not alter the study’s conclusions. Conclusions and Relevance In stable patients with a history of MI, the use of an intravenous chelation regimen with disodium EDTA, compared with placebo, modestly reduced the risk of a composite of adverse cardiovascular outcomes, many of which were revascularization procedures. These results provide evidence to guide further research but are not, by themselves, sufficient to support the routine use of chelation therapy for treatment of post-MI patients. PMID:23532240

ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 Appropriate Use Criteria for Coronary Revascularization in Patients With Stable Ischemic Heart Disease : A Report of the American College of Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society of Thoracic Surgeons.

PubMed

Patel, Manesh R; Calhoon, John H; Dehmer, Gregory J; Grantham, James Aaron; Maddox, Thomas M; Maron, David J; Smith, Peter K

2017-10-01

The American College of Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, and American Association for Thoracic Surgery, along with key specialty and subspecialty societies, have completed a 2-part revision of the appropriate use criteria (AUC) for coronary revascularization. In prior coronary revascularization AUC documents, indications for revascularization in acute coronary syndromes and stable ischemic heart disease (SIHD) were combined into 1 document. To address the expanding clinical indications for coronary revascularization, and to align the subject matter with the most current American College of Cardiology/American Heart Association guidelines, the new AUC for coronary artery revascularization were separated into 2 documents addressing SIHD and acute coronary syndromes individually. This document presents the AUC for SIHD.Clinical scenarios were developed to mimic patient presentations encountered in everyday practice. These scenarios included information on symptom status; risk level as assessed by noninvasive testing; coronary disease burden; and, in some scenarios, fractional flow reserve testing, presence or absence of diabetes, and SYNTAX score. This update provides a reassessment of clinical scenarios that the writing group felt were affected by significant changes in the medical literature or gaps from prior criteria. The methodology used in this update is similar to the initial document but employs the recent modifications in the methods for developing AUC, most notably, alterations in the nomenclature for appropriate use categorization.A separate, independent rating panel scored the clinical scenarios on a scale of 1 to 9. Scores of 7 to 9 indicate that revascularization is considered appropriate for the clinical scenario presented. Scores of 1 to 3 indicate that revascularization is considered rarely appropriate for the clinical scenario, whereas scores in the mid-range of 4 to 6 indicate that coronary revascularization may be appropriate for the clinical scenario.As seen with the prior coronary revascularization AUC, revascularization in clinical scenarios with high symptom burden, high-risk features, and high coronary disease burden, as well as in patients receiving antianginal therapy, are deemed appropriate. Additionally, scenarios assessing the appropriateness of revascularization before kidney transplantation or transcatheter valve therapy are now rated. The primary objective of the AUC is to provide a framework for the assessment of practice patterns that will hopefully improve physician decision making.

Autologous alternative veins may not provide better outcomes than prosthetic conduits for below-knee bypass when great saphenous vein is unavailable.

PubMed

Avgerinos, Efthymios D; Sachdev, Ulka; Naddaf, Abdallah; Doucet, Dannielle R; Mohapatra, Abhisekh; Leers, Steven A; Chaer, Rabih A; Makaroun, Michel S

2015-08-01

There is a need to better define the role of alternative autologous vein (AAV) segments over contemporary prosthetic conduits in patients with critical limb ischemia when great saphenous vein (GSV) is not available for use as the bypass conduit. Consecutive patients who underwent bypass to infrageniculate targets between 2007 and 2011 were categorized in three groups: GSV, AAV, and prosthetic. The primary outcome was graft patency. The secondary outcome was limb salvage. Cox proportional hazards regression was used to adjust for baseline confounding variables. A total of 407 infrainguinal bypasses to below-knee targets were analyzed; 255 patients (63%) received a single-segment GSV, 106 patients (26%) received an AAV, and 46 patients (11%) received a prosthetic conduit. Baseline characteristics were similar among groups, with the exception of popliteal targets and anticoagulation use being more frequent in the prosthetic group. Primary patency at 2 and 5 years was estimated at 47% and 32%, respectively, for the GSV group; 24% and 23% for the AAV group; and 43% and 38% for the prosthetic group. Primary assisted patency at 2 and 5 years was estimated at 71% and 55%, respectively, for the GSV group; 53% and 51% for the AAV group; and 45% and 40% for the prosthetic group. Secondary patency at 2 and 5 years was estimated at 75% and 60%, respectively, for the GSV group; 57% and 55% for the AAV group; and 46% and 41% for the prosthetic group. In Cox analysis, primary patency (hazard ratio [HR], 0.55; P < .001; 95% confidence interval [CI], 0.404-0.758), primary assisted patency (HR, 0.57; P = .004; 95% CI, 0.388-0.831), and secondary patency (HR, 0.56; P = .005; 95% CI, 0.372-0.840) were predicted by GSV compared with AAV, but there was no difference between AAV and prosthetic grafts except for the primary patency, for which prosthetic was protective (HR, 0.38; P < .001; 95% CI, 0.224-0.629). Limb salvage was similar among groups. AAV conduits may not offer a significant patency advantage in midterm follow-up over prosthetic bypasses. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Changes in ocular and nasal signs and symptoms among air crew in relation to air humidification on intercontinental flights.

PubMed

Norbäck, Dan; Lindgren, Torsten; Wieslander, Gunilla

2006-04-01

This study evaluates the influence of air humidification in aircraft on symptoms, tear-film stability, nasal patency, and peak expiratory flow. Commercial air crew (N=71) were given a medical examination during eight flights from Stockholm to Chicago and eight flights in the opposite direction. Examinations were done onboard one Boeing 767 aircraft equipped with an evaporation humidifier in the forward part of the cabin. The investigators followed the air crew, staying one night in Chicago and returning with the same crew. Four of the flights had the air humidification device active in-flight to Chicago and deactivated when returning to Stockholm. The other four flights had the inverse humidification sequence. The humidification sequence was randomized and double blind. Hygienic measurements were performed. The humidification increased the relative air humidity by 10% in the 1st row in business class, by 3% in the last row (39th row) in tourist class, and by 3% in the cockpit. Air humidification increased tear-film stability and nasal patency and decreased ocular, nasal, and dermal symptoms and headache. The mean concentration of viable bacteria [77-108 colony-forming units (cfu)/m(3)], viable molds (74-84 cfu/m(3)), and particulate matter (1-8 microg/m(3)) was low, both during the humidified and non-humidified flights. Relative air humidity is low (10-12%) during intercontinental flights and can be increased by the use of a ceramic evaporation humidifier, without any measurable increase of microorganisms in cabin air. Air humidification could increase passenger and crew comfort by increasing tear-film stability and nasal patency and reducing various symptoms.

Endovascular treatment of post-thrombotic and non-thrombotic iliofemoral venous outflow obstructions with self-expanding nitinol stents.

PubMed

Stuck, Anna K; Reich, Thomas; Engelberger, Rolf P; Sebastian, Tim; Kucher, Nils

2018-06-01

The aim of the study was to investigate venous patency and clinical outcomes for endovascular treatment of iliofemoral venous obstruction in patients with post-thrombotic syndrome (PTS) and non-thrombotic iliac vein lesion (NIVL) with dedicated self-expanding nitinol stents. Data were collected from the prospective Swiss Venous Stent Registry, enrolling consecutive patients with a standardized follow-up procedure since January 2008. Patency was evaluated by duplex sonography and clinical outcome by various scores including the Villalta score at baseline, three, six, and 12 months, and then annually after endovascular therapy. Overall, 93 patients (64 PTS, 29 NIVL) were analysed. Mean follow-up time was 20 ± 16 (range 3-70) months. A total of 11 (12 %) patients had a stent occlusion, all of which occurred in the PTS group, and 13 (14 %) patients had a symptomatic stent stenosis. Primary patency was 79 % (95 % CI 68-87 %) at 12 months and 72 % (95 % CI 59-82 %) at 24 months. In PTS patients, primary patency at 12 months was 75 % (95 % CI 61-84 %) vs. 89 % (95 % CI 63-97 %) in NIVL patients (p = 0.10). Secondary patency at 24 months was 94 % (95 % CI 84-98 %) in PTS and 100 % in NIVL, p = 0.19). Overall, 62 (67 %) patients were free from PTS at the latest follow-up with a Villalta score < 5 points. Predictive factors for the loss of primary patency were stents placed below the inguinal ligament (OR 2.59, 95 % CI, 0.99-6.84, p = 0.05). In symptomatic patients with chronic iliofemoral vein obstruction, endovascular therapy with self-expanding nitinol stents was associated with favourable patency rates and clinical improvement in the majority of patients.

Patency of the Internal Iliac Artery after Placement of Common and External Iliac Artery Stents.

PubMed

Vinogradova, Margie; Lee, Hye Joon; Armstrong, Ehrin J; Laird, John; Humphries, Misty D

2017-01-01

Treatment of severe aortoiliac occlusive disease (AIOD) frequently requires long-segment stenting of the common and external iliac arteries (CIA and EIA, respectively). This study aims to analyze the patency of the internal iliac artery (IIA) after placement of a CIA and EIA stents across the orifice. A retrospective analysis of all patients who underwent de novo ipsilateral stent placement in the CIA and EIA between 2006 and 2013 was performed. Kaplan-Meier analysis was used to analyze patency of the IIA, and Cox proportional hazard models were used to identify characteristics associated with occlusion. We identified 77 patients and 93 limbs where ipsilateral CIA and EIA stents were placed. Preintervention angiographic review found 52 cases of a patent ipsilateral IIA where stents were placed across the origin of the IIA in 31 cases and staggered across the orifice in 20 limbs. Kaplan-Meier analysis demonstrated a 37% patency in limbs where the stent covered the IIA orifice compared to 78% patency in uncovered arteries (P = 0.04). New-onset buttock claudication developed in 4 patients, 2 with patent IIAs and 2 with occluded. New-onset impotence also developed in 3 patients with occluded IIA and 5 patients with patent IIAs. Placement of stents across the origin of the IIA may not result in immediate occlusion, but long-term patency of covered IIAs is decreased compared to uncovered IIAs. This study is limited by a small sample size, but when treating AIOD, coverage of the internal iliac origin should be avoided to maintain patency of the pelvic circulation. Copyright © 2016 Elsevier Inc. All rights reserved.

Percutaneous Treatment of Central Venous Stenosis in Hemodialysis Patients: Long-Term Outcomes

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kim, Young Chul; Won, Jong Yun, E-mail: jywon@yumc.yonsei.ac.kr; Choi, Sun Young

2009-03-15

The purpose of this study was to evaluate the long-term outcomes of endovascular treatment of central venous stenosis in patients with arteriovenous fistulas (AVFs) for hemodialysis. Five hundred sixty-three patients with AVFs who were referred for a fistulogram were enrolled in this study. Among them, 44 patients showed stenosis (n = 35) or occlusions (n = 9) in the central vein. For the initial treatment, 26 patients underwent percutaneous transluminal angioplasty (PTA) and 15 patients underwent stent placements. Periods between AVF formation and first intervention ranged from 3 to 144 months. Each patient was followed for 14 to 60 months.more » Procedures were successful in 41 of 44 patients (93.2%). Primary patency rates for PTA at 12 and 36 months were 52.1% and 20.0%, and assisted primary patency rates were 77.8% and 33.3%, respectively. Primary patency rates for stent at 12 and 36 months were 46.7% and 6.7%, and assisted primary patency rates were 60.0% and 20.0%, respectively. Fifteen of 26 patients with PTAs underwent repeated interventions because of restenosis. Fourteen of 15 patients with a stent underwent repeated interventions because of restenosis and combined migration (n = 1) and shortening (n = 6) of the first stent. There was no significant difference in patency between PTAs and stent placement (p > 0.05). Average AVF patency duration was 61.8 months and average number of endovascular treatments was 2.12. In conclusion, endovascular treatments of central venous stenosis could lengthen the available period of AVFs. There was no significant difference in patency between PTAs and stent placement.« less

A prospective study of external stenting of saphenous vein grafts to the right coronary artery: the VEST II study.

PubMed

Taggart, David P; Amin, Sanaz; Djordjevic, Jasmina; Oikonomou, Evangelos K; Thomas, Sheena; Kampoli, Anna-Maria; Sabharwal, Nikant; Antoniades, Charalambos; Krasopoulos, George

2017-05-01

External stents significantly reduce intimal hyperplasia and improve lumen uniformity and flow pattern in saphenous vein grafts (SVG) 1 year after coronary artery bypass grafting. However, recent studies have shown that at 1 year there is a lower patency of externally stented SVG to the right coronary artery (RCA) (55-60%) when compared to the left sided coronary arteries (85-90%). In the current study, we investigated whether avoidance of both fixation of the external stent to the anastomoses and the use of metal clips to ligate SVG side branches would improve the early patency of externally stented SVG to the RCA. Thirty patients received a SVG to the right territory supported with an external stent. Graft patency was confirmed at the end of surgery in all patients. The primary endpoint was SVG patency assessed by computed tomography angiography (CTA) at 3-6 months. Graft failure was defined as > 50% stenosis. Twenty-nine patients (96.6%) completed the follow up period and CT angiography data was available for a total of 43 SVGs, (29 supported and 14 unsupported SVGs) and 47 arterial grafts. Patency of stented SVGs was 86.2% (25/29 on CTA). All non-stented SVGs to the left territory were patent. Patency rates of the left internal mammary arteries and right internal mammary arteries grafts were 96.6% and 83.3%, respectively. Avoidance of both metallic clips to ligate side branches and of fixation of venous external support trial (VEST) stents to the anastomoses mark a significant improvement in patency of stented SVG to the right coronary territory. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Is the use of AGILE patency capsule prior to videocapsule endoscopy useful in all patients with spondyloarthritis?

PubMed

Gheorghe, Andrada; Zahiu, Denise Carmen Mihaela; Voiosu, Theodor Alexandru; Mateescu, Bogdan Radu; Voiosu, Mihail Radu; Rimbaş, Mihai

2017-06-01

As already known, spondyloarthritis patients present a striking resemblance in intestinal inflammation with early Crohn's disease. Moreover, the frequent use of nonsteroidal anti-inflammatory drugs is an important part of their treatment. Both conditions could lead to intestinal stenoses. Therefore we proposed to investigate the usefulness of the patency capsule test in patients with spondyloarthritis. 64 consecutive patients (33 males; mean age 38 ± 11 years) that fulfilled the AMOR criteria for seronegative spondyloarthropathy (59.4% ankylosing spondylitis) lacking symptoms or signs of intestinal stenosis were enrolled and submitted to an AGILE™ capsule patency test followed by a video capsule endoscopy (PillCam SB2™), as part of a protocol investigating the presence of intestinal inflammatory lesions. After reviewing the VCE recordings, the Lewis score (of small bowel inflammatory involvement) was computed. In only 5 patients (7.8%) of the study group, the luminal patency test was negative. However, there was no retention of the videocapsule in any of the patients. From the 59 patients with a positive patency test, 3 patients presented single small bowel stenoses (two with ulcerated overlying inflamed mucosa, one cicatricial), all being traversed by the videocapsule along the length of the recording. None of the patients with a negative test had bowel stenoses. There was no correlation between the patency test and the Lewis score, the C reactive protein value, diagnosis of inflammatory bowel disease, or the family history of spondyloarthritis, psoriasis or inflammatory bowel disease. The AGILE patency capsule does not seem to be a useful tool for all patients with spondyloarthritis prior to small bowel videocapsule endoscopy (ClinicalTrial.gov ID NCT 00768950).

Root canal revascularization. The beginning of a new era in endodontics.

PubMed

Alrahabi, Mothanna K; Ali, Mahmoud M

2014-05-01

Endodontic management of immature anterior teeth with necrotic pulps is a great challenge. Although there are different treatment procedures to deal with this problem such as apexification by using calcium hydroxide dressings or applying a barrier of mineral trioxide aggregate and gutta-percha obturation, the outcomes are still unsatisfactory and the root might still be weak. Recently, a new treatment protocol by revascularization of immature non-vital, infected teeth was introduced to regenerate dental structure and complete the root maturation. However, larger case series with longer follow-up periods are required to accept revascularization as the standard protocol for management of immature non-vital, infected teeth. In this review, we discuss the concept of root canal revascularization, revascularization mechanisms, and the structure of the regenerated tissues.

Percutaneous lower-extremity arterial interventions with primary balloon angioplasty versus Silverhawk atherectomy and adjunctive balloon angioplasty: randomized trial.

PubMed

Shammas, Nicolas W; Coiner, Denise; Shammas, Gail A; Dippel, Eric J; Christensen, Lori; Jerin, Michael

2011-09-01

Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus SilverHawk atherectomy and adjunctive PTA of de novo infrainguinal disease has not been well defined. This study was conducted to compare the two approaches. In this prospective, two-center randomized trial of PTA versus atherectomy of infrainguinal vessels, the primary endpoint of TLR was evaluated at 1 year. Secondary endpoints included the rate of "bailout" stent placement for suboptimal acute angiographic results and the rate of target vessel revascularization (TVR). Fifty-eight patients were included in the study. Of these, 29 (36 vessels) were randomized to the atherectomy arm and 29 (48 vessels) to the PTA arm. Final acute angiographic success rates were 100% in the PTA arm and 97.2% in the atherectomy arm (P value not significant). There was no statistical difference in TLR (16.7% vs 11.1%) or TVR (21.4% vs 11.1%) between the PTA and atherectomy groups, respectively. Bailout stent placement was performed in 18 of 29 patients (62.1%) in the PTA arm and eight of 29 patients (27.6%) in the atherectomy arm (P = .017). Major adverse events were similar between the PTA and atherectomy arms. Finally, when embolic filter protection was used, distal macroembolization occurred in 11 of 17 patients (64.7%) treated with atherectomy versus none of 10 in the PTA group (P < .001). TLR and TVR at 1 year were statistically similar in atherectomy and primary PTA. Atherectomy reduced the need for bailout stent placement compared with primary PTA. Copyright © 2011 SIR. Published by Elsevier Inc. All rights reserved.

Myocardial revascularization with miniaturized extracorporeal circulation versus off pump: Evaluation of systemic and myocardial inflammatory response in a prospective randomized study.

PubMed

Formica, Francesco; Broccolo, Francesco; Martino, Antonello; Sciucchetti, Jennifer; Giordano, Vincenzo; Avalli, Leonello; Radaelli, Gianluigi; Ferro, Orazio; Corti, Fabrizio; Cocuzza, Clementina; Paolini, Giovanni

2009-05-01

This prospective randomized study sought to verify the systemic inflammatory response, inflammatory myocardial damage, and early clinical outcome in coronary surgery with the miniaturized extracorporeal circulation system or on the beating heart. Sixty consecutive patients were randomized to miniaturized extracorporeal circulation (n = 30) or off-pump coronary revascularization (off-pump coronary artery bypass grafting, n = 30). Intraoperative and postoperative data were recorded. Plasma levels of interleukin-6 and tumor necrosis factor-alpha were measured from systemic blood intraoperatively, at the end of operation, and 24 and 48 hours thereafter. Levels of the same markers and blood lactate were measured from coronary sinus blood intraoperatively to evaluate myocardial inflammation. Markers of myocardial damage were also analyzed. One patient died in the off-pump coronary artery bypass grafting group. There was no statistical difference in early clinical outcome in both groups. Release of interleukin-6 was higher in the off-pump coronary artery bypass grafting group 24 hours after the operation (P = .03), whereas levels of tumor necrosis factor-alpha were not different in both groups. Cardiac release of interleukin-6, tumor necrosis factor-alpha, and blood lactate were not different in both groups. Release of troponin T was not significantly different in both groups. Levels of creatine kinase mass were statistically higher in the miniaturized extracorporeal circulation group than in the off-pump coronary artery bypass grafting group, but only at the end of the operation (P < .0001). Hemoglobin levels were significantly higher in the miniaturized extracorporeal circulation group than in the off-pump coronary artery bypass grafting group after 24 hours (P = .01). Miniaturized extracorporeal circulation can be considered similar to off-pump surgery in terms of systemic inflammatory response, myocardial inflammation and damage, and early outcome.

Myocardial perfusion 320-row multidetector computed tomography-guided treatment strategy for the clinical management of patients with recent acute-onset chest pain: Design of the CArdiac cT in the treatment of acute CHest pain (CATCH)-2 randomized controlled trial.

PubMed

Sørgaard, Mathias; Linde, Jesper J; Hove, Jens D; Petersen, Jan R; Jørgensen, Tem B S; Abdulla, Jawdat; Heitmann, Merete; Kragelund, Charlotte; Hansen, Thomas Fritz; Udholm, Patricia M; Pihl, Christian; Kühl, J Tobias; Engstrøm, Thomas; Jensen, Jan Skov; Høfsten, Dan E; Kelbæk, Henning; Kofoed, Klaus F

2016-09-01

Patients admitted with chest pain are a diagnostic challenge because the majority does not have coronary artery disease (CAD). Assessment of CAD with coronary computed tomography angiography (CCTA) is safe, cost-effective, and accurate, albeit with a modest specificity. Stress myocardial computed tomography perfusion (CTP) has been shown to increase the specificity when added to CCTA, without lowering the sensitivity. This article describes the design of a randomized controlled trial, CATCH-2, comparing a clinical diagnostic management strategy of CCTA alone against CCTA in combination with CTP. Patients with acute-onset chest pain older than 50 years and with at least one cardiovascular risk factor for CAD are being prospectively enrolled to this study from 6 different clinical sites since October 2013. A total of 600 patients will be included. Patients are randomized 1:1 to clinical management based on CCTA or on CCTA in combination with CTP, determining the need for further testing with invasive coronary angiography including measurement of the fractional flow reserve in vessels with coronary artery lesions. Patients are scanned with a 320-row multidetector computed tomography scanner. Decisions to revascularize the patients are taken by the invasive cardiologist independently of the study allocation. The primary end point is the frequency of revascularization. Secondary end points of clinical outcome are also recorded. The CATCH-2 will determine whether CCTA in combination with CTP is diagnostically superior to CCTA alone in the management of patients with acute-onset chest pain. Copyright © 2015 Elsevier Inc. All rights reserved.

Rationale and design of the coronary artery bypass grafting surgery off or on pump revascularization study: a large international randomized trial in cardiac surgery.

PubMed

Lamy, Andre; Devereaux, Philip J; Prabhakaran, Dorairaj; Hu, Shengshou; Piegas, Leopoldo S; Straka, Zbynek; Paolasso, Ernesto; Taggart, David; Lanas, Fernando; Akar, A Ruchan; Jain, Anil; Noiseux, Nicolas; Ou, Yongning; Chrolavicius, Susan; Ng, Jennifer; Yusuf, Salim

2012-01-01

Uncertainty remains regarding the benefits and risks of the technique of operating on a beating heart (off pump) for coronary artery bypass grafting (CABG) surgery versus on-pump CABG. Prior trials had few events and relatively short follow-up. There is a need for a large randomized, controlled trial with long-term follow-up to inform both the short- and long-term impact of the 2 approaches to CABG. We plan to randomize 4,700 patients in whom CABG is planned to undergo the procedure on pump or off pump. The coprimary outcomes are a composite of total mortality, myocardial infarction (MI), stroke, and renal failure at 30 days and a composite of total mortality, MI, stroke, renal failure, and repeat revascularization at 5 years. We will also undertake a cost-effectiveness analysis at 30 days and 5 years after CABG surgery. Other outcomes include neurocognitive dysfunction, recurrence of angina, cardiovascular mortality, blood transfusions, and quality of life. As of May 3, 2011, CORONARY has recruited >3,884 patients from 79 centers in 19 countries. Currently, patient's mean age is 67.6 years, 80.7% are men, 47.0% have a history of diabetes, 51.4% have a history of smoking, and 34.4% had a previous MI. In addition, 20.9% of patients have a left main disease, and 96.6% have double or triple vessel disease. CORONARY is the largest trial yet conducted comparing off-pump CABG to on-pump CABG. Its results will lead to a better understanding of the safety and efficacy of off-pump CABG. Copyright © 2012 Mosby, Inc. All rights reserved.

Evaluation of Mediterranean diet adherence in patients with a history of coronary revascularization.

PubMed

Acar, B; Gucuk Ipek, E; Unal, S; Yayla, C; Karanfil, M; Burak, C; Kara, M; Bayraktar, F; Kuyumcu, M S; Aydogdu, S

Lifestyle modification is an important component of the secondary prevention strategies; and a healthy diet is one of the cornerstones in management of the coronary heart disease. We aimed to investigate the dietary habits of the patients with history of coronary revascularization, characteristics of the ones with good adherence by using alternate MedDiet questionnaire. We included outpatients who had a history of coronary revascularization at least 6 months prior to enrollment. Each participant filled out a questionnaire to collect the data of demographics and clinical characteristics. Alternate MedDiet score was calculated to evaluate the Mediterranean style dietary adherence. Alternate MedDiet was originally based on 14-item questionnaire; we adjusted it to our population (max 13 points). We enrolled 226 consecutive outpatients (age 61.7±10.9 years, 72% males). The median duration after revascularization was 60 months. A total of 112 (49.6%) patients had previous percutaneous coronary intervention (PCI), 77 (34.1%) had coronary by-pass graft surgery (CABG), and 36 (15.9%) had both revascularization procedures. The median MedDiet score was 6. Patients were stratified into two subgroups (MedDiet score ≥7 vs. <7). A total of 61 (26.9%) patients had MedDiet score ≥7. By univariate analysis, good MedDiet scores were associated with older age, waist circumference, body mass index, high education level, regular follow-up, duration after first revascularization and revascularization with CABG+PCI. In the multivariate analysis, high education level (P=.002, OR=8.212, 95%CI: 2.155-31.291) and duration after revascularization (P=.034, OR=1.007, 95%CI: 1.001-1.013) were independent predictors of good MedDiet scores. The adherence rate to a healthy diet was low in patients with previous coronary revascularization. MedDiet score seems to be practical and useful item to evaluate the dietary habits in outpatient setting. Mediterranean diet adherence rates were associated with high education level, and duration after revascularization. Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

Outcome of penile revascularization for arteriogenic erectile dysfunction after pelvic fracture urethral injuries.

PubMed

Zuckerman, Jack M; McCammon, Kurt A; Tisdale, Britton E; Colen, Larry; Uroskie, Ted; McAdams, Paul; Jordan, Gerald H

2012-12-01

To review our experience with penile revascularization for patients with bilateral occlusion of the deep internal pudendal arteries after pelvic fracture urethral injury (PFUI). We identified 17 patients who had undergone penile revascularization with end-to-side anastomosis of the deep inferior epigastric artery to the dorsal penile artery from July 1991 to December 2010. Success was defined as achieving erections sufficient for intercourse with or without pharmacologic assistance. All patients had had a PFUI causing arterial insufficiency and erectile dysfunction not responsive to pharmacologic intervention. Of the 17 patients, 4 (24%) underwent revascularization before and 13 (76%) after PFUI repair. The mean age at revascularization was 32.7 years (range 17-54). At an average follow-up of 3.1 years, the surgery was successful in 14 of the 17 patients (82%). In patients with erectile dysfunction as an indication for surgery, successful erections were achieved in 11 of 13. For those who underwent revascularization to prevent ischemic stenosis of the urethral repair, 3 of 4 achieved successful erections, and all subsequent urethral surgeries were successful. The penile duplex ultrasound parameters showed clinically and statistically significant improvements after revascularization. No operative complications developed. The average hospital length of stay was 4.7 days. Four patients experienced early postoperative complications, including an abdominal wall hematoma requiring evacuation in one, penile edema in two, and a superficial surgical site infection in one. No late complications occurred. Penile arterial revascularization in select patients can allow for successful treatment of PFUIs and the refractory erectile dysfunction caused by them. Copyright © 2012 Elsevier Inc. All rights reserved.

Hybrid coronary revascularization in the era of drug-eluting stents.

PubMed

Murphy, Gavin J; Bryan, Alan J; Angelini, Gianni D

2004-11-01

Left internal mammary artery to left anterior descending coronary artery bypass grafting integrated with percutaneous coronary angioplasty (hybrid procedure) offers multivessel revascularization with minimal morbidity in high-risk patients. This is caused in part by the avoidance of cardiopulmonary bypass-related morbidity and manipulation of the aorta coupled with minimally invasive techniques. Hybrid revascularization is currently reserved for particularly high-risk patients or those with favorable anatomic variants however, largely because of the emergence of off-pump coronary artery bypass grafting, which permits more complete multivessel revascularization, with low morbidity in high-risk groups. The wider introduction of hybrid revascularization is limited chiefly by the high number of repeat interventions compared with off-pump coronary artery bypass grafting, which occurs because of the target vessel failure rate of percutaneous coronary intervention. Other demerits are the costs and logistic problems associated with performing two procedures with differing periprocedural management protocols. Recently, drug-eluting stents have reduced the need for repeat intervention after percutaneous coronary intervention, and this has raised the possibility that the results of hybrid revascularization may now equal or even better those of off-pump coronary artery bypass grafting. Although undoubtedly effective at reducing in-stent restenosis, drug-eluting stents will not address the issues of incomplete revascularization or the logistic problems associated with hybrid. Uncertainty regarding the long-term effectiveness of drug-eluting stents in many patients, as well as their high cost when compared with those of off-pump coronary artery bypass grafting surgery, also militates against the wider introduction of hybrid revascularization.

Fast revascularization of the injured area is essential to support zebrafish heart regeneration

PubMed Central

Marín-Juez, Rubén; Marass, Michele; Gauvrit, Sebastien; Rossi, Andrea; Lai, Shih-Lei; Materna, Stefan C.; Black, Brian L.; Stainier, Didier Y. R.

2016-01-01

Zebrafish have a remarkable capacity to regenerate their heart. Efficient replenishment of lost tissues requires the activation of different cell types including the epicardium and endocardium. A complex set of processes is subsequently needed to support cardiomyocyte repopulation. Previous studies have identified important determinants of heart regeneration; however, to date, how revascularization of the damaged area happens remains unknown. Here, we show that angiogenic sprouting into the injured area starts as early as 15 h after injury. To analyze the role of vegfaa in heart regeneration, we used vegfaa mutants rescued to adulthood by vegfaa mRNA injections at the one-cell stage. Surprisingly, vegfaa mutants develop coronaries and revascularize after injury. As a possible explanation for these observations, we find that vegfaa mutant hearts up-regulate the expression of potentially compensating genes. Therefore, to overcome the lack of a revascularization phenotype in vegfaa mutants, we generated fish expressing inducible dominant negative Vegfaa. These fish displayed minimal revascularization of the damaged area. In the absence of fast angiogenic revascularization, cardiomyocyte proliferation did not occur, and the heart failed to regenerate, retaining a fibrotic scar. Hence, our data show that a fast endothelial invasion allows efficient revascularization of the injured area, which is necessary to support replenishment of new tissue and achieve efficient heart regeneration. These findings revisit the model where neovascularization is considered to happen concomitant with the formation of new muscle. Our work also paves the way for future studies designed to understand the molecular mechanisms that regulate fast revascularization. PMID:27647901

Direct versus indirect revascularization procedures for moyamoya disease: a comparative effectiveness study.

PubMed

Macyszyn, Luke; Attiah, Mark; Ma, Tracy S; Ali, Zarina; Faught, Ryan; Hossain, Alisha; Man, Karen; Patel, Hiren; Sobota, Rosanna; Zager, Eric L; Stein, Sherman C

2017-05-01

OBJECTIVE Moyamoya disease (MMD) is a chronic cerebrovascular disease that can lead to devastating neurological outcomes. Surgical intervention is the definitive treatment, with direct, indirect, and combined revascularization procedures currently employed by surgeons. The optimal surgical approach, however, remains unclear. In this decision analysis, the authors compared the effectiveness of revascularization procedures in both adult and pediatric patients with MMD. METHODS A comprehensive literature search was performed for studies of MMD. Using complication and success rates from the literature, the authors constructed a decision analysis model for treatment using a direct and indirect revascularization technique. Utility values for the various outcomes and complications were extracted from the literature examining preferences in similar clinical conditions. Sensitivity analysis was performed. RESULTS A structured literature search yielded 33 studies involving 4197 cases. Cases were divided into adult and pediatric populations. These were further subdivided into 3 different treatment groups: indirect, direct, and combined revascularization procedures. In the pediatric population at 5- and 10-year follow-up, there was no significant difference between indirect and combination procedures, but both were superior to direct revascularization. In adults at 4-year follow-up, indirect was superior to direct revascularization. CONCLUSIONS In the absence of factors that dictate a specific approach, the present decision analysis suggests that direct revascularization procedures are inferior in terms of quality-adjusted life years in both adults at 4 years and children at 5 and 10 years postoperatively, respectively. These findings were statistically significant (p < 0.001 in all cases), suggesting that indirect and combination procedures may offer optimal results at long-term follow-up.

Surgery for congenital choanal atresia.

PubMed

Cedin, Antonio C; Atallah, Alvaro N; Andriolo, Régis B; Cruz, Oswaldo L; Pignatari, Shirley N

2012-02-15

Congenital choanal atresia is a rare abnormality characterized by unilateral or bilateral lack of patency of the posterior end of the nasal cavity. With an incidence of 1:5000 to 1:8000 births, it is twice as prevalent in females as it is in males. Surgical procedures aim to provide adequate functional choanal patency and a low rate of restenosis, avoid harm to any structure in development, enable shorter surgery and hospitalization times, and minimize morbidity and mortality. To evaluate the effectiveness and safety of the available surgical techniques for the treatment of congenital choanal atresia in patients with unilateral and bilateral atresia. We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials. The date of the search was 31 January 2011. We planned to include parallel randomized or quasi-randomized controlled trials testing surgical approaches for the treatment of congenital atresia (irrespective of gender and age) that evaluated normal/adequate respiratory function (self reported or preserved nasal airway) and restenosis as the main primary outcomes. We did not consider reoperation and non-congenital atresia (e.g. traumatic, iatrogenic atresias) for inclusion. Three review authors independently assessed the titles and abstracts of the identified articles to determine potential relevance. For dichotomous and continuous variables, we planned to calculate risk ratios (relative risks; RR) and mean differences (MD) with 95% confidence intervals (CI), respectively. We planned to use the random-effects model since we were expecting substantial clinical and methodological heterogeneity. No randomized controlled trials were identified. From the 120 reports retrieved using our search strategy, 46 primary studies had the potential to be included since they had tested surgical approaches for choanal atresia. However, we excluded all of them during the final selection process because their study designs did not meet our inclusion criteria. There is no definitive evidence, based on randomized controlled trials, to demonstrate the potential advantages and disadvantages of any specific surgical technique for patients with choanal atresia. Specialists should unify their efforts in multicenter randomized controlled trials that test the effectiveness and safety of different surgical techniques in patients with choanal atresia.

Revascularization and Apical Plug in an Immature Molar

PubMed Central

Roghanizadeh, Leyla; Fazlyab, Mahta

2018-01-01

Managing of necrotic permanent teeth with immature apices is a treatment challenges. Treatment of such teeth includes apexification, apical plug and more recently, revascularization technique with the probable advantage of continuation of root development. In the present case report the referred patient had discomfort with a necrotic immature mandibular first molar. Periapical radiography showed a rather large apical lesion around immature roots. Revascularization protocol using calcium-enriched mixture (CEM) cement was indicated for the mesial root. However, in distal canal apical plug technique was applied. At 2-year follow-up, both procedures were successful in relieving patient’s symptoms. Dentin formation and increase in length of the mesial root was obvious. Apical plug and revascularization technique proved to be successful in management of necrotic immature teeth; moreover, revascularization carried the advantage of continuation of root development. PMID:29692851

Coronary Computed Tomography Angiography vs Functional Stress Testing for Patients With Suspected Coronary Artery Disease: A Systematic Review and Meta-analysis.

PubMed

Foy, Andrew J; Dhruva, Sanket S; Peterson, Brandon; Mandrola, John M; Morgan, Daniel J; Redberg, Rita F

2017-11-01

Coronary computed tomography angiography (CCTA) is a new approach for the diagnosis of anatomical coronary artery disease (CAD), but it is unclear how CCTA performs compared with the standard approach of functional stress testing. To compare the clinical effectiveness of CCTA with that of functional stress testing for patients with suspected CAD. A systematic literature search was conducted in PubMed and MEDLINE for English-language randomized clinical trials of CCTA published from January 1, 2000, to July 10, 2016. Researchers selected randomized clinical trials that compared a primary strategy of CCTA with that of functional stress testing for patients with suspected CAD and reported data on patient clinical events and changes in therapy. Two reviewers independently extracted data from and assessed the quality of the trials. This analysis followed the PRISMA statement for reporting systematic reviews and meta-analyses and used the Cochrane Collaboration's tool for assessing risk of bias in randomized trials. The Mantel-Haenszel method was used to conduct the primary analysis. Summary relative risks were calculated with a random-effects model. The outcomes of interest were all-cause mortality, cardiac hospitalization, myocardial infarction, invasive coronary angiography, coronary revascularization, new CAD diagnoses, and change in prescription for aspirin and statins. Thirteen trials were included, with 10 315 patients in the CCTA arm and 9777 patients in the functional stress testing arm who were followed up for a mean duration of 18 months. There were no statistically significant differences between CCTA and functional stress testing in death (1.0% vs 1.1%; risk ratio [RR], 0.93; 95% CI, 0.71-1.21) or cardiac hospitalization (2.7% vs 2.7%; RR, 0.98; 95% CI, 0.79-1.21), but CCTA was associated with a reduction in the incidence of myocardial infarction (0.7% vs 1.1%; RR, 0.71; 95% CI, 0.53-0.96). Patients undergoing CCTA were significantly more likely to undergo invasive coronary angiography (11.7% vs 9.1%; RR, 1.33; 95% CI, 1.12-1.59) and revascularization (7.2% vs 4.5%; RR, 1.86; 95% CI, 1.43-2.43). They were also more likely to receive a diagnosis of new CAD and to have initiated aspirin or statin therapy. Compared with functional stress testing, CCTA is associated with a reduced incidence of myocardial infarction but an increased incidence of invasive coronary angiography, revascularization, CAD diagnoses, and new prescriptions for aspirin and statins. Despite these differences, CCTA is not associated with a reduction in mortality or cardiac hospitalizations.

Coronary revascularization and mortality in men with congestive heart failure or prior myocardial infarction who receive androgen deprivation.

PubMed

Nguyen, Paul L; Chen, Ming H; Goldhaber, Samuel Z; Martin, Neil E; Beard, Clair J; Dosoretz, Daniel E; Katin, Michael J; Ross, Rudi; Salenius, Sharon A; D'Amico, Anthony V

2011-01-15

A study was undertaken to determine the impact of prior coronary revascularization (angioplasty, stent, or coronary artery bypass graft) on the risk of all-cause mortality after neoadjuvant hormonal therapy (HT) for prostate cancer (PC) in men with a history of coronary artery disease (CAD)-induced congestive heart failure (CHF) or myocardial infarction (MI). Among 7839 men who received radiation with or without a median of 4 months of HT for PC from 1991 to 2006, 495 (6.3%) had CAD-induced CHF or MI and formed the study cohort. Of these men, 250 (50.5%) had been revascularized before treatment for PC. Cox regression was used to determine whether HT increased the risk of all-cause mortality, and whether revascularization altered this risk, after adjusting for known PC prognostic factors and a propensity score for revascularization. Median follow-up was 4.1 years. Neoadjuvant HT was associated with an increased risk of all-cause mortality (28.9% vs 15.7% at 5 years; adjusted hazard ratio [HR], 1.73; 95% confidence interval [CI], 1.13-2.64; P = .01). Men who received HT without revascularization had the highest risk of all-cause mortality (33.3%; adjusted HR, 1.48; 95% CI, 1.01-2.18; P = .047), whereas men who were revascularized and did not receive HT had the lowest risk of all-cause mortality (9.4%; adjusted HR, 0.51; 95% CI, 0.28-0.93; P = .028). The reference group had an intermediate risk of all-cause mortality (23.4%) and was comprised of men in whom HT use and revascularization were either both given or both withheld. In men with a history of CAD-induced CHF or MI, neoadjuvant HT is associated with an excess risk of mortality, which appears to be reduced but not eliminated by prior revascularization. Copyright © 2010 American Cancer Society.

Predictors of Functional Dependence Despite Successful Revascularization in Large-Vessel Occlusion Strokes

PubMed Central

Shi, Zhong-Song; Liebeskind, David S.; Xiang, Bin; Ge, Sijian Grace; Feng, Lei; Albers, Gregory W.; Budzik, Ronald; Devlin, Thomas; Gupta, Rishi; Jansen, Olav; Jovin, Tudor G.; Killer-Oberpfalzer, Monika; Lutsep, Helmi L.; Macho, Juan; Nogueira, Raul G.; Rymer, Marilyn; Smith, Wade S.; Wahlgren, Nils; Duckwiler, Gary R.

2014-01-01

Background and Purpose High revascularization rates in large-vessel occlusion strokes treated by mechanical thrombectomy are not always associated with good clinical outcomes. We evaluated predictors of functional dependence despite successful revascularization among patients with acute ischemic stroke treated with thrombectomy. Methods We analyzed the pooled data from the Multi Mechanical Embolus Removal in Cerebral Ischemia (MERCI), Thrombectomy Revascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO), and TREVO 2 trials. Successful revascularization was defined as thrombolysis in cerebral infarction score 2b or 3. Functional dependence was defined as a score of 3 to 6 on the modified Rankin Scale at 3 months. We assessed relationship of demographic, clinical, angiographic characteristics, and hemorrhage with functional dependence despite successful revascularization. Results Two hundred and twenty-eight patients with successful revascularization had clinical outcome follow-up. The rates of functional dependence with endovascular success were 48.6% for Trevo thrombectomy and 58.0% for Merci thrombectomy. Age (odds ratio, 1.04; 95% confidence interval, 1.02–1.06 per 1-year increase), National Institutes of Health Stroke Scale score (odds ratio, 1.08; 95% confidence interval, 1.02–1.15 per 1-point increase), and symptom onset to endovascular treatment time (odds ratio, 1.11; 95% confidence interval, 1.01–1.22 per 30-minute delay) were predictors of functional dependence despite successful revascularization. Symptom onset to reperfusion time beyond 5 hours was associated with functional dependence. All subjects with symptomatic intracranial hemorrhage had functional dependence. Conclusions One half of patients with successful mechanical thrombectomy do not have good outcomes. Age, severe neurological deficits, and delayed endovascular treatment were associated with functional dependence despite successful revascularization. Our data support efforts to minimize delays to endovascular therapy in patients with acute ischemic stroke to improve outcomes. PMID:24876082

Effects of homocysteine-lowering with folic acid plus vitamin B12 vs placebo on mortality and major morbidity in myocardial infarction survivors: a randomized trial.

PubMed

Armitage, Jane M; Bowman, Louise; Clarke, Robert J; Wallendszus, Karl; Bulbulia, Richard; Rahimi, Kazem; Haynes, Richard; Parish, Sarah; Sleight, Peter; Peto, Richard; Collins, Rory

2010-06-23

Blood homocysteine levels are positively associated with cardiovascular disease, but it is uncertain whether the association is causal. To assess the effects of reducing homocysteine levels with folic acid and vitamin B(12) on vascular and nonvascular outcomes. Double-blind randomized controlled trial of 12,064 survivors of myocardial infarction in secondary care hospitals in the United Kingdom between 1998 and 2008. 2 mg folic acid plus 1 mg vitamin B(12) daily vs matching placebo. First major vascular event, defined as major coronary event (coronary death, myocardial infarction, or coronary revascularization), fatal or nonfatal stroke, or noncoronary revascularization. Allocation to the study vitamins reduced homocysteine by a mean of 3.8 micromol/L (28%). During 6.7 years of follow-up, major vascular events occurred in 1537 of 6033 participants (25.5%) allocated folic acid plus vitamin B(12) vs 1493 of 6031 participants (24.8%) allocated placebo (risk ratio [RR], 1.04; 95% confidence interval [CI], 0.97-1.12; P = .28). There were no apparent effects on major coronary events (vitamins, 1229 [20.4%], vs placebo, 1185 [19.6%]; RR, 1.05; 95% CI, 0.97-1.13), stroke (vitamins, 269 [4.5%], vs placebo, 265 [4.4%]; RR, 1.02; 95% CI, 0.86-1.21), or noncoronary revascularizations (vitamins, 178 [3.0%], vs placebo, 152 [2.5%]; RR, 1.18; 95% CI, 0.95-1.46). Nor were there significant differences in the numbers of deaths attributed to vascular causes (vitamins, 578 [9.6%], vs placebo, 559 [9.3%]) or nonvascular causes (vitamins, 405 [6.7%], vs placebo, 392 [6.5%]) or in the incidence of any cancer (vitamins, 678 [11.2%], vs placebo, 639 [10.6%]). Substantial long-term reductions in blood homocysteine levels with folic acid and vitamin B(12) supplementation did not have beneficial effects on vascular outcomes but were also not associated with adverse effects on cancer incidence. isrctn.org Identifier: ISRCTN74348595.

Long-term forecasting and comparison of mortality in the Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial: prospective validation of the SYNTAX Score II.

PubMed

Campos, Carlos M; van Klaveren, David; Farooq, Vasim; Simonton, Charles A; Kappetein, Arie-Pieter; Sabik, Joseph F; Steyerberg, Ewout W; Stone, Gregg W; Serruys, Patrick W

2015-05-21

To prospectively validate the SYNTAX Score II and forecast the outcomes of the randomized Evaluation of the Xience Everolimus-Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) Trial. Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization is a prospective, randomized multicenter trial designed to establish the efficacy and safety of percutaneous coronary intervention (PCI) with the everolimus-eluting stent compared with coronary artery bypass graft (CABG) surgery in subjects with unprotected left-main coronary artery (ULMCA) disease and low-intermediate anatomical SYNTAX scores (<33). After completion of patient recruitment in EXCEL, the SYNTAX Score II was prospectively applied to predict 4-year mortality in the CABG and PCI arms. The 95% prediction intervals (PIs) for mortality were computed using simulation with bootstrap resampling (10 000 times). For the entire study cohort, the 4-year predicted mortalities were 8.5 and 10.5% in the PCI and CABG arms, respectively [odds ratios (OR) 0.79; 95% PI 0.43-1.50). In subjects with low (≤22) anatomical SYNTAX scores, the predicted OR was 0.69 (95% PI 0.34-1.45); in intermediate anatomical SYNTAX scores (23-32), the predicted OR was 0.93 (95% PI 0.53-1.62). Based on 4-year mortality predictions in EXCEL, clinical characteristics shifted long-term mortality predictions either in favour of PCI (older age, male gender and COPD) or CABG (younger age, lower creatinine clearance, female gender, reduced left ventricular ejection fraction). The SYNTAX Score II indicates at least an equipoise for long-term mortality between CABG and PCI in subjects with ULMCA disease up to an intermediate anatomical complexity. Both anatomical and clinical characteristics had a clear impact on long-term mortality predictions and decision making between CABG and PCI. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Randomized Comparison of Paclitaxel-Eluting Balloon and Stenting Versus Plain Balloon Plus Stenting Versus Directional Atherectomy for Femoral Artery Disease (ISAR-STATH).

PubMed

Ott, Ilka; Cassese, Salvatore; Groha, Philipp; Steppich, Birgit; Hadamitzky, Martin; Ibrahim, Tareq; Kufner, Sebastian; Dewitz, Karl; Hiendlmayer, Regina; Laugwitz, Karl-Ludwig; Schunkert, Heribert; Kastrati, Adnan; Fusaro, Massimiliano

2017-06-06

Atherosclerosis in the superficial femoral artery is common in patients suffering from peripheral artery disease. Paclitaxel-eluting balloon (PEB) angioplasty, stenting, and directional atherectomy (DA) have provided new options for the treatment of superficial femoral artery disease; however, the comparative efficacy of these interventional strategies remains uncertain. One hundred and fifty-five patients with symptomatic peripheral artery disease due to de novo superficial femoral artery stenotic or occlusive lesions were randomized to treatment with plain balloon angioplasty (BA) followed by PEB angioplasty and stenting (n=48), BA and stenting (n=52), or DA with distal protection and bailout stenting (n=55). The primary end point of the study was percentage diameter stenosis after 6 months measured by angiography. Other end points included target lesion revascularization, thrombosis, ipsilateral amputation, binary restenosis, and all-cause mortality at 6 and 24 months. Baseline and lesion characteristics were comparable in all groups with a mean lesion length of 65.9±46.8 mm and 56% total occlusions. At 6 months angiography, the percent diameter stenosis was significantly lower in patients treated by PEB angioplasty and stenting (34±31%) as compared with BA angioplasty and stenting (56±29%, P =0.009) or DA (55±29%, P =0.007). Similarly, binary restenosis was significantly lower after treatment with PEB and stenting as compared with BA and stenting or DA. Clinical follow-up at 24 months revealed a lower risk for target lesion revascularization after PEB angioplasty and stenting as compared with BA and stenting or DA. We found no difference in terms of target lesion thrombosis and mortality among groups, and no patient underwent amputation. Treatment of de novo superficial femoral artery lesions with PEB angioplasty and stenting is superior to BA angioplasty and stenting or DA in terms of angiographic diameter stenosis at 6 months and target lesion revascularization at 24 months. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00986752. © 2017 American Heart Association, Inc.

PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock.

PubMed

Thiele, Holger; Akin, Ibrahim; Sandri, Marcus; Fuernau, Georg; de Waha, Suzanne; Meyer-Saraei, Roza; Nordbeck, Peter; Geisler, Tobias; Landmesser, Ulf; Skurk, Carsten; Fach, Andreas; Lapp, Harald; Piek, Jan J; Noc, Marko; Goslar, Tomaž; Felix, Stephan B; Maier, Lars S; Stepinska, Janina; Oldroyd, Keith; Serpytis, Pranas; Montalescot, Gilles; Barthelemy, Olivier; Huber, Kurt; Windecker, Stephan; Savonitto, Stefano; Torremante, Patrizia; Vrints, Christiaan; Schneider, Steffen; Desch, Steffen; Zeymer, Uwe

2017-12-21

In patients who have acute myocardial infarction with cardiogenic shock, early revascularization of the culprit artery by means of percutaneous coronary intervention (PCI) improves outcomes. However, the majority of patients with cardiogenic shock have multivessel disease, and whether PCI should be performed immediately for stenoses in nonculprit arteries is controversial. In this multicenter trial, we randomly assigned 706 patients who had multivessel disease, acute myocardial infarction, and cardiogenic shock to one of two initial revascularization strategies: either PCI of the culprit lesion only, with the option of staged revascularization of nonculprit lesions, or immediate multivessel PCI. The primary end point was a composite of death or severe renal failure leading to renal-replacement therapy within 30 days after randomization. Safety end points included bleeding and stroke. At 30 days, the composite primary end point of death or renal-replacement therapy had occurred in 158 of the 344 patients (45.9%) in the culprit-lesion-only PCI group and in 189 of the 341 patients (55.4%) in the multivessel PCI group (relative risk, 0.83; 95% confidence interval [CI], 0.71 to 0.96; P=0.01). The relative risk of death in the culprit-lesion-only PCI group as compared with the multivessel PCI group was 0.84 (95% CI, 0.72 to 0.98; P=0.03), and the relative risk of renal-replacement therapy was 0.71 (95% CI, 0.49 to 1.03; P=0.07). The time to hemodynamic stabilization, the risk of catecholamine therapy and the duration of such therapy, the levels of troponin T and creatine kinase, and the rates of bleeding and stroke did not differ significantly between the two groups. Among patients who had multivessel coronary artery disease and acute myocardial infarction with cardiogenic shock, the 30-day risk of a composite of death or severe renal failure leading to renal-replacement therapy was lower among those who initially underwent PCI of the culprit lesion only than among those who underwent immediate multivessel PCI. (Funded by the European Union 7th Framework Program and others; CULPRIT-SHOCK ClinicalTrials.gov number, NCT01927549 .).

Revascularization for a necrotic immature permanent lateral incisor: a case report and literature review.

PubMed

Kottoor, Jojo; Velmurugan, Natanasabapathy

2013-07-01

Revascularization is a valuable treatment in immature necrotic teeth that allows the continuation of root development. This article describes the successful revascularization treatment of an immature maxillary lateral incisor that was initially diagnosed with apical periodontitis. The tooth was asymptomatic and functional clinically and radiographically during the follow-up period of 5 years. The follow-up showed evidence of progressive thickening of the dentinal walls, development of root length and apical closure. The article also discusses the currently available literature regarding revascularization of immature permanent teeth. © 2012 John Wiley & Sons Ltd, BSPD and IAPD.

Current status of hybrid coronary revascularization.

PubMed

Jaik, Nikhil P; Umakanthan, Ramanan; Leacche, Marzia; Solenkova, Natalia; Balaguer, Jorge M; Hoff, Steven J; Ball, Stephen K; Zhao, David X; Byrne, John G

2011-10-01

Hybrid coronary revascularization combines coronary artery bypass surgery with percutaneous coronary intervention techniques to treat coronary artery disease. The potential benefits of such a technique are to offer the patients the best available treatments for coronary artery disease while minimizing the risks of the surgery. Hybrid coronary revascularization has resulted in the establishment of new 'hybrid operating suites', which incorporate and integrate the capabilities of a cardiac surgery operating room with that of an interventional cardiology laboratory. Hybrid coronary revascularization has greatly augmented teamwork and cooperation between both fields and has demonstrated encouraging as well as good initial outcomes.

Partially covered versus uncovered self-expandable nitinol stents with anti-migration properties for the palliation of malignant distal biliary obstruction: A randomized controlled trial.

PubMed

Yang, Min Jae; Kim, Jin Hong; Yoo, Byung Moo; Hwang, Jae Chul; Yoo, Jun Hwan; Lee, Ki Seong; Kang, Joon Koo; Kim, Soon Sun; Lim, Sun Gyo; Shin, Sung Jae; Cheong, Jae Youn; Lee, Kee Myung; Lee, Kwang Jae; Cho, Sung Won

2015-01-01

Covered self-expandable metal stents (SEMSs) are increasingly used as alternatives to uncovered SEMSs for the palliation of inoperable malignant distal biliary obstruction to counteract tumor ingrowth. We aimed to compare the outcomes of partially covered and uncovered SEMSs with identical mesh structures and anti-migration properties, such as low axial force and flared ends. One hundred and three patients who were diagnosed with inoperable malignant distal biliary obstruction between January 2006 and August 2013 were randomly assigned to either the partially covered (n = 51) or uncovered (n = 52) SEMS group. There were no significant differences in the cumulative stent patency, overall patient survival, stent dysfunction-free survival and overall adverse events, including pancreatitis and cholecystitis, between the two groups. Compared to the uncovered group, stent migration (5.9% vs. 0%, p = 0.118) and tumor overgrowth (7.8% vs. 1.9%, p = 0.205) were non-significantly more frequent in the partially covered group, whereas tumor ingrowth showed a significantly higher incidence in the uncovered group (5.9% vs. 19.2%, p = 0.041). Stent migration in the partially covered group occurred only in patients with short stenosis of the utmost distal bile duct (two in ampullary cancer, one in bile duct cancer), and did not occur in any patients with pancreatic cancer. For the palliation of malignant distal biliary obstruction, endoscopic placement of partially covered SEMSs with anti-migration designs and identical mesh structures to uncovered SEMSs failed to prolong cumulative stent patency or reduce stent migration.

Long-Term Outcomes After Percutaneous Lower Extremity Arterial Interventions With Atherectomy vs. Balloon Angioplasty　- Propensity Score-Matched Registry.

PubMed

Janas, Adam; Buszman, Piotr P; Milewski, Krzysztof P; Wiernek, Szymon; Janas, Ksenia; Pruski, Maciej; Wojakowski, Wojciech; Błachut, Aleksandra; Picheta, Wojciech; Buszman, Pawel; Kiesz, Stefan

2017-02-24

The impact of endovascular revascularization of the lower extremity arteries with atherectomy (AT) compared with percutaneous transluminal angioplasty (PTA) is still unclear. Therefore, the aim of the study was to compare long-term outcomes after percutaneous PTA and AT in patients requiring endovascular revascularization.Methods and Results:This was a single-center, retrospective registry of obstructive and symptomatic PAD patients who underwent endovascular revascularization. PTA was performed in 215 patients, and AT in 204 (Silver Hawk, EV3, n=125; CSI 360°, n=66; Pathway Medical Technologies, n=13). There were no significant between-group differences in baseline characteristics except for increased CAD, dialysis and CLI prevalence in the PTA group. Following propensity score analysis 131 well-matched pairs were included in analysis. Bail-out stenting was more frequent in the reference group (PTA, 6.1% vs. AT, 0%; P=0.004). At 6- and 12-month follow-up there were no differences in TLR between the groups (PTA, 8.3% vs. AT, 5.3%; P=0.47; and PTA, 16.7% vs. AT, 13.7%; P=0.73, respectively). The difference was in favor of AT at 24-month follow-up (PTA, 29.0% vs. AT, 16.7%; P=0.05). No difference was observed in amputation rate (PTA, 0.7% vs AT, 1.5%; P=0.62). On Kaplan-Meier analysis there were no significant differences between groups in time to TLR, amputation or death. AT was associated with lower risk of TLR, and this should be confirmed in randomized controlled trials.

[Clinical results of double versus single mammary artery myocardiac revascularization: 15 years of follow-up].

PubMed

López Rodríguez, F J; Voces, R; Lima, P; Reyes, G; Silva, J; Ruiz, M; Rico, M; González De Diego, F; Fortuny, R; Garrido, G; González Santos, J M; Albertos, J; Fernández Calella, D; Vallejo, J L

2001-07-01

Use of the left internal mammary artery to bypass the left anterior descending coronary artery reduces cardiac events and increases survival. However, there is some controversy as to the benefits of using both mammary arteries. To assess the long-term outcome of the use of both mammary arteries in comparison with the use of only one. A retrospective cohort study with a mean follow-up of 9.0 +/- 4.2 years was performed including 108 patients consecutively revascularized using both mammary arteries (II) and 108 patients randomly chosen in whom one mammary artery (I) was used for this purpose. Both groups were similar. There were no differences between the groups in operative morbidity or mortality. The survival at 10 years was similar (II: 84.61 +/- 4%; I: 85.18 +/- 3.8%), whereas recurrence of angina (II: 29.63 +/- 5.3%; I: 47.55 +/- 5.6%) (p = 0.012), the requirement for percutaneous angioplasty (II: 3.98 +/- 2%; I: 12.99 +/- 4.1%) (p = 0.009) and cardiologic events (II: 33.48 +/- 5.5%; I: 48.48 +/- 5.5%)(p = 0.022) were all lower in the group in which both mammary arteries were used. In the multivariate analysis, the use of both mammary arteries was an independent protective factor against angina recurrence (RR = 0.55), angioplasty (RR = 0.18) and cardiologic event (RR = 0.60). The use of both mammary arteries for revascularization does not increase operative morbidity. Since this procedure acts as an independent factor against angina recurrence, angioplasty and cardiologic event

Threaded biliary inside stents are a safe and effective therapeutic option in cases of malignant hilar obstruction.

PubMed

Inatomi, Osamu; Bamba, Shigeki; Shioya, Makoto; Mochizuki, Yosuke; Ban, Hiromitsu; Tsujikawa, Tomoyuki; Saito, Yasuharu; Andoh, Akira; Fujiyama, Yoshihide

2013-02-14

Although endoscopic biliary stents have been accepted as part of palliative therapy for cases of malignant hilar obstruction, the optimal endoscopic management regime remains controversial. In this study, we evaluated the safety and efficacy of placing a threaded stent above the sphincter of Oddi (threaded inside plastic stents, threaded PS) and compared the results with those of other stent types. Patients with malignant hilar obstruction, including those requiring biliary drainage for stent occlusion, were selected. Patients received either one of the following endoscopic indwelling stents: threaded PS, conventional plastic stents (conventional PS), or metallic stents (MS). Duration of stent patency and the incident of complication were compared in these patients. Forty-two patients underwent placement of endoscopic indwelling stents (threaded PS = 12, conventional PS = 17, MS = 13). The median duration of threaded PS patency was significantly longer than that of conventional PS patency (142 vs. 32 days; P = 0.04, logrank test). The median duration of threaded PS and MS patency was not significantly different (142 vs. 150 days, P = 0.83). Stent migration did not occur in any group. Among patients who underwent threaded PS placement as a salvage therapy after MS obstruction due to tumor ingrowth, the median duration of MS patency was significantly shorter than that of threaded PS patency (123 vs. 240 days). Threaded PS are safe and effective in cases of malignant hilar obstruction; moreover, it is a suitable therapeutic option not only for initial drainage but also for salvage therapy.

Feasibility of Multiple Burr Hole With Erythropoietin in Acute Moyamoya Patients.

PubMed

Hong, Ji Man; Lee, Seong-Joon; Lee, Jin Soo; Choi, Mun Hee; Lee, Sung Eun; Choi, Jin Wook; Lim, Yong Cheol

2018-05-01

In patients with acute symptomatic moyamoya (<2 weeks), the feasibility of a combination therapy of multiple burr hole procedure under local anesthesia and intravenous erythropoietin pretreatment was assessed. We also identified the factors associated with transdural revascularization. In this prospective single-arm study, perfusion-impaired patients presenting with transient ischemic attack or acute cerebral infarction were assessed. Combination therapy was performed to patients lacking transdural collaterals. Primary outcomes were evaluated clinically with modified Rankin Scale scores and radiologically with revascularization success (transhemispheric, trans-burr hole, and sufficient revascularizations [filling ≥33% of ipsilateral supratentorium]) at 6 months. Treatment-related adverse events were analyzed in 3 phases: pre burr hole, post burr hole, and after-discharge as secondary outcome. Factors associated with sufficient revascularization were investigated. Fifty hemispheres from 37 patients were included. Compared with discharge, modified Rankin Scale score at 6 months significantly improved (2.0 [0.0-5.0] versus 1.0 [0.0-4.0]; P <0.001). Majority had successful revascularization: trans-burr hole arteriogenesis (89.5%), transhemispheric arteriogenesis (98.0%), and sufficient revascularization (52.0%). There was no significant pre burr hole or post burr hole complication. Two (5.4%) transient ischemic attack and 1 (2.7%) cerebral infarction occurred after discharge. Presentation with acute infarction (odds ratio, 4.8; 95% confidence interval, 1.1-21.4), ipsilateral basal moyamoya vessels (odds ratio, 13.9; 95% confidence interval, 1.3-144.2), and delayed mean transit time (odds ratio, 3.9; 95% confidence interval, 1.3-12.2) predicted sufficient revascularization. Combination therapy allows safe and effective revascularization in moyamoya patients with acute ischemic presentation. URL: https://www.clinicaltrials.gov. Unique identifier: NCT03162588. © 2018 American Heart Association, Inc.

The Contemporary Use of Angiography and Revascularization Among Patients With Non-ST-Segment Elevation Myocardial Infarction in the United States Compared With South Korea.

PubMed

Kang, Hyun-Jae; Simon, Dajuanicia; Wang, Tracy Y; Alexander, Karen P; Jeong, Myung Ho; Kim, Hyo-Soo; Bates, Eric R; Henry, Timothy D; Peterson, Eric D; Roe, Matthew T

2015-12-01

Practice guidelines recommend an early invasive strategy for high-risk non-ST-segment elevation myocardial infarction (NSTEMI) patients, but international differences in the use of invasive strategies are unknown. Profiling NSTEMI patient management in the United States (U.S.) and South Korea could provide insight into how patients are triaged for an early invasive strategy in different health care environments and geographical regions. We evaluated the use of angiography and revascularization for NSTEMI patients treated at revascularization-capable hospitals (2007-2010) in both the ACTION Registry-GWTG (U.S.: n = 133,835; 433 hospitals) and KAMIR/KorMI Registry (South Korea: n = 7,901; 72 hospitals). Compared with South Korean patients, U.S. NSTEMI patients more commonly had established cardiovascular risk factors, disease, and prior cardiovascular events and procedures. From 2007-2010, the use of angiography for NSTEMI patients rose steadily in both countries, but the use of revascularization only rose in South Korea. Patients from South Korea more commonly underwent angiography and revascularization. Percutaneous coronary intervention was the most common type of revascularization in both countries, but coronary artery bypass grafting was less common in South Korea. The use of both angiography and revascularization was incrementally lower with a higher predicted mortality risk for patients from both countries, but greater differences between low- and high-risk patients occurred in the U.S. The profile, characteristics, and use of angiography and revascularization for NSTEMI patients in the U.S. vs South Korea differed substantially from 2007-2010, underscoring the heterogeneity of NSTEMI patients and treatment selection among different countries. © 2015 Wiley Periodicals, Inc.

Coronary angiography and myocardial revascularization following the first acute myocardial infarction in Norway during 2001-2009: Analyzing time trends and educational inequalities using data from the CVDNOR project.

PubMed

Sulo, Enxhela; Nygård, Ottar; Vollset, Stein Emil; Igland, Jannicke; Sulo, Gerhard; Ebbing, Marta; Egeland, Grace M; Hawkins, Nathaniel M; Tell, Grethe S

2016-06-01

We analyzed trends in the utilization of coronary angiography and revascularization - including percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) - related to the first AMI and explored potential educational inequalities in such procedures. All first AMI patients aged 35-89, hospitalized during 2001-2009 were retrieved from 'The Cardiovascular Disease in Norway' project. Information on education was obtained from The Norwegian Education Database. Gender and age group-specific trends in coronary procedures were analyzed using Joinpoint regression. Educational inequalities were explored using multivariable Poisson regression and reported as incidence rate ratios (IRR). A total of 104 836 patients (37.3% women) were included. Revascularization rates increased on average 9.0% and 15.4% per year among younger (35-64years) and older (65-89years) men. Corresponding increases among women were 5.6% and 16.6%. Compared to patients with primary education only, those with secondary and tertiary education had 8% (IRR=1.08, 95% CI; 1.06-1.10) and 12% (IRR=1.12, 95% CI; 1.09-1.14) higher revascularization rates. Educational inequalities were entirely driven by educational differences in receiving coronary angiography (IRR=1.10, 95% CI; 1.08-1.11 for secondary versus primary and IRR=1.14, 95% CI; 1.12-1.16 for tertiary versus primary education level.) Among diagnosed patients, no educational differences were observed in coronary revascularization rates. Revascularization rates increased whereas educational differences in revascularization decreased among AMI patients in Norway during 2001-2009. Lower coronary revascularization rates among patients with low education were explained by educational differences in receiving coronary angiography. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Comparison between imported versus domestic drug-eluting stents in China: A large single-center data.

PubMed

Liu, Ru; Gao, Zhan; Chen, Jue; Gao, Lijian; Song, Lei; Qiao, Shubin; Yang, Yuejin; Gao, Runlin; Xu, Bo; Yuan, Jinqing

2017-08-01

In recent years, most drug-eluting stents (DESs) were domestically produced in China, but how domestic DESs perform compared to imported DESs was still unknown. A total of 9011 consecutive cases with DESs implantation in a single center throughout 2013 were prospectively collected. Two-year clinical outcomes were evaluated between patients implanted with imported and domestic DESs. During 2-year follow-up, the rates of all-cause death, cardiac death, myocardial infarction, stroke, and stent thrombosis were not significantly different between two groups. However, the rate of revascularization was significantly higher in domestic DES group, shown as higher rates of overall revascularization, target vessel revascularization (TVR), and target lesion revascularization (TLR) (9.7% vs 6.4%, P < 0.001; 5.6% vs 3.2%, P < 0.001; 4.5% vs 2.2%, P < 0.001, respectively). Accordingly, major adverse cardiac events (MACE) rate was significantly higher in domestic DES group (12.1% vs 8.5%, P < 0.001). Multivariable Cox regression analysis indicated that domestic DES was an independent risk factor of MACE (HR [95%CI]: 1.22 [1.05-1.41]), overall revascularization (HR [95%CI]: 1.29 [1.09-1.53]), TVR (HR [95%CI]: 1.54 [1.22-1.94]), and TLR (HR [95%CI]: 1.85 [1.41-2.42]). After propensity score matching, the rates of overall revascularization, TVR, and TLR were still significantly higher in domestic DES group, and domestic DES was still predictive of overall revascularization, TVR, and TLR in multivariate Cox regression analysis. Domestic DESs showed the same safety as imported DESs in this real-world cohort. But, patients implanted with domestic DESs had a higher risk of revascularization than imported DESs. © 2017, Wiley Periodicals, Inc.

A comparison of hybrid coronary revascularization and off-pump coronary revascularization.

PubMed

Umakanthan, Ramanan; Leacche, Marzia; Gallion, Anna H; Byrne, John G

2013-04-01

Minimally invasive approaches to treat vascular disease have been accruing significant popularity over the last several decades. Due to progressive advances in technology, a variety of techniques are being now utilized in the field of cardiovascular surgery. The objectives of minimally invasive techniques are to curtail operative trauma and minimize perioperative morbidity without decreasing the quality of the treatment. The standard surgical approach for the treatment of coronary artery disease has traditionally been coronary artery bypass grafting surgery via median sternotomy. Off-pump coronary artery bypass grafting surgery offers a less invasive alternative and enables coronary revascularization to be performed without cardiopulmonary bypass. Hybrid coronary revascularization offers an even less invasive option in which minimally invasive direct coronary artery bypass can be combined with percutaneous coronary intervention. In this article, the authors review a recent publication comparing hybrid coronary revascularization and off-pump coronary artery bypass grafting surgery.

Impact of an absorbent silver-eluting dressing system on lower extremity revascularization wound complications.

PubMed

Childress, Beverly B; Berceli, Scott A; Nelson, Peter R; Lee, W Anthony; Ozaki, C Keith

2007-09-01

Surgical wounds for lower extremity revascularization are prone to infection and dehiscence. Acticoat Absorbent, an antimicrobial dressing, offers sustained release of ionic silver. We hypothesized that immediate application of Acticoat as a postoperative dressing would reduce wound complications in patients undergoing leg revascularization. All infrainguinal revascularization cases involving leg incisions at a single Veterans Administration Medical Center were identified from July 1, 2002, to September 30, 2005. The control group received conventional dressings, while the treatment group received an Acticoat dressing. Wound complication rates were captured via National Surgical Quality Improvement Program data. Patient characteristics and procedure distributions were similar between groups. The wound complication rate fell 64% with utilization of the Acticoat-based dressing (control 14% [17/118], treatment 5% [7/130]; P = 0.016). An Acticoat-based dressing system offers a potentially useful, cost-effective adjunct to reduce open surgical leg revascularization wound complications.

Follow-up of coronary artery bypass graft patency: diagnostic efficiency of high-pitch dual-source 256-slice MDCT findings.

PubMed

Yuceler, Zeyneb; Kantarci, Mecit; Yuce, Ihsan; Kizrak, Yesim; Bayraktutan, Ummugulsum; Ogul, Hayri; Kiris, Adem; Celik, Omer; Pirimoglu, Berhan; Genc, Berhan; Gundogdu, Fuat

2014-01-01

Our aim was to evaluate the diagnostic accuracy of 256-slice, high-pitch mode multidetector computed tomography (MDCT) for coronary artery bypass graft (CABG) patency. Eighty-eight patients underwent 256-slice MDCT angiography to evaluate their graft patency after CABG surgery using a prospectively synchronized electrocardiogram in the high-pitch spiral acquisition mode. Effective radiation doses were calculated. We investigated the diagnostic accuracy of high-pitch, low-dose, prospective, electrocardiogram-triggering, dual-source MDCT for CABG patency compared with catheter coronary angiography imaging findings. A total of 215 grafts and 645 vessel segments were analyzed. All graft segments had diagnostic image quality. The proximal and middle graft segments had significantly (P < 0.05) better mean image quality scores (1.18 ± 0.4) than the distal segments (1.31 ± 0.5). Using catheter coronary angiography as the reference standard, high-pitch MDCT had the following sensitivity, specificity, positive predictive value, and negative predictive value of per-segment analysis for detecting graft patency: 97.1%, 99.6%, 94.4%, and 99.8%, respectively. In conclusion, MDCT can be used noninvasively with a lower radiation dose for the assessment of restenosis in CABG patients.

Long-term outcome of permanent hemodialysis catheters: a controlled study.

PubMed

Jean, G; Charra, B; Chazot, C; Vanel, T; Terrat, J C; Hurot, J M

2001-01-01

Hemodialysis tunneled catheters are widely used nowadays. However, their complications, infection and dysfunction, remain much too frequent. Different types of tunneled silicone hemodialysis catheters are available. We prospectively compared the long-term outcome of the two most popular devices, Permcath cuffed double catheter and TwinCath uncuffed twin catheter, both inserted percutaneously. From January 1994 to April 1998, 125 tunneled catheters were inserted in the internal jugular vein of 86 chronic hemodialysis patients, 63 TwinCath MedComp (TC) and 62 Permcath Quinton (PC). They were prospectively followed looking for technical patency, infection and dysfunction rate. TC were used more often for iterative access (52 vs. 25%, p = 0.01) and were inserted more frequently in the left internal jugular vein (59 vs. 16% p < 0.001). Their median technical survival rate was longer (869 vs. 433 days for PC, p < 0.01) with a 1-year patency rate of 80 vs. 53% (p = 0.002). Total catheter extrusion was also slightly less frequent with TC (4.7 vs. 9.6%), but partial extrusion happened more frequently (43 vs. 16%, p = 0.02). No significant difference in infection rate was observed, 0.77 for TC vs. 1.3 local infection/1,000 catheter days; 1.08 vs. 1.30 bacteremia/1,000 catheter days. A persistent catheter thrombosis was observed in 7.9 vs. 20.9% in PC (p = 0.04), the number of dysfunction was 10.5 vs. 24/1,000 days in use (p = 0.0001) and the number of urokinase infusion was 4.4 vs. 12/1,000 days (p = 0.001). PC needed more radiological interventions for dysfunction with endolumenal brushes (4 vs. 0) or fibrin sleeve removal (4 vs. 0). The vena cava thrombosis incidence was not different (2 vs. 3). Although the study was not randomized, TC appears more efficient allowing for a longer patency with a lower dysfunction rate than PC. This was reinforced by less favorable conditions of TC including more left jugular side and more iterative catheters. The cuff does not offer a better bacteriological barrier or protection against extrusion, and the TC seems at a less risk of fibrin sleeves. However, a large randomized study is needed to definitively conclude. Copyright 2001 S. Karger AG, Basel

[Therapeutic impact of screening for myocardial ischemia among asymptomatic type 2 diabetic subjects].

PubMed

Wallemacq, Caroline M; Scheen, André J

2008-08-27

Coronary artery disease is the major cause of mortality of type 2 diabetic subjects. Its early diagnosis to prevent progression and clinical events has intuitive appeal. Somehow, rationale for screening has not been clearly established. Screening should not modify the medical therapy because diabetic subjects have to be treated in a secondary prevention strategy. We have no data from randomized trials concerning a better outcome after revascularization in this specific population. The question how to select the high risk population to be screened has no response by now. SPECT and stress echocardiography seem valuable for screening but not for risk stratification. A large randomized clinical trial is required to confirm the cost-utility ratio of such a screening.

Symptomatic retention of the Agile® patency capsule.

PubMed

Egea Valenzuela, Juan; Estrella Díez, Esther; Alberca de Las Parras, Fernando

2017-06-01

The Agile® capsule has shown to be useful when evaluating the patency of the small bowel in patients prior to capsule endoscopy studies. It is a safe tool and a low rate of complications have been reported, highlighting symptomatic retention, although references in literature are scarce and it is only observed in 1.2% of the procedures. We present the case of a symptomatic retention of this device in a patient with previously known colonic Crohn's disease in who a small bowel study was indicated and was sent for prior patency test.

Increased Hazard of Myocardial Infarction With Insulin-Provision Therapy in Actively Smoking Patients With Diabetes Mellitus and Stable Ischemic Heart Disease: The BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) Trial.

PubMed

Khan, Asrar A; Chung, Matthew J; Novak, Eric; Brown, David L

2017-09-13

In the BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial, randomization of diabetic patients with stable ischemic heart disease to insulin provision (IP) therapy, as opposed to insulin sensitization (IS) therapy, resulted in biochemical evidence of impaired fibrinolysis but no increase in adverse clinical outcomes. We hypothesized that the prothrombotic effect of IP therapy in combination with the hypercoagulable state induced by active smoking would result in an increased risk of myocardial infarction (MI). We analyzed BARI 2D patients who were active smokers randomized to IP or IS therapy. The primary end point was fatal or nonfatal MI. PAI-1 (plasminogen activator inhibitor 1) activity was analyzed at 1, 3, and 5 years. Of 295 active smokers, MI occurred in 15.4% randomized to IP and in 6.8% randomized to IS over the 5.3 years ( P =0.023). IP therapy was associated with a 3.2-fold increase in the hazard of MI compared with IS therapy (hazard ratio: 3.23; 95% confidence interval, 1.43-7.28; P =0.005). Baseline PAI-1 activity (19.0 versus 17.5 Au/mL, P =0.70) was similar in actively smoking patients randomized to IP or IS therapy. However, IP therapy resulted in significantly increased PAI-1 activity at 1 year (23.0 versus 16.0 Au/mL, P =0.001), 3 years (24.0 versus 18.0 Au/mL, P =0.049), and 5 years (29.0 versus 15.0 Au/mL, P =0.004) compared with IS therapy. Among diabetic patients with stable ischemic heart disease who were actively smoking, IP therapy was independently associated with a significantly increased hazard of MI. This finding may be explained by higher PAI-1 activity in active smokers treated with IP therapy. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00006305. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Developing a new hybrid revascularization program: a road map for hospital managers and physician leaders.

PubMed

Harjai, Kishore J; Samy, Sanjay; Pennypacker, Barbara; Onofre, Bonnie; Stanfield, Pamela; Yaeger, Lynne; Stapleton, Dwight; Esrig, Barry C

2012-12-01

Hybrid coronary revascularization, which involves minimally invasive direct coronary artery bypass surgery using the left internal mammary artery to left anterior descending and percutaneous coronary intervention using drug-eluting stents for the remaining diseased coronary vessels, is an innovative approach to decrease the morbidity of conventional surgery. Little information is available to guide hospital managers and physician leaders in implementing a hybrid revascularization program. In this article, we describe the people-process-technology issues that managers and leaders are likely to encounter as they develop a hybrid revascularization program in their practice. ©2012, Wiley Periodicals, Inc.

Revascularization for Left Main and Multivessel Coronary Artery Disease: Current Status and Future Prospects after the EXCEL and NOBLE Trials

PubMed Central

2018-01-01

Revascularization of severe left main and multivessel coronary artery disease has been shown to improve survival in both stable ischemic heart disease and acute coronary syndrome. While revascularization with coronary artery bypass surgery for these disease entities carries class I recommendation in most current guidelines, recent trials has shown potential comparable survival and cardiovascular outcomes between percutaneous and surgical interventions in patients with less complex coronary anatomy. Despite the conflicting results observed in the most recent left main revascularization trials, Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease (EXCEL) and Nordic-Baltic-British left main revascularization (NOBLE), both treatment strategies remain important for the management of left main disease (LMD) and multivessel disease (MVD) reflecting on the importance of heart team discussion. This review is focused on revascularization of LMD and MVD in patients who are not presenting with ST-segment elevation myocardial infarction, encompassing the evidence from historic and contemporary trials which shaped up current practices. This review discusses the heart team approach to guide decision making, including special populations that are not represented in clinical trials. PMID:29856140

Revascularization for Left Main and Multivessel Coronary Artery Disease: Current Status and Future Prospects after the EXCEL and NOBLE Trials.

PubMed

Al-Hijji, Mohammed; El Sabbagh, Abdallah; Holmes, David R

2018-06-01

Revascularization of severe left main and multivessel coronary artery disease has been shown to improve survival in both stable ischemic heart disease and acute coronary syndrome. While revascularization with coronary artery bypass surgery for these disease entities carries class I recommendation in most current guidelines, recent trials has shown potential comparable survival and cardiovascular outcomes between percutaneous and surgical interventions in patients with less complex coronary anatomy. Despite the conflicting results observed in the most recent left main revascularization trials, Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease (EXCEL) and Nordic-Baltic-British left main revascularization (NOBLE), both treatment strategies remain important for the management of left main disease (LMD) and multivessel disease (MVD) reflecting on the importance of heart team discussion. This review is focused on revascularization of LMD and MVD in patients who are not presenting with ST-segment elevation myocardial infarction, encompassing the evidence from historic and contemporary trials which shaped up current practices. This review discusses the heart team approach to guide decision making, including special populations that are not represented in clinical trials. Copyright © 2018. The Korean Society of Cardiology.

Dental Pulp Revascularization of Necrotic Permanent Teeth with Immature Apices.

PubMed

El Ashiry, Eman A; Farsi, Najat M; Abuzeid, Sawsan T; El Ashiry, Mohamed M; Bahammam, Hammam A

The treatment of immature necrotic teeth with apical periodontitis presents challenges in endodontic and pediatric dentistry. Revascularization is a recent treatment for such cases as an alternative to conventional apexification. The purpose is to examine the effect of a pulpal revascularization procedure on immature necrotic teeth with apical periodontitis. Twenty patients were enrolled for pulp revascularization procedure by root canal disinfection using a triple antibiotic mixture for 1-2 weeks, followed by creating a blood clot, sealing the root canal orifice using white mineral trioxide aggregate and a coronal seal of composite resin. Patients were recalled periodically for up to 24 months. During follow-up, all patients were asymptomatic. Three cases of chronic apical periodontitis showed clinical disappearance of the sinus tract 2 weeks after treatment. Radiography revealed progressive periapical radiolucency resolution within the first 12 months. Within 12-24 months, the treated teeth showed progressive increases in dentinal wall thickness, root length and continued root development. Clinical and radiographic evidence showed successful revascularization treatments of immature necrotic permanent teeth with apical periodontitis. More studies are necessary to understand the underlying mechanisms and to perform histopathology of the pulp space contents after revascularization procedures.

Functional outcomes of transmetatarsal amputation in the diabetic foot: timing of revascularization, wound healing and ambulatory status.

PubMed

Mandolfino, T; Canciglia, A; Salibra, M; Ricciardello, D; Cuticone, G

2016-12-01

Transmetatarsal amputation (TMA) is an effective surgical approach to treat forefoot infection and gangrene in diabetic patients. However, a high rate of complications and failure to heal require reamputation in a large number of cases. We analysed the outcomes of TMA to define the role of revascularization, wound healing and ambulatory status. From January 2008 to January 2013, 218 diabetic patients with foot infection and gangrene, submitted to TMA associated to revascularization were followed until healing, amputation or death. Revascularization was done in 202 (92 %) cases. In 16 (7 %) no revascularization was required. The TMA was closed in 135 (62 %) and left open in 83 (38 %) cases. The reamputation rate was 34 % and major amputation 12.6 % at 1-year follow-up. Patient following ranged 2-30 months with a mean of 15 months. The functional outcomes, living at home and ambulation outdoors, were 60 and 36 % at hospital discharge after TMA, 81 and 77 % at 1-year follow-up. TMA associated to revascularization can provide an effective limb salvage and functional results in diabetic patients with forefoot tissue loss and infection.

Pulp revascularization of immature permanent teeth: a review of the literature and a proposal of a new clinical protocol.

PubMed

Namour, Mélanie; Theys, Stephanie

2014-01-01

Tissue engineering is a growing field. In the near future, it will probably be possible to generate a complete vital tooth from a single stem cell. Pulp revascularization is dependent on the ability of residual pulp and apical and periodontal stem cells to differentiate. These cells have the ability to generate a highly vascularized and a conjunctive rich living tissue. This one is able to colonize the available pulp space. Revascularization is a new treatment method for immature necrotic permanent teeth. Up to now, apexification procedures were applied for these teeth, using calcium dihydroxide or MTA to produce an artificial apical barrier. However, the pulp revascularization allows the stimulation of the apical development and the root maturation of immature teeth. Two pulp revascularization techniques are used in the literature, one using calcium dihydroxide and the second using a triple antibiotic paste. Based on these two different pulp revascularization protocols, which obtain the desired therapeutic success, the literature will be reviewed and analyzed according to the relevance of their choice of materials. Based on the literature, we propose a new relevant protocol and a new mixture of antibiotics.

ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 Appropriate use criteria for coronary revascularization focused update: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, and the Society of Cardiovascular Computed Tomography.

PubMed

Patel, Manesh R; Dehmer, Gregory J; Hirshfeld, John W; Smith, Peter K; Spertus, John A

2012-02-28

The American College of Cardiology Foundation (ACCF), Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, and the American Association for Thoracic Surgery, along with key specialty and subspecialty societies, conducted an update of the appropriate use criteria (AUC) for coronary revascularization frequently considered. In the initial document, 180 clinical scenarios were developed to mimic patient presentations encountered in everyday practice and included information on symptom status, extent of medical therapy, risk level as assessed by noninvasive testing, and coronary anatomy. This update provides a reassessment of clinical scenarios the writing group felt to be affected by significant changes in the medical literature or gaps from prior criteria. The methodology used in this update is similar to the initial document, and the definition of appropriateness was unchanged. The technical panel scored the clinical scenarios on a scale of 1 to 9. Scores of 7 to 9 indicate that revascularization is considered appropriate and likely to improve patients' health outcomes or survival. Scores of 1 to 3 indicate revascularization is considered inappropriate and unlikely to improve health outcomes or survival. Scores in the mid-range (4 to 6) indicate a clinical scenario for which the likelihood that coronary revascularization will improve health outcomes or survival is uncertain. In general, as seen with the prior AUC, the use of coronary revascularization for patients with acute coronary syndromes and combinations of significant symptoms and/or ischemia is appropriate. In contrast, revascularization of asymptomatic patients or patients with low-risk findings on noninvasive testing and minimal medical therapy are viewed less favorably. The technical panel felt that based on recent studies, coronary artery bypass grafting remains an appropriate method of revascularization for patients with high burden of coronary artery disease (CAD). Additionally,percutaneous coronary intervention may have a role in revascularization of patients with high burden of CAD. The primary objective of the appropriate use criteria is to improve physician decision making and patient education regarding expected benefits from revascularization and to guide future research.

ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 appropriate use criteria for coronary revascularization focused update: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, and the Society of Cardiovascular Computed Tomography.

PubMed

Patel, Manesh R; Dehmer, Gregory J; Hirshfeld, John W; Smith, Peter K; Spertus, John A; Masoudi, Frederick A; Dehmer, Gregory J; Patel, Manesh R; Smith, Peter K; Chambers, Charles E; Ferguson, T Bruce; Garcia, Mario J; Grover, Frederick L; Holmes, David R; Klein, Lloyd W; Limacher, Marian C; Mack, Michael J; Malenka, David J; Park, Myung H; Ragosta, Michael; Ritchie, James L; Rose, Geoffrey A; Rosenberg, Alan B; Russo, Andrea M; Shemin, Richard J; Weintraub, William S; Wolk, Michael J; Bailey, Steven R; Douglas, Pamela S; Hendel, Robert C; Kramer, Christopher M; Min, James K; Patel, Manesh R; Shaw, Leslee; Stainback, Raymond F; Allen, Joseph M

2012-04-01

The American College of Cardiology Foundation (ACCF), Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, and the American Association for Thoracic Surgery, along with key specialty and subspecialty societies, conducted an update of the appropriate use criteria (AUC) for coronary revascularization frequently considered. In the initial document, 180 clinical scenarios were developed to mimic patient presentations encountered in everyday practice and included information on symptom status, extent of medical therapy, risk level as assessed by noninvasive testing, and coronary anatomy. This update provides a reassessment of clinical scenarios the writing group felt to be affected by significant changes in the medical literature or gaps from prior criteria. The methodology used in this update is similar to the initial document, and the definition of appropriateness was unchanged. The technical panel scored the clinical scenarios on a scale of 1 to 9. Scores of 7 to 9 indicate that revascularization is considered appropriate and likely to improve patients' health outcomes or survival. Scores of 1 to 3 indicate revascularization is considered inappropriate and unlikely to improve health outcomes or survival. Scores in the mid-range (4 to 6) indicate a clinical scenario for which the likelihood that coronary revascularization will improve health outcomes or survival is uncertain. In general, as seen with the prior AUC, the use of coronary revascularization for patients with acute coronary syndromes and combinations of significant symptoms and/or ischemia is appropriate. In contrast, revascularization of asymptomatic patients or patients with low-risk findings on noninvasive testing and minimal medical therapy are viewed less favorably. The technical panel felt that based on recent studies, coronary artery bypass grafting remains an appropriate method of revascularization for patients with high burden of coronary artery disease (CAD). Additionally, percutaneous coronary intervention may have a role in revascularization of patients with high burden of CAD. The primary objective of the appropriate use criteria is to improve physician decision making and patient education regarding expected benefits from revascularization and to guide future research.

Comparative effectiveness of anticoagulation on midterm infrainguinal bypass graft patency.

PubMed

Liang, Nathan L; Baril, Donald T; Avgerinos, Efthymios D; Leers, Steven A; Makaroun, Michel S; Chaer, Rabih A

2017-08-01

Therapeutic anticoagulation (AC) is used clinically for prolongation of infrainguinal bypass patency, but evidence for the efficacy of this practice is conflicting. The objective of our study was to determine the association of AC with bypass graft primary patency. Clinical and comorbid data of patients undergoing infrainguinal bypass grafts to a below-knee target with at least 1 year of follow-up performed from 2003 to 2015 were obtained from the Society for Vascular Surgery Vascular Quality Initiative. Inverse propensity of treatment-weighted Cox regression was used to assess the effect of AC on patency in the total cohort while adjusting for clinical, operative, and comorbid differences between treatment groups. Subgroup analyses of distal targets and conduit type were performed. Perioperative complications were analyzed using propensity-weighted logistic regression. We identified 7612 bypass grafts with intact 1-year follow-up information from 2003 to 2015. The mean age was 67.5 ± 11.2 years; 30.5% (n = 2320) were female, and 28.6% (n = 2165) were discharged on therapeutic AC. The anticoagulated group had a higher rate of tibial, ankle, and pedal targets (52.1% [n = 1127] vs 47.6% [n = 2269]; P < .001), had a greater use of non-single-segment vein conduits (44.3% [n = 951] vs 26.5% [n = 1426]; P < .001), and was more likely to have had a previous ipsilateral bypass (27.2% [n = 589] vs 14.7% [n = 794]; P < .001) or stent (25.4% [n = 550] vs 20.9% [n = 1130]; P < .001). Estimated unadjusted primary patency was 70.8% ± 0.6% at 1 year and lower for anticoagulated bypasses (66.9% ± 1.2% vs 72.4% ± 0.7%; P < .001). Propensity-weighted analysis showed no significant association of AC with primary patency in the overall cohort (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.86-1.11; P = .8) but demonstrated a trend toward improvement of primary patency in those with a non-single-segment vein conduit to a below-knee popliteal target (HR, 0.85; 95% CI, 0.80-1.02; P = .09). AC was associated with significantly improved secondary patency in those with prosthetic bypass grafts (HR, 0.77; 95% CI, 0.62-0.96; P = .02) or prosthetic bypasses to an infrapopliteal target (HR, 0.72; 95% CI, 0.54-0.97; P = .02). Odds of postoperative wound complications were significantly higher in those receiving AC (odds ratio, 1.33; 95% CI, 1.11-1.61; P = .002). This study does not demonstrate a significant impact of therapeutic AC on primary patency for infrainguinal bypass grafts. Treatment with AC may benefit secondary patency in those with a prosthetic bypass, especially to an infrapopliteal target, but at an increased risk of postoperative wound complications. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Clinical application of laser treatment for cardiovascular surgery

PubMed Central

Okada, Masayoshi; Yoshida, Masato; Tsuji, Yoshihiko; Horii, Hiroyuki

2011-01-01

Background: Recently, several kinds of lasers have been widely employed in the field of medicine and surgery. However, laser applications are very rare in the field of cardiovascular surgery throughout the world. So, we have experimentally tried to use lasers in the field of cardiovascular surgery. There were three categories: 1) Transmyocardial laser revascularization (TMLR), 2) Laser vascular anastomosis, and 3) Laser angioplasty in the peripheral arterial diseases. By the way, surgery for ischemic heart disease has been widely performed in Japan. Especially coronary artery bypass grafting (CABG) for these patients has been done as a popular surgical method. Among these patients there are a few cases for whom CABG and percutaneous coronary intervention (PCI) could not be carried out, because of diffuse stenosis and small caliber of coronary arteries. Materials and methods of TMLR: A new method of tranasmyocardial revascularization by CO2 laser (output 100 W, irradiation time 0.2 sec) was experimentally performed to save severely ill patients. In this study, a feasibility of transmyocardial laser revascularization from left ventricular cavity through artificially created channels by laser was precisely evaluated. Results: In trials on dogs laser holes 0.2mm in diameter have been shown microscopically to be patent even 3 years after their creation, thus this procedure could be used as a new method of transmyocardial laser revascularization. Clinical application of TMLR: Subsequently, transmyocardial laser revascularization was employed in a 55-year-old male patient with severe angina pectoris who had undergone pericardiectomy 7 years before. He was completely recovered from severe chest pain. Conclusions of TMLR: This patient was the first successful case in the world with TMLR alone. This method might be done for the patients who percutaneous coronary intervention and coronary artery bypass grafting could be carried out. Laser vascular anastomosis: At present time, in vascular surgery there are some problems to keep long-term patency after anastomosis of the conventional suture method, especially for small-caliber vessels. Materials and methods of Laser vascular anastomosis: From these standpoints, a low energy CO2 laser was employed experimentally in vascular anastomosis for small-caliber vessels. Resullts of Laser vascular anastomosis: From preliminary experiments it could be concluded that the optimal laser output was 20–40 mW and irradiation time was 6–12 sec/mm for vascular anastomosis of small-caliber vessels in the extremities. And then, histologic findings and intensity of the laser anastomotic sites were investigated thereafter. Subseqently, good enough intensity and good healing of laser anastomotic sites as well as the conventional suture method could be observed. There were no statistic differences between laser and suture methods. A feasibility of laser anastomosis could be considered and clinical application could be recognized. Clinical applications of Laser vascular anastomosis: On February 21, 1985, arterio-venous laser anastomosis for the patient with renal failure was smoothly done and she could accept hemodialysis. Conclusions of Laser vascular anastomosis: This patient was the first clinical successful case in the world. Thereafter, Laser vascular anastomosis were in 111 patients with intermittent claudication, refractory crural ulcer, and coronary disorders. Thereafter, they are going well. Laser angioplasty: Laser angioplasty for peripheral arterial diseases. There are many methods to treat peripheral arterial diseases such as balloon method, atherectomy, laser technique and stenting graft in the field of endovascular treatment. Recent years, minimal invasive treatment should be employed even in the surgical treatment. However, there are different images between these methods. Materials and methods of Laser angioplasty: We have chosen to use laser for endovascular treatment for peripheral arterial diseases. We have tried to check between laser energy and vessel wall. Results of Laser angioplasty: Subsequently, it could be concluded that optimal conditions for laser angioplasty were 6 W in output and irradiation time was 5 sec. And with another method of feedback control system, temperature of metal tip probe was 200°C and irradiation time was 5 sec for each shot. And histological study and feasibility of angioscopic guidance could be done and clinical application was started. Until now, 115 patients were successfully treated with their life longevity. Conclusions of Laser angioplasty: Thus, laser applications were useful methods to treat a lot of patients with some ischemic problems. PMID:24155531

Heparin-bonded, expanded polytetrafluoroethylene-lined stent graft in the treatment of femoropopliteal artery disease: 1-year results of the VIPER (Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) trial.

PubMed

Saxon, Richard R; Chervu, Arun; Jones, Paul A; Bajwa, Tanvir K; Gable, Dennis R; Soukas, Peter A; Begg, Richard J; Adams, John G; Ansel, Gary M; Schneider, Darren B; Eichler, Charles M; Rush, Michael J

2013-02-01

To evaluate the performance of a heparin-bonded, expanded polytetrafluoroethylene (ePTFE)-lined nitinol endoprosthesis in the treatment of long-segment occlusive disease of the femoropopliteal artery (FPA) and to identify factors associated with loss of patency. In a single-arm, prospective, 11-center study (VIPER [Gore Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease] trial), 119 limbs (113 patients; 69 men; mean age, 67 y), including 88 with Rutherford category 3-5 disease and 72 with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) C or D lesions of the FPA, underwent stent graft implantation. The mean lesion length was 19 cm; 56% of lesions were occlusions. Follow-up evaluations included color duplex ultrasonography in all patients, with patency defined as a peak systolic velocity ratio< 2.5. At 12 months, Rutherford category and ankle-brachial index (ABI) were significantly improved (mean category improvement, 2.4; ABI increased from 0.6±0.2 to 0.9±0.19; P<.0001). Primary and secondary patency rates were 73% and 92%. The primary patency for devices oversized<20% at the proximal landing zone was 88%, whereas the primary patency for devices oversized by>20% was 70% (P = .047). Primary patency was not significantly affected by device diameter (5 vs 6 vs 7 mm) or lesion length (≤20 cm vs>20 cm). The 30-day major adverse event rate was 0.8%. The heparin-bonded, ePTFE/nitinol stent graft provided clinical improvement and a primary patency rate of 73% at 1 year in the treatment of long-segment FPA disease. Careful sizing of the device relative to vessel landing zones is essential for achieving optimal outcomes. Copyright © 2013 SIR. Published by Elsevier Inc. All rights reserved.

Comparison of sequential left internal thoracic artery grafting and separate left internal thoracic artery and venous grafting : A 5-year follow-up.

PubMed

Wendt, D; Schmidt, D; Wasserfuhr, D; Osswald, B; Thielmann, M; Tossios, P; Kühl, H; Jakob, H; Massoudy, P

2010-09-01

The superiority of left internal thoracic artery (LITA) grafting to the left anterior descending artery (LAD) is well established. Patency rates of 80%-90% have been reported at 10-year follow-up. However, the superiority of sequential LITA grafting has not been proven. Our aim was to compare patency rates after sequential LITA grafting to a diagonal branch and the LAD with patency rates of LITA grafting to the LAD and separate vein grafting to a diagonal branch. A total of 58 coronary artery bypass graft (CABG) patients, operated on between 01/2000 and 12/2002, underwent multi-slice computed tomography (MSCT) between 2006 and 2008. Of these patients, 29 had undergone sequential LITA grafting to a diagonal branch and to the LAD ("Sequential" Group), while in 29 the LAD and a diagonal branch were separately grafted with LITA and vein ("Separate" Group). Patencies of all anastomoses were investigated. Mean follow-up was 1958±208 days. The patency rate of the LAD anastomosis was 100% in the Sequential Group and 93% in the Separate Group (p=0.04). The patency rate of the diagonal branch anastomosis was 100% in the Sequential Group and 89% in the Separate Group (p=0.04). Mean intraoperative flow on LITA graft was not different between groups (69±8ml/min in the Sequential Group and 68±9ml/min in the Separate Group, p=n.s.). Patency rates of both the LAD and the diagonal branch anastomoses were higher after sequential arterial grafting compared with separate arterial and venous grafting at 5-year follow-up. This indicates that, with regard to the antero-lateral wall of the left ventricle, there is an advantage to sequential arterial grafting compared with separate arterial and venous grafting.

Primary Stenting Is Not Necessary in Benign Central Venous Stenosis.

PubMed

Rangel, Lynsey E; Lyden, Sean P; Clair, Daniel G

2018-01-01

The aim of this study is to evaluate central venous stenosis (CVS) etiologies and presentation within a vascular surgery practice. We evaluated endovascular treatment modalities and the patency rates of our interventions. Five-year retrospective review of endovascular intervention for CVS. Patient demographics, medical comorbidities, and variables were collected including etiology, indwelling device, previous upper extremity (UE) deep venous thrombosis, long-term UE indwelling device (defined as >30 days), malignancy status, hypercoagulable disorders, history of radiation or mediastinal fibrosis or masses, and anticoagulation and/or antiplatelet therapy. Follow-up variables included symptoms, imaging, and anticoagulation and/or antiplatelet utilization. Living patients without recent follow-up were contacted with a telephone survey regarding current symptoms. Patency was evaluated by imaging or clinically by recurrence of signs or symptoms through January 2016. A total of 61 patients underwent attempted endovascular CVS interventions from January 2007 to 2013. Forty-seven (83%) patients had successful interventions. There were 22 (36%) end-stage renal disease (ESRD) patients. The primary etiology in 79% of patients was benign CVS secondary to an indwelling device. Eighty-nine percent of the interventions were primary angioplasty (PTA). The overall primary patency rates at 6, 12, and 24 months were 49%, 34%, and 24%, respectively. Secondary patency rates at 6, 12, and 24 months were 97%, 93%, and 88%, respectively. There were no statistical differences in demographics or outcomes in patients treated successfully with PTA or those requiring stenting. There was no statistical difference in the patency rates between ESRD and non-ESRD patients. Previous interventions were not a predictor of loss of patency. Our study supported the rising trend of benign CVS predominantly secondary to indwelling devices. We demonstrated acceptable secondary patency with PTA alone. This study adds further support for a primary angioplasty strategy in treating benign CVS. The optimal endovascular treatment for benign CVS is still undefined. Copyright © 2017 Elsevier Inc. All rights reserved.

Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial).

PubMed

Généreux, Philippe; Lee, Arthur C; Kim, Christopher Y; Lee, Michael; Shlofmitz, Richard; Moses, Jeffrey W; Stone, Gregg W; Chambers, Jeff W

2015-06-15

Percutaneous coronary intervention of severely calcified lesions has historically been associated with major adverse cardiac event (MACE) rates as high as 30%. In the ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial, treatment of de novo severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) resulted in low rates of procedural and 30-day adverse ischemic events. The long-term results from this trial have not been reported. We sought to determine the 1-year outcomes after orbital atherectomy of severely calcified coronary lesions. ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites with severely calcified lesions usually excluded from randomized trials. OAS utilizes a centrifugal differential sanding mechanism of action for plaque modification prior to stent implantation. After OAS drug-eluting stents were implanted in 88.2% of the patients. The primary safety end point was 30-day MACE, the composite of cardiac death, myocardial infarction, or target vessel revascularization [TVR]. The present analysis reports the 1-year follow-up results from ORBIT II. One-year data were available in 433 of 443 patients (97.7%), with median follow-up time of 16.7 months. The 1-year MACE rate was 16.4%, including cardiac death (3.0%), myocardial infarction (9.7%), and target vessel revascularization (5.9%). The 1-year target lesion revascularization rate was 4.7%, and stent thrombosis occurred in 1 patient (0.2%). Independent predictors of 1-year MACE and target vessel revascularization were diameter stenosis at baseline and the use of bare-metal stents. In patients with severely calcified lesions who underwent percutaneous coronary intervention, the use of OAS was associated with low rates of 1-year adverse ischemic events compared with historical controls. This finding has important clinical implications for the selection of optimum treatment strategies for patients with severely calcified lesions. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Percutaneous Coronary Intervention versus Coronary Artery Bypass Grafting in Patients with Diabetic Nephropathy and Left Main Coronary Artery Disease.

PubMed

Li, Hsin-Ru; Hsu, Chiao-Po; Sung, Shih-Hsien; Shih, Chun-Che; Lin, Shing-Jong; Chan, Wan-Leong; Wu, Cheng-Hsueh; Lu, Tse-Min

2017-03-01

Patients with diabetic nephropathy and unprotected left main (LM) coronary artery disease suffer from high cardiovascular morbidity and mortality. Although surgical revascularization is currently recommended in this special patient population, the optimal revascularization method for this distinct patient group has remained unclear. We collected 99 consecutive patients with unprotected LM disease and diabetic nephropathy, including 46 patients who had undergone percutaneous coronary intervention (PCI), and 53 who had coronary artery bypass grafting (CABG), with a mean age of 72 ± 10; with 80.8% male. Diabetic nephropathy was defined as overt proteinuria (proteinuria > 500 mg/day) and estimated glomerular filtration rate (eGFR) by the modified Modification of Diet in Renal Disease (MDRD) equation of less than 60 mL/min/1.73 m 2 . The baseline characteristics, angiographic results and long-term clinical outcomes were retrospectively analyzed. The baseline characteristic of all patients were similar except for smokers, low density lipoprotein (LDL) level and extension of coronary artery disease involvement. The median follow-up period was 3.8 years. There were 73 patients (74%) considered as high risk with additive European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥ 6. During follow-up period, the long term rate of all-cause death (PCI vs. CABG: 45.7% vs. 58.5%, p = 0.20) and all-cause death/myocardial infarction (MI)/stroke (PCI vs. CABG: 52.2% vs. 60.4%, p = 0.41) were comparable between the PCI and CABG group, whereas the repeat revascularization rate was significantly higher in the PCI group (PCI vs. CABG: 32.6% vs. 9.4%, p < 0.01). eGFR remained an independent predictor for all-cause death [hazard ratio: 0.97, 95% confidence interval: 0.96 to 0.99; p = 0.002] in multivariate logistic regression. In the real-world practice of high-risk patients with unprotected LM disease and diabetic nephropathy, we found that PCI was a comparable alternative to CABG in terms of long-term risks of all-cause death/MI/stroke, with significantly higher repeat revascularization rate. Given the small patient number and retrospective nature, our findings should be validated by larger-scale randomized studies.

Cost-effectiveness of percutaneous coronary intervention with drug-eluting stents versus bypass surgery for patients with 3-vessel or left main coronary artery disease: final results from the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial.

PubMed

Cohen, David J; Osnabrugge, Ruben L; Magnuson, Elizabeth A; Wang, Kaijun; Li, Haiyan; Chinnakondepalli, Khaja; Pinto, Duane; Abdallah, Mouin S; Vilain, Katherine A; Morice, Marie-Claude; Dawkins, Keith D; Kappetein, A Pieter; Mohr, Friedrich W; Serruys, Patrick W

2014-09-30

The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial demonstrated that in patients with 3-vessel or left main coronary artery disease, coronary artery bypass graft surgery (CABG) was associated with a lower rate of cardiovascular death, myocardial infarction, stroke, or repeat revascularization compared with percutaneous coronary revascularization with drug-eluting stents (DES-PCI)). The long-term cost-effectiveness of these strategies is unknown. Between 2005 and 2007, 1800 patients with left main or 3-vessel coronary artery disease were randomized to CABG (n=897) or DES-PCI (n=903). Costs were assessed from a US perspective, and health state utilities were evaluated with the EuroQOL questionnaire. A patient-level microsimulation model based on the 5-year in-trial data was used to extrapolate costs, life expectancy, and quality-adjusted life expectancy over a lifetime horizon. Although initial procedural costs were $3415 per patient lower with CABG, total hospitalization costs were $10 036 per patient higher. Over the next 5 years, follow-up costs were higher with DES-PCI as a result of more frequent hospitalizations, revascularization procedures, and higher medication costs. Over a lifetime horizon, CABG remained more costly than DES-PCI, but the incremental cost-effectiveness ratio was favorable ($16 537 per quality-adjusted life-year gained) and remained <$20 000 per quality-adjusted life-year in most bootstrap replicates. Results were consistent across a wide range of assumptions about the long-term effect of CABG versus DES-PCI on events and costs. In patients with left main disease or a SYNTAX score ≤22, however, DES-PCI was economically dominant compared with CABG, although these findings were less certain. For most patients with 3-vessel or left main coronary artery disease, CABG is a clinically and economically attractive revascularization strategy compared with DES-PCI. However, among patients with less complex disease, DES-PCI may be preferred on both clinical and economic grounds. www.clinicaltrials.gov. Unique identifier: NCT00114972. © 2014 American Heart Association, Inc.

ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2016 Appropriate Use Criteria for Coronary Revascularization in Patients With Acute Coronary Syndromes : A Report of the American College of Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and the Society of Thoracic Surgeons.

PubMed

Patel, Manesh R; Calhoon, John H; Dehmer, Gregory J; Grantham, James Aaron; Maddox, Thomas M; Maron, David J; Smith, Peter K

2017-04-01

The American College of Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, and American Association for Thoracic Surgery, along with key specialty and subspecialty societies, have completed a 2-part revision of the appropriate use criteria (AUC) for coronary revascularization. In prior coronary revascularization AUC documents, indications for revascularization in acute coronary syndromes (ACS) and stable ischemic heart disease were combined into 1 document. To address the expanding clinical indications for coronary revascularization, and in an effort to align the subject matter with the most current American College of Cardiology/American Heart Association guidelines, the new AUC for coronary artery revascularization were separated into 2 documents addressing ACS and stable ischemic heart disease individually. This document presents the AUC for ACS. Clinical scenarios were developed to mimic patient presentations encountered in everyday practice and included information on symptom status, presence of clinical instability or ongoing ischemic symptoms, prior reperfusion therapy, risk level as assessed by noninvasive testing, fractional flow reserve testing, and coronary anatomy. This update provides a reassessment of clinical scenarios that the writing group felt to be affected by significant changes in the medical literature or gaps from prior criteria. The methodology used in this update is similar to the initial document but employs the recent modifications in the methods for developing AUC, most notably, alterations in the nomenclature for appropriate use categorization. A separate, independent rating panel scored the clinical scenarios on a scale of 1 to 9. Scores of 7 to 9 indicate that revascularization is considered appropriate for the clinical scenario presented. Scores of 1 to 3 indicate that revascularization is considered rarely appropriate for the clinical scenario, whereas scores in the mid-range (4 to 6) indicate that coronary revascularization may be appropriate for the clinical scenario. Seventeen clinical scenarios were developed by a writing committee and scored by the rating panel: 10 were identified as appropriate, 6 as may be appropriate, and 1 as rarely appropriate. As seen with the prior coronary revascularization AUC, revascularization in clinical scenarios with ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction were considered appropriate. Likewise, clinical scenarios with unstable angina and intermediate- or high-risk features were deemed appropriate. Additionally, the management of nonculprit artery disease and the timing of revascularization are now also rated. The primary objective of the AUC is to provide a framework for the assessment of practice patterns that will hopefully improve physician decision making.

Biodegradable metals for cardiovascular stents: from clinical concerns to recent Zn - alloys

PubMed Central

Bowen, Patrick K.; Shearier, Emily R.; Zhao, Shan; Guillory, Roger J.; Zhao, Feng; Goldman, Jeremy; Drelich, Jaroslaw W.

2016-01-01

Metallic stents are commonly used to promote revascularization and maintain patency of plaqued or damaged arteries following balloon angioplasty. To mitigate the long-term side effects associated with corrosion-resistant stents (i.e. chronic inflammation and late stage thrombosis), a new generation of so-called “bioabsorbable” stents is currently being developed. The bioabsorbable coronary stents will corrode and be absorbed by the artery after completing their task as vascular scaffolding. Research spanning the last two decades has focused on biodegradable polymeric, iron-based, and magnesium-based stent materials. The inherent mechanical and surface properties of metals make them more attractive stent material candidates than their polymeric counterparts. Unfortunately, iron produces a voluminous, retained oxide product in the arterial wall, whereas magnesium and its alloys corrode too rapidly. A third class of metallic bioabsorbable materials that are based on zinc has been introduced in the last few years. As summarized in this contribution, this new zinc-based class of materials demonstrates the potential for an absorbable metallic stent with the mechanical and biodegradation characteristics required for optimal stent performance. They appear to be free of flaws that limit the application of iron- and magnesium-based alloys, and polymers. This review compares bioabsorbable materials and summarizes progress towards bioabsorbable stents. It emphasizes on current understanding of physiological and biological benefits of zinc and its biocompatibility. Finally, the review provides an outlook on challenges in designing zinc-based stents of optimal mechanical properties and biodegradation rate. PMID:27094868

Occipital Artery to Middle Cerebral Artery Bypass in Cases of Unavailable Superficial Temporal Artery.

PubMed

Hirano, Tsukasa; Mikami, Takeshi; Suzuki, Hime; Hirano, Toru; Kimura, Yusuke; Komatsu, Katusya; Akiyama, Yukinori; Wanibuchi, Masahiko; Mikuni, Nobuhiro

2018-04-01

In neurosurgery, extracranial-to-intracranial (EC-IC) bypass surgery is necessary for patients who have undergone surgery in which the superficial temporal artery (STA) was already used for a different bypass procedure or was damaged. Here we report our experience with EC-IC bypass using the occipital artery (OA) in patients in whom the STA was unavailable, and discuss the technical considerations and pitfalls. Five patients with ischemic-onset moyamoya disease and atherosclerotic disease were included. Two patterns of skin incisions were planned according to the OA pathway and recipient artery location. In one of these methods, a skin incision is made above the OA, and a craniotomy is performed under this incision after OA dissection. In the other method, a skin incision is made above the OA to enable its dissection, and a craniotomy is performed via a separate skin incision. No major perioperative complications developed in any of the 5 cases, and bypass patency was confirmed in all patients. There was a significant difference between the preoperative and postoperative asymmetry ratios of the mean transit time values. Our findings suggest that OA-to-middle cerebral artery (MCA) bypass is a simple and effective technique in patients in whom the STA was already used or was damaged by previous intracranial revascularization or craniotomy. This procedure could be an alternative to STA-MCA bypass in patients without an available STA. Copyright © 2018 Elsevier Inc. All rights reserved.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schuermann, Karl; Vorwerk, Dierk; Buecker, Arno

Purpose: To compare nonferromagnetic iliac artery prostheses in their suitability for patency monitoring with magnetic resonance angiography (MRA) using conventional angiography as a reference. Methods: In experiment 1, three Memotherm stents were inserted into the iliac arteries of each of six sheep: two 'tandem' stents on one side and a single stent on the other side. In experiment 2, four prostheses (normal and low-porosity Corvita stent-grafts, Memotherm, ZA-stent) were inserted in each of 11 sheep. Patency was monitored before and 1, 3, and 6 months after insertion with 3D phase-contrast and two 2D time-of-flight sequences (TOF-1: TR/TE = 18/6.9, TOF-2:more » 13/2.5) with and without contrast at 1.5 T. On 206 coronal MIP images (72 pre-, 134 post-stenting), three readers analyzed 824 iliac segments (206 x 4) for patency and artifacts. Results: There was no difference in the number of artifacts between tandem and single iliac Memotherm stents. The ZA-stent induced significantly fewer artifacts than the other prostheses (p < 0.00001). With MRA, patency of the ZA-stent was correctly diagnosed in 88% of cases, which was almost comparable to nonstented iliac segments (95%), patency of the Memotherm stent in 59%, and of the Corvita stent-grafts in 57% and 55%. The TOF-2 sequence with contrast yielded the best images. Conclusion: MRA compatibility of nonferromagnetic prostheses depends strongly on the design of the device. MRA may be used to monitor the patency of iliac ZA-stents, whereas iliac Memotherm stents and Corvita stent-grafts appear to be less suited for follow-up with MRA.« less

Threaded biliary inside stents are a safe and effective therapeutic option in cases of malignant hilar obstruction

PubMed Central

2013-01-01

Background Although endoscopic biliary stents have been accepted as part of palliative therapy for cases of malignant hilar obstruction, the optimal endoscopic management regime remains controversial. In this study, we evaluated the safety and efficacy of placing a threaded stent above the sphincter of Oddi (threaded inside plastic stents, threaded PS) and compared the results with those of other stent types. Methods Patients with malignant hilar obstruction, including those requiring biliary drainage for stent occlusion, were selected. Patients received either one of the following endoscopic indwelling stents: threaded PS, conventional plastic stents (conventional PS), or metallic stents (MS). Duration of stent patency and the incident of complication were compared in these patients. Results Forty-two patients underwent placement of endoscopic indwelling stents (threaded PS = 12, conventional PS = 17, MS = 13). The median duration of threaded PS patency was significantly longer than that of conventional PS patency (142 vs. 32 days; P = 0.04, logrank test). The median duration of threaded PS and MS patency was not significantly different (142 vs. 150 days, P = 0.83). Stent migration did not occur in any group. Among patients who underwent threaded PS placement as a salvage therapy after MS obstruction due to tumor ingrowth, the median duration of MS patency was significantly shorter than that of threaded PS patency (123 vs. 240 days). Conclusions Threaded PS are safe and effective in cases of malignant hilar obstruction; moreover, it is a suitable therapeutic option not only for initial drainage but also for salvage therapy. PMID:23410217

Clinical usefulness of novel tag-less Agile patency capsule prior to capsule endoscopy for patients with suspected small bowel stenosis.

PubMed

Nakamura, Masanao; Hirooka, Yoshiki; Yamamura, Takeshi; Miyahara, Ryoji; Watanabe, Osamu; Ando, Takafumi; Ohmiya, Naoki; Goto, Hidemi

2015-01-01

The Agile patency capsule (PC; Given Imaging Ltd, Yoqneam, Israel) is used as a dummy prior to capsule endoscopy (CE) to avoid retention of the CE capsule. However, impaction of the PC's inner radio frequency identification (RFID) tag in a stricture could cause small-bowel ileus. Recently, the RFID tag-less PC was introduced into clinical practice. Herein, we aimed to retrospectively evaluate the usefulness of the tag-less PC. Of 154 patients who were scheduled to undergo CE, 100 consecutive patients (65%) who underwent PC evaluation were enrolled in the present study. Primary study end point was the retention rate of the CE capsule after successful passage of the PC. Secondary end point was analysis of the significant factors affecting the passage of the PC. In total, 87 patients (87%) had bowel patency confirmed by PC evaluation. There was no capsule retention in any of these 87 patients during CE. Abnormal findings were obtained from 60 CE, and 41 patients received new or modified treatment. Multivariate analysis of factors related to the confirmation of patency demonstrated that stenosis on imaging was the most influential factor (P = 0.002, odds ratio 16.387). The results confirmed that passage of the PC depends on stenosis on imaging. Use of the tag-less PC confirmed gastrointestinal tract patency for most of the patients who did not have stenosis on imaging and allowed estimation of the patency for patients who did have stenosis on imaging. © 2014 The Authors. Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society.

Intraoperative sonographic assessment of graft patency during extracranial-intracranial bypass.

PubMed

Badie, B; Lee, F T; Pozniak, M A; Strother, C M

2000-09-01

Extracranial-intracranial (EC-IC) bypass may be necessary to facilitate treatment of unclippable posterior circulation fusiform aneurysms. Although intraoperative digital subtraction angiography (DSA) allows assessment of graft patency, this technique, because of difficulties inherent in performing selective catheterization and angiography in the operating room, has limitations. Duplex sonography, in contrast, is easily performed, and provides information regarding graft patency and blood flow direction during EC-IC bypass procedures. This latter information proved useful in determining the time of parent artery occlusion after two EC-IC bypass procedures performed for treatment of a fusiform midbasilar artery aneurysm.

[Damage to cranial and peripheral nerves following patency restoration of the internal carotid artery].

PubMed

Myrcha, P; Ciostek, P; Szopiński, P; Noszczyk, W

2001-01-01

The aim of the study was an assessment of the incidence of injury to cranial and peripheral nerves as complication of patency restoration of the internal carotid artery, and analysis of the effect of peripheral nerve injury on the results of carotid patency restoration. From Oct 1987 to Sept 1999 543 procedures were carried out for restoration of patency of the internal carotid artery. After the operation hypoglossus nerve injury was found in 7 cases (1.4%), vagus injury in 9 (1.8%). Signs of exclusively recurrent laryngeal nerve damage were found in 6 cases (1.2%). Glossopharyngeus nerve was damaged in 2 cases (0.4%), transient phrenic nerve palsy as a result of conduction anaesthesia was noted in 2 cases (0.4%). Damage to the transverse cervical nerve was found in 96 cases (60%). In 2 patients (1.2%) lower position of mouth angle was due to section of the mandibular ramus of the facial nerve. In another 2 cases skin sensation disturbances were a consequence of lesion of the auricularis magnus nerve and always they coexisted with signs of transverse cervical nerve damage. damage to the cranial nerves during operation for carotid patency restoration are frequent but mostly they are not connected with any health risks and often they regress spontaneously.

Bile Flow Phantom Model and Animal Bile Duct Dilation Model for Evaluating Biliary Plastic Stents with Advanced Hydrophilic Coating

PubMed Central

Kwon, Chang-Il; Kim, Gwangil; Jeong, Seok; Lee, Won Seop; Lee, Don Haeng; Ko, Kwang Hyun; Hong, Sung Pyo; Hahm, Ki Baik

2016-01-01

Background/Aims The efforts to improve biliary plastic stents (PSs) for decreasing biofilm formation and overcome short patency time have been continued. The aim of this study is to evaluate the effect of advanced hydrophilic coating for patency and biodurability of PS. Methods Using an in vitro bile flow phantom model, we compared patency between prototype PS with hydrophilic coating (PS+HC) and prototype PS without hydrophilic coating (PS−HC). We performed an analysis of the degree of luminal narrowing by microscopic examination. Using an in vivo swine bile duct dilation model made by endoscopic papillary closure and stent insertion, we evaluated biodurability of hydrophilic coating. Results In the phantom model, PS+HC showed less biofilm formation and luminal narrowing than PS−HC at 8 weeks (p<0.05). A total of 31 stents were inserted into the dilated bile duct of seven swine models, and 24 stents were successfully retrieved 8 weeks later. There was no statistical difference of stent patency between the polyethylene PS+HC and the polyurethane PS+HC. The biodurability of hydrophilic coating was sustained up to 8 weeks, when assessing the coating layer by scanning electron microscopy examination. Conclusions Advanced hydrophilic coating technology may extend the patency of PS compared to uncoated PS. PMID:27021507

The association of statin therapy with the primary patency of femoral and popliteal artery stents.

PubMed

de Grijs, Derek; Teixeira, Pedro; Katz, Steven

2018-05-01

It has long been known that hydroxymethylglutaryl-coenzyme A reductase inhibitors (statins) broadly reduce cardiovascular events in patients with peripheral vascular disease. It was the goal of this study to determine whether there is an association between statin therapy and primary patency after stenting of superficial femoral and popliteal arteries. The records of all patients undergoing primary nitinol stenting of the femoral and popliteal arteries at a single institution and by a single surgeon during a 10-year period were reviewed. Demographic characteristics of the patients and risk factors were identified. TransAtlantic Inter-Society Consensus (TASC II) classifications were determined for all stented lesions. Analysis was performed to determine whether the use of statins at the time of stent placement was associated with a change in rates of primary patency. Loss of primary patency was said to have occurred when an intrastent occlusion or a ≥70% stenosis was identified by arterial duplex ultrasound or angiography. Kaplan-Meier survival curves were plotted, and differences between groups were tested by log-rank method. Between 2004 and 2014, primary femoral or popliteal stenting was performed on 308 limbs in 250 patients. At the time of intervention, 52.4% of these patients were being treated with statin therapy; 137 interventions were done for claudication and 113 for critical limb ischemia. Of the lesions treated, 165 were TASC A or B and 85 were TASC C or D. Primary patency rates for all stented lesions were 75%, 54%, and 35% at 12, 24, and 36 months. The patency rates at 12, 24, and 36 months, respectively, were 80%, 55%, and 40% for those taking statins and 68%, 49%, and 28% for those not taking statins (P = .178). Statin therapy demonstrated a trend toward an association with improved primary patency rates in TASC A/B lesions but had no association in TASC C/D lesions (TASC A/B, P = .056; TASC C/D, P = .537). Statin compliance was found to be 87% at a mean follow-up of 24.1 months. Although the use of statins has been shown to reduce cardiovascular morbidity and mortality in patients with peripheral vascular disease, overall there is not an association of these drugs with improved primary patency after primary stenting of femoral and popliteal artery lesions. However, when limbs are stratified for severity, less severe (TASC A/B) lesions demonstrated a trend toward a significant association between statin use and improved primary patency. This finding was not seen in more severe (TASC C/D) disease. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

First-in-man experience with the ReVive PV peripheral thrombectomy device for the revascularization of below-the-knee embolic occlusions.

PubMed

Landau, David; Moomey, Charles; Fiorella, David

2014-10-01

To report the initial use of a novel thrombectomy device for revascularization of below-the-knee thromboembolic occlusions encountered during proximal revascularization procedures. The ReVive PV Peripheral Thrombectomy Device is a non-detachable, self-expanding stent-like device recently approved for peripheral thrombectomy. Four patients (3 women; mean age 68.8 years) undergoing proximal revascularization procedures experienced embolic occlusions of all 3 trifurcation vessels in 1 patient, the tibioperoneal trunk alone in 2 cases, and the peroneal artery alone in the last patient. In all cases, the involved arteries represented the primary or sole vessel(s) providing outflow to the lower extremity. In each case, the ReVive PV device was used to successfully extract the thrombus and restore flow to the distal extremity. No complications were encountered during any of the procedures. The ReVive PV peripheral thrombectomy device may facilitate the safe and efficient revascularization of distal arterial embolic occlusions.

Clinical outcome following conservative vs revascularization therapy in patients with stable coronary artery disease and borderline fractional flow reserve measurements.

PubMed

Lindstaedt, Michael; Halilcavusogullari, Yasemin; Yazar, Aydan; Holland-Letz, Tim; Bojara, Waldemar; Mügge, Andreas; Germing, Alfried

2010-02-01

Fractional flow reserve (FFR) measurements in the so-called gray-zone range of > or = 0.75 and < or =0.80 are associated with uncertainty concerning the guidance of patient therapy. It is unclear whether any difference in clinical outcome exists when revascularization treatment of FFR-evaluated lesions in this borderline range is deferred or performed. The objective of this study is to compare the clinical outcome of these patients with respect to their recommended treatment strategy. Out of a single center database of 900 consecutive patients with stable coronary artery disease, 97 patients with borderline FFR measurements were identified and included in the study. The rate of major adverse cardiac events (MACE; cardiac death, myocardial infarction (MI), coronary revascularization) and the presence of angina were evaluated at follow-up. A total of 48 patients were deferred from revascularization and 49 patients underwent revascularization. There was no difference in risk profile between these groups. At a mean follow-up of 24+/-16 months, event-free survival in the deferred group was significantly better regarding overall MACE, combined rate of cardiac death, and MI, as well as MACE related to the FFR-evaluated vessel. No difference with regard to the presence of angina was observed. Patients with coronary lesions in the borderline FFR range can be deferred from revascularization without putting them at increased risk for major adverse events. Revascularization may be considered in the course of therapy on an individual basis if typical angina persists or worsens despite maximal medical treatment. Copyright 2010 Wiley Periodicals, Inc.

Coronary Computed Tomographic Angiography-Derived Fractional Flow Reserve for Therapeutic Decision Making.

PubMed

Tesche, Christian; Vliegenthart, Rozemarijn; Duguay, Taylor M; De Cecco, Carlo N; Albrecht, Moritz H; De Santis, Domenico; Langenbach, Marcel C; Varga-Szemes, Akos; Jacobs, Brian E; Jochheim, David; Baquet, Moritz; Bayer, Richard R; Litwin, Sheldon E; Hoffmann, Ellen; Steinberg, Daniel H; Schoepf, U Joseph

2017-12-15

This study investigated the performance of coronary computed tomography angiography (cCTA) with cCTA-derived fractional flow reserve (CT-FFR) compared with invasive coronary angiography (ICA) with fractional flow reserve (FFR) for therapeutic decision making in patients with suspected coronary artery disease (CAD). Seventy-four patients (62 ± 11 years, 62% men) with at least 1 coronary stenosis of ≥50% on clinically indicated dual-source cCTA, who had subsequently undergone ICA with FFR measurement, were retrospectively evaluated. CT-FFR values were computed using an on-site machine-learning algorithm to assess the functional significance of CAD. The therapeutic strategy (optimal medical therapy alone vs revascularization) and the appropriate revascularization procedure (percutaneous coronary intervention vs coronary artery bypass grafting) were selected using cCTA-CT-FFR. Thirty-six patients (49%) had a functionally significant CAD based on ICA-FFR. cCTA-CT-FFR correctly identified a functionally significant CAD and the need of revascularization in 35 of 36 patients (97%). When revascularization was deemed indicated, the same revascularization procedure (32 percutaneous coronary interventions and 3 coronary artery bypass grafting) was chosen in 35 of 35 patients (100%). Overall, identical management strategies were selected in 73 of the 74 patients (99%). cCTA-CT-FFR shows excellent performance to identify patients with and without the need for revascularization and to select the appropriate revascularization strategy. cCTA-CT-FFR as a noninvasive "one-stop shop" has the potential to change diagnostic workflows and to directly inform therapeutic decision making in patients with suspected CAD. Copyright © 2017 Elsevier Inc. All rights reserved.

Endovascular thrombectomy for acute ischemic stroke in failed intravenous tissue plasminogen activator versus non-intravenous tissue plasminogen activator patients: revascularization and outcomes stratified by the site of arterial occlusions.

PubMed

Shi, Zhong-Song; Loh, Yince; Walker, Gary; Duckwiler, Gary R

2010-06-01

Intracranial mechanical thrombectomy is a therapeutic option for acute ischemic stroke patients failing intravenous tissue plasminogen activator (IV tPA). We compared patients treated by mechanical embolus removal in cerebral ischemia (MERCI) thrombectomy after failed IV tPA with those treated with thrombectomy alone. We pooled MERCI and Multi MERCI study patients, grouped them either as failed IV tPA or non-IV tPA, and assessed revascularization rates, procedural complications, symptomatic hemorrhage rates, clinical outcomes, and mortality. We also evaluated outcomes stratified by the occlusion site and final revascularization. Among 305 patients, 48 failed, and 257 were ineligible for IV tPA. Nonresponders to IV tPA trended toward a higher revascularization rate (73% versus 63%) and less mortality (27.7% versus 40.1%) and had similar rates of symptomatic hemorrhage and procedural complications. Favorable 90-day outcomes were similar in failed and non-IV tPA patients (38% versus 31%), with no difference according to occlusion site. Among patients failing IV tPA, good outcomes tended to occur more frequently in revascularized patients (47.1% versus 15.4%), although this relationship was attributable solely to middle cerebral artery and not internal carotid artery occlusions, with no difference in mortality. Among IV tPA-ineligible patients, revascularization correlated with good outcome (47.4% versus 4.4%) and less mortality (28.5% versus 59.6%). The risks of hemorrhage and procedure-related complications after mechanical thrombectomy do not differ with respect to previous IV tPA administration. Thrombectomy after IV tPA achieves similar rates of good outcomes, a tendency toward lower mortality, and similar revascularization rates when stratified by clot location. Good outcomes correlate with successful revascularization except with internal carotid artery occlusions in tPA-nonresponders.

Impact of minimally invasive surgery on medical spending and employee absenteeism.

PubMed

Epstein, Andrew J; Groeneveld, Peter W; Harhay, Michael O; Yang, Feifei; Polsky, Daniel

2013-07-01

As many surgical procedures have undergone a transition from a standard, open surgical approach to a minimally invasive one in the past 2 decades, the diffusion of minimally invasive surgery may have had sizeable but overlooked effects on medical expenditures and worker productivity. To examine the impact of standard vs minimally invasive surgery on health plan spending and workplace absenteeism for 6 types of surgery. Cross-sectional regression analysis. National health insurance claims data and matched workplace absenteeism data from January 1, 2000, to December 31, 2009. A convenience sample of adults with employer-sponsored health insurance who underwent either standard or minimally invasive surgery for coronary revascularization, uterine fibroid resection, prostatectomy, peripheral revascularization, carotid revascularization, or aortic aneurysm repair. Health plan spending and workplace absenteeism from 14 days before through 352 days after the index surgery. There were 321,956 patients who underwent surgery; 23,814 were employees with workplace absenteeism data. After multivariable adjustment, mean health plan spending was lower for minimally invasive surgery for coronary revascularization (-$30,850; 95% CI, -$31,629 to -$30,091), uterine fibroid resection (-$1509; 95% CI, -$1754 to -$1280), and peripheral revascularization (-$12,031; 95% CI, -$15,552 to -$8717) and higher for prostatectomy ($1350; 95% CI, $611 to $2212) and carotid revascularization ($4900; 95% CI, $1772 to $8370). Undergoing minimally invasive surgery was associated with missing significantly fewer days of work for coronary revascularization (mean difference, -37.7 days; 95% CI, -41.1 to -34.3), uterine fibroid resection (mean difference, -11.7 days; 95% CI, -14.0 to -9.4), prostatectomy (mean difference, -9.0 days; 95% CI, -14.2 to -3.7), and peripheral revascularization (mean difference, -16.6 days; 95% CI, -28.0 to -5.2). For 3 of 6 types of surgery studied, minimally invasive procedures were associated with significantly lower health plan spending than standard surgery. For 4 types of surgery, minimally invasive procedures were consistently associated with significantly fewer days of absence from work.

A comparison of patency and interventions in thigh versus Hemodialysis Reliable Outflow grafts for chronic hemodialysis vascular access.

PubMed

Brownie, Evan R; Kensinger, Clark D; Feurer, Irene D; Moore, Derek E; Shaffer, David

2016-11-01

With improvements in medical management and survival of patients with end-stage renal disease, maintaining durable vascular access is increasingly challenging. This study compared primary, assisted primary, and secondary patency, and procedure-specific complications, and evaluated whether the number of interventions to maintain or restore patency differed between prosthetic femoral-femoral looped inguinal access (thigh) grafts and Hemodialysis Reliable Outflow (HeRO; Hemosphere Inc, Minneapolis, Minn) grafts. A single-center, retrospective, intention-to-treat analysis was conducted of consecutive thigh and HeRO grafts placed between May 2004 and June 2015. Medical history, interventions to maintain or restore patency, and complications were abstracted from the electronic medical record. Data were analyzed using parametric and nonparametric statistical tests, Kaplan-Meier survival methods, and multivariable proportional hazards regression and logistic regression. Seventy-six (43 thigh, 33 HeRO) grafts were placed in 61 patients (54% male; age 53 [standard deviation, 13] years). Median follow-up time in the intention-to-treat analysis was 21.2 months (min, 0.0; max, 85.3 months) for thigh grafts and 6.7 months (min, 0.0; max, 56.3 months) for HeRO grafts (P = .02). The groups were comparable for sex, age, coronary artery disease, diabetes mellitus, peripheral vascular disease, and smoking history (all P ≥ .12). One thigh graft (2%) and five HeRO (15%) grafts failed primarily. In the intention-to-treat analysis, patency durations were significantly longer in the thigh grafts (all log-rank P ≤ .01). Point estimates of primary patency at 6 months, 1 year, and 3 years were 61%, 46%, and 4% for the thigh grafts and 25%, 15%, and 6% for the HeRO grafts. Point estimates of assisted primary patency at 6 months, 1 year, and 3 years were 75%, 66%, and 54% for the thigh grafts and 41%, 30%, and 10% for the HeRO grafts. Point estimates of secondary patency at 6 months, 1 year, and 3 years were 88%, 88%, and 70% for the thigh grafts and 53%, 43%, and 12% for the HeRO grafts. There were no differences in ischemic (P = .63) or infectious (P = .79) complications between the groups. Multivariable logistic regression demonstrated that after adjusting for follow-up time, HeRO grafts were associated with an increased number of interventions (P = .03). Thigh grafts have significantly better primary, assisted primary, and secondary patency compared with HeRO grafts. There is no significant difference between thigh grafts and HeRO grafts in ischemic or infectious complications. Our logistic regression model demonstrated an association between HeRO grafts and an increased number of interventions to maintain or restore patency. Although HeRO grafts may extend the use of the upper extremity, thigh grafts provide a more durable option for chronic hemodialysis. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Left subclavian artery stenting: an option for the treatment of the coronary-subclavian steal syndrome

PubMed Central

de Almeida, Bruno Lorenção; Kambara, Antonio Massamitsu; Rossi, Fabio Henrique; Moreira, Samuel Martins; de Oliveira, Eduardo Silva Jordao; Linhares Filho, Frederico Augusto de Carvalho; Metzger, Patrick Bastos; Passalacqua, Aldo Zampieri

2014-01-01

Introduction The subclavian steal syndrome is characterized by the vertebral artery flow inversion, due to a stenotic lesion in the origin of the subclavian artery. The Coronary-subclavian Steal Syndrome is a variation of the Subclavian Steal Syndrome and is characterized by inversion of flow in the Internal Thracic artery that has been used as conduct in a myocardial revascularization. Its diagnosis must be suspected in patients with difference in pulse and arterial pressure in the upper limbs, that present with angina pectoris and that have done a myocardial revascularization. Its treatment must be a surgical bypass or a transluminal angioplasty. Objective The objective is to show the left subclavian artery stenting as a safe and effective method to treat the coronary-subclavian steal syndrome. Methods Historical prospective, non-randomized trial, through revision of the hospital records of the patients treated with the stenting of the left subclavian artery, from January 2006 to September 2012. Results In the mentioned period, 4.291 miocardial revascularizations were performed with the use of the left mammary artery, and 16 patients were identified to have the Coronary-subclavian steal syndrome. All of them were submitted to endovascular treatment. The success rate was 100%; two patients experienced minor complications; none of them presented with major complications. Eleven of the 16 patients had ultrassonographic documentation of patent stent for at least one year; two patients lost follow up and other two died. Conclusion The stenting of the left subclavian artery is a good option for the treatment of the Coronary-subclavian Steal Syndrome, with high level of technical and clinical success. PMID:25140474

Risk Factors for Incident Peripheral Arterial Disease in Type 2 Diabetes: Results From the Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes (BARI 2D) Trial

PubMed Central

Althouse, Andrew D.; Abbott, J. Dawn; Forker, Alan D.; Bertolet, Marnie; Barinas-Mitchell, Emma; Thurston, Rebecca C.; Mulukutla, Suresh; Aboyans, Victor; Brooks, Maria Mori

2014-01-01

OBJECTIVE The aim of this article was to define risk factors for incidence of peripheral arterial disease (PAD) in a large cohort of patients with type 2 diabetes mellitus (T2DM), overall and within the context of differing glycemic control strategies. RESEARCH DESIGN AND METHODS The Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes (BARI 2D) randomized controlled trial assigned participants to insulin-sensitizing (IS) therapy versus insulin-providing (IP) therapy. A total of 1,479 participants with normal ankle-brachial index (ABI) at study entry were eligible for analysis. PAD outcomes included new ABI ≤0.9 with decrease at least 0.1 from baseline, lower extremity revascularization, or lower extremity amputation. Baseline risk factors within the overall cohort and time-varying risk factors within each assigned glycemic control arm were assessed using Cox proportional hazards models. RESULTS During an average 4.6 years of follow-up, 303 participants (20.5%) experienced an incident case of PAD. Age, sex, race, and baseline smoking status were all significantly associated with incident PAD in the BARI 2D cohort. Additional baseline risk factors included pulse pressure, HbA1c, and albumin-to-creatinine ratio (P < 0.05 for each). In stratified analyses of time-varying covariates, changes in BMI, LDL, HDL, systolic blood pressure, and pulse pressure were most predictive among IS patients, while change in HbA1c was most predictive among IP patients. CONCLUSIONS Among patients with T2DM, traditional cardiovascular risk factors were the main predictors of incident PAD cases. Stratified analyses showed different risk factors were predictive for patients treated with IS medications versus those treated with IP medications. PMID:24595631

Risk factors for incident peripheral arterial disease in type 2 diabetes: results from the Bypass Angioplasty Revascularization Investigation in type 2 Diabetes (BARI 2D) Trial.

PubMed

Althouse, Andrew D; Abbott, J Dawn; Forker, Alan D; Bertolet, Marnie; Barinas-Mitchell, Emma; Thurston, Rebecca C; Mulukutla, Suresh; Aboyans, Victor; Brooks, Maria Mori

2014-01-01

The aim of this article was to define risk factors for incidence of peripheral arterial disease (PAD) in a large cohort of patients with type 2 diabetes mellitus (T2DM), overall and within the context of differing glycemic control strategies. The Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes (BARI 2D) randomized controlled trial assigned participants to insulin-sensitizing (IS) therapy versus insulin-providing (IP) therapy. A total of 1,479 participants with normal ankle-brachial index (ABI) at study entry were eligible for analysis. PAD outcomes included new ABI ≤0.9 with decrease at least 0.1 from baseline, lower extremity revascularization, or lower extremity amputation. Baseline risk factors within the overall cohort and time-varying risk factors within each assigned glycemic control arm were assessed using Cox proportional hazards models. During an average 4.6 years of follow-up, 303 participants (20.5%) experienced an incident case of PAD. Age, sex, race, and baseline smoking status were all significantly associated with incident PAD in the BARI 2D cohort. Additional baseline risk factors included pulse pressure, HbA1c, and albumin-to-creatinine ratio (P < 0.05 for each). In stratified analyses of time-varying covariates, changes in BMI, LDL, HDL, systolic blood pressure, and pulse pressure were most predictive among IS patients, while change in HbA1c was most predictive among IP patients. Among patients with T2DM, traditional cardiovascular risk factors were the main predictors of incident PAD cases. Stratified analyses showed different risk factors were predictive for patients treated with IS medications versus those treated with IP medications.

Coronary heart disease risk in patients with stroke or transient ischemic attack and no known coronary heart disease: findings from the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial.

PubMed

Amarenco, Pierre; Goldstein, Larry B; Sillesen, Henrik; Benavente, Oscar; Zweifler, Richard M; Callahan, Alfred; Hennerici, Michael G; Zivin, Justin A; Welch, K Michael A

2010-03-01

Noncoronary forms of atherosclerosis (including transient ischemic attacks or stroke of carotid origin or >50% stenosis of the carotid artery) are associated with a 10-year vascular risk of >20% and are considered as a coronary heart disease (CHD) -risk equivalent from the standpoint of lipid management. The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial included patients with stroke or transient ischemic attack and no known CHD regardless of the presence of carotid atherosclerosis. We evaluated the risk of developing clinically recognized CHD in SPARCL patients. A total of 4731 patients (mean age, 63 years) was randomized to 80 mg/day atorvastatin placebo. The rates of major coronary event, any CHD event, and any revascularization procedure were evaluated. After 4.9 years of follow-up, the risks of a major coronary event and of any CHD end point in the placebo group were 5.1% and 8.6%, respectively. The rate of outcome of stroke decreased over time, whereas the major coronary event rate was stable. Relative to those having a large vessel-related stroke at baseline, those having a transient ischemic attack, hemorrhagic stroke, small vessel stroke, or a stroke of unknown cause had similar absolute rates for a first major coronary event and for any CHD event; transient ischemic attack, small vessel, and unknown cause groups had lower absolute revascularization procedure rates. Major coronary event, any CHD event, and any revascularization procedure rates were similarly reduced in all baseline stroke subtypes in the atorvastatin arm compared with placebo with no heterogeneity between groups. CHD risk can be substantially reduced by atorvastatin therapy in patients with recent stroke or transient ischemic attack regardless of stroke subtype.

Does coronary Atherosclerosis Deserve to be Diagnosed earlY in Diabetic patients? The DADDY-D trial. Screening diabetic patients for unknown coronary disease.

PubMed

Turrini, Fabrizio; Scarlini, Stefania; Mannucci, Caterina; Messora, Roberto; Giovanardi, Paolo; Magnavacchi, Paolo; Cappelli, Carlo; Evandri, Valeria; Zanasi, Andrea; Romano, Stefania; Cavani, Rita; Ghidoni, Italo; Tondi, Stefano; Bondi, Marco

2015-07-01

To evaluate if screening and treatment of asymptomatic coronary artery disease (CAD) are effective in preventing first cardiac event in diabetics. Diabetic patients without known CAD were randomly assigned to undergo a screening for silent myocardial ischemia followed by revascularization or to continue follow-up. The reduction of cardiac death (CD) or nonfatal myocardial infarction (MI) represented the primary aim; secondary aim was the prevention of heart failure (HF). From September 2007 to May 2012, 520 patients (62 years; 104 female) were enrolled. Silent CAD was found in 20 of 262 patients (7.6%), revascularization was performed in 12 (4.6%). After a mean follow-up of 3.6 years 12 events (4.6%) occurred in the study group and 14 (5.4%) in the follow-up (HR=0.849, 95% CI: 0.393-1.827, P=0.678). The occurrence of first HF episode did not differ between groups: 2 (0.8%) in screened and 7 (2.7%) in follow-up (HR=0.273, 95% CI: 0.057-1.314, P=0.083). Subgroup analysis revealed a significantly lower HF episodes among patients with intermediate cardiovascular risk (Log rank P=0.022). Additionally, when CD and MI were analysed within subgroups, a significant lower number of CDs was observed among older than 60 years (P=0.044). Screening and revascularization of silent CAD in diabetics, failed to demonstrate a significant reduction in cardiac events and HF episodes. However, our data indicate that further research is warranted in patients older than 60 years and those with an intermediate cardiovascular risk. CLINICALTRIALS.GOV: NCT00547872. Copyright © 2015. Published by Elsevier B.V.

Prospective randomized comparison of mitomycin C application in endoscopic and external dacryocystorhinostomy.

PubMed

Mudhol, Rekha R; Zingade, N D; Mudhol, R S; Harugop, Anil S; Das, Amal T

2013-08-01

The aim of the study is to compare the subjective (relief of symptoms) and objective (endoscopic visualization of ostium patency at the time of syringing) outcomes at the end of two procedures-Endonasal DCR versus External DCR with Mitomycin C and to assess the role of Mitomycin C in maintaining patency of nasolacrimal drainage system. Prospective randomized comparative study was performed. Thirty-five patients were enrolled in each endoscopic and external dacryocystorhinostomy groups with Mitomycin C (MMC) application. The 37 eyes underwent endonasal DCR (28 unilateral primary eyes + 1 bilateral primary eyes + 5 unilateral revision eyes + 1 bilateral revision eye) while 35 eyes underwent external DCR (34 unilateral primary eyes + 1 unilateral revision eye). Mitomycin C 0.2 mg/ml was applied intra-operatively for 5 min to the ostium site at the end of endonasal or external DCR procedure. Objective assessment by syringing at the end of 1 year in the endonasal group showed 35 eyes (94%) were patent, 1 (3%) was partially blocked and 1(3%) was completely blocked; while in external group all 35 eyes (100%) were patent. Endoscopic visualization of the ostium at the time of syringing showed only one eye (3%) in the endonasal group was blocked while all the other eyes in both groups were patent. Both groups had a mean follow-up of 6-36 months. No complications were associated with use of Mitomycin C. In conclusion, intra-operative use of Mitomycin C in both endoscopic DCR and external DCR is safe and effective in increasing the success rate.

Patency of the posterior communicating artery following treatment with the Pipeline Embolization Device.

PubMed

Daou, Badih; Valle-Giler, Edison P; Chalouhi, Nohra; Starke, Robert M; Tjoumakaris, Stavropoula; Hasan, David; Rosenwasser, Robert H; Hebert, Ryan; Jabbour, Pascal

2017-02-01

OBJECTIVE The Pipeline Embolization Device (PED) has become an effective treatment strategy for some cerebral aneurysms. Concerns regarding the patency of branch arteries have been raised. The objective of this study was to assess the patency of the posterior communicating artery (PCoA) following treatment of PCoA aneurysms using the PED. METHODS All patients with PCoA aneurysms treated with the PED who had angiographic follow-up were retrospectively identified. The patency of the PCoA at follow-up was evaluated by 2 authors who were not involved in the intervention. Univariate and multivariate analyses were performed to identify factors associated with the following: 1) PCoA patency versus no or diminished flow, and 2) PCoA patency and diminished flow versus PCoA occlusion. RESULTS Thirty patients with an angiographic follow-up of 6 months were included. Aneurysm obliteration was achieved in 25 patients (83.3%). The PCoA was patent in 7 patients (23.3%), had diminished flow in 7 patients (23.3%), and was occluded in 16 patients (53.3%). In the univariate analysis of outcome, there was a trend for aneurysms with incomplete occlusion, aneurysms not previously treated, those with presence of a fetal PCoA, and those with an artery coming from the aneurysm to have higher odds of the PCoA remaining patent. In univariate and multivariate analyses of factors associated with outcome, fetal PCoA and presence of an artery coming from the aneurysm were associated with the PCoA remaining open with or without diminished flow. No patients had symptoms related to PCoA occlusion. CONCLUSIONS Occlusion and diminished flow through the PCoA is common following PED treatment of PCoA aneurysms. However, it is clinically insignificant in most cases.

MRI Assessment of Uterine Artery Patency and Fibroid Infarction Rates 6 Months after Uterine Artery Embolization with Nonspherical Polyvinyl Alcohol

DOE Office of Scientific and Technical Information (OSTI.GOV)

Das, Raj, E-mail: rajdas@nhs.net; Gonsalves, Michael; Vlahos, Ioannis

Purpose: We have observed significant rates of uterine artery patency after uterine artery embolization (UAE) with nonspherical polyvinyl alcohol (nsPVA) on 6 month follow-up MR scanning. The study aim was to quantitatively assess uterine artery patency after UAE with nsPVA and to assess the effect of continued uterine artery patency on outcomes. Methods: A single centre, retrospective study of 50 patients undergoing bilateral UAE for uterine leiomyomata was undertaken. Pelvic MRI was performed before and 6 months after UAE. All embolizations were performed with nsPVA. Outcome measures included uterine artery patency, uterine and dominant fibroid volume, dominant fibroid percentage infarction,more » presence of ovarian arterial collaterals, and symptom scores assessed by the Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QOL). Results: Magnetic resonance angiographic evidence of uterine artery recanalization was demonstrated in 90 % of the patients (64 % bilateral, 26 % unilateral) at 6 months. Eighty percent of all dominant fibroids demonstrated >90 % infarction. The mean percentage reduction in dominant fibroid volume was 35 %. No significant difference was identified between nonpatent, unilateral, and bilateral recanalization of the uterine arteries with regard to percentage dominant fibroid infarction or dominant fibroid volume reduction. The presence of bilaterally or unilaterally patent uterine arteries was not associated with inferior clinical outcomes (symptom score or UFS-QOL scores) at 6 months. Conclusion: The high rates of uterine artery patency challenge the current paradigm that nsPVA is a permanent embolic agent and that permanent uterine artery occlusion is necessary to optimally treat uterine fibroids. Despite high rates of uterine artery recanalization in this cohort, satisfactory fibroid infarction rates and UFS-QOL scores were achieved.« less

Plastic biliary stent patency in patients with locally advanced pancreatic adenocarcinoma receiving downstaging chemotherapy.

PubMed

Ge, Phillip S; Hamerski, Christopher M; Watson, Rabindra R; Komanduri, Srinadh; Cinnor, Birtukan B; Bidari, Kiran; Klapman, Jason B; Lin, Cui L; Shah, Janak N; Wani, Sachin; Donahue, Timothy R; Muthusamy, V Raman

2015-02-01

Plastic stents in patients with biliary obstruction caused by pancreatic adenocarcinoma are typically exchanged at 3-month intervals. Plastic stents may have reduced durability in patients receiving chemotherapy. To determine the duration of plastic biliary stent patency in patients undergoing chemotherapy for pancreatic adenocarcinoma. Retrospective, multicenter cohort study. Three tertiary academic referral centers. A total of 173 patients receiving downstaging chemotherapy for locally advanced or borderline resectable pancreatic adenocarcinoma from 1996 to 2013. Placement of 10F or larger plastic biliary stents. Primary outcome was overall duration of stent patency. Secondary outcomes included the incidence of premature stent exchange (because of cholangitis or jaundice) and hospitalization rates. A total of 233 plastic stents were placed, and the overall median duration of stent patency was 53 days (interquartile range [IQR] 25-99 days). Eighty-seven stents were removed at the time of surgical resection, and 63 stents were exchanged routinely per protocol. The remaining 83 stent exchanges were performed for worsening liver function test results, jaundice, or cholangitis, representing a 35.6% rate of premature stent exchange. The median stent patency duration in the premature stent exchange group was 49 days (IQR 25-91 days) with a 44.6% hospitalization rate. The overall rate of cholangitis was 15.0% of stent exchanges, occurring a median of 56 days after stent placement (IQR 26-89 days). Retrospective study. Plastic biliary stents placed during chemotherapy/chemoradiation for pancreatic adenocarcinoma have a shorter-than-expected patency duration, and a substantial number of patients will require premature stent exchange. Consideration should be given to shortening the interval for plastic biliary stent exchange. Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Role of 3.0 Tesla magnetic resonance hysterosalpingography in the diagnostic work-up of female infertility.

PubMed

Cipolla, Valentina; Guerrieri, Daniele; Pietrangeli, Daniela; Santucci, Domiziana; Argirò, Renato; de Felice, Carlo

2016-09-01

Imaging evaluation plays a crucial role in the diagnostic work-up of female infertility. In recent years, the possibility to evaluate tubal patency using 1.5 Tesla magnetic resonance (1.5T MR) has been studied. To assess the feasibility of 3.0 Tesla magnetic resonance (3.0T MR) hysterosalpingography and its role in the diagnostic work-up of female infertility and to evaluate if this fast "one-stop-shop" imaging approach should be proposed as a first-line examination. A total of 116 infertile women were enrolled in this prospective study; all underwent 3.0T MR hysterosalpingography. After standard imaging of the pelvis, tubal patency was assessed by acquiring 3D dynamic time-resolved T1-weighted (T1W) sequences during manual injection of 4-5 mL of contrast solution consisting of gadolinium and normal sterile saline. Images were evaluated by two radiologists with different experience in MR imaging (MRI). The examination was successfully completed in 96.5% of cases, failure rate was 3.5%. Dynamic sequences showed bilateral tubal patency in 64.3%, unilateral tubal patency in 25.9%, and bilateral tubal occlusion in 9.8%. Extratubal abnormalities were found in 69.9% of patients. Comprehensive analysis of morphological and dynamic sequences showed extratubal abnormalities in 43.1% of patients with bilateral tubal patency. 3.0T MR hysterosalpingography is a feasible, simple, fast, safe, and well-tolerated examination, which allows evaluation of tubal patency and other pelvic causes of female infertility in a single session, and it may thus represent a "one-stop-shop" solution in female infertility diagnostic work-up. © The Foundation Acta Radiologica 2015.

Iliocaval Confluence Stenting for Chronic Venous Obstructions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Graaf, Rick de, E-mail: r.de.graaf@mumc.nl; Wolf, Mark de, E-mail: markthewolf@gmail.com; Sailer, Anna M., E-mail: anni.sailer@mumc.nl

PurposeDifferent techniques have been described for stenting of venous obstructions. We report our experience with two different confluence stenting techniques to treat chronic bi-iliocaval obstructions.Materials and MethodsBetween 11/2009 and 08/2014 we treated 40 patients for chronic total bi-iliocaval obstructions. Pre-operative magnetic resonance venography showed bilateral extensive post-thrombotic scarring in common and external iliac veins as well as obstruction of the inferior vena cava (IVC). Stenting of the IVC was performed with large self-expandable stents down to the level of the iliocaval confluence. To bridge the confluence, either self-expandable stents were placed inside the IVC stent (24 patients, SECS group) ormore » high radial force balloon-expandable stents were placed at the same level (16 patients, BECS group). In both cases, bilateral iliac extensions were performed using nitinol stents.ResultsRecanalization was achieved for all patients. In 15 (38 %) patients, a hybrid procedure with endophlebectomy and arteriovenous fistula creation needed to be performed because of significant involvement of inflow vessels below the inguinal ligament. Mean follow-up was 443 ± 438 days (range 7–1683 days). For all patients, primary, assisted-primary, and secondary patency rate at 36 months were 70, 73, and 78 %, respectively. Twelve-month patency rates in the SECS group were 85, 85, and 95 % for primary, assisted-primary, and secondary patency. In the BECS group, primary patency was 100 % during a mean follow-up period of 134 ± 118 (range 29–337) days.ConclusionStenting of chronic bi-iliocaval obstruction shows relatively high patency rates at medium follow-up. Short-term patency seems to favor confluence stenting with balloon-expandable stents.« less

Impact of the Learning Curve for Endoscopic Vein Harvest on Conduit Quality and Early Graft Patency

PubMed Central

Desai, Pranjal; Kiani, Soroosh; Thiruvanthan, Nannan; Henkin, Stanislav; Kurian, Dinesh; Ziu, Pluen; Brown, Alex; Patel, Nisarg; Poston, Robert

2014-01-01

Background Recent studies have suggested that endoscopic vein harvest (EVH) compromises graft patency. To test whether the learning curve for EVH alters conduit integrity owing to increased trauma compared with an open harvest, we analyzed the quality and early patency of conduits procured by technicians with varying EVH experience. Methods During coronary artery bypass grafting, veins were harvested open (n = 10) or by EVH (n = 85) performed by experienced (>900 cases, >30/month) versus novice <100 cases, <3/month) technicians. Harvested conduits were imaged intraoperatively using optical coherence tomography and on day 5 to assess graft patency using computed tomographic angiography. Results Conduits from experienced (n = 55) versus novice (n = 30) harvesters had similar lengths (33 versus 34 cm) and harvest times (32.4 versus 31.8 minutes). Conduit injury was noted in both EVH groups with similar distribution among disruption of the adventitia (62%), intimal tears at branch points (23%), and intimal or medial dissections (15%), but the incidence of these injuries was less with experienced harvesters and rare in veins procured with an open technique. Overall, the rate of graft attrition was similar between the two EVH groups (6.45% versus 4.34% of grafts; p = 0.552). However, vein grafts with at least 4 intimal or medial dissections showed significantly worse patency (67% versus 96% patency; p = 0.05). Conclusions High-resolution imaging confirmed that technicians inexperienced with EVH are more likely to cause intimal and deep vessel injury to the saphenous vein graft, which increases graft failure risk. Endoscopic vein harvest remains the most common technique for conduit harvest, making efforts to better monitor the learning curve an important public health issue. PMID:21524447

Lesion complexity drives the cost of superficial femoral artery endovascular interventions

PubMed Central

Walker, Karen L.; Nolan, Brian W.; Columbo, Jesse A.; Rzucidlo, Eva M.; Goodney, Philip P.; Walsh, Daniel B.; Atkinson, Benjamin J.; Powell, Richard J.

2017-01-01

Objective Patients who undergo endovascular treatment of superficial femoral artery (SFA) disease vary greatly in lesion complexity and treatment options. This study examined the association of lesion severity and cost of SFA stenting and to determine if procedure cost affects primary patency at 1 year. Methods A retrospective record review identified patients undergoing initial SFA stenting between January 1, 2010, and February 1, 2012. Medical records were reviewed to collect data on demographics, comorbidities, indication for the procedure, TransAtlantic Inter-Society Consensus (TASC) II severity, and primary patency. The interventional radiology database and hospital accounting database were queried to determine cost drivers of SFA stenting. Procedure supply cost included any item with a bar code used for the procedure. Associations between cost drivers and lesion characteristics were explored. Primary patency was determined using Kaplan-Meier survival curves and a log-rank test. Results During the study period, 95 patients underwent stenting in 98 extremities; of these, 61% of SFA stents were performed for claudication, with 80% of lesions classified as TASC II A or B. Primary patency at 1 year was 79% for the entire cohort. The mean total cost per case was $10,333. Increased procedure supply cost was associated with adjunct device use, the number of stents, and TASC II severity. Despite higher costs of treating more complex lesions, primary patency at 1 year was similar at 80% for high-cost (supply cost >$4000) vs 78% for low-cost (supply cost <$4000) interventions. Conclusions SFA lesion complexity, as defined by TASC II severity, drives the cost of endovascular interventions but does not appear to disadvantage patency at 1 year. Reimbursement agencies should consider incorporating disease severity into reimbursement algorithms for lower extremity endovascular interventions. PMID:26206581

Regional peak mucosal cooling predicts the perception of nasal patency.

PubMed

Zhao, Kai; Jiang, Jianbo; Blacker, Kara; Lyman, Brian; Dalton, Pamela; Cowart, Beverly J; Pribitkin, Edmund A

2014-03-01

Nasal obstruction is the principal symptom that drives patients with rhinosinus disease to seek medical treatment. However, patient perception of obstruction often bears little relationship to actual measured physical obstruction of airflow. This lack of an objective clinical tool hinders effective diagnosis and treatment. Previous work has suggested that the perception of nasal patency may involve nasal trigeminal activation by cool inspiratory airflow; we attempt to derive clinically relevant variables following this phenomenon. Prospective healthy cohort. Twenty-two healthy subjects rated unilateral nasal patency in controlled room air using a visual analog scale, followed by rhinomanometry, acoustic rhinometry, and butanol lateralization thresholds (BLTs). Each subject then immediately underwent a computed tomography scan, enabling the construction of a real-time computational fluid dynamics (CFD) nasal airway model, which was used to simulate nasal mucosa heat loss during steady resting breathing. Among all measured and computed variables, only CFD-simulated peak heat loss posterior to the nasal vestibule significantly correlated with patency ratings (r = -0.46, P < .01). Linear discriminant analysis predicted patency categories with 89% success rate, with BLT and rhinomanometric nasal resistance being two additional significant variables. As validation, CFD simulated nasal resistance significantly correlated with rhinomanometrically measured resistance (r = 0.41, P < .01). These results reveal that our noses are sensing patency via a mechanism involving localized peak nasal mucosal cooling. The analysis provides a strong rationale for combining the individualized CFD with other objective and neurologic measures to create a novel clinical tool to diagnose nasal obstruction and to predict and evaluate treatment outcomes. © 2013 The American Laryngological, Rhinological and Otological Society, Inc.

Lesion complexity drives the cost of superficial femoral artery endovascular interventions.

PubMed

Walker, Karen L; Nolan, Brian W; Columbo, Jesse A; Rzucidlo, Eva M; Goodney, Philip P; Walsh, Daniel B; Atkinson, Benjamin J; Powell, Richard J

2015-10-01

Patients who undergo endovascular treatment of superficial femoral artery (SFA) disease vary greatly in lesion complexity and treatment options. This study examined the association of lesion severity and cost of SFA stenting and to determine if procedure cost affects primary patency at 1 year. A retrospective record review identified patients undergoing initial SFA stenting between January 1, 2010, and February 1, 2012. Medical records were reviewed to collect data on demographics, comorbidities, indication for the procedure, TransAtlantic Inter-Society Consensus (TASC) II severity, and primary patency. The interventional radiology database and hospital accounting database were queried to determine cost drivers of SFA stenting. Procedure supply cost included any item with a bar code used for the procedure. Associations between cost drivers and lesion characteristics were explored. Primary patency was determined using Kaplan-Meier survival curves and a log-rank test. During the study period, 95 patients underwent stenting in 98 extremities; of these, 61% of SFA stents were performed for claudication, with 80% of lesions classified as TASC II A or B. Primary patency at 1 year was 79% for the entire cohort. The mean total cost per case was $10,333. Increased procedure supply cost was associated with adjunct device use, the number of stents, and TASC II severity. Despite higher costs of treating more complex lesions, primary patency at 1 year was similar at 80% for high-cost (supply cost >$4000) vs 78% for low-cost (supply cost <$4000) interventions. SFA lesion complexity, as defined by TASC II severity, drives the cost of endovascular interventions but does not appear to disadvantage patency at 1 year. Reimbursement agencies should consider incorporating disease severity into reimbursement algorithms for lower extremity endovascular interventions. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Role of Catheter-directed Thrombolysis in Management of Iliofemoral Deep Venous Thrombosis.

PubMed

Chen, James X; Sudheendra, Deepak; Stavropoulos, S William; Nadolski, Gregory J

2016-01-01

The treatment for iliofemoral deep venous thrombosis (DVT) is challenging, as the use of anticoagulation alone can be insufficient for restoring venous patency and thus lead to prolongation of acute symptoms and an increased risk of chronic complications, including venous insufficiency and postthrombotic syndrome (PTS). In these cases, earlier and more complete thrombus removal can ameliorate acute symptoms and reduce long-term sequelae. Endovascular therapies involving the use of pharmacologic, mechanical, and combined pharmacomechanical modalities have been developed to achieve these goals. The most frequently used of these techniques, catheter-directed thrombolysis (CDT), involves the infusion of a thrombolytic agent through a multiple-side-hole catheter placed within the thrombosed vein to achieve high local doses and thereby break down the clot while minimizing systemic thrombolytic agent exposure. Randomized controlled trial results have indicated decreased PTS rates and improved venous patency rates in patients treated with CDT compared with these rates in patients treated with anticoagulation. The use of newer pharmacomechanical techniques, as compared with conventional CDT, reduces procedural times and thrombolytic agent doses and is the subject of ongoing investigations. Endovascular thrombus removal techniques offer a means to improve venous valvular function and decrease the risk of debilitating long-term complications such as PTS and are a promising option for treating patients with iliofemoral DVT. (©)RSNA, 2016.

Racial/Ethnic Variations in Physician Recommendations for Cardiac Revascularization

PubMed Central

Ibrahim, Said A.; Whittle, Jeff; Bean-Mayberry, Bevanne; Kelley, Mary E.; Good, Chester; Conigliaro, Joseph

2003-01-01

Objectives. We sought to examine whether physician recommendations for cardiac revascularization vary according to patient race. Methods. We studied patients scheduled for coronary angiography at 2 hospitals, one public and one private, between November 1997 and June 1999. Cardiologists were interviewed regarding their recommendations for cardiac resvacularization. Results. African American patients were less likely than Whites to be recommended for revascularization at the public hospital (adjusted odds ratio [OR] = 0.31; 95% confidence interval [CI] = 0.12, 0.77) but not at the private hospital (adjusted OR = 1.69; 95% CI = 0.69, 4.14). Conclusions. Physician recommendations for cardiac revascularization vary by patient race. Further studies are needed to examine physician bias as a factor in racial disparities in cardiac care and outcomes. PMID:14534223

Microvascular management of ring avulsion injuries.

PubMed

Urbaniak, J R; Evans, J P; Bright, D S

1981-01-01

Microsurgical revascularization has proved to be a useful method in managing the ring avulsion injury where both neurovascular bundles are damaged with only partial skin avulsion. Representative cases are used to illustrate guidelines for a practical classification for helping to decide the optimal method of treatment of acute ring avulsion injuries in light of digital revascularization techniques. Nine ring fingers were successfully revascularized of 24 acute ring avulsion injuries reviewed. Sensibility recovery was good and a functional range of motion obtained. No patient who has had his ring finger revascularized has requested its amputation because of appearance, painful neuromas, stiffness, or cold intolerance. Complete amputations, especially proximal to the superficialis insertion, and complete degloving injuries of the ring finger are usually best managed by surgical amputation of the digit.

Design and Methodology of the Trial to Assess Chelation Therapy (TACT)

PubMed Central

Lamas, Gervasio A.; Goertz, Christine; Boineau, Robin; Mark, Daniel B.; Rozema, Theodore; Nahin, Richard L.; Drisko, Jeanne A.; Lee, Kerry L.

2011-01-01

The Trial to Assess Chelation Therapy (TACT) is an NIH-sponsored, randomized, double blind, placebo-controlled, 2×2 factorial clinical trial testing the benefits and risks of 40 infusions of a multi-component Na2EDTA-chelation solution compared with placebo, and of an oral, high-dose multivitamin and mineral supplement. TACT has randomized and will follow 1708 patients for an average of approximately 4 years. The primary endpoint is a composite of all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. A 900 patient substudy will examine quality of life outcomes. The trial is designed to have >85% power to detect a 25% relative reduction in the primary endpoint for each treatment factor. Enrollment began in September 2003 and completed in October 2010. PMID:22172430

Forearm versus upper arm grafts for vascular access.

PubMed

Gage, Shawn M; Lawson, Jeffrey H

2017-03-06

Forearm and upper arm arteriovenous grafts perform similarly in terms of patency and complications. Primary patency at 1 year for forearm arteriovenous grafts versus upper arm grafts ranges from 22%-50% versus 22%-42%, and secondary patency at 1 year ranges from 78%-89% versus 52%-67%), respectively. Secondary patency at 2 years, ranges from 30%-64% versus 35%-60% for forearm and upper arteriovenous graft, respectively. Ample pre-operative planning is essential to improved clinical success and the decision to place a graft at one location versus the other should be based solely on previous access history, physical exam, appropriate venous imaging, and other factors that make up the clinical picture. Operative implant strategies and risk of complications are very similar between the two configurations. Postoperative ischemia due to steal syndrome is a potential complication that requires immediate attention. Utilization of the proximal radial or ulnar artery for inflow for the graft can minimize risk of clinically relevant steal syndrome.

Correlation of Nasal Mucosal Temperature With Subjective Nasal Patency in Healthy Individuals

PubMed Central

Bailey, Ryan S.; Casey, Kevin P.; Pawar, Sachin S.; Garcia, Guilherme J. M.

2016-01-01

Importance Historically, otolaryngologists have focused on nasal resistance to airflow and minimum airspace cross-sectional area as objective measures of nasal obstruction using methods such as rhinomanometry and acoustic rhinometry. However, subjective sensation of nasal patency may be more associated with activation of cold receptors by inspired air than with respiratory effort. Objective To investigate whether subjective nasal patency correlates with nasal mucosal temperature in healthy subjects. Design, Setting, and Participants Twenty-two healthy adults were recruited for this study. Subjects first completed the Nasal Obstruction Symptom Evaluation (NOSE) and a unilateral visual analog scale (VAS) to quantify subjective nasal patency. A miniaturized thermocouple sensor was then used to record nasal mucosal temperature bilaterally in two locations along the nasal septum: at the vestibule and across from the inferior turbinate head. Results The range of temperature oscillations during the breathing cycle, defined as the difference between end-expiratory and end-inspiratory temperatures, was greater during deep breaths (ΔTexp-insp = 6.2 ± 2.6°C) than during resting breathing (ΔTexp-insp = 4.2 ± 2.3°C) in both locations (p < 10−13). Mucosal temperature measured at the right vestibule had a statistically significant correlation with both right-side VAS score (Pearson r = −0.55, p=0.0076) and NOSE score (Pearson r = −0.47, p=0.028). No other statistically significant correlations were found between mucosal temperature and subjective nasal patency scores. Nasal mucosal temperature was lower in the first cavity to be measured, which was the right cavity in all subjects. Conclusions and Relevance The greater mucosal temperature oscillations during deep breathing is consistent with the common experience that airflow sensation is enhanced during deep breaths, thus supporting the hypothesis that mucosal cooling plays a central role in nasal airflow sensation. A possible correlation was found between subjective nasal patency scores and nasal mucosal temperature, but our results were inconsistent. The higher temperature in the left cavity suggests that the sensor irritated the nasal mucosa, affecting the correlation between patency scores and mucosal temperature. Future studies should consider non-contact temperature sensors to prevent mucosa irritation. PMID:27918749

Benefit of heparin in peripheral venous and arterial catheters: systematic review and meta-analysis of randomised controlled trials

PubMed Central

Randolph, Adrienne G; Cook, Deborah J; Gonzales, Calle A; Andrew, Maureen

1998-01-01

Objective: To evaluate the effect of heparin on duration of catheter patency and on prevention of complications associated with use of peripheral venous and arterial catheters. Design: Critical appraisal and meta-analysis of 26 randomised controlled trials that evaluated infusion of heparin intermittently or continuously. Thirteen trials of peripheral venous catheters and two of peripheral arterial catheters met criteria for inclusion. Main outcome measures: Data on the populations, interventions, outcomes, and methodological quality. Results: For peripheral venous catheters locked between use flushing with 10 U/ml of heparin instead of normal saline did not reduce the incidence of catheter clotting and phlebitis or improve catheter patency. When heparin was given as a continuous infusion at 1 U/ml the risk of phlebitis decreased (relative risk 0.55; 95% confidence interval 0.39 to 0.77), the duration of patency increased, and infusion failure was reduced (0.88; 0.72 to 1.07). Heparin significantly prolonged duration of patency of radial artery catheters and decreased the risk of clot formation (0.51; 0.42 to 0.61). Conclusions: Use of intermittent heparin flushes at doses of 10 U/ml in peripheral venous catheters locked between use had no benefit over normal saline flush. Infusion of low dose heparin through a peripheral arterial catheter prolonged the duration of patency but further study is needed to establish its benefit for peripheral venous catheters. Key messages Despite almost universal use, agreement has not been reached on the need to administer heparin through peripheral intravascular catheters The results of 13 trials on peripheral venous catheters and two trials on peripheral arterial catheters were critically appraised to clarify what evidence supports the use of heparin Flushing peripheral venous catheters locked between use with heparinised saline at 10 U/ml is no more beneficial than flushing with normal saline Heparin significantly prolongs the duration of peripheral arterial catheter patency and decreases the risk of clot formation In peripheral venous catheters heparin added to the infusion at 1 U/ml decreases phlebitis and may prolong duration of catheter patency and decrease infusion failure PMID:9550955

A novel animal model for skin flap prelamination with biomaterials

NASA Astrophysics Data System (ADS)

Zhou, Xianyu; Luo, Xusong; Liu, Fei; Gu, Chuan; Wang, Xi; Yang, Qun; Qian, Yunliang; Yang, Jun

2016-09-01

Several animal models of skin flap construction were reported using biomaterials in a way similar to prefabrication. However, there are few animal model using biomaterials similar to prelamination, another main way of clinical skin flap construction that has been proved to be reliable. Can biomaterials be added in skin flap prelamination to reduce the use of autogenous tissues? Beside individual clinical attempts, animal model is needed for randomized controlled trial to objectively evaluate the feasibility and further investigation. Combining human Acellular Dermal Matrix (hADM) and autologous skin graft, we prelaminated flaps based on inguinal fascia. One, two, three and four weeks later, hADM exhibited a sound revascularization and host cell infiltration. Prelaminated skin flaps were then raised and microsurgically transplanted back to groin region. Except for flaps after one week of prelamination, flaps from other subgroups successfully reconstructed defects. After six to sixteen weeks of transplantation, hADM was proved to being able to maintain its original structure, having a wealth of host tissue cells and achieving full revascularization.To our knowledge, this is the first animal model of prelaminating skin flap with biomaterials. Success of this animal model indicates that novel flap prelamination with biomaterials is feasible.

Chlamydia trachomatis IgG3 seropositivity is a predictor of reproductive outcomes in infertile women with patent fallopian tubes

PubMed Central

Steiner, Anne Z.; Diamond, Michael P.; Legro, Richard S.; Schlaff, William D.; Barnhart, Kurt T.; Casson, Peter R.; Christman, Gregory M.; Alvero, Ruben; Hansen, Karl R.; Geisler, William M.; Thomas, Tracey; Santoro, Nanette; Zhang, Heping; Eisenberg, Esther

2015-01-01

Objective To determine if Chlamydia trachomatis (Ct) seropositivity as detected by the Ct elementary body (EB)-based enzyme linked immunosorbent assay (Ct EB ELISA) predicts pregnancy and pregnancy outcome among infertile women with documented tubal patency. Design Cohort study Setting Outpatient clinics participating in the reproductive medicine network Patients 1250 infertile women with documented tubal patency enrolled in one of two randomized controlled trials: PPCOSII and AMIGOS Intervention Sera were analyzed for anti-Ct IgG1 and IgG3 antibodies using a research Ct EB ELISA. OD405 readings ≥0.35 and ≥0.1 were considered positive for IgG1 and IgG3, respectively. Main Outcome Measures Primary outcomes included pregnancy, live birth, and ectopic pregnancy. Log linear regression was used to determine the relative risk after adjusting for age, race, treatment medication, smoking status, and current alcohol use. Results 243 (19%) women were seropositive for anti-Ct IgG3. They tended to be non-White and smokers. Anti-Ct IgG3 seropositive women were significantly less likely to conceive (RR 0.65, 95% CI 0.52-0.83) or to have a live birth (RR 0.59, 95% 0.43-0.80); these associations were weakened after adjusting for number of HSG-documented patent tubes (RR 0.73, 95% CI 0.56-0.97) and (0.73, 95% CI: 0.50-1.04), respectively. Anti-Ct IgG3 seropositive women who conceived had 2.7 (95% CI: 1.40-5.34) times the risk of ectopic pregnancy. Conclusions Even in the presence of tubal patency, anti-Ct IgG3 seropositivity is associated with lower likelihood of pregnancy. Anti-Ct IgG3 seropositive women have up to 3 times the risk of ectopic pregnancy. PMID:26413816

Efficiency of the Penumbra 5MAX ACE Reperfusion Catheter in Acute Ischemic Stroke Patients.

PubMed

Suzuki, Kentaro; Aoki, Junya; Sakamoto, Yuki; Kanamaru, Takuya; Abe, Arata; Suda, Satoshi; Okubo, Seiji; Kimura, Kazumi

2016-12-01

This study was performed to investigate whether the Penumbra 5MAX ACE is superior to other Penumbra systems. We performed a retrospective, single center analysis of patients with acute ischemic stroke with occlusion of the internal carotid artery or middle cerebral artery (M1 segment) who underwent endovascular therapy using a Penumbra system. The reperfusion success rate, puncture-to-revascularization time, and number of passes were assessed. Multivariate regression analysis was conducted to evaluate independent factors related to revascularization within 60 minutes. Successful revascularization was defined by a thrombolysis in cerebral infarction score ≥2b. The Penumbra 5MAX ACE was used in 24 of the 40 patients (60%). Although the revascularization success rate was similar between patient groups (P = .229), the number of passes was significantly lower (1.5 ± .8 versus 2.6 ± 1.3, P = .006) and the puncture-to-revascularization time was shorter (50 ± 26 minutes versus 116 ± 69 minutes, P = .002) in patients treated with the Penumbra 5MAX ACE. The Penumbra 5MAX ACE was identified as an independent factor for early revascularization (odds ratio, 5.80; P = .041). Among patients with a premorbid modified Rankin Scale score of 0-1, a modified Rankin Scale score of 0-2 at 3 months was observed in 15 of the 19 patients (79%) treated with the Penumbra 5MAX ACE and in 8 of the 16 (50%) who were not (P = .072). Acute revascularization therapy using the Penumbra 5MAX ACE can achieve rapid successful recanalization and tend to improve clinical outcomes. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Disability pension after coronary revascularization: a prospective nationwide register-based Swedish cohort study.

PubMed

Zetterström, Katharina; Vaez, Marjan; Alexanderson, Kristina; Ivert, Torbjörn; Pehrsson, Kenneth; Hammar, Niklas; Voss, Margaretha

2015-03-01

Scientific knowledge on disability pension (DP) after revascularization by coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) is scarce. The aim was to study the incidence of and risk factors for being granted DP in the 5 years following a first CABG or PCI, accounting for socio-demographic and medical factors. This is a nationwide population-based study using Swedish registers including all patients 30-63 years of age (n = 34,643, 16.4% women) who had a first CABG (n = 14,107) or PCI (n = 20,536) during 1994-2003. All were alive and without reintervention 30 days after the procedure and were not on DP or old-age pension. Multivariable adjusted Cox proportional hazard ratios (HR) for DP were estimated with 95% confidence intervals (CI). In 5 years following revascularization, 32.4% had been granted DP and the hazard ratio (HR) was higher in women (HR 1.55, 95% CI 1.48-1.62), and in CABG patients compared with PCI patients (HR 1.35, 95% CI 1.30-1.40). Long-term sick leave in the year before intervention was the strongest predictor for DP following revascularization. After adjustments for socio-demographic factors and sick-leave days in the 12 months before revascularization, HR remained high in all patients with diabetes mellitus regardless of type of revascularization. DP after coronary revascularization was common, especially among women and CABG patients. Most studied medical covariates, including mental and musculoskeletal disorders, were risk factors for future DP, especially long-term sickness absence. © The European Society of Cardiology 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Revascularization experience and results in ischaemic cerebrovascular disease: Moyamoya disease and carotid occlusion.

PubMed

Arikan, Fuat; Rubiera, Marta; Serena, Joaquín; Rodríguez-Hernández, Ana; Gándara, Darío; Lorenzo-Bosquet, Carles; Tomasello, Alejandro; Chocrón, Ivette; Quintana-Corvalan, Maximiliano; Sahuquillo, Juan

2018-03-14

Cerebral revascularization techniques are an indispensable tool in the current armamentarium of vascular neurosurgeons. We present revascularization surgery experience and results in both moyamoya disease and occlusive cerebral ischaemia. Patients with ischaemic occlusive disease and moyamoya disease who underwent microsurgical revascularization between October 2014 and September 2017 were analysed. In the study period, 23 patients with occlusive ischaemic disease underwent microsurgical revascularization. Three patients presented with serious postoperative complications (2 intraparenchymal haemorrhages in the immediate postoperative period and one thrombosis of the femoral artery). All patients, except one, achieved normalization of the cerebral hemodynamic reserve (CHR) in the SPECT study. Twenty patients had a good neurological result, with no ischaemic recurrence of the revascularized territory. Among patients with moyamoya, 20 had moyamoya disease and 5 had moyamoya syndrome with unilateral involvement. Five patients were treated at paediatric age. Haemorrhagic onset occurred in 2 patients. The CHR study showed hemodynamic compromise in all patients. Cerebral SPECT at one year showed resolution of the hemodynamic failure in all patients. There have been 4 postoperative complications (acute subdural hematoma, two subdural collections and one dehiscence of the surgical wound). No patient presented with neurological worsening at 6 and 12months of follow-up. Cerebral revascularization through end-to-side anastomosis between the superficial temporal artery and a cortical branch of the middle cerebral artery is an indisputable technique in the treatment of moyamoya disease and possibly in a subgroup of patients with symptomatic occlusive ischaemic cerebrovascular disease. Copyright © 2018 Sociedad Española de Neurocirugía. Publicado por Elsevier España, S.L.U. All rights reserved.

Correlation of Nasal Mucosal Temperature With Subjective Nasal Patency in Healthy Individuals.

PubMed

Bailey, Ryan S; Casey, Kevin P; Pawar, Sachin S; Garcia, Guilherme J M

2017-01-01

Historically, otolaryngologists have focused on nasal resistance to airflow and minimum airspace cross-sectional area as objective measures of nasal obstruction using methods such as rhinomanometry and acoustic rhinometry. However, subjective sensation of nasal patency may be more associated with activation of cold receptors by inspired air than with respiratory effort. To investigate whether subjective nasal patency correlates with nasal mucosal temperature in healthy individuals. Healthy adult volunteers first completed the Nasal Obstruction Symptom Evaluation (NOSE) and a unilateral visual analog scale to quantify subjective nasal patency. A miniaturized thermocouple sensor was then used to record nasal mucosal temperature bilaterally in 2 locations along the nasal septum: at the vestibule and across from the inferior turbinate head. Nasal mucosal temperature and subjective patency scores in healthy individuals. The 22 healthy adult volunteers (12 [55%] male; mean [SD] age, 28.3 [7.0] years) had a mean (SD) NOSE score of 5.9 (8.4) (range, 0-30) and unilateral VAS score of 1.2 (1.4) (range, 0-5). The range of temperature oscillations during the breathing cycle, defined as the difference between end-expiratory and end-inspiratory temperatures, was greater during deep breaths (mean [SD] change in temperature, 6.2°C [2.6°C]) than during resting breathing (mean [SD] change in temperature, 4.2°C [2.3°C]) in both locations (P < .001). Mucosal temperature measured at the right vestibule had a statistically significant correlation with both right-side visual analog scale score (Pearson r = -0.55; 95% CI, -0.79 to -0.17; P = .008) and NOSE score (Pearson r = -0.47; 95% CI, -0.74 to -0.06; P = .03). No other statistically significant correlations were found between mucosal temperature and subjective nasal patency scores. Nasal mucosal temperature was lower (mean of 1.5°C lower) in the first cavity to be measured, which was the right cavity in all participants. The greater mucosal temperature oscillations during deep breathing are consistent with the common experience that airflow sensation is enhanced during deep breaths, thus supporting the hypothesis that mucosal cooling plays a central role in nasal airflow sensation. A possible correlation was found between subjective nasal patency scores and nasal mucosal temperature, but our results were inconsistent. The higher temperature in the left cavity suggests that the sensor irritated the nasal mucosa, affecting the correlation between patency scores and mucosal temperature. Future studies should consider noncontact temperature sensors to prevent mucosa irritation. NA.

Predictors for adverse outcome after iliac angioplasty and stenting for limb-threatening ischemia.

PubMed

Timaran, Carlos H; Stevens, Scott L; Freeman, Michael B; Goldman, Mitchell H

2002-09-01

The role of iliac artery angioplasty and stenting (IAS) for the treatment of limb-threatening ischemia is not defined. IAS has been used primarily for patients with disabling claudication. Because poorer results have been shown in patients with critical ischemia after iliac artery angioplasty, the purpose of this study was to estimate the influence of risk factors on the outcome of iliac angioplasty and stent placement in patients with limb-threatening ischemia. During a 5-year period (from 1996 to 2001), 85 iliac angioplasty and stent placement procedures (107 stents) were performed in 31 women and 43 men with limb-threatening ischemia. Patients with claudication were specifically excluded. The criteria prepared by the Ad Hoc Committee on Reporting Standards (Society for Vascular Surgery/International Society for Cardiovascular Surgery) were followed to define the variables. The TransAtlantic InterSociety Consensus classification was used to characterize the type of iliac lesions. Both univariate (Kaplan-Meier [KM]) and multivariate analyses (Cox proportional hazards model) were used to determine the association between variables, cumulative patency, limb salvage, and survival. Indications for iliac angioplasty with stenting were ischemic rest pain (56%) and tissue loss (44%). Primary stenting was performed in 36 patients (42%). Stents were placed selectively after iliac angioplasty mainly for residual stenosis or pressure gradient (43%). Overall, primary stent patency rate was 90% at 1 year, 74% at 3 years, and 69% at 5 years. Primary stent patency rate was significantly reduced in women compared with men (KM, log-rank test, P <.001). Primary patency rates at 1, 3, and 5 years were 79%, 57%, and 38% for women and 92%, 88%, and 88% for men. Primary stent patency rate also was significantly reduced in patients with renal insufficiency (creatinine level, >1.6 mg/dL; KM, log-rank test, P <.001). Cox regression analysis identified female gender (relative risk, 5.1; 95% CI, 1.8 to 7.9; P =.002) and renal insufficiency (relative risk, 6.6; 95% CI, 1.6 to 14.2; P =.01) as independent predictors of decreased primary stent patency. No independent predictors for limb salvage and survival were identified. Women undergoing iliac angioplasty and stenting for limb-threatening ischemia have significantly reduced primary stent patency rates and may need additional procedures to obtain satisfactory clinical improvement and limb salvage. Patients with renal insufficiency and critical ischemia also have reduced primary stent patency rates after IAS. Limb salvage, as shown in this study, is not affected by previous iliac stent failure.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ciampi, Juan J., E-mail: juanciampi@hotmail.com; Lanciego, Carlos; Navarro, Sofia

The objective of the present study was to evaluate, in a prospective, single-center study, the effectiveness of the Wilhelm-type stent used in interventional radiology for the management of epiphora. Patients (n = 104; mean age 64 [range 25-88]; 33 male and 71 female) with severe epiphora had the stents inserted (135 stents in 115 eyes) to treat obstruction of the nasolacrimal system. The etiology of the obstruction was idiopathic in 83 cases, chronic dacryocystitis in 31, cases and postsurgical status in 1 case. The overall technical success rate of stent placement was near 94%. Resolution of epiphora was complete inmore » 105 cases and partial in 3 cases. During a mean 13-month follow-up (range 1 week to 28 months), the median duration of primary patency was 11 months, and the percentage of patency at 6 months was 60.8%, at 1 year was 39.6%, and at 2 years was 25%. Stents malfunctioned in 54 cases, and all were easily withdrawn except in 1 case. Of these 27 cases, patency recovered spontaneously in 9 and by way of a second stent in 18. Secondary patency was 50%. Factors presdisposing to lower primary patency are inflammatory etiology and location of the obstruction. The benefit of stent deployment is clear with respect to the resolution of epiphora in candidate patients for percutaneous treatment. Technical and/or design improvements would be welcomed.« less

Free Radical Damage in Ischemia-Reperfusion Injury: An Obstacle in Acute Ischemic Stroke after Revascularization Therapy

PubMed Central

Jin, Hang; Sun, Xin; Huang, Shuo; Zhang, Fu-Liang; Guo, Zhen-Ni

2018-01-01

Acute ischemic stroke is a common cause of morbidity and mortality worldwide. Thrombolysis with recombinant tissue plasminogen activator and endovascular thrombectomy are the main revascularization therapies for acute ischemic stroke. However, ischemia-reperfusion injury after revascularization therapy can result in worsening outcomes. Among all possible pathological mechanisms of ischemia-reperfusion injury, free radical damage (mainly oxidative/nitrosative stress injury) has been found to play a key role in the process. Free radicals lead to protein dysfunction, DNA damage, and lipid peroxidation, resulting in cell death. Additionally, free radical damage has a strong connection with inducing hemorrhagic transformation and cerebral edema, which are the major complications of revascularization therapy, and mainly influencing neurological outcomes due to the disruption of the blood-brain barrier. In order to get a better clinical prognosis, more and more studies focus on the pharmaceutical and nonpharmaceutical neuroprotective therapies against free radical damage. This review discusses the pathological mechanisms of free radicals in ischemia-reperfusion injury and adjunctive neuroprotective therapies combined with revascularization therapy against free radical damage. PMID:29770166

Surgical myocardial revascularization in patients with reduced systolic left ventricular function.

PubMed

Bruno, Piergiorgio; Iafrancesco, Mauro; Massetti, Massimo

2018-04-20

Surgical myocardial revascularization in patients with reduced left ventricular function has been a matter of debate for decades. Recently published 10-years extension follow-up of the STICH trial have conclusively demonstrated benefit of surgical myocardial revascularization in patients with significant coronary artery disease and low left ventricular ejection fraction. However, selection of patients for surgery remains challenging as well as decision to perform percutaneous rather than surgical revascularization in this class of patients. New evidence helped to clarify the role of preoperative patients' characteristics as risk factors for surgery and to identify those patients who may benefit the most from surgery. Focus of this review is to review epidemiology, aetiology and pathophysiology of coronary artery disease in patients with reduced left ventricular function, role of viability and results of observational and investigational studies on revascularization in patients with reduced left ventricular function with a particular emphasis on relative indication of coronary artery bypass grafting and percutaneous coronary intervention and the surgical implications of development of ischemic mitral regurgitation or ischemic left ventricular aneurysm.

[Value of preserved saphenous vein graft for the creation of access ports in hemodialyzed patients: report of 309 cases].

PubMed

Schneider, Marc; Barrou, Benoît; Cluzel, Philippe; Hamani, Aziz; Bitker, Marc-Olivier; Richard, François

2003-09-01

Biological grafts are rarely used for the creation of vascular access, despite their many advantages. Our group prefers to use distal vascular accesses with interposition of a biological graft when direct access cannot be achieved. The objective of this study was to determine the long-term patency and the complication rate of a series of 309 vascular access procedures using a preserved saphenous (PS) vein homograft. 410 (27%) of the 1,500 vascular access procedures performed by our group required the use of a graft, including 376 PS vein homografts (25%). This retrospective study comprised complete data collection for 309 arteriovenous fistulas (AVF) using preserved saphenous (PS) vein graft in the forearm performed in 267 patients between 1985 and 2000. Primary patency was defined as the interval between creation of the vascular access and the first complication requiring surgical or radiological correction; secondary patency was defined as the interval between creation and loss of the graft, with or without revision of the fistula. Survival rates were calculated according to the Kaplan-Meier method. Inter-group comparison was performed by the Logrank test and analysis of variance was performed by logistic regression. Primary patency rates were 77%, 40% and 27% at 1,2 and 5 years, respectively. Secondary patency rates were 79% and 47% at 1 year and 5 years, respectively. The thrombosis rate was 42%. Two episodes of thrombosis occurred in 25% of grafts and 3 episodes were observed in 10% of cases. Infection rates were 1.9% postoperatively and 5% after dialysis, respectively. An aneurysm occurred on 10% of grafts. The operator's experience (RR = 1.58; p < 0.05) and diabetic nephropathy (RR = 1.89; p = 0.059) significantly influenced graft patency. In contrast, the position of the graft, the fact that it crossed the elbow joint, and the site of the arterial anastomosis did not have any negative impact on graft patency. Preservation of the patient's vascular capital is an essential objective in patients with chronic renal insufficiency, which is sometimes difficult to reconcile with the need to create vascular accesses with a long life span. The strategic choice between a distal access requiring a graft and a direct proximal access depends on the clinical context: cardiac function, waiting list for renal transplantation. Our preferred material in the case of bypass graft is the PS graft, as it presents the same resistance and the same patency rates as synthetic grafts, without the associated septic complications. The PS vein graft is a good material for the creation of vascular accesses with similar patency rates to those of prosthetic grafts. Vein grafts present a number of advantages, particularly a greater ease of use facilitating distal implantation of the graft and a low infection rate.

Combining PCI and CABG: the role of hybrid revascularization.

PubMed

Green, Kelly D; Lynch, Donald R; Chen, Tyffany P; Zhao, David

2013-04-01

Hybrid coronary revascularization combines the benefits of both percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in the treatment of multivessel coronary artery disease (CAD) by combining the benefits of the LIMA-to-LAD graft and drug eluting stent (DES) to non-LAD regions. Through this approach, a patient receives the long-term benefit of the LIMA graft and avoids the morbidity of a full sternotomy and saphenous vein grafts. Available data related to outcomes following hybrid revascularization is limited to small studies. In this review we seek to provide an overview of hybrid revascularization in the era of modern drug eluting stent technology, discuss appropriate patient selection, and comment on future trial design. Additionally, we review the recent literature pertaining to the hybrid approach.

What’s Age Got to do with it? A Review of Contemporary Revascularization in the Elderly

PubMed Central

Vandermolen, Sebastian; Abbott, Jane; Silva, Kalpa De

2015-01-01

Currently a quarter of all patients treated with percutanous coronary intervention (PCI) are aged >75 years, with this proportion steadily growing. This subset of patients have a number of unique characteristics, such as a greater number of cardiovascular risk factors and frequently a larger burden of coronary artery disease, when compared to younger patients, therefore potentially deriving increased benefit from revascularization. Nonetheless this population are also more likely to experience procedural complications, secondary to age-related physiological alterations, increased frailty and increased prevalence of other co-morbidities. This article reviews the various aspects and data available to clinicians pertaining to and guiding revascularization in the elderly, including the use of adjuvant pharmacotherapy, specific considerations when considering age-related physiology, and revascularization in acute coronary syndromes. PMID:25329923

New-Onset Atrial Fibrillation After PCI or CABG for Left Main Disease: The EXCEL Trial.

PubMed

Kosmidou, Ioanna; Chen, Shmuel; Kappetein, A Pieter; Serruys, Patrick W; Gersh, Bernard J; Puskas, John D; Kandzari, David E; Taggart, David P; Morice, Marie-Claude; Buszman, Paweł E; Bochenek, Andrzej; Schampaert, Erick; Pagé, Pierre; Sabik, Joseph F; McAndrew, Thomas; Redfors, Björn; Ben-Yehuda, Ori; Stone, Gregg W

2018-02-20

There is limited information on the incidence and prognostic impact of new-onset atrial fibrillation (NOAF) following percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD). This study sought to determine the incidence of NOAF following PCI and CABG for LMCAD and its effect on 3-year cardiovascular outcomes. In the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, 1,905 patients with LMCAD and low or intermediate SYNTAX scores were randomized to PCI with everolimus-eluting stents versus CABG. Outcomes were analyzed according to the development of NOAF during the initial hospitalization following revascularization. Among 1,812 patients without atrial fibrillation on presentation, NOAF developed at a mean of 2.7 ± 2.5 days after revascularization in 162 patients (8.9%), including 161 of 893 (18.0%) CABG-treated patients and 1 of 919 (0.1%) PCI-treated patients (p < 0.0001). Older age, greater body mass index, and reduced left ventricular ejection fraction were independent predictors of NOAF in patients undergoing CABG. Patients with versus without NOAF had a significantly longer duration of hospitalization, were more likely to be discharged on anticoagulant therapy, and had an increased 30-day rate of Thrombolysis In Myocardial Infarction major or minor bleeding (14.2% vs. 5.5%; p < 0.0001). By multivariable analysis, NOAF after CABG was an independent predictor of 3-year stroke (6.6% vs. 2.4%; adjusted hazard ratio [HR]: 4.19; 95% confidence interval [CI]: 1.74 to 10.11; p = 0.001), death (11.4% vs. 4.3%; adjusted HR: 3.02; 95% CI: 1.60 to 5.70; p = 0.0006), and the primary composite endpoint of death, MI, or stroke (22.6% vs. 12.8%; adjusted HR: 2.13; 95% CI: 1.39 to 3.25; p = 0.0004). In patients with LMCAD undergoing revascularization in the EXCEL trial, NOAF was common after CABG but extremely rare after PCI. The development of NOAF was strongly associated with subsequent death and stroke in CABG-treated patients. Further studies are warranted to determine whether prophylactic strategies to prevent or treat atrial fibrillation may improve prognosis in patients with LMCAD who are undergoing CABG. (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776). Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Effect of sleeping position on nasal patency in newborns

PubMed Central

Olarinde, O; Banerjee, A R; O'Callaghan, C

2006-01-01

Sleeping posture has been implicated in the pathophysiology of sudden infant death syndrome. The effect of supine and lateral sleeping positions on nasal patency was investigated using acoustic rhinometry in 11 healthy newborns. The implications of the findings in sudden infant death syndrome are discussed. PMID:16923934

Causes of Death Following PCI Versus CABG in Complex CAD: 5-Year Follow-Up of SYNTAX.

PubMed

Milojevic, Milan; Head, Stuart J; Parasca, Catalina A; Serruys, Patrick W; Mohr, Friedrich W; Morice, Marie-Claude; Mack, Michael J; Ståhle, Elisabeth; Feldman, Ted E; Dawkins, Keith D; Colombo, Antonio; Kappetein, A Pieter; Holmes, David R

2016-01-05

There are no data available on specific causes of death from randomized trials that have compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI). The purpose of this study was to investigate specific causes of death, and its predictors, after revascularization for complex coronary disease in patients. An independent Clinical Events Committee consisting of expert physicians who were blinded to the study treatment subclassified causes of death as cardiovascular (cardiac and vascular), noncardiovascular, or undetermined according to the trial protocol. Cardiac deaths were classified as sudden cardiac, related to myocardial infarction (MI), and other cardiac deaths. In the randomized cohort, there were 97 deaths after CABG and 123 deaths after PCI during a 5-year follow-up. After CABG, 49.4% of deaths were cardiovascular, with the greatest cause being heart failure, arrhythmia, or other causes (24.6%), whereas after PCI, the majority of deaths were cardiovascular (67.5%) and as a result of MI (29.3%). The cumulative incidence rates of all-cause death were not significantly different between CABG and PCI (11.4% vs. 13.9%, respectively; p = 0.10), whereas there were significant differences in terms of cardiovascular (5.8% vs. 9.6%, respectively; p = 0.008) and cardiac death (5.3% vs. 9.0%, respectively; p = 0.003), which were caused primarily by a reduction in MI-related death with CABG compared with PCI (0.4% vs. 4.1%, respectively; p <0.0001). Treatment with PCI versus CABG was an independent predictor of cardiac death (hazard ratio: 1.55; 95% confidence interval: 1.09 to 2.33; p = 0.045). The difference in MI-related death was seen largely in patients with diabetes, 3-vessel disease, or high SYNTAX (TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries) trial scores. During a 5-year follow-up, CABG in comparison with PCI was associated with a significantly reduced rate of MI-related death, which was the leading cause of death after PCI. Treatments following PCI should target reducing post-revascularization spontaneous MI. Furthermore, secondary preventive medication remains essential in reducing events post-revascularization. (TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Five-Year Outcomes with PCI Guided by Fractional Flow Reserve.

PubMed

Xaplanteris, Panagiotis; Fournier, Stephane; Pijls, Nico H J; Fearon, William F; Barbato, Emanuele; Tonino, Pim A L; Engstrøm, Thomas; Kääb, Stefan; Dambrink, Jan-Henk; Rioufol, Gilles; Toth, Gabor G; Piroth, Zsolt; Witt, Nils; Fröbert, Ole; Kala, Petr; Linke, Axel; Jagic, Nicola; Mates, Martin; Mavromatis, Kreton; Samady, Habib; Irimpen, Anand; Oldroyd, Keith; Campo, Gianluca; Rothenbühler, Martina; Jüni, Peter; De Bruyne, Bernard

2018-05-22

Background We hypothesized that fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) would be superior to medical therapy as initial treatment in patients with stable coronary artery disease. Methods Among 1220 patients with angiographically significant stenoses, those in whom at least one stenosis was hemodynamically significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus medical therapy or to medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy and were entered into a registry. The primary end point was a composite of death, myocardial infarction, or urgent revascularization. Results A total of 888 patients underwent randomization (447 patients in the PCI group and 441 in the medical-therapy group). At 5 years, the rate of the primary end point was lower in the PCI group than in the medical-therapy group (13.9% vs. 27.0%; hazard ratio, 0.46; 95% confidence interval [CI], 0.34 to 0.63; P<0.001). The difference was driven by urgent revascularizations, which occurred in 6.3% of the patients in the PCI group as compared with 21.1% of those in the medical-therapy group (hazard ratio, 0.27; 95% CI, 0.18 to 0.41). There were no significant differences between the PCI group and the medical-therapy group in the rates of death (5.1% and 5.2%, respectively; hazard ratio, 0.98; 95% CI, 0.55 to 1.75) or myocardial infarction (8.1% and 12.0%; hazard ratio, 0.66; 95% CI, 0.43 to 1.00). There was no significant difference in the rate of the primary end point between the PCI group and the registry cohort (13.9% and 15.7%, respectively; hazard ratio, 0.88; 95% CI, 0.55 to 1.39). Relief from angina was more pronounced after PCI than after medical therapy. Conclusions In patients with stable coronary artery disease, an initial FFR-guided PCI strategy was associated with a significantly lower rate of the primary composite end point of death, myocardial infarction, or urgent revascularization at 5 years than medical therapy alone. Patients without hemodynamically significant stenoses had a favorable long-term outcome with medical therapy alone. (Funded by St. Jude Medical and others; FAME 2 ClinicalTrials.gov number, NCT01132495 .).

Predicting the Benefits of Percutaneous Coronary Intervention on 1-Year Angina and Quality of Life in Stable Ischemic Heart Disease: Risk Models From the COURAGE Trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation).

PubMed

Zhang, Zugui; Jones, Philip; Weintraub, William S; Mancini, G B John; Sedlis, Steven; Maron, David J; Teo, Koon; Hartigan, Pamela; Kostuk, William; Berman, Daniel; Boden, William E; Spertus, John A

2018-05-01

Percutaneous coronary intervention (PCI) is a therapy to reduce angina and improve quality of life in patients with stable ischemic heart disease. However, it is unclear whether the quality of life after PCI is more dependent on the PCI or other patient-related factors. To address this question, we created models to predict angina and quality of life 1 year after PCI and medical therapy. Using data from the 2287 stable ischemic heart disease patients randomized in the COURAGE trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) to PCI plus optimal medical therapy (OMT) versus OMT alone, we built prediction models for 1-year Seattle Angina Questionnaire angina frequency, physical limitation, and quality of life scores, both as continuous outcomes and categorized by clinically desirable states, using multivariable techniques. Although most patients improved regardless of treatment, marked variability was observed in Seattle Angina Questionnaire scores 1 year after randomization. Adding PCI conferred a greater mean improvement (about 2 points) in Seattle Angina Questionnaire scores that were not affected by patient characteristics ( P values for all interactions >0.05). The proportion of patients free of angina or having very good/excellent physical limitation (physical function) or quality of life at 1 year was 57%, 58%, 66% with PCI+OMT and 50%, 55%, 59% with OMT alone group, respectively. However, other characteristics, such as baseline symptoms, age, diabetes mellitus, and the magnitude of myocardium subtended by narrowed coronary arteries were as, or more, important than revascularization in predicting symptoms (partial R 2 =0.07 versus 0.29, 0.03 versus 0.22, and 0.05 versus 0.24 in the domain of angina frequency, physical limitation, and quality of life, respectively). There was modest/good discrimination of the models (C statistic=0.72-0.82) and excellent calibration (coefficients of determination for predicted versus observed deciles=0.83-0.97). The health status outcomes of stable ischemic heart disease patients treated by OMT+PCI versus OMT alone can be predicted with modest accuracy. Angina and quality of life at 1 year is improved by PCI but is more strongly associated with other patient characteristics. URL: https://www.clinicaltrials.gov. Unique identifier: NCT00007657. © 2018 American Heart Association, Inc.

Endovascular Thrombectomy for Acute Ischemic Stroke: A Meta-analysis.

PubMed

Badhiwala, Jetan H; Nassiri, Farshad; Alhazzani, Waleed; Selim, Magdy H; Farrokhyar, Forough; Spears, Julian; Kulkarni, Abhaya V; Singh, Sheila; Alqahtani, Abdulrahman; Rochwerg, Bram; Alshahrani, Mohammad; Murty, Naresh K; Alhazzani, Adel; Yarascavitch, Blake; Reddy, Kesava; Zaidat, Osama O; Almenawer, Saleh A

2015-11-03

Endovascular intervention for acute ischemic stroke improves revascularization. But trials examining endovascular therapy yielded variable functional outcomes, and the effect of endovascular intervention among subgroups needs better definition. To examine the association between endovascular mechanical thrombectomy and clinical outcomes among patients with acute ischemic stroke. We systematically searched MEDLINE, EMBASE, CINAHL, Google Scholar, and the Cochrane Library without language restriction through August 2015. Eligible studies were randomized clinical trials of endovascular therapy with mechanical thrombectomy vs standard medical care, which includes the use of intravenous tissue plasminogen activator (tPA). Independent reviewers evaluated the quality of studies and abstracted the data. We calculated odds ratios (ORs) and 95% CIs for all outcomes using random-effects meta-analyses and performed subgroup and sensitivity analyses to examine whether certain imaging, patient, treatment, or study characteristics were associated with improved functional outcome. The strength of the evidence was examined for all outcomes using the GRADE method. Ordinal improvement across modified Rankin scale (mRS) scores at 90 days, functional independence (mRS score, 0-2), angiographic revascularization at 24 hours, symptomatic intracranial hemorrhage within 90 days, and all-cause mortality at 90 days. Data were included from 8 trials involving 2423 patients (mean [SD] age, 67.4 [14.4] years; 1131 [46.7%] women), including 1313 who underwent endovascular thrombectomy and 1110 who received standard medical care with tPA. In a meta-analysis of these trials, endovascular therapy was associated with a significant proportional treatment benefit across mRS scores (OR, 1.56; 95% CI, 1.14-2.13; P = .005). Functional independence at 90 days (mRS score, 0-2) occurred among 557 of 1293 patients (44.6%; 95% CI, 36.6%-52.8%) in the endovascular therapy group vs 351 of 1094 patients (31.8%; 95% CI, 24.6%-40.0%) in the standard medical care group (risk difference, 12%; 95% CI, 3.8%-20.3%; OR, 1.71; 95% CI, 1.18-2.49; P = .005). Compared with standard medical care, endovascular thrombectomy was associated with significantly higher rates of angiographic revascularization at 24 hours (75.8% vs 34.1%; OR, 6.49; 95% CI, 4.79-8.79; P < .001) but no significant difference in rates of symptomatic intracranial hemorrhage within 90 days (70 events [5.7%] vs 53 events [5.1%]; OR, 1.12; 95% CI, 0.77-1.63; P = .56) or all-cause mortality at 90 days (218 deaths [15.8%] vs 201 deaths [17.8%]; OR, 0.87; 95% CI, 0.68-1.12; P = .27). Among patients with acute ischemic stroke, endovascular therapy with mechanical thrombectomy vs standard medical care with tPA was associated with improved functional outcomes and higher rates of angiographic revascularization, but no significant difference in symptomatic intracranial hemorrhage or all-cause mortality at 90 days.

CPAP Does Not Reduce Inflammatory Biomarkers in Patients With Coronary Artery Disease and Nonsleepy Obstructive Sleep Apnea: A Randomized Controlled Trial.

PubMed

Thunström, Erik; Glantz, Helena; Yucel-Lindberg, Tülay; Lindberg, Kristin; Saygin, Mustafa; Peker, Yüksel

2017-11-01

Obstructive sleep apnea (OSA) and enhanced vascular inflammation coexist in patients with coronary artery disease (CAD). Continuous positive airway pressure (CPAP) is first-line treatment for OSA with daytime sleepiness. This analysis of data from the RICCADSA (Randomized Intervention with CPAP in Coronary Artery Disease and Sleep Apnea) trial investigated the effects of CPAP on inflammatory markers in patients with CAD and nonsleepy OSA. This single-center, randomized, controlled, open-label trial enrolled consecutive revascularized patients with nonsleepy OSA (apnea-hypopnea index >15/h; Epworth Sleepiness Scale score <10). Levels of high-sensitivity C-reactive protein (hs-CRP), interleukin (IL)-6, IL-8, and tumor necrosis factor-α (TNF-α) were measured in blood samples taken at baseline (median 94 days after revascularization) and after 1 year of follow-up in patients randomized to CPAP or no-CPAP. A total of 220 patients with analyzable blood samples at baseline and 1 year were included. Baseline IL-6 levels were significantly lower in the CPAP versus no-CPAP group (median 3.1 pmol/L [interquartile range 1.3-5.7] vs. 4.2 pmol/L [2.0-8.9], respectively; p = .005). At 1-year follow-up, median IL-6 levels were significantly reduced in both groups (to 2.2 pmol/L [1.2-3.9] in the CPAP group and to 2.2 [1.2-4.7] in no-CPAP group; both p < .001 vs. baseline). IL-8, hs-CRP, and TNF-α did not change significantly from baseline. There was no association between CPAP adherence and changes in inflammatory marker levels. In patients with stable CAD and nonsleepy OSA, inflammatory biomarkers did not change significantly over time except for IL-6 levels, which reduced to the same extent in the CPAP and no-CPAP groups. ClinicalTrials.gov, ID: NCT00519597; researchweb.org, VGSKAS-4731. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

Safety and Efficacy of Solitaire Stent Thrombectomy: Individual Patient Data Meta-Analysis of Randomized Trials.

PubMed

Campbell, Bruce C V; Hill, Michael D; Rubiera, Marta; Menon, Bijoy K; Demchuk, Andrew; Donnan, Geoffrey A; Roy, Daniel; Thornton, John; Dorado, Laura; Bonafe, Alain; Levy, Elad I; Diener, Hans-Christoph; Hernández-Pérez, María; Pereira, Vitor Mendes; Blasco, Jordi; Quesada, Helena; Rempel, Jeremy; Jahan, Reza; Davis, Stephen M; Stouch, Bruce C; Mitchell, Peter J; Jovin, Tudor G; Saver, Jeffrey L; Goyal, Mayank

2016-03-01

Recent positive randomized trials of endovascular therapy for ischemic stroke used predominantly stent retrievers. We pooled data to investigate the efficacy and safety of stent thrombectomy using the Solitaire device in anterior circulation ischemic stroke. Patient-level data were pooled from trials in which the Solitaire was the only or the predominant device used in a prespecified meta-analysis (SEER Collaboration): Solitaire FR With the Intention for Thrombectomy as Primary Endovascular Treatment (SWIFT PRIME), Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE), Extending the Time for Thrombolysis in Emergency Neurological Deficits-Intra-Arterial (EXTEND-IA), and Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting Within Eight Hours of Symptom Onset (REVASCAT). The primary outcome was ordinal analysis of modified Rankin Score at 90 days. The primary analysis included all patients in the 4 trials with 2 sensitivity analyses: (1) excluding patients in whom Solitaire was not the first device used and (2) including the 3 Solitaire-only trials (excluding ESCAPE). Secondary outcomes included functional independence (modified Rankin Score 0-2), symptomatic intracerebral hemorrhage, and mortality. The primary analysis included 787 patients: 401 randomized to endovascular thrombectomy and 386 to standard care, and 82.6% received intravenous thrombolysis. The common odds ratio for modified Rankin Score improvement was 2.7 (2.0-3.5) with no heterogeneity in effect by age, sex, baseline stroke severity, extent of computed tomography changes, site of occlusion, or pretreatment with alteplase. The number needed to treat to reduce disability was 2.5 and for an extra patient to achieve independent outcome was 4.25 (3.29-5.99). Successful revascularization occurred in 77% treated with Solitaire device. The rate of symptomatic intracerebral hemorrhage and overall mortality did not differ between treatment groups. Solitaire thrombectomy for large vessel ischemic stroke was safe and highly effective with substantially reduced disability. Benefits were consistent in all prespecified subgroups. © 2016 The Authors.

Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease.

PubMed

Ellis, Stephen G; Kereiakes, Dean J; Metzger, D Christopher; Caputo, Ronald P; Rizik, David G; Teirstein, Paul S; Litt, Marc R; Kini, Annapoorna; Kabour, Ameer; Marx, Steven O; Popma, Jeffrey J; McGreevy, Robert; Zhang, Zhen; Simonton, Charles; Stone, Gregg W

2015-11-12

In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes. In this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt-chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year. Target-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95% confidence interval, -0.5 to 3.9; P=0.007 for noninferiority and P=0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P=0.29), target-vessel myocardial infarction (6.0% and 4.6%, respectively; P=0.18), or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively; P=0.50). Device thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in 0.7% of patients in the Xience group (P=0.13). In this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt-chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. (Funded by Abbott Vascular; ABSORB III ClinicalTrials.gov number, NCT01751906.).

A Randomized Factorial Trial of Vitamins C, E, and Beta-Carotene in the Secondary Prevention of Cardiovascular Events in Women

PubMed Central

Cook, Nancy R.; Albert, Christine M.; Gaziano, J. Michael; Zaharris, Elaine; MacFadyen, Jean; Danielson, Eleanor; Buring, Julie E.; Manson, JoAnn E.

2007-01-01

Background Randomized trials have largely failed to support an effect of antioxidant vitamins on risk of cardiovascular disease (CVD). Few trials have examined interactions among antioxidants, and no previous trial has examined the individual effect of vitamin C on CVD. Methods WACS tested the effects of vitamins C (500 mg daily), E (600 IU every other day), and beta-carotene (50 mg every other day) on the combined outcome of myocardial infarction (MI), stroke, coronary revascularization, or CVD death among 8,171 female health professionals at increased risk in a 2×2×2 factorial design. Participants were 40 years or older with a prior history of CVD or three or more CVD risk factors, and were followed an average 9.4 years, from 1995-96 to 2005. Results 1,450 women experienced one or more CVD outcomes. There was no overall effect of vitamin C (RR=1.02, 95% CI=0.92-1.13, p=0.71), vitamin E (RR=0.94, 95% CI=0.85-1.04, p=0.23), or beta-carotene (RR=1.02, 95% CI=0.92-1.13, p=0.71) on the primary combined endpoint, or on the individual secondary outcomes of MI, stroke, coronary revascularization, or CVD death. A marginally significant reduction in the primary outcome with active vitamin E was observed among the pre-specified subgroup of women with prior CVD (RR=0.89, 95% CI=0.79-1.00, p=0.04; p-interaction=0.07). There were no significant interactions between agents for the primary endpoint, but those randomized to both active vitamin C and E experienced fewer strokes (p for interaction=0.03). Conclusion There were no overall effects of vitamins C, E or beta-carotene on cardiovascular events among women at high risk for CVD. Trial Registration clinicaltrials.gov Identifier: NCT00000541 PMID:17698683

SYNTAX Score and Long-Term Outcomes: The BARI-2D Trial.

PubMed

Ikeno, Fumiaki; Brooks, Maria Mori; Nakagawa, Kaori; Kim, Min-Kyu; Kaneda, Hideaki; Mitsutake, Yoshiaki; Vlachos, Helen A; Schwartz, Leonard; Frye, Robert L; Kelsey, Sheryl F; Waseda, Katsuhisa; Hlatky, Mark A

2017-01-31

The extent of coronary disease affects clinical outcomes and may predict the effectiveness of coronary revascularization with either coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI). The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score quantifies the extent of coronary disease. This study sought to determine whether SYNTAX scores predicted outcomes and the effectiveness of coronary revascularization compared with medical therapy in the BARI-2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial. Baseline SYNTAX scores were retrospectively calculated for BARI-2D patients without prior revascularization (N = 1,550) by angiographic laboratory investigators masked to patient characteristics and outcomes. The primary outcome was major cardiovascular events (a composite of death, myocardial infarction, and stroke) over 5 years. A mid/high SYNTAX score (≥23) was associated with a higher risk of major cardiovascular events (hazard ratio: 1.36, confidence interval: 1.07 to 1.75, p = 0.01). Patients in the CABG stratum had significantly higher SYNTAX scores: 36% had mid/high SYNTAX scores compared with 13% in the PCI stratum (p < 0.001). Among patients with low SYNTAX scores (≤22), major cardiovascular events did not differ significantly between revascularization and medical therapy, either in the CABG stratum (26.1% vs. 29.9%, p = 0.41) or in the PCI stratum (17.8% vs. 19.2%, p = 0.84). Among patients with mid/high SYNTAX scores, however, major cardiovascular events were lower after revascularization than with medical therapy in the CABG stratum (15.3% vs. 30.3%, p = 0.02), but not in the PCI stratum (35.6% vs. 26.5%, p = 0.12). Among patients with diabetes and stable ischemic heart disease, higher SYNTAX scores predict higher rates of major cardiovascular events and were associated with more favorable outcomes of revascularization compared with medical therapy among patients suitable for CABG. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes; NCT00006305). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Lipid abnormalities in women: data for risk, data for management.

PubMed

Wenger, Nanette K

2006-01-01

In multiple randomized, controlled clinical trials, statin treatment of elevated low-density lipoprotein cholesterol in women at increased risk of or with coronary heart disease decreased the risk of coronary events: coronary death, nonfatal myocardial infarction, and myocardial revascularization procedures. Total mortality was unchanged, potentially reflecting the underrepresentation of women in these trials and consequent small number of fatal events. Statin therapy provided comparable benefit for women and men with acute coronary syndromes. Application of lipid-lowering therapy with statin drugs is currently underutilized in women, and represents an opportunity to improve clinical cardiovascular outcomes for women.

High-Dose Versus Low-Dose Pitavastatin in Japanese Patients With Stable Coronary Artery Disease (REAL-CAD): A Randomized Superiority Trial.

PubMed

Taguchi, Isao; Iimuro, Satoshi; Iwata, Hiroshi; Takashima, Hiroaki; Abe, Mitsuru; Amiya, Eisuke; Ogawa, Takanori; Ozaki, Yukio; Sakuma, Ichiro; Nakagawa, Yoshihisa; Hibi, Kiyoshi; Hiro, Takafumi; Fukumoto, Yoshihiro; Hokimoto, Seiji; Miyauchi, Katsumi; Yamazaki, Tsutomu; Ito, Hiroshi; Otsuji, Yutaka; Kimura, Kazuo; Takahashi, Jun; Hirayama, Atsushi; Yokoi, Hiroyoshi; Kitagawa, Kazuo; Urabe, Takao; Okada, Yasushi; Terayama, Yasuo; Toyoda, Kazunori; Nagao, Takehiko; Matsumoto, Masayasu; Ohashi, Yasuo; Kaneko, Tetsuji; Fujita, Retsu; Ohtsu, Hiroshi; Ogawa, Hisao; Daida, Hiroyuki; Shimokawa, Hiroaki; Saito, Yasushi; Kimura, Takeshi; Inoue, Teruo; Matsuzaki, Masunori; Nagai, Ryozo

2018-05-08

Current guidelines call for high-intensity statin therapy in patients with cardiovascular disease on the basis of several previous "more versus less statins" trials. However, no clear evidence for more versus less statins has been established in an Asian population. In this prospective, multicenter, randomized, open-label, blinded end point study, 13 054 Japanese patients with stable coronary artery disease who achieved low-density lipoprotein cholesterol (LDL-C) <120 mg/dL during a run-in period (pitavastatin 1 mg/d) were randomized in a 1-to-1 fashion to high-dose (pitavastatin 4 mg/d; n=6526) or low-dose (pitavastatin 1 mg/d; n=6528) statin therapy. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, or unstable angina requiring emergency hospitalization. The secondary composite end point was a composite of the primary end point and clinically indicated coronary revascularization excluding target-lesion revascularization at sites of prior percutaneous coronary intervention. The mean age of the study population was 68 years, and 83% were male. The mean LDL-C level before enrollment was 93 mg/dL with 91% of patients taking statins. The baseline LDL-C level after the run-in period on pitavastatin 1 mg/d was 87.7 and 88.1 mg/dL in the high-dose and low-dose groups, respectively. During the entire course of follow-up, LDL-C in the high-dose group was lower by 14.7 mg/dL than in the low-dose group ( P <0.001). With a median follow-up of 3.9 years, high-dose as compared with low-dose pitavastatin significantly reduced the risk of the primary end point (266 patients [4.3%] and 334 patients [5.4%]; hazard ratio, 0.81; 95% confidence interval, 0.69-0.95; P =0.01) and the risk of the secondary composite end point (489 patients [7.9%] and 600 patients [9.7%]; hazard ratio, 0.83; 95% confidence interval, 0.73-0.93; P =0.002). High-dose pitavastatin also significantly reduced the risks of several other secondary end points such as all-cause death, myocardial infarction, and clinically indicated coronary revascularization. The results for the primary and the secondary composite end points were consistent across several prespecified subgroups, including the low (<95 mg/dL) baseline LDL-C subgroup. Serious adverse event rates were low in both groups. High-dose (4 mg/d) compared with low-dose (1 mg/d) pitavastatin therapy significantly reduced cardiovascular events in Japanese patients with stable coronary artery disease. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01042730. © 2018 The Authors.

Emory Angioplasty Versus Surgery Trial (EAST): design, recruitment, and baseline description of patients.

PubMed

King, S B; Lembo, N J; Weintraub, W S; Kosinski, A S; Barnhart, H X; Kutner, M H

1995-03-23

In patients with multivessel coronary artery disease who require revascularization there is uncertainty as to the selection of the appropriate patients for percutaneous transluminal coronary angioplasty (PTCA) as opposed to coronary artery bypass grafting (CABG). To define the relative roles of PTCA and CABG for multivessel disease, 392 patients were randomly assigned to revascularization by PTCA or CABG and followed for 3 years. This is a single-center randomized study in which individual group assignment was known but grouped data remained blinded until a full 3 years of follow-up was complete on all patients. The patients were randomized in 4 strata: (1) 2-vessel disease with 1 lesion per vessel; (2) 2-vessel disease with multiple lesions in at least 1 vessel; (3) 3-vessel disease with 1 lesion per vessel; and (4) 3-vessel disease with multiple lesions in at least 1 vessel. All data were collected on study-specific forms and sent to an independent biostatistical coordinating center for entry into a computerized database. All data will be analyzed by intention-to-treat. The primary endpoint of the trial is the composite of death of any cause, Q-wave myocardial infarction within 3 years, or a large reversible thallium defect at 3 years. Multiple secondary endpoints will include each of the components of the primary endpoint, the need for additional procedures, angiographic status at 1 and 3 years measured by an independent quantitative coronary arteriography laboratory, and measures of quality of life. A total of 5,118 patients were screened, of whom 3,371 were excluded for angiographic reasons, 191 because the angioplasty operators or surgeons believed that the patients were anatomically unsuitable, and 714 for clinical exclusions, leaving 842 eligible patients, of whom 392 were randomized. Of these, 40% had triple-vessel disease and 60% had double-vessel disease. There was no baseline difference between the 2 treatment arms for any clinical or major angiographic variable. This randomized trial will permit an in-depth comparison of coronary angioplasty and coronary surgery in comparable patients suitable for either procedure. Clinical, angiographic, and quality-of-life comparisons will be made and should be helpful in medical decision making between the 2 procedures.

What do patients think about while waiting for myocardial revascularization?

PubMed

Bulhões Mendonça, Kelminda Maria; de Andrade, Tarcísio Matos

2013-12-01

Coronary artery disease constitutes a public health issue involving high mortality rates. The objectives of this study were to evaluate the feelings and perception of patients hospitalized before myocardial revascularization and to explore doctor-patient interactions before cardiac surgery with special attention to existential challenges. A qualitative, exploratory study involving patients admitted to a university teaching hospital in the city of Salvador, Bahia, Brazil, awaiting myocardial revascularization. The data were obtained from in-depth interviews that followed a previously defined script based on the study objectives. The data collected at each interview were allocated into content blocks in common with the selected categories and illustrated by quotations from the patients' speech. Twelve patients were interviewed. Data collection was closed when saturation was achieved, in the sense that new main issues did not appear in subsequent dialogues. The various strategies used by the patients to administer their emotions during the period preceding myocardial revascularization highlight the importance that factors of a subjective nature acquire at this specific time in their lives. The patients recognized the benefit of being able to discuss their heart problems as a means of diminishing their fear and anxiety. It is vital for the medical team to be more supportive and understanding concerning the emotions experienced by the patients in the period preceding myocardial revascularization. This study emphasizes the importance of the task of helping patients administer their perceptions and feelings and even planning their life while awaiting myocardial revascularization.

External-to-Internal Iliac Stent-Graft: Medium-Term Patency Following Exclusion of a Retrogradely Perfused Common Iliac Aneurysm

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nicholls, Marcus John, E-mail: marcusnicholls@hotmail.co; McPherson, Simon

2010-08-15

Following complicated aortic aneurysm surgery a complete left iliac occlusion resulted in buttock claudication. A retrogradely perfused right common iliac aneurysm expanded. Exclusion was by external-to-internal iliac stent-graft. No deterioration in claudication occurred with medium-term stent-graft patency.

Comparison by meta-analysis of percutaneous coronary intervention versus coronary artery bypass grafting in patients with a mean age of ≥70 years.

PubMed

Alam, Mahboob; Virani, Salim S; Shahzad, Saima A; Siddiqui, Sahar; Siddiqui, Khaleeq H; Mumtaz, Shahzad A; Kleiman, Neal S; Coselli, Joseph S; Lakkis, Nasser M; Jneid, Hani

2013-09-01

A paucity of published data evaluating the outcomes of older patients (age ≥70 years) undergoing revascularization for unprotected left main coronary artery disease is available. We performed aggregate data meta-analyses of the clinical outcomes (all-cause mortality, nonfatal myocardial infarction, stroke, repeat revascularization, and major adverse cardiac and cerebrovascular events at 30 days and 12 and 22 months) in studies comparing percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with a mean age of ≥70 years and unprotected left main coronary artery disease. A comprehensive, time-unlimited literature search to January 31, 2013 identified 10 studies with a total of 2,386 patients (PCI, n = 909; CABG, n = 1,477). Summary odds ratios (ORs) and 95% confidence intervals (CIs) were estimated using the random-effects model. The patients in the PCI group were more likely than those in the CABG group to present with acute coronary syndrome (59.6% vs 44.8%, p <0.001). PCI was associated with a shorter hospital stay (4.2 ± 0.8 vs 8.3 ± 0.01 days, p <0.001). No significant differences were found between PCI and CABG for all cause-mortality, nonfatal myocardial infarction, and major adverse cardiac and cerebrovascular events at 30 days and 12 and 22 months. However, PCI was associated with lower rates of stroke at 30 days (OR 0.14, 95% CI 0.02 to 0.76) and 12 months (OR 0.14, 95% CI 0.03 to 0.60) and higher rates of repeat revascularization at 22 months (OR 4.34, 95% CI 2.69 to 7.01). These findings were consistent with the findings from a subgroup analysis of patients aged ≥75 years. In conclusion, older patients (age ≥70 years) with unprotected left main coronary artery disease had comparable rates of all-cause mortality, nonfatal myocardial infarction, and major adverse cardiac and cerebrovascular events after PCI or CABG. The patients undergoing PCI had a shorter hospital stay and lower rates of early stroke; however, they experienced higher repeat revascularization rates at longer term follow-up. Copyright © 2013 Elsevier Inc. All rights reserved.