Laser doppler imaging as additional monitoring after digital replanting: A prospective study.

PubMed

Schmid, Marc; Seyed Jafari, S Morteza; Haug, Luzian; Surke, Carsten; Hunger, Robert E; Van De Ville, Dimitri; Juon Personeni, Bettina; Shafighi, Maziar; Voegelin, Esther

2018-03-14

Despite various exisiting monitoring methods, there is still a need for new technologies to improve the quality of post-operative evaluation of digital replantation. The purpose of the study is using a laser Doppler imaging device (Easy-LDI) as an additional tool to assess perfusion. In this method, the changes in the frequency of the laser ligth provide information regarding perfusion of the monitored tissue. This study included seven patients (10 fingers; age of patients: 21-57 years) who suffered from a total (n = 6) or subtotal amputation (n = 4) due to accidents. In addition to hourly standard monitoring with clinical evaluation and skin thermometry, revascularized fingers were hourly monitored with Easy LDI for 48 h. LDI measurement values ranged between 0.8 and 223 (mean 90.62 ± 21.42) arbitrary perfusion units (APU). The mean LDI values before and after revascularization were 7.1 ± 2.85 and 65.30 ± 30.83 APU, respectively. For the successful revascularized fingers (8 of 10 fingers) values from 19 to 223 APU (mean 98.52 ± 15.48) were demonstrated. All of the replants survived, but due to venous occlusion two digits required revision 12 and 35 h after revascularization, respectively. In the two cases, Easy-LDI also showed a constant and slow decline of the perfusion values. Furthermore, Pearson normalized correlation coefficient showed a positive significant correlation between temperatures of the replants and LDI-values (P < .001, r = +0.392) and a negative significant correlation between Δtemperature and LDI-values (P < .001, r = -0.474). The LDI-device might be a promising additional monitoring technique in detection of perfusion disturbance in monitoring digital replantations. © 2018 Wiley Periodicals, Inc.

Clinical outcomes in middle cerebral artery trunk occlusions versus secondary division occlusions after mechanical thrombectomy: pooled analysis of the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) and Multi MERCI trials.

PubMed

Shi, Zhong-Song; Loh, Yince; Walker, Gary; Duckwiler, Gary R

2010-05-01

The benefit of endovascular revascularization of patients with acute ischemic stroke with middle cerebral artery (MCA) secondary division (M2) occlusions as compared with MCA trunk (M1) occlusions is not known. In this analysis, we compared revascularization status and clinical outcomes in patients with angiographically confirmed MCA M1 versus isolated M2 occlusions treated with mechanical thrombectomy using the Merci Retriever devices. We retrospectively analyzed the pooled data of patients with MCA strokes from the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) and Multi MERCI trials. Patient data were dichotomized into 2 groups: MCA M1 occlusions and isolated M2 occlusions. Baseline characteristics, revascularization rates, hemorrhage rates, complications, outcomes, and mortality were evaluated for both groups. Of 178 patients with MCA occlusion treated in the MERCI and Multi MERCI trials, 84.3% had M1 lesions and 15.7% had isolated M2 lesions. Patients with isolated M2 occlusions were revascularized at a higher rate, required a lower mean number of passes, and were associated with a trend toward shorter mean procedure time than patients with M1 occlusions. No statistically significant differences were found between M2 and M1 groups for symptomatic hemorrhage, clinically significant procedural adverse events, favorable 90-day outcome, or 90-day mortality, although in all instances, the M2 outcomes were numerically better than those in M1 subjects. In multivariate analysis, final revascularization was the strongest independent predictor of good outcome at 90 days. Patients with both MCA M1 occlusions and isolated M2 occlusions can achieve a relatively high rate of revascularization and favorable clinical outcomes after mechanical thrombectomy. In fact, patients with isolated M2 occlusions had a higher rate of revascularization, required fewer passes, and had no increased complications compared with patients with M1 occlusions.

Initial Experience and Feasibility of the New Low-Profile Stingray Catheter as Part of the Antegrade Dissection and Re-Entry Revascularization Strategy for Coronary Chronic Total Occlusions

PubMed Central

Maeremans, Joren; Palmers, Pieter-Jan; Dens, Joseph

2017-01-01

Case series Patient: Male, 77 • Male, 57 • Male, 73 Final Diagnosis: Coronary chronic total occlusion Symptoms: Angina pectoris Medication: — Clinical Procedure: Percutaneous coronary intervention of coronary chronic total occlusions Specialty: Cardiology Objective: Unusual setting of medical care Background: During antegrade dissection re-entry (ADR) of chronic total occlusions (CTO), the first-generation Stingray catheter requires the use of large-bore guides (sheathless 7.5 Fr or 8 Fr), which increases the risk for access site-related complications and compromises radial approaches. Smaller guiding sizes necessitate long guidewires (e.g., 300 cm) or guidewire extensions for catheter advancement or removal. However, friction between guides and the Stingray catheter can result in unstable guidewire position or unintentional removal. Furthermore, failure to deliver the catheter at the distal re-entry zone is a common problem. To overcome issues of deliverability and reduce the need for pre-dilatations, with its inherent risk of creating subintimal hematomas, the Stingray low-profile (LP) balloon catheter was developed. Case Report: We describe 3 cases of successful application of the novel Stingray LP catheter during ADR. In all cases, 7 Fr guiding catheters were successfully used in combination with the device. The lower profile facilitated a good exchange and delivery of the device, without the need for balloon pre-dilatations in 2 cases. This resulted in a limited subintimal plane, enabling a smooth puncture into the true lumen. One case presented with extreme levels of calcification and tortuosity, resulting in a high degree of friction, despite the lower catheter profile. No in-hospital coronary or access site-related complications occurred. Conclusions: This case report illustrates the feasibility of the Stingray LP catheter for the treatment of CTOs via the ADR technique. The lower profile of the catheter potentially increases the deliverability, safety, and exchangeability of the device. PMID:28138123

78 FR 76307 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-17

...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization. FDA intends...

Successful weaning of a left ventricular assist device implanted for ischemic heart failure.

PubMed

Beurtheret, Sylvain; Mordant, Pierre; Pavie, Alain; Leprince, Pascal

2010-10-01

We report the case of a patient stabilized under extra-corporeal membrane oxygenation after a refractory cardiogenic shock following myocardial infarction. Persistent left ventricular failure required secondary implantation of the left ventricular assist device (LVAD) HeartMate II. LVAD succeeded in the gradual recovery of myocardial contractility, allowing weaning of the device five months after implantation. Simultaneously, the patient beneficiated from coronary revascularization and resumed normal activity. This case emphasizes potential late recoveries after myocardial infarction complicated by left ventricular failure.

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

Jeromel, Miran, E-mail: miran.jeromel@gmail.com; Milosevic, Z. V., E-mail: zoran.milosevic@guest.arnes.si; Kocijancic, I. J., E-mail: igor.kocijancic@gmail.com

BackgroundEndovascular mechanical revascularization (thrombectomy) is an increasingly used method for intracranial large vessel recanalization in acute stroke. The purpose of the study was to analyze the recanalization rate, clinical outcome, and complication rate in our stroke patients treated with mechanical revascularization. A total of 57 patients with large vessel stroke (within 3 h for anterior and 12 h for posterior circulation) were treated with mechanical revascularization at a single center during 24 months. The primary goal of endovascular treatment using different mechanical devices was recanalization of the occluded vessel. Recanalization rate (reported as thrombolysis in cerebral infarction [TICI] score), clinicalmore » outcome (reported as National Institutes of Health Stroke Scale [NIHSS] score and modified Rankin scale [mRS] score), as well as periprocedural complications were analyzed. The mean age of the patients was 63.1 {+-} 12.9 years, with baseline median NIHSS score of 14 (interquartile range, 9.5-19). Successful recanalization (TICI 2b or 3) was achieved in 41 (72 %) patients. Twenty patients (35 %) presented with favorable outcome (mRS {<=}2) 30 days after stroke. Overall, significant neurological improvement ({>=}4 NIHSS point reduction) occurred in 36 (63 %) patients. A clinically significant procedure-related adverse events (vessel disruption, peri/postprocedural intracranial bleeding) defined with decline in NIHSS of {>=}4 or death occurred in three (5 %) patients. The study showed a high recanalization rate with improved clinical outcome and a low rate of periprocedural complications in our stroke patients treated with mechanical revascularization. Therefore, we could conclude that endovascular revascularization (primary or in combination with a bridging thrombolysis) was an effective and safe procedure for intracranial large vessel recanalization in acute stroke.« less

Approach for chronic total occlusion with intravascular ultrasound-guided reverse controlled antegrade and retrograde tracking technique: single center experience.

PubMed

Dai, Jian; Katoh, Osamu; Kyo, Eisho; Tsuji, Takafumi; Watanabe, Satoshi; Ohya, Hidefumi

2013-10-01

Controlled antegrade and retrograde subintimal tracking (CART) or reverse CART techniques is the final step for percutaneous revascularization of coronary chronic total occlusion (CTO), but it still represents technical challenges and risk in interventional procedures. Our purpose was to utilize intravascular ultrasound (IVUS)-guided reverse CART approach for percutaneous revascularization of CTO in our heart center, focusing on its safety, efficacy, and latest technical developments. From November 2006 to November 2012, 49 patients with CTO failed to antegrade and/or retrograde percutaneous revascularization of CTO from true lumen to true lumen were enrolled in and underwent IVUS guided reverse CART approach. The mean J-CTO score of cases was 2.5. IVUS guidance was successfully implemented in 95.9%; IVUS identified that 61.7% of retrograde wires were located at intimal space, and 59.5% of antegrade wires were located at subintimal space. A Corsair channel dilator was used in 77.6% of cases. The success rates of technique and procedure were 95.9% and 93.9%, respectively; the technical minor complications were observed in 10.2% of cases, without significant clinic outcomes; 2.0% of cases occurred with a major adverse cardiac event of non-ST-elevation myocardial infarction; and no case occurred with target vessel revascularization or death. The mean length of stent implanted in a single CTO vessel was 51.3 mm. No patient appeared with radiation dermatitis and contrast-induced rise of creatinine. IVUS guided reverse CART approach is effective and safe for percutaneous revascularization of complex CTO, with a high success and a low complication rate. It is feasible to develop this approach for percutaneous revascularization of complex CTO. However, suitable case selection and lately device handling by experienced operators are the crucial points of success. © 2013, Wiley Periodicals, Inc.

Cost Analysis of Initial Treatment With Endovascular Revascularization, Open Surgery, or Primary Major Amputation in Patients With Peripheral Artery Disease.

PubMed

Tang, Linda; Paravastu, Sharath C V; Thomas, Shannon D; Tan, Elaine; Farmer, Eric; Varcoe, Ramon L

2018-05-01

To compare the total initial treatment costs for open surgery, endovascular revascularization, and primary major amputation within a single-payer healthcare system. A multicenter, retrospective analysis was undertaken to evaluate 1138 patients with symptomatic peripheral artery disease (PAD) who underwent 1017 endovascular procedures, 86 open surgeries, and 35 major amputations between 2013 and 2016. A cost-mix analysis was performed on individual patient data generated for selected diagnosis-related groups. Mean costs are presented with the 95% confidence interval (CI). There was no intergroup difference in demographics or private health insurance status. However, the amputation group had a higher proportion of emergency procedures (68.6% vs 13.3% vs 27.9%, p<0.001) and critical limb ischemia (88.6% vs 35.9% vs 37.2%, p<0.001) compared with the endovascular therapy and open surgery groups, respectively. The endovascular revascularization group spent less time in hospital and used fewer intensive care unit (ICU) resources compared with the open surgery and major amputation groups (hospital length of stay: 3.4 vs 10.0 vs 20.2 days, p<0.01; ICU: 2.4 vs 22.6 vs 54.6 hours, p<0.01), respectively. While mean prosthetic and device costs were higher in the endovascular group [AUD$2770 vs AUD$1658 (open) and AUD$1219 (amputation), p<0.01], substantial disparities were observed in costs associated with longer operating theater times, length of stay, and ICU utilization, which resulted in significantly higher costs in the open and amputation groups. After adjusting for confounders, the AUD$18 396 (95% CI AUD$16 436 to AUD$20 356) mean cost per admission for the endovascular revascularization group was significantly less (p<0.001) than the open surgery (AUD$31 908, 95% CI AUD$28 285 to AUD$35 530) and major amputation groups (AUD$43 033, 95% CI AUD$37 706 to AUD$48 361). Endovascular revascularization procedures for PAD cost the health payer less compared with open surgery and primary amputation. While devices used to deliver contemporary endovascular therapy are more expensive, the reduction in bed days, ICU utilization, and related hospital resources results in a significantly lower mean total cost per admission for the initial treatment.

Circulatory support for OPCAB procedures.

PubMed

Mueller, Xavier M; von Segesser, Ludwig K

2002-07-01

During off-pump coronary artery bypass grafting (OPCAB) which allows complete revascularization through a median sternotomy, revascularization of the lateral and posterior walls requires the verticalization of the heart, which may cause haemodynamic disturbance. This concern has stimulated the development of circulatory support with mini-pumps. Initially, these pumps were designed for the right side of the heart, which was found to be the main contributor to haemodynamic instability under experimental conditions. The three types of mini-pumps that have been developed so far - two for the right side of the heart and one for both sides - are reviewed as well as a new concept of integrated cardiopulmonary bypass (CPB) circuit with reduced surface and priming volume. However, with increasing experience and improved methods of exposition, OPCAB has become a procedure that can be performed without support in the majority of the cases. Nevertheless, the concept of miniaturization and the possibility to insert these devices through a peripheral access has opened the way to new indications, mainly short-term circulatory support for acute heart failure. This development is welcome in a field where available devices are invasive and plagued with a heavy morbidity.

Intermediate coronary revascularization using the Deltastream blood pump: results from an experimental study.

PubMed

Litmathe, J; Hansen, E; Feindt, P; Kurt, M; Boeken, U; Gams, E

2009-01-01

Myocardial revascularization using a complete heart-lung machine may involve many problems, as do complete off-pump attempts. Thus, it was the aim of this study to evaluate the effects of intermediate on-pump/off-pump myocardial revascularization using the miniaturized Deltastream blood pump, on ischemia and hemolysis, in comparison with standard myocardial revascularization. In a group of 8 mini-pigs, combined on-pump/off-pump myocardial revascularization was performed using the Deltastream blood pump as beating-heart support for the on-pump part of the operation (group A). Seven other animals served as controls and underwent standard myocardial revascularization with the same device as integrated pump of a complete heart-lung machine (group B). Blood samples for blood gas metabolism, creatine kinase (CK), troponin I, lactate dehydrogenase (LDH), and hydroxybutyrate dehydrogenase (HBDH) were taken before and after the entire operation. Comparing the baseline values, the increase of CK was more pronounced in group B than in group A (176.4-/+41.2 to 279.7-/+29 U/L vs. 274-/+142.7 to 288.1-/+118.6 U/L, respectively; p=0.0006). Increase of troponin I was significantly higher in group B than in group A (1-/+0.3 to 2.9-/+1 ng/mL vs. 1.1-/+0.9 to 3-/+3.8 ng/mL, respectively; p=0.002). LDH increase was also more pronounced in group B (231.7-/+54.3 to 299.9-/+39.8 U/L vs. 274.9-/+59.7 to 263.8-/+57.9 U/L, respectively; p=0.01). HBDH values increased significantly in group B after the operation (group A: 215.9-/+34.7 to 200-/+39.2 U/L vs. group B: 195.4-/+41.7 to 274.9-/+51.6 U/L; p=0.02). Hemodynamic measures and LDH values under luxation (group A: 1.9-/+0.6 U/L; B: 3.5-/+1 U/L,p=0.001) were also superior in the study group. The current set-up might be superior to conventional extracorporeal circulation and thus be an alternative for high-risk candidates to avoid the adverse events of a complete heart-lung machine, when they are scheduled for complete myocardial revascularization.

Coronary revascularization in Japan. Part 2: comparison of facilities between 1997 and 1999.

PubMed

Tsuchihashi, M; Tsutsui, H; Shihara, M; Shigematsu, H; Yamamoto, S; Koike, G; Kono, S; Takeshita, A

2001-12-01

A nation-wide survey on the procedures and facilities of coronary revascularization, percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) conducted by the Japanese Coronary Intervention Study (JCIS) group during 1997 revealed that PCI is more often used than CABG and is mainly carried out in low-volume facilities without surgical backup. The present study aimed to investigate the temporal changes in the usage of revascularization therapies and facilities from 1997 to 1999. A questionnaire was mailed in 1998 to the delegates of 1,086 PCI and 582 CABG facilities identified by the previous survey, and 89% of PCIs surveyed and 94% of CABGs surveyed reported back. The number of PCI procedures had increased by 19% from 97,831 to 116,479 and that of CABG procedures also increased by 21% from 16,374 to 19,846. The ratio of PCI to CABG was 5.9 in 1999, showing no significant change from 6.0 in 1997. In parallel, the number of PCI and CABG facilities increased from 888 to 941 and from 442 to 453, respectively. The use of coronary stents and other interventional devices increased during these 2 years. Coronary stents were used regardless of the annual procedural volume of the facilities, whereas other interventional devices, directional and rotational coronary atherectomy, were used mainly in the high-volume laboratories (p<0.01). Beating-heart, off-pump CABG had increased from 2% to 11% of total cases. Continued monitoring of trends in PCI and CABG facilities and procedures will be needed for nation-wide assessment of the use of new technology.

Instantaneous wave-free ratio as an alternative to fractional flow reserve in assessment of moderate coronary stenoses: A meta-analysis of diagnostic accuracy studies.

PubMed

Maini, Rohit; Moscona, John; Katigbak, Paul; Fernandez, Camilo; Sidhu, Gursukhmandeep; Saleh, Qusai; Irimpen, Anand; Samson, Rohan; LeJemtel, Thierry

2017-12-27

Fractional flow reserve (FFR) remains underutilized due to practical concerns related to the need for hyperemic agents. These concerns have prompted the study of instantaneous wave-free ratio (iFR), a vasodilator-free index of coronary stenosis. Non-inferior cardiovascular outcomes have been demonstrated in two recent randomized clinic trials. We performed this meta-analysis to provide a necessary update of the diagnostic accuracy of iFR referenced to FFR based on the addition of eight more recent studies and 3727 more lesions. We searched the PubMed, EMBASE, Central, ProQuest, and Web of Science databases for full text articles published through May 31, 2017 to identify studies addressing the diagnostic accuracy of iFR referenced to FFR≤0.80. The following keywords were used: "instantaneous wave-free ratio" OR "iFR" AND "fractional flow reserve" OR "FFR." In total, 16 studies comprising 5756 lesions were identified. Pooled diagnostic accuracy estimates of iFR versus FFR≤0.80 were: sensitivity, 0.78 (95% CI, 0.76-0.79); specificity, 0.83 (0.81-0.84); positive likelihood ratio, 4.54 (3.85-5.35); negative likelihood ratio, 0.28 (0.24-0.32); diagnostic odds ratio, 17.38 (14.16-21.34); area under the summary receiver-operating characteristic curve, 0.87; and an overall diagnostic accuracy of 0.81 (0.78-0.84). In conclusion, iFR showed excellent agreement with FFR as a resting index of coronary stenosis severity without the undesired effects and cost of hyperemic agents. When considering along with its clinical outcome data and ease of application, the diagnostic accuracy of iFR supports its use as a suitable alternative to FFR for physiology-guided revascularization of moderate coronary stenoses. We performed a meta-analysis of the diagnostic accuracy of iFR referenced to FFR. iFR showed excellent agreement with FFR as a resting index of coronary stenosis severity without the undesired effects and cost of hyperemic agents. This supports its use as a suitable alternative to FFR for physiology-guided revascularization of moderate coronary stenoses. Copyright © 2017. Published by Elsevier Inc.

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.

Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries

PubMed Central

Laird, John R.; Tepe, Gunnar; Brodmann, Marianne; Zeller, Thomas; Scheinert, Dierk; Metzger, Christopher; Micari, Antonio; Sachar, Ravish; Jaff, Michael R.; Wang, Hong; Hasenbank, Melissa S.; Krishnan, Prakash

2018-01-01

Background— Randomized controlled trials have reported favorable 1-year outcomes with drug-coated balloons (DCBs) for the treatment of symptomatic peripheral arterial disease when compared with standard percutaneous transluminal angioplasty (PTA). Evidence remains limited on the durability of the treatment effect with DCBs in the longer term. Methods and Results— IN.PACT SFA is a single-blind, randomized trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 patients with symptomatic (Rutherford 2–4) femoropopliteal lesions up to 18 cm in length. Patients were randomized 2:1 to receive treatment with DCB or PTA. The 36-month assessments included primary patency, freedom from clinically driven target lesion revascularization, major adverse events, and functional outcomes. At 36 months, primary patency remained significantly higher among patients treated with DCB compared with PTA (69.5% versus 45.1%; log rank P<0.001). The rates of clinically driven target lesion revascularization were 15.2% and 31.1% (P=0.002) for the DCB and PTA groups, respectively. Functional outcomes were similarly improved between treatment groups even though subjects in the DCB group required significantly fewer reinterventions versus those in the PTA group (P<0.001 for target lesion revascularization, P=0.001 for target vessel revascularization). There were no device- or procedure-related deaths as adjudicated by an independent Clinical Events Committee. Conclusions— Three-year results demonstrate a durable and superior treatment effect among patients treated with DCB versus standard PTA, with significantly higher primary patency and lower clinically driven target lesion revascularization, resulting in similar functional improvements with reduced need for repeat interventions. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01175850 for IN.PACT SFA phase I in the European Union and NCT01566461 for IN.PACT SFA phase II in the United States. PMID:29326153

The role of atherectomy in the treatment of lower extremity peripheral artery disease

PubMed Central

2012-01-01

Background The incidence of lower extremity peripheral artery disease (LE-PAD) continues to increase and associated morbidity remains high. Despite the significant development of percutaneous revascularization strategies, over the past decade, LE-PAD still represents a unique challenge for interventional cardiologists and vascular surgeons. Method Typical features of atherosclerosis that affects peripheral vascular bed (diffuse nature, poor distal runoff, critical limb ischemia, chronic total occlusion) contribute to the disappointing results of traditional percutaneous transluminal angioplasty (PTA). New technologies have been developed in attempt to improve the safety and effectiveness of percutaneous revascularization. Among these, atherectomy, debulking and removing atherosclerotic plaque, offers the potential advantage of eliminating stretch on arterial walls and reducing rates of restenosis. Conclusions This review summarizes the features and the current applications of new debulking devices. PMID:23173800

Orbital atherectomy for the treatment of severely calcified coronary lesions: evidence, technique, and best practices.

PubMed

Shlofmitz, Evan; Martinsen, Brad J; Lee, Michael; Rao, Sunil V; Généreux, Philippe; Higgins, Joe; Chambers, Jeffrey W; Kirtane, Ajay J; Brilakis, Emmanouil S; Kandzari, David E; Sharma, Samin K; Shlofmitz, Richard

2017-11-01

The presence of severe coronary artery calcification is associated with higher rates of angiographic complications during percutaneous coronary intervention (PCI), as well as higher major adverse cardiac events compared with non-calcified lesions. Incorporating orbital atherectomy (OAS) for effective preparation of severely calcified lesions can help maximize the benefits of PCI by attaining maximal luminal gain (or stent expansion) and improve long-term outcomes (by reducing need for revascularization). Areas covered: In this manuscript, the prevalence, risk factors, and impact of coronary artery calcification on PCI are reviewed. Based on current data and experience, the authors review orbital atherectomy technique and best practices to optimize lesion preparation. Expert Commentary: The coronary OAS is the only device approved for use in the U.S. as a treatment for de novo, severely calcified coronary lesions to facilitate stent delivery. Advantages of the device include its ease of use and a mechanism of action that treats bi-directionally, allowing for continuous blood flow during treatment, minimizing heat damage, slow flow, and subsequent need for revascularization. The OAS technique tips reviewed in this article will help inform interventional cardiologists treating patients with severely calcified lesions.

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

Stent fracture in the superficial femoral and proximal popliteal arteries: literature summary and economic impacts.

PubMed

Neil, Nancy

2013-06-01

To summarize available evidence regarding stent fracture in the femoropopliteal region. We searched PubMed, 2000-2011, using MeSH search terms "stents," "popliteal artery," and "femoral artery." We identified 29 original studies reporting 0% to 65% incidence of stent fracture. Fracture-related repeat revascularization could be avoided in the absence of device failure. Recently published data suggest that even a 5% rate of fracture-related reintervention would generate $118.4 million in health care cost in the United States. These excess procedures would also result in major complications and deaths that might have been avoided in the absence of stent fracture. Reported incidence and clinical relevance of femoropopliteal stent fractures vary across studies. Stent fracture may lead to repeat revascularization. These reinterventions create considerable--and potentially avoidable--economic burden for patients and payers. Further, these costs are effectively invisible wherever stent fractures are not systematically documented as the reason for reintervention.

Effects of Sacubitril/Valsartan in the PARADIGM-HF Trial (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) According to Background Therapy.

PubMed

Okumura, Naoki; Jhund, Pardeep S; Gong, Jianjian; Lefkowitz, Martin P; Rizkala, Adel R; Rouleau, Jean L; Shi, Victor C; Swedberg, Karl; Zile, Michael R; Solomon, Scott D; Packer, Milton; McMurray, John J V

2016-09-01

In the PARADIGM-HF trial (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure), the angiotensin receptor neprilysin inhibitor sacubitril/valsartan was more effective than the angiotensin-converting enzyme inhibitorenalapril in patients with heart failure and reduced ejection fraction. We examined whether this benefit was consistent irrespective of background therapy. We examined the effect of study treatment in the following subgroups: diuretics (yes/no), digitalis glycoside (yes/no), mineralocorticoid receptor antagonist (yes/no),and defibrillating device (implanted defibrillating device, yes/no). We also examined the effect of study drug according to β-blocker dose (≥50% and <50% of target dose) and according to whether patients had undergone previous coronary revascularization. We analyzed the primary composite end point of cardiovascular death or heart failure hospitalization, as well as cardiovascular death. Most randomized patients (n=8399)were treated with a diuretic (80%) and β-blocker (93%); 47% of those taking a β-blocker were treated with ≥50% of the recommended dose. In addition, 4671 (56%) were treated with a mineralocorticoid receptor antagonist, 2539 (30%) with digoxin, and 1243 (15%) had a defibrillating device; 2640 (31%) had undergone coronary revascularization. Overall, the sacubitril/valsartan versus enalapril hazard ratio for the primary composite end point was 0.80 (95% confidence interval,0.73-0.87;P<0.001) and for cardiovascular death was0.80 (0.71-0.89;P<0.001). The effect of sacubitril/valsartan was consistent across all subgroups examined. The hazard ratio for primary end point ranged from 0.74 to 0.85 and for cardiovascular death rangedfrom 0.75 to 0.89, with no treatment-by-subgroup interaction. The benefit of sacubitril/valsartan, over an angiotensin-converting enzyme inhibitor, was consistent regardless of background therapy and irrespective of previouscoronary revascularization or β-blocker dose. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035255. © 2016 American Heart Association, Inc.

Correction to: ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 Appropriate Use Criteria for Coronary Revascularization in Patients With Stable Ischemic Heart Disease.

PubMed

Patel, Manesh R; Calhoon, John H; Dehmer, Gregory J; Grantham, James Aaron; Maddox, Thomas M; Maron, David J; Smith, Peter K

2018-05-10

To more clearly reflect the relationship between iFR (instantaneous wave-free ratio) and FFR (fractional flow reserve), this Correction document highlights the following changes to the original document published in the Journal of Nuclear Cardiology; the version available at JACC [1] has been updated to reflect the changes, with JACC's Correction document available at [2].

The Effect of Revascularization on the Hemodynamic Profile of Patients with Infrarenal Aortic Occlusion.

PubMed

Argyriou, Christos; Georgakarakos, Efstratios; Georgiadis, George S; Schoretsanitis, Nikolaos; Lazarides, Miltos K

2017-08-01

Patients undergoing revascularization for infrarenal aortic occlusion (IAO) have been reported to present improved survival rates compared to those treated conservatively. Aim of this study was to investigate the hemodynamic changes induced after revascularization for IAO, as expressed with pulse wave velocity (PWV), augmentation index (Aix), augmentation pressure (AP), and pulse wave reflection coefficient (RC). Twelve patients underwent revascularization (9 aortobifemoral/aortobiiliac bypasses, 2 primary iliac stenting, and 1 hybrid procedure of unilateral aortoiliac stenting and crossover bypass). Calculation of hemodynamic parameters was performed in all patients preoperatively, at 1 month, and 1 year postoperatively. Pulse wave analysis was performed noninvasively with a novel validated brachial cuff-based automatic oscillometric device (Mobil-O-Graph; IEM, Stolberg, Germany). The estimated hemodynamic parameters were AIx, AP, RC, and PWV. Data were analyzed with the Friedman analysis of variance test. Aix decreased significantly at 1 month and further at 1 year postoperatively compared to preoperative values (24 ± 11 and 17 ± 13 vs. 34 ± 13.5, respectively, P = 0.0006). AP decreased at 1 month and 1 year postoperatively compared to preoperative values (6.5 ± 4 mm Hg and 8 ± 6.5 mm Hg vs. 13 ± 12 mm Hg, respectively, P = 0.045). RC decreased also at 1-month and 1-year postoperatively compared to preoperative values (62 ± 5.5, 64 ± 4.3 vs. 73 ± 5.1, respectively, P = 0.002). However, changes in PWV were less prominent in this short-term postoperative period. Improved hemodynamic profile may theoretically contribute to the enhanced survival rates of these patients. Copyright © 2017 Elsevier Inc. All rights reserved.

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.

Respiratory physiotherapy in the pre and postoperative myocardial revascularization surgery.

PubMed

Cavenaghi, Simone; Ferreira, Lucas Lima; Marino, Lais Helena Carvalho; Lamari, Neuseli Marino

2011-01-01

The cardiovascular diseases are among the main death causes in the developed world. They have been increasing epidemically in the developing countries. In spite of several alternatives for the treatment of the coronary artery disease; the surgery of the myocardial revascularization is an option with proper indications of medium and long-term with good results. It provides the remission of the angina symptoms contributing to the increase of the expectation and improvement of the life quality. Most of patients undergoing myocardial revascularization surgery develop postoperative lung dysfunction with important reduction of the lung volumes, damages in the respiratory mechanism, decrease in the lung indulgence and increase of the respiratory work. The reduction of volumes and lung capacities can contribute to alterations in the gas exchanges, resulting in hypoxemia and decrease in the diffusion capacity. Taking this into account, the Physiotherapy has been requested more and more to perform in the pre as well as in the postoperative period of this surgery. This study aimed at updating the knowledge regarding the respiratory physiotherapy performance in the pre and postoperative period of the myocardial revascularization surgery enhancing the prevention of lung complications. The Physiotherapy uses several techniques in the preoperative period; such as: the incentive spirometry, exercises of deep breathing, cough, inspiratory muscle training, earlier ambulation and physiotherapeutic orientations. While in the postoperative period, the objective is the treatment after lung complications took place, performed by means of physiotherapeutic maneuvers and noninvasive respiratory devices, aiming at improving the respiratory mechanism, the lung reexpansion and the bronchial hygiene. Respiratory physiotherapy is an integral part in the care management of the patient with cardiopathy, either in the pre or in the postoperative period, since it contributes significantly to a better prognosis of these patients with the use of specific techniques.

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.

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.

Twelve-Month Outcomes With a Bioresorbable Everolimus-Eluting Scaffold: Results of the ESHC-BVS Registry at Two Australian Centers.

PubMed

Robaei, Daniel; Back, Liam; Ooi, Sze-Yuan; Pitney, Mark; Jepson, Nigel

2016-08-01

The Absorb bioresorbable vascular scaffold (BVS; Abbott Vascular) is a relatively new type of coronary stent designed to provide temporary vessel scaffolding following percutaneous coronary intervention. International use of the device has grown despite a relative paucity of clinical data regarding the performance of the device and the optimal strategy for its use. We report 12-month clinical data on the Absorb BVS from a real-world registry in order to contribute to the overall understanding of the BVS device. Absorb BVS implantation was attempted in 152 lesions in 100 patients at two Sydney hospitals, as part of the prospective ESHC-BVS registry. Patients selected harbored a range of complex lesions as encountered in real-world practice. Type-C lesions made up 37% of all lesions treated, with 64% of these being long lesions (>20 mm). Device success was achieved in 98.8% of cases. Predilation was performed in all scaffolds and postdilation was performed in 95% of scaffolds to a mean of 19.6 ± 4.6 atm. Twelve-month follow-up data were available for 99% of patients. At 12 months, the cumulative incidence of target-lesion revascularization was 4%, while the incidence of myocardial infarction was 2% and the incidence of scaffold thrombosis was 1%. There were no deaths in the follow-up period. In a cohort including complex lesions encountered in real-world practice, the Absorb BVS was associated with low rates of target-lesion revascularization, myocardial infarction, and scaffold thrombosis at 12 months when used with a strategy of meticulous lesion preparation, routine postdilation, and 12 months of dual-antiplatelet therapy.

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.

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.

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.

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

Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI).

PubMed

Moussa, Issam D; Klein, Lloyd W; Shah, Binita; Mehran, Roxana; Mack, Michael J; Brilakis, Emmanouil S; Reilly, John P; Zoghbi, Gilbert; Holper, Elizabeth; Stone, Gregg W

2014-01-01

Numerous definitions have been proposed for the diagnosis of myocardial infarction (MI) after coronary revascularization. The universal definition for MI designates post procedural biomarker thresholds for defining percutaneous coronary intervention (PCI)-related MI (type 4a) and coronary artery bypass grafting (CABG)-related MI (type 5) which are of uncertain prognostic importance. In addition, for both MI types cTn is recommended as the biomarker of choice, the prognostic significance of which is less well validated than CK-MB. Widespread adoption of a MI definition not clearly linked to subsequent adverse events such as mortality or heart failure may have serious consequences for the appropriate assessment of devices and therapies, may affect clinical care pathways, and may result in misinterpretation of physician competence. Rather than employing an MI definition sensitive for small degrees of myonecrosis (the occurrence of which, based on contemporary large-scale studies, are unlikely to have important clinical consequences), it is instead recommended that a threshold level of biomarker elevation which has been strongly linked to subsequent adverse events in clinical studies be used to define a "clinically relevant MI." The present document introduces a new definition for "clinically relevant MI" after coronary revascularization (PCI or CABG) which is applicable for use in clinical trials, patient care, and quality outcomes assessment. Copyright © 2013 Wiley Periodicals, Inc.

TREVO stent-retriever mechanical thrombectomy for acute ischemic stroke secondary to large vessel occlusion registry

PubMed Central

Zaidat, Osama O; Castonguay, Alicia C; Nogueira, Raul G; Haussen, Diogo C; English, Joey D; Satti, Sudhakar R; Chen, Jennifer; Farid, Hamed; Borders, Candace; Veznedaroglu, Erol; Binning, Mandy J; Puri, Ajit; Vora, Nirav A; Budzik, Ron F; Dabus, Guilherme; Linfante, Italo; Janardhan, Vallabh; Alshekhlee, Amer; Abraham, Michael G; Edgell, Randall; Taqi, Muhammad Asif; Khoury, Ramy El; Mokin, Maxim; Majjhoo, Aniel Q; Kabbani, Mouhammed R; Froehler, Michael T; Finch, Ira; Ansari, Sameer A; Novakovic, Roberta; Nguyen, Thanh N

2018-01-01

Background Recent randomized clinical trials (RCTs) demonstrated the efficacy of mechanical thrombectomy using stent-retrievers in patients with acute ischemic stroke (AIS) with large vessel occlusions; however, it remains unclear if these results translate to a real-world setting. The TREVO Stent-Retriever Acute Stroke (TRACK) multicenter Registry aimed to evaluate the use of the Trevo device in everyday clinical practice. Methods Twenty-three centers enrolled consecutive AIS patients treated from March 2013 through August 2015 with the Trevo device. The primary outcome was defined as achieving a Thrombolysis in Cerebral Infarction (TICI) score of ≥2b. Secondary outcomes included 90-day modified Rankin Scale (mRS), mortality, and symptomatic intracranial hemorrhage (sICH). Results A total of 634patients were included. Mean age was 66.1±14.8 years and mean baseline NIH Stroke Scale (NIHSS) score was 17.4±6.7; 86.7% had an anterior circulation occlusion. Mean time from symptom onset to puncture and time to revascularization were 363.1±264.5 min and 78.8±49.6 min, respectively. 80.3% achieved TICI ≥2b. 90-day mRS ≤2 was achieved in 47.9%, compared with 51.4% when restricting the analysis to the anterior circulation and within 6 hours (similar to recent AHA/ASA guidelines), and 54.3% for those who achieved complete revascularization. The 90-day mortality rate was 19.8%. Independent predictors of clinical outcome included age, baseline NIHSS, use of balloon guide catheter, revascularization, and sICH. Conclusion The TRACK Registry results demonstrate the generalizability of the recent thrombectomy RCTs in real-world clinical practice. No differences in clinical and angiographic outcomes were shown between patients treated within the AHA/ASA guidelines and those treated outside the recommendations. PMID:28963367

TREVO stent-retriever mechanical thrombectomy for acute ischemic stroke secondary to large vessel occlusion registry.

PubMed

Zaidat, Osama O; Castonguay, Alicia C; Nogueira, Raul G; Haussen, Diogo C; English, Joey D; Satti, Sudhakar R; Chen, Jennifer; Farid, Hamed; Borders, Candace; Veznedaroglu, Erol; Binning, Mandy J; Puri, Ajit; Vora, Nirav A; Budzik, Ron F; Dabus, Guilherme; Linfante, Italo; Janardhan, Vallabh; Alshekhlee, Amer; Abraham, Michael G; Edgell, Randall; Taqi, Muhammad Asif; Khoury, Ramy El; Mokin, Maxim; Majjhoo, Aniel Q; Kabbani, Mouhammed R; Froehler, Michael T; Finch, Ira; Ansari, Sameer A; Novakovic, Roberta; Nguyen, Thanh N

2018-06-01

Recent randomized clinical trials (RCTs) demonstrated the efficacy of mechanical thrombectomy using stent-retrievers in patients with acute ischemic stroke (AIS) with large vessel occlusions; however, it remains unclear if these results translate to a real-world setting. The TREVO Stent-Retriever Acute Stroke (TRACK) multicenter Registry aimed to evaluate the use of the Trevo device in everyday clinical practice. Twenty-three centers enrolled consecutive AIS patients treated from March 2013 through August 2015 with the Trevo device. The primary outcome was defined as achieving a Thrombolysis in Cerebral Infarction (TICI) score of ≥2b. Secondary outcomes included 90-day modified Rankin Scale (mRS), mortality, and symptomatic intracranial hemorrhage (sICH). A total of 634patients were included. Mean age was 66.1±14.8 years and mean baseline NIH Stroke Scale (NIHSS) score was 17.4±6.7; 86.7% had an anterior circulation occlusion. Mean time from symptom onset to puncture and time to revascularization were 363.1±264.5 min and 78.8±49.6 min, respectively. 80.3% achieved TICI ≥2b. 90-day mRS ≤2 was achieved in 47.9%, compared with 51.4% when restricting the analysis to the anterior circulation and within 6 hours (similar to recent AHA/ASA guidelines), and 54.3% for those who achieved complete revascularization. The 90-day mortality rate was 19.8%. Independent predictors of clinical outcome included age, baseline NIHSS, use of balloon guide catheter, revascularization, and sICH. The TRACK Registry results demonstrate the generalizability of the recent thrombectomy RCTs in real-world clinical practice. No differences in clinical and angiographic outcomes were shown between patients treated within the AHA/ASA guidelines and those treated outside the recommendations. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

In vitro characterizations of mesoporous hydroxyapatite as a controlled release delivery device for VEGF in orthopedic applications.

PubMed

Poh, Chye Khoon; Ng, Suxiu; Lim, Tee Yong; Tan, Hark Chuan; Loo, Joachim; Wang, Wilson

2012-11-01

Following bone implant surgery, prolonged ischemic conditions at the implant site often result in postsurgical complications like failure of osseointegration at the bone-implant interface which can lead to implant failure. Thus, restoration of the vascular supply is paramount to the proper development of the bone. High surface area mesostructured materials have been shown to be attractive candidates for bone regeneration to enhance cell adhesion and cell proliferation. This study uses hydroxyapatite, a naturally occurring mineral in the bone, fabricated to a range of suitable pore sizes, infused with vascular endothelial growth factor (VEGF), to be progressively released to stimulate revascularization. In this study, several characterizations including nitrogen adsorption analysis, Fourier-transformed infrared spectroscopy, X-ray diffraction, field emission scanning electron microscope, and transmission electron microscope were used to evaluate the synthesized mesoporous hydroxyapatite (MHA). The results showed that MHA can gradually release VEGF for enhancing revascularization, which is beneficial for orthopedic applications. Copyright © 2012 Wiley Periodicals, Inc.

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

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.

Outcomes of Thoracic Endovascular Aortic Repair and Subclavian Revascularization Techniques

PubMed Central

Zamor, Kimberly C; Eskandari, Mark K; Rodriguez, Heron E; Ho, Karen J; Morasch, Mark D; Hoel, Andrew W

2015-01-01

Background Practice guidelines regarding management of the left subclavian artery (LSA) during thoracic endovascular aortic repair (TEVAR) are based on low quality evidence and there is limited literature that addresses optimal revascularization techniques. The purpose of this study is to compare outcomes of LSA coverage during TEVAR and revascularization techniques. Study Design We performed a single-center retrospective cohort study from 2001–2013. Patients were categorized by LSA revascularization and by revascularization technique, carotid-subclavian bypass (CSB) or subclavian-carotid transposition (SCT). Thirty-day and mid-term stroke, spinal cord ischemia, vocal cord paralysis, upper extremity ischemia, primary patency of revascularization, and mortality were compared. Results Eighty patients underwent TEVAR with LSA coverage, 25% (n=20) were unrevascularized and the remaining patients underwent CSB (n=22, 27.5%) or SCT (n=38, 47.5%). Mean follow-up time was 24.9 months. Comparisons between unrevascularized and revascularized patients were significant for a higher rate of 30-day stroke (25% vs. 2%, p=0.003) and upper extremity ischemia (15% vs. 0%, p=0.014). However, there was no difference in 30-day or mid-term rates of spinal cord ischemia, vocal cord paralysis, or mortality. There were no statistically significant differences in 30-day or midterm outcomes for CSB vs. SCT. Primary patency of revascularizations was 100%. Survival analysis comparing unrevascularized vs. revascularized LSA, was statistically significant for freedom from stroke and upper extremity ischemia, p=0.02 and p=0.003, respectively. After adjustment for advanced age, urgency and coronary artery disease, LSA revascularization was associated with lower rates of peri-operative adverse events (OR 0.23, p=0.034). Conclusions During TEVAR, LSA coverage without revascularization is associated with an increased risk of stroke and upper extremity ischemia. When LSA coverage is required during TEVAR, CSB and SCT are equally acceptable options. PMID:25872688

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.

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.

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.

Evaluation of Sidestream Darkfield Microscopy for Real-Time Imaging Acellular Dermal Matrix Revascularization.

PubMed

DeGeorge, Brent R; Olenczak, J Bryce; Cottler, Patrick S; Drake, David B; Lin, Kant Y; Morgan, Raymond F; Campbell, Christopher A

2016-06-01

Acellular dermal matrices (ADMs) serve as a regenerative framework for host cell integration and collagen deposition to augment the soft tissue envelope in ADM-assisted breast reconstruction-a process dependent on vascular ingrowth. To date noninvasive intra-operative imaging techniques have been inadequate to evaluate the revascularization of ADM. We investigated the safety, feasibility, and efficacy of sidestream darkfield (SDF) microscopy to assess the status of ADM microvascular architecture in 8 patients at the time of tissue expander to permanent implant exchange during 2-stage ADM-assisted breast reconstruction. The SDF microscopy is a handheld device, which can be used intraoperatively for the real-time assessment of ADM blood flow, vessel density, vessel size, and branching pattern. The SDF microscopy was used to assess the microvascular architecture in the center and border zone of the ADM and to compare the native, non-ADM-associated capsule in each patient as a within-subject control. No incidences of periprosthetic infection, explantation, or adverse events were reported after SDF image acquisition. Native capsules demonstrate a complex, layered architecture with an average vessel area density of 14.9 mm/mm and total vessel length density of 12.3 mm/mm. In contrast to native periprosthetic capsules, ADM-associated capsules are not uniformly vascularized structures and demonstrate 2 zones of microvascular architecture. The ADM and native capsule border zone demonstrates palisading peripheral vascular arcades with continuous antegrade flow. The central zone of the ADM demonstrates punctate perforating vascular plexi with intermittent, sluggish flow, and intervening 2- to 3-cm watershed zones. Sidestream darkfield microscopy allows for real-time intraoperative assessment of ADM revascularization and serves as a potential methodology to compare revascularization parameters among commercially available ADMs. Thr SDF microscopy demonstrates that the periprosthetic capsule in ADM-assisted implant-based breast reconstruction is not a uniformly vascularized structure.

Adventitial Drug Delivery of Dexamethasone to Improve Primary Patency in the Treatment of Superficial Femoral and Popliteal Artery Disease: 12-Month Results From the DANCE Clinical Trial.

PubMed

Razavi, Mahmood K; Donohoe, Dennis; D'Agostino, Ralph B; Jaff, Michael R; Adams, George

2018-05-28

This study was designed to evaluate outcomes of adventitial dexamethasone delivery adjunctive to standard endovascular revascularization in femoropopliteal peripheral artery disease. Drug-coated balloons and drug-eluting stents improve patency of endovascular interventions with passive diffusion of antiproliferative drugs. Adventitial dexamethasone delivery targets the initial triggers of the inflammatory reaction to injury, thus potentially providing a potent antirestenotic strategy. The single-arm DANCE (Dexamethasone to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization) trial enrolled 262 subjects (283 limbs) with symptomatic peripheral artery disease (Rutherford category 2 to 4) receiving percutaneous transluminal angioplasty (PTA) (n = 124) or atherectomy (ATX) (n = 159) in femoropopliteal lesions ≤15 cm in length. A mixture of dexamethasone/contrast medium (80%/20%) was delivered to the adventitia and perivascular tissues surrounding target lesions in all subjects. Thirty-day assessments included major adverse limb events (MALE) and post-operative death. Twelve-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), Rutherford scoring, and walking impairment questionnaire. At 12 months, primary patency rates in DANCE-ATX and -PTA per-protocol populations were 78.4% (74.8% intent-to-treat [ITT]) and 75.5% (74.3% ITT), respectively. Rates of CD-TLR in DANCE-ATX and -PTA subjects were 10.0% (13.1% ITT) and 11.0% (13.7% ITT), respectively. There were no 30-day MALE + post-operative death events nor 12-month device- or drug-related deaths or MALE. Direct adventitial delivery of dexamethasone appears to be an effective and safe therapy to prevent restenosis. Randomized studies are needed to further test this possibility. (Dexamethasone to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization [DANCE]; NCT01983449). Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI).

PubMed

Moussa, Issam D; Klein, Lloyd W; Shah, Binita; Mehran, Roxana; Mack, Michael J; Brilakis, Emmanouil S; Reilly, John P; Zoghbi, Gilbert; Holper, Elizabeth; Stone, Gregg W

2013-10-22

Numerous definitions have been proposed for the diagnosis of myocardial infarction (MI) after coronary revascularization. The universal definition for MI designates post procedural biomarker thresholds for defining percutaneous coronary intervention (PCI)-related MI (type 4a) and coronary artery bypass grafting (CABG)-related MI (type 5), which are of uncertain prognostic importance. In addition, for both the MI types, cTn is recommended as the biomarker of choice, the prognostic significance of which is less well validated than CK-MB. Widespread adoption of a MI definition not clearly linked to subsequent adverse events such as mortality or heart failure may have serious consequences for the appropriate assessment of devices and therapies, may affect clinical care pathways, and may result in misinterpretation of physician competence. Rather than using an MI definition sensitive for small degrees of myonecrosis (the occurrence of which, based on contemporary large-scale studies, are unlikely to have important clinical consequences), it is instead recommended that a threshold level of biomarker elevation which has been strongly linked to subsequent adverse events in clinical studies be used to define a "clinically relevant MI." The present document introduces a new definition for "clinically relevant MI" after coronary revascularization (PCI or CABG), which is applicable for use in clinical trials, patient care, and quality outcomes assessment. Copyright © 2013. Published by Elsevier Inc.

Tight contact technique during side-to-side laser tissue soldering of rabbit aortas improves tensile strength.

PubMed

Alfieri, A; Bregy, A; Constantinescu, M; Stuker, F; Schaffner, T; Frenz, M; Banic, A; Reinert, M

2008-01-01

Cerebral revascularization may be indicated either for blood flow preservation or flow augmentation, often in clinical situations where neither endovascular nor standard surgical intervention can be performed. Cerebral revascularization can be performed by using a temporary occlusive or a non-occlusive technique. Both of these possibilities have their specific range of feasibility. Therefore non-occlusive revascularization techniques have been developed. To further reduce the risks for patients, less time consuming, sutureless techniques such as laser tissue soldering are currently being investigated. In the present study, a new technique for side-to-side anastomosis was developed. Using a "sandwich technique", two vessels are kept in close contact during the laser soldering. Thoraco-abdominal aortas from 24 different rabbits were analyzed for laser irradiation induced tensile strength. Two different irradiation modes (continuous and pulsed) were used. The results were compared to conventional, noncontact laser soldering. Histology was performed using HE, Mason's Trichrome staining. The achieved tensile strengths were significantly higher using the close contact "sandwich technique" as compared to the conventional adaptation technique. Furthermore, tensile strength was higher in the continuously irradiated specimen as compared to the specimen undergoing pulsed laser irradiation. The histology showed similar denaturation areas in both groups. The addition of a collagen membrane between vessel components reduced the tensile strength. These first results proved the importance of close and tight contact during the laser soldering procedure thus enabling the development of a "sandwich laser irradiation device" for in vivo application in the rabbit.

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.

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.

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

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.

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

A multicenter post-marketing evaluation of the Elixir DESolve® Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study.

PubMed

Nef, Holger; Wiebe, Jens; Boeder, Niklas; Dörr, Oliver; Bauer, Timm; Hauptmann, Karl-Eugen; Latib, Azeem; Colombo, Antonio; Fischer, Dieter; Rudolph, Tanja; Foin, Nicolas; Richardt, Gert; Hamm, Christian

2018-03-06

To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease. The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor. One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined. The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in % diameter stenosis from 61.00 ± 11.29 to 12.69 ± 0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths. Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed. © 2018 Wiley Periodicals, Inc.

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.

Beware of parotitis induced by iodine-containing contrast media.

PubMed

Kohat, A K; Jayantee, K; Phadke, R V; Muthu, R; Singh, V; Misra, U K

2014-01-01

Carotid stenting is being increasingly used for revascularization of the moderate to severe carotid stenosis and thus its complications are increasingly being recognized. We report a rare complication of induced by iodine contrast in a patient undergoing carotid stenting. s. A 51 year old man after the second stenting developed multiple small infarcts in spite of the distal device. He also had painful parotid swelling which improved within a week. One should be aware of iodine parotitis s in the patients undergoing iodinated contrast study.

German disease management guidelines: surgical therapies for chronic heart failure.

PubMed

Sindermann, J R; Klotz, S; Rahbar, K; Hoffmeier, A; Drees, G

2010-02-01

The German Disease Management Guideline "Chronic Heart Failure" intends to guide physicians working in the field of diagnosis and treatment of heart failure. The guideline provides a tool on the background of evidence based medicine. The following short review wants to give insights into the role of some surgical treatment options to improve heart failure, such as revascularization, ventricular reconstruction and aneurysmectomy, mitral valve reconstruction, ventricular assist devices and heart transplantation. (c) Georg Thieme Verlag KG Stuttgart-New York.

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.

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

First Pass Effect: A New Measure for Stroke Thrombectomy Devices.

PubMed

Zaidat, Osama O; Castonguay, Alicia C; Linfante, Italo; Gupta, Rishi; Martin, Coleman O; Holloway, William E; Mueller-Kronast, Nils; English, Joey D; Dabus, Guilherme; Malisch, Tim W; Marden, Franklin A; Bozorgchami, Hormozd; Xavier, Andrew; Rai, Ansaar T; Froehler, Michael T; Badruddin, Aamir; Nguyen, Thanh N; Taqi, M Asif; Abraham, Michael G; Yoo, Albert J; Janardhan, Vallabh; Shaltoni, Hashem; Novakovic, Roberta; Abou-Chebl, Alex; Chen, Peng R; Britz, Gavin W; Sun, Chung-Huan J; Bansal, Vibhav; Kaushal, Ritesh; Nanda, Ashish; Nogueira, Raul G

2018-03-01

In acute ischemic stroke, fast and complete recanalization of the occluded vessel is associated with improved outcomes. We describe a novel measure for newer generation devices: the first pass effect (FPE). FPE is defined as achieving a complete recanalization with a single thrombectomy device pass. The North American Solitaire Acute Stroke Registry database was used to identify a FPE subgroup. Their baseline features and clinical outcomes were compared with non-FPE patients. Clinical outcome measures included 90-days modified Rankin Scale score, National Institutes of Health Stroke Scale score, mortality, and symptomatic intracranial hemorrhage. Multivariate analyses were performed to determine whether FPE independently resulted in improved outcomes and to identify predictors of FPE. A total of 354 acute ischemic stroke patients underwent thrombectomy in the North American Solitaire Acute Stroke registry. FPE was achieved in 89 out of 354 (25.1%). More middle cerebral artery occlusions (64% versus 52.5%) and fewer internal carotid artery occlusions (10.1% versus 27.7%) were present in the FPE group. Balloon guide catheters were used more frequently with FPE (64.0% versus 34.7%). Median time to revascularization was significantly faster in the FPE group (median 34 versus 60 minutes; P =0.0003). FPE was an independent predictor of good clinical outcome (modified Rankin Scale score ≤2 was seen in 61.3% in FPE versus 35.3% in non-FPE cohort; P =0.013; odds ratio, 1.7; 95% confidence interval, 1.1-2.7). The independent predictors of achieving FPE were use of balloon guide catheters and non-internal carotid artery terminus occlusion. The achievement of complete revascularization from a single Solitaire thrombectomy device pass (FPE) is associated with significantly higher rates of good clinical outcome. The FPE is more frequently associated with the use of balloon guide catheters and less likely to be achieved with internal carotid artery terminus occlusion. © 2018 American Heart Association, Inc.

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.

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.

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.

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.

The potential cost-effectiveness of the Diamondback 360® Coronary Orbital Atherectomy System for treating de novo, severely calcified coronary lesions: an economic modeling approach

PubMed Central

Chambers, Jeffrey; Généreux, Philippe; Lee, Arthur; Lewin, Jack; Young, Christopher; Crittendon, Janna; Mann, Marita; Garrison, Louis P.

2015-01-01

Background: Patients who undergo percutaneous coronary intervention (PCI) for severely calcified coronary lesions have long been known to have worse clinical and economic outcomes than patients with no or mildly calcified lesions. We sought to assess the likely cost-effectiveness of using the Diamondback 360® Orbital Atherectomy System (OAS) in the treatment of de novo, severely calcified lesions from a health-system perspective. Methods and results: In the absence of a head-to-head trial and long-term follow up, cost-effectiveness was based on a modeled synthesis of clinical and economic data. A cost-effectiveness model was used to project the likely economic impact. To estimate the net cost impact, the cost of using the OAS technology in elderly (⩾ 65 years) Medicare patients with de novo severely calcified lesions was compared with cost offsets. Elderly OAS patients from the ORBIT II trial (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) [ClinicalTrials.gov identifier: NCT01092426] were indirectly compared with similar patients using observational data. For the index procedure, the comparison was with Medicare data, and for both revascularization and cardiac death in the following year, the comparison was with a pooled analysis of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI)/Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trials. After adjusting for differences in age, gender, and comorbidities, the ORBIT II mean index procedure costs were 17% (p < 0.001) lower, approximately US$2700. Estimated mean revascularization costs were lower by US$1240 in the base case. These cost offsets in the first year, on average, fully cover the cost of the device with an additional 1.2% cost savings. Even in the low-value scenario, the use of the OAS is cost-effective with a cost per life-year gained of US$11,895. Conclusions: Based on economic modeling, the recently approved coronary OAS device is projected to be highly cost-effective for patients who undergo PCI for severely calcified lesions. PMID:26702147

The potential cost-effectiveness of the Diamondback 360® Coronary Orbital Atherectomy System for treating de novo, severely calcified coronary lesions: an economic modeling approach.

PubMed

Chambers, Jeffrey; Généreux, Philippe; Lee, Arthur; Lewin, Jack; Young, Christopher; Crittendon, Janna; Mann, Marita; Garrison, Louis P

2016-04-01

Patients who undergo percutaneous coronary intervention (PCI) for severely calcified coronary lesions have long been known to have worse clinical and economic outcomes than patients with no or mildly calcified lesions. We sought to assess the likely cost-effectiveness of using the Diamondback 360(®) Orbital Atherectomy System (OAS) in the treatment of de novo, severely calcified lesions from a health-system perspective. In the absence of a head-to-head trial and long-term follow up, cost-effectiveness was based on a modeled synthesis of clinical and economic data. A cost-effectiveness model was used to project the likely economic impact. To estimate the net cost impact, the cost of using the OAS technology in elderly (⩾ 65 years) Medicare patients with de novo severely calcified lesions was compared with cost offsets. Elderly OAS patients from the ORBIT II trial (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) [ClinicalTrials.gov identifier: NCT01092426] were indirectly compared with similar patients using observational data. For the index procedure, the comparison was with Medicare data, and for both revascularization and cardiac death in the following year, the comparison was with a pooled analysis of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI)/Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trials. After adjusting for differences in age, gender, and comorbidities, the ORBIT II mean index procedure costs were 17% (p < 0.001) lower, approximately US$2700. Estimated mean revascularization costs were lower by US$1240 in the base case. These cost offsets in the first year, on average, fully cover the cost of the device with an additional 1.2% cost savings. Even in the low-value scenario, the use of the OAS is cost-effective with a cost per life-year gained of US$11,895. Based on economic modeling, the recently approved coronary OAS device is projected to be highly cost-effective for patients who undergo PCI for severely calcified lesions. © The Author(s), 2015.

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.

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.

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.

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.

[Revascularization of the carotid and vertebral arteries in the elderly].

PubMed

Illuminati, G; Bezzi, M; D'Urso, A; Giacobbi, D; Ceccanei, G; Vietri, F

2004-01-01

From January 1994 to July 2004, 323 patients underwent 348 revascularization of carotid bifurcation for atherosclerotic stenoses. Eighty eight patients (group A) were 75 year-old or older, whereas 235 (group B) were younger than 75 years. Postoperative mortality/neurologic morbidity rate was 1% in group A, and 1.4% in group B. At 5 years, patency and freedom from symptoms/stroke were, respectively, 91% and 92% in group A, and 89% and 91% in group B. None of these differences was statistically significant. In the same time period, 26 internal carotid arteries were revascularized in 24 patients, 75 or more aged, for a symptomatic kinking. Postoperative mortality/morbidity rate was absent, whereas, at 5 years, patency and freedom from symptoms/stroke were, respectively, 88% and 92%. Twelve vertebral arteries were revascularized in 12 patients, 75 or more aged, for invalidating symptoms of vertebrobasilar insufficiency. Postoperative mortality/neurologic morbidity rate was absent. In one case postoperative recurrence of symptoms occurred, despite a patent revascularization. Patency and freedom from symptoms/stroke were 84% and 75%, at 5 years. Revascularization of carotid and vertebral arteries in the elderly can be accomplished with good results, superposable to those of standard revascularization of carotid bifurcation in a younger patients' population.

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.

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

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

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.

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.

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 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.

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

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

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.

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.

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

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.

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

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.

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.

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.

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.

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.

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.

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.

Percutaneous assist devices in acute myocardial infarction with cardiogenic shock: Review, meta-analysis

PubMed Central

Romeo, Francesco; Acconcia, Maria Cristina; Sergi, Domenico; Romeo, Alessia; Francioni, Simona; Chiarotti, Flavia; Caretta, Quintilio

2016-01-01

AIM: To assess the impact of percutaneous cardiac support in cardiogenic shock (CS) complicating acute myocardial infarction (AMI), treated with percutaneous coronary intervention. METHODS: We selected all of the studies published from January 1st, 1997 to May 15st, 2015 that compared the following percutaneous mechanical support in patients with CS due to AMI undergoing myocardial revascularization: (1) intra-aortic balloon pump (IABP) vs Medical therapy; (2) percutaneous left ventricular assist devices (PLVADs) vs IABP; (3) complete extracorporeal life support with extracorporeal membrane oxygenation (ECMO) plus IABP vs IABP alone; and (4) ECMO plus IABP vs ECMO alone, in patients with AMI and CS undergoing myocardial revascularization. We evaluated the impact of the support devices on primary and secondary endpoints. Primary endpoint was the inhospital mortality due to any cause during the same hospital stay and secondary endpoint late mortality at 6-12 mo of follow-up. RESULTS: One thousand two hundred and seventy-two studies met the initial screening criteria. After detailed review, only 30 were selected. There were 6 eligible randomized controlled trials and 24 eligible observational studies totaling 15799 patients. We found that the inhospital mortality was: (1) significantly higher with IABP support vs medical therapy (RR = +15%, P = 0.0002); (2) was higher, although not significantly, with PLVADs compared to IABP (RR = +14%, P = 0.21); and (3) significantly lower in patients treated with ECMO plus IABP vs IABP (RR = -44%, P = 0.0008) or ECMO (RR = -20%, P = 0.006) alone. In addition, Trial Sequential Analysis showed that in the comparison of IABP vs medical therapy, the sample size was adequate to demonstrate a significant increase in risk due to IABP. CONCLUSION: Inhospital mortality was significantly higher with IABP vs medical therapy. PLVADs did not reduce early mortality. ECMO plus IABP significantly reduced inhospital mortality compared to IABP. PMID:26839661

Stent Thrombosis With Drug-Eluting Stents and Bioresorbable Scaffolds: Evidence From a Network Meta-Analysis of 147 Trials.

PubMed

Kang, Si-Hyuck; Chae, In-Ho; Park, Jin-Joo; Lee, Hak Seung; Kang, Do-Yoon; Hwang, Seung-Sik; Youn, Tae-Jin; Kim, Hyo-Soo

2016-06-27

This study sought to perform a systematic review and network meta-analysis to compare the relative safety and efficacy of contemporary DES and BVS. To improve outcomes of patients undergoing percutaneous coronary revascularization, there have been advances in the design of drug-eluting stents (DES), including the development of drug-eluting bioresorbable vascular scaffolds (BVS). Prospective, randomized, controlled trials comparing bare-metal stents (BMS), paclitaxel-eluting stents (PES), sirolimus-eluting stents (SES), Endeavor zotarolimus-eluting stents (E-ZES), cobalt-chromium (CoCr) everolimus-eluting stents (EES), platinum-chromium (PtCr)-EES, biodegradable polymer (BP)-EES, Resolute zotarolimus-eluting stents (R-ZES), BP biolimus-eluting stents (BP-BES), hybrid sirolimus-eluting stents (H [Orsiro]-SES), polymer-free sirolimus- and probucol-eluting stents, or BVS were searched in online databases. The primary endpoint was definite or probable stent thrombosis at 1 year. A total of 147 trials including 126,526 patients were analyzed in this study. All contemporary DES were superior to BMS and PES in terms of definite or probable stent thrombosis at 1 year. CoCr-EES, PtCr-EES, and H-SES were associated with significantly lower risk than BVS. CoCr-EES and H-SES were superior to SES and BP-BES. The risk of myocardial infarction was significantly lower with H-SES than with BVS. There were no significant differences regarding all-cause or cardiac mortality. Contemporary devices including BVS showed comparably low risks of repeat revascularization. Contemporary DES, including biocompatible DP-DES, BP-DES, and polymer-free DES, showed a low risk of definite or probable stent thrombosis at 1 year. BVS had an increased risk of device thrombosis compared with CoCr-EES, PtCr-EES, and H-SES. Data from extended follow-up are warranted to confirm the long-term safety of contemporary coronary devices. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Procedural and longer-term outcomes of wire- versus device-based antegrade dissection and re-entry techniques for the percutaneous revascularization of coronary chronic total occlusions.

PubMed

Azzalini, Lorenzo; Dautov, Rustem; Brilakis, Emmanouil S; Ojeda, Soledad; Benincasa, Susanna; Bellini, Barbara; Karatasakis, Aris; Chavarría, Jorge; Rangan, Bavana V; Pan, Manuel; Carlino, Mauro; Colombo, Antonio; Rinfret, Stéphane

2017-03-15

There are few data regarding the procedural and follow-up outcomes of different antegrade dissection/re-entry (ADR) techniques for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We compiled a multicenter registry of consecutive patients undergoing ADR-based CTO PCI at four high-volume specialized institutions. Patients were divided according to the specific ADR technique used: subintimal tracking and re-entry (STAR), limited antegrade subintimal tracking (LAST), or device-based with the CrossBoss/Stingray system (Boston Scientific, Marlborough, MA). Major adverse cardiac events (MACE: cardiac death, target-vessel myocardial infarction and target-vessel revascularization) on follow-up were the main outcome of this study. Independent predictors of MACE were sought with Cox regression analysis. A total of 223 patients were included (STAR n=39, LAST n=68, CrossBoss/Stingray n=116). Baseline characteristics were similar across groups. Technical and procedural success was lower with STAR (59% and 59%), as compared with LAST (96% and 96%) and CrossBoss/Stingray (89% and 87%; p<0.001 for both). At 24-month follow-up, MACE rates were higher in STAR (15.4%) and LAST (17.5%), as compared with device-based ADR with CrossBoss/Stingray (4.3%, p=0.02), driven by TVR (7.7% vs. 15.5% vs. 3.1%, respectively; p=0.02). Multivariable Cox regression analysis identified wire-based ADR (STAR and LAST) and total stent length as independent predictors of MACE. In this multicenter cohort of patients undergoing CTO PCI with ADR techniques, STAR had lower success rates, as compared with the CrossBoss/Stingray system and LAST. The CrossBoss/Stingray system was independently associated with lower risk of MACE on follow-up, as compared with wire-based ADR techniques. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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.

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.

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.

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.

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.

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

Airoldi, Flavio, E-mail: flavio.airoldi@multimedica.it; Faglia, Ezio, E-mail: ezio.faglia@multimedica.it; Losa, Sergio, E-mail: sergio.losa@multimedica.it

Subintimal angioplasty (SAP) is frequently performed for the treatment of critical limb ischemia (CLI) and has been recognized as an effective technique for these patients. Nevertheless, this approach is limited by the lack of controlled re-entry into the true lumen of the target vessel. We describe a novel device for true lumen re-entry after subintimal recanalization of superficial femoral arteries (SFA). We report our experience with six patients treated between April 2009 and January 2010 with a novel system designed to facilitate true lumen re-entry. The device was advanced by ipsilateral antegrade approach through a 6-French sheath. Successful reaccess intomore » the true lumen was obtained in five of six patients without complications. The patient in whom the reaccess to the true lumen was not possible underwent successful bypass surgery. At 30 days follow-up, the SFA was patent in all patients according to echo-Doppler examination. Our preliminary experience indicates that this novel re-entry device increases the success rate of percutaneous revascularization of chronically occluded SFA.« less

Navigation within the heart and vessels in clinical practice.

PubMed

Beyar, Rafael

2010-02-01

The field of interventional cardiology has developed at an unprecedented pace on account of the visual and imaging power provided by constantly improving biomedical technologies. Transcatheter-based technology is now routinely used for coronary revascularization and noncoronary interventions using balloon angioplasty, stents, and many other devices. In the early days of interventional practice, the operating physician had to manually navigate catheters and devices under fluoroscopic imaging and was exposed to radiation, with its comcomitant necessity for wearing heavy lead aprons for protection. Until recently, very little has changed in the way procedures have been carried out in the catheterization laboratory. The technological capacity to remotely manipulate devices, using robotic arms and computational tools, has been developed for surgery and other medical procedures. This has brought to practice the powerful combination of the abilities afforded by imaging, navigational tools, and remote control manipulation. This review covers recent developments in navigational tools for catheter positioning, electromagnetic mapping, magnetic resonance imaging (MRI)-based cardiac electrophysiological interventions, and navigation tools through coronary arteries.

[Value of the optical coherence tomography in the treatment guided of the stent failure. Case report].

PubMed

Macías, Enrico; Tellez, Alejandro; Ochoa, Jorge; Ortíz, José E

2014-01-01

Since the advent of bare metal and drug-eluting stents, the surgical revascularization have declined considerably, however the thrombosis and in-stent restenosis are important complications of these devices. There are several factors that predispose to thrombosis and in-stent restenosis. Conventional angiography has serious limitations to determine the causes of stent failure. Optical coherence tomography is a very sensitive technique to determine the cause of thrombosis and in-stent restenosis. Copyright © 2013 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

12-Month Results From the First-in-Human Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment.

PubMed

Steiner, Sabine; Willfort-Ehringer, Andrea; Sievert, Horst; Geist, Volker; Lichtenberg, Michael; Del Giudice, Costantino; Sauguet, Antoine; Diaz-Cartelle, Juan; Marx, Claudia; Ströbel, Armin; Schult, Ingolf; Scheinert, Dierk

2018-05-28

The authors sought to evaluate the performance of the Ranger paclitaxel-coated balloon versus uncoated balloon angioplasty for femoropopliteal lesions at 12 months. Drug-coated balloons (DCBs) are a promising endovascular treatment option for peripheral artery disease of the femoropopliteal segment, and each unique device requires dedicated clinical study. The prospective, randomized RANGER SFA (Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries) study (NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2 to 4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68 ± 8 years, n = 53 men) were enrolled in the Ranger DCB arm, and 34 patients (mean age 67 ± 9 years, n = 23 men) were assigned to the control group. Twelve-month analysis included patency, safety, and clinical outcomes and quality-of-life assessments. The DCB group had a greater primary patency rate at 12 months (Kaplan-Meier estimate 86.4% vs. 56.5%), with a significantly longer time to patency failure (log-rank p < 0.001). The estimated freedom from target lesion revascularization rate was 91.2% in the DCB group and 69.9% in the control group at 12 months, with a significantly longer time to reintervention (p = 0.010). No target limb amputations or device-related deaths occurred in either group. Twelve-month results show that patency was maintained longer after Ranger DCB treatment than after conventional balloon angioplasty, and this result was associated with a low revascularization rate and good clinical outcomes. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Safety and efficacy of the Aperio thrombectomy device when compared to the Solitaire AB/FR and the Revive devices in a pulsatile flow system.

PubMed

Saleh, Mahdi; Spence, John Nathan; Nayak, Sanjeev; Pearce, Gillian; Tennuci, Christopher; Roffe, Christine

2012-01-01

There are a limited number of studies comparing the Aperio mechanical thrombectomy device to other stent-based devices. In this paper, we compared the Aperio thrombectomy device to the Solitaire AB, FR and Revive devices in a model of the middle cerebral artery (MCA) within a modified pulsatile flow system. Thrombi made of lamb's blood were placed into a pulsatile flow system perfused with Hartmann's solution at 80 bpm with a mean pressure of 90 mm Hg. 30 experiments were run with each device. Recanalization rates were similar for all three devices (90% with the Solitaire AB, FR, 80% with the Revive, and 90% with the Aperio). The mean number of attempts to retrieve the thrombus was also similar for all three devices (1.7 with the Solitaire AB, FR, 2.1 with the Revive, 1.6 with the Aperio). Clot fragmentation and embolization rates revealed no statistical significance but there was a trend towards lower embolization rates with the Aperio (23% compared to 40% with the Solitaire AB, FR and 47% with the Revive). The Aperio was the fastest to recanalize the MCA (mean of 66 seconds compared to 186 seconds for the Solitaire AB, FR and 169 seconds for the Revive). In this in vitro setting, the Aperio device seems to be an efficacious and safe device when compared to other similar clinically used mechanical thrombectomy devices. Larger clinical trials are warranted.

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.

77 FR 35747 - Highway Safety Programs; Conforming Products List of Evidential Breath Alcohol Measurement Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-14

...-0061] Highway Safety Programs; Conforming Products List of Evidential Breath Alcohol Measurement... Evidential Breath Alcohol Measurement Devices dated, September 17, 1993 (58 FR 48705). DATES: Effective Date... Safety Administration (NHTSA) published the Standards for Devices to Measure Breath Alcohol (38 FR 30459...

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.

Standardized definitions and clinical endpoints in carotid artery and supra-aortic trunk revascularization trials.

PubMed

Nedeltchev, Krassen; Pattynama, Peter M; Biaminoo, Giancarlo; Diehm, Nicolas; Jaff, Michael R; Hopkins, L Nelson; Ramee, Stephen; van Sambeek, Marc; Talen, Aly; Vermassen, Frank; Cremonesi, Alberto

2010-09-01

Endovascular therapy has emerged as a promising alternative to open surgery for stroke prevention in patients with obstructive disease of the supra-aortic arteries. Although most previous studies have used similar safety and efficacy endpoints, differences in definitions, timing of assessments, and standards of reporting have hampered direct comparisons across various trials. The DEFINE group, an informal collaboration of multidisciplinary physicians, involved in the therapy of patients with obstructive disease of the supra-aortic arteries in Europe and the United States reviewed the current literature and, after extensive correspondence and meetings, proposed the definitions outlined in the present manuscript. Three meetings including all authors of the manuscript, along with representatives of the United States Food and Drug Administration (FDA) and commercial device manufacturers were held in Barcelona, Spain, in May 2008, in Munich, Germany, in July 2008, and in New York in November 2008. The proposed definitions encompass baseline clinical and anatomic characteristics, clinical and radiologic outcomes, complications, standards of reporting, and timing of assessment. Considering the broad consensus between the multidisciplinary scientific members and the regulatory authorities, the proposed definitions are expected to find adoption in future clinical investigations. These definitions can be applied to both endovascular and open surgery trials and will allow reliable comparisons between these two revascularization methods.

Feasibility, safety, and changes in systolic blood pressure associated with endovascular revascularization of symptomatic and chronically occluded cervical internal carotid artery using a newly suggested radiographic classification of chronically occluded cervical internal carotid artery: pilot study.

PubMed

Hasan, David; Zanaty, Mario; Starke, Robert M; Atallah, Elias; Chalouhi, Nohra; Jabbour, Pascal; Singla, Amit; Guerrero, Waldo R; Nakagawa, Daichi; Samaniego, Edgar A; Mbabuike, Nnenna; Tawk, Rabih G; Siddiqui, Adnan H; Levy, Elad I; Novakovic, Roberta L; White, Jonathan; Schirmer, Clemens M; Brott, Thomas G; Shallwani, Hussain; Hopkins, L Nelson

2018-05-18

OBJECTIVE The overall risk of ischemic stroke from a chronically occluded internal carotid artery (COICA) is around 5%-7% per year despite receiving the best available medical therapy. Here, authors propose a radiographic classification of COICA that can be used as a guide to determine the technical success and safety of endovascular recanalization for symptomatic COICA and to assess the changes in systemic blood pressure following successful revascularization. METHODS The radiographic images of 100 consecutive subjects with COICA were analyzed. A new classification of COICA was proposed based on the morphology, location of occlusion, and presence or absence of reconstitution of the distal ICA. The classification was used to predict successful revascularization in 32 symptomatic COICAs in 31 patients, five of whom were female (5/31 [16.13%]). Patients were included in the study if they had a COICA with ischemic symptoms refractory to medical therapy. Carotid artery occlusion was defined as 100% cross-sectional occlusion of the vessel lumen as documented on CTA or MRA and confirmed by digital subtraction angiography. RESULTS Four types (A-D) of radiographic COICA were identified. Types A and B were more amenable to safe revascularization than types C and D. Recanalization was successful at a rate of 68.75% (22/32 COICAs; type A: 8/8; type B: 8/8; type C: 4/8; type D: 2/8). The perioperative complication rate was 18.75% (6/32; type A: 0/8 [0%]; type B: 1/8 [12.50%]; type C: 3/8 [37.50%], type D: 2/8 [25.00%]). None of these complications led to permanent morbidity or death. Twenty (64.52%) of 31 subjects had improvement in their symptoms at the 2-6 months' follow-up. A statistically significant decrease in systolic blood pressure (SBP) was noted in 17/21 (80.95%) patients who had successful revascularization, which persisted on follow-up (p = 0.0001). The remaining 10 subjects in whom revascularization failed had no significant changes in SBP (p = 0.73). CONCLUSIONS The pilot study suggested that our proposed classification of COICA may be useful as an adjunctive guide to determine the technical feasibility and safety of revascularization for symptomatic COICA using endovascular techniques. Additionally, successful revascularization may lead to a significant decrease in SBP postprocedure. A Phase 2b trial in larger cohorts to assess the efficacy of endovascular revascularization using our COICA classification is warranted.

Safety and efficacy of the Aperio thrombectomy device when compared to the Solitaire AB/FR and the Revive devices in a pulsatile flow system

PubMed Central

Saleh, Mahdi; Spence, John Nathan; Nayak, Sanjeev; Pearce, Gillian; Tennuci, Christopher; Roffe, Christine

2012-01-01

Background and Purpose: There are a limited number of studies comparing the Aperio mechanical thrombectomy device to other stent-based devices. In this paper, we compared the Aperio thrombectomy device to the Solitaire AB, FR and Revive devices in a model of the middle cerebral artery (MCA) within a modified pulsatile flow system. Methods: Thrombi made of lamb’s blood were placed into a pulsatile flow system perfused with Hartmann’s solution at 80 bpm with a mean pressure of 90 mm Hg. 30 experiments were run with each device. Results: Recanalization rates were similar for all three devices (90% with the Solitaire AB, FR, 80% with the Revive, and 90% with the Aperio). The mean number of attempts to retrieve the thrombus was also similar for all three devices (1.7 with the Solitaire AB, FR, 2.1 with the Revive, 1.6 with the Aperio). Clot fragmentation and embolization rates revealed no statistical significance but there was a trend towards lower embolization rates with the Aperio (23% compared to 40% with the Solitaire AB, FR and 47% with the Revive). The Aperio was the fastest to recanalize the MCA (mean of 66 seconds compared to 186 seconds for the Solitaire AB, FR and 169 seconds for the Revive). Conclusions: In this in vitro setting, the Aperio device seems to be an efficacious and safe device when compared to other similar clinically used mechanical thrombectomy devices. Larger clinical trials are warranted. PMID:23173104

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.

Pulp Revascularization on Permanent Teeth with Open Apices in a Middle-aged Patient.

PubMed

Wang, Yu; Zhu, Xiaofei; Zhang, Chengfei

2015-09-01

Pulp revascularization is a promising procedure for the treatment of adolescents' immature permanent teeth with necrotic pulp and/or apical periodontitis. However, the ability to successfully perform pulp revascularization in a middle-aged patient remains unclear. A 39-year-old woman was referred for treatment of teeth #20 and #29 with necrotic pulp, extensive periapical radiolucencies, and incomplete apices. Pulp revascularization procedures were attempted, including root canal debridement, triple antibiotic paste medication, and platelet-rich plasma transplantation to act as a scaffold. Periapical radiographic and cone-beam computed tomographic examinations were used to review the changes in the apical lesions and root apex configuration. The patient remained asymptomatic throughout the 30-month follow-up. Periapical radiographic examination revealed no change in the apical lesions of either tooth at 8 months. The periapical radiolucency disappeared on tooth #20 and significantly decreased on tooth #29 by the 30-month follow-up, findings that were also confirmed by cone-beam computed tomographic imaging. No evidence of root lengthening or thickening was observed. Successful revascularization was achieved in a middle-aged patient's teeth. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Whole blood gene expression testing for coronary artery disease in nondiabetic patients: major adverse cardiovascular events and interventions in the PREDICT trial.

PubMed

Rosenberg, Steven; Elashoff, Michael R; Lieu, Hsiao D; Brown, Bradley O; Kraus, William E; Schwartz, Robert S; Voros, Szilard; Ellis, Stephen G; Waksman, Ron; McPherson, John A; Lansky, Alexandra J; Topol, Eric J

2012-06-01

The majority of first-time angiography patients are without obstructive coronary artery disease (CAD). A blood gene expression score (GES) for obstructive CAD likelihood was validated in the PREDICT study, but its relation to major adverse cardiovascular events (MACE) and revascularization was not assessed. Patients (N = 1,160) were followed up for MACE and revascularization 1 year post-index angiography and GES, with 1,116 completing follow-up. The 30-day event rate was 23% and a further 2.2% at 12 months. The GES was associated with MACE/revascularizations (p < 0.001) and added to clinical risk scores. Patients with GES >15 trended towards increased >30 days MACE/revascularization likelihood (odds ratio = 2.59, 95% confidence interval = 0.89-9.14, p = 0.082). MACE incidence overall was 1.5% (17 of 1,116) and 3 of 17 patients had GES ≤ 15. For the total low GES group (N = 396), negative predictive value was 90% for MACE/revascularization and >99% for MACE alone, identifying a group of patients without obstructive CAD and highly unlikely to suffer MACE within 12 months.

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.

Current indications for left thoracotomy in coronary revascularization and valvular procedures.

PubMed

Pratt, J W; Williams, T E; Michler, R E; Brown, D A

2000-10-01

Left thoracotomy is infrequently used for cardiac procedures, but its application in reoperative and minimally invasive coronary revascularization and in valvular procedures has been reported recently. Three case reports and a review of the current literature illustrate the unique benefits of this approach for myocardial revascularization and valve replacement. Reoperative coronary revascularization of the left anterior descending and circumflex coronary arteries was performed off-pump via a left posterolateral thoracotomy. For the second case, this approach was used for coronary artery bypass grafting of the right coronary and left anterior descending arteries with femoral-femoral cardiopulmonary bypass in a patient with congestive heart failure and coronary artery disease who also required closure of a patent ductus arteriosus. In the third case, mitral valve replacement using femoral venous and aortic cannulation for cardiopulmonary bypass was performed via a left thoracotomy to avoid a retrosternal gastric conduit in a patient with severe mitral stenosis and congestive heart failure. All patients returned to normal activity and are asymptomatic. These case reports and a comprehensive review of the literature demonstrate the utility of left thoracotomy as an alternative approach to standard median sternotomy in selected cases of revascularization and valvular procedures.

Design Principles of Bioresorbable Polymeric Scaffolds.

PubMed

Kossuth, Mary Beth; Perkins, Laura E L; Rapoza, Richard J

2016-07-01

The concept for a bioresorbable vascular scaffold combines the best features of the first 3 generations of percutaneous coronary intervention (namely), balloon angioplasty, bare metallic stents, and drug-eluting stents, into a single device. The principles of operation of a BRS follow 3 phases of functionality that reflect the different physiologic requirements over time; revascularization, restoration, and resorption. Most BRS designs make use of the continuum of hydrolytic degradation in aliphatic polyesters, such as poly(l-lactide), in which molecular weight, strength, and mass decrease progressively in 3 distinct stages, consistent with the in vivo requirements of each performance phase. Copyright © 2016 Elsevier Inc. All rights reserved.

Review of the treatment of acute coronary syndrome in elderly patients.

PubMed

Jokhadar, Maan; Wenger, Nanette K

2009-01-01

Advances in treatment and early revascularization have led to improved outcomes for patients with acute coronary syndrome (ACS). However, elderly ACS patients are less likely to receive evidence-based treatment, including revascularization therapy, due to uncertainty of the associated benefits and risks in this population. This article addresses key issues regarding medical and revascularization therapy in elderly ACS patients based on a review of the medical literature and in concordance with clinical practice guidelines from the American Heart Association (AHA) and the American College of Cardiology (ACC).

[Gender perspective can result in better research on sex differences and revascularization].

PubMed

Löfmark, U; Hammarström, A

2001-07-25

This article focuses on how sex differences in revascularization, PTCA and CABG, are discussed in medical research. We selected and analyzed 10 articles identified through Medline, for the purpose of studying such discussions. Three explanatory models were identified by qualitative analysis: biological, psychosocial and discriminatory. Although the articles focused on sex differences in revascularization, the discussions in the articles on this issue were sparse. We demonstrate how a gender perspective can generate new questions and theories and contribute to a better prognosis for women and men with heart disease.

Early endovascular treatment of superior mesenteric occlusion secondary to thromboemboli.

PubMed

Jia, Z; Jiang, G; Tian, F; Zhao, J; Li, S; Wang, K; Wang, Y; Jiang, L; Wang, W

2014-02-01

To evaluate our early experience with endovascular revascularization in patients with acute thromboembolic occlusion of the superior mesenteric artery (SMA). A retrospective review was conducted of all patients who underwent endovascular revascularization for acute thromboembolic SMA occlusion from May 2005 to May 2012. Endovascular revascularization was performed using aspiration, intra-arterial thrombolysis, and adjunctive stent-placement techniques. Laparotomy was performed if the patient developed clinical signs of advanced bowel ischemia after endovascular procedure. Twenty-one patients underwent endovascular revascularization for acute thromboembolic SMA occlusion. All presented with acute-onset abdominal pain. Three patients had rebound tenderness before the procedure. Computed tomography angiography revealed complete occlusion in seven cases and incomplete occlusion in 14 cases, with no evidence of free gas or bowel necrosis. The median duration from onset of symptoms to revascularization was 8.7 ± 4.1 hours (range, 2-18 hours). Completely successful endovascular revascularization occurred in six cases (aspiration alone, 3 cases; combined aspiration and urokinase, 3 cases); partial success was achieved in 15 cases (aspiration alone, 4 cases; combined aspiration and urokinase, 10 cases; and combined aspiration, urokinase, and stent placement, 1 case). Laparotomy was required in five patients, all of whom had SMA main trunk complete occlusion and required small bowel resection. The 30-day mortality for all patients was 9.5%. During a median follow-up of 26 months, 15 patients remained asymptomatic, three patients reported occasional abdominal pain, and one patient had temporary short-bowel syndrome. Percutaneous revascularization is a promising alternative to surgery for acute SMA occlusion in selected patients who have no signs of advanced bowel ischemia. Early diagnosis followed by prompt endovascular intervention with close postprocedural monitoring is key. Laparotomy is indicated in patients who develop new or worsening signs of peritonism after endovascular procedure, particularly in those who had complete occlusion of the main trunk of the SMA. Copyright © 2013 European Society for Vascular Surgery. All rights reserved.

Incidence and outcome of surgical procedures after coronary artery bypass grafting compared with those after percutaneous coronary intervention: a report from the Coronary Revascularization Demonstrating Outcome Study in Kyoto PCI/CABG Registry Cohort-2.

PubMed

Tokushige, Akihiro; Shiomi, Hiroki; Morimoto, Takeshi; Ono, Koh; Furukawa, Yutaka; Nakagawa, Yoshihisa; Kadota, Kazushige; Ando, Kenji; Shizuta, Satoshi; Tada, Tomohisa; Tazaki, Junichi; Kato, Yoshihiro; Hayano, Mamoru; Abe, Mitsuru; Hamasaki, Shuichi; Ohishi, Mitsuru; Nakashima, Hitoshi; Mitsudo, Kazuaki; Nobuyoshi, Masakiyo; Kita, Toru; Imoto, Yutaka; Sakata, Ryuzo; Okabayashi, Hitoshi; Hanyu, Michiya; Shimamoto, Mitsuomi; Nishiwaki, Noboru; Komiya, Tatsuhiko; Kimura, Takeshi

2014-08-01

Noncardiac surgery after percutaneous coronary intervention (PCI) has been reported to be carrying high risk for both ischemic and bleeding complications. However, there has been no report comparing the incidence and outcomes of surgical procedures after coronary artery bypass grafting (CABG) with those after PCI. Among 14 383 patients undergoing first coronary revascularization (PCI, n=12 207; CABG, n=2176) enrolled in the Coronary Revascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) PCI/CABG Registry Cohort-2, surgical procedures were performed more frequently after CABG (n=560) than after PCI (n=2398; cumulative 3-year incidence: 27% versus 22%; unadjusted P<0.0001), particularly <6 months of coronary revascularization. The risk for the primary ischemic outcome measure (death/myocardial infarction) at 30-day postsurgical procedures was not significantly different between the CABG and PCI groups (cumulative incidence: 3.1% versus 3.2%; unadjusted P=0.9; adjusted hazard ratio, 0.97; 95% confidence interval, 0.47-1.89; P=0.9). The risk for the primary bleeding outcome measure (moderate or severe bleeding by Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries classification) was lower in the CABG groups than in the PCI group (cumulative incidence: 1.3% versus 2.6%; unadjusted P=0.07; adjusted hazard ratio, 0.36; 95% confidence interval, 0.12-0.87; P=0.02). There were no interactions between the timing of surgery and the types of coronary revascularization (CABG/PCI) for both ischemic and bleeding outcomes. Surgical procedures were performed significantly more frequently after CABG than after PCI, particularly <6 months after coronary revascularization. Surgical procedures after CABG as compared with those after PCI were associated with similar risk for ischemic events and lower risk for bleeding events, regardless of the timing after coronary revascularization. © 2014 American Heart Association, Inc.

Implementation of a cardiac PET stress program: comparison of outcomes to the preceding SPECT era.

PubMed

Knight, Stacey; Min, David B; Le, Viet T; Meredith, Kent G; Dhar, Ritesh; Biswas, Santanu; Jensen, Kurt R; Mason, Steven M; Ethington, Jon-David; Lappe, Donald L; Muhlestein, Joseph B; Anderson, Jeffrey L; Knowlton, Kirk U

2018-05-03

Cardiac positron emission testing (PET) is more accurate than single photon emission computed tomography (SPECT) at identifying coronary artery disease (CAD); however, the 2 modalities have not been thoroughly compared in a real-world setting. We conducted a retrospective analysis of 60-day catheterization outcomes and 1-year major adverse cardiovascular events (MACE) after the transition from a SPECT- to a PET-based myocardial perfusion imaging (MPI) program. MPI patients at Intermountain Medical Center from January 2011-December 2012 (the SPECT era, n = 6,777) and January 2014-December 2015 (the PET era, n = 7,817) were studied. Outcomes studied were 60-day coronary angiography, high-grade obstructive CAD, left main/severe 3-vessel disease, revascularization, and 1-year MACE-revascularization (MACE-revasc; death, myocardial infarction [MI], or revascularization >60 days). Patients were 64 ± 13 years old; 54% were male and 90% were of European descent; and 57% represented a screening population (no prior MI, revascularization, or CAD). During the PET era, compared with the SPECT era, a higher percentage of patients underwent coronary angiography (13.2% vs. 9.7%, P < 0.0001), had high-grade obstructive CAD (10.5% vs. 6.9%, P < 0.0001), had left main or severe 3-vessel disease (3.0% vs. 2.3%, P = 0.012), and had coronary revascularization (56.7% vs. 47.1%, P = 0.0001). Similar catheterization outcomes were seen when restricted to the screening population. There was no difference in 1-year MACE-revasc (PET [5.8%] vs. SPECT [5.3%], P = 0.31). The PET-based MPI program resulted in improved identification of patients with high-grade obstructive CAD, as well as a larger percentage of revascularization, thus resulting in fewer patients undergoing coronary angiography without revascularization. This observational study was funded using internal departmental funds.

The role of endothelial cells on islet function and revascularization after islet transplantation.

PubMed

Del Toro-Arreola, Alicia; Robles-Murillo, Ana Karina; Daneri-Navarro, Adrian; Rivas-Carrillo, Jorge David

2016-01-02

Islet transplantation has become a widely accepted therapeutic option for selected patients with type 1 diabetes mellitus. However, in order to achieve insulin independence a great number of islets are often pooled from 2 to 4 pancreata donors. Mostly, it is due to the massive loss of islets immediately after transplant. The endothelium plays a key role in the function of native islets and during the revascularization process after islet transplantation. However, if a delayed revascularization occurs, even the remaining islets will also undergo to cell death and late graft dysfunction. Therefore, it is essential to understand how the signals are released from endothelial cells, which might regulate both differentiation of pancreatic progenitors and thereby maintenance of the graft function. New strategies to facilitate islet engraftment and a prompt revascularization could be designed to intervene and might lead to improve future results of islet transplantation.

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.

[Immediate and remote results of endovascular treatment of patients with postinfarction cardiosclerosis].

PubMed

Patrikeev, A V; Rudman, V Ia; Maksimkin, D A; Baranovich, V Iu; Faĭbushevich, A G; Veretnik, G I; Mambetov, A V; Shugushev, Z Kh

2015-01-01

Two approaches in treatment of 131 patients with postinfarction cardiosclerosis are compared in the work. Tactics of "total" myocardial revascularization means restoration of coronary blood flow in all arteries with hemodynamically significant lesion while "selective" revascularization provides restoration of coronary blood flow only in those arteries which have a viable myocardium in their pool. It was concluded that restoration of coronary blood flow in patients after myocardial infarction permits to prevent postinfarction heart remodeling, development of heart failure thereby affecting on the prognosis. Evaluation of myocardial viability in the area of suggested surgery increases efficiency of revascularization, reduces number of implantable stents and decreases frequency of unfounded coronary interventions. Elimination of ischemia in the area of hibernation provides a rapid restoration of myocardial contractility in most of left ventricle segments with initially impaired kinetics. It was revealed that terms of contractility restoration of hibernating myocardium depend on duration of hibernation period up to revascularization.

One Year Clinical Outcomes of Renal Artery Stenting: The Results of ODORI Registry

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

Sapoval, M., E-mail: marc.sapoval2@egp.aphp.f; Tamari, I.; Goffette, P.

2010-06-15

The safety, efficacy and long term clinical benefits of renal artery revascularization by stenting are still a matter of debate. The aim of our study was to define the safety and efficacy of renal artery stenting with the Tsunami peripheral stent (Terumo Corporation, Tokyo, Japan). The ODORI was a prospective, multicentre registry which enrolled 251 consecutive patients, (276 renal arteries) in 36 centres across Europe. The primary endpoint was acute procedural success defined as <30% residual stenosis after stent placement. Secondary endpoints included major adverse events, blood pressure control, serum creatinine level, and target lesion revascularization (TLR) at 6 andmore » 12 months. Patients were 70 {+-} 10 years old, 59% were male, 33% had diabetes, and 96% hypertension. The main indications for renal stent implantation were hypertension in 83% and renal salvage in 39%. Direct stent implantation was performed in 76% of the cases. Acute success rate was 100% with residual stenosis of 2.5 {+-} 5.4%. Systolic/diastolic blood pressure decreased from a mean of 171/89 at baseline to 142/78 mmHg at 6 months (p < 0.0001 vs. baseline), and 141/80 mmHg at 12 months (p < 0.0001 vs. baseline). Mean serum creatinine concentration did not change significantly in the total population. However, there was significant improvement in the highest tercile (from 283 {mu}mol/l at baseline to 205 and 209 {mu}mol/l at 6 and 12 months respectively). At 12-months, rates of restenosis and TLR were 6.6 and 0.8% respectively. The 12 month cumulative rate of all major clinical adverse events was 6.4% while the rate of device or procedure related events was 2.4%. In hypertensive patients with atherosclerotic renal artery stenosis Tsunami peripheral balloon-expandable stent provides a safe revascularization strategy, with a potential beneficial impact on hypertension control and renal function in the highest risk patients.« less

Financial impact of coronary stenting in emergency for acute coronary syndromes.

PubMed

Nidegger, Delphine; Metz, Damien; Vacter, Christophe; Tassan-Mangina, Sophie; Deschildre, Alain; Gawron, Michel; Bourgeois, Jacqueline

2009-05-01

Since the prospective payment system, health institutions have only specific payments for the emergency care in the emergency room. The direct urgent admissions in coronary care units for acute coronary syndrome (ACS) do not collect this complementary refund. For the patient's stay, hospital is remunerated with fixed national prices which are similar even in case of emergent or planed coronary revascularization when realized. To analyze and compare the financial impact between emergent and planed coronary stenting in the setting of ACS. This retrospective study was based on patients suffering from ACS who experienced emergent coronary stenting during the year 2005. On 154 patients, 127 were age-, sex- and diagnosis-related group (called "groupe homogène de malades" in the French Health Care system)-matched with 127 suffering from same ACS but with planed "ad hoc" coronary stenting. The overall charges (medical and paramedical team, pharmacy, biology, implantable coronary devices, radiology) were compared between the two groups. Mean stay duration was 6.7 days and did not differ between the two groups. Mean financial retributions were significantly higher in the emergent group (7338 euro [6831-7846] IC95 vs 6509 euro [5994-7023]; p=0,02) but with a much more raised consumption (6810 euro [6283-7336] vs 5223 euro [4632-5814]; p=0,001). This overcost was due especially to drugs and biological expenses. The hospitalization payments did not cover the overall expenses for 25% of the patients' stays (N=64) among whom 39 have had emergent coronary stenting (30.7%, p=0.04). Among the different GHM, the most important difference was observed in non-STEMI without complication with a negative receipts/costs ratio for 37.8% of the stay with coronary stenting in emergency. The application of the recent guidelines for coronary revascularization in the management of ACS represents a financial venture for hospital institutions. The engaged charges for emergent coronary stenting are covered with difficulties contrary to planed revascularization.

Clinical presentation and outcomes of coronary in-stent restenosis across 3-stent generations.

PubMed

Magalhaes, Marco A; Minha, Sa'ar; Chen, Fang; Torguson, Rebecca; Omar, Al Fazir; Loh, Joshua P; Escarcega, Ricardo O; Lipinski, Michael J; Baker, Nevin C; Kitabata, Hironori; Ota, Hideaki; Suddath, William O; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

2014-12-01

Clinical presentation of bare metal stent in-stent restenosis (ISR) in patients undergoing target lesion revascularization is well characterized and negatively affects on outcomes, whereas the presentation and outcomes of first- and second-generation drug-eluting stents (DESs) remains under-reported. The study included 909 patients (1077 ISR lesions) distributed as follows: bare metal stent (n=388), first-generation DES (n=425), and second-generation DES (n=96), categorized into acute coronary syndrome (ACS) or non-ACS presentation mode at the time of first target lesion revascularization. ACS was further classified as myocardial infarction (MI) and unstable angina. For bare metal stent, first-generation DES and second-generation DES, ACS was the clinical presentation in 67.8%, 71.0%, and 66.7% of patients, respectively (P=0.470), whereas MI occurred in 10.6%, 10.1%, and 5.2% of patients, respectively (P=0.273). The correlates for MI as ISR presentation were current smokers (odds ratio, 3.02; 95% confidence interval [CI], 1.78-5.13; P<0.001), and chronic renal failure (odds ratio, 2.73; 95% CI, 1.60-4.70; P<0.001), with a protective trend for the second-generation DES ISR (odds ratio, 0.35; 95% CI, 0.12-1.03; P=0.060). ACS presentations had an independent effect on major adverse cardiac events (death, MI, and re-target lesion revascularization) at 6 months (MI versus non-ACS: adjusted hazard ratio, 4.06; 95% CI, 1.84-8.94; P<0.001; unstable angina versus non-ACS: adjusted hazard ratio, 1.98; 95% CI, 1.01-3.87; P=0.046). ISR clinical presentation is similar irrespective of stent type. MI as ISR presentation seems to be associated with patient and not device-related factors. ACS as ISR presentation has an independent effect on major adverse cardiac events, suggesting that ISR remains a hazard and should be minimized. © 2014 American Heart Association, Inc.

Outcomes of percutaneous coronary intervention in intermediate coronary artery disease: fractional flow reserve-guided versus intravascular ultrasound-guided.

PubMed

Nam, Chang-Wook; Yoon, Hyuck-Jun; Cho, Yun-Kyeong; Park, Hyoung-Seob; Kim, Hyungseop; Hur, Seung-Ho; Kim, Yoon-Nyun; Chung, In-Sung; Koo, Bon-Kwon; Tahk, Seung-Jae; Fearon, William F; Kim, Kwon-Bae

2010-08-01

This study sought to evaluate the long-term clinical outcomes of a fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) strategy compared with intravascular ultrasound (IVUS)-guided PCI for intermediate coronary lesions. Both FFR- and IVUS-guided PCI strategies have been reported to be safe and effective in intermediate coronary lesions. The study included 167 consecutive patients, with intermediate coronary lesions evaluated by FFR or IVUS (FFR-guided, 83 lesions vs. IVUS-guided, 94 lesions). Cutoff value of FFR in FFR-guided PCI was 0.80, whereas that for minimal lumen cross sectional area in IVUS-guided PCI was 4.0 mm(2). The primary outcome was defined as a composite of major adverse cardiac events including death, myocardial infarction, and ischemia-driven target vessel revascularization at 1 year after the index procedure. Baseline percent diameter stenosis and lesion length were similar in both groups (51 +/- 8% and 24 +/- 12 mm in the FFR group vs. 52 +/- 8% and 24 +/- 13 mm in the IVUS group, respectively). However, the IVUS-guided group underwent revascularization therapy significantly more often (91.5% vs. 33.7%, p < 0.001). No significant difference was found in major adverse cardiac event rates between the 2 groups (3.6% in FFR-guided PCI vs. 3.2% in IVUS-guided PCI). Independent predictors for performing intervention were guiding device: FFR versus IVUS (relative risk [RR]: 0.02); left anterior descending coronary artery versus non-left anterior descending coronary artery disease (RR: 5.60); and multi- versus single-vessel disease (RR: 3.28). Both FFR- and IVUS-guided PCI strategy for intermediate coronary artery disease were associated with favorable outcomes. The FFR-guided PCI reduces the need for revascularization of many of these lesions. Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Evaluation of the 4-French Pulsar-18 Self-expanding Nitinol Stent in Long Femoropopliteal Lesions.

PubMed

Lichtenberg, Michael; Hailer, Birgit; Kaeunicke, Matthias; Stahlhoff, Wilhelm-Friedrich; Boese, Dirk; Breuckmann, Frank

2014-01-01

To evaluate the patency and the freedom of target lesion revascularization of the 4-French Pulsar-18 self-expandable (SE) nitinol stent for the treatment of long femoropopliteal occlusive disease in a two-center, prospective, all-comers registry with a follow-up period of 12 months. This registry enrolled 36 patients with symptomatic femoropopliteal long lesions for recanalization and implantation of the 4-French Pulsar-18 SE nitinol stent. Routine follow-up examination including duplex ultrasound was performed after 6 and 12 months. Primary patency was defined as no binary restenosis on duplex ultrasound (Peak systolic velocitiy ration (PSVR) <2.5) and no target lesion revascularization was performed within 12 months' follow-up. No drug-eluting devices were allowed in this registry. Average lesion length of the femoropopliteal segment was 182.3 ± 51.8 mm. Mean stent implantation length was 181.5 ± 35.4 mm. Total occlusion was present in 46 of the 48 (95.8%) treated lesions. Involvement of popliteal segment I-III was present in 3 (6.3%) lesions. The primary patency after 6 and 12 months was 87.5% and 85.4%, respectively. The clinically driven overall freedom from target lesion revascularization (fTLR) was 89.6% after 6 months and 87.5% after 12 months. ABI, pain-free walking distance and Rutherford category, all improved significantly (P < 0.001) after 6 and 12 months. The primary patency rate in patients with diabetes (P = 0.18) and renal insufficiency (P = 0.3) was not significantly lower as compared to the overall primary patency. In this two-center, all-comers registry, the use of the Pulsar-18 SE nitinol stent for endovascular intervention of femoropopliteal disease with a mean lesion length of 182.3 ± 51.8 mm showed promising primary patency and fTLR rates after 6 and 12 months. Diabetes and renal insufficiency had no negative impact on the patency rate.

[Importance of mechanical assist devices in acute circulatory arrest].

PubMed

Ferrari, Markus Wolfgang

2016-03-01

Mechanical assist devices are indicated for hemodynamic stabilization in acute circulatory arrest if conventional means of cardiopulmonary resuscitation are unable to re-establish adequate organ perfusion. Their temporary use facilitates further diagnostic and therapeutic options in selected patients, e.g. coronary angiography followed by revascularization.External thorax compression devices allow sufficient cardiac massage in case of preclinical or in-hospital circulatory arrest, especially under complex transfer conditions. These devices perform standardized thorax compressions at a rate of 80-100 per minute. Invasive mechanical support devices are used in the catheter laboratory or in the intensive care unit. Axial turbine pumps, e.g. the Impella, continuously pump blood from the left ventricle into the aortic root. The Impella can also provide right ventricle support by pumping blood from the vena cava into the pulmonary artery. So-called emergency systems or ECMO devices consist of a centrifugal pump and a membrane oxygenator allowing complete takeover of cardiac and pulmonary functions. Withdrawing blood from the right atrium and vena cava, oxygenated blood is returned to the abdominal aorta. Isolated centrifugal pumps provide left heart support without an oxygenator after transseptal insertion of a venous cannula into the left atrium.Mechanical assist devices are indicated for acute organ protection and hemodynamic stabilization for diagnostic and therapeutic measures as well as bridge to myocardial recovery. Future technical developments and better insights into the pathophysiology of mechanical circulatory support will broaden the spectrum of indications of such devices in acute circulatory arrest.

Cytokine-mediated deployment of SDF-1 induces revascularization through recruitment of CXCR4+ hemangiocytes

PubMed Central

Jin, David K; Shido, Koji; Kopp, Hans-Georg; Petit, Isabelle; Shmelkov, Sergey V; Young, Lauren M; Hooper, Andrea T; Amano, Hideki; Avecilla, Scott T; Heissig, Beate; Hattori, Koichi; Zhang, Fan; Hicklin, Daniel J; Wu, Yan; Zhu, Zhenping; Dunn, Ashley; Salari, Hassan; Werb, Zena; Hackett, Neil R; Crystal, Ronald G; Lyden, David; Rafii, Shahin

2009-01-01

The mechanisms through which hematopoietic cytokines accelerate revascularization are unknown. Here, we show that the magnitude of cytokine-mediated release of SDF-1 from platelets and the recruitment of nonendothelial CXCR4+VEGFR1+ hematopoietic progenitors, ‘hemangiocytes,’ constitute the major determinant of revascularization. Soluble Kit-ligand (sKitL), thrombopoietin (TPO, encoded by Thpo) and, to a lesser extent, erythropoietin (EPO) and granulocyte-macrophage colony-stimulating factor (GM-CSF) induced the release of SDF-1 from platelets, enhancing neovascularization through mobilization of CXCR4+VEGFR1+ hemangiocytes. Although revascularization of ischemic hindlimbs was partially diminished in mice deficient in both GM-CSF and G-CSF (Csf2−/−Csf3−/−), profound impairment in neovascularization was detected in sKitL-deficient Mmp9−/− as well as thrombocytopenic Thpo−/− and TPO receptor–deficient (Mpl−/−) mice. SDF-1–mediated mobilization and incorporation of hemangiocytes into ischemic limbs were impaired in Thpo−/−, Mpl−/− and Mmp9−/− mice. Transplantation of CXCR4+VEGFR1+ hemangiocytes into Mmp9−/− mice restored revascularization, whereas inhibition of CXCR4 abrogated cytokine- and VEGF-A–mediated mobilization of CXCR4+VEGFR1+ cells and suppressed angiogenesis. In conclusion, hematopoietic cytokines, through graded deployment of SDF-1 from platelets, support mobilization and recruitment of CXCR4+VEGFR1+ hemangiocytes, whereas VEGFR1 is essential for their angiogenic competency for augmenting revascularization. Delivery of SDF-1 may be effective in restoring angiogenesis in individuals with vasculopathies. PMID:16648859

Comparison of newer-generation drug-eluting with bare-metal stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of the EXAMINATION (clinical Evaluation of the Xience-V stent in Acute Myocardial INfArcTION) and COMFORTABLE-AMI (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) trials.

PubMed

Sabaté, Manel; Räber, Lorenz; Heg, Dik; Brugaletta, Salvatore; Kelbaek, Henning; Cequier, Angel; Ostojic, Miodrag; Iñiguez, Andrés; Tüller, David; Serra, Antonio; Baumbach, Andreas; von Birgelen, Clemens; Hernandez-Antolin, Rosana; Roffi, Marco; Mainar, Vicente; Valgimigli, Marco; Serruys, Patrick W; Jüni, Peter; Windecker, Stephan

2014-01-01

This study sought to study the efficacy and safety of newer-generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in an appropriately powered population of patients with ST-segment elevation myocardial infarction (STEMI). Among patients with STEMI, early generation DES improved efficacy but not safety compared with BMS. Newer-generation DES, everolimus-eluting stents, and biolimus A9-eluting stents, have been shown to improve clinical outcomes compared with early generation DES. Individual patient data for 2,665 STEMI patients enrolled in 2 large-scale randomized clinical trials comparing newer-generation DES with BMS were pooled: 1,326 patients received a newer-generation DES (everolimus-eluting stent or biolimus A9-eluting stent), whereas the remaining 1,329 patients received a BMS. Random-effects models were used to assess differences between the 2 groups for the device-oriented composite endpoint of cardiac death, target-vessel reinfarction, and target-lesion revascularization and the patient-oriented composite endpoint of all-cause death, any infarction, and any revascularization at 1 year. Newer-generation DES substantially reduce the risk of the device-oriented composite endpoint compared with BMS at 1 year (relative risk [RR]: 0.58; 95% confidence interval [CI]: 0.43 to 0.79; p = 0.0004). Similarly, the risk of the patient-oriented composite endpoint was lower with newer-generation DES than BMS (RR: 0.78; 95% CI: 0.63 to 0.96; p = 0.02). Differences in favor of newer-generation DES were driven by both a lower risk of repeat revascularization of the target lesion (RR: 0.33; 95% CI: 0.20 to 0.52; p < 0.0001) and a lower risk of target-vessel infarction (RR: 0.36; 95% CI: 0.14 to 0.92; p = 0.03). Newer-generation DES also reduced the risk of definite stent thrombosis (RR: 0.35; 95% CI: 0.16 to 0.75; p = 0.006) compared with BMS. Among patients with STEMI, newer-generation DES improve safety and efficacy compared with BMS throughout 1 year. It remains to be determined whether the differences in favor of newer-generation DES are sustained during long-term follow-up. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Pooled diagnostic accuracy of resting distal to aortic coronary pressure referenced to fractional flow reserve: The importance of resting coronary physiology.

PubMed

Maini, Rohit; Moscona, John; Sidhu, Gursukhman; Katigbak, Paul; Fernandez, Camilo; Irimpen, Anand; Mogabgab, Owen; Ward, Charisse; Samson, Rohan; LeJemtel, Thierry

2018-04-29

Both resting and hyperemic physiologic methods to guide coronary revascularization improve cardiovascular outcomes compared with angiographic guidance alone. Fractional flow reserve (FFR) remains underutilized due to concerns regarding hyperemia, prompting study of resting distal to aortic coronary pressure (Pd/Pa). Pd/Pa is a vasodilator-free resting index unlike FFR. While Pd/Pa is similar to another resting index, instantaneous wave-free ratio (iFR), it is a whole-cycle measurement not limited to the wave-free diastolic period. Pd/Pa is not validated clinically although multiple accuracy studies have been performed. Our meta-analysis examines the overall diagnostic accuracy of Pd/Pa referenced to FFR, the accepted invasive standard of ischemia. We searched PubMed, EMBASE, Central, ProQuest, and Web of Science databases for full text articles published through August 9, 2017 addressing the diagnostic accuracy of Pd/Pa referenced to FFR < 0.80. The following keywords were used: "distal coronary artery pressure" OR "Pd/Pa" AND "fractional flow reserve" OR "FFR." In total, 14 studies comprising 7004 lesions were identified. Pooled diagnostic accuracy estimates of Pd/Pa versus FFR < 0.80 were: sensitivity, 0.77 (95% CI, 0.75-0.78); specificity, 0.82 (0.81-0.83); positive likelihood ratio, 4.7 (3.3-6.6); negative likelihood ratio, 0.29 (0.24-0.34); diagnostic odds ratio, 18.1 (14.4-22.6); area under the summary receiver-operating characteristic curve of 0.88; and diagnostic accuracy of 0.80 (0.76-0.83). Pd/Pa shows adequate agreement with FFR as a resting index of coronary stenosis severity without the undesired effects and cost of hyperemic agents. Pd/Pa has the potential to guide coronary revascularization with easier application and availability compared with iFR and FFR. © 2018, Wiley Periodicals, Inc.

Percutaneous left ventricular assist device with TandemHeart for high-risk percutaneous coronary intervention: the Mayo Clinic experience.

PubMed

Alli, Oluseun O; Singh, Inder M; Holmes, David R; Pulido, Juan N; Park, Soon J; Rihal, Charanjit S

2012-11-01

In patients with poor left ventricular function and severe left main or multivessel coronary disease, coronary artery bypass grafting (CABG) surgery has been the preferred therapy. However, a number of these patients are either inoperable or poor surgical candidates due to comorbid conditions and previous cardiac surgical procedures. These patients are generally poor candidates for standard percutaneous coronary intervention (PCI) techniques. A hybrid PCI approach with hemodynamic support may be a viable strategy for these patients. We report our experience using the TandemHeart percutaneous left ventricular assist device during high-risk PCI. Retrospective cross-sectional analysis of prospectively collected data in 54 patients undergoing high-risk PCI using the TandemHeart device for support. Hemodynamic and clinical data were collected and analyzed. Baseline clinical characteristics were as follows: mean age 72 ± 1.7 years, males 78%, median ejection fraction 20%, mean serum creatinine 1.6 ± 0.3 2 mg/dL, recent myocardial infarction 52%, COPD 33%, previous CABG 50%, diabetes mellitus 41%, and hypertension 83%. The median SYNTAX score was 33, and the median Jeopardy score was 10. The predicted surgical revascularization mortality was 13% by the Society for Thoracic Surgery risk score and 33% by Euroscore. There was a significant decrease in right and left heart pressures (P < 0.05) with a concomitant increase in the cardiac output from 4.7 to 5.7 L/min (P = 0.03) during TandemHeart support. Left main and multivessel PCI was performed in 62% of patients, and rotablation was used in 48%. Procedural success rate was 97%, whereas 30-day and 6 month survival were 90% and 87%, respectively. Major vascular complications occurred in 13% of cases. None of our patients developed contrast induced nephropathy or needed dialysis. High-risk PCI with percutaneous left ventricular support using TandemHeart is a viable therapeutic strategy for a select subset of patients at very high risk with standard percutaneous revascularization techniques. Copyright © 2012 Wiley Periodicals, Inc.

Treatment of Necrotic Teeth by Apical Revascularization: Meta-analysis.

PubMed

He, Ling; Zhong, Juan; Gong, Qimei; Kim, Sahng G; Zeichner, Samuel J; Xiang, Lusai; Ye, Ling; Zhou, Xuedong; Zheng, Jinxuan; Liu, Yongxing; Guan, Chenyu; Cheng, Bin; Ling, Junqi; Mao, Jeremy J

2017-10-24

Each year ~5.4 million children and adolescents in the United States suffer from dental infections, leading to pulp necrosis, arrested tooth-root development and tooth loss. Apical revascularization, adopted by the American Dental Association for its perceived ability to enable postoperative tooth-root growth, is being accepted worldwide. The objective of the present study is to perform a meta-analysis on apical revascularization. Literature search yielded 22 studies following PRISMA with pre-defined inclusion and exclusion criteria. Intraclass correlation coefficient was calculated to account for inter-examiner variation. Following apical revascularization with 6- to 66-month recalls, root apices remained open in 13.9% cases (types I), whereas apical calcification bridge formed in 47.2% (type II) and apical closure (type III) in 38.9% cases. Tooth-root lengths lacked significant postoperative gain among all subjects (p = 0.3472) or in subgroups. Root-dentin area showed significant increases in type III, but not in types I or II cases. Root apices narrowed significantly in types II and III, but not in type I patients. Thus, apical revascularization facilitates tooth-root development but lacks consistency in promoting root lengthening, widening or apical closure. Post-operative tooth-root development in immature permanent teeth represents a generalized challenge to regenerate diseased pediatric tissues that must grow to avoid organ defects.

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

Translation, adaptation and validation of the Coronary Revascularization Outcome Questionnaire into Greek.

PubMed

Takousi, Maria G; Schmeer, Stefanie; Manaras, Irene; Olympios, Christoforos D; Fakiolas, Constantine N; Makos, Georgios; Troop, Nick A

2016-04-01

Evaluating the impact of coronary revascularization on patients' health related quality of life with a patient-based and disease-specific tool is important for drawing conclusions about treatment and outcomes. This study reports on the translation, adaptation and psychometric evaluation of a Greek version of the Coronary Revascularization Outcome Questionnaire (CROQ-Gr). A total of 609 (81.7% male) patients who had undergone coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) were recruited from four hospitals in Athens. After translating the CROQ into Greek, a preliminary qualitative study and a pilot quantitative study were conducted. A full psychometric evaluation was carried out on the main study's data. The psychometric evaluation demonstrated that the CROQ-Gr is acceptable to patients (high response rate, low missing data) and has a good level of reliability (internal consistency >0.70, test-retest reliability >0.90) and validity (both content and construct validity). The results of this study show the CROQ-Gr to be a psychometrically rigorous patient-based measure of outcomes of coronary revascularization. It would be appropriate for use in evaluative research as well as a routine clinical tool to aid cardiologists in monitoring the outcomes of care. © The European Society of Cardiology 2015.

Revascularization of smokers with claudication is not predicted to limit quality of life despite a higher risk of late failure.

PubMed

Mixson, Joshua D; Brothers, Thomas E

2017-01-01

Tobacco smoking after lower extremity revascularization for claudication has repeatedly been shown to increase the risk of adverse events, such that many vascular specialists consider that refusal to abstain from smoking constitutes a major contraindication to open surgical bypass or endovascular intervention. A Markov decision analysis (DA) model was used to compare the options of direct revascularization vs medical therapy only in smokers with claudication. The primary outcome was calculated quality of life (cQoL), determined for each patient at follow-up based on the outcomes of the treatment received. Markov DA software was used to predict the QoL for each treatment option preoperatively based on smoking status. Among patients referred during a recent 64-month period with vasculogenic claudication, 94 were actively smoking compared with 217 who were not. The DA model predicted that if the patients who smoked were to discontinue smoking, the best therapy would be bypass surgery for 77% and endovascular intervention for 17%. However, despite at least doubling the risks with intervention in the patients who continue to smoke, the DA model still predicted that 78% and 9% would fare better with open surgical or endovascular intervention, respectively. Among actively smoking patients, open surgical (3%) or endovascular (4%) therapies were initially performed in few patients, whereas 93% were offered only medical therapy. Among initial nonsmokers, revascularization was performed by open (27%) or endovascular (42%) means. At 3 years, the median (interquartile range [IQR]) cQoL was lower in initial smokers than in nonsmokers (0.73 [IQR, 0.73-0.77] vs 0.82 [IQR, 0.75-0.86]; P < .0001), primarily because of a lack of revascularization for smokers. Among initial smokers who did undergo revascularization initially, because of progression of symptoms, or after smoking cessation, cQoL was similar to initial nonsmokers (0.77 [IQR, 0.73-0.84] vs 0.73 [IQR, 0.73-0.73]; P = .37). Although 26% of initial smokers had stopped by the time of their last follow-up, 10% of initially nonsmoking patients were smoking at follow-up. However, among all patients undergoing intervention, the cQoL of patients smoking at the time of last their follow-up was similar to nonsmokers (0.82 [IQR, 0.82-0.86] vs 0.83 [IQR, 0.73-0.86]; P = .99). Patients with claudication who smoke may be denied the symptom improvement associated with revascularization, yet recidivism for smoking also occurs among patients who have stopped smoking in order to receive revascularization. The strategy not to directly revascularize patients with claudication who continue to smoke does not appear to maximize patient midterm QoL. Published by Elsevier Inc.

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.

Short-term effect of percutaneous recanalization of chronic total occlusions on QT dispersion and heart rate variability parameters

PubMed Central

Erdogan, Ercan; Akkaya, Mehmet; Bacaksız, Ahmet; Tasal, Abdurrahman; Sönmez, Osman; Asoglu, Emin; Kul, Seref; Sahın, Musa; Turfan, Murat; Vatankulu, Mehmet Akif; Göktekin, Omer

2013-01-01

Background QT dispersion (QTd), which is a measure of inhomogeneity of myocardial repolarization, increases following impaired myocardial perfusion. Its prolongation may provide a suitable substrate for life-threatening ventricular arrhythmias. We investigated the changes in QTd and heart rate variability (HRV) parameters after successful coronary artery revascularization in a patient with chronic total occlusions (CTO). Material/Methods This study included 139 successfully revascularized CTO patients (118 men, 21 women, mean age 58.3±9.6 years). QTd was measured from a 12-lead electrocardiogram and was defined as the difference between maximum and minimum QT interval. HRV analyses of all subjects were obtained. Frequency domain (LF: HF) and time domain (SDNN, pNN50, and rMSSD) parameters were analyzed. QT intervals were also corrected for heart rate using Bazett’s formula, and the corrected QT interval dispersion (QTcd) was then calculated. All measurements were made before and after percutaneous coronary intervention (PCI). Results Both QTd and QTcd showed significant improvement following successful revascularization of CTO (55.83±14.79 to 38.87±11.69; p<0.001 and 61.02±16.28 to 42.92±13.41; p<0.001). The revascularization of LAD (n=38), Cx (n=28) and RCA (n=73) resulted in decrease in HRV indices, including SDDN, rMSSD, and pNN50, but none of the variables reached statistical significance. Conclusions Successful revascularization of CTO may result in improvement in regional heterogeneity of myocardial repolarization, evidenced as decreased QTcd after the PCI. The revascularization in CTO lesions does not seem to have a significant impact on HRV. PMID:23969577

Analysis of the Use of Extracorporeal Circulation on the In-Hospital Outcomes of Dialytic Patients Who Underwent Myocardial Revascularization Surgery.

PubMed

Miranda, Matheus; Branco, João Nelson Rodrigues; Vargas, Guilherme Flora; Hossne, Nelson Americo; Yoshimoto, Michele Costa; Fonseca, José Honorio de Almeida Palma da; Pestana, José Osmar Medina de Abreu; Buffolo, Enio

2016-12-01

Myocardial revascularization surgery is the best treatment for dyalitic patients with multivessel coronary disease. However, the procedure still has high morbidity and mortality. The use of extracorporeal circulation (ECC) can have a negative impact on the in-hospital outcomes of these patients. To evaluate the differences between the techniques with ECC and without ECC during the in-hospital course of dialytic patients who underwent surgical myocardial revascularization. Unicentric study on 102 consecutive, unselected dialytic patients, who underwent myocardial revascularization surgery in a tertiary university hospital from 2007 to 2014. Sixty-three patients underwent surgery with ECC and 39 without ECC. A high prevalence of cardiovascular risk factors was found in both groups, without statistically significant difference between them. The group "without ECC" had greater number of revascularizations (2.4 vs. 1.7; p <0.0001) and increased need for blood components (77.7% vs. 25.6%; p <0.0001) and inotropic support (82.5% vs 35.8%; p <0.0001). In the postoperative course, the group "without ECC" required less vasoactive drugs, (61.5% vs. 82.5%; p = 0.0340) and shorter time of mechanical ventilation (13.0 hours vs. 36,3 hours, p = 0.0217), had higher extubation rates in the operating room (58.9% vs. 23.8%, p = 0.0006), lower infection rates (7.6% vs. 28.5%; p = 0.0120), and shorter ICU stay (5.2 days vs. 8.1 days; p = 0.0054) as compared with the group with ECC surgery. No difference in mortality was found between the groups. Myocardial revascularization with ECC in patients on dialysis resulted in higher morbidity in the perioperative period in comparison with the procedure without ECC, with no difference in mortality though.

Risk model for estimating the 1-year risk of deferred lesion intervention following deferred revascularization after fractional flow reserve assessment.

PubMed

Depta, Jeremiah P; Patel, Jayendrakumar S; Novak, Eric; Gage, Brian F; Masrani, Shriti K; Raymer, David; Facey, Gabrielle; Patel, Yogesh; Zajarias, Alan; Lasala, John M; Amin, Amit P; Kurz, Howard I; Singh, Jasvindar; Bach, Richard G

2015-02-21

Although lesions deferred revascularization following fractional flow reserve (FFR) assessment have a low risk of adverse cardiac events, variability in risk for deferred lesion intervention (DLI) has not been previously evaluated. The aim of this study was to develop a prediction model to estimate 1-year risk of DLI for coronary lesions where revascularization was not performed following FFR assessment. A prediction model for DLI was developed from a cohort of 721 patients with 882 coronary lesions where revascularization was deferred based on FFR between 10/2002 and 7/2010. Deferred lesion intervention was defined as any revascularization of a lesion previously deferred following FFR. The final DLI model was developed using stepwise Cox regression and validated using bootstrapping techniques. An algorithm was constructed to predict the 1-year risk of DLI. During a mean (±SD) follow-up period of 4.0 ± 2.3 years, 18% of lesions deferred after FFR underwent DLI; the 1-year incidence of DLI was 5.3%, while the predicted risk of DLI varied from 1 to 40%. The final Cox model included the FFR value, age, current or former smoking, history of coronary artery disease (CAD) or prior percutaneous coronary intervention, multi-vessel CAD, and serum creatinine. The c statistic for the DLI prediction model was 0.66 (95% confidence interval, CI: 0.61-0.70). Patients deferred revascularization based on FFR have variation in their risk for DLI. A clinical prediction model consisting of five clinical variables and the FFR value can help predict the risk of DLI in the first year following FFR assessment. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Very late stent thrombosis and late target lesion revascularization after sirolimus-eluting stent implantation: five-year outcome of the j-Cypher Registry.

PubMed

Kimura, Takeshi; Morimoto, Takeshi; Nakagawa, Yoshihisa; Kawai, Kazuya; Miyazaki, Shunichi; Muramatsu, Toshiya; Shiode, Nobuo; Namura, Masanobu; Sone, Takahito; Oshima, Shigeru; Nishikawa, Hideo; Hiasa, Yoshikazu; Hayashi, Yasuhiko; Nobuyoshi, Masakiyo; Mitudo, Kazuaki

2012-01-31

There is a scarcity of long-term data from large-scale drug-eluting stent registries with a large enough sample to evaluate low-frequency events such as stent thrombosis (ST). Five-year outcomes were evaluated in 12 812 consecutive patients undergoing sirolimus-eluting stent (SES) implantation in the j-Cypher registry. Cumulative incidence of definite ST was low (30 day, 0.3%; 1 year, 0.6%; and 5 years, 1.6%). However, late and very late ST continued to occur without attenuation up to 5 years after sirolimus-eluting stent implantation (0.26%/y). Cumulative incidence of target lesion revascularization within the first year was low (7.3%). However, late target lesion revascularization beyond 1 year also continued to occur without attenuation up to 5 years (2.2%/y). Independent risk factors of ST were completely different according to the timing of ST onset, suggesting the presence of different pathophysiological mechanisms of ST according to the timing of ST onset: acute coronary syndrome and target of proximal left anterior descending coronary artery for early ST; side-branch stenting, diabetes mellitus, and end-stage renal disease with or without hemodialysis for late ST; and current smoking and total stent length >28 mm for very late ST. Independent risk factors of late target lesion revascularization beyond 1 year were generally similar to those risk factors identified for early target lesion revascularization. Late adverse events such as very late ST and late target lesion revascularization are continuous hazards, lasting at least up to 5 years after implantation of the first-generation drug-eluting stents (sirolimus-eluting stents), which should be the targets for developing improved coronary stents.

Fractional flow reserve by computerized tomography and subsequent coronary revascularization

PubMed Central

Packard, René R. Sevag; Li, Dong; Budoff, Matthew J.; Karlsberg, Ronald P.

2017-01-01

Aims Fractional flow reserve by computerized tomography (FFR-CT) provides non-invasive functional assessment of the hemodynamic significance of coronary artery stenosis. We determined the FFR-CT values, receiver operator characteristic (ROC) curves, and predictive ability of FFR-CT for actual standard of care guided coronary revascularization. Methods and results Consecutive outpatients who underwent coronary CT angiography (coronary CTA) followed by invasive angiography over a 24-month period from 2012 to 2014 were identified. Studies that fit inclusion criteria (n = 75 patients, mean age 66, 75% males) were sent for FFR-CT analysis, and results stratified by coronary artery calcium (CAC) scores. Coronary CTA studies were re-interpreted in a blinded manner, and baseline FFR-CT values were obtained retrospectively. Therefore, results did not interfere with clinical decision-making. Median FFR-CT values were 0.70 in revascularized (n = 69) and 0.86 in not revascularized (n = 138) coronary arteries (P < 0.001). Using clinically established significance cut-offs of FFR-CT ≤0.80 and coronary CTA ≥70% stenosis for the prediction of clinical decision-making and subsequent coronary revascularization, the positive predictive values were 74 and 88% and negative predictive values were 96 and 84%, respectively. The area under the curve (AUC) for all studied territories was 0.904 for coronary CTA, 0.920 for FFR-CT, and 0.941 for coronary CTA combined with FFR-CT (P = 0.001). With increasing CAC scores, the AUC decreased for coronary CTA but remained higher for FFR-CT (P < 0.05). Conclusion The addition of FFR-CT provides a complementary role to coronary CTA and increases the ability of a CT-based approach to identify subsequent standard of care guided coronary revascularization. PMID:27469588

Outcomes of a contemporary cohort of 536 consecutive patients with acute ischemic stroke treated with endovascular therapy.

PubMed

Abilleira, Sònia; Cardona, Pere; Ribó, Marc; Millán, Mònica; Obach, Víctor; Roquer, Jaume; Cánovas, David; Martí-Fàbregas, Joan; Rubio, Francisco; Alvarez-Sabín, José; Dávalos, Antoni; Chamorro, Angel; de Miquel, Maria Angeles; Tomasello, Alejandro; Castaño, Carlos; Macho, Juan M; Ribera, Aida; Gallofré, Miquel

2014-04-01

We sought to assess outcomes after endovascular treatment/therapy of acute ischemic stroke, overall and by subgroups, and looked for predictors of outcome. We used data from a mandatory, population-based registry that includes external monitoring of completeness, which assesses reperfusion therapies for consecutive patients with acute ischemic stroke since 2011. We described outcomes overall and by subgroups (age ≤ or >80 years; onset-to-groin puncture ≤ or >6 hours; anterior or posterior strokes; previous IV recombinant tissue-type plasminogen activator or isolated endovascular treatment/therapy; revascularization or no revascularization), and determined independent predictors of good outcome (modified Rankin Scale score ≤2) and mortality at 3 months by multivariate modeling. We analyzed 536 patients, of whom 285 received previous IV recombinant tissue-type plasminogen activator. Overall, revascularization (modified Thrombolysis In Cerebral Infarction scores, 2b and 3) occurred in 73.9%, 5.6% developed symptomatic intracerebral hemorrhages, 43.3% achieved good functional outcome, and 22.2% were dead at 90 days. Adjusted comparisons by subgroups systematically favored revascularization (lower proportion of symptomatic intracerebral hemorrhages and death rates and higher proportion of good outcome). Multivariate analyses confirmed the independent protective effect of revascularization. Additionally, age >80 years, stroke severity, hypertension (deleterious), atrial fibrillation, and onset-to-groin puncture ≤6 hours (protective) also predicted good outcome, whereas lack of previous disability and anterior circulation strokes (protective) as well as and hypertension (deleterious) independently predicted mortality. This study reinforces the role of revascularization and time to treatment to achieve enhanced functional outcomes and identifies other clinical features that independently predict good/fatal outcome after endovascular treatment/therapy.

Revascularization with percutaneous coronary intervention does not affect androgen status in males with chronic stable angina pectoris.

PubMed

Gosai, J N; Charalampidis, P; Nikolaidou, T; Parviz, Y; Morris, P D; Channer, K S; Jones, T H; Grech, E D

2016-05-01

There is a clear association between low serum testosterone and coronary artery disease (CAD) in men. Hypotestosteronaemia is associated with accelerated atherosclerosis and a quarter of men with CAD are biochemically hypogonadal. Amongst those with CAD, hypotestosteronaemia is associated with increased mortality. Testosterone vasodilates coronary arteries, and exogenous testosterone reduces ischaemia. Whether hypotestosteronaemia is a cause or a consequence of CAD remains unanswered. The aim of this prospective observational study was to investigate whether coronary revascularization affected androgen status in men with stable angina pectoris. Twenty five men (mean age 62.7, SD 9.18) with angiographically significant CAD and symptomatic angina underwent full coronary revascularization by percutaneous coronary intervention. Androgen status and symptoms of angina, stress, depression and sexual function were assessed before, and at one and 6 months after the coronary revascularization. All patients underwent complete revascularization which was associated with a significant reduction in angina symptoms and ischaemia. No significant difference was seen in total testosterone (11.33 nmol/L baseline; 12.56, 1 month post; 13.04 at 6 months; p = 0.08). A significant and sustained rise in sex hormone-binding globulin was seen (33.99 nm/L baseline; 36.11 nm/L 1 month post PCI; 37.94 nm/L at 6 months; p = 0.03) Overall, there was no significant alteration in any other marker of androgen status including free testosterone or bioavailable testosterone. There was no change in symptoms of anxiety, depression or sexual function. Coronary revascularization has no sustained effect on androgen status. This supports the hypothesis that hypotestosteronaemia is not a consequence of angina pectoris or myocardial ischaemia. © 2016 American Society of Andrology and European Academy of Andrology.

Combined Direct and Indirect Cerebral Revascularization Using Local and Flow-Through Flaps.

PubMed

Azadgoli, Beina; Leland, Hyuma A; Wolfswinkel, Erik M; Bakhsheshian, Joshua; Russin, Jonathan J; Carey, Joseph N

2018-02-01

 Extracranial-intracranial bypass is indicated in ischemic disease such as moyamoya, certain intracranial aneurysms, and other complex neurovascular diseases. In this article, we present our series of local and flow-through flaps for cerebral revascularization as an additional tool to provide direct and indirect revascularization and/or soft tissue coverage.  A retrospective review of a prospectively maintained database was performed identifying nine patients. Ten direct arterial bypass procedures with nine indirect revascularization and/or soft tissue reconstruction were performed.  Indications for arterial bypass included intracranial aneurysm ( n  = 2) and moyamoya disease ( n  = 8). Indications for soft tissue transfer included infected cranioplasty (one) and indirect cerebral revascularization (eight). Four flow-through flaps and five pedicled flaps were used including a flow-through radial forearm fasciocutaneous flap (one), flow-through radial forearm fascial flaps (three), and pedicled temporoparietal fascial (TPF) flaps with distal end anastomosis (five). The superficial temporal vessels (seven) and facial vessels (two) were used as the vascular inflow. Arterial bypass was established into the middle cerebral artery (six) and anterior communicating artery (three). There were no intraoperative complications. All flaps survived with no donor-site complications. In one case of flow-through TPF flap, the direct graft failed, but the indirect flap remained vascularized.  Local and flow-through flaps can improve combined direct and indirect revascularization and provide soft tissue reconstruction. Minimal morbidity has been encountered in early outcomes though long-term results remain under investigation for these combined neurosurgery and plastic surgery procedures.  The level of evidence is IV. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

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.

Revascularization of Transplanted Pancreatic Islets and Role of the Transplantation Site

PubMed Central

Pepper, Andrew R.; Ziff, Oliver; Shapiro, A. M. James

2013-01-01

Since the initial reporting of the successful reversal of hyperglycemia through the transplantation of pancreatic islets, significant research efforts have been conducted in elucidating the process of revascularization and the influence of engraftment site on graft function and survival. During the isolation process the intrinsic islet vascular networks are destroyed, leading to impaired revascularization after transplant. As a result, in some cases a significant quantity of the beta cell mass transplanted dies acutely following the infusion into the portal vein, the most clinically used site of engraftment. Subsequently, despite the majority of patients achieving insulin independence after transplant, a proportion of them recommence small, supplemental exogenous insulin over time. Herein, this review considers the process of islet revascularization after transplant, its limiting factors, and potential strategies to improve this critical step. Furthermore, we provide a characterization of alternative transplant sites, analyzing the historical evolution and their role towards advancing transplant outcomes in both the experimental and clinical settings. PMID:24106517

Is there an additional benefit from coronary revascularization in diabetic patients with acute coronary syndromes or stable angina who are already on optimal medical treatment?

PubMed Central

Athyros, Vasilios G.; Gossios, Thomas D.; Tziomalos, Konstantinos; Florentin, Matilda; Karagiannis, Asterios

2011-01-01

Cardiovascular disease (CVD) is common in patients with diabetes mellitus (DM) and related clinical outcomes are worse compared with non-diabetics. The optimal treatment in diabetic patients with coronary heart disease (CHD) is currently not established. We searched MEDLINE (1975-2010) using the key terms diabetes mellitus, coronary heart disease, revascularization, coronary artery bypass, angioplasty, coronary intervention and medical treatment. Most studies comparing different revascularization procedures in patients with CHD favoured coronary artery bypass graft (CABG) surgery in patients with DM. However, most of this evidence comes from subgroup analyses. Recent evidence suggests that advanced percutaneous coronary intervention (PCI) techniques along with best medical treatment may be non-inferior and more cost-effective compared with CABG. Treatment of vascular risk factors is a key option in terms of improving CVD outcomes in diabetic patients with CHD. The choice between medical therapy and revascularization warrants further assessment. PMID:22328892

77 FR 35745 - Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-14

..., battery powered device with a semiconductor sensor. (2) Alcohol Countermeasure Systems Corp., submitted...-0062] Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in... Screening Devices to Measure Alcohol in Bodily Fluids dated, March 31, 2008 (73 FR 16956). DATES: Effective...

Revascularization Trends in Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease Presenting With Non-ST Elevation Myocardial Infarction: Insights From the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry-Get with the Guidelines (NCDR ACTION Registry-GWTG).

PubMed

Pandey, Ambarish; McGuire, Darren K; de Lemos, James A; Das, Sandeep R; Berry, Jarett D; Brilakis, Emmanouil S; Banerjee, Subhash; Marso, Steven P; Barsness, Gregory W; Simon, DaJuanicia N; Roe, Matthew; Goyal, Abhinav; Kosiborod, Mikhail; Amsterdam, Ezra A; Kumbhani, Dharam J

2016-05-01

Current guidelines recommend surgical revascularization (coronary artery bypass graft [CABG]) over percutaneous coronary intervention (PCI) in patients with diabetes mellitus and multivessel coronary artery disease. Few data are available describing revascularization patterns among these patients in the setting of non-ST-segment-elevation myocardial infarction. Using Acute Coronary Treatment and Intervention Outcomes Network Registry-Get with the Guidelines (ACTION Registry-GWTG), we compared the in-hospital use of different revascularization strategies (PCI versus CABG versus no revascularization) in diabetes mellitus patients with non-ST-segment-elevation myocardial infarction who had angiography, demonstrating multivessel coronary artery disease between July 2008 and December 2014. Factors associated with use of CABG versus PCI were identified using logistic multivariable regression analyses. A total of 29 769 patients from 539 hospitals were included in the study, of which 10 852 (36.4%) were treated with CABG, 13 760 (46.2%) were treated with PCI, and 5157 (17.3%) were treated without revascularization. The overall use of revascularization increased over the study period with an increase in the proportion undergoing PCI (45% to 48.9%; Ptrend=0.0002) and no change in the proportion undergoing CABG (36.1% to 34.7%; ptrend=0.88). There was significant variability between participating hospitals in the use of PCI and CABG (range: 22%-100%; 0%-78%, respectively; P value <0.0001 for both). Patient-level, but not hospital-level, characteristics were statistically associated with the use of PCI versus CABG, including anatomic severity of the disease, early treatment of adenosine diphosphate receptor antagonists at presentation, older age, female sex, and history of heart failure. Among patients with diabetes mellitus and multivessel coronary artery disease presenting with non-ST-segment-elevation myocardial infarction, only one third undergo CABG during the index admission. Furthermore, the use of PCI, but not CABG, increased modestly over the past 6 years. © 2016 American Heart Association, Inc.

Prediction of revascularization after myocardial perfusion SPECT by machine learning in a large population.

PubMed

Arsanjani, Reza; Dey, Damini; Khachatryan, Tigran; Shalev, Aryeh; Hayes, Sean W; Fish, Mathews; Nakanishi, Rine; Germano, Guido; Berman, Daniel S; Slomka, Piotr

2015-10-01

We aimed to investigate if early revascularization in patients with suspected coronary artery disease can be effectively predicted by integrating clinical data and quantitative image features derived from perfusion SPECT (MPS) by machine learning (ML) approach. 713 rest (201)Thallium/stress (99m)Technetium MPS studies with correlating invasive angiography with 372 revascularization events (275 PCI/97 CABG) within 90 days after MPS (91% within 30 days) were considered. Transient ischemic dilation, stress combined supine/prone total perfusion deficit (TPD), supine rest and stress TPD, exercise ejection fraction, and end-systolic volume, along with clinical parameters including patient gender, history of hypertension and diabetes mellitus, ST-depression on baseline ECG, ECG and clinical response during stress, and post-ECG probability by boosted ensemble ML algorithm (LogitBoost) to predict revascularization events. These features were selected using an automated feature selection algorithm from all available clinical and quantitative data (33 parameters). Tenfold cross-validation was utilized to train and test the prediction model. The prediction of revascularization by ML algorithm was compared to standalone measures of perfusion and visual analysis by two experienced readers utilizing all imaging, quantitative, and clinical data. The sensitivity of machine learning (ML) (73.6% ± 4.3%) for prediction of revascularization was similar to one reader (73.9% ± 4.6%) and standalone measures of perfusion (75.5% ± 4.5%). The specificity of ML (74.7% ± 4.2%) was also better than both expert readers (67.2% ± 4.9% and 66.0% ± 5.0%, P < .05), but was similar to ischemic TPD (68.3% ± 4.9%, P < .05). The receiver operator characteristics areas under curve for ML (0.81 ± 0.02) was similar to reader 1 (0.81 ± 0.02) but superior to reader 2 (0.72 ± 0.02, P < .01) and standalone measure of perfusion (0.77 ± 0.02, P < .01). ML approach is comparable or better than experienced readers in prediction of the early revascularization after MPS, and is significantly better than standalone measures of perfusion derived from MPS.

Optimal Timing of Surgical Revascularization for Myocardial Infarction and Left Ventricular Dysfunction

PubMed Central

Wang, Rong; Cheng, Nan; Xiao, Cang-Song; Wu, Yang; Sai, Xiao-Yong; Gong, Zhi-Yun; Wang, Yao; Gao, Chang-Qing

2017-01-01

Background: The optimal timing of surgical revascularization for patients presenting with ST-segment elevation myocardial infarction (STEMI) and impaired left ventricular function is not well established. This study aimed to examine the timing of surgical revascularization after STEMI in patients with ischemic heart disease and left ventricular dysfunction (LVD) by comparing early and late results. Methods: From January 2003 to December 2013, there were 2276 patients undergoing isolated coronary artery bypass grafting (CABG) in our institution. Two hundred and sixty-four (223 male, 41 females) patients with a history of STEMI and LVD were divided into early revascularization (ER, <3 weeks), mid-term revascularization (MR, 3 weeks to 3 months), and late revascularization (LR, >3 months) groups according to the time interval from STEMI to CABG. Mortality and complication rates were compared among the groups by Fisher's exact test. Cox regression analyses were performed to examine the effect of the time interval of surgery on long-term survival. Results: No significant differences in 30-day mortality, long-term survival, freedom from all-cause death, and rehospitalization for heart failure existed among the groups (P > 0.05). More patients in the ER group (12.90%) had low cardiac output syndrome than those in the MR (2.89%) and LR (3.05%) groups (P = 0.035). The mean follow-up times were 46.72 ± 30.65, 48.70 ± 32.74, and 43.75 ± 32.43 months, respectively (P = 0.716). Cox regression analyses showed a severe preoperative condition (odds ratio = 7.13, 95% confidence interval 2.05–24.74, P = 0.002) rather than the time interval of CABG (P > 0.05) after myocardial infarction was a risk factor of long-term survival. Conclusions: Surgical revascularization for patients with STEMI and LVD can be performed at different times after STEMI with comparable operative mortality and long-term survival. However, ER (<3 weeks) has a higher incidence of postoperative low cardiac output syndrome. A severe preoperative condition rather than the time interval of CABG after STEMI is a risk factor of long-term survival. PMID:28218210

Temporary cerebral revascularization using a radial artery in the hand-eyeshade posture: technical note.

PubMed

Hiramoto, Jun; Tanaka, Yuichiro

2014-06-17

Kamiyama introduced a unique method of temporary cerebral revascularization using a radial artery graft (RAG) in his technical review. We tried original method with Sugita frame, and pointed out some disadvantages that include to avoid taking instruments or hands in and out, stability of hands, and unrestricted usage of brain retractors during temporary bypass between radial artery and M2 potion of middle cerebral artery (RA-M2 bypass). To solve those disadvantages, especially for Sugita head frame users, we here present a modified Kamiyama's method of temporary cerebral revascularization with the forearm elevated over the face like as hand-eyeshade posture.

Hepatorenal bypass using autogenous, free internal iliac artery graft: An attractive alternative to revascularize the right kidney in Takayasu's disease.

PubMed

Khattar, Nikhil; Guleria, Sandeep; Sharma, Sanjeev

2012-04-01

Nonspecific aortoarteritis or Takayasu's disease (TD) is a chronic pan endarteritis of unknown origin involving the aorta and its major branches affecting young adults especially women. The disease is more common in eastern Asian countries. Hypertension in these patients generally reflects as renal artery stenosis, which is seen in 28-75% of patients. Surgical revascularization is occasionally needed in patients with failed medical management or endovascular interventions. We report two cases of Takayasu's arteritis in young women where renal revascularization was done using free internal iliac artery hepatorenal bypass graft with excellent control of hypertension in the postoperative period.

Magnetic navigation facilitates percutaneous coronary intervention for complex lesions.

PubMed

Sandhu, Gurpreet S; Sanon, Saurabh; Holmes, David R; Gulati, Rajiv; Brilakis, Emmanouil S; Lennon, Ryan J; Rihal, Charanjit S

2014-10-01

We sought to determine the utility of a magnetic navigation system (MNS) in treating a variety of coronary artery lesions including those that could not be revascularized with standard percutaneous coronary intervention (PCI). MNS may add value in the treatment of tortuous arteries and bifurcation lesions; however its widespread adoption has lagged because of cost and a lack of clear advantage over conventional PCI. We performed a retrospective analysis to determine whether MNS improved procedural success for highly complex lesions. One hundred and forty-eight patients underwent treatment with MNS at Mayo Clinic, Rochester. Clinical data, angiographic and procedural characteristics, lesion crossing success and outcomes were reviewed. Overall 133 patients underwent successful revascularization with 87% (143) of 164 lesions crossed using MNS alone. Another six lesions required a combination of MNS and conventional devices resulting in overall success of 91% (149/164). Eighteen complex lesions had previously failed PCI and 12 (67%) were successfully treated with MNS. Success after failed PCI was higher (88%) when a frequent user operated MNS, but occasional users also noted incremental success (30%). Twenty-five chronic total occlusions were included amongst these 164 lesions, with observed antegrade MNS lesion crossing rates of 78% for regular and 14% for occasional users. MNS is a useful adjunct to performance of PCI. This specialized technology has a clear learning curve and can facilitate treatment of highly complex lesions. © 2013 Wiley Periodicals, Inc.

Survival benefits of revascularization in patients with critical limb ischemia and renal insufficiency.

PubMed

Ortmann, Jana; Gahl, Brigitta; Diehm, Nicolas; Dick, Florian; Traupe, Tobias; Baumgartner, Iris

2012-09-01

Evidence for the best treatment strategy for patients with critical limb ischemia (CLI) at different stages of renal insufficiency (RI) is rare. Therefore, we determined the benefit of revascularization vs medical therapy (MT) only in CLI patients with different levels of RI. This intention-to-treat cohort study with follow-up at 2, 6, and 12 months was conducted in a consecutive series of 351 patients with CLI. Revascularization by surgical (78 patients) or endovascular techniques (191 patients) was performed in 269 patients. MT as first-line therapy was administered in 82 patients. Patients were grouped according to glomerular filtration rate (GFR), estimated with the Modification of Diet in Renal Disease equation, into absent/mild RI (estimated GFR [eGFR], ≥ 60 mL/min/1.73 m(2)), moderate RI (eGFR, 30-59 mL/min/1.73 m(2)), and severe RI (eGFR, <30 mL/min/1.73 m(2) or dialysis). Primary outcome measures were overall and amputation-free survival. Cox regression models adjusted for baseline characteristics after Kaplan-Meier survival estimates were performed. The mean age differed significantly between groups (P < .001), and patients with absent/mild RI were more often men (P < .001) or smokers (P < .001) and less often hypertensive (P < .001). Risk factor adjustment showed that revascularized CLI patients with absent/mild RI had a longer amputation-free survival (hazard ratio [HR], 0.46; 95% confidence interval [CI], 0.26-0.82; P = .008), higher limb salvage (HR, 0.29; 95% CI, 0.17-0.91; P < .029), and better clinical success than MT patients (HR, 0.33; 95% CI, 0.17-0.65; P = .001). The moderate RI group benefited from revascularization in overall survival (HR, 0.51; 95% CI, 0.26-0.99; P = .049), amputation-free survival (HR, 0.51; 95% CI, 0.29-0.90; P = .020), and clinical success (HR, 0.42; 95% CI, 0.22-0.80; P = .008). A beneficial effect on overall survival was found even in patients with severe RI when revascularized (HR, 0.33; 95% CI, 0.12-0.91; P = .032 vs MT). Patients with CLI may benefit from revascularization compared with MT alone at all levels of renal impairment. Thus, revascularization should not be withheld in CLI patients at any level of RI. Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. 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.

Regenerative endodontic treatment (revascularization) of immature necrotic molars medicated with calcium hydroxide: a case series.

PubMed

Cehreli, Zafer C; Isbitiren, Beste; Sara, Sezgi; Erbas, Gizem

2011-09-01

Revascularization is an emerging regenerative treatment protocol with little published data available in immature molar teeth. The present case series demonstrates the outcome of revascularization treatment with intracanal medicament of calcium hydroxide in immature necrotic molars. Immature necrotic permanent first molars (n = 6) of patients 8-11 years old were treated by a revascularization protocol that used 2.5% NaOCl irrigation, medication with calcium hydroxide placed in the coronal third of the root canals, induction of apical bleeding, and coronal sealing with white mineral trioxide aggregate. Among the treated teeth, 4 molars had undergone prior root canal instrumentation by the referring dentists. National Institutes of Health Image-J program with TurboReg plug-in was used for standardization of the radiographs and to determine the increase in root length and root width. After a follow-up period of 10 months, all teeth demonstrated radiographic evidence of complete periapical healing, progressive thickening of dentinal walls, and continued apical development in the absence of clinical symptoms. Two uninstrumented molars showed a positive response to cold testing at 9 months. On the basis of a follow-up period of 10 months, the present cases demonstrate a favorable outcome of the revascularization procedure in immature necrotic molars by using calcium hydroxide medication in the coronal third of the root canals. Copyright © 2011 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Symptom Expression in Coronary Heart Disease and Revascularization Recommendations for Black and White Patients

PubMed Central

Hravnak, Marilyn; Whittle, Jeff; Kelley, Mary E.; Sereika, Susan; Good, Chester B.; Ibrahim, Said A.; Conigliaro, Joseph

2007-01-01

Objectives. We examined whether symptoms of coronary heart disease vary between Black and White patients with coronary heart disease, whether presenting symptoms affect physicians’ revascularization recommendations, and whether the effect of symptoms upon recommendations differs in Black and White patients. Methods. We interviewed Black and White patients in Pittsburgh in 1997 to 1999 who were undergoing elective coronary catheterization. We interviewed them regarding their symptoms, and we interviewed their cardiologist decision-makers regarding revascularization recommendations. We obtained coronary catheterization results by chart review. Results. Black and White patients (N=1196; 9.7% Black) expressed similar prevalence of chest pain, angina equivalent, fatigue, and other symptoms, but Black patients had more shortness of breath (87% vs 72%, P=.001). When we considered only those patients with significant stenosis (n=737, 7.1% Black) and controlled for race, age, gender, and number of stenotic vessels, those who expressed shortness of breath were less likely to be recommended for revascularization (odds ratio=0.535; 95% confidence interval=0.375, 0.762; P<.001), but there was no significant interaction with race. Conclusions. Black patients reported shortness of breath more frequently than did White subjects. Shortness of breath was a negative predictor for revascularization for all patients with significant stenosis, but there was no difference in the recommendations by symptom by race. PMID:17329655

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.

New re-entry device for revascularization of chronic coronary total occlusions: preliminary single Japanese center experience.

PubMed

Tsuchikane, Etsuo; Kimura, Masashi; Suzuki, Takahiko; Habara, Maoto; Kurita, Tairo; Tanaka, Nobuyoshi; Nasu, Kenya; Ito, Tatsuya; Kinoshita, Yoshihisa; Wyman, R Michael

2012-08-01

Although retrograde approach for coronary chronic total occlusion (CTO) has been introduced, the procedure is still time and resource consuming. A simplified antegrade approach mightbe another resort. The aim of this study was to evaluate a new device designed to facilitate guidewire re-entry into the true lumen of a CTO from the adjacent subintimal space. Patients with CTO were entered into a prospective registry regardless of lesion characteristics. A new metal-tip catheter was used initially in primary use cases. If it created subintimal tracking, a new re-entry tool (a flat balloon with 2 exit ports offset by 180 degrees) was used as a platform to attempt guidewire penetration into the distal true lumen. In rescue use cases after unsuccessful conventional wiring, the re-entry procedure was subsequently attempted. In 11 CTO lesions attempted, device success was achieved in 8 cases (72.7%). Re-entry procedure success rate was higher in primary use cases (80%) compared to rescue use cases (33.3%). Retrograde approach was conducted immediately after unsuccessful antegrade procedure using this device in the other 3 cases and successful recanalization was achieved in all cases. All lesions were stented, resulting in TIMI 3 flow without major complications. A new coronary re-entry device may provide another strategic option in the antegrade approach to recanalize CTOs.

Transcatheter aortic valve implantation and off-pump coronary artery bypass surgery: an effective hybrid procedure in selected patients.

PubMed

Mayr, Benedikt; Firschke, Christian; Erlebach, Magdalena; Bleiziffer, Sabine; Krane, Markus; Joner, Michael; Herold, Ulf; Nöbauer, Christian; Lange, Rüdiger; Deutsch, Marcus-André

2018-02-26

Simultaneous surgical off-pump coronary revascularization and transcatheter aortic valve implantation (TAVI) as a hybrid procedure may be a therapeutic option for patients with a TAVI indication who are not suitable for percutaneous coronary intervention and for patients who have an indication for combined surgical aortic valve implantation and coronary artery bypass grafting but present with a porcelain aorta. Early outcomes of these patients are analysed in this study. From February 2011 to April 2017, hybrid TAVI/off-pump coronary artery bypass (OPCAB) was performed in 12 (60%) patients, hybrid TAVI/minimally invasive direct coronary artery bypass in 6 (30%) patients and staged TAVI/OPCAB in 2 (10%) patients. Endpoints of this study were 30-day mortality, device success and postoperative adverse events as defined by the updated Valve Academic Research Consortium (VARC-2). The median age at the time of surgery was 77 years [interquartile range (IQR), 70-81] with a median logistic EuroSCORE and Society of Thoracic Surgeons' Predicted Risk score of 16.1% (IQR, 9.3-28.1) and 3.9% (IQR, 2.2-5.6), respectively. The median Synergy between PCI with Taxus and Cardiac Surgery score was 16.5 (IQR, 9.8-22.8). TAVI implantation routes were transaortic in 9 (45%) patients, transapical and transfemoral in 5 (25%) patients each and transsubclavian in 1 (5%) patient. Complete myocardial revascularization was achieved in 75% of patients. Device success rate was 100%. Paravalvular aortic regurgitation did not exceed mild in any patient. Stroke/transient ischaemic attack, vascular complications and myocardial infarction were not observed. Re-exploration for bleeding was required in 1 (5%) patient. Thirty-day mortality was 0%. Hybrid OPCAB/MIDCAB and TAVI prove to be a safe and effective alternative treatment option in selected higher risk patients.

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.

Correlation between clot density and recanalization success or stroke etiology in acute ischemic stroke patients

PubMed Central

Kallmes, David F; Brinjikji, Waleed

2017-01-01

Background Predicting recanalization success for patients undergoing endovascular treatment for acute ischemic stroke is of significant interest. Studies have previously correlated the success of recanalization with the density of the clot. We evaluated clot density and its relationship to revascularization success and stroke etiology. Methods We conducted a retrospective review of 118 patients undergoing intra-arterial therapy for acute ischemic stroke. Mean and maximum thrombus density was measured by drawing a circular region of interest on an axial slice of a non-contrast computed tomography scan. T-tests were used to compare clot density to recanalization success or to stroke etiology, namely large artery atherosclerosis and cardioembolism. Recanalization success was compared in four device groups: aspiration, stent retriever, aspiration and stent retriever, and all other. Results There was no significant difference in the mean clot density in patients with successful (n = 80) versus unsuccessful recanalization (n = 38, 50.1 ± 7.4 Hounsfield unit (HU) vs. 53 ± 12.7 HU; P = 0.17). Comparing the large artery thromboembolism (n = 35) to the cardioembolic etiology group (n = 56), there was no significant difference in mean clot density (51.5 ± 7.7 HU vs. 49.7 ± 8.5 HU; P = 0.31). A subgroup analysis of middle cerebral artery occlusions (n = 65) showed similar, non-statistically significant differences between groups. There was no difference in the rate of recanalization success in patients with a mean clot density greater than 50 HU or less than 50 HU in each of the four device groups. Conclusions There was no relationship between clot density and revascularization success or stroke etiology in our study. More research is needed to determine if clot density can predict recanalization rates or indicate etiology. PMID:28604188

Autologus Platelet Rich Fibrin aided Revascularization of an immature, non-vital permanent tooth with apical periodontitis: A case report.

PubMed

Jadhav, Ganesh Ranganath; Shah, Dipali; Raghvendra, Srinidhi Surya

2015-01-01

Caries or trauma induced non-vital immature permanent tooth with blunderbuss, thin root which are very common among childrens are corrected using regenerative endodontic (revascularization) procedures. In the presented case, a 16-year-old boy reported with chief complaint of pain in maxillary left central incisor (Tooth #21). Tooth #21 showed grade III mobility, draining labial sinus, and short blunderbuss root with diffuse periapical radiolucency. Patient was explained the treatment plan and written informed consent was taken. Platelet rich fibrin (PRF) was prepared according to standard protocol. Autologous PRF was carried to the apical portion of the root canal after inducing revascularization. Access opening was double sealed with MTA and resin modified glass ionomer cement (RMGI). Baseline, 12 month and 18 month follow-up intraoral radiographs were taken. Clinically case was asymptomatic with complete resolution of intraoral sinus. Periapical healing, apical closure, root lengthening and dentinal wall thickening were uneventful. Thus PRF supplementation hastens the predictability and rate of revascularization in non-vital immature permanent teeth.

Bone marrow mononuclear cell implantation in myocardial laser channels in the ischemic heart disease surgery. Long-term results

NASA Astrophysics Data System (ADS)

Chernyavskiy, Alexander; Fomichev, Alexey; Minin, Stanislav; Nikitin, Nikita

2017-10-01

Background: The problem of incomplete myocardial revascularization for diffuse and distal lesions of the myocardium is still relevant. We assessed the clinical and instrumental long-term results of autologous bone marrow cell (BMC) implantation in laser channels in ischemic heart disease with diffuse and distal coronary disease. 35 coronary heart disease (CHD) patients with diffuse and distal coronary disease during coronary artery bypass grafting (CABG) underwent BMC implantation in laser channels. The control group consisted of 29 patients. All patients in this group underwent only CABG. Clinical and instrumental assessment of the method's effect was carried out at two weeks, six months, and six years after surgery. Indirect revascularization showed more significant decreasing of the functional class (FC) New York Heart Association (NYHA), myocardial perfusion and contractility improvement. Autologous BMC implantation in laser channels is an effective method of CHD surgical treatment if it is impossible to perform direct myocardial revascularization. The indirect revascularization effect is formed in the first six months after surgery and remains at the same level for six years.

77 FR 1083 - Certain Portable Electronic Devices and Related Software; Determination Not To Review Initial...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-09

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-797] Certain Portable Electronic Devices and Related Software; Determination Not To Review Initial Determination Granting Motion To Amend the... the United States after importation of certain portable electronic devices and related software. 76 FR...

Recanalization Therapies in Acute Ischemic Stroke: Pharmacological Agents, Devices, and Combinations

PubMed Central

Sharma, Vijay K.; Teoh, Hock Luen; Wong, Lily Y. H.; Su, Jie; Ong, Benjamin K. C.; Chan, Bernard P. L.

2010-01-01

The primary aim of thrombolysis in acute ischemic stroke is recanalization of an occluded intracranial artery. Recanalization is an important predictor of stroke outcome as timely restoration of regional cerebral perfusion helps salvage threatened ischemic tissue. At present, intravenously administered tissue plasminogen activator (IV-TPA) remains the only FDA-approved therapeutic agent for the treatment of ischemic stroke within 3 hours of symptom onset. Recent studies have demonstrated safety as well as efficacy of IV-TPA even in an extended therapeutic window. However, the short therapeutic window, low rates of recanalization, and only modest benefits with IV-TPA have prompted a quest for alternative approaches to restore blood flow in an occluded artery in acute ischemic stroke. Although intra-arterial delivery of the thrombolytic agent seems effective, various logistic constraints limit its routine use and as yet no lytic agent have not received full regulatory approval for intra-arterial therapy. Mechanical devices and approaches can achieve higher rates of recanalization but their safety and efficacy still need to be established in larger clinical trials. The field of acute revascularization is rapidly evolving, and various combinations of pharmacologic agents, mechanical devices, and novel microbubble/ultrasound technologies are being tested in multiple clinical trials. PMID:20798838

Depressive symptoms are associated with incident coronary heart disease or revascularization among Blacks but not among Whites in the Reasons for Geographical and Racial Differences in Stroke (REGARDS) Study

PubMed Central

Sims, Mario; Redmond, Nicole; Khodneva, Yulia; Durant, Raegan W.; Halanych, Jewell; Safford, Monika M.

2015-01-01

Purpose To examine the association of depressive symptoms with coronary heart disease (CHD) endpoints by race and income. Methods Study participants were Blacks and Whites (n=24,443) without CHD at baseline from the national REasons for Geographical and Racial Differences in Stroke (REGARDS) cohort. Outcomes included acute CHD and CHD or revascularization. We estimated race-stratified multivariable Cox proportional hazards models of incident CHD and incident CHD or revascularization with the 4-item Center for Epidemiological Studies-Depression scale, adjusting for risk factors. Results Mean follow-up was 4.2+1.5 years, CHD incidence was 8.3 events per 1000 person years (n=366) among Blacks and 8.8 events per 1000 person years (n=613) among Whites. After adjustment for age, sex, marital status, region, and socioeconomic status, depressive symptoms were significantly associated with incident CHD among Blacks [HR 1.39 (95%CI 1.00-1.91)], but not among Whites [HR 1.10 (95%CI 0.74-1.64)]. In the fully-adjusted model, compared to Blacks who reported no depressive symptoms, those reporting depressive symptoms had greater risk for the composite endpoint of CHD or revascularization [HR 1.36 (95%CI 1.01-1.81)]. Depressive symptoms were not associated with incident CHD endpoints among Whites. Conclusions High depressive symptoms were associated with higher risk of CHD or revascularization for Blacks but not Whites. PMID:25891100

Survival Benefits of Invasive Versus Conservative Strategies in Heart Failure in Patients With Reduced Ejection Fraction and Coronary Artery Disease: A Meta-Analysis.

PubMed

Wolff, Georg; Dimitroulis, Dimitrios; Andreotti, Felicita; Kołodziejczak, Michalina; Jung, Christian; Scicchitano, Pietro; Devito, Fiorella; Zito, Annapaola; Occhipinti, Michele; Castiglioni, Battistina; Calveri, Giuseppe; Maisano, Francesco; Ciccone, Marco M; De Servi, Stefano; Navarese, Eliano P

2017-01-01

Heart failure with reduced ejection fraction caused by ischemic heart disease is associated with increased morbidity and mortality. It remains unclear whether revascularization by either coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) carries benefits or risks in this group of stable patients compared with medical treatment. We performed a meta-analysis of available studies comparing different methods of revascularization (PCI or CABG) against each other or medical treatment in patients with coronary artery disease and left ventricular ejection fraction ≤40%. The primary outcome was all-cause mortality; myocardial infarction, revascularization, and stroke were also analyzed. Twenty-one studies involving a total of 16 191 patients were included. Compared with medical treatment, there was a significant mortality reduction with CABG (hazard ratio, 0.66; 95% confidence interval, 0.61-0.72; P<0.001) and PCI (hazard ratio, 0.73; 95% confidence interval, 0.62-0.85; P<0.001). When compared with PCI, CABG still showed a survival benefit (hazard ratio, 0.82; 95% confidence interval, 0.75-0.90; P<0.001). The present meta-analysis indicates that revascularization strategies are superior to medical treatment in improving survival in patients with ischemic heart disease and reduced ejection fraction. Between the 2 revascularization strategies, CABG seems more favorable compared with PCI in this particular clinical setting. © 2017 American Heart Association, Inc.

[Effect of revascularization treatment of immature permanent teeth with endodontic infection].

PubMed

Huang, Yibin; Chen, Ke; Zhang, Ying; Xiong, Huacui; Liu, Caiqi

2013-05-01

To observe the effect of revascularization for treatment of immature teeth with endodontic infection mediated by calcium hydroxide. Seventeen pediatric patients with endodontic infections of the permanent teeth were treated with routine root canal and pulp cavity irrigation and disinfection followed by application of calcium hydroxide paste to the root canal orifice to induce revascularization. Another 17 patients received conventional apexification procedures to serve as the control group. The patients were followed up to observe the therapeutic effect of the treatments. In the revascularization treatment group, 4 cases showed healed periapical lesions 6 to 18 months after the surgery with thickened root canal walls and closure of the apical foramen; in 10 cases, the periapical lesions healed 12 to 18 months postoperatively with lengthened root, thickened root canal wall, and narrowed apical foramen. One patient reported pain and swelling at 2 months, and 2 patients showed the formation of gum fistula and ceased development of the roots at 7 and 8 months. In the control group, the periapical lesions healed in 1 cases at 12 months postoperatively with apical foramen closure; in 11 cases, hard tissues formed in the root apex without obviously lengthened roots 6 to 8 months after the surgery; in 5 cases, no apical barrier formed even 12 to 18 months after the surgery. The overall effective rates were similar between the two groups (P>0.05). Revascularization by calcium hydroxide sealing can promote root development of immature permanent teeth with pulpitis or periradicular periodontitis.

Diagnosis of myocardial infarction using the new universal definition: is it enough for risk stratification and guiding decision for revascularization?

PubMed

Calé, Rita; Ferreira, Jorge; Aguiar, Carlos; Santos, Nuno; Carmo, Pedro; Figueira, João; Raposo, Luis; Gonçalves, Pedro; Silva, José Aniceto

2010-12-01

Abstract Objectives: Evaluate the new ESC/ACCF/AHA/WHF universal definition of myocardial infarction (MI) in relation to its prognostic implications and the role for guiding decision for revascularization. It was also compared with the multivariable based GRACE Risk Score (GRS). Single centre registry of 389 consecutive patients admitted with non-ST-segment elevation (NSTE) ACS. We calculated the adjusted HR & 95%CI for death/MI at 30-days and one-year follow-up, between the presence or absence of MI using: (1) universal definition: > 99th URL for cTnI (> 0.06 ng/ml) or MBm (> 3.2 ng/ml); (2) MBm > 2 × URL (> 12.2 ng/ml); 3) old WHO: MBact > 2 × URL (> 32U/l). Logistic analysis was performed to test the interaction between tertiles of biomarkers or GRS and the effect of revascularization on the outcome. The universal definition increased the incidence of MI in 3.5-fold for cTnI, but was not an independent predictor of outcome. The GRS was the only independent predictor of prognosis at 30-days and one-year. The interaction with the prognostic impact of revascularization was only present for the GRS categorized by tertiles. In a contemporary unselected population with NSTE-ACS, the universal definition of MI alone was not adequate for risk assessment and revascularization decision making. These purposes were fully addressed with the GRS.

Postischemic revascularization: from cellular and molecular mechanisms to clinical applications.

PubMed

Silvestre, Jean-Sébastien; Smadja, David M; Lévy, Bernard I

2013-10-01

After the onset of ischemia, cardiac or skeletal muscle undergoes a continuum of molecular, cellular, and extracellular responses that determine the function and the remodeling of the ischemic tissue. Hypoxia-related pathways, immunoinflammatory balance, circulating or local vascular progenitor cells, as well as changes in hemodynamical forces within vascular wall trigger all the processes regulating vascular homeostasis, including vasculogenesis, angiogenesis, arteriogenesis, and collateral growth, which act in concert to establish a functional vascular network in ischemic zones. In patients with ischemic diseases, most of the cellular (mainly those involving bone marrow-derived cells and local stem/progenitor cells) and molecular mechanisms involved in the activation of vessel growth and vascular remodeling are markedly impaired by the deleterious microenvironment characterized by fibrosis, inflammation, hypoperfusion, and inhibition of endogenous angiogenic and regenerative programs. Furthermore, cardiovascular risk factors, including diabetes, hypercholesterolemia, hypertension, diabetes, and aging, constitute a deleterious macroenvironment that participates to the abrogation of postischemic revascularization and tissue regeneration observed in these patient populations. Thus stimulation of vessel growth and/or remodeling has emerged as a new therapeutic option in patients with ischemic diseases. Many strategies of therapeutic revascularization, based on the administration of growth factors or stem/progenitor cells from diverse sources, have been proposed and are currently tested in patients with peripheral arterial disease or cardiac diseases. This review provides an overview from our current knowledge regarding molecular and cellular mechanisms involved in postischemic revascularization, as well as advances in the clinical application of such strategies of therapeutic revascularization.

Parameters influencing the physical activity of patients with a history of coronary revascularization.

PubMed

Acar, Burak; Yayla, Cagri; Gucuk Ipek, Esra; Unal, Sefa; Ertem, Ahmet Goktug; Burak, Cengiz; Senturk, Bihter; Bayraktar, Fatih; Kara, Meryem; Demirkan, Burcu; Guray, Yesim

2017-10-01

Coronary artery disease is the leading cause of mortality worldwide. Regular physical activity is part of a comprehensive management strategy for these patients. We investigated the parameters that influence physical activity in patients with a history of coronary revascularization. We included outpatients with a history of coronary revascularization at least six months prior to enrollment. Data on physical activity, demographics, and clinical characteristics were collected via a questionnaire. A total of 202 consecutive outpatients (age 61.3±11.2 years, 73% male) were enrolled. One hundred and four (51%) patients had previous percutaneous coronary intervention, 67 (33%) had coronary bypass graft surgery, and 31 (15%) had both procedures. Only 46 patients (23%) engaged in regular physical activity. Patients were classified into two subgroups according to their physical activity. There were no significant differences between subgroups in terms of age, comorbid conditions or revascularization type. Multivariate regression analysis revealed that low education level (OR=3.26, 95% CI: 1.31-8.11, p=0.01), and lack of regular follow-up (OR=2.95, 95% CI: 1.01-8.61, p=0.04) were independent predictors of non-adherence to regular physical activity among study subjects. Regular exercise rates were lower in outpatients with previous coronary revascularization. Education level and regular follow-up visits were associated with adherence to physical activity in these patients. Copyright © 2017 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

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.

[Surgical treatment of ishemic mitral regurgitation: repair, replacement or revascularization alone?].

PubMed

Vrenes, Mile; Velinović, Milos; Kocica, Mladen; Mikić, Aleksandar; Putnik, Svetozar; Djukić, Petar; Djordjević, Aleksandar

2010-01-01

Treatment of ischemic mitral regurgitation in patients that require revascularization of myocardium is still debatable. The aim of this study was to compare three surgical approaches: valve repair and revascularization; valve replacement and revascularization, and revascularization alone. In 2006 and 2007 at the Institute for Cardiovascular Diseases, Clinical Centre of Serbia, Belgrade, 1,040 patients with coronary disease underwent surgery. Forty-three patients (4.3%) had also mitral insufficiency 3-4+. The patients were examined clinically, echocardiographically and haemodynamically. In group I there were 14 (32.3%) patients, in group II 16 (37.2%) patients and in group III 3 (30.5%) patients. Ninety-three per cent of patients were classified as New York Heart Association (NYHA) class III and IV, and three (7%) patients had congestive heart weakness with ejection fraction < or =30%. The decision as to surgical procedure was made by the surgeon. Postoperatively, patients were checked clinically and echocardiographically after 3, 6 and 12 months. The follow-up period was approximately 15 months (8-20). Hospital mortality for the whole group was 6.9% (3 patients). In group I mortality was 14.2% (2 patients), in group II 6.25% and in group III there was no mortality. Long term results, up to 15 months, showed 100% survival in groups I and II, and in group III one patient died (7.7%). Short term results upto 30 days were best in group III, but longer term results were better in groups I and II.

Management and decision-making process leading to coronary angiography and revascularization in octogenarians with coronary artery disease: Insights from a large single-center registry.

PubMed

Martin, Anne-Céline; Dumas, Florence; Spaulding, Christian; Manzo-Silberman, Stéphane

2015-05-01

Cardiovascular diseases remain the most common cause of death in older adults. Guidelines state that advanced age alone should not limit the use of invasive therapy. However, coronary angiograms and subsequent revascularization are often not carried out in octogenarians. The benefit/risk balance of an invasive strategy and the decision-making process are not clearly defined. The aim of the present study was to assess the decision-making process, and the in-hospital and long-term mortality based on the clinical presentation, the diagnostic approach (coronary angiogram or conservative) and the therapeutic management (revascularization or not). The present study was a single-center retrospective analysis. A total of 522 patients aged ≥80 years, with a diagnosis of coronary disease were included from 2003 to 2009. The mean age was 82 ± 2.6 years. A total of 195 of 522 (37%) presented with a ST segment elevation myocardial infarction (STEMI). A coronary angiogram was carried out in 316 patients (60.5%) and 71% were treated by percutaneous coronary revascularization. A total of 39.5% were considered ineligible for a coronary angiogram due to cardiological reasons or comorbidities. Excluding cardiogenic shock, overall in-hospital mortality was 4.9%. Clinical presentation strongly influenced both in-hospital and 6-month mortality rates (cardiogenic shock 20% and 28.7%, stable angina 1% and 4.1%, respectively, P < 0.001). Long-term mortality was reduced in the coronary angiography arm compared with the conservative group (14.3% vs 20.9%, P = 0.04) whether or not revascularization was carried out. In the present study, in octogenarians, long-term mortality was lower in the group of patients who underwent a coronary angiogram, regardless of revascularization. The selection process for coronary angiography and angioplasty was mostly influenced by the existence of age-associated comorbidities. Risk prediction models are required to reduce age-dependent biases. © 2014 Japan Geriatrics Society.

Predictive scoring model of mortality after surgical or endovascular revascularization in patients with critical limb ischemia.

PubMed

Shiraki, Tatsuya; Iida, Osamu; Takahara, Mitsuyoshi; Okamoto, Shin; Kitano, Ikurou; Tsuji, Yoshihiko; Terashi, Hiroto; Uematsu, Masaaki

2014-08-01

The latest guideline points to life expectancy of <2 years as the main determinant in revascularization modality selection (bypass surgery [BSX] or endovascular therapy [EVT]) in patients with critical limb ischemia (CLI). This study examined predictors and a predictive scoring model of 2-year mortality after revascularization. We performed Cox proportional hazards regression analysis of data in a retrospective database, the Bypass and Endovascular therapy Against Critical limb ischemia from Hyogo (BEACH) registry, of 459 consecutive CLI patients who underwent revascularization (396 EVT and 63 BSX cases between January 2007 and December 2011) to determine predictors of 2-year mortality. The predictive performance of the score was assessed with the area under the time-dependent receiver operating characteristic curve. Of 459 CLI patients (mean age, 72 ± 10 years; 64% male; 49% nonambulatory status, 68% diabetes mellitus, 47% on regular dialysis, and 18% rest pain and 82% tissue loss as treatment indication), 84 died within 2 years after revascularization. In a multivariate model, age >75 years (hazard ratio [HR], 1.77; 95% confidence interval [CI], 1.10-2.85), nonambulatory status (HR, 5.32; 95% CI, 2.96-9.56), regular dialysis (HR, 1.90; 95% CI, 1.10-3.26), and ejection fraction <50% (HR, 2.49; 95% CI, 1.48-4.20) were independent predictors of 2-year mortality. The area under the time-dependent receiver operating characteristic curve for the developed predictive BEACH score was 0.81 (95% CI, 0.76-0.86). Predictors of 2-year mortality after EVT or BSX in CLI patients included age >75 years, nonambulatory status, regular dialysis, and ejection fraction <50%. The BEACH score derived from these predictors allows risk stratification of CLI patients undergoing revascularization. Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Heart Failure with Preserved Ejection Fraction: Comparison of Patients With and Without Angina Pectoris (From the Duke Databank for Cardiovascular Disease)

PubMed Central

Mentz, Robert J.; Broderick, Samuel; Shaw, Linda K.; Fiuzat, Mona; O'Connor, Christopher M.

2013-01-01

Objectives We aimed to investigate the characteristics and outcomes of patients with heart failure with preserved ejection fraction (HFpEF) and angina pectoris (AP). Background AP is a predictor of adverse events in patients with heart failure with reduced EF. The implications of AP in HFpEF are unknown. Methods We analyzed HFpEF patients (EF≥50%) who underwent coronary angiography at Duke University Medical Center from 2000–2010 with and without AP in the previous 6 weeks. Time to first event was examined using Kaplan-Meier methods for the primary endpoint of death/myocardial infarction (MI)/revascularization/stroke (i.e., MACE) and secondary endpoints of death/MI/revascularization, death/MI/stroke, death/MI, death and cardiovascular death/cardiovascular hospitalization. Results In the Duke Databank, 3517 patients met criteria for inclusion and 1402 (40%) had AP. Those with AP were older with more comorbidities, and prior revascularization vs. non-AP patients. AP patients more often received beta-blockers, ACE-inhibitors, nitrates, and statins (all P<0.05). In unadjusted analysis, AP patients had increased MACE and death/MI/revascularization (both P <0.001), lower rates of death and death/MI (both P<0.05), and similar rates of death/MI/stroke and cardiovascular death/cardiovascular hospitalization (both P>0.1). After multivariable adjustment, those with AP remained at increased risk for MACE (Hazard Ratio [HR] 1.30; 95% Confidence Interval [CI], 1.17–1.45) and death/MI/revascularization (HR 1.29; 95% CI, 1.15–1.43), but were at similar risk for other endpoints (P>0.06). Conclusions AP in HFpEF patients with a history of coronary artery disease is common despite medical therapy and is independently associated with increased MACE due to revascularization with similar risk of death, MI, and hospitalization. PMID:24161322

The impact of ICD-9 revascularization procedure codes on estimates of racial disparities in ischemic stroke.

PubMed

Boan, Andrea D; Voeks, Jenifer H; Feng, Wuwei Wayne; Bachman, David L; Jauch, Edward C; Adams, Robert J; Ovbiagele, Bruce; Lackland, Daniel T

2014-01-01

The use of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9) diagnostic codes can identify racial disparities in ischemic stroke hospitalizations; however, inclusion of revascularization procedure codes as acute stroke events may affect the magnitude of the risk difference. This study assesses the impact of excluding revascularization procedure codes in the ICD-9 definition of ischemic stroke, compared with the traditional inclusive definition, on racial disparity estimates for stroke incidence and recurrence. Patients discharged with a diagnosis of ischemic stroke (ICD-9 codes 433.00-434.91 and 436) were identified from a statewide inpatient discharge database from 2010 to 2012. Race-age specific disparity estimates of stroke incidence and recurrence and 1-year cumulative recurrent stroke rates were compared between the routinely used traditional classification and a modified classification of stroke that excluded primary ICD-9 cerebral revascularization procedures codes (38.12, 00.61, and 00.63). The traditional classification identified 7878 stroke hospitalizations, whereas the modified classification resulted in 18% fewer hospitalizations (n = 6444). The age-specific black to white rate ratios were significantly higher in the modified than in the traditional classification for stroke incidence (rate ratio, 1.50; 95% confidence interval [CI], 1.43-1.58 vs. rate ratio, 1.24; 95% CI, 1.18-1.30, respectively). In whites, the 1-year cumulative recurrence rate was significantly reduced by 46% (45-64 years) and 49% (≥ 65 years) in the modified classification, largely explained by a higher rate of cerebral revascularization procedures among whites. There were nonsignificant reductions of 14% (45-64 years) and 19% (≥ 65 years) among blacks. Including cerebral revascularization procedure codes overestimates hospitalization rates for ischemic stroke and significantly underestimates the racial disparity estimates in stroke incidence and recurrence. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

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.

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.

Effectiveness of a Medical vs Revascularization Intervention for Intermittent Leg Claudication Based on Patient-Reported Outcomes.

PubMed

Devine, Emily B; Alfonso-Cristancho, Rafael; Yanez, N David; Edwards, Todd C; Patrick, Donald L; Armstrong, Cheryl A L; Devlin, Allison; Symons, Rebecca G; Meissner, Mark H; Derrick, Ellen L T; Lavallee, Danielle C; Kessler, Larry G; Flum, David R

2016-10-19

Intermittent claudication (IC) is the most common presentation of infrainguinal peripheral artery disease. Both medical and revascularization interventions for IC aim to increase walking comfort and distance, but there is inconclusive evidence of the comparative benefit of revascularization given the possible risk of limb loss. To compare the effectiveness of a medical (walking program, smoking cessation counseling, and medications) vs revascularization (endovascular or surgical) intervention for IC in the community, focusing on outcomes of greatest importance to patients. Longitudinal (12-month follow-up) prospective observational cohort study conducted between July 3, 2011, and November 5, 2014, at 15 clinics associated with 11 hospitals in Washington State. Participants were 21 years or older with newly diagnosed or established IC. Medical or revascularization interventions. Primary end points were 12-month change scores on the distance, speed, and stair-climb domains of the Walking Impairment Questionnaire (score range, 0-100). Secondary outcomes were change scores on the Walking Impairment Questionnaire pain domain (score range, 0-100), Vascular Quality of Life Questionnaire (VascuQol) (score range, 1-7), European Quality of Life-5 Dimension Questionnaire (EQ-5D) (score range, 0-1), and Claudication Symptom Instrument (CSI) (score range, 0-4). A total of 323 adults were enrolled, with 282 (87.3%) in the medical cohort. At baseline, the mean duration of disease was longer for participants in the medical cohort, while those in the revascularization cohort reported more severe disease. Other characteristics were well balanced. At 12 months, change scores in the medical cohort reached significance for the following 3 outcomes: speed (5.9; 95% CI, 0.5-11.3; P = .03), VascuQol (0.28; 95% CI, 0.08-0.49; P = .008), and EQ-5D (0.038; 95% CI, 0.011-0.066; P = .006). In the revascularization cohort, there were significant improvements in the following 7 outcomes: distance (19.5; 95% CI, 7.9-31.0; P = .001), speed (12.1; 95% CI, 1.4-22.8; P = .03), stair climb (11.4; 95% CI, 1.3-21.5; P = .03), pain (20.7; 95% CI, 11.0-30.4; P < .001), VascuQol (1.10; 95% CI, 0.80-1.41; P < .001), EQ-5D (0.113; 95% CI, 0.067-0.159; P < .001), and CSI (-0.63; 95% CI, -0.96 to -0.31; P < .001). Relative improvements (percentage changes) at 12 months in the revascularization cohort over the medical cohort were observed as follows: distance (39.1%), speed (15.6%), stair climb (9.7%), pain (116.9%), VascuQol (41%), EQ-5D (18%), and CSI (13.5%). Among patients with IC, those in the revascularization cohort had significantly improved function (Walking Impairment Questionnaire), better health-related quality of life (VascuQol and EQ-5D), and fewer symptoms (CSI) at 12 months compared with those in the medical cohort, providing important information to inform treatment strategies in the community.

77 FR 40083 - Certain Personal Data and Mobile Communications Devices and Related Software; Institution of a...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-06

... Communications Devices and Related Software; Institution of a Formal Enforcement Proceeding; Denial of Request... subsidiary NeXT Software, Inc., both of Cupertino, California (collectively, ``Apple''), alleging a violation... importation of certain personal data and mobile communications devices and related software. 75 FR 17434 (Apr...

Successful rotational atherectomy over RG3 guidewire after failure of various techniques to deliver RotaWire.

PubMed

Kaneko, Umihiko; Kashima, Yoshifumi; Kanno, Daitaro; Sugie, Takuro; Kobayashi, Ken; Fujita, Tsutomu

2017-10-01

Although performing rotational atherectomy (RA) requires guidewire exchange for the dedicated guidewire, RotaWire guidewire (Boston Scientific) exhibits much lower performance than conventional guidewire. Consequently, there are times when RotaWire cannot be advanced past the lesion independently or using a microcatheter exchange technique, rendering RA impossible. We present a case of a heavily calcified, device-uncrossable, and non-expansible chronic total occlusion lesion successfully revascularized with RA over RG3 guidewire (Asahi Intecc), which has a length of 330 cm, hydrophilic coating, and a 0.010-inch-long shaft. RG3 provided excellent cross-ability and RA could also be performed over RG3 without guidewire exchange for the RotaWire.

Multiple Coaxial Catheter System for Reliable Access in Interventional Stroke Therapy

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

Kulcsar, Zsolt, E-mail: kulcsarzsolt22@gmail.com; Yilmaz, Hasan; Bonvin, Christophe

2010-12-15

In some patients with acute cerebral vessel occlusion, navigating mechanical thrombectomy systems is difficult due to tortuous anatomy of the aortic arch, carotid arteries, or vertebral arteries. Our purpose was to describe a multiple coaxial catheter system used for mechanical revascularization that helps navigation and manipulations in tortuous vessels. A triple or quadruple coaxial catheter system was built in 28 consecutive cases presenting with acute ischemic stroke. All cases were treated by mechanical thrombectomy with the Penumbra System. In cases of unsuccessful thrombo-aspiration, additional thrombolysis or angioplasty with stent placement was used for improving recanalization. The catheter system consisted ofmore » an outermost 8-Fr and an intermediate 6-Fr guiding catheter, containing the inner Penumbra reperfusion catheters. The largest, 4.1-Fr, reperfusion catheter was navigated over a Prowler Select Plus microcatheter. The catheter system provided access to reach the cerebral lesions and provided stability for the mechanically demanding manipulations of thromboaspiration and stent navigation in all cases. Apart from their mechanical role, the specific parts of the system could also provide access to different types of interventions, like carotid stenting through the 8-Fr guiding catheter and intracranial stenting and thrombolysis through the Prowler Select Plus microcatheter. In this series, there were no complications related to the catheter system. In conclusion, building up a triple or quadruple coaxial system proved to be safe and efficient in our experience for the mechanical thrombectomy treatment of acute ischemic stroke.« less

21 CFR 872.2060 - Jaw tracking device.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2060 Jaw tracking device. (a) Jaw tracking device... Controls Guidance Document: Dental Sonography and Jaw Tracking Devices.” [68 FR 67367, Dec. 2, 2003] ...

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

Reliability of clinical guideline development using mail-only versus in-person expert panels.

PubMed

Washington, Donna L; Bernstein, Steven J; Kahan, James P; Leape, Lucian L; Kamberg, Caren J; Shekelle, Paul G

2003-12-01

Clinical practice guidelines quickly become outdated. One reason they might not be updated as often as needed is the expense of collecting expert judgment regarding the evidence. The RAND-UCLA Appropriateness Method is one commonly used method for collecting expert opinion. We tested whether a less expensive, mail-only process could substitute for the standard in-person process normally used. We performed a 4-way replication of the appropriateness panel process for coronary revascularization and hysterectomy, conducting 3 panels using the conventional in-person method and 1 panel entirely by mail. All indications were classified as inappropriate or not (to evaluate overuse), and coronary revascularization indications were classified as necessary or not (to evaluate underuse). Kappa statistics were calculated for the comparison in ratings from the 2 methods. Agreement beyond chance between the 2 panel methods ranged from moderate to substantial. The kappa statistic to detect overuse was 0.57 for coronary revascularization and 0.70 for hysterectomy. The kappa statistic to detect coronary revascularization underuse was 0.76. There were no cases in which coronary revascularization was considered inappropriate by 1 method, but necessary or appropriate by the other. Three of 636 (0.5%) hysterectomy cases were categorized as inappropriate by 1 method but appropriate by the other. The reproducibility of the overuse and underuse assessments from the mail-only compared with the conventional in-person conduct of expert panels in this application was similar to the underlying reproducibility of the process. This suggests a potential role for updating guidelines using an expert judgment process conducted entirely through the mail.

Revascularization procedures for Kienböck disease.

PubMed

Kakar, Sanjeev; Giuffre, Jennifer L; Shin, Alexander Y

2011-03-01

The goals of treatment in Kienböck disease include preservation of wrist function, maintaining normal wrist kinematics, and revascularization of the necrotic lunate when and if possible. A variety of pedicled vascularized bone graft options exist and include but are not limited to pedicled grafts from the volar radius, dorsal radius, metacarpal heads or bases, and pisiform. Of the various treatment options, pedicled vascularized bone grafts from the dorsal distal radius based on the fourth and fifth extensor compartment arteries has been successful in the revascularization of the necrotic lunate at our institution. Vascularized bone grafting is an attractive alternative to conventional bone grafting by improving the local biological environment and thereby promoting revascularization. Recent advances in the anatomy and physiology of vascularized pedicled bone grafts have increased our ability to apply them to the treatment of Kienböck disease. The purpose of this article is to describe the various types of pedicled vascularized bone graft available, to detail the vascular anatomy of the dorsal distal radius, and to describe the surgical technique of our preferred vascularized bone graft (the fourth+fifth extensor compartment artery graft). In addition, the indications, contraindications, and outcomes are described.

Follow-up of renal and mesenteric artery revascularization with duplex ultrasonography

PubMed Central

Taylor, David C.; Houston, Gordon T.M.; Anderson, Caroline; Jameson, Margot; Popatia, Shelley

1996-01-01

Objective To evaluate the long-term anatomic results of renal revascularization procedures using duplex ultrasonography. Design A case series. Setting A university-affiliated hospital. Patients Twenty-five patients who had undergone renal percutaneous transluminal angioplasty (PTA) (18 arteries), renal bypass (10 arteries) and mesenteric bypass (6 arteries). The mean follow-up was 22 months (range from 3 to 48 months) for those who underwent renal PTA, 23 months (range from 1.5 to 70 months) for those who underwent renal bypass and 34 months (range from 8 to 144 months) for those who underwent mesenteric bypass. Main Outcome Measures Patency rates for the three procedures as assessed by duplex ultrasonography. Results Duplex ultrasonography demonstrated patency without stenosis after renal and mesenteric artery revascularization in 14 arteries subjected to renal PTA, 9 arteries subjected to renal bypass and 6 arteries subjected to mesenteric bypass. Three arteries that had renal PTA had recurrent vessel stenosis and one had occlusion. One artery that had renal bypass showed occlusion. Conclusions Renal PTA, renal bypass and mesenteric bypass are durable procedures at 2 years of follow-up, and duplex ultrasonography is a valuable method for assessing the patency of arteries after renal and mesenteric revascularization. PMID:8599785

Revascularization of immature mandibular premolar with pulpal necrosis - a case report.

PubMed

Raju, S Murali Krishna; Yadav, Sarjeev Singh; Kumar M, Sita Rama

2014-09-01

This case report describes the Revascularization of a Permanent Immature Mandibular Premolar with Pulp Necrosis and apical periodontitis. Access opening was done & the canal was disinfected with copious irrigation using 2.5% NaOCl and triple antibiotic paste (Ciprofloxacin, Metronidazole, and Minocycline) as intracanal medicament. After the disinfection protocol is complete, it is followed by revascularization procedure. The apex was mechanically irritated to initiate bleeding into the canal to produce a blood clot to the level just below the level of cementoenamel junction. Mineral trioxide aggregate was placed over the blood clot followed by bonded resin restoration above it. After one year follow up; the patient was asymptomatic, no sinus tract was evident. Apical periodontitis was resolved, and there was radiographic evidence of continuing thickness of dentinal walls.

[Oxygen-transporting function of the blood circulation system in sevoflurane anesthesia during myocardial revascularization under extracorporeal circulation].

PubMed

Skopets, A A; Lomivorotov, V V; Karakhalis, N B; Makarov, A A; Duman'ian, E S; Lomivorotova, L V

2009-01-01

The purpose of the study was to evaluate the efficiency of oxygen-transporting function of the circulatory system under sevoflurane anesthesia during myocardial revascularization operations under extracorporeal circulation. Twenty-five patients with coronary heart disease were examined. Mean blood pressure, heart rate, cardiac index, total peripheral vascular resistance index, pulmonary pressure, pulmonary wedge pressure, and central venous pressure were measured. Arterial and mixed venous blood oxygen levels, oxygen delivery and consumption index, arteriovenous oxygen difference, and glucose and lactate concentrations were calculated. The study has demonstrated that sevoflurane is an effective and safe anesthetic for myocardial revascularization operations in patients with coronary heart disease. The use of sevoflurane contributes to steady-state oxygen-transporting function of the circulatory system at all surgical stages.

Patient selection and perioperative outcomes of bypass and endovascular intervention as first revascularization strategy for infrainguinal arterial disease.

PubMed

Bodewes, Thomas C F; Darling, Jeremy D; Deery, Sarah E; O'Donnell, Thomas F X; Pothof, Alexander B; Shean, Katie E; Moll, Frans L; Schermerhorn, Marc L

2018-01-01

The optimal initial revascularization strategy remains uncertain for patients with peripheral arterial disease. The purpose of this study was to evaluate current nationwide selection and perioperative outcomes of patients undergoing bypass or endovascular intervention for infrainguinal disease in those with no prior ipsilateral revascularization. Patients undergoing nonemergent first-time infrainguinal revascularization were identified in the Targeted Vascular module of the National Surgical Quality Improvement Program (NSQIP) for 2011 to 2014 and stratified by symptom status (chronic limb-threatening ischemia [CLTI] or claudication). Patients treated with endovascular intervention were compared with those who underwent bypass. Multivariable logistic regression was used to evaluate current selection of patients and to establish independent associations between first-time procedures and postoperative outcomes. Of 5998 first-time infrainguinal revascularizations performed, 3193 were bypass procedures (63% for CLTI) and 2805 were endovascular interventions (64% for CLTI). Current patient characteristics associated with an endovascular-first approach as opposed to bypass-first in CLTI patients were age ≥80 years, tissue loss, nonsmoking, functional dependence, diabetes, dialysis, and tibial lesions, whereas age ≥80 years, nonwhite race, nonsmoking, diabetes, and tibial lesions were associated with an endovascular approach for claudication. In comparing first-time endovascular intervention with bypass, there was no difference in 30-day mortality in CLTI patients (univariate: 2.1% vs 2.2%; adjusted: odds ratio [OR], 0.7; 95% confidence interval [CI], 0.4-1.1) or claudication patients (0.3% vs 0.6%). Among CLTI patients, endovascular-first intervention was associated with lower rates of major adverse cardiovascular event (3.6% vs 4.7%; OR, 0.6; 95% CI, 0.4-0.9), surgical site infection (0.9% vs 7.7%; OR, 0.1; 95% CI, 0.1-0.2), bleeding (8.5% vs 17%; OR, 0.4; 95% CI, 0.3-0.5), unplanned reoperation (13% vs 17%; OR, 0.7; 95% CI, 0.5-0.8), and unplanned readmission (17% vs 18%; OR, 0.8; 95% CI, 0.7-0.9). Patients with claudication undergoing endovascular-first intervention also had lower rates of major adverse cardiovascular event (0.8% vs 1.6%; OR, 0.4; 95% CI, 0.2-0.95), surgical site infection (0.7% vs 6.6%; OR, 0.1; 95% CI, 0.04-0.2), bleeding (2.3% vs 6.0%; OR, 0.3; 95% CI, 0.2-0.5), unplanned reoperation (4.3% vs 6.6%; OR, 0.6; 95% CI, 0.4-0.9), and unplanned readmission (5.9% vs 9.0%; OR, 0.6; 95% CI, 0.4-0.8). Conversely, endovascular-first intervention was associated with a higher rate of secondary revascularizations within 30 days for CLTI (4.3% vs 3.1%; OR, 1.6; 95% CI, 1.04-2.3) but not for claudication (2.6% vs 1.9%; OR, 1.7; 95% CI, 0.9-3.4). An endovascular-first approach as a revascularization strategy for infrainguinal disease was associated with substantially lower early morbidity but not mortality, at the cost of higher rates of postoperative secondary revascularizations. As a national representation of first-time revascularizations, this study highlights the early endovascular perioperative benefit, although more robust long-term data are needed to adopt either one strategy or the other in select patients with peripheral arterial disease. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Initial experience with a dedicated coronary re-entry device for revascularization of chronic total occlusions.

PubMed

Whitlow, Patrick L; Lombardi, William L; Araya, Mario; Michael Wyman, R; Torres, Humberto; Dauvergne, Christian; Tsuchikane, Etsuo; Lansky, Alexandra; Thompson, Craig A

2012-11-01

The aim of this registry was to evaluate a new device designed to facilitate antegrade guidewire re-entry into the true lumen of a chronic total coronary occlusion (CTO) from the adjacent subintimal space. Successful recanalization of CTOs results in clinical improvement in appropriately selected patients. CTO intervention is time- and resource-consuming, and a simplified approach enabling antegrade guidewire re-entry into the distal true lumen might improve success. Patients with CTO and ischemia were entered into a prospective registry regardless of lesion characteristics. If wire manipulation resulted in subintimal wire entrapment, a new re-entry tool (a 2.5-mm flat subintimal balloon with two exit ports offset by 180°) was used as a platform to attempt guidewire penetration into the distal true lumen. The primary endpoint assessed was successful device-guided re-entry. Standard techniques were then utilized to open the CTO. In 40 consecutive CTO lesions attempted, 19 resulted in subintimal wire entrapment (mean occlusion length 44 mm). Sixteen of these 19 were successfully crossed with an antegrade guidewire into the distal true lumen using the new device (84%). One patient with unsuccessful re-entry was subsequently recanalized with a retrograde technique. All crossed lesions were stented (17/17), resulting in TIMI 3 flow without major complications. Two cases were unsuccessful. One patient had a grade I coronary perforation requiring no treatment. A new device to recanalize CTOs complicated by subintimal wire entrapment can be used successfully by experienced operators. Further study of this coronary re-entry device is ongoing. Copyright © 2011 Wiley Periodicals, Inc.

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.

Use of a Temporary Shunt as a Salvage Technique for Distal Extremity Amputations Requiring Repair by Vessel Grafting during Critical Ischemia

PubMed Central

Dadaci, Mehmet; Altuntas, Zeynep

2016-01-01

Background Although the use of temporary shunts in proximal extremity amputations has been reported, no study has described the use of temporary shunts in distal extremity amputations that require vein grafting. Moreover, the total volume of blood loss when temporary shunts are used has not been reported. The aim of this study was to investigate the applicability of a temporary shunt for distal extremity amputations requiring repair by vessel grafting with an ischemia time of >6 hours. This study also aimed to determine the total volume of blood loss when temporary shunts were used. Methods Patients who underwent distal major extremity replantation and/or revascularization with a vessel graft and who experienced ischemia for 6–8 hours between 2013 and 2014 were included in the study. A 6-Fr suction catheter was cut to 5 cm in length after the infusion of heparin, and secured with a 5-0 silk suture between the distal and the proximal ends of the artery. While bleeding continued, the bones were shortened and fixed. After the complete restoration of circulation, the arterial shunt created using the catheter was also repaired with a vein graft. Results Six patients were included in this study. The mean duration of ischemia was 7.25 hours. The mean duration of suction catheter use during limb revascularization was 7 minutes. The mean transfusion volume was 7.5 units. No losses of the extremity were observed. Conclusions This procedure should be considered in distal extremity amputations requiring repair by vessel grafting during critical ischemia. PMID:27896186

Incessant ventricular tachycardia early after acute myocardial infarction: efficacy of radiofrequency catheter ablation but not of optimal coronary revascularization.

PubMed

Bonanno, C; Ometto, R; Finocchi, G; Rulfo, F; La Vecchia, L; Vincenzi, M

1999-12-01

Incessant ventricular tachycardia is an arrhythmia refractory to conventional antiarrhythmic treatment. We describe the case of 55-year-old man who presented incessant ventricular tachycardia in the early post-acute phase of myocardial infarction. Optimal coronary revascularization was not effective, but radiofrequency catheter ablation was able to eliminate the anatomic substrate and clinical arrhythmic recurrence.

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

The Effect of Clinical Care Location on Clinical Outcomes After Peripheral Vascular Intervention in Medicare Beneficiaries.

PubMed

Turley, Ryan S; Mi, Xiaojuan; Qualls, Laura G; Vemulapalli, Sreekanth; Peterson, Eric D; Patel, Manesh R; Curtis, Lesley H; Jones, W Schuyler

2017-06-12

Modifications in reimbursement rates by Medicare in 2008 have led to peripheral vascular interventions (PVI) being performed more commonly in outpatient and office-based clinics. The objective of this study was to determine the effects of this shift in clinical care setting on clinical outcomes after PVI. Modifications in reimbursement have led to peripheral vascular intervention (PVI) being more commonly performed in outpatient hospital settings and office-based clinics. Using a 100% national sample of Medicare beneficiaries from 2010 to 2012, we examined 30-day and 1-year rates of all-cause mortality, major lower extremity amputation, repeat revascularization, and all-cause hospitalization by clinical care location of index PVI. A total of 218,858 Medicare beneficiaries underwent an index PVI between 2010 and 2012. Index PVIs performed in inpatient settings were associated with higher 1-year rates of all-cause mortality (23.6% vs. 10.4% and 11.7%; p < 0.001), major lower extremity amputation (10.1% vs. 3.7% and 3.5%; p < 0.001), and all-cause repeat hospitalization (63.3% vs. 48.5% and 48.0%; p < 0.001), but lower rates of repeat revascularization (25.1% vs. 26.9% vs. 38.6%; p < 0.001) when compared with outpatient hospital settings and office-based clinics, respectively. After adjustment for potential confounders, patients treated in office-based clinics remained more likely than patients in inpatient hospital settings to require repeat revascularization within 1 year across all specialties. There was also a statistically significant interaction effect between location of index revascularization and geographic region on the occurrence of all-cause hospitalization, repeat revascularization, and lower extremity amputation. Index PVI performed in office-based settings was associated with a higher hazard of repeat revascularization when compared with other settings. Differences in clinical outcomes across treatment settings and geographic regions suggest that inconsistent application of PVI may exist and highlights the need for studies to determine optimal delivery of PVI in clinical practice. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Heart failure with preserved ejection fraction: comparison of patients with and without angina pectoris (from the Duke Databank for Cardiovascular Disease).

PubMed

Mentz, Robert J; Broderick, Samuel; Shaw, Linda K; Fiuzat, Mona; O'Connor, Christopher M

2014-01-28

This study investigated the characteristics and outcomes of patients with heart failure with preserved ejection fraction (HFpEF) and angina pectoris (AP). AP is a predictor of adverse events in patients with heart failure with reduced EF. The implications of AP in HFpEF are unknown. We analyzed HFpEF patients (EF ≥50%) who underwent coronary angiography at Duke University Medical Center from 2000 through 2010 with and without AP in the previous 6 weeks. Time to first event was examined using Kaplan-Meier methods for the primary endpoint of death/myocardial infarction (MI)/revascularization/stroke (i.e., major adverse cardiac events [MACE]) and secondary endpoints of death/MI/revascularization, death/MI/stroke, death/MI, death, and cardiovascular death/cardiovascular hospitalization. In the Duke Databank, 3,517 patients met criteria for inclusion and 1,402 (40%) had AP. Those with AP were older with more comorbidities and prior revascularization compared with non-AP patients. AP patients more often received beta-blockers, angiotensin-converting enzyme inhibitors, nitrates, and statins (all p < 0.05). In unadjusted analysis, AP patients had increased MACE and death/MI/revascularization (both p < 0.001), lower rates of death and death/MI (both p < 0.05), and similar rates of death/MI/stroke and cardiovascular death/cardiovascular hospitalization (both p > 0.1). After multivariable adjustment, those with AP remained at increased risk for MACE (hazard ratio [HR]: 1.30, 95% confidence interval [CI]: 1.17 to 1.45) and death/MI/revascularization (HR: 1.29, 95% CI: 1.15 to 1.43), but they were at similar risk for other endpoints (p > 0.06). AP in HFpEF patients with a history of coronary artery disease is common despite medical therapy and is independently associated with increased MACE due to revascularization with similar risk of death, MI, and hospitalization. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Multivessel disease in patients over 75years old with ST elevated myocardial infarction. Current management strategies and related clinical outcomes in the ESTROFA MI+75 nation-wide registry.

PubMed

de La Torre Hernandez, Jose M; Gomez Hospital, Joan A; Baz, Jose A; Brugaletta, Salvatore; Perez de Prado, Armando; Linares, Jose A; Lopez Palop, Ramón; Cid, Belen; Garcia Camarero, Tamara; Diego, Alejandro; Gutierrez, Hipolito; Fernandez Diaz, Jose A; Sanchis, Juan; Alfonso, Fernando; Blanco, Roberto; Botas, Javier; Navarro Cuartero, Javier; Moreu, Jose; Bosa, Francisco; Vegas, Jose M; Elizaga, Jaime; Arrebola, Antonio L; Hernandez, Felipe; Salvatella, Neus; Monteagudo, Marta; Gomez Jaume, Alfredo; Carrillo, Xavier; Martin Reyes, Roberto; Lozano, Fernando; Rumoroso, Jose R; Andraka, Leire; Dominguez, Antonio J

2017-12-06

In elderly patients with ST elevated myocardial infarction (STEMI) and multivessel disease (MVD the outcomes related with different revascularization strategies are not well known. Subgroup-analysis of a nation-wide registry of primary angioplasty in the elderly (ESTROFA MI+75) with 3576 patients over 75years old from 31 centers. Patients with MVD were analyzed to describe treatment approaches and 2years outcomes. Of 1830 (51%) with MVD, 847 (46%) underwent multivessel revascularization either in acute (51%), staged (44%) or both procedures (5%). Patients with previous myocardial infarction and those receiving drug-eluting stents or IIb-IIIa inhibitors were more prone to be revascularized, whereas older patients, females and those with Killip III-IV, renal failure and higher ejection fraction were less likely. Survival free of cardiac death and infarction at 2years was better for those undergoing multivessel PCI (85.8% vs. 80.4%, p<0.0008), regardless of Killip class. Multivessel PCI was protective of cardiac death and infarction (HR 0.60, 95% CI 0.40-0.89; p=0.011). Complete revascularization made no difference in outcomes among those patients undergoing multivessel PCI. The best prognosis corresponded to those undergoing multivessel PCI in staged procedures (p<0.001). A propensity score matching analysis (514 patients in each group) yielded similar results. In elderly patients with STEMI and MVD, multivessel PCI was related with better outcomes especially after staged procedures. Among those undergoing multivessel PCI, anatomically defined completeness of revascularization had not prognostic influence. We sought to investigate the revascularization strategies applied and their prognostic implications in patients aged over 75years with ST elevated myocardial infarction showing multivessel disease. Of 1830 patients, 847 (46%) underwent multivessel PCI either in acute (51%), staged (44%) or both procedures (5%). Multivessel PCI was independent predictor of cardiac death and infarction with the best prognosis corresponding to those undergoing staged procedures. Copyright © 2017. Published by Elsevier Inc.

Comparison of the survival between coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with poor left ventricular function (ejection fraction <30%): a propensity-matched analysis.

PubMed

Shah, Shaneel; Benedetto, Umberto; Caputo, Massimo; Angelini, Gianni D; Vohra, Hunaid A

2018-06-22

Existing evidence comparing the outcomes of coronary artery bypass graft (CABG) surgery versus percutaneous coronary intervention (PCI) in patients with poor left ventricular function (LVF) is sparse and flawed. This is largely due to patients with poor LVF being underrepresented in major research trials and the outdated nature of some studies that do not consider drug-eluting stent PCI. Following strict inclusion criteria, 717 patients who underwent revascularization by CABG or PCI between 2002 and 2015 were enrolled. All patients had poor LVF (defined by ejection fraction <30%). By employing a propensity score analysis, 134 suitable matches (67 CABG and 67 PCI) were identified. Several outcomes were evaluated, in the matched population, using data extracted from national registry databases. CABG patients required a longer length of hospital stay post-revascularization compared to PCI in the propensity-matched population, 7 days (lower-upper quartile; 6-12) and 2 days (lower-upper quartile; 1-6), respectively (Mood's median test, P = 0.001). Stratified Cox-regression proportional-hazards analysis of the propensity-matched population found that PCI patients experienced a higher adjusted 8-year mortality rate (hazard ratio 3.291, 95% confidence interval 1.776-6.101; P < 0.001). This trend was consistent amongst urgent cases of revascularization: patients with 3 or more vessels with coronary artery disease and patients where complete revascularization was achieved. Although sub-analyses found no difference between survival distributions of on-pump versus off-pump CABG (log-rank P = 0.726), both modes of CABG were superior to PCI (stratified log-rank P = 0.002). Despite a longer length of hospital stay, patients with impaired LVF requiring intervention for coronary artery disease experienced a greater post-procedural survival benefit if they received CABG compared to PCI. We have demonstrated this at 30 days, 90 days, 1 year, 3 years, 5 years and 8 years following revascularization. At present, CABG remains a superior revascularization modality to PCI in patients with poor LVF.

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

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.

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

Early Ventricular Tachycardia or Fibrillation in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention and Impact on Mortality and Stent Thrombosis (from the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction Trial).

PubMed

Kosmidou, Ioanna; Embacher, Monica; McAndrew, Thomas; Dizon, José M; Mehran, Roxana; Ben-Yehuda, Ori; Mintz, Gary S; Stone, Gregg W

2017-11-15

The prevalence and impact of early ventricular arrhythmias (ventricular tachycardia [VT]/ventricular fibrillation [VF]) occurring before mechanical revascularization for acute ST segment elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention are poorly understood. We sought to investigate the association between early VT/VF and long-term clinical outcomes using data from the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial. Among 3,602 patients with STEMI, 108 patients (3.0%) had early VT/VF. Baseline clinical characteristics were similar in patients with versus without early VT/VF. Patients with early VT/VF had shorter symptom-to-balloon times and lower left ventricular ejection fraction and underwent more frequent thrombectomy compared with patients without early VT/VF. Adjusted 3-year rates of all-cause death (15.7% vs 6.5%; adjusted hazard ratio 2.62, 95% confidence interval 1.48 to 4.61, p <0.001) and stent thrombosis (13.7% vs 5.7%; adjusted hazard ratio 2.74, 95% confidence interval 1.52 to 4.93, p <0.001) were significantly higher in patients with early VT/VF compared with patients without early VT/VF. In conclusion, in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial, VT/VF occurring before coronary angiography and revascularization in patients with STEMI was strongly associated with increased 3-year rates of death and stent thrombosis. Further investigation into the mechanisms underlying the increased risk of early stent thrombosis in patients with early VT/VF is required. Copyright © 2017 Elsevier Inc. All rights reserved.

Increased Arterial Stiffness after Coronary Artery Revascularization Correlates with Serious Coronary Artery Lesions and Poor Clinical Outcomes in Patients with Chronic Kidney Disease

PubMed Central

Zhu, Zhengbin; Yan, Zijun; Zhang, Lin; Du, Run; Zhu, Jinzhou; Zuo, Junli; Chu, Shaoli; Shen, Weifeng; Zhang, Ruiyan

2014-01-01

Objectives This study aimed to clarify the relationship between arterial stiffness and coronary artery lesions as well as their influence on long-term outcomes after coronary artery revascularization in patients with chronic kidney disease (CKD). Methods A total of 205 patients who had a coronary angiography and received coronary artery revascularization on demand were enrolled and followed up for 5 years. Demographic and clinical indicators, arterial stiffness indexes, angiographic characteristics and the Gensini score (GS) were recorded at baseline. Major adverse cardiac events (MACE), including cardiac death and repeat coronary artery revascularization, that occurred during the 5 years of follow-up were also recorded. Results All indexes reflecting the degree of arterial stiffness, including PWV, C1, C2, CSBP, CDBP, AP and Aix, were significantly higher in CKD than in non-CKD patients (all p < 0.05). Patients with CKD also had a higher rate of coronary artery disease and a higher GS (p < 0.05 and p < 0.01, respectively). Logistic regression analysis revealed CKD to be an independent risk factor for increased arterial stiffness (OR = 2.508, 95% CI 1.308-4.808, p = 0.006). During follow-up, CKD patients with PWV >13 m/s or Aix@75 >30 had a significantly higher MACE occurrence rate after coronary artery revascularization (both p < 0.05). Conclusion These results highlight that CKD and arterial stiffness correlate with the severity of coronary artery lesions. CKD patients with impaired arterial stiffness have poor clinical outcomes, suggesting a further clinical use of the arterial stiffness index as a surrogate of worse cardiovascular prognosis in CKD than in non-CKD patients. PMID:25737692

Drug-Eluting Versus Bare-Metal Stents During PCI in Patients With End-Stage Renal Disease on Dialysis

PubMed Central

Chang, Tara I.; Montez-Rath, Maria E.; Tsai, Thomas T.; Hlatky, Mark A.; Winkelmayer, Wolfgang C.

2016-01-01

BACKGROUND In patients undergoing percutaneous coronary intervention (PCI), drug-eluting stents (DES) reduce repeat revascularizations compared with bare metal stents (BMS), but their effects on death and myocardial infarction (MI) are mixed. Few studies have focused on patients with end-stage renal disease (ESRD). OBJECTIVES We compared mortality and cardiovascular morbidity during PCI with DES and with BMS in dialysis patients. METHODS We identified 36,117 dialysis patients from the U.S. Renal Data System who had coronary stenting in the U.S. between 4/23/03 and 12/31/10, and examined the association of DES versus BMS with 1-year outcomes: death; death or MI; and death, MI or repeat revascularization. We conducted a temporal analysis by dividing the study period into 3 DES eras: Transitional (4/23/03 – 6/30/04); Liberal (7/1/04 – 12/31/06); and Selective (1/1/07 – 12/31/10). RESULTS One-year event rates were high, with 38 deaths, 55 death or MI events and 71 death, MI or repeat revascularization events per 100 person-years. DES was associated with a significant 18% lower risk of death, 16% lower risk of death or MI, and 13% lower risk of death, MI or repeat revascularization, compared with BMS. DES use varied, from 56% in the Transitional era to 85% in the Liberal era and 62% in the Selective era. DES outcomes in the Liberal era were significantly better than in the Transitional Era, but not significantly better than in the Selective Era. CONCLUSIONS DES for PCI appears safe in U.S. dialysis patients, and is associated with lower rates of death, MI and repeat revascularization. PMID:27012407

Does a similar procedure result in similar survival for women and men undergoing isolated coronary artery bypass grafting?

PubMed

Attia, Tamer; Koch, Colleen G; Houghtaling, Penny L; Blackstone, Eugene H; Sabik, Ellen Mayer; Sabik, Joseph F

2017-03-01

To (1) identify sex-related differences in risk factors and revascularization strategies for patients undergoing coronary artery bypass grafting (CABG), (2) assess whether these differences influenced early and late survival, and (3) determine whether clinical effectiveness of the same revascularization strategy was influenced by sex. From January 1972 to January 2011, 57,943 adults-11,009 (19%) women-underwent primary isolated CABG. Separate models for long-term mortality were developed for men and women, followed by assessing sex-related differences in strength of risk factors (interaction terms). Incomplete revascularization was more common in men than women (26% vs 22%, P < .0001), but women received fewer bilateral internal thoracic artery (ITA) grafts (4.8% vs 12%; P < .0001) and fewer arterial grafts (68% vs 70%; P < .0001). Overall, women had lower survival than men after CABG (65% and 31% at 10 and 20 years, respectively, vs 74% and 41%; P ≤ .0001), even after risk adjustment. Incomplete revascularization was associated equally (P > .9) with lower survival in both sexes. Single ITA grafting was associated with equally (P = .3) better survival in women and men. Although bilateral ITA grafting was associated with better survival than single ITA grafting, it was less effective in women-11% lower late mortality (hazard ratio, 0.89 [0.77-1.022]) versus 27% lower in men (hazard ratio, 0.73 [0.69-0.77]; P = .01). Women on average have longer life expectancies than men but not after CABG. Every attempt should be made to use arterial grafting and complete revascularization, but for unexplained reasons, sex-related differences in effectiveness of bilateral arterial grafting were identified. Copyright © 2016. Published by Elsevier Inc.

Spinal cord stimulation for patients with refractory angina and previous coronary surgery.

PubMed

Lapenna, Elisabetta; Rapati, Dino; Cardano, Paola; De Bonis, Michele; Lullo, Francesca; Zangrillo, Alberto; Alfieri, Ottavio

2006-11-01

Refractory angina pectoris is an exceptionally debilitating condition affecting patients who have typically failed multiple percutaneous and surgical revascularizations and optimal medical therapy and who are not amenable for further revascularization procedures. Spinal cord stimulation (SCS) has been adopted in this context at our institution and midterm mortality, anginal status, and quality of life have been evaluated. From 1998 to 2004, 51 patients with refractory class III-IV angina, who were not considered candidates for revascularization procedures, underwent SCS. All patients had already undergone previous surgical revascularization and a median of two percutaneous procedures. Transmyocardial laser revascularization had been previously performed in 8 cases (15.6%). Most of the patients (70.5%) had experienced a myocardial infarction. Mean ejection fraction was 0.42 +/- 0.121, Canadian Cardiovascular Society class 3.5 +/- 0.5, quality of life (Spitzer index) 4.5 +/- 1.2, and the median frequency of weekly angina episodes was 10. There were no SCS implantation-related complications. At follow-up (100% complete, mean 24 +/- 18 months), a significant improvement of anginal symptoms (>50% reduction of weekly anginal episodes) occurred in 45 patients (88.2%). In those patients (Responders), the quality of life improved significantly (6.8 +/- 1.5; p < 0.0001), CCS class decreased to 2 +/- 0.7 (p < 0.0001), and the median frequency of weekly angina episodes to 3 (p < 0.0001). At 3 years, Responders' survival was 91.8 +/- 4.6% and the freedom from cardiac events 72.6 +/- 8.42%. Spinal cord stimulation is a safe and effective procedure in truly no-option patients affected by refractory angina. A midterm sustained improvement of symptoms and quality of life have been documented with a satisfactory 3-year survival rate.

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.

Coronary revascularization and adverse events in joint arthroplasty.

PubMed

Tabatabaee, Reza Mostafavi; Rasouli, Mohammad R; Rezapoor, Maryam; Maltenfort, Mitchell G; Ong, Alvin C; Parvizi, Javad

2015-09-01

There is a paucity of literature about outcome of total joint arthroplasty in patients with the history of angioplasty and/or stent or coronary artery bypass graft (CABG). The present study aimed to evaluate perioperative complications and mortality in these patients. We used the Nationwide Inpatient Sample data from 2002-2011. Using the Ninth Revision of the International Classification of Disease, Clinical Modification codes for disorders and procedures, we identified patients with a history of coronary revascularization (angioplasty and/or stent or CABG) and compared the inhospital adverse events in these patients with patients without a history of coronary revascularization. Cardiac complications occurred in 1.06% patients with a history of CABG; 0.95% of patients with a coronary angioplasty and/or stent and 0.82% of the control patients. In the multivariate analysis, neither the history of CABG (P = 0.07) nor the history of angioplasty and/or stenting (P = 0.86) was associated with a higher risk of cardiac complications. However, myocardial infarction occurred in a significantly higher proportion of patients with the history of CABG (0.66%, odds ratio, 1.24, P = 0.001) and coronary angioplasty and/or stenting (0.67%, odds ratio, 1.96, P < 0.001) compared with that in the controls (0.27%). History of coronary revascularization did not increase the risk of respiratory, renal, and wound complications, surgical site infection, and mortality. Based on the findings of this study, it appears that there is no increased risk of inhospital mortality and complications (except for myocardial infarction) in patients with a history of coronary artery revascularization undergoing total joint arthroplasty. We also found perioperative cardiac arrhythmia, particularly atrial fibrillation, to be an independent predictor of inhospital adverse events. Copyright © 2015 Elsevier Inc. All rights reserved.

Significance of Intermediate Values of Fractional Flow Reserve in Patients With Coronary Artery Disease.

PubMed

Adjedj, Julien; De Bruyne, Bernard; Floré, Vincent; Di Gioia, Giuseppe; Ferrara, Angela; Pellicano, Mariano; Toth, Gabor G; Bartunek, Jozef; Vanderheyden, Marc; Heyndrickx, Guy R; Wijns, William; Barbato, Emanuele

2016-02-02

The fractional flow reserve (FFR) value of 0.75 has been validated against ischemic testing, whereas the FFR value of 0.80 has been widely accepted to guide clinical decision making. However, revascularization when FFR is 0.76 to 0.80, within the so-called gray zone, is still debatable. From February 1997 to June 2013, all patients with single-segment disease and an FFR value within the gray zone or within the 2 neighboring FFR strata (0.70-0.75 and 0.81-0.85) were included. Study end points consisted of major adverse cardiovascular events (death, myocardial infarction, and any revascularization) up to 5 years. Of 17 380 FFR measurements, 1459 patients were included. Of them, 449 patients were treated with revascularization and 1010 patients were treated with medical therapy. In the gray zone, the major adverse cardiovascular events rate was similar (37 [13.9%] versus 21 [11.2%], respectively; P=0.3) between medical therapy and revascularization, whereas a strong trend toward a higher rate of death or myocardial infarction (25 [9.4] versus 9 [4.8], P=0.06) and overall death (20 [7.5] versus 6 [3.2], P=0.059) was observed in the medical therapy group. Among medical therapy patients, a significant step-up increase in major adverse cardiovascular events rate was observed across the 3 FFR strata, especially with proximal lesion location. In revascularization patients, the major adverse cardiovascular events rate was not different across the 3 FFR strata. FFR in and around the gray zone bears a major prognostic value, especially in proximal lesions. These data confirm that FFR≤0.80 is valid to guide clinical decision making. © 2016 American Heart Association, 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

Association Between Clinical Pathways Leading to Medical Management and Prognosis in Patients With NSTEACS.

PubMed

Bueno, Héctor; Pocock, Stuart; Medina, Jesús; Danchin, Nicolas; Annemans, Lieven; Licour, Muriel; Gregson, John; Vega, Ana María; van de Werf, Frans

2017-10-01

A large proportion of patients with non-ST-segment elevation acute coronary syndrome (NSTEACS) are initially selected for medical management (MM) and do not undergo coronary revascularization during or immediately after the index event. The aim of this study was to explore the clinical pathways leading to MM in NSTEACS patients and their influence on prognosis. Patient characteristics, pathways leading to MM, and 2-year outcomes were recorded in a prospective cohort of 5591 NSTEACS patients enrolled in 555 hospitals in 20 countries across Europe and Latin America. Cox models were used to assess the impact of hospital management on postdischarge mortality. Medical management was the selected strategy in 2306 (41.2%) patients, of whom 669 (29%) had significant coronary artery disease (CAD), 451 (19.6%) had nonsignificant disease, and 1186 (51.4%) did not undergo coronary angiography. Medically managed patients were older and had higher risk features than revascularized patients. Two-year mortality was higher in medically managed patients than in revascularized patients (11.0% vs 4.4%; P < .001), with higher mortality rates in patients who did not undergo angiography (14.6%) and in those with significant CAD (9.3%). Risk-adjusted mortality was highest for patients who did not undergo angiography (HR = 1.81; 95%CI, 1.23-2.65), or were not revascularized in the presence of significant CAD (HR = 1.90; 95%CI, 1.23-2.95) compared with revascularized patients. Medically managed NSTEACS patients represent a heterogeneous population with distinct risk profiles and outcomes. These differences should be considered when designing future studies in this population. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Impact of Percutaneous Coronary Revascularization of Severe Coronary Lesions on Secondary Branches.

PubMed

Cano-García, Macarena; Millán-Gómez, Mercedes; Sánchez-González, Carlos; Alonso-Briales, Juan H; Muñoz-Jiménez, Luz D; Carrasco-Chinchilla, Fernando; Domínguez-Franco, Antonio; Muñoz-García, Antonio J; Bullones-Ramírez, Juan A; Álvarez-Rubiera, Jesús M; de Mora-Martín, Manuel; de Teresa-Galván, Eduardo; Hernández-García, José M; Urbano-Carrillo, Cristóbal A; Jiménez-Navarro, Manuel F

2018-05-30

To analyze the percutaneous revascularization strategy for severe lesions in the secondary branches (SB) (diameter ≥ 2mm) of major epicardial arteries compared with conservative treatment. This study analyzed patients with severe SB lesions who underwent percutaneous revascularization treatment compared with patients who received pharmacological treatment. The study examined the percentage of branch-related events (cardiovascular death, myocardial infarction attributable to SB, or the need for revascularization of the SB). We analyzed 679 SB lesions (662 patients). After a mean follow-up of 22.2±10.5 months, there were no significant differences between the 2 treatment groups regarding the percentage of death from cardiovascular causes (1.7% vs 0.4%; P=.14), nonfatal acute myocardial infarction (AMI) (1.7% vs 1.7%; P=.96), the need for SB revascularization (4.1% vs 5.4%; P=.45) or in the total percentage of events (5.1% vs 6.3%; P=.54). The variables showing an association with event occurrence on multivariate analysis were diabetes (SHR, 2.87; 95%CI, 1.37-5.47; P=.004), prior AMI (SHR, 3.54; 95%CI, 1.77-7.30; P<.0001), SB reference diameter (SHR, 0.16; 95%CI, 0.03-0.97; P=.047), and lesion length (SHR, 3.77; 95%CI, 1.03-1.13; P<.0001). These results remained the same after the propensity score analysis. The percentage of SB-related events during follow-up is low, with no significant differences between the 2 treatment strategies. The variables associated with event occurrence in the multivariate analysis were the presence of diabetes mellitus, prior AMI, and greater lesion length. Copyright © 2018 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

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.

Rapid resolution of brain ischemic hypoxia after cerebral revascularization in moyamoya disease.

PubMed

Arikan, Fuat; Vilalta, Jordi; Torne, Ramon; Noguer, Montserrat; Lorenzo-Bosquet, Carles; Sahuquillo, Juan

2015-03-01

In moyamoya disease (MMD), cerebral revascularization is recommended in patients with recurrent or progressive ischemic events and associated reduced cerebral perfusion reserve. Low-flow bypass with or without indirect revascularization is generally the standard surgical treatment. Intraoperative monitoring of cerebral partial pressure of oxygen (PtiO2) with polarographic Clark-type probes in cerebral artery bypass surgery for MMD-induced chronic cerebral ischemia has not yet been described. To describe basal brain tissue oxygenation in MMD patients before revascularization as well as the immediate changes produced by the surgical procedure using intraoperative PtiO2 monitoring. Between October 2011 and January 2013, all patients with a diagnosis of MMD were intraoperatively monitored. Cerebral oxygenation status was analyzed based on the Ptio2/PaO2 ratio. Reference thresholds of PtiO2/PaO2 had been previously defined as below 0.1 for the lower reference threshold (hypoxia) and above 0.35 for the upper reference threshold (hyperoxia). Before STA-MCA bypass, all patients presented a situation of severe tissue hypoxia confirmed by a PtiO2/PaO2 ratio <0.1. After bypass, all patients showed a rapid and sustained increase in PtiO2, which reached normal values (PtiO2/PaO2 ratio between 0.1 and 0.35). One patient showed an initial PtiO2 improvement followed by a decrease due to bypass occlusion. After repeat anastomosis, the patient's PtiO2 increased again and stabilized. Direct anastomosis quickly improves cerebral oxygenation, immediately reducing the risk of ischemic stroke in both pediatric and adult patients. Intraoperative PtiO2 monitoring is a very reliable tool to verify the effectiveness of this revascularization procedure.

Temporal trends in revascularization and outcomes after acute myocardial infarction among the very elderly

PubMed Central

Pagé, Maude; Doucet, Michel; Eisenberg, Mark J.; Behlouli, Hassan; Pilote, Louise

2010-01-01

Background Few data are available on time-related changes in use and outcomes of invasive procedures after acute myocardial infarction in very elderly patients. Our objective was to describe trends in revascularization procedures and outcomes in a provincial cohort of very elderly patients who had experienced acute myocardial infarction. Methods We used a database of hospital discharge summaries to identify all patients aged 80 years or older admitted for acute myocardial infarction in Quebec. We used the provincial database of physicians’ services and medication claims to assess treatment and obtain data on survival. Results Between March 1996 and March 2007, 29 750 patients aged 80 years or older were admitted to hospital for acute myocardial infarction. During this period, use of percutaneous coronary interventions increased from 2.2% to 24.9%, and use of coronary artery bypass graft surgery increased from 0.8% to 3.1%. Evidence-based prescriptions of medication increased over time (p < 0.001). The prevalence of reported comorbidities was higher during the period of 2003–2006 than during the 1996–1999 period. One-year mortality improved over time (46.5% for 1996–1999 v. 40.9% for 2003–2006, p < 0.001) but remained unchanged in the subgroup of patients who did not undergo revascularization. Interpretation The use of revascularization, especially percutaneous coronary interventions, in the very elderly after acute myocardial infarction has been growing at a rapid pace, while the prevalence of reported comorbidities has been increasing in this population. Revascularization procedures are no longer restricted to younger patients. In the context of an aging population, it is imperative to determine whether these changes in practice are cost-effective. PMID:20682731

76 FR 45860 - In the Matter of Certain Electronic Devices, Including Wireless Communication Devices, Portable...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-01

..., Including Wireless Communication Devices, Portable Music and Data Processing Devices, and Tablet Computers... electronic devices, including wireless communication devices, portable music and data processing devices, and... electronic devices, including wireless communication devices, portable music and data processing devices, and...

Revascularization Induced Maturogenesis of Non-Vital Immature Permanent Tooth Using Platelet-Rich-Fibrin: A Case Report.

PubMed

Nagaveni, N B; Pathak, Sidhant; Poornima, P; Joshi, Jooie S

2016-01-01

The aim of this report is to describe a novel method of revascularization therapy done in a non-vital, immature permanent tooth using Platelet-rich fibrin (PRF),in a recently developed scaffold material to overcome limitations associated with the traditional method of revascularization using natural blood clot. PRF prepared from autologous blood was placed in the root canal and patient was followed up regularly at one, three, six, nine and 12 months for detailed clinical and radiographic evaluation. At 12 months, radiographic examination revealed root elongation, root end closure, continued thickening of the root dentinal walls, obliteration of root canal space, and normal periradicular anatomy. However, more long term prospective trials and histological studies are highly needed before to testify PRF a panacea for the regenerative endodontic therapy in children.

Vital Pulp Therapy—Current Progress of Dental Pulp Regeneration and Revascularization

PubMed Central

Zhang, Weibo; Yelick, Pamela C.

2010-01-01

Pulp vitality is extremely important for the tooth viability, since it provides nutrition and acts as biosensor to detect pathogenic stimuli. In the dental clinic, most dental pulp infections are irreversible due to its anatomical position and organization. It is difficult for the body to eliminate the infection, which subsequently persists and worsens. The widely used strategy currently in the clinic is to partly or fully remove the contaminated pulp tissue, and fill and seal the void space with synthetic material. Over time, the pulpless tooth, now lacking proper blood supply and nervous system, becomes more vulnerable to injury. Recently, potential for successful pulp regeneration and revascularization therapies is increasing due to accumulated knowledge of stem cells, especially dental pulp stem cells. This paper will review current progress and feasible strategies for dental pulp regeneration and revascularization. PMID:20454445

Application of autologous platelet-rich plasma to enhance wound healing after lower limb revascularization: A case series and literature review.

PubMed

Massara, Mafalda; Barillà, David; De Caridi, Giovanni; Serra, Raffaele; Volpe, Alberto; Surace, Rosangela; Foti, Giovanni; Marcuccio, Daniela; Pucci, Giulia; Volpe, Pietro

2015-01-01

Dermal tissue loss in patients affected by critical limb ischemia represents a serious wound-healing problem, with high morbidity, prolonged hospital stay, and high patient care costs. Treatment of ischemic foot lesions requires limb revascularization by endovascular or open surgical intervention and individualized patient-specific wound care, including antibiotic therapy; devitalized/infected wound debridement; and advanced wound dressing. In selected patients, spinal cord stimulation, vacuum-assisted closure therapy, and bioengineered tissue or skin substitutes and growth factors have been shown to improve wound healing. In this study, we present our preliminary results on topical application of autologous platelet-rich plasma to enhance the process of wound healing after revascularization of lower limbs in patients affected by critical limb ischemia. Copyright © 2016 Elsevier Inc. All rights reserved.

Narrowing of the Coronary Sinus: A Device-Based Therapy for Persistent Angina Pectoris.

PubMed

Konigstein, Maayan; Verheye, Stefan; Jolicœur, E Marc; Banai, Shmuel

2016-01-01

Alongside the remarkable advances in medical and invasive therapies for the treatment of ischemic heart disease, an increasing number of patients with advanced coronary artery disease unsuitable for revascularization continue to suffer from angina pectoris despite optimal medical therapy. Patients with chronic angina have poor quality of life and increased levels of anxiety and depression. A considerable number of innovative therapeutic modalities for the treatment of chronic angina have been investigated over the years; however, none of these therapeutic options has become a standard of care, and none are widely utilized. Current treatment options for refractory angina focus on medical therapy and secondary risk factor modification. Interventions to create increased pressure in the coronary sinus may alleviate myocardial ischemia by forcing redistribution of coronary blood flow from the less ischemic subepicardium to the more ischemic subendocardium, thus relieving symptoms of ischemia. Percutaneous, transvenous implantation of a balloon expandable, hourglass-shaped, stainless steel mesh in the coronary sinus to create a fixed focal narrowing and to increase backwards pressure, may serve as a new device-based therapy destined for the treatment of refractory angina pectoris.

Contemporary management of critical lower limb ischemia in TASC D lesions with subintimal angioplasty in femoro-popliteal lesions, tibial angioplasty and sequential compression biomechanical device for infra-inguinal arterial occlusion. Experience and quality of life outcome learned over 25 years.

PubMed

Sultan, S; Hynes, N

2014-12-01

Patients with end-stage critical limb ischemia (CLI) survive on borrowed time and amputation is inevitable if an aggressive management stratagem is not instigated. Our primary aim was to equate effectiveness of subintimal angioplasty (SIA) and tibial balloon angioplasty (TBA) in sustaining clinical improvement and amputation free survival (AFS) in patients with CLI TASD II D. Moreover, patients with severe CLI, who were not suitable for revascularization and who were offered therapy with a sequential compression biomechanical device (SCBD) were scrutinised as part of a comprehensive lower limb salvage program. From 2002-2012, 5876 patients were referred with peripheral vascular disease (PVD); 987 presented with CLI and 798 had intervention; 189 patients presenting with CLI were not candidates for revascularisation, out of which 171 were offered SCBD. We formed a prospective observational group study of 441 patient who had TASC D disease. All of these patients presented as emergencies and were allocated to the next available treatment list. Duplex ultrasound arterial mapping (DUAM) was the sole preoperative investigation tool in 92% of all cases. Of the 441 patients studied, 190 patients (206 procedures) has SIA for TASC D femero-popliteal occlusions, 80 patients (89 procedures) had TBA and cool eximer laser angioplasty (CELA) for tibial artery occlusions and 171 patients with severe CLI were not suitable for revascularization and joined the SCBD program. Mean age (SIA 73±13 years vs. TBA/CELA 74±8 years vs. SCBD 75±13 years), and comorbidity severity scores (P>0.05) were similar between groups. Perioperative mortality within the SIA group was 1.6% vs. 0% within the TBA group and 0.6% in SCBD. Length of hospital stay within the TBA group was 3.8±2 days vs. SIA 14±16 days, P<0.0001. The 5-year freedom from major adverse events (MAE) for the SIA group was 68% that was comparable to the results obtained for both the TBA group; 59%, and SCBD group: 62.5% (P=0.1935). Five-year freedom from target lesion revascularization was 85.9% within the SIA group and 79% within the TBA group. A sustained clinical improvement was seen in 82.8% of primary SIA and 68% of TBA, which mimics the outcome of SCBD at 68% at one year. A total of 83% SCBD patients had no rest pain within one week of starting the program and gangrene remained dry and non-progressive. Ulceration healed in all but 12 patients. There were no device-related complications. Limb salvage was 94% at 5 years. All-cause survival was 69%. Quality time spent without symptoms of disease or toxicity of treatment (Q-TWiST) was 24.7 months for SIA and 8.5 months for TBA and was 38.13 for SCBD for a total of 708 months of usage. Cost per quality adjusted-life years (QALY) for SIA was € 5662.79, € 12,935.18 for TBA and € 2943.56 for SCBD. All treatment pathways augmented patient-specific Q-TWiST with substantial cost reduction. SIA, TBA and SCBD expand AFS and symptom-free survival. All treatment modalities are minimally invasive and allow for a high patient turnover without compromising limb salvage, once they are performed by experienced vascular surgeons in high deliberate practice volume centers.

Carotid Disease Management: Surgery, Stenting, or Medication.

PubMed

Khandelwal, Priyank; Chaturvedi, Seemant

2015-09-01

Internal carotid artery stenosis accounts for about 7-10 % of ischemic strokes. Conventional risk factors such as aging, hypertension, diabetes mellitus, and smoking increase the risk for carotid atherosclerosis. All patients with carotid stenosis should receive aggressive medical therapy. Carotid revascularization with either endarterectomy or stenting can benefit select patients with severe stenosis. New clinical trials will examine the contemporary role of carotid revascularization relative to optimal medical therapy.

Novel use of platelet-rich fibrin matrix and MTA as an apical barrier in the management of a failed revascularization case.

PubMed

Yadav, Pankaj; Pruthi, Preeti Jain; Naval, Ruchika Roongta; Talwar, Sangeeta; Verma, Mahesh

2015-08-01

We report management of a failed revascularization/revitalization case, which could be due to inadequate removal of biofilm and bacteria in dentinal tubules. The use of an apical matrix barrier in form of a platelet-rich fibrin (PRF) membrane for stabilization of MTA in root end apexification procedure is described. The canal was cleansed of old MTA present in the cervical third using H files, irrigated using saline and finally irrigated with 2.5% NaOCl and saline. To obtain canal disinfection, calcium hydroxide paste was temporized in the canal. In subsequent appointments, PRF was placed at the root tip followed by 5-mm apical plug with mineral trioxide aggregate. One week later, the root canal was obturated with thermoplasticized gutta-percha. A 6-month and a 2-year follow ups showed reduction of periapical radiolucency and adequately functional tooth. One-visit apexification techniques provide an alternative treatment for failed revascularization cases. Follow up confirmed complete healing periradicularly. Apexification in one step using an apical barrier of PRF and a plug of MTA can be considered a predictable treatment and may be an alternative to long-term revascularization failures. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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.

Thrombospondins deployed by thrombopoietic cells determine angiogenic switch and extent of revascularization

PubMed Central

Kopp, Hans-Georg; Hooper, Andrea T.; Broekman, M. Johan; Avecilla, Scott T.; Petit, Isabelle; Luo, Min; Milde, Till; Ramos, Carlos A.; Zhang, Fan; Kopp, Tabitha; Bornstein, Paul; Jin, David K.; Marcus, Aaron J.; Rafii, Shahin

2006-01-01

Thrombopoietic cells may differentially promote or inhibit tissue vascularization by releasing both pro- and antiangiogenic factors. However, the molecular determinants controlling the angiogenic phenotype of thrombopoietic cells remain unknown. Here, we show that expression and release of thrombospondins (TSPs) by megakaryocytes and platelets function as a major antiangiogenic switch. TSPs inhibited thrombopoiesis, diminished bone marrow microvascular reconstruction following myelosuppression, and limited the extent of revascularization in a model of hind limb ischemia. We demonstrate that thrombopoietic recovery following myelosuppression was significantly enhanced in mice deficient in both TSP1 and TSP2 (TSP-DKO mice) in comparison with WT mice. Megakaryocyte and platelet levels in TSP-DKO mice were rapidly restored, thereby accelerating revascularization of myelosuppressed bone marrow and ischemic hind limbs. In addition, thrombopoietic cells derived from TSP-DKO mice were more effective in supporting neoangiogenesis in Matrigel plugs. The proangiogenic activity of TSP-DKO thrombopoietic cells was mediated through activation of MMP-9 and enhanced release of stromal cell–derived factor 1. Thus, TSP-deficient thrombopoietic cells function as proangiogenic agents, accelerating hemangiogenesis within the marrow and revascularization of ischemic hind limbs. As such, interference with the release of cellular stores of TSPs may be clinically effective in augmenting neoangiogenesis. PMID:17143334

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.

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North American SOLITAIRE Stent-Retriever Acute Stroke Registry: choice of anesthesia and outcomes.

PubMed

Abou-Chebl, Alex; Zaidat, Ossama O; Castonguay, Alicia C; Gupta, Rishi; Sun, Chung-Huan J; Martin, Coleman O; Holloway, William E; Mueller-Kronast, Nils; English, Joey D; Linfante, Italo; Dabus, Guilherme; Malisch, Timothy W; Marden, Franklin A; Bozorgchami, Hormozd; Xavier, Andrew; Rai, Ansaar T; Froehler, Micahel T; Badruddin, Aamir; Nguyen, Thanh N; Taqi, Muhammad; Abraham, Michael G; Janardhan, Vallabh; Shaltoni, Hashem; Novakovic, Roberta; Yoo, Albert J; Chen, Peng R; Britz, Gavin W; Kaushal, Ritesh; Nanda, Ashish; Issa, Mohammad A; Nogueira, Raul G

2014-05-01

Previous work that predated the availability of the safer stent-retriever devices has suggested that general anesthesia (GA) may have a negative impact on outcomes in patients with acute ischemic stroke undergoing endovascular therapy. We reviewed demographic, clinical, procedural (GA versus local anesthesia [LA], etc), and site-adjudicated angiographic and clinical outcomes data from consecutive patients treated with the Solitaire FR device in the investigator-initiated North American SOLITAIRE Stent-Retriever Acute Stroke (NASA) Registry. The primary outcomes were 90-day modified Rankin Scale, mortality, and symptomatic intracranial hemorrhage. A total of 281 patients from 18 centers were enrolled. GA was used in 69.8% (196/281) of patients. Baseline demographic and procedural factors were comparable between the LA and GA groups, except the former demonstrated longer time-to-groin puncture (395.4±254 versus 337.4±208 min; P=0.04), lower National Institutes of Health Stroke Scale (NIHSS; 16.2±5.8 versus 18.8±6.9; P=0.002), lower balloon-guide catheter usage (22.4% versus 49.2%; P=0.0001), and longer fluoroscopy times (39.5±33 versus 28±22.8 min; P=0.008). Recanalization (thrombolysis in cerebral infarction ≥2b; 72.94% versus 73.6%; P=0.9) and rate of symptomatic intracranial hemorrhage (7.1% versus 11.2%; P=0.4) were similar but modified Rankin Scale ≤2 was achieved in more LA patients, 52.6% versus 35.6% (odds ratio, 1.4 [1.1-1.8]; P=0.01). In multivariate analysis, hypertension, NIHSS, unsuccessful revascularization, and GA use (odds ratio, 3.3 [1.6-7.1]; P=0.001) were associated with death. When only anterior circulation and elective GA patients were included, there was a persistent difference in good outcomes in favor of LA patients (50.7% versus 35.5%; odds ratio, 1.3 [1.01-1.6]; P=0.04). The NASA Registry has demonstrated that clinical outcomes and survival are significantly better in patients treated with LA, without increased symptomatic intracranial hemorrhage risk. Future trials should prospectively evaluate the effect of GA on outcomes.

Making sense of endovascular therapies for femoropopliteal disease.

PubMed

Altin, S Elissa; Abbott, J Dawn

2018-06-01

The femoropoliteal segment is a common target for endovascular intervention and the unique biomechanical forces on the arteries increase the risk of restenosis This large meta-analysis supports drug coated balloons as the initial endovascular strategy due to lower risk of target lesion revascularization compared to other modalities Whether there are subgroups of patients or lesion types that benefit from an alternative revascularization approach is unclear and warrants investigation. © 2018 Wiley Periodicals, Inc.

Transmyocardial laser revascularization with a high-power (800 W) CO2 laser: clinical report with 50 cases

NASA Astrophysics Data System (ADS)

Qu, Zheng; Zhang, Zhaoguang; Ye, Jianguang; Yu, Jianbo

1999-09-01

This paper reports the clinical experience in transmyocardial laser revascularization (TMLR) with high power CO2 laser and evaluates the preliminary results of TMLR. TMLR may improve angina pectoris and myocardial perfusion significantly. To switch on the laser in proper order may be helpful to shorten duration of surgery. A gentle removal of fat on the apex may increase the successful transmyocardial penetration.

Pulp Revascularization: A Literature Review

PubMed Central

Araújo, Pollyana Rodrigues de Souza; Silva, Luciano Barreto; Neto, Alexandrino Pereira dos Santos; Almeida de Arruda, José Alcides; Álvares, Pâmella Recco; Sobral, Ana Paula Veras; Júnior, Severino Alves; Leão, Jair Carneiro; Braz da Silva, Rodivan; Sampaio, Gerhilde Callou

2017-01-01

Reestablishing blood flow and allowing the continuation of root development are some of the objectives of pulp revascularization. This procedure is currently indicated for teeth with incomplete root formation as an alternative to the traditional treatment of apecification, which consists of inserting calcium hydroxide paste into the root canal for a determined time period in order to induce the formation of a calcified barrier. Although it is considered as the most classically employed therapy, the permanence of the paste for long time periods may lead to the weakening of the root due to hygroscopic properties, as well as proteolytic activities of calcium hydroxide. Therefore, there has been a permanent search for alternatives which allow the full development of immature teeth. Revascularization has emerged as such an alternative, and a range of treatment protocols can be found in the scientific literature. The aim of this paper is to accomplish a literature review concerning this issue. PMID:28567136

Aneurysmectomy and revascularization of a large hepatic artery aneurysm.

PubMed

Adkisson, Cameron D; Sibulesky, Lens; Collis, George N; McLaughlin, Daniel W; Oldenburg, W A; Nguyen, Justin H

2011-05-01

Aneurysms of the hepatic artery are rare, but are associated with significant mortality because of their lack of symptoms at presentation and risk of rupture. We report a case of an enlarging 4-cm hepatic artery aneurysm involving the proximal common hepatic artery to the bifurcation of the right and left hepatic arteries which was found incidentally on ultrasound examination. Endovascular treatment with a stent was considered, but because of the location of the aneurysm as well as the presence of significant thrombosis involving the right and left hepatic arteries, aneurysmectomy and revascularization using saphenous vein was performed. Doppler ultrasound measurements demonstrated good flow through the graft postoperatively and at 1-month follow-up. Although a variety of endovascular techniques exist to treat hepatic artery aneurysms, our results indicate that open excision and revascularization may be required and can have a good outcome. Copyright © 2011 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.

Pulp revascularization of immature teeth with apical periodontitis: a clinical study.

PubMed

Ding, Rui Yu; Cheung, Gary Shun-pan; Chen, Jie; Yin, Xing Zhe; Wang, Qian Qian; Zhang, Cheng Fei

2009-05-01

The purpose of this study was to examine the effect of a pulpal revascularization procedure for immature necrotic teeth with apical periodontitis. Twelve patients, each with an immature permanent tooth with chronic or acute apical periodontitis, were recruited. A triantibiotic mix (ciprofloxacin, metronidazole, and minocycline) was used to disinfect the pulp for 1 week. Then a blood clot was created in the canal, over which grey mineral trioxide aggregate was placed. Patients were recalled periodically. Six patients dropped from the study (as a result of pain or failure to induce bleeding after canal disinfection) and instead received a standard apexification procedure. Another 3 patients did not attend any recall appointments. The remaining teeth (n = 3) were found to exhibit complete root development, with a positive response to pulp testing. Revascularization could be effective for managing immature permanent teeth with apical periodontitis with appropriate case selection.

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.

Successful limb salvage through staged bypass combined with free gracilis muscle transfer for critical limb ischemia with osteomyelitis after failed endovascular therapy.

PubMed

Miyake, Keisuke; Kikuchi, Shinsuke; Okuda, Hiroko; Koya, Atsuhiro; Abe, Satomi; Sawa, Yoshiki; Ota, Tetsuo; Azuma, Nobuyoshi

2018-05-02

Critical limb ischemia with osteomyelitis is so difficult to treat that even appropriate revascularization and wound therapy cannot achieve limb salvage because of uncontrollable infection. It is still difficult to judge the possibility of limb salvage before revascularization. A 73-year-old male complained of a small ulcer on his left toe, which was treated with multiple endovascular therapy. After failed endovascular therapy, he suffered extensive tissue loss with tibial osteomyelitis. We carried out staged surgery that was composed of dual bypass to the sural artery and posterior tibial artery. After intensive debridement and wound care, insertion of a subsequent free gracilis muscle flap to cover the exposed tibial bone was performed, achieving functional limb salvage. Even in the threatened limb with extensive tissue loss and osteomyelitis, intensive and multidisciplinary treatment with staged revascularization, muscle transfer, and appropriate wound care achieved functional limb salvage.

Contemporary Results of Surgical Management of Peripheral Mycotic Aneurysms.

PubMed

Salzler, Gg; Long, B; Avgerinos, Ed; Chaer, Ra; Leers, S; Hager, E; Makaroun, Ms; Eslami, Mh

2018-06-07

Mycotic aneurysms of the extremities occur infrequently but can cause severe life and limb complications. Traditional treatment typically includes debridement and revascularization, though in select patients ligation may be well tolerated. We reviewed our experience with these aneurysms treated with these two modalities. A retrospective review of patients treated for peripheral mycotic aneurysms at one institution from January 2005 to December 2015 was performed under an Institutional Review Board-approved protocol. Demographics, perioperative details, and long-term outcomes were collected and standard statistical methods were used to compare treatments. We identified 28 patients with 29 peripheral mycotic aneurysms. The majority of patients (19: 67.9%) were male with an average age of 60.1 ± 17 years. Among cases with a known cause, direct injury to artery was the most common precursor to mycotic aneurysm formation; iatrogenic causes were the most common (15: 51.7%) followed by intravenous drug use (5: 17.2%). Distal bacterial translocation was the other cause of mycotic aneurysm formation due to osteomyelitis (2:10.5%) and bacterial endocarditis (1:3.5%). The causes of the remainder of cases (6:20.7%) were unknown. Symptoms included fever (46.4%), drainage (42.9%), rupture (35.7%), erythema (21.4%), and limb ischemia (17.9%). Staphylococcus aureus was the most common bacteria isolated (38.5%, from 7 positive blood cultures and 3 positive wound culture) with 30% of these being MRSA, followed by Streptococcus species (11.5%), and other Staphylococcus (7.7%). Eight (30.7%) patients had negative cultures. The most common location of arterial aneurysm was the common femoral artery (17:58.6%), with 17.2% (5) occurring in the popliteal artery, 13.8% (4) in the brachial artery, 10.3% (3) in the radial or ulnar artery, and 3.5%(1) in the external iliac artery. 18 patients underwent revascularization, while 11 had resection/ligation without revascularization (4 femoral, 2 popliteal, 3 radial/ulnar, 1 brachial, and 1 external iliac). There was no significant difference in limb threatening ischemia between these two groups (p=0.14). Of those who were not revascularized, one developed significant initial ischemia but died prior to amputation and the other underwent revascularization within one year after tolerating the initial ligation. Upper extremity aneurysms were more likely to be reintervention-free than those in the lower extremities (p=0.01). In this series, resection or ligation of peripheral mycotic aneurysms without revascularization was well tolerated. With close follow-up of these patients, resection or ligation may obviate the more extensive initial revascularization procedures in these infected fields. Copyright © 2018 Elsevier Inc. All rights reserved.

Downstream resource utilization following hybrid cardiac imaging with an integrated cadmium-zinc-telluride/64-slice CT device.

PubMed

Fiechter, Michael; Ghadri, Jelena R; Wolfrum, Mathias; Kuest, Silke M; Pazhenkottil, Aju P; Nkoulou, Rene N; Herzog, Bernhard A; Gebhard, Cathérine; Fuchs, Tobias A; Gaemperli, Oliver; Kaufmann, Philipp A

2012-03-01

Low yield of invasive coronary angiography and unnecessary coronary interventions have been identified as key cost drivers in cardiology for evaluation of coronary artery disease (CAD). This has fuelled the search for noninvasive techniques providing comprehensive functional and anatomical information on coronary lesions. We have evaluated the impact of implementation of a novel hybrid cadmium-zinc-telluride (CZT)/64-slice CT camera into the daily clinical routine on downstream resource utilization. Sixty-two patients with known or suspected CAD were referred for same-day single-session hybrid evaluation with CZT myocardial perfusion imaging (MPI) and coronary CT angiography (CCTA). Hybrid MPI/CCTA images from the integrated CZT/CT camera served for decision-making towards conservative versus invasive management. Based on the hybrid images patients were classified into those with and those without matched findings. Matched findings were defined as the combination of MPI defect with a stenosis by CCTA in the coronary artery subtending the respective territory. All patients with normal MPI and CCTA as well as those with isolated MPI or CCTA finding or combined but unmatched findings were categorized as "no match". All 23 patients with a matched finding underwent invasive coronary angiography and 21 (91%) were revascularized. Of the 39 patients with no match, 5 (13%, p < 0.001 vs matched) underwent catheterization and 3 (8%, p < 0.001 vs matched) were revascularized. Cardiac hybrid imaging in CAD evaluation has a profound impact on patient management and may contribute to optimal downstream resource utilization.

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.

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

Treating Refractory Cardiogenic Shock With the TandemHeart and Impella Devices: A Single Center Experience

PubMed Central

Schwartz, Bryan G.; Ludeman, Daniel J.; Mayeda, Guy S.; Kloner, Robert A.; Economides, Christina; Burstein, Steven

2012-01-01

Background Patients with cardiogenic shock (CS) are routinely treated with intra-aortic balloon pumps (IABPs). The utility of 2 new percutaneous left ventricular assist devices (PLVADs), the Impella and TandemHeart, is unknown. The objective of this study was to describe the use of PLVADs for patients with CS at our institution. Methods All cases involving PLVADs in patients with CS between between January 1, 2008 and June 30, 2010 at a private, tertiary referral hospital were reviewed retrospectively. Results All 76 cases were identified (50 IABP only, 7 Impella, 19 TandemHeart). Most Impella (5/7) and TandemHeart (10/19) patients were initially treated with an IABP before "upgrading" for increased hemodynamic support. All 76 devices (100%) were initiated successfully. Percutaneous revascularization was attempted in 63 patients with angiographic success in 57 (90%). The incidences of major complications were similar between groups, except bleeding occurred less frequently with the IABP. Mean ejection fraction on presentation was 30.4±16.5% and increased by a mean of 6.6±11.4% (P < 0.001). With the institutional approach of treating patients with CS initially with vasopressors and IABPs, then upgrading to an Impella or TandemHeart device for patients refractory to IABP therapy, the overall mortality rate was 40%. Conclusion The Impella and TandemHeart devices can be initiated successfully in patients with CS, are associated with high rates of angiographic success during high risk percutaneous interventions and may benefit the myocardium during myocardial infarction. Randomized trials are warranted investigating use of the Impella and TandemHeart devices in patients with CS and in patients refractory to conventional IABP therapy. PMID:28348673

48 CFR 252.225-7017 - Photovoltaic Devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

... articles from which it was transformed. Designated country means— (i) A World Trade Organization Government..., Taiwan (known in the World Trade Organization as “the Separate Customs Territory of Taiwan, Penghu... country photovoltaic devices. (End of clause) [76 FR 78861, Dec. 20, 2011, as amended at 77 FR 13013, Mar...

76 FR 41522 - In the Matter of Certain Electronic Devices, Including Mobile Phones, Mobile Tablets, Portable...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-14

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-771] In the Matter of Certain Electronic Devices, Including Mobile Phones, Mobile Tablets, Portable Music Players, and Computers, and Components... certain mobile phones, mobile tablets, portable music players, and computers. 76 FR 24051 (Apr. 29, 2011...

78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

... the device materials must be performed; (iv) Performance data must demonstrate acceptable mechanical properties under simulated clinical use conditions including insertion and removal of the device; (v...

Outcomes of Critical Limb Ischemia in an Urban, Safety Net Hospital Population with High WIfI Amputation Scores

PubMed Central

Ward, Robert; Dunn, Joie; Clavijo, Leonardo; Shavelle, David; Rowe, Vincent; Woo, Karen

2017-01-01

Background Patients presenting to a public hospital with critical limb ischemia (CLI) typically have advanced disease with significant comorbidities. The purpose of this study was to assess the influence of revascularization on 1-year amputation rate of CLI patients presenting to Los Angeles County USC Medical Center, classified according to the Society for Vascular Surgery Wound, Ischemia and foot Infection (WIfI). Methods A retrospective review of patients who presented to a public hospital with CLI from February 2010 to July 2014 was performed. Patients were classified according to the WIfI system. Only patients with complete data who survived at least 12 months after presentation were included. Results Ninety-three patients with 98 affected limbs were included. The mean age was 62.8 years. Eighty-two patients (84%) had hypertension and 71 (72%) had diabetes. Fifty (57.5%) limbs had Trans-Atlantic Inter-Society Consensus (TASC) C or D femoral–popliteal lesions and 82 (98%) had significant infrapopliteal disease. The majority had moderate or high WIfI amputation and revascularization scores. Eighty-four (86%) limbs underwent open, endovascular, or hybrid revascularization. Overall, one year major amputation (OYMA) rate was 26.5%. In limbs with high WIfI amputation score, the OYMA was 34.5%: 21.4% in those who were revascularized and 57% in those who were not. On univariable analysis, factors associated with increased risk of OYMA were nonrevascularization (P = 0.005), hyperlipidemia (P = 0.06), hemodialysis (P = 0.005), gangrene (P = 0.02), ulcer classification (P = 0.05), WIfI amputation score (P = 0.026), and WIfI wound grade (P = 0.04). On multivariable analysis, increasing WIfI amputation score (odds ratio [OR] 1.84, 95% confidence interval [CI] 1.0–3.39) was associated with increased risk of OYMA while revascularization (OR 0.24, 95% CI 0.07–0.80) was associated with decreased risk of OYMA. Conclusions The OYMA rates in this population were consistent with those predicted by the WIfI classification system. In this population, revascularization significantly reduced the risk of amputation. Comorbidities including diabetes mellitus and TASC classification did not moderate the association of WIfI amputation score with risk of 1-year major amputation. PMID:27546850

Outcomes of Critical Limb Ischemia in an Urban, Safety Net Hospital Population with High WIfI Amputation Scores.

PubMed

Ward, Robert; Dunn, Joie; Clavijo, Leonardo; Shavelle, David; Rowe, Vincent; Woo, Karen

2017-01-01

Patients presenting to a public hospital with critical limb ischemia (CLI) typically have advanced disease with significant comorbidities. The purpose of this study was to assess the influence of revascularization on 1-year amputation rate of CLI patients presenting to Los Angeles County USC Medical Center, classified according to the Society for Vascular Surgery Wound, Ischemia and foot Infection (WIfI). A retrospective review of patients who presented to a public hospital with CLI from February 2010 to July 2014 was performed. Patients were classified according to the WIfI system. Only patients with complete data who survived at least 12 months after presentation were included. Ninety-three patients with 98 affected limbs were included. The mean age was 62.8 years. Eighty-two patients (84%) had hypertension and 71 (72%) had diabetes. Fifty (57.5%) limbs had Trans-Atlantic Inter-Society Consensus (TASC) C or D femoral-popliteal lesions and 82 (98%) had significant infrapopliteal disease. The majority had moderate or high WIfI amputation and revascularization scores. Eighty-four (86%) limbs underwent open, endovascular, or hybrid revascularization. Overall, one year major amputation (OYMA) rate was 26.5%. In limbs with high WIfI amputation score, the OYMA was 34.5%: 21.4% in those who were revascularized and 57% in those who were not. On univariable analysis, factors associated with increased risk of OYMA were nonrevascularization (P = 0.005), hyperlipidemia (P = 0.06), hemodialysis (P = 0.005), gangrene (P = 0.02), ulcer classification (P = 0.05), WIfI amputation score (P = 0.026), and WIfI wound grade (P = 0.04). On multivariable analysis, increasing WIfI amputation score (odds ratio [OR] 1.84, 95% confidence interval [CI] 1.0-3.39) was associated with increased risk of OYMA while revascularization (OR 0.24, 95% CI 0.07-0.80) was associated with decreased risk of OYMA. The OYMA rates in this population were consistent with those predicted by the WIfI classification system. In this population, revascularization significantly reduced the risk of amputation. Comorbidities including diabetes mellitus and TASC classification did not moderate the association of WIfI amputation score with risk of 1-year major amputation. Published by Elsevier Inc.

Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial.

PubMed

Lee, Michael; Généreux, Philippe; Shlofmitz, Richard; Phillipson, Daniel; Anose, Bynthia M; Martinsen, Brad J; Himmelstein, Stevan I; Chambers, Jeff W

2017-06-01

The presence of heavy coronary artery calcification increases the complexity of percutaneous coronary intervention (PCI) and increases the incidence of major adverse cardiac events (MACE): death, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis. The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial reported low rates of procedural, 30-day, 1-year, and 2-year ischemic complications after treatment of de novo, severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc.). ORBIT II was a single-arm trial that enrolled 443 patients at 49U.S. sites; in this study, de novo, severely calcified coronary lesions were treated with OAS prior to stenting. The primary safety endpoint was 30-day MACE: the composite of cardiac death, MI, and TVR (inclusive of target lesion revascularization (TLR)). The primary efficacy endpoint was procedural success: stent delivery with a residual stenosis of <50% without the occurrence of in-hospital MACE.The present analysis reports the final, 3-year follow-up results from ORBIT II. The majority of subjects (88.2%) underwent PCI with drug-eluting stents after orbital atherectomy. There were 360 (81.3%) subjects who completed the protocol-mandated 3-year visit.The overall cumulative rate of 3-year MACE was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%). The 3-year target lesion revascularization rate was 7.8%. In the final 3-year analysis of the ORBIT II trial, orbital atherectomy of severely calcified coronary lesions followed by stenting resulted in a low rate of adverse ischemic events compared with historical controls.Orbital atherectomy represents a safe and effective revascularization strategy for patients with severely calcified coronary lesions. The ORBIT II trial enrolled 443 subjects to study orbital atherectomy followed by stenting for de novo severely calcified coronary lesions. The overall cumulative 3-year MACE rate was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%); the 3-year target lesion revascularization rate was 7.8%. Orbital atherectomy of heavily calcified coronary lesions followed by stenting results in a low rate of adverse ischemic events compared with historical controls; it represents a reasonable revascularization strategy for patients with severely calcified coronary lesions. Copyright © 2017 Elsevier Inc. All rights reserved.

Further Insight into the Cardiovascular Risk Calculator Controversy: The Roles of Statins, Revascularizations, and Under-Ascertainment in the Women's Health Study

PubMed Central

Cook, Nancy R.; Ridker, Paul M

2015-01-01

Importance While the Pooled Cohort Equations from the recent ACC/AHA Guideline on the Assessment of Cardiovascular Risk have over-estimated cardiovascular risk in multiple external cohorts, the reasons for the discrepancy are unclear. Objective To determine whether increased use of statins over time, incident coronary revascularization procedures, or under-ascertainment of vascular events explain over-estimation of risk in a more contemporary population. Design, Setting, and Participants 27,542 women aged 45-79 with complete ascertainment of plasma lipids and other risk factors from the Women's Health Study (WHS), a nationwide cohort of US women free of cardiovascular disease, cancer or other major illness at baseline in 1992-95. Women were followed for a median of 10 years. Main Outcomes and Measures Atherosclerotic cardiovascular disease (ASCVD), defined as any myocardial infarction, any stroke, or death due to cardiovascular cause. Results 632 women experienced an ASCVD event over follow-up. The average predicted risk from the Pooled Cohort Equations was 3.6% over 10 years, compared to an actual observed risk of 2.2%. Predicted rates were 90% higher than the observed rates in the 0-<5% and 5-<7.5% risk groups and 40% higher in the 7.5-<10% and 10%+ risk groups. Rates of statin use and revascularizations increased over follow-up time and by risk group, and in sensitivity analyses, we estimated the hypothetical rates if no women were on statins or underwent revascularization procedures. After adjustment for intervention effects of statins and revascularization as well as hypothetical confounding by indication, predicted rates remained 80% higher than observed rates in the lower two risk groups and 30% higher in the upper two risk groups. Under-ascertainment is unlikely since follow-up rates in the WHS were 97%, and overall we would need 60% more events to match the numbers predicted using the Pooled Cohort Equations. Conclusions and Relevance Neither statin use, revascularization procedures, nor under-ascertainment of events explain the discrepancy between observed rates of ASCVD in the WHS and those predicted by the ACC/AHA Pooled Cohort Equations. Other explanations include changing patterns of risk within more contemporary populations. PMID:25285455

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.

PCI Versus CABG in Patients With Type 1 Diabetes and Multivessel Disease.

PubMed

Nyström, Thomas; Sartipy, Ulrik; Franzén, Stefan; Eliasson, Björn; Gudbjörnsdottir, Soffia; Miftaraj, Mervete; Lagerqvist, Bo; Svensson, Ann-Marie; Holzmann, Martin J

2017-09-19

It is unknown if coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) may offer a survival benefit in patients with type 1 diabetes (T1D) in need of multivessel revascularization. This study sought to determine if patients with T1D and multivessel disease may benefit from CABG compared with PCI. In an observational cohort study, the authors included all patients with T1D who underwent a first multivessel revascularization in Sweden from 1995 to 2013. The authors used the SWEDEHEART (Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies) register, the Swedish National Diabetes Register, and the Swedish National Patient Register to retrieve information about patient characteristics and outcomes. They estimated hazard ratios (HRs) adjusted for confounders with 95% confidence intervals (CIs) for all-cause and coronary heart disease mortality, myocardial infarction, repeat revascularization, stroke, and heart failure using inverse probability of treatment weighting based on propensity scores. In total, 683 patients who underwent CABG and 1,863 patients who underwent PCI were included. During a mean follow-up of 10.6 years, 53% of patients in the CABG group and 45% in the PCI group died. PCI, compared with CABG, was associated with a similar risk of all-cause mortality (HR: 1.14; 95% CI: 0.99 to 1.32), but higher risks of death from coronary heart disease (HR: 1.45; 95% CI: 1.21 to 1.74), myocardial infarction (HR: 1.47; 95% CI: 1.23 to 1.78), and repeat revascularization (HR: 5.64; 95% CI: 4.67 to 6.82). No differences in risks of stroke or heart failure were found. Notwithstanding the inclusion of patients with T1D who might not have been able to undergo CABG in the PCI group we found that PCI, compared with CABG, was associated with higher rates and risks of coronary heart disease mortality, myocardial infarction, and repeat revascularizations. Our findings indicate that CABG may be the preferred strategy in patients with T1D in need of multivessel revascularization. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

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.).

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.

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.

75 FR 14170 - Medical Device Epidemiology Network: Developing Partnership Between the Center for Devices and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-24

... methods for medical device comparative analyses, best practices and best design and analysis methods. II... the performance of medical devices (including comparative effectiveness studies). The centers...

78 FR 24775 - Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-745] Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and Components Thereof; Commission Decision... importation of certain wireless communication devices, portable music and data processing devices, computers...

78 FR 12785 - Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-25

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-745] Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and Components Thereof; Commission Decision... importation of certain wireless communication devices, portable music and data processing devices, computers...

Contact Aspiration Versus Stent Retriever in Patients With Acute Ischemic Stroke With M2 Occlusion in the ASTER Randomized Trial (Contact Aspiration Versus Stent Retriever for Successful Revascularization).

PubMed

Gory, Benjamin; Lapergue, Bertrand; Blanc, Raphael; Labreuche, Julien; Ben Machaa, Malek; Duhamel, Alain; Marnat, Gautier; Saleme, Suzana; Costalat, Vincent; Bracard, Serge; Desal, Hubert; Mazighi, Mikael; Consoli, Arturo; Piotin, Michel

2018-02-01

Middle cerebral artery M2-segment occlusions represent an important subgroup of patients with acute stroke with large-vessel occlusion. The safety of mechanical thrombectomy, especially contact aspiration (CA), in such distal intracranial occlusions is still under debate. We compared reperfusion, adverse events, neurological recovery, and functional outcome of patients with isolated M2 occlusions according to the first-line strategy mechanical thrombectomy devices (CA versus stent retriever [SR]). This is a post hoc analysis of the ASTER trial (Contact Aspiration Versus Stent Retriever for Successful Revascularization). The primary outcome was successful reperfusion at the end of all endovascular procedures, defined as modified Thrombolysis in Cerebral Infarction (mTICI) scores 2b/3. Secondary outcomes were mTICI 2c/3 and mTICI 3, 90-day functional outcome, assessed with the modified Rankin Scale score. Safety outcomes included 90-day mortality and any symptomatic intracerebral hemorrhage. Seventy-nine patients were included: 48 were allocated to the CA group and 31 to the SR group. There were no significant differences between CA and SR groups in reperfusion after all endovascular procedures regarding mTICI 2b/3 (89.6% versus 83.9%; P =0.36), mTICI 2c/3 (54.2% versus 54.8%; P =0.90), and mTICI 3 (35.4% versus 41.9%; P =0.36) rates. There were no significant differences between CA and SR groups in 90-day modified Rankin Scale ≤2 rate (54.4% versus 50.0%; P =0.84), 24-hour change in National Institutes of Health Stroke Scale (mean difference, -3.9; 95% confidence interval, -7.9 to 0.01), and Alberta Stroke Program Early Computed Tomography score (mean difference, 0.9; 95% confidence interval, -0.1 to 2.0) scores. Safety parameters were well balanced between the 2 groups except for a higher 90-day mortality rate in the CA group (19.6% versus 3.3%; P =0.078). First-line mechanical thrombectomy with CA compared with SR did not result in an increased successful revascularization rate in patients with acute stroke with isolated M2 occlusion. © 2017 American Heart Association, Inc.

Transmyocardial laser revascularization

NASA Astrophysics Data System (ADS)

Aretz, H. Thomas

1996-09-01

Transmyocardial laser revascularization (TMR) for the treatment of medically unresponsive angina pectoris has been shown to be clinically effective. The mechanism of its action, however, is not quite understood. Over the last five years my collaborators and I have conducted a variety of in vivo and in vitro studies using different animal models, lasers and experimental protocols. The results seem to indicate that the mechanism of action of TMR is related to neovascularization rather than chronically patent channels, as originally proposed.

The SDF-1–CXCR4 signaling pathway: a molecular hub modulating neo-angiogenesis

PubMed Central

Petit, Isabelle; Jin, David; Rafii, Shahin

2010-01-01

Pro-angiogenic bone marrow (BM) cells include subsets of hematopoietic cells that provide vascular support and endothelial progenitor cells (EPCs), which under certain permissive conditions could differentiate into functional vascular cells. Recent evidence demonstrates that the chemokine stromal-cell derived factor-1 (SDF-1, also known as CXCL12) has a major role in the recruitment and retention of CXCR4+ BM cells to the neo-angiogenic niches supporting revascularization of ischemic tissue and tumor growth. However, the precise mechanism by which activation of CXCR4 modulates neo-angiogenesis is not clear. SDF-1 not only promotes revascularization by engaging with CXCR4 expressed on the vascular cells but also supports mobilization of pro-angiogenic CXCR4+VEGFR1+ hematopoietic cells, thereby accelerating revascularization of ischemic organs. Here, we attempt to define the multiple functions of the SDF-1–CXCR4 signaling pathway in the regulation of neo-vascularization during acute ischemia and tumor growth. In particular, we introduce the concept that, by modulating plasma SDF-1 levels, the CXCR4 antagonist AMD3100 acutely promotes, while chronic AMD3100 treatment inhibits, mobilization of pro-angiogenic cells. We will also discuss strategies to modulate the mobilization of essential subsets of BM cells that participate in neo-angiogenesis, setting up the stage for enhancing revascularization or targeting tumor vessels by exploiting CXCR4 agonists and antagonists, respectively. PMID:17560169

[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.

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

78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

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2013-11-15

...] International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot... Drug Administration (FDA) is announcing participation in the Medical Device Single Audit Program International Coalition Pilot Program. The Medical Device Single Audit Program (MDSAP) was designed and...

77 FR 52759 - Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and...

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75 FR 33169 - Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation...

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.... FDA-2008-N-0163] (formerly Docket No. 2001N-0067) RIN 0910-AG21 Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam... the Federal Register of August 4, 2009 (74 FR 38686) which classified dental amalgam as a class II...

77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

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... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No... Serological Reagents; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction. SUMMARY: In the Federal Register of March 9, 2012 (76 FR 14272), the Food and Drug Administration (FDA...

Trends in hospital discharges, management and in-hospital mortality from acute myocardial infarction in Switzerland between 1998 and 2008

PubMed Central

2013-01-01

Background Since the late nineties, no study has assessed the trends in management and in-hospital outcome of acute myocardial infarction (AMI) in Switzerland. Our objective was to fill this gap. Methods Swiss hospital discharge database for years 1998 to 2008. AMI was defined as a primary discharge diagnosis code I21 according to the ICD10 classification. Invasive treatments and overall in-hospital mortality were assessed. Results Overall, 102,729 hospital discharges with a diagnosis of AMI were analyzed. The percentage of hospitalizations with a stay in an Intensive Care Unit decreased from 38.0% in 1998 to 36.2% in 2008 (p for trend < 0.001). Percutaneous revascularizations increased from 6.0% to 39.9% (p for trend < 0.001). Bare stents rose from 1.3% to 16.6% (p for trend < 0.001). Drug eluting stents appeared in 2004 and increased to 23.5% in 2008 (p for trend < 0.001). Coronary artery bypass graft increased from 1.0% to 3.0% (p for trend < 0.001). Circulatory assistance increased from 0.2% to 1.7% (p for trend < 0.001). Among patients managed in a single hospital (not transferred), seven-day and total in-hospital mortality decreased from 8.0% to 7.0% (p for trend < 0.01) and from 11.2% to 10.1%, respectively. These changes were no longer significant after multivariate adjustment for age, gender, region, revascularization procedures and transfer type. After multivariate adjustment, differing trends in revascularization procedures and in in-hospital mortality were found according to the geographical region considered. Conclusion In Switzerland, a steep rise in hospital discharges and in revascularization procedures for AMI occurred between 1998 and 2008. The increase in revascularization procedures could explain the decrease in in-hospital mortality rates. PMID:23530470

Prognostic Value of Transthoracic Doppler Echocardiography Coronary Flow Velocity Reserve in Patients with Nonculprit Stenosis of Intermediate Severity Early after Primary Percutaneous Coronary Intervention.

PubMed

Tesic, Milorad; Djordjevic-Dikic, Ana; Giga, Vojislav; Stepanovic, Jelena; Dobric, Milan; Jovanovic, Ivana; Petrovic, Marija; Mehmedbegovic, Zlatko; Milasinovic, Dejan; Dedovic, Vladimir; Zivkovic, Milorad; Juricic, Stefan; Orlic, Dejan; Stojkovic, Sinisa; Vukcevic, Vladan; Stankovic, Goran; Nedeljkovic, Milan; Ostojic, Miodrag; Beleslin, Branko

2018-04-03

Treatment of nonculprit coronary stenosis during primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction may be beneficial, but the mode and timing of the intervention are still controversial. The aim of this study was to examine the significance and prognostic value of preserved coronary flow velocity reserve (CFVR) in patients with nonculprit intermediate stenosis early after primary percutaneous coronary intervention. Two hundred thirty patients with remaining intermediate (50%-70%) stenosis of non-infarct-related arteries, in whom CFVR was performed within 7 days after primary percutaneous coronary intervention, were prospectively enrolled. Twenty patients with reduced CFVR and positive results on stress echocardiography or impaired fractional flow reserve underwent revascularization and were not included in further analysis. The final study population of 210 patients (mean age, 58 ± 10 years; 162 men) was divided into two groups on the basis of CFVR: group 1, CFVR > 2 (n = 174), and group 2, CFVR ≤ 2 (n = 36). Cardiac death, nonfatal myocardial infarction, and revascularization of the evaluated vessel were considered adverse events. Mean follow-up duration was 47 ± 16 months. Mean CFVR for the whole group was 2.36 ± 0.40. There were six adverse events (3.4%) related to the nonculprit coronary artery in group 1, including one cardiac death, one ST-segment elevation myocardial infarction, and four revascularizations. In group 2, there were 30 adverse events (83.3%, P < .001 vs group 1), including two cardiac deaths, two ST-segment elevation myocardial infarctions, and 26 revascularizations. In patients with CFVR > 2 of the intermediate nonculprit coronary lesion, deferral of revascularization is safe and associated with excellent long-term clinical outcomes. Copyright © 2018 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.

Early risk of mortality after coronary artery revascularization in patients with left ventricular dysfunction and potential role of the wearable cardioverter defibrillator.

PubMed

Zishiri, Edwin T; Williams, Sarah; Cronin, Edmond M; Blackstone, Eugene H; Ellis, Stephen G; Roselli, Eric E; Smedira, Nicholas G; Gillinov, A Marc; Glad, Jo Ann; Tchou, Patrick J; Szymkiewicz, Steven J; Chung, Mina K

2013-02-01

Implantation of implantable cardioverter defibrillator for prevention of sudden cardiac death is deferred for 90 days after coronary revascularization, but mortality may be highest early after cardiac procedures in patients with ventricular dysfunction. We determined mortality risk in postrevascularization patients with left ventricular ejection fraction ≤35% and compared survival with those discharged with a wearable cardioverter defibrillator (WCD). Hospital survivors after surgical (coronary artery bypass graft surgery) or percutaneous (percutaneous coronary intervention [PCI]) revascularization with left ventricular ejection fraction ≤35% were included from Cleveland Clinic and national WCD registries. Kaplan-Meier, Cox proportional hazards, propensity score-matched survival, and hazard function analyses were performed. Early mortality hazard was higher among 4149 patients discharged without a defibrillator compared with 809 with WCDs (90-day mortality post-coronary artery bypass graft surgery 7% versus 3%, P=0.03; post-PCI 10% versus 2%, P<0.0001). WCD use was associated with adjusted lower risks of long-term mortality in the total cohort (39%, P<0.0001) and both post-coronary artery bypass graft surgery (38%, P=0.048) and post-PCI (57%, P<0.0001) cohorts (mean follow-up, 3.2 years). In propensity-matched analyses, WCD use remained associated with lower mortality (58% post-coronary artery bypass graft surgery, P=0.002; 67% post-PCI, P<0.0001). Mortality differences were not attributable solely to therapies for ventricular arrhythmia. Only 1.3% of the WCD group had a documented appropriate therapy. Patients with left ventricular ejection fraction ≤35% have higher early compared to late mortality after coronary revascularization, particularly after PCI. As early hazard seemed less marked in WCD users, prospective studies in this high-risk population are indicated to confirm whether WCD use as a bridge to left ventricular ejection fraction improvement or implantable cardioverter defibrillator implantation can improve outcomes after coronary revascularization.

Sex-related differences in coronary revascularization practices: the perspective from a Canadian queue management project.

PubMed

Naylor, C D; Levinton, C M

1993-10-01

To assess sex-related differences in coronary revascularization practices in a Canadian setting. Prospective analytic cohort study. Regional referral office in Toronto. A selected but consecutive group of 131 women and 440 men referred by cardiologists for revascularization procedures between Jan. 3, 1989, and June 30, 1991. Coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA). Nurse-coordinators placed the referral with a surgeon or interventional cardiologist at one of three hospitals, who then communicated directly with the referring cardiologist. Symptom status at referral, procedures requested and performed, and time from referral to procedure. Although the women were more likely than the men to have unstable angina at the time of referral (odds ratio [OR] 2.28, 95% confidence interval [CI] 1.38 to 3.79, p = 0.0006), more women than men (16.8% v. 12.1%) were turned down for a procedure. Significant sex-related differences in practice patterns (p < 0.001) persisted after controlling for age or for the referring cardiologists' perception of expected procedural risk. A stepwise multivariate model showed that anatomy was the main determinant of case management; sex was the only other significant variable (p = 0.016). The referring physicians requested CABG more often for men than for women (p = 0.009), and the men accepted for a procedure were much more likely to undergo CABG than the women (OR 2.40, CI 1.47 to 3.93, p = 0.0002). Although the women undergoing CABG waited shorter periods than the men (p = 0.0035), this difference was attributable to their more severe symptoms. In this selected group women had more serious symptoms before referral but were turned down for revascularization more often than men. Reduced use of CABG rather than PTCA largely accounted for the sex-related differences in revascularization. Once accepted for a procedure women had shorter waiting times, which was appropriate given their more severe symptoms.

A comparison of outcomes with coronary artery calcium scanning in unselected populations: the Multi-Ethnic Study of Atherosclerosis (MESA) and Heinz Nixdorf RECALL study (HNR).

PubMed

Budoff, Matthew J; Möhlenkamp, Stefan; McClelland, Robyn; Delaney, Joseph A; Bauer, Marcus; Jöckel, Heinz Karl; Kälsch, Hagen; Kronmal, Richard; Nasir, Khurram; Lehmann, Nils; Moebus, Susanne; Mukamal, Ken; Erbel, Raimund

2013-01-01

The Multi-Ethnic Study of Atherosclerosis (MESA) and the Heinz Nixdorf RECALL (Risk factors, Evaluation of Coronary Calcium and Lifestyle Factors) study (HNR) differed in regard to informing physicians and patients of the results of their subclinical atherosclerosis. This study investigates whether the association of the presence of coronary calcium with incident nonfatal and fatal cardiovascular events is different among these 2 large, population-based observational studies. All white subjects aged 45 to 75 years, free of baseline cardiovascular disease were included (n = 2232 in MESA; n = 3119 HNR participants). We studied the association between coronary calcium and event rates at 5 years, including hard cardiac events (myocardial infarction, cardiac death, resuscitated cardiac arrest), and separately added revascularizations and strokes (fatal and nonfatal) to determine adjusted hazard ratios. Both cohorts showed low coronary heart disease (including revascularization) rates with zero coronary calcium (1.13% and 1.16% over 5 years in MESA and HNR, respectively) and increasing significantly in both groups with Agatston score 100 to 399 (6.71% and 4.52% in MESA and HNR, respectively) and Agatston score > 400 (12.5% and 13.54% in MESA and HNR, respectively) and showing strong independent predictive values for Agatston scores of 100 to 399 and >400, despite multivariable adjustment for risk factors. Risk factor-adjusted 5-year revascularization rates were nearly identical for HNR and MESA and were generally low for both studies (1.4% [45 of 3119] for HNR and 1.9% [43 of 2232] for MESA) over 5 years. Across 2 culturally diverse populations, Agatston score >400 is a strong predictor of events. High Agatston score did not statistically result in revascularization, and knowledge of the presence of coronary calcium did not increase revascularizations. Copyright © 2013 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

The feasibility and safety of off-pump coronary bypass surgery in emergency revascularization

PubMed Central

Joo, Hyun-Chel; Youn, Young-Nam; Chang, Byung-Chul

2018-01-01

Background The efficacy and safety of off-pump coronary artery bypass grafting (OPCAB) in emergency revascularization remains controversial despite its widespread use. The aim of our study was to examine the applicability and safety of OPCAB in patients who were indicated for emergency surgery. Methods This single-center study reviewed the indication, operative data, and early and long-term outcomes of 113 patients (mean age, 67.2±9.0 years; logistic EuroSCORE, 14.3±13.5) who underwent emergency OPCAB from January 2003 to December 2014 and were followed up (94.6% completion rate) for a mean 51.1±40.3 (range, 1–135) months. Results Emergency OPCAB was associated with favorable surgical outcomes (number of distal anastomoses per patient, 3.04±0.87; internal thoracic artery (IMA) use, 98.2%; complete revascularization, 79.6%) and in-hospital outcomes (mortality, 5.3%; low cardiac output syndrome, 5.3%; stroke, 2.7%; pulmonary complications, 8.8%; renal failure, 11.5%). Only five patients (4.4%) required on-pump conversion. The 10-year outcomes were also acceptable (survival, 75.4%±5.6%; major cerebral and cardiovascular events, 52.1%±1.8%). The multivariate risk factors for late mortality were peripheral vascular disease (HR 2.95, 95% CI: 1.11–11.83), cardiogenic shock (HR 3.67, 95% CI: 1.35–9.96), and incomplete revascularization (HR 3.41, 95% CI: 1.06–14.26). When patients were separated by whether the procedure was performed early (<2010) or late (≥2010) in the study period, the late period cohort had better outcomes despite containing higher-risk patients. Conclusions Our study suggests that emergency OPCAB can be performed safely and effectively with good hospital outcomes and adequate long-term results. OPCAB strategy can be considered as a good option in emergency revascularization. PMID:29850131

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.

Prognostic value of high-dose dobutamine stress magnetic resonance imaging in 1,493 consecutive patients: assessment of myocardial wall motion and perfusion.

PubMed

Korosoglou, Grigorios; Elhmidi, Yacine; Steen, Henning; Schellberg, Dieter; Riedle, Nina; Ahrens, Johannes; Lehrke, Stephanie; Merten, Constanze; Lossnitzer, Dirk; Radeleff, Jannis; Zugck, Christian; Giannitsis, Evangelos; Katus, Hugo A

2010-10-05

This study sought to determine the prognostic value of wall motion and perfusion assessment during high-dose dobutamine stress (DS) cardiac magnetic resonance imaging (MRI) in a large patient cohort. DS-MRI offers the possibility to integrate myocardial perfusion and wall motion analysis in a single examination for the detection of coronary artery disease (CAD). A total of 1,493 consecutive patients with suspected or known CAD underwent DS-MRI, using a standard protocol in a 1.5-T magnetic resonance scanner. Wall motion and perfusion were assessed at baseline and during stress, and outcome data including cardiac death, nonfatal myocardial infarction ("hard events"), and "late" revascularization performed >90 days after the MR scans were collected during a 2 ± 1 year follow-up period. Fifty-three hard events, including 14 cardiac deaths and 39 nonfatal infarctions, occurred during the follow-up period, whereas 85 patients underwent "late" revascularization. Using multivariable regression analysis, an abnormal result for wall motion or perfusion during stress yielded the strongest independent prognostic value for both hard events and late revascularization, clearly surpassing that of clinical and baseline magnetic resonance parameters (for wall motion: adjusted hazard ratio [HR] of 5.9 [95% confidence interval (CI): 2.5 to 13.6] for hard events and of 3.1 [95% CI: 1.7 to 5.6] for late revascularization, and for perfusion: adjusted HR of 5.4 [95% CI: 2.3 to 12.9] for hard events and of 6.2 [95% CI: 3.3 to 11.3] for late revascularization, p < 0.001 for all). DS-MRI can accurately identify patients who are at increased risk for cardiac death and myocardial infarction, separating them from those with normal findings, who have very low risk for future cardiac events. (Prognostic Value of High Dose Dobutamine Stress Magnetic Resonance Imaging; NCT00837005). Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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.

Endovascular revascularization results in IMS III: intracranial ICA and M1 occlusions.

PubMed

Tomsick, Thomas A; Yeatts, Sharon D; Liebeskind, David S; Carrozzella, Janice; Foster, Lydia; Goyal, Mayank; von Kummer, Ruediger; Hill, Michael D; Demchuk, Andrew M; Jovin, Tudor; Yan, Bernard; Zaidat, Osama O; Schonewille, Wouter; Engelter, Stefan; Martin, Renee; Khatri, Pooja; Spilker, Judith; Palesch, Yuko Y; Broderick, Joseph P

2015-11-01

Interventional Management of Stroke III did not show that combining IV recombinant tissue plasminogen activator (rt-PA) with endovascular therapies (EVTs) is better than IV rt-PA alone. To report efficacy and safety results for EVT of intracranial internal carotid artery (ICA) and middle cerebral artery trunk (M1) occlusion. Five revascularization methods for persistent occlusions after IV rt-PA treatment were evaluated for prespecified primary and secondary endpoints, after accounting for differences in key baselines variables using propensity scores. Revascularization was scored using the arterial occlusive lesion (AOL) and the modified Thrombolysis in Cerebral Ischemia (mTICI) scores. EVT of 200 subjects with intracranial ICA or M1 occlusion resulted in 81.5% AOL 2-3 recanalization, in addition to 76% mTICI 2-3 and 42.5% mTICI 2b-3 reperfusion. Adverse events included symptomatic intracranial hemorrhage (SICH) (8.0%), vessel perforations (1.5%), and new emboli (14.9%). EVT techniques used were standard microcatheter n=51; EKOS n=14; Merci n=77; Penumbra n=39; Solitaire n=4; multiple n=15. Good clinical outcome was associated with both TICI 2-3 and TICI 2b-3 reperfusion. Neither modified Rankin scale (mRS) 0-2 (28.5%), nor 90-day mortality (28.5%), nor asymptomatic ICH (36.0%) differed among revascularization methods after propensity score adjustment for subjects with intracranial ICA or M1 occlusion. Good clinical outcome was associated with good reperfusion for ICA and M1 occlusion. No significant differences in efficacy or safety among revascularization methods were demonstrated after adjustment. Lack of high-quality reperfusion, adverse events, and prolonged time to treatment contributed to lower-than-expected mRS 0-2 outcomes and study futility compared with IV rt-PA. NCT00359424. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Comparison of Clinical Characteristics and Outcomes of Patients With Versus Without Diabetes Mellitus and With Versus Without Angina Pectoris (from the Duke Databank for Cardiovascular Disease).

PubMed

Banks, Adam; Broderick, Samuel; Chiswell, Karen; Shaw, Linda; Devore, Adam; Fiuzat, Mona; O'Connor, Christopher; Felker, Gary Michael; Velazquez, Eric; Mentz, Robert

2017-06-01

Angina pectoris (AP) has different prognostic implications in various populations. Patients with diabetes mellitus (DM) may experience neuropathy such that AP may not be perceived in the setting of coronary artery disease (CAD). The prognostic utility of AP in DM patients with CAD is not well known. We analyzed patients with CAD who underwent coronary angiography at Duke University from 2002 to 2011 and compared patients with and without AP within the previous 6 weeks stratified by DM status. We used multivariable Cox regression to assess the association between AP and the outcomes of cardiovascular (CV) hospitalization/revascularization, all-cause mortality/myocardial infarction/revascularization, and all-cause mortality. Of 17,211 patients with CAD, 5,284 (31%) had DM and AP was present in 69% of DM and 67% of non-DM. After risk adjustment, the risk of CV hospitalization/revascularization and all-cause mortality/myocardial infarction/revascularization in patients with and without AP was similar regardless of DM status (all p ≥0.05). In patients with or without DM, AP was associated with lower all-cause mortality compared with no AP (adjusted hazard ratio 0.89, 95% confidence interval 0.82 to 0.97, p = 0.005 for DM patients). The relation between AP status and clinical outcomes was not dependent on DM status (all interaction p >0.10). In conclusion, in patients with CAD, AP was associated with similar risk for CV hospitalization and revascularization and lower all-cause mortality compared with patients without AP regardless of DM status. Future studies are needed to assess whether these findings are related to increased severity of disease in those without AP or whether AP leads to differential management that improves survival. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparison of one-year outcomes of percutaneous coronary intervention versus coronary artery bypass grafting in patients with unprotected left main coronary artery disease and acute coronary syndromes (from the CUSTOMIZE Registry).

PubMed

Caggegi, Anna; Capodanno, Davide; Capranzano, Piera; Chisari, Alberto; Ministeri, Margherita; Mangiameli, Andrea; Ronsivalle, Giuseppe; Ricca, Giovanni; Barrano, Giombattista; Monaco, Sergio; Di Salvo, Maria Elena; Tamburino, Corrado

2011-08-01

Uncertainty surrounds the optimal revascularization strategy for patients with left main coronary artery disease presenting with acute coronary syndromes (ACSs), and adequately sized specific comparisons of percutaneous and surgical revascularization in this scenario are lacking. The aim of this study was to evaluate the incidence of 1-year major adverse cardiac events (MACEs) in patients with left main coronary artery disease and ACS treated with percutaneous coronary intervention (PCI) and drug-eluting stent implantation or coronary artery bypass grafting (CABG). A total of 583 patients were included. At 1 year, MACEs were significantly higher in patients treated with PCI (n = 222) compared to those treated with CABG (n = 361, 14.4% vs 5.3%, p <0.001), driven by a higher rate of target lesion revascularization (8.1% vs 1.7%, p = 0.001). This finding was consistent after statistical adjustment for MACEs (adjusted hazard ratio [HR] 2.7, 95% confidence interval [CI] 1.2 to 5.9, p = 0.01) and target lesion revascularization (adjusted HR 8.0, 95% CI 2.2 to 28.7, p = 0.001). No statistically significant differences between PCI and CABG were noted for death (adjusted HR 1.1, 95% CI 0.4 to 3.0, p = 0.81) and myocardial infarction (adjusted HR 4.8, 95% CI 0.3 to 68.6, p = 0.25). No interaction between clinical presentation (ST-segment elevation myocardial infarction or unstable angina/non-ST-segment elevation myocardial infarction) and treatment (PCI or CABG) was observed (p for interaction = 0.68). In conclusion, in patients with left main coronary artery disease and ACS, PCI is associated with similar safety compared to CABG but higher risk of MACEs driven by increased risk of repeat revascularization. Copyright © 2011 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.

Microbial evaluation of traumatized teeth treated with triple antibiotic paste or calcium hydroxide with 2% chlorhexidine gel in pulp revascularization.

PubMed

Nagata, Juliana Y; Soares, Adriana J; Souza-Filho, Francisco J; Zaia, Alexandre A; Ferraz, Caio C R; Almeida, José F A; Gomes, Brenda P F A

2014-06-01

Revascularization outcome depends on microbial elimination because apical repair will not happen in the presence of infected tissues. This study evaluated the microbial composition of traumatized immature teeth and assessed their reduction during different stages of the revascularization procedures performed with 2 intracanal medicaments. Fifteen patients (7-17 years old) with immature teeth were submitted to the revascularization procedures; they were divided into 2 groups according to the intracanal medicament used: TAP group (n = 7), medicated with a triple antibiotic paste, and CHP group (n = 8), dressed with calcium hydroxide + 2% chlorhexidine gel. Samples were taken before any treatment (S1), after irrigation with 6% NaOCl (S2), after irrigation with 2% chlorhexidine (S3), after intracanal dressing (S4), and after 17% EDTA irrigation (S5). Cultivable bacteria recovered from the 5 stages were counted and identified by means of polymerase chain reaction assay (16S rRNA). Both groups had colony-forming unit counts significantly reduced after S2 (P < .05); however, no significant difference was found between the irrigants (S2 and S3, P = .99). No difference in bacteria counts was found between the intracanal medicaments used (P = .95). The most prevalent bacteria detected were Actinomyces naeslundii (66.67%), followed by Porphyromonas endodontalis, Parvimonas micra, and Fusobacterium nucleatum, which were detected in 33.34% of the root canals. An average of 2.13 species per canal was found, and no statistical correlation was observed between bacterial species and clinical/radiographic features. The microbial profile of infected immature teeth is similar to that of primarily infected permanent teeth. The greatest bacterial reduction was promoted by the irrigation solutions. The revascularization protocols that used the tested intracanal medicaments were efficient in reducing viable bacteria in necrotic immature teeth. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Fractional flow reserve-guided revascularization: practical implications of a diagnostic gray zone and measurement variability on clinical decisions.

PubMed

Petraco, Ricardo; Sen, Sayan; Nijjer, Sukhjinder; Echavarria-Pinto, Mauro; Escaned, Javier; Francis, Darrel P; Davies, Justin E

2013-03-01

This study sought to evaluate the effects of fractional flow reserve (FFR) measurement variability on FFR-guided treatment strategy. Current appropriateness guidelines recommend the utilization of FFR to guide coronary revascularization based on a fixed cut-off of 0.8. This rigid approach does not take into account the intrinsic biological variability of a single FFR result and the clinical judgment of experienced interventional cardiologists. [corrected]. FFR reproducibility data from the landmark Deferral Versus Performance of PTCA in Patients Without Documented Ischemia (DEFER) trial was analyzed (two repeated FFR measurements in the same lesion, 10 min apart) and the standard deviation of the difference (SDD) between repeated measurements was calculated. The measurement certainty (probability that the FFR-guided revascularization strategy will not change if the test is repeated 10 min later) was subsequently established across the whole range of FFR values, from 0.2 to 1. Outside the [0.75 to 0.85] FFR range, measurement certainty of a single FFR result is >95%. However, closer to its cut-off, certainty falls to less than 80% within 0.77 to 0.83, reaching a nadir of 50% around 0.8. In clinical practice, that means that each time a single FFR value falls between 0.75 and 0.85, there is a chance that the FFR-derived revascularization recommendation will change if the measurement is repeated 10 min later, with this chance increasing the closer the FFR result is to 0.8. A measurement FFR gray-zone is found between 0.75 and 0.85]. Therefore, clinicians should make revascularization decisions based on broadened clinical judgment when a single FFR result falls within this uncertainty zone, particularly between 0.77 and 0.83, when measurement certainty falls to less than 80%. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

76 FR 7222 - Medical Device Innovation Initiative; Public Meeting; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-09

...] Medical Device Innovation Initiative; Public Meeting; Request for Comments AGENCY: Food and Drug... Administration (FDA) is announcing a public meeting entitled ``CDRH's Medical Device Innovation Initiative Public... Center for Devices and Radiological Health's (CDRH) document, ``Medical Device Innovation Initiative...

77 FR 18829 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-28

...] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory... and 11, 2012, the committee will discuss general issues related to medical devices intended for obese...

78 FR 77688 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

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2013-12-24

...] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave...

76 FR 29006 - In the Matter of Certain Motion-Sensitive Sound Effects Devices and Image Display Devices and...

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2011-05-19

... Effects Devices and Image Display Devices and Components and Products Containing Same; Notice of... United States after importation of certain motion-sensitive sound effects devices and image display... devices and image display devices and components and products containing same that infringe one or more of...

76 FR 14028 - Center for Devices and Radiological Health 510(k) Implementation: Online Repository of Medical...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-15

...] Center for Devices and Radiological Health 510(k) Implementation: Online Repository of Medical Device... public meeting entitled ``510(k) Implementation: Discussion of an Online Repository of Medical Device... establish an online public repository of medical device labeling and strategies for displaying device...

76 FR 28689 - Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-18

.... FDA-2011-N-0103] Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus... of the Microbiology Devices Advisory Panel (the Panel). In addition, the proposed rule would... in the Federal Register. 1. Transcript of the FDA Microbiology Devices Panel meeting, March 7, 2002...

75 FR 30794 - Notice of Intent To Grant Exclusive Patent License; AmberWave Systems Corporation

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-02

..., power transistor devices, and power devices in the United States, the Government-owned inventions... amplifiers, radio frequency power transistor devices, and power devices and their use for the fabrication of...

Revascularization to preserve renal function in patients with atherosclerotic renovascular disease.

PubMed

Novick, A C; Textor, S C; Bodie, B; Khauli, R B

1984-08-01

There are a significant number of patients with advanced atherosclerotic renovascular disease whose blood pressure is well controlled with medical therapy but in whom such vascular disease poses a grave risk to overall renal function. This article reviews current concepts regarding screening, evaluation, and selection of patients with this disease for revascularization to preserve renal function. The underlying rationale for this approach is an increasing awareness that, in selected patients, atherosclerotic renovascular disease represents a surgically correctable cause of progressive renal failure.

75 FR 64742 - In the Matter of Certain Devices Having Elastomeric Gel and Components Thereof; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-20

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-732] In the Matter of Certain Devices... (EDIS) at http://edis.usitc.gov . Hearing-impaired persons are advised that information on this matter... supplemented, of Interactive Life Forms, LLC of Austin, Texas (``ILF''). 75 FR 47027 (Aug. 4, 2010). The...

76 FR 18227 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-01

...] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting... comment period for the notice announcing a meeting of the Molecular and Clinical Genetics Panel (the panel... Register of February 7, 2011 (76 FR 6623), FDA published a notice announcing a meeting of the Molecular and...

75 FR 35495 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-22

...] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... Glaukos iStent Trabecular Micro-Bypass Stent, Model GTS-100 L/R, sponsored by Glaukos Corp. The device is...

76 FR 50485 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-15

...] Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY... an amendment to the notice of meeting of the Obstetrics and Gynecology Devices Panel of the Medical... Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee would be held on September...

75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the..., FDA announced that a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices...

78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-01

...] Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY... Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Through the...

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.

Periostin Limits Tumor Response to VEGFA Inhibition.

PubMed

Keklikoglou, Ioanna; Kadioglu, Ece; Bissinger, Stefan; Langlois, Benoît; Bellotti, Axel; Orend, Gertraud; Ries, Carola H; De Palma, Michele

2018-03-06

Resistance to antiangiogenic drugs limits their applicability in cancer therapy. Here, we show that revascularization and progression of pancreatic neuroendocrine tumors (PNETs) under extended vascular-endothelial growth factor A (VEGFA) blockade are dependent on periostin (POSTN), a matricellular protein expressed by stromal cells. Genetic deletion of Postn in RIP1-Tag2 mice blunted tumor rebounds of M2-like macrophages and αSMA + stromal cells in response to prolonged VEGFA inhibition and suppressed PNET revascularization and progression on therapy. POSTN deficiency also impeded the upregulation of basic fibroblast growth factor (FGF2), an adaptive mechanism previously implicated in PNET evasion from antiangiogenic therapy. Higher POSTN expression correlated with markers of M2-like macrophages in human PNETs, and depleting macrophages with a colony-stimulating factor 1 receptor (CSF1R) antibody inhibited PNET revascularization and progression under VEGFA blockade despite continued POSTN production. These findings suggest a role for POSTN in orchestrating resistance to anti-VEGFA therapy in PNETs. Copyright © 2018 The Author(s). Published by 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.

76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Immunology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY... postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled...

76 FR 6625 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

76 FR 12973 - Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

...] Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY: Food and Drug... notice of meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee. This... INFORMATION: In the Federal Register of February 7, 2011, FDA announced that a meeting of the Neurological...

76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-22

...] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and... of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee. General... also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus...

77 FR 25183 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-27

...] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and... of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee. General..., introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper. FDA intends to...

78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Microbiology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

76 FR 69034 - Microbiology Devices; Classification of In Vitro Diagnostic Device for Yersinia Species Detection

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

... Drug Administration 21 CFR Part 866 Microbiology Devices; Classification of In Vitro Diagnostic Device... CFR Part 866 [Docket No. FDA-2011-N-0729] Microbiology Devices; Classification of In Vitro Diagnostic... of the Microbiology Devices Advisory Panel (the panel). FDA is publishing in this document the...

75 FR 57968 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-23

...] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory... committee will discuss, make recommendations, and vote on information related to the PMA for the LAP-BAND...

76 FR 54156 - National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-31

... traffic control device design, location, or operation that have made some existing devices in the field...-2010-0159] RIN 2125-AF43 National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for Streets and Highways; Revision AGENCY: Federal Highway Administration (FHWA...

75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...

78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

75 FR 19340 - Wireless Technologies, Devices, and Services

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-14

... Technologies, Devices, and Services AGENCY: Federal Communications Commission. ACTION: Proposed rule. SUMMARY... technologies, devices, and services. Specifically, the Commission seeks comment regarding particular changes to... concise rules that facilitate new wireless technologies, devices and services, and are easy for the public...

[Relationship between hyperuricemia and prognosis in patients with heart failure of coronary heart disease after revascularization].

PubMed

Peng, D; Wang, S P; Zhao, D H; Fan, Q C; Shu, J; Liu, J H

2018-05-08

Objective: To explore the effect of hyperuricemia on prognosis in patients with heart failure of coronary heart disease (CHD) after revascularization. Methods: A single-center retrospective study of all subjects who underwent percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) as revascularization for CHD at Beijing Anzhen Hospital, Capital Medical University, between January 2005 and December 2014 was performed.Patients were divided into two groups by with or without hyperuricemia.The average follow-up was 1 818 d. Results: The Logistic regression analysis revealed that hyperuricemia was independent risk factors of readmission of heart failure( P =0.018, OR =1.499, 95% CI 1.071-2.098). The Cox regression analysis revealed that hyperuricemia was independent risk factor of all-cause mortality( P =0.002, RR =1.520, 95% CI 1.166-1.982), cardiovascular ( CV ) mortality( P =0.001, RR =1.811, 95% CI 1.279-2.566), heart failure mortality( P =0.006, RR =2.151, 95% CI 1.247-3.711). Conclusions: There is negative correlation between level of uric acid and left ventricular ejection fraction (LVEF). The patients with heart failure of coronary heart disease complicated with hyperuricemia have high risk of readmission of heart failure, all-cause mortality, CV mortality andheart failure mortality than patients with normal uric acid level. Hyperuricemia is an independent risk factor for patients with heart failure of coronary heart disease after revascularization.

Coronary Revascularization in Children at a Mexican Cardiac Center: Thirteen-Year Outcomes.

PubMed

Ramírez-Marroquín, Samuel E; Iturriaga-Hernández, Alejandra; Calderón-Colmenero, Juan; Benita-Bordes, Antonio; Cervantes-Salazar, Jorge L

2017-09-01

The indications for pediatric coronary revascularization are diverse. There are a large proportion of patients with sequelae of severe inflammatory diseases such as Kawasaki disease, and other less common causes. Retrospective review of ten pediatric patients undergoing coronary artery bypass surgery from January 2004 to December 2016. Ten children and adolescents ranging in age from 2 to 17 (median, 6) years at operation were followed up for as long as 13 years with a median follow-up of 2 years. The surgical indications include ischemia symptoms and/or coronary stenosis angiographically documented. Diagnoses include Kawasaki disease, anomalous origin of the left coronary artery from the pulmonary artery, and iatrogenic lesion of the right coronary artery. All the surgical procedures were performed with cardiopulmonary bypass with crystalloid cardioplegic arrest. The number of distal anastomoses was 1.6 per patient, and the left internal thoracic artery was used in one patient, the right internal thoracic artery in four patients, bilateral internal thoracic artery in four patients, and bilateral internal thoracic artery plus left radial artery in one patient, most frequently for right coronary artery revascularization. The patients underwent noninvasive diagnostic study during follow-up to evaluate their coronary status. The ten patients had no symptoms, and there was no mortality. Although survival was excellent after pediatric coronary bypass in our center, we need to continue the follow-up. Coronary revascularization by means of arterial grafting is a safe and reliable surgical modality for coronary disease in children.

Increase in electrocardiographic R-waves after revascularization in patients with acute myocardial infarction.

PubMed

Isobe, Satoshi; Takada, Yasuo; Ando, Akitada; Ohshima, Satoru; Yamada, Kiyoyasu; Nanasato, Mamoru; Unno, Kazumasa; Ogawa, Takuo; Kondo, Takahisa; Izawa, Hideo; Inden, Yasuya; Hirai, Makoto; Murohara, Toyoaki

2006-11-01

The physiological mechanism of the increase in the electrocardiographic (ECG) R-wave voltage after revascularization in patients with acute myocardial infarction (MI) needs to be elucidated. One hundred and thirty-eight MI patients (83: anterior MI, 45: inferior MI, 10: lateral MI) underwent ECG and echocardiography in both the acute and subacute phases after emergency revascularization, as well as a resting thallium-201/iodine-123 15-p-iodophenyl-3-(R,S)-methyl pentadecanoic acid myocardial scintigraphy in the acute phase. The total sum of the R-wave voltage (SigmaR) was calculated over multiple leads on ECG for each infarcted lesion. Scintigraphic defect on each tracer was expressed as the percentage (%) defect of the total left ventricular (LV) myocardium. The % defect-discordance on both images in the acute phase and the % increase in SigmaR and the absolute increase in LV ejection fraction from the acute to the subacute phase (DeltaEF) were also calculated. The SigmaR in the subacute phase was significantly greater than that in the acute phase (p<0.0001). The % increase in SigmaR significantly correlated with the DeltaEF (r=0.57, p<0.0001). The % increase in SigmaR also correlated with the % defect-discordance (r=0.68, p<0.0001). The increase in the ECG R-wave voltage reflects not only the improvement in myocardial perfusion but also the presence of salvaged myocardium after revascularization in acute MI patients.

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.

Biodegradable membrane-covered stent from chitosan-based polymers.

PubMed

Thierry, Benjamin; Merhi, Yahye; Silver, Jim; Tabrizian, Maryam

2005-12-01

Membrane-covered devices could help treat disease of the vasculature such as aneurysm, rupture, and fistulas. They are also investigated to reduce embolic complication associated with revascularization of saphenous vein graft. The aim of this study is to design a clinically applicable biodegradable membrane-covered stent based on the natural polysaccharide chitosan, which has been developed. The mechanical properties of the membrane is optimized through blending with polyethylene oxide (70:30% Wt CH:PEO). The membrane was able to sustain the mechanical deformation of the supporting self-expandable metallic stents during its deployment. The membrane was demonstrated to resist physiological transmural pressure (burst pressure resistance >500 mm Hg) and presented a high-water permeation resistance (1 mL/cm(2) min(-1) at 120 mmHg). The CH-PEO membrane showed a good hemocompatibility in an ex vivo assay. Heparin and hyaluronan surface complexation with the membrane further reduced platelet adhesion by 50.1 and 63% (p = 0.05). The ability of the membrane-covered devices to be used as a drug reservoir was investigated using the nitric oxide donor sodium nitroprusside (SNP). SNP-loaded membranes displayed significantly reduced platelet adhesion. (c) 2005 Wiley Periodicals, Inc.

Semiclosed transfemoral iliac endarterectomy with an oscillating ring stripper.

PubMed

Stevick, C A; Bloom, R J

1989-10-01

The technique of endarterectomy for the removal of occlusive atherosclerotic lesions of the aorta and iliac arteries has been utilized successfully in the revascularization of ischemic limbs since its introduction in 1951. The oscillating loop endarterectomy device (Amsco-Hall arterial oscillator) has proven to be useful for endarterectomy of segmental occlusive disease as a substitute for bypass with prosthetic graft. For our elderly debilitated patients, we have adopted a new technique of semiclosed transfemoral iliac endarterectomy for management of occlusive external iliac disease with a patent common iliac artery. We report seven patients treated during May 1987 through May 1988 for external iliac artery occlusion by transfemoral oscillating loop endarterectomy. At 12 months for follow-up review, the cumulative limb salvage rate was 80% with no perioperative mortality. One patient required above-knee amputation eight months following endarterectomy to control forefoot sepsis. Two patients required subsequent leg bypass procedures to achieve full healing of foot level amputation. One patient required dilatation of residual stenosis at the iliac bifurcation by percutaneous balloon angioplasty. Semiclosed transfemoral endarterectomy with the Amsco-Hall oscillating loop device remains an attractive option to the vascular surgeon for recanalization of the iliac artery without the need for an extensive retroperitoneal dissection.

The LIBERTY study: Design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease.

PubMed

Adams, George L; Mustapha, Jihad; Gray, William; Hargus, Nick J; Martinsen, Brad J; Ansel, Gary; Jaff, Michael R

2016-04-01

Most peripheral artery disease (PAD) clinical device trials are supported by commercial manufacturers and designed for regulatory device approval, with extensive inclusion/exclusion criteria to support homogeneous patient populations. High-risk patients with advanced disease, including critical limb ischemia (CLI), are often excluded leading to difficulty in translating trial results into real-world clinical practice. As a result, physicians have no direct guidance regarding the use of endovascular devices. There is a need for objectively assessed studies to evaluate clinical, functional, and economic outcomes in PAD patient populations. LIBERTY is a prospective, observational, multicenter study sponsored by Cardiovascular Systems Inc (St Paul, MN) to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic lower extremity PAD. Approximately 1,200 patients will be enrolled and followed up to 5 years: 500 patients in the "Claudicant Rutherford 2-3" arm, 600 in the "CLI Rutherford 4-5" arm, and 100 in the "CLI Rutherford 6" arm. The study will use 4 core laboratories for independent analysis and will evaluate the following: procedural and lesion success, rates of major adverse events, duplex ultrasound interpretations, wound status, quality of life, 6-minute walk test, and economic analysis. The LIBERTY Patient Risk Score(s) will be developed as a clinical predictor of outcomes to provide guidance for interventions in this patient population. LIBERTY will investigate real-world PAD patients treated with endovascular revascularization with rigorous study guidelines and independent oversight of outcomes. This study will provide observational, all-comer patient clinical data to guide future endovascular therapy. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

77 FR 16126 - Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

.... FDA-2012-N-0159] Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for... convened a meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee (Microbiology Devices Panel) on June 29, 2011 (Ref. 2). Although not a formal reclassification meeting, panel...

77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

...] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug... transport devices commonly known as stairlifts. These devices are used to assist transfers of a mobility... behalf of Bruno Independent Living Aids, Inc., for powered patient transport devices (commonly known as...

75 FR 44172 - Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-28

... [Docket No. FDA-2009-N-0493] RIN 0910-ZA37 Neurological and Physical Medicine Devices; Designation of... document proposed to amend certain neurological and physical medicine device regulations to establish... to amend certain neurological device and physical medicine device regulations to establish special...

75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-17

... Suction Apparatus Device Intended for Negative Pressure Wound Therapy AGENCY: Food and Drug Administration...- powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II... ``Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative...

The impact of coronary chronic total occlusion percutaneous coronary intervention upon donor vessel fractional flow reserve and instantaneous wave-free ratio: Implications for physiology-guided PCI in patients with CTO.

PubMed

Mohdnazri, Shah R; Karamasis, Grigoris V; Al-Janabi, Firas; Cook, Christopher M; Hampton-Till, James; Zhang, Jufen; Al-Lamee, Rasha; Dungu, Jason N; Gedela, Swamy; Tang, Kare H; Kelly, Paul A; Davies, Justin E; Davies, John R; Keeble, Thomas R

2018-03-22

To investigate the immediate and short term impact of right coronary artery (RCA) chronic total coronary occlusion (CTO) percutaneous coronary intervention (PCI) upon collateral donor vessel fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR). CTO PCI influences collateral donor vessel physiology, making the indication and/or timing of donor vessel revascularization difficult to determine. In patients with RCA CTO, FFR, iFR, and collateral function index (FFR coll ) were measured in LAD and LCx pre-CTO PCI, immediately post and at 4 month follow-up. 34 patients underwent successful PCI. In the predominant donor vessel immediately post PCI, FFR, and FFR coll did not change (0.76 ± 0.12 to 0.75 ± 0.13, P = 0.267 and 0.31 ± 0.10 vs. 0.34 ± 0.11, P = 0.078), but iFR increased significantly (0.86 ± 0.10 to 0.88 ± 0.10, P = 0.012). At follow-up, there was a significant increase in predominant donor FFR and iFR (0.76 ± 0.12 to 0.79 ± 0.11, P = 0.047 and 0.86 ± 0.10 to 0.90 ± 0.07, P = 0.003), accompanied by a significant reduction in FFR coll (0.31 ± 0.10 to 0.18 ± 0.07 P < 0.0001). These changes resulted in a reclassification of the predominant donor vessel from ischemic to nonischemic in 18% (FFR) and 25% (iFR) of the cases, respectively. Successful recanalization of an RCA CTO resulted in a modest but statistically significant increase in the predominant donor vessel immediately post CTO PCI in the case of iFR and at 4-month follow-up for FFR and iFR compared to pre-PCI with a concomitant reduction in collateral function. © 2018 Wiley Periodicals, Inc.

Cost-minimization analysis of three decision strategies for cardiac revascularization: results of the "suspected CAD" cohort of the european cardiovascular magnetic resonance registry.

PubMed

Moschetti, Karine; Petersen, Steffen E; Pilz, Guenter; Kwong, Raymond Y; Wasserfallen, Jean-Blaise; Lombardi, Massimo; Korosoglou, Grigorios; Van Rossum, Albert C; Bruder, Oliver; Mahrholdt, Heiko; Schwitter, Juerg

2016-01-11

Coronary artery disease (CAD) continues to be one of the top public health burden. Perfusion cardiovascular magnetic resonance (CMR) is generally accepted to detect CAD, while data on its cost effectiveness are scarce. Therefore, the goal of the study was to compare the costs of a CMR-guided strategy vs two invasive strategies in a large CMR registry. In 3'647 patients with suspected CAD of the EuroCMR-registry (59 centers/18 countries) costs were calculated for diagnostic examinations (CMR, X-ray coronary angiography (CXA) with/without FFR), revascularizations, and complications during a 1-year follow-up. Patients with ischemia-positive CMR underwent an invasive CXA and revascularization at the discretion of the treating physician (=CMR + CXA-strategy). In the hypothetical invasive arm, costs were calculated for an initial CXA and a FFR in vessels with ≥50% stenoses (=CXA + FFR-strategy) and the same proportion of revascularizations and complications were applied as in the CMR + CXA-strategy. In the CXA-only strategy, costs included those for CXA and for revascularizations of all ≥50% stenoses. To calculate the proportion of patients with ≥50% stenoses, the stenosis-FFR relationship from the literature was used. Costs of the three strategies were determined based on a third payer perspective in 4 healthcare systems. Revascularizations were performed in 6.2%, 4.5%, and 12.9% of all patients, patients with atypical chest pain (n = 1'786), and typical angina (n = 582), respectively; whereas complications (=all-cause death and non-fatal infarction) occurred in 1.3%, 1.1%, and 1.5%, respectively. The CMR + CXA-strategy reduced costs by 14%, 34%, 27%, and 24% in the German, UK, Swiss, and US context, respectively, when compared to the CXA + FFR-strategy; and by 59%, 52%, 61% and 71%, respectively, versus the CXA-only strategy. In patients with typical angina, cost savings by CMR + CXA vs CXA + FFR were minimal in the German (2.3%), intermediate in the US and Swiss (11.6% and 12.8%, respectively), and remained substantial in the UK (18.9%) systems. Sensitivity analyses proved the robustness of results. A CMR + CXA-strategy for patients with suspected CAD provides substantial cost reduction compared to a hypothetical CXA + FFR-strategy in patients with low to intermediate disease prevalence. However, in the subgroup of patients with typical angina, cost savings were only minimal to moderate.

Five-year outcomes of percutaneous versus surgical coronary revascularization in patients with diabetes mellitus (from the CREDO-Kyoto PCI/CABG Registry Cohort-2).

PubMed

Marui, Akira; Kimura, Takeshi; Nishiwaki, Noboru; Mitsudo, Kazuaki; Komiya, Tatsuhiko; Hanyu, Michiya; Shiomi, Hiroki; Tanaka, Shiro; Sakata, Ryuzo

2015-04-15

We investigated the impact of diabetes mellitus on long-term outcomes of percutaneous coronary intervention (PCI) in the drug-eluting stent era versus coronary artery bypass grafting (CABG) in a real-world population with advanced coronary disease. We identified 3,982 patients with 3-vessel and/or left main disease of 15,939 patients with first coronary revascularization enrolled in the Coronary Revascularization Demonstrating Outcome Study in Kyoto PCI/CABG Registry Cohort-2 (patients without diabetes: n = 1,984 [PCI: n = 1,123 and CABG: n = 861], and patients with diabetes: n = 1,998 [PCI: n = 1,065 and CABG: n = 933]). Cumulative 5-year incidence of all-cause death after PCI was significantly higher than after CABG both in patients without and with diabetes (19.8% vs 16.2%, p = 0.01, and 22.9% vs 19.0%, p = 0.046, respectively). After adjusting confounders, the excess mortality risk of PCI relative to CABG was no longer significant (hazard ratio [HR] 1.16; 95% confidence interval [CI] 0.88 to 1.54; p = 0.29) in patients without diabetes, whereas it remained significant (HR 1.31; 95% CI 1.01 to 1.70; p = 0.04) in patients with diabetes. The excess adjusted risks of PCI relative to CABG for cardiac death, myocardial infarction (MI), and any coronary revascularization were significant in both patients without (HR 1.59, 95% CI 1.01 to 2.51, p = 0.047; HR 2.16, 95% CI 1.20 to 3.87, p = 0.01; and HR 3.30, 95% CI 2.55 to 4.25, p <0.001, respectively) and with diabetes (HR 1.45, 95% CI 1.00 to 2.51, p = 0.047; HR 2.31, 95% CI 1.31 to 4.08, p = 0.004; and HR 3.70, 95% CI 2.91 to 4.69, p <0.001, respectively). There was no interaction between diabetic status and the effect of PCI relative to CABG for all-cause death, cardiac death, MI, and any revascularization. In conclusion, in both patients without and with diabetes with 3-vessel and/or left main disease, CABG compared with PCI was associated with better 5-year outcomes in terms of cardiac death, MI, and any coronary revascularization. There was no difference in the direction and magnitude of treatment effect of CABG relative to PCI regardless of diabetic status. Copyright © 2015 Elsevier Inc. All rights reserved.

Retrograde Transpedal Access for Revascularization of Below-the-Knee Arteries in Patients with Critical Limb Ischemia after an Unsuccessful Antegrade Transfemoral Approach.

PubMed

Goltz, J P; Planert, M; Horn, M; Wiedner, M; Kleemann, M; Barkhausen, J; Stahlberg, E

2016-10-01

To evaluate the safety and technical and clinical success of endovascular below-the-knee (BTK) artery revascularization by a retrograde transpedal access. We retrospectively identified 16/172 patients (9.3 %) with endovascular BTK revascularization in whom a transfemoral approach had failed and transpedal access had been attempted. The dorsal pedal (n = 13) or posterior tibial (n = 3) artery was accessed using a dedicated access set and ultrasound guidance. The procedure was finished in antegrade fashion by plain old balloon angioplasty (POBA). Comorbidities, vessel diameter and calcification at the access site were recorded. The analyzed outcomes were technical success, procedural complications, procedure time, crossing (guidewire beyond lesion and intra-luminal) and procedural (residual stenosis < 30 % after POBA) success, and limb salvage. Diabetes, coronary artery disease and hypertension were present in 15 patients (93.8 %), and both renal impairment and previous amputations in 7 (43.8 %). Pedal access vessel calcification was present in 5/16 patients (31.3 %). The mean diameter was 1.75 +/-0.24 mm. The procedure time was 92.4 +/-23 min. The success rate for achieving retrograde access was 100 %. Retrograde crossing was successful in 12/16 patients (75.0 %). Procedural success was observed in 10/16 patients (68.8 %). Minor complications occurred in 2/16 patients (12.5 %). The rate of limb salvage was 72.9 %, and the overall survival was 100 % at 12 months. Major amputations after revascularization occurred in 2/16 patients (12.5 %). If an antegrade transfemoral approach to BTK lesions fails, a retrograde transpedal approach may nevertheless facilitate treatment. This approach appears to be safe and offers high technical and acceptable clinical success rates. • Retrograde approaches via transpedal or transtibial vessels are safe and offer high technical success.• One problem after technically successful puncture might be the re-entry following subintimal retrograde lesion crossing.• After a failed attempt at antegrade revascularization of a BTK occlusion, a retrograde approach should be performed. Citation Format: • Goltz JP, Planert M, Horn M et al. Retrograde Transpedal Access for Revascularization of Below-the-Knee Arteries in Patients with Critical Limb Ischemia after an Unsuccessful Antegrade Transfemoral Approach. Fortschr Röntgenstr 2016; 188: 940 - 948. © Georg Thieme Verlag KG Stuttgart · New York.

Economic modeling of new stent platforms to evaluate cost effectiveness: analysis of the TAXUS Liberté versus TAXUS express stents.

PubMed

Turco, Mark A; Kansal, Anuraag R; Stern, Sean; Amorosi, Stacey L; Underwood, Paul L; Lissovoy, Greg D E; Dawkins, Keith D

2012-08-01

With the changing health care environment, cost effectiveness is an important adjunct to clinical investigation when assessing new medical devices. This study presents an economic model to evaluate cost effectiveness of coronary stents. Markov modeling was developed comparing total costs (Medicare payer perspective) between TAXUS Liberté and TAXUS Express based on 3-year clinical outcomes from the TAXUS ATLAS Small Vessel and Long Lesion trials. The TAXUS Liberté 2.25-mm stent provided cost savings relative to TAXUS Express from a payer perspective ($17,605 vs. $20,281), driven by reduced target vessel revascularization (0.16 events/patient vs. 0.33 events/patient). In probabilistic sensitivity analyses, TAXUS Liberté was less costly with fewer major adverse cardiac events in over 99% of parameter sets. The TAXUS Liberté Long (38 mm) stent was cost neutral relative to TAXUS Express from a payer perspective ($18,545 vs. $18,551) with fewer myocardial infarctions and cardiac deaths. Accounting for angiography-driven revascularizations, TAXUS Liberté 2.25 mm still provided cost savings relative to TAXUS Express ($16,822 vs. $19,139), although TAXUS Liberté Long was more expensive than TAXUS Express ($17,886 vs. $17,652). From a hospital perspective, TAXUS Liberté Long provided cost savings up to a price premium of $671/stent, driven by fewer stents employed per patient. This analysis confirms the utility of economic modeling in assessing new stent platforms. TAXUS Liberté 2.25 mm is economically dominant relative to TAXUS Express when treating small vessels. TAXUS Liberté Long is cost neutral to modestly more costly than TAXUS Express 2.25 mm from a payer perspective. ©2012, Wiley Periodicals, Inc.

Status update and interim results from the asymptomatic carotid surgery trial-2 (ACST-2).

PubMed

Halliday, Alison; Bulbulia, Richard; Gray, William; Naughten, Ally; den Hartog, Anne; Delmestri, Antonella; Wallis, Carol; le Conte, Stephanie; Macdonald, Sumaira

2013-11-01

ACST-2 is currently the largest trial ever conducted to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in patients with severe asymptomatic carotid stenosis requiring revascularization. Patients are entered into ACST-2 when revascularization is felt to be clearly indicated, when CEA and CAS are both possible, but where there is substantial uncertainty as to which is most appropriate. Trial surgeons and interventionalists are expected to use their usual techniques and CE-approved devices. We report baseline characteristics and blinded combined interim results for 30-day mortality and major morbidity for 986 patients in the ongoing trial up to September 2012. A total of 986 patients (687 men, 299 women), mean age 68.7 years (SD ± 8.1) were randomized equally to CEA or CAS. Most (96%) had ipsilateral stenosis of 70-99% (median 80%) with contralateral stenoses of 50-99% in 30% and contralateral occlusion in 8%. Patients were on appropriate medical treatment. For 691 patients undergoing intervention with at least 1-month follow-up and Rankin scoring at 6 months for any stroke, the overall serious cardiovascular event rate of periprocedural (within 30 days) disabling stroke, fatal myocardial infarction, and death at 30 days was 1.0%. Early ACST-2 results suggest contemporary carotid intervention for asymptomatic stenosis has a low risk of serious morbidity and mortality, on par with other recent trials. The trial continues to recruit, to monitor periprocedural events and all types of stroke, aiming to randomize up to 5,000 patients to determine any differential outcomes between interventions. ISRCTN21144362. Copyright © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Drug-Coated Balloon Versus Standard Percutaneous Transluminal Angioplasty for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease

PubMed Central

Tepe, Gunnar; Schneider, Peter; Brodmann, Marianne; Krishnan, Prakash; Micari, Antonio; Metzger, Christopher; Scheinert, Dierk; Zeller, Thomas; Cohen, David J.; Snead, David B.; Alexander, Beaux; Landini, Mario; Jaff, Michael R.

2015-01-01

Background— Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease. Methods and Results— The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94±4.89 and 8.81±5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedure-related deaths and no major amputations. Conclusions— In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and NCT01566461. PMID:25472980

Edge-to-Edge Technique to Minimize Ovelapping of Multiple Bioresorbable Scaffolds Plus Drug Eluting Stents in Revascularization of Long Diffuse Left Anterior Descending Coronary Artery Disease.

PubMed

Rigatelli, Gianluca; Avvocata, Fabio Dell'; Ronco, Federico; Giordan, Massimo; Roncon, Loris; Caprioglio, Francesco; Grassi, Giuseppe; Faggian, Giuseppe; Cardaioli, Paolo

2016-06-01

Implantation of Drug Eluting Stents (DES) plus bioresorbable scaffolds (BVS) in very long diffuse left anterior descending coronary artery (LAD) disease may be problematic because of multiple devices overlapping. We sought to assess the short and mid-tern outcomes of combined implantation of DES and BVS using a novel "edge-to-edge" technique in patients with diffuse LAD disease. Patients with long diffuse LAD disease were enrolled in a prospective registry from 1st August 2014 to 1st August 2015 and treated with IVUS-aided percutaneous coronary intervention using a DES plus a single or multiple BVS using a novel "edge-to-edge" technique. Clinical follow up and invasive follow up driven by clinical justification was performed. Twenty-three patients (5 females, mean age 59.1± 9.1 years) were enrolled. Mean length of LAD disease was 73.1 ± 20.6 mm. Mean number of DES and BVS implanted was 1.2 ± 0.4 and 1.7 ± 1.3, respectively. At a mean follow-up of 11.3 ± 3.8 months, no stent thrombosis or MACE were observed. Angiographic and IVUS follow-up at a mean of 6.6 ± 0.7 months showed no significant angiographic restenosis and no appreciable stent gaps. In revascularization of long diffuse disease of the LAD, the edge-to-edge implantation technique appears to be feasible resulting in no restenosis or thrombosis on the short-term follow-up. (J Interven Cardiol 2016;29:275-284). © 2016, Wiley Periodicals, Inc.

77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

... elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are... inclined platform lifts and vertical platform lifts), classified under 21 CFR 890.3930. IV. Comments...

78 FR 35173 - Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-12

.... Electromagnetic interference: The device may interfere with the operation of other electrical devices or be... electromagnetic compatibility testing as well as characterization of speed/acceleration, battery longevity, and... electrical safety and electromagnetic compatibility of the device. Performance testing must demonstrate...

78 FR 11612 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-19

... information that will have been reviewed by the applicant during the course of its development of the device..., infants, children, adolescents) that suffer from the disease or condition that the device is intended to.... FDA-2009-N-0458] RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices; Requirement for Submission...

Proximal protection with hybrid stent, a safer combination for carotid artery stenting against carotid endarterectomy?

PubMed

Gürkaş, E; Ak, F; Orhan, G; Bozkurt, E; Ulusoy, E K

2015-12-01

Carotid revascularization is an established theurapeutic modality in preventing stroke and death among patients with severe carotid stenosis. Although carotid endarterectomy remains as the primary option, carotid stenting is accepted as an alternative for patients with high risk for carotid endarterectomy. Recently published reports have better results with proximal protection devices when compared with distal protection devices. These studies have revealed less microembolic signals and less periprocedural new ischemic lesions on diffusion weighted magnetic resonance imaging. Stent choice may be also important for these procedures as open cell stent design has advantage of better flexibility whereas closed cell systems have an advantage of better scaffolding. Hybrid stents which are composed of open cells in the proximal and distal part and closed cells in the middle may carry both advantages. The aim of this study is to demonstrate whether combination of proximal protection devices with hybrid stents can be a safe alternative for carotid stenting in terms of periprocedural and 30-day outcomes. Here we retrospectively evaluated 68 symptomatic carotid stenosis patients undergoing carotid stenting with hybrid stent (Cristallo Ideale®, Invatec s.r.l., Medtronic, Italy) and proximal protection device (MO.MA®, Invatec s.r.l., Medtronic, Italy). Our results showed only 1 minor stroke in the periprocedural period and during the first 30-day after stenting, with no death or myocardial infarction. Although our case number is not large, we propose that carotid stenting may be safer with utilization of proximal protection system and hybrid type carotid stents.

Automatic three-dimensional registration of intra-vascular optical coherence tomography images for the clinical evaluation of stent implantation over time

NASA Astrophysics Data System (ADS)

Ughi, Giovanni J.; Adriaenssens, Tom; Larsson, Matilda; Dubois, Christophe; Sinnaeve, Peter; Coosemans, Mark; Desmet, Walter; D'hooghe, Jan

2012-01-01

In the last decade a large number of new intracoronary devices (i.e. drug-eluting stents, DES) have been developed to reduce the risks related to bare metal stent (BMS) implantation. The use of this new generation of DES has been shown to substantially reduce, compared with BMS, the occurrence of restenosis and recurrent ischemia that would necessitate a second revascularization procedure. Nevertheless, safety issues on the use of DES persist and full understanding of mechanisms of adverse clinical events is still a matter of concern and debate. Intravascular Optical Coherence Tomography (IV-OCT) is an imaging technique able to visualize the microstructure of blood vessels with an axial resolution <20 μm. Due to its very high spatial resolution, it enables detailed in-vivo assessment of implanted devices and vessel wall. Currently, the aim of several major clinical trials is to observe and quantify the vessel response to DES implantation over time. However, image analysis is currently performed manually and corresponding images, belonging to different IV-OCT acquisitions, can only be matched through a very labor intensive and subjective procedure. The aim of this study is to develop and validate a new methodology for the automatic registration of IV-OCT datasets on an image level. Hereto, we propose a landmark based rigid registration method exploiting the metallic stent framework as a feature. Such a tool would provide a better understanding of the behavior of different intracoronary devices in-vivo, giving unique insights about vessel pathophysiology and performance of new generation of intracoronary devices and different drugs.

Coronary perforation with tamponade successfully managed by retrograde and antegrade coil embolization

PubMed Central

Boukhris, Marouane; Tomasello, Salvatore Davide; Azzarelli, Salvatore; Elhadj, Zied Ibn; Marzà, Francesco; Galassi, Alfredo Ruggero

2015-01-01

In recent years, retrograde approach for chronic total occlusions has rapidly evolved, enabling a higher rate of revascularization success. Compared to septal channels, epicardial collaterals tend to be more tortuous, more difficult to negotiate, and more prone to rupture. Coronary perforation is a rare but potentially life-threatening complication of coronary angioplasty, often leading to emergency cardiac surgery. We report a case of a retrograde chronic total occlusion revascularization through epicardial collaterals, complicated by both retrograde and antegrade coronary perforation with tamponade, and successfully managed by coil embolization. PMID:26136637

77 FR 39498 - Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection...

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2012-07-03

...] Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection Devices Applied... Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to... guidance, entitled ``Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device...

77 FR 52742 - Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System; Request...

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2012-08-30

...] Public Meeting--Strengthening the National Medical Device Postmarket Surveillance System; Request for... ``Public Meeting--Strengthening the National Medical Device Postmarket Surveillance System.'' The purpose of the meeting is to solicit public feedback regarding the medical device postmarket surveillance...

78 FR 1162 - Cardiovascular Devices; Reclassification of External Cardiac Compressor

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... safety and electromagnetic compatibility; For devices containing software, software verification... electromagnetic compatibility; For devices containing software, software verification, validation, and hazard... electrical components, appropriate analysis and testing must validate electrical safety and electromagnetic...

75 FR 62565 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-12

... Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and..., portable music and data processing devices, computers and components thereof. The complaint names as...

77 FR 2555 - Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-18

... editorial changes were made to improve clarity. Some terminology was changed to harmonize terminology within.../MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm , or http://www.regulations.gov...

Bioresorbable Scaffolds: Current Evidences in the Treatment of Coronary Artery Disease

PubMed Central

2016-01-01

Percutaneous coronary revascularization strategies have gradually progressed over a period of last few decades. The advent of newer generation drug-eluting stents has significantly improved the outcomes of Percutaneous Coronary Intervention (PCI) by substantially reducing in-stent restenosis and stent thrombosis. However, vascular inflammation, restenosis, thrombosis, and neoatherosclerosis due to the permanent presence of a metallic foreign body within the artery limit their usage in complex Coronary Artery Disease (CAD). Bioresorbable Scaffolds (BRS) represent a novel approach in coronary stent technology. Complete resorption of the scaffold liberates the treated vessel from its cage and restores pulsatility, cyclical strain, physiological shear stress, and mechanotransduction. In this review article, we describe the advances in this rapidly evolving technology, present the evidence from the pre-clinical and clinical evaluation of these devices, and provide an overview of the ongoing clinical trials that were designed to examine the effectiveness of BRS in the clinical setting. PMID:27891384

77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus... AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part 866 continues to read as follows...

75 FR 68619 - In the Matter of Certain Wireless Communication Devices, Portable Music and Data Processing...

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Comparison of Five-Year Outcome of Percutaneous Coronary Intervention With Coronary Artery Bypass Grafting in Triple-Vessel Coronary Artery Disease (from the Coronary Revascularization Demonstrating Outcome Study in Kyoto PCI/CABG Registry Cohort-2).

PubMed

Shiomi, Hiroki; Morimoto, Takeshi; Furukawa, Yutaka; Nakagawa, Yoshihisa; Tazaki, Junichi; Sakata, Ryuzo; Okabayashi, Hitoshi; Hanyu, Michiya; Shimamoto, Mitsuomi; Nishiwaki, Noboru; Komiya, Tatsuhiko; Kimura, Takeshi

2015-07-01

Studies evaluating long-term (≥5 years) outcomes of percutaneous coronary intervention (PCI) using drug-eluting stents compared with coronary artery bypass grafting (CABG) in patients with triple-vessel coronary artery disease (TVD) are still limited. We identified 2,978 patients with TVD (PCI: n = 1,824, CABG: n = 1,154) of 15,939 patients with first coronary revascularization enrolled in the Coronary Revascularization Demonstrating Outcome Study in Kyoto PCI/CABG Registry Cohort-2. The primary outcome measure in the present analysis was a composite of death, myocardial infarction (MI), and stroke. Median follow-up duration for the surviving patients was 1,973 days (interquartile range 1,700 to 2,244). The cumulative 5-year incidence of death/MI/stroke was significantly higher in the PCI group than in the CABG group (28.2% vs 24.0%, log-rank p = 0.006). After adjusting for confounders, the excess risk of PCI relative to CABG for death/MI/stroke remained significant (hazard ratio [HR] 1.38, 95% confidence interval [CI] 1.13 to 1.68, p = 0.002). The excess risks of PCI relative to CABG for all-cause death, MI, and any coronary revascularization were also significant (HR 1.38, 95% CI 1.10 to 1.74, p = 0.006; HR 2.81, 95% CI 1.69 to 4.66, p <0.001; and HR 4.10, 95% CI 3.32 to 5.06, p <0.001, respectively). The risk for stroke was not significantly different between the PCI and CABG groups (HR 0.88, 95% CI 0.61 to 1.26, p = 0.48). There were no interactions for the primary outcome measure between the mode of revascularization (PCI or CABG) and the subgroup factors such as age, diabetes, and Synergy Between PCI With Taxus and Cardiac Surgery score. In conclusion, CABG compared with PCI was associated with better long-term outcome in patients with TVD. Copyright © 2015 Elsevier Inc. All rights reserved.

Transpedal access after failed anterograde recanalization of complex below-the-knee and femoropoliteal occlusions in critical limb ischemia.

PubMed

Ruzsa, Zoltán; Nemes, Balázs; Bánsághi, Zoltán; Tóth, Károly; Kuti, Ferenc; Kudrnova, Slavka; Berta, Balázs; Hüttl, Kálmán; Merkely, Béla

2014-05-01

Successful angioplasty is one of the main factor of limb salvage during critical limb ischemia. In complex femoropopliteal to infrapopliteal occlusions, an anterograde recanalization attempt can fail in up to 20% of the cases. The purpose of this dual center pilot study was to evaluate the acute success and clinical impact of retrograde transpedal access for retrograde below-the-knee and femoropopliteal chronic total occlusions after failed anterograde attempt and to access the late complications at the puncture site. The clinical and angiographic data of 51 consecutive patients with CLI treated by retrograde transpedal recanalization between 2010 and 2011 were evaluated in a pilot study. We have examined the 2-month and 1 year major adverse events (MAEs) and clinical success. In all cases after failure of the anterograde recanalization of occluded below-the-knee segments due to unsuccessful penetration or failed re-entry, the anterior tibial or posterior tibial artery was punctured under fluoroscopic guidance and retrograde recanalization was performed. Direct revascularization was tried firstly following the angiographic zones, but in failed cases indirect revascularization was carried out with increasing the collateral flow to the wound. Successful direct retrograde revascularization was achieved successfully in 40 patients (78.4%) and indirect revascularization was done in 10 patients (19.6%). Revascularization was failed in one patient (2%). MAE at 2 and 12 months follow-up was 6 (11.7%) and 11 (24%). Limb salvage at 2 and 12 months was 93% and 82.3%, respectively. Balloon angioplasty was performed in all interventions and provisional stenting was done in 34 patients (66.7%). One major and three minor vascular complications occurred after the procedure. The mean basal and control creatinine level was 120.9 ± 133.4 and 123.8 ± 131.3 μmol/L (P = 0.83) after the procedure. Failed antegrade attempts to recanalize CTO-s of femoropopliteal and infrapopliteal vessels can be salvaged using a retrograde transpedal access, with a low acute and late complication rate. This technique could be valuable for patients with critical limb ischemia due to femoropopliteal and infrapopliteal occlusions. Copyright © 2013 Wiley Periodicals, Inc.

2-year results of the AUTAX (Austrian Multivessel TAXUS-Stent) registry beyond the SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) study.

PubMed

Gyöngyösi, Mariann; Christ, Günter; Lang, Irene; Kreiner, Gerhard; Sochor, Heinz; Probst, Peter; Neunteufl, Thomas; Badr-Eslam, Rosa; Winkler, Susanne; Nyolczas, Noemi; Posa, Aniko; Leisch, Franz; Karnik, Ronald; Siostrzonek, Peter; Harb, Stefan; Heigert, Matthias; Zenker, Gerald; Benzer, Werner; Bonner, Gerhard; Kaider, Alexandra; Glogar, Dietmar

2009-08-01

The multicenter AUTAX (Austrian Multivessel TAXUS-Stent) registry investigated the 2-year clinical/angiographic outcomes of patients with multivessel coronary artery disease after implantation of TAXUS Express stents (Boston Scientific, Natick, Massachusetts), in a "real-world" setting. The AUTAX registry included patients with 2- or 3-vessel disease, with/without previous percutaneous coronary intervention (PCI) and concomitant surgery. Patients (n = 441, 64 +/- 12 years, 78% men) (n = 1,080 lesions) with possible complete revascularization by PCI were prospectively included. Median clinical follow-up was 753 (quartiles 728 to 775) days after PCI in 95.7%, with control angiography of 78% at 6 months. The primary end point was the composite of major adverse cardiac (nonfatal acute myocardial infarction [AMI], all-cause mortality, target lesion revascularization [TLR]) and cerebrovascular events (MACCE). Potential risk factor effects on 2-year MACCE were evaluated using Cox regression. Complete revascularization was successful in 90.5%, with left main PCI of 6.8%. Rates of acute, subacute, and late stent thrombosis were 0.7%, 0.5%, and 0.5%. Two-year follow-up identified AMI (1.4%), death (3.6%), stroke (0.2%), and TLR (13.1%), for a composite MACCE of 18.3%. The binary restenosis rate was 10.8%. The median of cumulative SYNTAX score was 23.0 (range 12.0 to 56.5). The SYNTAX score did not predict TLR or MACCE, due to lack of scoring of restenotic or bypass stenoses (29.8%). Age (hazard ratio [HR]: 1.03, p = 0.019) and acute coronary syndrome (HR: 2.1, p = 0.001) were significant predictors of 2-year MACCE. Incomplete revascularization predicted death or AMI (HR: 3.84, p = 0.002). With the aim of complete revascularization, TAXUS stent implantations can be safe for patients with multivessel disease. The AUTAX registry including patients with post-PCI lesions provides additional information to the SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) study. (Austrian Multivessel TAXUS-Stent Registry; NCT00738686).

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.

Superficial femoral artery TASC D Registry: twelve-month effectiveness analysis of the Pulsar-18 SE nitinol stent in patients with critical limb ischemia.

PubMed

Lichtenberg, M; Stahlhoff, W; Boese, D

2013-08-01

Single center observational study analyzing the primary patency rate and freedom from target lesions revascularization rate of the Pulsar-18 nitinol stent after recanalization of long superficial femoral artery (SFA) occlusions (TASC D) in 22 patients with critical limb ischemia (CLI). Between 1/2011 and 7/2011, 22 consecutive patients (9 male, 13 female) with chronic total occlusions (CTO) of the femoro-popliteal arteries presenting with CLI (17 patients with Rutherford 4 score, and 5 patients with Rutherford 5 score) were enrolled and successfully recanalized using the Pulsar-18 self-expanding (SE) nitinol stent (BIOTRONIK AG, Buelach, Switzerland). Primary patency at 12 months was defined as no binary restenosis (>50%) on Duplex ultrasound (PSVR<2.5) and respectively no target lesion revascularization performed within 12 months. The average lesion length of the treated femoro-popliteal segment was 315 mm. Performing spot stenting average stent length in all patients was 245 mm (minimal 215 mm, maximal 315 mm). Technical success, with establishing an antegrade straight line flow to the foot through a reopened SFA, was achieved in all 22 patients. Subintimal and intraluminal recanalization techniques were used. Two patients with Rutherford 5 score had a minor amputation shortly after the recanalization procedure. All other patients had a complete wound healing of their lesions during a 6 month follow-up. After 12 month follow-up the primary patency rate of the Pulsar-18 SE nitinol stent was 77% with a per protocol restenosis in 5 of 22 patients. Seventeen patients showed a walking capacity on treadmill test >300 meters (Rutherford II). Two patients with a documented restenosis were Rutherford, these patients were treated conservatively. Three patients with restenosis and a Rutherford III score were scheduled for an endovascular target lesion revascularization leading to a freedom from target lesion revascularization rate of 86%. Endovascular intervention of long SFA occlusions using subintimal or intraluminal recanalization technique with implantation of the Pulsar-18 SE nitinol stent in CLI patients is safe and clinically effective with a primary patency rate after 12 months of 77% and a freedom from target lesion revascularization rate of 86%.

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.

[CARDIOREABILITATION PECULIARITIES AND CORRECTION OF VIOLATIONS OF SISTOLIC, DIASOLIC FUNCTION AND HEART RATE VARIABILITY IN PATIENTS WITH ACUTE CORONARY SYNDROME AND CORONARY ARTERY REVASCULARIZATION].

PubMed

Shved, M; Tsuglevych, L; Kyrychok, I; Levytska, L; Boiko, T; Kitsak, Ya

2017-04-01

In patients with acute coronary syndrome (ACS) who underwent coronary arteries revascularization, violations of hemodynamics, metabolism and heart rate variability often develop in the postoperative period, therefore, the goal of the study was to establish the features of disturbances and the effectiveness of correction of left ventricular systolic and diastolic dysfunction and heart rate variability in stages of cardiorehabilitation in patients with acute coronary syndrome who underwent coronary arteries revascularization. The experimental group included 40 patients with ACS in the postoperative period who underwent balloon angioplasty and stenting of the coronary arteries (25 patients with ST-segment elevation ACS and 15 patients without ST-segment elevation ACS). The age of examined patients was 37 to 74 years, an average of 52.6±6.7 years. The control group consisted of 20 patients, comparable in age and clinico-laboratory manifestations of ACS, who underwent drug treatment with direct anticoagulants, double antiplatelet therapy, β-blockers, ACE inhibitors and statins. Clinical efficacy of cardiorespiratory process in patients of both groups was assessed by the dynamics of general clinical symptoms and parameters of natriuretic propeptide, systolic and diastolic function of the left ventricle and heart rate variability. In the initial state, clinical and laboratory-instrumental signs of myocardial ischemia disappear in patients with ACS undergoing surgical revascularization of the coronary arteries, but clinical and subclinical manifestations of heart failure were diagnosed. The use of the accelerated program of cardiac rehabilitation already during the first month of studies leads to a decreasement of the signs of systolic and diastolic dysfunction, the level of NT-proBNP and improve in the variability of the heart rhythm wich significantly improves the life quality of patients with ACS. To monitor the effectiveness and safety of cardiac rehabilitation in patients with ACS who underwent coronary arteries revascularization, in addition to the generally accepted methods (determination of heart rate, blood pressure, a 6-minute test), it is advisable to diagnose the subclinical stage of heart failure by determining the level of NT-proBNP, Doppler echocardiogram, parameters of the left ventricular systolic and diastolic function and heart rate variability.

Outcomes following percutaneous coronary revascularization among South Asian and Chinese Canadians.

PubMed

Mackay, Martha H; Singh, Robinder; Boone, Robert H; Park, Julie E; Humphries, Karin H

2017-04-19

Previous data suggest significant ethnic differences in outcomes following percutaneous coronary revascularization (PCI), though previous studies have focused on subgroups of PCI patients or used administrative data only. We sought to compare outcomes in a population-based cohort of men and women of South Asian (SA), Chinese and "Other" ethnicity. Using a population-based registry, we identified 41,792 patients who underwent first revascularization via PCI in British Columbia, Canada, between 2001 and 2010. We defined three ethnic groups (SA, 3904 [9.3%]; Chinese, 1345 [3.2%]; and all "Others" 36,543 [87.4%]). Differences in mortality, repeat revascularization (RRV) and target vessel revascularization (TVR), at 30 days and from 31 days to 2 years were examined. Adjusted mortality from 31 days to 2 years was lower in Chinese patients than in "Others" (hazard ratio [HR] 0.72; 95% confidence interval [CI] 0.53-0.97), but not different between SAs and "Others". SA patients had higher RRV at 30 days (adjusted odds ratio [OR] 1.30; 95% CI: 1.12-1.51) and from 31 days to 2 years (adjusted hazard ratio [HR] 1.17; 95% CI: 1.06-1.30) compared to "Others". In contrast, Chinese patients had a lower rate of RRV from 31 days to 2 years (adjusted HR 0.79; 95% CI: 0.64-0.96) versus "Others". SA patients also had higher rates of TVR at 30 days (adjusted OR 1.35; 95% CI: 1.10-1.66) and from 31 days to 2 years (adjusted HR 1.19; 95% CI: 1.06-1.34) compared to "Others". Chinese patients had a lower rate of TVR from 31 days to 2 years (adjusted HR 0.76; 95% CI: 0.60-0.96). SA had higher RRV and TVR rates while Chinese Canadians had lower rates of long-term RRV, compared to those of "Other" ethnicity. Further research to elucidate the reasons for these differences could inform targeted strategies to improve outcomes.

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.

47 CFR 80.271 - Technical requirements for portable survival craft radiotelephone transceivers.

Code of Federal Regulations, 2011 CFR

2011-10-01

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Revascularization of the upper posterior circulation with the anterior temporal artery: an anatomical feasibility study.

PubMed

Tayebi Meybodi, Ali; Lawton, Michael T; Griswold, Dylan; Mokhtari, Pooneh; Payman, Andre; Tabani, Halima; Yousef, Sonia; Benet, Arnau

2017-09-22

OBJECTIVE In various disease processes, including unclippable aneurysms, a bypass to the upper posterior circulation (UPC) including the superior cerebellar artery (SCA) and posterior cerebral artery (PCA) may be needed. Various revascularization options exist, but the role of intracranial (IC) donors has not been scrutinized. The objective of this study was to evaluate the anatomical feasibility of utilizing the anterior temporal artery (ATA) for revascularization of the UPC. METHODS ATA-SCA and ATA-PCA bypasses were performed on 14 cadaver specimens. After performing an orbitozygomatic craniotomy and opening the basal cisterns, the ATA was divided at the M 3 -M 4 junction and mobilized to the crural cistern to complete an end-to-side bypass to the SCA and PCA. The length of the recipient artery between the anastomosis and origin was measured. RESULTS Seventeen ATAs were found. Successful anastomosis was performed in 14 (82%) of the ATAs. The anastomosis point on the PCA was 14.2 mm from its origin on the basilar artery. The SCA anastomosis point was 10.1 mm from its origin. Three ATAs did not reach the UPC region due to a common opercular origin with the middle temporal artery. The ATA-SCA bypass was also applied to the management of an incompletely coiled SCA aneurysm. CONCLUSIONS The ATA is a promising IC donor for UPC revascularization. The ATA is exposed en route to the proximal SCA and PCA through the pterional-orbitozygomatic approach. Also, the end-to-side anastomosis provides an efficient and straightforward bypass without the need to harvest a graft or perform multiple or difficult anastomoses.

Carotid and coronary disease management prior to open and endovascular aortic surgery. What are the current guidelines?

PubMed

Thompson, J P

2014-04-01

Several bodies produce broadly concurring and updated guidelines for the evaluation and treatment of cardiovascular disease in both surgical and non-surgical patients. Recent developments include revised recommendations on preoperative stress testing, referral for possible coronary revascularization and medical management. It is recognized that non-invasive cardiac tests are relatively poor at predicting perioperative risk, and "prophylactic" coronary revascularization has a limited role. The planned aortic intervention (open or endovascular repair) also influences preoperative management. Patients presenting for elective abdominal aortic aneurysm (AAA) repair should only be referred for cardiological testing if they have active symptoms of coronary artery disease (CAD), known CAD and poor functional exercise capacity, or multiple risk factors for CAD. Coronary revascularization before AAA surgery should be limited to patients with established indications, so cardiac stress testing should only be performed if it would change management i.e. the patient is a candidate for and would benefit from coronary revascularization. When endovascular aortic repair is planned, it is reasonable to proceed to surgery without further cardiac stress testing or evaluation unless otherwise indicated. All non-emergency patients require medical optimization, but perioperative beta blockade benefits only certain patients. Some of the data informing recent guidelines have been questioned and some guidelines are being revised. Current guidelines do not specifically address the management of patients with known or suspected carotid artery disease who may require aortic surgery. For these patients, an individualized approach is required. This review considers recent guidelines. Algorithms for investigation and management based on their recommendations are included.

Determinants and Long-Term Outcomes of Percutaneous Coronary Interventions vs. Surgery for Multivessel Disease According to Clinical Presentation.

PubMed

Hong, Sung-Jin; Kim, Byeong-Keuk; Shin, Sanghoon; Suh, Yongsung; Kim, Seunghwan; Ahn, Chul-Min; Kim, Jung-Sun; Ko, Young-Guk; Choi, Donghoon; Hong, Myeong-Ki; Jang, Yangsoo

2018-03-23

The long-term outcome of percutaneous coronary intervention (PCI) vs. coronary artery bypass graft (CABG), particularly for patients with non-ST-elevation acute coronary syndrome (NSTE-ACS), remains controversial.Methods and Results:We retrospectively analyzed 2,827 patients (stable coronary artery disease [SCAD], n=1,601; NSTE-ACS, n=1,226) who underwent either PCI (n=1,732) or CABG (n=1,095). The 8-year composite of cardiac death and myocardial infarction (MI) was compared between PCI and CABG before and after propensity matching. For patients with NSTE-ACS, PCI was performed more frequently for those with higher Thrombolysis in Myocardial Infarction risk score and 3-vessel disease, and PCI led to significantly higher 8-year composite of cardiac death and MI than CABG (14.1% vs. 5.9%, hazard ratio [HR]=2.22, 95% confidence interval [CI]=1.37-3.58, P=0.001). There was a significant interaction between clinical presentation and revascularization strategy (P-interaction=0.001). However, after matching, the benefit of CABG vs. PCI was attenuated in patients with NSTE-ACS, whereas it was pronounced in those with SCAD. Interactions between clinical presentation and revascularization strategy were not observed (P-interaction=0.574). Although the determinants of PCI vs. CABG in real-world clinical practice differ according to the clinical presentation, a significant interaction between clinical presentation and revascularization strategy was not noted for long-term outcomes. The revascularization strategy for patients with NSTE-ACS can be based on the criteria applied to patients with SCAD.

Efficacy and Safety of Endovascular Intervention for the Management of Primary Entire-Inferior Vena Cava Occlusion

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

Zhang, Qingqiao, E-mail: 1427286069@qq.com; Huang, Qianxin, E-mail: 18705206105@163.com; Shen, Bin, E-mail: 753021357@qq.com

PurposeThis study was designed to investigate the safety and efficacy of endovascular intervention for the treatment of primary entire-inferior vena cava (IVC) occlusion.MethodsEndovascular interventions were performed in six patients for the treatment of primary entire-IVC occlusion. IVC and hepatic venography were performed via the jugular and femoral veins. Balloon angioplasty was used to revascularize the hepatic vein and IVC and a stent was placed in the IVC to maintain patency. Postoperative color Doppler ultrasonography was performed at 1, 3, 6, and 12 months, and then annually, to monitor the patency of the hepatic vein and IVC.ResultsThe IVC and one or twomore » hepatic veins were successfully revascularized in five patients. Revascularization was successful in the right and left hepatic veins in one patient; however, IVC patency could not be established in this patient. Eleven Z-type, self-expanding stents were placed into the IVCs of five patients (three stents in two patients, two stents in two patients, and one stent in one patient). There were no instances of postoperative bleeding or mortality. Follow-up was conducted for 18–90 months (42.8 ± 26.5 months). None of the five patients suffered restenosis of the IVC or hepatic veins. However, there was one of the six cases of right hepatic vein restenosis at 18 months postprocedure that was revascularized after a second balloon dilatation.ConclusionsEndovascular intervention is safe and efficacious for the treatment of primary entire-IVC occlusion.« less

Clinical events in coronary heart disease patients with an ejection fraction of 40% or less: 3-year follow-up results.

PubMed

Pischke, Claudia R; Elliott-Eller, Melanie; Li, Minmin; Mendell, Nancy; Ornish, Dean; Weidner, Gerdi

2010-01-01

It is unclear whether lifestyle changes can delay the need for surgical procedures in coronary heart disease (CHD) patients with asymptomatic reduced left ventricular ejection fraction (LVEF). The aim of this pilot study was to examine whether lifestyle changes can delay the need for surgical procedures in this population. We compared 3-year clinical events in 27 CHD patients eligible to receive revascularization (by insurance standards), but underwent lifestyle changes (low-fat diet, exercise, stress management) instead (intervention group [IG], LVEF < or =40%), with those of a historically matched (age, gender, LVEF, and stenosis of the 3 major coronary arteries) control group receiving usual care (UCG; n = 13) who received revascularization at study entry. Both IG and UCG patients were enrolled in the health insurance companies participating in the Multicenter Lifestyle Demonstration Project, an insurance-sponsored, community-based, secondary prevention study implemented at 8 hospital sites in the United States. At 3 months, there were more cardiac events in the UCG (6 events) than in the IG (1 event; P < .006; odds ratio = 13.27; confidence interval = 1.57-111.94). This difference was maintained over 3 years (P < .06; odds ratio = 2.75; confidence interval = 1.05-7.19). Of the 26 surviving (1 cardiac death) IG patients, 23 did not require primary revascularization. In conclusion, CHD patients with asymptomatic reduced LVEF may be able to safely delay revascularization by making changes in lifestyle with no increased risk for cardiac events or overt heart failure over 3 years.

The Prognostic Effects of Coronary Disease Severity and Completeness of Revascularization on Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement.

PubMed

Witberg, Guy; Regev, Ehud; Chen, Shmuel; Assali, Abbid; Barbash, Israel M; Planer, David; Vaknin-Assa, Hana; Guetta, Victor; Vukasinovic, Vojislav; Orvin, Katia; Danenberg, Haim D; Segev, Amit; Kornowski, Ran

2017-07-24

The study sought to examine the effect of coronary artery disease (CAD) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR). CAD is common in the TAVR population. However, there are conflicting data on the prognostic significance of CAD and its treatment in this population. The authors analyzed 1,270 consecutive patients with severe aortic stenosis (AS) undergoing TAVR at 3 Israeli centers. They investigated the association of CAD severity (no CAD, nonsevere CAD [i.e., SYNTAX score (SS) <22], severe CAD [SS >22]) and revascularization completeness ("reasonable" incomplete revascularization [ICR] [i.e., residual SS <8]; ICR [residual SS >8]) with all-cause mortality following TAVR using a Cox proportional hazards ratio model adjusted for multiple prognostic variables. Of the 1,270 patients, 817 (64%) had no CAD, 331 (26%) had nonsevere CAD, and 122 (10%) had severe CAD. Over a median follow-up of 1.9 years, 311 (24.5%) patients died. Mortality was higher in the severe CAD and the ICR groups, but not in the nonsevere CAD or "reasonable" ICR groups, versus no CAD. After multivariate adjustment, both severe CAD (hazard ratio: 2.091; p = 0.017) and ICR (hazard ratio: 1.720; p = 0.031) were associated with increased mortality. Only severe CAD was associated with increased mortality post-TAVR. More complete revascularization pre-TAVR may attenuate the association of severe CAD and mortality. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Validity of the Talk Test for exercise prescription after myocardial revascularization.

PubMed

Zanettini, Renzo; Centeleghe, Paola; Franzelli, Cristina; Mori, Ileana; Benna, Stefania; Penati, Chiara; Sorlini, Nadia

2013-04-01

For exercise prescription, rating of perceived exertion is the subjective tool most frequently used in addition to methods based on percentage of peak exercise variables. The aim of this study was the validation of a subjective method widely called the Talk Test (TT) for optimization of training intensity in patients with recent myocardial revascularization. Fifty patients with recent myocardial revascularization (17 by coronary artery bypass grafting and 33 by percutaneous coronary intervention) were enrolled in a cardiac rehabilitation programme. Each patient underwent three repetitions of the TT during three different exercise sessions to evaluate the within-patient and between-operators reliability in assessing the workload (WL) at TT thresholds. These parameters were then compared with the data of a final cardiopulmonary exercise testing, and the WL range between the individual aerobic threshold (AeT) and anaerobic threshold (AnT) was considered as the optimal training zone. The within-patient and between-operators reliability in assessing TT thresholds were satisfactory. No significant differences were found between patients' and physiotherapists' evaluations of WL at different TT thresholds. WL at Last TT+ was between AeT and AnT in 88% of patients and slightly

Synergistic Interactions Between Direct and Indirect Bypasses in Combined Procedures: The Significance of Indirect Bypasses in Moyamoya Disease.

PubMed

Uchino, Haruto; Kim, Jae-Hoon; Fujima, Noriyuki; Kazumata, Ken; Ito, Masaki; Nakayama, Naoki; Kuroda, Satoshi; Houkin, Kiyohiro

2017-02-01

Whether additional indirect bypasses effectively contribute to revascularization in combined procedures remains unclear in patients with moyamoya disease. To evaluate the longitudinal changes associated with combined procedures while following up pediatric and adult patients long term and to assess whether any other clinical factors or hemodynamic parameters affected these changes to determine an optimal surgical strategy. We studied 58 hemispheres in 43 adults and 39 hemispheres in 26 children who underwent combined revascularization for moyamoya disease. To evaluate bypass development, we assessed the sizes of the superficial temporal artery and middle meningeal artery using magnetic resonance angiography. Multivariate analysis determined the effects of multiple variables on bypass development. Indirect bypass (middle meningeal artery) development occurred in 95% and 78% of the pediatric and adult hemispheres, respectively. Of these, dual development of direct and indirect bypasses occurred in 54% of the pediatric hemispheres and in 47% of the adult hemispheres. Reciprocal superficial temporal artery regression occurred in 28% of the hemispheres during the transition from the postoperative acute phase to the chronic phase during indirect bypass development. Good indirect bypass development was associated with adult hemispheres at Suzuki stage 4 or greater (odds ratio, 7.4; 95% confidence interval, 1.4-39.4; P = .02). Disease onset type and preoperative hemodynamic parameters were not considered predictors for the development of surgical revascularization. Simultaneous direct and indirect bypass development was most frequently observed, regardless of patient age and hemodynamic status. Applying indirect bypass as an adjunct to direct bypass could maximize revascularization in adults and children.

76 FR 66283 - Notice of Intent To Grant Partially Exclusive Patent License; BOLD Industries, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-26

... Method for a Mobile Tracking Device.//U.S. Patent Application No. 20110036998 filed on August 14, 2009: Countermeasure Device for a Mobile Tracking Device.//U.S. Patent Application No. 20110113949 filed on May 12, 2010: Modulation Device for a Mobile Tracking Device.//U.S. Patent Application Serial No. 12/778,643...

75 FR 17093 - Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-05

... [Docket No. FDA-2009-N-0493] RIN 0910-ZA37 Neurological and Physical Medicine Devices; Designation of... proposing to amend certain neurological device and physical medicine device regulations to establish special..., FDA is proposing to amend the physical medicine devices regulation at Sec. 890.5850 (21 CFR 890.5850...

75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...

76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...

77 FR 16239 - Medical Device User Fee Act; Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-20

...] Medical Device User Fee Act; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of... public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee... use them for the process for the review of medical device applications. The current legislative...

75 FR 8399 - In the Matter of Certain Mobile Communications and Computer Devices and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-24

... Communications and Computer Devices and Components Thereof; Notice of Investigation AGENCY: U.S. International... States after importation of certain mobile communications and computer devices and components thereof by... importation of certain mobile communications or computer devices or components thereof that infringe one or...

76 FR 21237 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-15

... reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge... provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its...

78 FR 68091 - Certain Marine Sonar Imaging Devices, Products Containing the Same, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-13

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-898] Certain Marine Sonar Imaging Devices... importation of certain marine sonar imaging devices, products containing the same, and components thereof by... marine sonar imaging devices, products containing the same, and components thereof by reason of...

75 FR 10502 - In the Matter of Certain Electronic Devices, Including Handheld Wireless Communications Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-08

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-667; Investigation No. 337-TA-673] In the Matter of Certain Electronic Devices, Including Handheld Wireless Communications Devices; Notice of... Entirety AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that...

78 FR 33447 - Draft Applications for Sealed Source and Device Evaluation and Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-04

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0104] Draft Applications for Sealed Source and Device... for sealed source and device evaluation and registration. The NRC is requesting public comment on... for Sealed Source and Device Evaluation and Registration.'' The document has been updated from the...

78 FR 19717 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction...

77 FR 20417 - Certain Cameras and Mobile Devices, Related Software and Firmware, and Components Thereof and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-04

... INTERNATIONAL TRADE COMMISSION [DN 2891] Certain Cameras and Mobile Devices, Related Software and... complaint entitled Certain Cameras and Mobile Devices, Related Software and Firmware, and Components Thereof... cameras and mobile devices, related software and firmware, and components thereof and products containing...

76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food and Drug Administration, HHS. ACTION...

75 FR 69447 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-12

... serious adverse health consequences, (2) the device is intended to be implanted in the human body for more... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0555] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device...

77 FR 14989 - Medicare Program; Revisions to the Durable Medical Equipment, Prosthetics, Orthotics, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-14

... wheelchairs. Prosthetic devices are included in the definition of ``medical and other health services'' in section 1861(s)(8) of the Act. Prosthetic devices are defined as devices (other than dental) which replace... examples of prosthetic devices include cardiac pacemakers, cochlear implants, electrical continence aids...

75 FR 52629 - Medicare Program; Establishing Additional Medicare Durable Medical Equipment, Prosthetics...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-27

... wheelchairs. Prosthetic devices are included in the definition of ``medical and other health services'' under section 1861(s)(8) of the Act. Prosthetic devices are defined in this section of the Act as ``devices... insertion of an intraocular lens.'' Other examples of prosthetic devices include cardiac pacemakers...

78 FR 11207 - Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-15

...] Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Guidance for... devices intended for the treatment of atrial fibrillation. DATES: Submit either electronic or written... Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation'' to the Division of...

78 FR 27441 - NIJ Evaluation of Hand-Held Cell Phone Detector Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-10

... Hand-Held Cell Phone Detector Devices AGENCY: National Institute of Justice, Department of Justice...-held cell phone detector devices for participation in an evaluation by the NIJ Corrections Technology...-held cell phone detector devices for participation in an evaluation by the NIJ Corrections Technology...

76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-02

...] Draft Guidance for Industry and FDA Staff: Processing/ Reprocessing Medical Devices in Health Care... Devices in Health Care Settings: Validation Methods and Labeling.'' The recommendations in this guidance... Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling...

77 FR 36951 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

... into class II (special controls). FDA is proposing this reclassification on its own initiative based on... categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II...

77 FR 48160 - Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop; Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-13

...] Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop; Request for Comments... Cardiovascular Devices 30-Day Notices and Annual Reports.'' This public workshop will be cosponsored with... approval applications (PMAs), 30-day notices and annual reports, specifically for cardiovascular devices...

78 FR 25273 - Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-30

... Respiratory Protection Devices, and Respiratory Support Devices signed by then Secretary Michael Leavitt on... Act Declaration for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices signed by then Secretary Michael Leavitt on December 17, 2008. Notice of the EUAs...

The Robo4 cytoplasmic domain is dispensable for vascular permeability and neovascularization.

PubMed

Zhang, Feng; Prahst, Claudia; Mathivet, Thomas; Pibouin-Fragner, Laurence; Zhang, Jiasheng; Genet, Gael; Tong, Raymond; Dubrac, Alexandre; Eichmann, Anne

2016-11-24

Vascular permeability and neovascularization are implicated in many diseases including retinopathies and diabetic wound healing. Robo4 is an endothelial-specific transmembrane receptor that stabilizes the vasculature, as shown in Robo4 -/- mice that develop hyperpermeability, but how Robo4 signals remained unclear. Here we show that Robo4 deletion enhances permeability and revascularization in oxygen-induced retinopathy (OIR) and accelerates cutaneous wound healing. To determine Robo4 signalling pathways, we generated transgenic mice expressing a truncated Robo4 lacking the cytoplasmic domain (Robo4ΔCD). Robo4ΔCD expression is sufficient to prevent permeability, and inhibits OIR revascularization and wound healing in Robo4 -/- mice. Mechanistically, Robo4 does not affect Slit2 signalling, but Robo4 and Robo4ΔCD counteract Vegfr2-Y949 (Y951 in human VEGFR2) phosphorylation by signalling through the endothelial UNC5B receptor. We conclude that Robo4 inhibits angiogenesis and vessel permeability independently of its cytoplasmic domain, while activating VEGFR2-Y951 via ROBO4 inhibition might accelerate tissue revascularization in retinopathy of prematurity and in diabetic patients.

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.

75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-23

...] Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and... entitled ``Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility... experience or expertise with nanotechnology. There will be a limited number of round-table participants. FDA...

75 FR 53704 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0427] Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and... Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.'' The...

Effect of Dielectric and Liquid on Plasma Sterilization Using Dielectric Barrier Discharge Plasma

PubMed Central

Mastanaiah, Navya; Johnson, Judith A.; Roy, Subrata

2013-01-01

Plasma sterilization offers a faster, less toxic and versatile alternative to conventional sterilization methods. Using a relatively small, low temperature, atmospheric, dielectric barrier discharge surface plasma generator, we achieved ≥6 log reduction in concentration of vegetative bacterial and yeast cells within 4 minutes and ≥6 log reduction of Geobacillus stearothermophilus spores within 20 minutes. Plasma sterilization is influenced by a wide variety of factors. Two factors studied in this particular paper are the effect of using different dielectric substrates and the significance of the amount of liquid on the dielectric surface. Of the two dielectric substrates tested (FR4 and semi-ceramic (SC)), it is noted that the FR4 is more efficient in terms of time taken for complete inactivation. FR4 is more efficient at generating plasma as shown by the intensity of spectral peaks, amount of ozone generated, the power used and the speed of killing vegetative cells. The surface temperature during plasma generation is also higher in the case of FR4. An inoculated FR4 or SC device produces less ozone than the respective clean devices. Temperature studies show that the surface temperatures reached during plasma generation are in the range of 30°C–66°C (for FR4) and 20°C–49°C (for SC). Surface temperatures during plasma generation of inoculated devices are lower than the corresponding temperatures of clean devices. pH studies indicate a slight reduction in pH value due to plasma generation, which implies that while temperature and acidification may play a minor role in DBD plasma sterilization, the presence of the liquid on the dielectric surface hampers sterilization and as the liquid evaporates, sterilization improves. PMID:23951023

Effect of dielectric and liquid on plasma sterilization using dielectric barrier discharge plasma.

PubMed

Mastanaiah, Navya; Johnson, Judith A; Roy, Subrata

2013-01-01

Plasma sterilization offers a faster, less toxic and versatile alternative to conventional sterilization methods. Using a relatively small, low temperature, atmospheric, dielectric barrier discharge surface plasma generator, we achieved ≥ 6 log reduction in concentration of vegetative bacterial and yeast cells within 4 minutes and ≥ 6 log reduction of Geobacillus stearothermophilus spores within 20 minutes. Plasma sterilization is influenced by a wide variety of factors. Two factors studied in this particular paper are the effect of using different dielectric substrates and the significance of the amount of liquid on the dielectric surface. Of the two dielectric substrates tested (FR4 and semi-ceramic (SC)), it is noted that the FR4 is more efficient in terms of time taken for complete inactivation. FR4 is more efficient at generating plasma as shown by the intensity of spectral peaks, amount of ozone generated, the power used and the speed of killing vegetative cells. The surface temperature during plasma generation is also higher in the case of FR4. An inoculated FR4 or SC device produces less ozone than the respective clean devices. Temperature studies show that the surface temperatures reached during plasma generation are in the range of 30°C-66 °C (for FR4) and 20 °C-49 °C (for SC). Surface temperatures during plasma generation of inoculated devices are lower than the corresponding temperatures of clean devices. pH studies indicate a slight reduction in pH value due to plasma generation, which implies that while temperature and acidification may play a minor role in DBD plasma sterilization, the presence of the liquid on the dielectric surface hampers sterilization and as the liquid evaporates, sterilization improves.

Electrical neuromodulation for disabling angina pectoris related to isolated stenoses of small epicardial coronary arteries.

PubMed

Jessurun, G A; Hautvast, R W; DeJongste, M J; Meyler, W J; van Boven AJ; Crijns, H J

1999-07-01

Patients with symptomatic small vessel coronary artery disease may be inadequate candidates for revascularization procedures. They may suffer from refractory angina, which does not respond to maximal anti-anginal drug therapy. In addition to patients with end stage coronary artery disease and syndrome X, this newly defined group of subjects with an isolated stenosis of a small coronary artery may benefit from electrical neurostimulation. We describe two patients with intractable angina caused by a significant narrowing of a diagonal branch. This treatment modality should be considered as an alternative method for unsatisfactory revascularization procedures.

Bronchial blood supply after lung transplantation without bronchial artery revascularization.

PubMed

Nicolls, Mark R; Zamora, Martin R

2010-10-01

This review discusses how the bronchial artery circulation is interrupted following lung transplantation and what may be the long-term complications of compromising systemic blood flow to allograft airways. Preclinical and clinical studies have shown that the loss of airway microcirculations is highly associated with the development of airway hypoxia and an increased susceptibility to chronic rejection. The bronchial artery circulation has been highly conserved through evolution. Current evidence suggests that the failure to routinely perform bronchial artery revascularization at the time of lung transplantation may predispose patients to develop the bronchiolitis obliterans syndrome.

The impact of socioeconomic factors on outcome and hospital costs associated with femoropopliteal revascularization.

PubMed

Durham, Christopher A; Mohr, Margaret C; Parker, Frank M; Bogey, William M; Powell, Charles S; Stoner, Michael C

2010-09-01

Within the context of healthcare system reform, the cost efficacy of lower extremity revascularization remains a timely topic. The impact of an individual patient's socioeconomic status represents an under-studied aspect of vascular care, especially with respect to longitudinal costs and outcomes. The purpose of this study is to examine the relationship between socioeconomic status and clinical outcomes as well as inpatient hospital costs. A retrospective femoropopliteal revascularization database, which included socioeconomic factors (household income, education level, and payor status), in addition to standard demographic, clinical, anatomical, and procedural variables were analyzed over a 3-year period. Patients were stratified by income level (low income [LI] <200% federal poverty level [$42,400 for a household of 4], and higher income [HI] >200% federal poverty level) and revascularization technique (open vs endovascular) and analyzed for the endpoints of primary assisted patency, amortized cost-per-day of patency, and limb salvage. Data were analyzed with univariate and multivariate techniques. A total of 187 cases were identified with complete data for analysis, 146 in the LI and 41 in the HI cohorts. LI patients differed from HI patients by mean age (66.2 +/- 1.0 vs 61.8 +/- 1.5 years, P = .04), high school graduate rate (51.4% vs 85.4%, P < .001), presence of tissue loss (30.1% vs 14.6%, P = .05), female gender (43.7% vs 22.0%, P = .01) and preoperative statin use (45.8% vs 75.6%, P < .001). There were no differences with respect to other comorbidities including smoking status, presence of diabetes, renal insufficiency, anatomic factors or treatment modality (open vs endovascular). Ninety-seven patients underwent endovascular revascularization. The following outcomes were noted in the endovascular subset of LI and HI patients respectively: primary assisted patency (66% vs 71%, P = NS) and 12-month cost-per-day of patency ($166.30 +/- 77.40 vs $22.45 +/- 12.45, P = .05). Ninety-eight patients underwent open revascularization, with the following outcomes in LI and HI patients respectively: primary assisted patency (78% vs 86%, P = NS) and 12-month cost-per-day of patency ($319.43 +/- 225.44 vs $40.47 +/- 4.63, P = .07). Of the 77 patients with critical limb ischemia, 19 underwent eventual amputation. Multivariate analysis demonstrated that income above 100% of the federal poverty line was protective against limb loss (odds ratio 0.06, 95% confidence interval 0.01-0.51, P < .001). Income level correlates with advanced presentation, advanced age, and lack of statin use. Although primary assisted patency rate is not affected by income status, an increased cost-per-day of patency and inferior limb salvage is found in lower income patients.

76 FR 48169 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-08

...] Advancing Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices; Public... Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices.'' The purpose of the public meeting is to discuss performance evaluation of highly multiplexed microbiology/medical...

76 FR 58019 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-19

... Ablation System to be used for the treatment of atrial fibrillation in patients who are undergoing open... catheter-based device developed for the treatment of atrial fibrillation. The system consists of the...

75 FR 5335 - Workshop on Pediatric Neurological and Neurocognitive Assessments for Cardiovascular Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-02

...] Workshop on Pediatric Neurological and Neurocognitive Assessments for Cardiovascular Devices; Public... Neurocognitive Assessments for Cardiovascular Devices.'' The purpose of the public workshop is to solicit... various neurological and neurocognitive assessments for pediatric patients implanted with cardiovascular...

Treatment of Angio-Seal-Related Femoral Artery Occlusion Using Directional Atherectomy-Primary Results and Midterm Follow-Up.

PubMed

Babaev, Anvar; Gokhale, Rohit; Zavlunova, Susanna; Attubato, Michael

2016-11-01

We describe a novel approach for the endovascular treatment of femoral artery occlusion as a result of Angio-Seal closure device deployment. Angio-Seal is the most commonly used vascular closure device following percutaneous coronary and peripheral catheterizations worldwide. A rare complication of Angio-Seal deployment is an occlusion of the femoral artery leading to limb ischemia requiring revascularization. Given its unique ability to cut both atherosclerotic plaque and the Angio-Seal anchor with a collagen plug at operator-directed planes, TurboHawk/HawkOne atherectomy device can be a fast and effective approach to treat Angio-Seal-associated femoral artery occlusions. We studied 13 consecutive patients who developed Angio-Seal-associated femoral artery occlusions that occurred from 3 hours to several weeks after catheterization. These patients were successfully treated with TurboHawk/HawkOne directional atherectomy followed by balloon angioplasty with no complications. During a mean follow-up period of 20.4 ± 17.3 months, 12 patients remained claudication free with no evidence of obstructive arterial disease of the treated segment on imaging studies. One patient developed restenosis that was treated with repeat atherectomy and balloon angioplasty following which he was asymptomatic at follow-up. The use of directional atherectomy followed by balloon angioplasty is a quick, safe, and effective endovascular approach to treating Angio-Seal-associated femoral artery occlusions. It is associated with an excellent success rate, no complications, and good midterm outcomes.

Platelet Activation in Patients with Atherosclerotic Renal Artery Stenosis Undergoing Stent Revascularization

PubMed Central

Adlakha, Satjit; Reed, Grant; Brewster, Pamela; Kennedy, David; Burket, Mark W.; Colyer, William; Yu, Haifeng; Zhang, Dong; Shapiro, Joseph I.; Cooper, Christopher J.

2011-01-01

Summary Background and objectives Soluble CD40 ligand (sCD40L) is a marker of platelet activation; whether platelet activation occurs in the setting of renal artery stenosis and stenting is unknown. Additionally, the effect of embolic protection devices and glycoprotein IIb/IIIa inhibitors on platelet activation during renal artery intervention is unknown. Design, setting, participants, & measurements Plasma levels of sCD40L were measured in healthy controls, patients with atherosclerosis without renal stenosis, and patients with renal artery stenosis before, immediately after, and 24 hours after renal artery stenting. Results Soluble CD40L levels were higher in renal artery stenosis patients than normal controls (347.5 ± 27.0 versus 65.2 ± 1.4 pg/ml, P < 0.001), but were similar to patients with atherosclerosis without renal artery stenosis. Platelet-rich emboli were captured in 26% (9 of 35) of embolic protection device patients, and in these patients sCD40L was elevated before the procedure. Embolic protection device use was associated with a nonsignificant increase in sCD40L, whereas sCD40L declined with abciximab after the procedure (324.9 ± 42.5 versus 188.7 ± 31.0 pg/ml, P = 0.003) and at 24 hours. Conclusions Atherosclerotic renal artery stenosis is associated with platelet activation, but this appears to be related to atherosclerosis, not renal artery stenosis specifically. Embolization of platelet-rich thrombi is common in renal artery stenting and is inhibited with abciximab. PMID:21817131

76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-19

...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the... INFORMATION: In the Federal Register of July 7, 2011, FDA announced that a meeting of the General and Plastic...

77 FR 51572 - Certain Wireless Consumer Electronics Devices and Components Thereof; Institution of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-24

... Electronics Devices and Components Thereof; Institution of Investigation Pursuant to 19 U.S.C. 1337 AGENCY: U... importation of certain wireless consumer electronics devices and components thereof by reason of infringement... wireless consumer electronics devices and components thereof that infringe one or more of claims 1, 6, 7, 9...

76 FR 41523 - In the Matter of Certain Mobile Communications and Computer Devices and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-14

... Communications and Computer Devices and Components Thereof; Notice of Commission Determination Not To Review an... in its entirety Inv. No. 337-TA-704, Certain Mobile Communications and Computer Devices and... importation of certain mobile communications and computer devices and components thereof by reason of...

76 FR 5206 - In the Matter of Certain Game Devices, Components Thereof, and Products Containing the Same...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-28

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-757] In the Matter of Certain Game Devices... importation of certain game devices, components thereof, and products containing the same by reason of... certain game devices, components thereof, and products containing the same that infringe one or more of...

78 FR 41937 - Joint Meeting of the Gastroenterology-Urology Panel and the Radiological Devices Panel of the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-12

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0816] Joint Meeting of the Gastroenterology-Urology Panel and the Radiological Devices Panel of the Medical...: Gastroenterology-Urology Panel and Radiological Devices Panel of the Medical Devices Advisory Committee. General...

21 CFR 870.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... devices intended for human use that are in commercial distribution. (b) The identification of a device in... device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic... referenced in this part are available on the Internet at http://www.fda.gov/cdrh/guidance.html. [52 FR 17735...

21 CFR 882.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... devices intended for human use that are in commercial distribution. (b) The identification of a device in... device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic... referenced in this part are available on the Internet at http://www.fda.gov/cdrh/guidance.html. [52 FR 17739...

21 CFR 886.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... devices intended for human use that are in commercial distribution. (b) The identification of a device in... that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device... in this part are available on the Internet at http://www.fda.gov/cdrh/guidance.html. [52 FR 33355...

21 CFR 868.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... devices intended for human use that are in commercial distribution. (b) The identification of a device in... device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic... referenced in this part are available on the Internet at http://www.fda.gov/cdrh/guidance.html. [52 FR 17734...

21 CFR 888.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... devices intended for human use that are in commercial distribution. (b) The identification of a device in... that has two or more types of uses (e.g., used both as a diagnostic device and as a surgical device) is... part are available on the Internet at http://www.fda.gov/cdrh/guidance.html. [52 FR 33702, Sept. 4...

78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-13

...] Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Dental Products Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the...

77 FR 61768 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-11

... vasculature via partial occlusion of the descending aorta, including in patients with acute ischemic stroke... device is placed in the descending aorta. On March 30, 2005, a Humanitarian Device Exemption application... selectively stopping or controlling flow in the peripheral vasculature, which includes the descending aorta...

75 FR 34484 - In the Matter of: Certain Portable Electronic Devices and Related Software; Notice of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

... Devices and Related Software; Notice of Investigation AGENCY: U.S. International Trade Commission. ACTION... of certain portable electronic devices and related software by reason of infringement of certain... after importation of certain portable electronic devices or related software that infringe one or more...

76 FR 14414 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Microbiology...

78 FR 69694 - Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-20

...] Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and... for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How to Estimate and Reward... other interested parties of the development of medical devices for the treatment of morbid obesity and...

77 FR 2758 - Certain Portable Communication Devices; Institution of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-19

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-827] Certain Portable Communication Devices... communication devices by reason of infringement of certain claims of U.S. Patent No. 5,926,636 (``the '636... certain portable communication devices that infringe one or more of claims 7-13 and 15 of the '636 patent...

76 FR 18472 - Medicare Program; Revisions to the Durable Medical Equipment, Prosthetics, Orthotics, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-04

....Prosthetic devices are included in the definition of ``medical and other health services'' under section 1861(s)(8) of the Act. Prosthetic devices are defined in this section of the Act as ``devices (other than... intraocular lens.'' Other examples of prosthetic devices include cardiac pacemakers, cochlear implants...

75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-05

... Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION... controls guidance documents for 11 neurological and physical medicine devices. FDA has developed a draft... stimulator device achieves ``aesthetic effects through physical change to the structure of the body'' as well...

75 FR 875 - Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-06

... imaging devices for use with imaging contrast agents or radiopharmaceuticals. FDA intends this guidance to..., for medical imaging devices for use with imaging contrast agents or radiopharmaceuticals. Further, the...] Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved Drug and...

77 FR 18828 - Guidance for Industry and Food and Drug Administration Staff; Factors To Consider When Making...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-28

... Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New... CONTACT: For devices regulated by CDRH: Ruth Fischer, Center for Devices and Radiological Health, Food and... search capability is available for all CDRH guidance documents at http://www.fda.gov/MedicalDevices...

76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-23

... test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls... devices into class II (special controls) because special controls, in addition to general controls, will...

76 FR 34845 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-15

... control by other users with a similar medical device. Exposure to non-ionizing radiation Wireless... Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable...

78 FR 79300 - Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems for Acute...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-30

... balloon and control system (IABP) devices when indicated for acute coronary syndrome, cardiac and non... and non-cardiac surgery, or complications of heart failure. The special controls for this device are.... FDA-2013-N-0581] Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems...

77 FR 8117 - Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-14

... Administration (FDA) is classifying the endovascular suturing system into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance..., or FDA issues an order finding the device to be substantially equivalent, in accordance with section...

75 FR 27791 - Agency Information Collection Activities; Proposed Collection; Comment Request; Invitation to...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-18

... use device to be a medical device intended for users in a non-clinical environment that is managed... promoting the safe use of medical devices presented a significant health challenge for which the HHCC could... pilot program, we are requesting manufacturers and distributors of medical devices cleared for home use...