Self-expandable metallic stent placement plus laparoscopy for acute malignant colorectal obstruction.

PubMed

Zhou, Jia-Min; Yao, Li-Qing; Xu, Jian-Min; Xu, Mei-Dong; Zhou, Ping-Hong; Chen, Wei-Feng; Shi, Qiang; Ren, Zhong; Chen, Tao; Zhong, Yun-Shi

2013-09-07

To investigate the clinical advantages of the stent-laparoscopy approach to treat colorectal cancer (CRC) patients with acute colorectal obstruction (ACO). From April 2008 to April 2012, surgery-related parameters, complications, overall survival (OS), and disease-free survival (DFS) of 74 consecutive patients with left-sided CRC presented with ACO who underwent self-expandable metallic stent (SEMS) placement followed by one-stage open (n = 58) or laparoscopic resection (n = 16) were evaluated retrospectively. The stent-laparoscopy group was also compared with a control group of 96 CRC patients who underwent regular laparoscopy without ACO between January 2010 and December 2011 to explore whether SEMS placement influenced the laparoscopic procedure or reduced long-term survival by influencing CRC oncological characteristics. The characteristics of patients among these groups were comparable. The rate of conversion to open surgery was 12.5% in the stent-laparoscopy group. Bowel function recovery and postoperative hospital stay were significantly shorter (3.3 ± 0.9 d vs 4.2 ± 1.5 d and 6.7 ± 1.1 d vs 9.5 ± 6.7 d, P = 0.016 and P = 0.005), and surgical time was significantly longer (152.1 ± 44.4 min vs 127.4 ± 38.4 min, P = 0.045) in the stent-laparoscopy group than in the stent-open group. Surgery-related complications and the rate of admission to the intensive care unit were lower in the stent-laparoscopy group. There were no significant differences in the interval between stenting and surgery, intraoperative blood loss, OS, and DFS between the two stent groups. Compared with those in the stent-laparoscopy group, all surgery-related parameters, complications, OS, and DFS in the control group were comparable. The stent-laparoscopy approach is a feasible, rapid, and minimally invasive option for patients with ACO caused by left-sided CRC and can achieve a favorable long-term prognosis.

Paclitaxel Drug-eluting Tracheal Stent Could Reduce Granulation Tissue Formation in a Canine Model

PubMed Central

Wang, Ting; Zhang, Jie; Wang, Juan; Pei, Ying-Hua; Qiu, Xiao-Jian; Wang, Yu-Ling

2016-01-01

Background: Currently available silicone and metallic stents for tracheal stenosis are associated with many problems. Granulation proliferation is one of the main complications. The present study aimed to evaluate the efficacy of paclitaxel drug-eluting tracheal stent in reducing granulation tissue formation in a canine model, as well as the pharmacokinetic features and safety profiles of the coated drug. Methods: Eight beagles were randomly divided into a control group (bare-metal stent group, n = 4) and an experimental group (paclitaxel-eluting stent group, n = 4). The observation period was 5 months. One beagle in both groups was sacrificed at the end of the 1st and 3rd months, respectively. The last two beagles in both groups were sacrificed at the end of 5th month. The proliferation of granulation tissue and changes in tracheal mucosa were compared between the two groups. Blood routine and liver and kidney function were monitored to evaluate the safety of the paclitaxel-eluting stent. The elution method and high-performance liquid chromatography were used to characterize the rate of in vivo release of paclitaxel from the stent. Results: Compared with the control group, the proliferation of granulation tissue in the experimental group was significantly reduced. The drug release of paclitaxel-eluting stent was the fastest in the 1st month after implantation (up to 70.9%). Then, the release slowed down gradually. By the 5th month, the release reached up to 98.5%. During the observation period, a high concentration of the drug in the trachea (in the stented and adjacent unstented areas) and lung tissue was not noted, and the blood test showed no side effect. Conclusions: The paclitaxel-eluting stent could safely reduce the granulation tissue formation after stent implantation in vivo, suggesting that the paclitaxel-eluting tracheal stent might be considered for potential use in humans in the future. PMID:27824004

Stenting versus non-stenting following uncomplicated ureteroscopic lithotripsy: Comparsion and evaluation of symptoms.

PubMed

Savić, Slaviša; Vukotić, Vinka; Lazić, Miodrag; Savić, Nataša

2016-09-01

Currently, ureterorenoscopic (URS) stone fragmentation and removal is the treatment of choice for managing ureteral stones, especially mid and distal ones and is advocated as initial management of ureteric stones. The aim of this work was to evaluate the symptoms, necessity, potential benefits and adverse effects of ureteral stent placement after uncomplicated ureteroscopic lithotripsy. This retrospective-prospective study evaluated a total of 125 patients who had underwent ureteroscopic lithotripsy (URSL). The patients were divided into two groups: stented (59 patients) and unstented (controls, 66 patients). The outcomes measured and compared between the two groups included: stone free rate, postoperative patient pain validated by scale, lower urinary tract symptoms (LUTS), the need for unplanned hospital care, stent related complications, and functional recovery in the form return to normal physical activities. A successful outcome, defined as being stonefree after 12 weeks, was achieved in all 125 (100%) patients. The stone-free rate showed no significant differences between the two groups. LUTS was frequent complaint in the stented group, with statistically significant difference in the domain of frequency/urgency (p = 0.0314). There was a statistically significant difference between the groups in the mean operative time and mean hospitalization time, mean pain visual analog scale (VAS) score and in the use of nonnarcotic analgesic. On the day of the surgery and until postoperative day 3 (POD 3) and postoperative day 5 (POD 5), the pain score was much higher among stented patients than among the controls (p = 0.0001) and non-narcotic analgesic use (p = 0.001) was frequently required in the stented group. Routine placement of ureteral stent after URSL is not mandatory and may be associated with stent side effects. Uncomplicated URSL is safe without stent placement after the treatment.

Comparison of the SYNERGY with the PROMUS (XIENCE V) and bare metal and polymer-only Element control stents in porcine coronary arteries.

PubMed

Wilson, Gregory J; Huibregtse, Barbara A; Pennington, Douglas E; Dawkins, Keith D

2012-06-20

This study evaluated vascular compatibility of the novel platinum chromium alloy Element stent platform delivering abluminal everolimus from a poly-lactide-co-glycolide bioabsorbable polymer (SYNERGY stent), currently undergoing clinical trial, compared with the PROMUS (XIENCE V) and bare metal and polymer-only Element stents. Stents (n=161) were implanted one per coronary artery in 72 swine at a stent-to-artery ratio of 1.1:1. Similar numbers of each device group were explanted at each of 30, 90, 180, and 360 days (except no PROMUS (XIENCE V) stent at 360 days) for pathological analysis. There was no stent thrombosis, myocardial infarction, or strut fractures in any group. Vascular response was similar between the SYNERGY and PROMUS (XIENCE V) stents, with no thrombi and complete endothelialisation on both scanning electron microscopy and histology at 30, 90 and 180 days. There were no significant differences for the morphologic parameters of luminal thrombus, endothelial cell coverage, strut tissue coverage, inflammation, internal elastic lamina (IEL) disruption, external elastic lamina (EEL) disruption and medial smooth muscle cell loss across device groups or between time points, but there was mild but greater (p<0.0001) para-strut fibrin at 30 days for both drug-eluting stents (DES) compared with the bare and polymer-only controls; this difference completely dissipated by 90 days. Inflammation was predominantly minimal to mild for all device types. No morphometric parameters, including intimal thickness, stent profile-based area stenosis, and EEL area were significantly different when comparing the SYNERGY stent with the bare metal Element and polymer-only Element control stents at 90, 180 and 360 days. In this non-injured porcine coronary artery model, the bioabsorbable polymer SYNERGY stent demonstrated vascular compatibility equivalent to the PROMUS (XIENCE V) stent and to the bare metal and polymer-only Element stents.

Ureterorenoscopy with Stenting and Its Effect on Female Sexual Function.

PubMed

Akdeniz, Ekrem; Bolat, Mustafa Suat

2017-05-23

Various etiological factors have been studied which negatively affect female sexual function, but theeffects of ureteroscopic stone surgery on women's sexual dysfunction remain unknown. The aim of this study wasto investigate the effect of ureteroscopic stone surgery with postoperative stenting on female sexual function. This study included 30 sexually active female patients who underwent ureteroscopicstone surgery with JJ stenting (study group) and 26 age-matched female patients with ureteral stone surgerywithout JJ stenting (control group). Sexual function was assessed at preoperative and at the first and 3rd monthspostoperative using the Female Sexual Function Index. Overall satisfaction in relation to the age, operation time,presence of stents, body mass index, educational status, previous operations, income status, and psychogenic statuswas evaluated. Sexual function was adversely affected by ureteroscopic stone surgery with JJ stenting; but psychogenic,educational and income status remained stable. Mean individual female sexual function subscores were statistically significant between the study and control groups, but the differences in the mean Beck scores minimally improved between the two groups at preoperative (p = 0.19) visit, whereas first month (p = 0.08) and third month (p = 0.31) of postoperative controls were deteriorated but the differences were not statistically significant, respectively. Ureterorenoscopy with JJ stenting has considerably negative effects on female sexual function. JJ stenting causes temporary sexual deterioration in women and it generally ceases at the end of the 3rd month after ureteroscopic surgery. Therefore, JJ stenting should be avoided or used for as short a time as possible. If JJ stenting is inevitable, patients should be warned about a temporary decline in their sexual function during the first month of the operation that resolves at most in three months.

Reduction of Intimal Hyperplasia with Re-188-labeled Stents in a Rabbit Model at 7 and 26 Weeks: An Experimental Study

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

Tepe, Gunnar, E-mail: gunnar.tepe@med.uni-tuebingen.de; Dietrich, Tobias; Grafen, Franziska

2005-06-15

The aim of this study was to analyze the feasibility of {sup 188}Re-labeled stents to reduce neointimal formation in a rabbit atherosclerosis model and to test the long-term effects at 7 and 26 weeks. Fifty-nine male New Zealand White rabbits were fed a 0.5% cholesterol diet for 4 weeks before balloon angioplasty and insertion of Palmaz stents in the infrarenal aorta. The animals were sacrificed 7 and 26 weeks after stent implantation. Control stents were compared with {sup 188}Re stents: (dose 1) 11.3 {+-} 1.8 MBq; (dose 2) 37.3 {+-} 4.2 MBq, and (dose 3) 80.1 {+-} 7.8 MBq. Eachmore » activity group consisted of a short-term (7 weeks) and a long-term group (26 weeks), resulting in a total of eight study groups. No thrombotic occlusion was observed. The neointimal formation in the control group was 2.11 [95% confidence interval (CI): 0.68-6.52] mm{sup 2} at 7 weeks and 2.10 (0.62-7.11) at 26 weeks. In the treatment groups, neointima reduction was detectable at 7 weeks [dose 1: 0.33 (0.09-1.22) mm{sup 2}; dose 2: 0.17 (0.05-0.57) mm{sup 2}; dose 3: 0.03 (0.01-0.13) mm{sup 2}]. After 26 weeks, a catch-up of neointimal formation in the radioactive groups was most obvious in the low-dose group [dose 1: 0.80 (0.28-2.29) mm{sup 2}; dose 2: 0.18([0.06-0.52) mm{sup 2}; dose 3: 0.50 (0.17-1.42) mm{sup 2}]. Compared to the long-term control group, neointimal reduction was still >60%. No induction of neointimal formation was observed at the edges of the stents. Radiation resulted in delayed re-endothelialization. {sup 188}Re stents were capable to reduce intimal hyperplasia and did not cause thrombosis. The edge effect, which was the major limitation of {sup 32}P stents, was not observed in {sup 188}Re stents.« less

The modified pancreatic stent system for prevention of post-ERCP pancreatitis: a case-control study.

PubMed

Zhang, Cheng; Yang, Yu-Long; Ma, Yue-Feng; Zhang, Hong-Wei; Li, Jing-Yi; Lin, Mei-Ju; Shi, Li-Jun; Qi, Chun-Chun

2017-10-18

Prophylactic pancreatic stents after endoscopic retrograde cholangiopancreatography (ERCP) can help prevent post-ERCP pancreatitis. However most of the pancreatic stents need to be removed by another ERCP. The aim of this observational study was to investigate the feasibility and effectiveness of the modified pancreatic stent system for prevention of post-ERCP pancreatitis. From November 2013 to November 2015, a total of 230 patients who had prophylactic pancreatic stent placed for prevention of post-ERCP pancreatitis at a single institution were identified and stratified. In this case-control design, 150 patients received an ordinary pancreatic stent, and 80 patients received the modified pancreatic stent. The main outcome measures were the difficulty level and complications of pancreatic stent placement and extraction between the two groups. In ordinary group, the average time of pancreatic stent and nasal biliary drainage placement was 3.5 ± 0.6 min. There were 13 cases of stent proximal migration (8.7%), 20 cases of stent spontaneous abscission (13.3%), 5 cases of acute pancreatitis (3.3%) (2 cases for stent abscission) and 7 cases of hyperamylasemia (4.7%) after ERCP. One hundred thirty patients received extra duodenoscope (86.7%) to remove the stent, and 4 cases had acute pancreatitis and 5 patients had hyperamylasemia after removing the proximal migratory stents. In modified group, the average time of pancreatic stent system placement was 4.9 ± 0.7 min, but there was only one case of stent abscission (1.3%), 2 cases of acute pancreatitis (2.5%) and 3 cases of hyperamylasemia (3.8%). The new pancreatic stents were removed directly under x-ray without complication. The modified pancreatic stent system has the same effect of preventing post-ERCP pancreatitis, lower rate of stents proximal migration and spontaneous abscission, and the advantage of easier removed compared with ordinary pancreatic stent.

Palliative self-expandable metal stents for acute malignant colorectal obstruction: clinical outcomes and risk factors for complications.

PubMed

Han, Jae Pil; Hong, Su Jin; Kim, Shin Hee; Choi, Jong Hyo; Jung, Hee Jae; Cho, Youn Hee; Ko, Bong Min; Lee, Moon Sung

2014-08-01

Self-expandable metal stents (SEMSs) have been used as palliative treatment or bridge to surgery for obstructions caused by colorectal cancer (CRC). We assessed the long-term outcomes of palliative SEMSs and evaluated the risk factors influencing complications. One hundred and seventy-five patients underwent SEMS placement for acute malignant colorectal obstruction. Of the 72 patients who underwent palliative treatment for primary CRC, 30 patients received chemotherapy (CT) for primary cancer (CT group) and 42 underwent best supportive treatment (BST) without CT (BST group). There was a significant difference in late migration between the CT group and the BST group (20.0% in CT group, 2.4% in BST group, p = 0.018). Response to CT influenced the rate of late obstruction (0% in disease control, 35.7% in disease progression, p = 0.014). However, late obstruction was not associated with stent properties, such as diameter or type (≤22 mm vs. >22 mm, 13.5% vs. 14.3%, p = 1.00; uncovered stent vs. covered stent, 15.5% vs. 7.1%, p = 0.675) and migration (≤22 mm vs. >22 mm, 16.2% vs. 2.9%, p = 0.108; uncovered stent vs. covered stent, 8.6% vs. 14.3%, p = 0.615) in palliative SEMS. The administration of CT increases the rate of stent migration, and disease control by CT can reduce the risk of obstruction by maintaining the luminal patency of palliative SEMSs.

Technical feasibility and tissue reaction after silicone-covered biodegradable magnesium stent insertion in the oesophagus: a primary study in vitro and in vivo.

PubMed

Zhu, Yue-Qi; Edmonds, Laura; Wei, Li-Ming; Zheng, Rei-La; Cheng, Ruo-Yu; Cui, Wen-Guo; Cheng, Ying-Sheng

2017-06-01

Determine the feasibility of and tissue response to biodegradable magnesium-silicone stent insertion into the oesophagus of rabbits. Mechanical compression-recovery and degradation behaviours of the stents were investigated in vitro. Thirty rabbits were randomly divided into a magnesium-silicone stent group (n = 15) that received stent insertion into the lower 1/3 of the oesophagus under fluoroscopic guidance and a control group (n = 15). Oesophagography was performed at 1, 2 and 4 weeks. Five rabbits in each group were euthanized at each time point for histological examination. Magnesium-silicone stents showed good flexibility and elasticity, and degraded more slowly than bare stents at pH 4.0 and 7.4. All stent insertions were well tolerated. The oesophageal diameters at 1, 2 and 4 weeks were 9.7 ± 0.7, 9.6 ± 0.8 and 9.6 ± 0.5 mm, respectively (vs. 9.2 ± 0.8 mm before intervention; P > 0.05). Stent migration occurred in six rabbits (one at 1 week, one at 2 and four at 4). Microscopy demonstrated dilation of the oesophageal wall within 1 week of insertion. Oesophageal injury and collagen deposition following stent insertion were similar to control (P > 0.05). Oesophageal magnesium-silicone stent insertion was feasible and provided reliable support for 2 weeks without causing oesophageal injury or collagen deposition. • Mg stent provided apparently adequate radial force and silicone membrane reduced magnesium biodegradation • Stent insertion provided good support for at least 2 weeks before biodegradation • Stenting effectively resulted in oesophageal wall remodelling, without demonstrable injury.

Meta-Analysis of Stenting versus Non-Stenting for the Treatment of Ureteral Stones

PubMed Central

Wang, Hai; Man, Libo; Li, Guizhong; Huang, Guanglin; Liu, Ning; Wang, Jianwei

2017-01-01

Background and aim Ureteroscopic lithotripsy (URL) and extracorporeal shock wave lithotripsy (ESWL) are two widely used methods for the treatment of ureteral stones. The need for ureteral stenting during these procedures is controversial. In this meta-analysis, we evaluated the benefits and disadvantages of ureteral stents for the treatment of ureteral stones. Methods Databases including PubMed, Embase and Cochrane library were selected for systematic review of randomized controlled trials (RCTs) comparing outcomes with or without stenting during URL and ESWL. Meta-analysis was performed using RevMan 5.3 and STATA 13.0 software. Results We identified 22 RCTs comparing stenting and non-stenting. The stented group was associated with longer operation time (WMD: 4.93; 95% CI: 2.07 to 7.84; p < 0.001), lower stone-free rate (OR: 0.55; 95% CI: 0.34 to 0.89; p = 0.01). In terms of complications, the incidence of hematuria (OR: 3.68; 95% CI: 1.86 to 7.29; p < 0.001), irritative urinary symptoms (OR: 4.40; 95% CI: 2.19 to 9.10; p < 0.001), urinary infection (OR: 2.23; 95% CI: 1.57 to 3.19; p < 0.001), and dysuria (OR: 3.90; 95% CI: 2.51 to 6.07; p < 0.001) were significantly higher in the stented group. No significant differences in visual analogue score (VAS), stricture formation, fever, or hospital stay were found between stenting and non-stenting groups. The risk of unplanned readmissions (OR: 0.63; 95% CI: 0.41 to 0.97; p = 0.04) was higher in the non-stented group. Conclusions Our analysis showed that stenting failed to improve the stone-free rate, and instead, it resulted in additional complications. However, ureteral stents are valuable in preventing unplanned re-hospitalization. Additional randomized controlled trials are still required to corroborate our findings. PMID:28068364

Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

PubMed

Ederle, Jörg; Dobson, Joanna; Featherstone, Roland L; Bonati, Leo H; van der Worp, H Bart; de Borst, Gert J; Lo, T Hauw; Gaines, Peter; Dorman, Paul J; Macdonald, Sumaira; Lyrer, Philippe A; Hendriks, Johanna M; McCollum, Charles; Nederkoorn, Paul J; Brown, Martin M

2010-03-20

Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470. The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4.0%) events of disabling stroke or death in the stenting group compared with 27 (3.2%) events in the endarterectomy group (hazard ratio [HR] 1.28, 95% CI 0.77-2.11). The incidence of stroke, death, or procedural myocardial infarction was 8.5% in the stenting group compared with 5.2% in the endarterectomy group (72 vs 44 events; HR 1.69, 1.16-2.45, p=0.006). Risks of any stroke (65 vs 35 events; HR 1.92, 1.27-2.89) and all-cause death (19 vs seven events; HR 2.76, 1.16-6.56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0.0197). Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery. Medical Research Council, the Stroke Association, Sanofi-Synthélabo, European Union. Copyright 2010 Elsevier Ltd. All rights reserved.

Stent-induced coronary artery stenosis characterized by multimodal nonlinear optical microscopy

NASA Astrophysics Data System (ADS)

Wang, Han-Wei; Simianu, Vlad; Locker, Mattew J.; Cheng, Ji-Xin; Sturek, Michael

2011-02-01

We demonstrate for the first time the applicability of multimodal nonlinear optical (NLO) microscopy to the interrogation of stented coronary arteries under different diet and stent deployment conditions. Bare metal stents and Taxus drug-eluting stents (DES) were placed in coronary arteries of Ossabaw pigs of control and atherogenic diet groups. Multimodal NLO imaging was performed to inspect changes in arterial structures and compositions after stenting. Sum frequency generation, one of the multimodalities, was used for the quantitative analysis of collagen content in the peristent and in-stent artery segments of both pig groups. Atherogenic diet increased lipid and collagen in peristent segments. In-stent segments showed decreased collagen expression in neointima compared to media. Deployment of DES in atheromatous arteries inhibited collagen expression in the arterial media.

Drug treatment of bothersome lower urinary tract symptoms after ureteric JJ-stent insertion: A contemporary, comparative, prospective, randomised placebo-controlled study, single-centre experience.

PubMed

Hekal, Ihab A

2016-12-01

To provide a guide for medication to alleviate bothersome lower urinary tract symptoms (LUTS) in patients after JJ ureteric stenting. Between June 2011 and June 2015, a prospective randomised placebo-controlled study was conducted on 200 consecutive cases of ureteric stones that required JJ stents. All patients had signed informed consent and JJ-stent placement confirmed by X-ray. The patients were randomised into five groups: A, solifenacin 5 mg; B, trospium chloride 20 mg; C, antispasmodic; and E, α-blocker; and a placebo group (D). A standard model was created to lessen patient selection bias. Eligible patients were enrolled and assessed for side-effects and bothersome LUTS using the validated Ureteric Stent Symptoms Questionnaire. Appropriate statistical analysis was carried out. In all, 150 male patients in the five groups were compared. LUTS were less in groups A and B ( P  < 0.05), while dry mouth was significantly reported in Group A. Individual comparisons with the placebo group showed a non-significant difference with Group C, while Group E had significant nocturia improvement. Selective comparison of two best groups (A and B) showed less frequency in Group B, while the other LUTS were less in Group A with comparable side-effects. In symptomatic patients following JJ-stent insertion, anti-muscarinic medication, namely solifenacin 5 mg or trospium chloride 20 mg, was the best. The advantage of trospium over solifenacin is in the control of frequency rather than the other symptoms. Addition of an α-blocker (alfuzosin 10 mg) is valuable when nocturia is the predominant symptom.

Systematic review and meta-analysis of metal versus plastic stents for preoperative biliary drainage in resectable periampullary or pancreatic head tumors.

PubMed

Crippa, S; Cirocchi, R; Partelli, S; Petrone, M C; Muffatti, F; Renzi, C; Falconi, M; Arcidiacono, P G

2016-09-01

Preoperative biliary drainage (PBD) with stenting increases complications compared with surgery without PBD. Metallic stents are considered superior to plastic stents when considering stent-related complications. Aim of the present systematic review and meta-analysis is to compare the rate of endoscopic re-intervention before surgery and postoperative outcomes of metal versus plastic stents in patients with resectable periampullary or pancreatic head neoplasms. We conducted a bibliographic research using the National Library of Medicine's PubMed database, including both randomized controlled trials (RCTs) and non-RCTs. Quantitative synthesis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Statistical heterogeneity was assessed using the I(2) tests. One RCT and four non-RCTs were selected, including 704 patients. Of these, 202 patients (29.5%) were treated with metal stents and 502 (70.5%) with plastic stents. The majority of patients (86.4%) had pancreatic cancer. The rate of endoscopic re-intervention after preoperative biliary drainage was significantly lower in the metal stent (3.4%) than in the plastic stent (14.8%) group (p < 0.0001). The rate of postoperative pancreatic fistula was significantly lower in the meta stent group as well (5.1% versus 11.8%, p = 0.04). The rate of post-operative surgical complications and of - post-operative mortality did not differ between the two groups. Although the present systematic review and meta-analysis demonstrates that metal stent are more effective than plastic stents for PBD in patients with resectable periampullary tumors, randomized controlled trials are needed in order to confirm these data with a higher level of evidence. Copyright © 2016 Elsevier Ltd. All rights reserved.

Temporary placement of a paclitaxel or rapamycin-eluting stent is effective to reduce stenting induced inflammatory reaction and scaring in benign cardia stricture models.

PubMed

Wang, Lin; Zhu, Yue-Qi; Cheng, Ying-Sheng; Cui, Wen-Guo; Chen, Ni-Wei

2014-12-01

To investigate whether temporary placement of a paclitaxel or rapamycin eluting stent is more effective to reduce stenting induced inflammatory reaction and scaring than a bared stent in benign cardia stricture models. Eighty dog models of stricture were randomly divided into a control group (CG, n=20, no stent insertion), a bare stent group (BSG, n=20), a paclitaxel eluting (Pacl-ESG, n=20) and a rapamycin eluting stent group (Rapa-ESG, n=20), with one-week stent retention. Lower-oesophageal-sphincter pressure (LOSP), 5-minute barium height (5-mBH) and cardia diameter were assessed before, immediately after the procedure, and regularly for 6 months. Five dogs in each group were euthanized for histological examination at each follow-up assessment. Stent insertion was well tolerated, with similar migration rates in three groups. At 6 months, LOSP and 5-mBH improved in Pacl-ESG and Rapa-ESG compared to BSG (p<0.05), with no difference between Pacl-ESG and Rapa-ESG (p>0.05). Cardia kept more patency in the Pacl-ESG and Rapa-ESG than in BSG (p<0.05). Reduced peak inflammatory reactions and scarring occurred in the Pacl-ESG and Rapa-ESG compared to BSG (p<0.05), with a similar outcome in the Pacl-ESG and Rapa-ESG (p>0.05). Paclitaxel or rapamycin-eluting stents insertion led to better outcomes than bare stents in benign cardia stricture models.

Comparative Case-Control analysis of a dedicated self-expanding Biolimus A9-eluting Bifurcation stent versus provisional or mandatory side branch intervention strategies in the treatment of coronary bifurcation lesions.

PubMed

Ohlow, Marc-Alexander; Farah, Ahmed; Richter, Stefan; El-Garhy, Mohamad; von Korn, Hubertus; Lauer, Bernward

2017-07-01

In a number of coronary bifurcation lesions, both the main vessel and the side branch (SB) need stent coverage. To analyze the procedural performance and the impact on radiation times (RT) and contrast medium consumption (CMC) of the Axxess™ stent system (Biosensors, Switzerland) treating de novo bifurcation lesions (DBL). One hundred and ten consecutive prospectively enrolled cases (Axxess Group) and 110 age, sex, and lesion location matched controls undergoing mandatory (Group A, n = 56) or provisional (Group B, n = 54) SB intervention were analyzed. Although more pre-dilatation was performed in the Axxess Group (92.7% vs. 46.4% [Group A] vs. 24.1% [Group B]), and more stents were used (2.4 vs. 1.2 vs. 1.05), RT and CMC were significantly lower in the Axxess Group [7.9 min/129 ml vs. 14.2 min/209 ml vs. 7.8 min/152 ml; P < 0.001]. Final Thrombolysis In Myocardial Infarction three flow in both branches was significantly more frequent in the Axxess Group (98.2% vs. 94.6% vs. 88.9%; P = 0.02), and post-interventional troponin T elevations were the lowest in the Axxess Group. Eighty one percent of the Axxess-stents could be implanted without technical difficulties. Difficult implantations procedures were mainly related to coronary anatomy. There was no safety concerns (cardiac death, stent-thrombosis) compared to controls. Cumulative 6-months MACE rates were 11% versus 23% versus 25%. TLR rates at 6-months were 5%, 18%, and 15%, respectively. Axxess bifurcation stent system procedures were associated with significantly less RT and CMC compared to conventional DBL therapy strategies. Difficult coronary anatomy may hinder successful implantation and a learning curve has to be considered. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

[Stents in iliac vascular changes].

PubMed

Gross-Fengels, W; Friedmann, G; Fischbach, R; Erasmi, H; Bulling, B

1991-01-01

The results of 79 iliac stent placements in 64 patients are reported. The technical success rate was 96%. The systolic pressure gradient dropped from 44 mmHg before to 2.8 mmHg after stent placement. This differed significantly as compared to a group treated by conventional PTA (gradient 5.8 mmHg). The cumulative patency after 18-20 months was 90%. Angiographic controls up to 19 months after "stenting" demonstrated only one secondary stent occlusion. Iliac stents therefore are a very valuable supplement to classic PTA.

Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

PubMed Central

2010-01-01

Summary Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470. Findings The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4·0%) events of disabling stroke or death in the stenting group compared with 27 (3·2%) events in the endarterectomy group (hazard ratio [HR] 1·28, 95% CI 0·77–2·11). The incidence of stroke, death, or procedural myocardial infarction was 8·5% in the stenting group compared with 5·2% in the endarterectomy group (72 vs 44 events; HR 1·69, 1·16–2·45, p=0·006). Risks of any stroke (65 vs 35 events; HR 1·92, 1·27–2·89) and all-cause death (19 vs seven events; HR 2·76, 1·16–6·56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0·0197). Interpretation Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery. Funding Medical Research Council, the Stroke Association, Sanofi-Synthélabo, European Union. PMID:20189239

Role of Esophageal Metal Stents Placement and Combination Therapy in Inoperable Esophageal Carcinoma: A Systematic Review and Meta-analysis.

PubMed

Lai, Andrew; Lipka, Seth; Kumar, Ambuj; Sethi, Sajiv; Bromberg, David; Li, Nanxing; Shen, Huafeng; Stefaniwsky, Lilia; Brady, Patrick

2018-04-01

More than 50% of patients with esophageal cancer already have inoperable disease at the time of diagnosis. Controversy surrounds the outcomes of patients with advanced esophageal cancer who receive palliative care by either stent alone or stent plus an additional modality. We set out to perform a systematic review and meta-analysis of studies assessing the use of metal stents as treatment options for symptomatic improvement, survival, and adverse events. We searched Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception until January 14, 2016, as well as other databases for randomized controlled trials (RCTs) comparing esophageal stent versus either esophageal stent plus brachytherapy, radiotherapy, or chemotherapy. For quality assurance purposes throughout the systematic review, multiple independent extractions were performed, and the process was executed as per the standards of the Cochrane collaboration. Primary outcomes were mean change in dysphagia score, overall survival, and quality of life. Secondary outcomes were adverse events including fever, severe pain, aspiration, fistula, stent migration, perforation, and restenosis. Eight RCTs enrolling 732 patients were included with three distinct comparisons: stents combination therapy vs stents alone (5 studies, n = 417), stents alone versus brachytherapy alone (2 studies, n = 274), and stents + brachytherapy vs brachytherapy alone (1 study, n = 41). Stents combination therapy was defined as stents plus radiotherapy, chemotherapy, or both. Mean change in dysphagia scores favored stents combination therapy versus stents alone, and the effect was seen in patients surviving longer than 3 months. Stents combination therapy was also associated with a more favorable overall survival. The risks of stent migration, aspiration pneumonia, and restenosis were lower in the stents combination group compared to stents alone, while the risks of severe pain, hemorrhage, and fistula formation were higher. Changes in dysphagia scores and overall survival did not differ significantly in the brachytherapy-alone vs stents-alone comparison. The risk of fistula formation and hemorrhage were higher in the stents-alone group, while the risk of perforation was lower, compared to brachytherapy alone. Quality of life improvements were seen in all treatment groups, but were not pooled in analysis due to differing methods of measurement. While there appears to be no immediate short-term differences, those who live longer than 3 months experience a significant improvement in dysphagia score using a stents combination therapy approach vs stents alone. The combination therapy significantly improves the overall survival as well as showed improvements in quality of life scores. Larger randomized controlled trials are needed to assess improvements in dysphagia score, overall survival, quality of life, and adverse events.

Effectiveness of Positioning Stents in Radiation-Induced Xerostomia in Patients with Tongue Carcinoma: A Randomized Controlled Trial.

PubMed

Mall, Priyanka; Chand, Pooran; Singh, Balendra Pratap; Rao, Jitendra; Siddarth, Ramashanker; Srivastava, Kirti

2016-01-01

The aim of this study was to perform an objective and subjective evaluation of the efficacy of positioning stents in radiation-induced xerostomia in patients with tongue carcinoma. A total of 30 patients with tongue carcinoma and undergoing conventional radiotherapy were randomly assigned to control (n = 15) and study (n = 15) groups, without and with a positioning stent, respectively. Assessment of salivary output reduction was done before and after radiotherapy, at 3- and 6-month intervals, by measurement of unstimulated and stimulated salivary flow rates (objective evaluation). Xerostomia (subjective evaluation) was noted using six items from the Quality of Life Head and Neck Module (QLQ-H&N35) as proposed by the European Organization for Research and Treatment of Cancer. The significance level was set at .05. Mean unstimulated and stimulated salivary flow rates at 3- and 6-month intervals revealed significantly (P < .05) higher scores for the study group as compared with the control group. The mean quality of life scores in the study group were significantly (P < .05) lower compared with the control group. The use of a positioning stent minimized radiation-induced xerostomia and its symptoms.

Use of ureteral stent in extracorporeal shock wave lithotripsy for upper urinary calculi: a systematic review and meta-analysis.

PubMed

Shen, Pengfei; Jiang, Min; Yang, Jie; Li, Xiong; Li, Yutao; Wei, Wuran; Dai, Yi; Zeng, Hao; Wang, Jia

2011-10-01

This systematic review was performed to assess the necessity and complications of stenting before extracorporeal shock wave lithotripsy in the management of upper urinary stones. A systematic research of PubMed®, EMBASE® and the Cochrane Library was performed to identify all randomized controlled trials. The comparisons were about the outcomes and complications of extracorporeal shock wave lithotripsy in the management of upper urinary stones with or without Double-J stenting before extracorporeal shock wave lithotripsy, including stone-free rate, Steinstrasse, lower urinary tract symptoms, hematuria, fever, urinary tract infection, pain and analgesia, auxiliary treatment, and nausea and vomiting. We used the Cochrane Collaboration's Review Manager (RevMan) 5.0.2 software for statistical analysis. Eight randomized controlled trials were included in analysis that reported 876 patients in total, divided into the stented group of 453 and the stentless group of 423. All studies recorded the stone-free rate and the results of the meta-analysis showed no difference between the groups (RR 0.97, 95% CI 0.91-1.03, p = 0.27). The total incidence of Steinstrasse in the stented group was similar to that of the stentless group with the exception of 1 study. However, the incidence of lower urinary tract symptoms was significantly higher in the stented group than in the stentless group (RR 4.10, 95% CI 2.21-7.61, p <0.00001). Significant differences could not be found in hematuria, fever, urinary tract infection, pain and analgesia, auxiliary treatment, or nausea and vomiting between the groups. The systematic review suggested significant advantages of stenting before extracorporeal shock wave lithotripsy compared to in situ extracorporeal shock wave lithotripsy in terms of Steinstrasse. However, stenting did not benefit stone-free rate and auxiliary treatment after extracorporeal shock wave lithotripsy, and it induced more lower urinary tract symptoms. More high quality, randomized controlled trials are needed to address this issue. Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Primary Stenting of the Superficial Femoral Artery in Patients with Intermittent Claudication Has Durable Effects on Health-Related Quality of Life at 24 Months: Results of a Randomized Controlled Trial.

PubMed

Lindgren, Hans I V; Qvarfordt, Peter; Bergman, Stefan; Gottsäter, Anders

2018-06-01

Intermittent claudication (IC) is commonly caused by lesions in the superficial femoral artery (SFA), yet invasive treatment is still controversial and longer term patient-reported outcomes are lacking. This prospective randomized trial assessed the 24-month impact of primary stenting with nitinol self-expanding stents compared to best medical treatment (BMT) alone in patients with stable IC due to SFA disease on health-related quality of life (HRQoL). One hundred patients with stable IC due to SFA disease treated with BMT were randomized to either stent (n = 48) or control (n = 52) group. HRQoL assessed by Short Form 36 Health Survey (SF-36) and EuroQoL 5-dimensions (EQ5D) 24 months after treatment were primary outcome measures. Walking Impairment Questionnaire, ankle-brachial index (ABI), and walking distance were secondary outcomes. Significantly better SF-36 Physical Component Summary (P = 0.024) and physical domain scores such as Physical Function (P = 0.012), Bodily Pain (P = 0.002), General Health (P = 0.037), and EQ5D (P = 0.010) were reported in intergroup comparison between the stent and the control group. Both ABI (from 0.58 ± 0.11 to 0.85 ± 0.18; P < 0.001 in the stent group and from 0.63 ± 0.17 to 0.69 ± 0.18; P = 0.036 in the control group) and walking distance (from 170 ± 90 m to 616 ± 375 m; P < 0.001 in the stent group and from 209 ± 111 m to 331 ± 304 m; P = 0.006 in the control group) improved significantly in intragroup comparisons. In patients with IC caused by lesions in the SFA, primary stenting compared to BMT alone was associated with significant improvements in HRQoL, ABI, and walking distance durable up to 24 months of follow-up. Clinical Trial Registration http://www.clinicaltrials.gov . Unique Identifier: NCT01230229.

Dilation or biodegradable stent placement for recurrent benign esophageal strictures: a randomized controlled trial.

PubMed

Walter, Daisy; van den Berg, Maarten W; Hirdes, Meike M; Vleggaar, Frank P; Repici, Alessandro; Deprez, Pierre H; Viedma, Bartolomé L; Lovat, Laurence B; Weusten, Bas L; Bisschops, Raf; Haidry, Rehan; Ferrara, Elisa; Sanborn, Keith J; O'Leary, Erin E; van Hooft, Jeanin E; Siersema, Peter D

2018-06-08

 Dilation is the standard of care for recurrent benign esophageal strictures (BES). Biodegradable stents may prolong the effect of dilation and reduce recurrences. Efficacy and safety of dilation and biodegradable stent placement early in the treatment algorithm of recurrent BES were compared.  This multicenter, randomized study enrolled patients with BES treated with previous dilations to ≥ 16 mm. The primary end point was number of repeat endoscopic dilations for recurrent stricture within 3 and 6 months. Secondary outcomes through 12 months included safety, time to first dilation for recurrent stricture, dysphagia, and level of activity.  At 3 months, the biodegradable stent group (n = 32) underwent significantly fewer endoscopic dilations for recurrent stricture compared with the dilation group (n = 34; P  < 0.001). By 6 months, the groups were similar. The number of patients experiencing adverse events was similar between the groups. Two patients in the biodegradable stent group died after developing tracheoesophageal fistulas at 95 and 96 days post-placement; no deaths were attributed to the stent. Median time to first dilation of recurrent stricture for the biodegradable stent group was significantly longer (106 vs. 41.5 days; P  = 0.003). Dysphagia scores improved for both groups. Patients in the biodegradable stent group had a significantly higher level of activity through 12 months ( P  < 0.001).  Biodegradable stent placement is associated with temporary reduction in number of repeat dilations and prolonged time to recurrent dysphagia compared with dilation. Additional studies are needed to better define the exact role of biodegradable stent placement to treat recurrent BES. © Georg Thieme Verlag KG Stuttgart · New York.

Clinical effect of pancreaticojejunostomy with a long-internal stent during pancreaticoduodenectomy in patients with a main pancreatic duct of small diameter.

PubMed

Yamamoto, Tomohisa; Satoi, Sohei; Yanagimoto, Hiroaki; Hirooka, Satoshi; Yamaki, So; Ryota, Hironori; Kotsuka, Masaya; Matsui, Yoichi; Kon, Masanori

2017-06-01

Post-operative pancreatic fistula (POPF) is one of the most common causes of death following pancreaticoduodenectomy (PD). The aim of this study was to evaluate the clinical effect of a long-internal stent on the development of POPF in patients with a main pancreatic duct diameter of 3 mm or less. Patients (N = 108) with a main pancreatic duct (≤3 mm) who underwent PD were included in this single-institution historical control study. Between January 2012 and December 2013, 54 patients had undergone PJ with a long-internal stent across the duct-to-mucosa anastomosis (long-stent group), and between February 2009 and December 2011, 54 patients had undergone PJ without a stent (control). There was no significant difference between groups (long-stent vs control) in the incidence of POPF (70% vs. 56%, p = 0.110) and grade B/C POPF (26% vs. 26%, p = 1.000). Univariate analysis identified body mass index, extent of blood loss and soft pancreatic parenchyma as risk factors related to POPF. Multivariate analysis identified extent of blood loss and soft pancreatic parenchyma as significant risk factors. Placement of a long-internal stent during PJ did not reduce POPF after PD in patients with a main pancreatic duct of small diameter. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Prospective, randomized study of one, two, or three trabecular bypass stents in open-angle glaucoma subjects on topical hypotensive medication

PubMed Central

Katz, L Jay; Erb, Carl; Carceller, Guillamet Amadeu; Fea, Antonio M; Voskanyan, Lilit; Wells, Jeffrey M; Giamporcaro, Jane Ellen

2015-01-01

Purpose To assess the safety and efficacy of one, two, or three trabecular microbypass stents in eyes with primary open-angle glaucoma (OAG) not controlled on ocular hypotensive medication. A total of 119 subjects were followed for 18 months postoperatively. Materials and methods Subjects with medicated intraocular pressure (IOP) 18–30 mmHg and postmedication-washout baseline IOP 22–38 mmHg were randomized to implantation of one, two, or three stents. Ocular hypotensive medication was to be used if postoperative IOP exceeded 18 mmHg. Results A total of 38 subjects were implanted with one stent, 41 subjects with two stents, and 40 subjects with three stents. Both month 12 IOP reduction ≥20% without ocular hypotensive medication vs baseline unmedicated IOP and month 12 unmedicated IOP ≤18 mmHg were achieved by 89.2%, 90.2%, and 92.1% of one-, two-, and three-stent eyes, respectively. Furthermore, 64.9%, 85.4%, and 92.1% of the three respective groups achieved unmedicated IOP ≤15 mmHg. Over the 18-month follow-up period, medication was required in seven one-stent subjects, four two-stent subjects, and three three-stent subjects. At 18 months, mean unmedicated IOP was 15.9±0.9 mmHg in one-stent subjects, 14.1±1.0 mmHg in two-stent subjects, and 12.2±1.1 mmHg in three-stent subjects. Month 18 IOP reduction was significantly greater (P<0.001) with implantation of each additional stent, with mean differences in reduction of 1.84 mmHg (95% confidence interval 0.96–2.73) for three-stent vs two-stent groups and 1.73 mmHg (95% confidence interval 0.83–2.64) for two-stent vs one-stent groups. Adverse events through 18 months were limited to cataract progression with best-corrected visual acuity loss and subsequent cataract surgery. Conclusion In this series, implantation of each additional stent resulted in significantly greater IOP reduction with reduced medication use. Titratability of stents as a sole procedure was shown to be effective and safe, with sustained effect through 18 months postoperatively in OAG not controlled with medication. PMID:26715834

Tracheal Self-Expandable Metallic Stents: A Comparative Study of Three Different Stents in a Rabbit Model.

PubMed

Serrano, Carolina; Lostalé, Fernando; Rodríguez-Panadero, Francisco; Blas, Ignacio de; Laborda, Alicia; de Gregorio, Miguel Angel

2016-03-01

The objective of this study was to assess tracheal reactivity after the deployment of different self-expandable metal stents (SEMS). Forty female New Zealand rabbits were divided into four groups. Three groups received three different SEMS: steel (ST), nitinol (NiTi), or nitinol drug-eluting stent (DES); the fourth group was the control group (no stent). Stents were deployed percutaneously under fluoroscopic guidance. Animals were assessed by multi-slice, computed tomography (CT) scans, and tracheas were collected for anatomical pathology (AP) study. Data from CT and AP were statistically analyzed and correlated. The DES group had the longest stenosis (20.51±14.08mm vs. 5.84±12.43 and 6.57±6.54mm in NiTi and ST, respectively, day 30; P<.05), and higher granuloma formation on CT (50% of cases). The NiTi group showed the lowest grade of stenosis (2.86±6.91% vs. 11.28±13.98 and 15.54±25.95% in DES and ST, respectively; P<.05). The AP study revealed that the ST group developed intense proliferative reactivity compared to the other groups. In the DES group, a destructive response was observed in 70% of the animals, while the NiTi was the least reactive stent. CT was more effective in detecting wall thickening (positive correlation of 68.9%; P<.001) than granuloma (not significant). The ST group developed granulomas and significant stenosis. NiTi was the least reactive stent, while DES caused significant lesions that may be related to drug dosage. This type of DES stent is therefore not recommended for the treatment of tracheobronchial stenosis. Copyright © 2015 SEPAR. Published by Elsevier Espana. All rights reserved.

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

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

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

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

Preservation of keratinized mucosa around implants using a prefabricated implant-retained stent: a case-control study

PubMed Central

2016-01-01

Purpose The aim of this study was to clinically assess the impact of a prefabricated implant-retained stent clipped over healing abutments on the preservation of keratinized mucosa around implants after implant surgery, and to compare it with horizontal external mattress sutures. Methods A total of 50 patients were enrolled in this study. In the test group, a prefabricated implant-retained stent was clipped on the healing abutment after implant surgery to replace the keratinized tissue bucco-apically. In the control group, horizontal external mattress sutures were applied instead of using a stent. After the surgical procedure, the width of the buccal keratinized mucosa was measured at the mesial, middle, and distal aspects of the healing abutment. The change in the width of the buccal keratinized mucosa was assessed at 1 and 3 months. Results Healing was uneventful in both groups. The difference of width between baseline and 1 month was −0.26±0.85 mm in the test group, without any statistical significance (P=0.137). Meanwhile, the corresponding difference in the control group was −0.74±0.73 mm and it showed statistical significance (P<0.001). The difference of width between baseline and 3 months was −0.57±0.97 mm in the test group and −0.86±0.71 mm in the control group. These reductions were statistically significant (P<0.05); however, there was no difference between the 2 groups. Conclusions Using a prefabricated implant-retained stent was shown to be effective in the preservation of the keratinized mucosa around implants and it was simple and straightforward in comparison to the horizontal external mattress suture technique. PMID:27800215

The burden of chronic ureteral stenting in cervical cancer survivors

PubMed Central

Fan, Yunhua; Jarosek, Stephanie; Elliott, Sean P.

2017-01-01

ABSTRACT Purpose Ureteral obstruction in cervical cancer occurs in up to 11% of patients, many of whom undergo ureteral stenting. Our aim was to describe the patient burden of chronic ureteral stenting in a population-based cohort by detailing two objectives: (1) the frequency of repeat procedures for ureteral obstruction; and, (2) the frequency of urinary adverse effects (UAEs) (e.g., lower urinary tract symptoms, flank pain). Materials and Methods From SEER-Medicare, we identified 202 women who underwent ureteral stent placement prior to or following cervical cancer treatment. The frequency of repeat procedures and rate ratios were compared between treatment modalities. The rates and rate ratios of UAEs were compared between our primary cohort (stent + cervical cancer) and the following groups: no stent + cervical cancer, stent + no cancer, and no stent + no cancer. The “no cancer” group was drawn from the 5% Medicare sample. Results 117/202 women (58%) underwent >1 stent procedure. The frequency of additional procedures was significantly higher in patients who received radiation as part of their treatment. UAEs were very common in women with stent + cancer. The rate of UTI was 190 (per 100 person-years), 67 for LUTS, 42 for stones, and 6 for flank pain. These rates were 3-10 fold higher than in the no stent + no cancer control group; rates were also higher than in the no stent + cancer and the stent + no cancer women. Conclusions The burden of disease associated with ureteral stents is higher than expected and urologists should be actively involved in stent management, screening for associated symptoms and offering definitive reconstruction when appropriate. PMID:27649113

Proximal protection with the Gore PAES can reduce DWI lesion size in high-grade stenosis during carotid stenting.

PubMed

Grunwald, Iris Quasar; Reith, Wolfgang; Kühn, Anna Luisa; Balami, Joyce S; Karp, Kerstin; Fassbender, Klaus; Walter, Silke; Papanagiotou, Panagiotis; Krick, Christoph

2014-06-01

The aim was to determine the incidence of new ischaemic lesions on diffusion-weighted MR imaging (DWI) in a non-randomised cohort of patients after protected and unprotected carotid artery stent placement using the Parodi Anti-Emboli System (PAES). A retrospective review was conducted on 269 patients who received DWI prior to, and 24-72 hours after, stent placement. All patients were enrolled in one centre. Forty patients stented with the PAES device were matched with 229 patients stented without protection (control group). New diffusion restriction on DWI was detected in 25.8% (PAES) versus 32.3% (control group); p=0.64. On average there were 0.7 lesions (PAES) versus 0.8 lesions (control group) per patient. The area of lesions was 1.7 (PAES) versus 5.6 mm2. In a subanalysis of patients (32 PAES, 148 non-protected) with >80% stenosis, the area of restricted diffusion was less when proximal protection was used (p<0.05). The number and area of DWI lesions did not differ on the contralateral, non-stented side. When the PAES system was used, patients were more likely not to have any lesion at all (p=0.028). In high-grade stenosis, the use of the Gore PAES device significantly reduced the area of new DWI lesions and patients were more likely not to have any new DWI lesion at all.

Preoperative Belladonna and Opium Suppository for Ureteral Stent Pain: A Randomized, Double-blinded, Placebo-controlled Study.

PubMed

Lee, Franklin C; Holt, Sarah K; Hsi, Ryan S; Haynes, Brandon M; Harper, Jonathan D

2017-02-01

To investigate whether the use of a belladonna and opium (B&O) rectal suppository administered immediately before ureteroscopy (URS) and stent placement could reduce stent-related discomfort. A randomized, double-blinded, placebo-controlled study was performed from August 2013 to December 2014. Seventy-one subjects were enrolled and randomized to receive a B&O (15 mg/30 mg) or a placebo suppository after induction of general anesthesia immediately before URS and stent placement. Baseline urinary symptoms were assessed using the American Urological Association Symptom Score (AUASS). The Ureteral Stent Symptom Questionnaire and AUASS were completed on postoperative days (POD) 1, 3, and after stent removal. Analgesic use intraoperatively, in the recovery unit, and at home was recorded. Of the 71 subjects, 65 had treatment for ureteral (41%) and renal (61%) calculi, 4 for renal urothelial carcinoma, and 2 were excluded for no stent placed. By POD3, the B&O group reported a higher mean global quality of life (QOL) score (P = .04), a better mean quality of work score (P = .05), and less pain with urination (P = .03). The B&O group reported an improved AUASS QOL when comparing POD1 with post-stent removal (P = .04). There was no difference in analgesic use among groups (P = .67). There were no episodes of urinary retention. Age was associated with unplanned emergency visits (P <.00) and "high-pain" measure (P = .02) CONCLUSION: B&O suppository administered preoperatively improved QOL measures and reduced urinary-related pain after URS with stent. Younger age was associated with severe stent pain and unplanned hospital visits. Copyright © 2016 Elsevier Inc. All rights reserved.

Preoperative Belladonna and Opium Suppository for Ureteral Stent Pain: A Randomized, Double-blinded, Placebo-controlled Study

PubMed Central

Lee, Franklin C.; Holt, Sarah K.; Hsi, Ryan S.; Haynes, Brandon M.; Harper, Jonathan D.

2017-01-01

OBJECTIVE To investigate whether the use of a belladonna and opium (B&O) rectal suppository administered immediately before ureteroscopy (URS) and stent placement could reduce stent-related discomfort. METHODS A randomized, double-blinded, placebo-controlled study was performed from August 2013 to December 2014. Seventy-one subjects were enrolled and randomized to receive a B&O (15 mg/30 mg) or a placebo suppository after induction of general anesthesia immediately before URS and stent placement. Baseline urinary symptoms were assessed using the American Urological Association Symptom Score (AUASS). The Ureteral Stent Symptom Questionnaire and AUASS were completed on postoperative days (POD) 1, 3, and after stent removal. Analgesic use intra-operatively, in the recovery unit, and at home was recorded. RESULTS Of the 71 subjects, 65 had treatment for ureteral (41%) and renal (61%) calculi, 4 for renal urothelial carcinoma, and 2 were excluded for no stent placed. By POD3, the B&O group reported a higher mean global quality of life (QOL) score (P = .04), a better mean quality of work score (P = .05), and less pain with urination (P = .03). The B&O group reported an improved AUASS QOL when comparing POD1 with post-stent removal (P = .04). There was no difference in analgesic use among groups (P = .67). There were no episodes of urinary retention. Age was associated with unplanned emergency visits (P <.00) and “high-pain” measure (P = .02) CONCLUSION B&O suppository administered preoperatively improved QOL measures and reduced urinary-related pain after URS with stent. Younger age was associated with severe stent pain and unplanned hospital visits. PMID:27658661

Assessment of tissue blood flow following small artery welding with an intraluminal dissolvable stent.

PubMed

He, F C; Wei, L P; Lanzetta, M; Owen, E R

1999-01-01

Using the technique of radioactive 51Cr-labeled biological microspheres, this study evaluated arterial blood flow following small vessel anastomosis by CO2 laser welding and a dissolvable stent in the lumen. A total of 30 Sprague-Dawley rats were divided into two groups. Group A: 11 rats had their femoral arteries ligated on one side. The contralateral side served as a control, with the artery transected and repaired using conventional microsuturing. Group B: 19 rats had their femoral arteries transected and repaired using CO2 laser welding and an intraluminal dissolvable stent technique. The contralateral side was again used as a control using conventional microsuturing. At 1 hr postoperatively, 51Cr-labeled biological microspheres were injected centripetally into the left common carotid artery and the legs and thighs immediately harvested for measurement of radioactivity. All repaired arteries were patent (30/30 in the microsuturing group and 19/19 in the stented welding group), with no detectable stenosis or dilation at the repaired site. Statistical analysis showed that tissue radioactivity (cpm/g) in the ligated group (3,972 +/- 384 in thighs and 3,142 +/- 742 in legs) was significantly lower than in the microsuturing group (7,132 +/- 1,723 in thighs and 6,557 +/- 1,469 in legs) (P < 0.01). In the ligated group, a significant reduction of blood flow was seen in the legs when compared with the thighs (P < 0.05). There was no significant difference in radioactivity when comparing the microsuturing control with the stented welding group, in both thighs (7,064 +/- 2,599 and 7,006 +/- 2,406, respectively; P > 0.05) and legs (6,386 +/- 1,703 and 6,288 +/- 1,757, respectively; P > 0.05). This study provided evidence that the dissolvable stent placed intraluminally does not impair blood circulation and that when coupled with CO2 laser welding offers a high-quality alternative to conventional small vessel anastomosis.

Endoscopic dacryocystorhinostomy with and without silicone intubation: 4 years retrospective study.

PubMed

Longari, F; Dehgani Mobaraki, P; Ricci, A L; Lapenna, R; Cagini, C; Ricci, G

2016-08-01

The objective of this study is to assess different outcomes between endoscopic dacryocystorhinostomy (En-DCR) with and without silicone intubation. We retrospectively analyzed 84 patients (89 procedures), suffering from chronic epiphora for primary acquired nasolacrimal duct obstruction, treated with En-DCR and divided into two groups depending on silicone stent intubation. The surgical outcomes were evaluated at 7 post-operative controls using Munk's score criteria. Functional success was defined as absence of epiphora, no further episodes of dacryocystitis, and a patent ostium after fluorescein irrigation. 45 En-DCR with stent and 44 En-DCR without stent were performed. Success rate after 18 months follow-up were, respectively, 82.2 % in the stent group and 88.6 % in the non-stent group (OR 0.59) with no statistical differences. The ostial size reduction has been reported in higher percentage in the stent group, mainly due to peristomal granuloma (OR 3.64), scar tissue formation (OR 2.25), and turbinoseptal synaechia (OR 1.76). The benefits of non-intubation are less patient discomfort, reduced surgical time and costs, simpler follow-up regimen and less intubation-associated complications. En-DCR without silicone stent intubation should be the first choice of procedure, stent intubation should be reserved in selected cases with poor local conditions pre and intra-operatively assessed.

Metal or plastic stents for preoperative biliary drainage in resectable pancreatic cancer.

PubMed

Tol, J A M G; van Hooft, J E; Timmer, R; Kubben, F J G M; van der Harst, E; de Hingh, I H J T; Vleggaar, F P; Molenaar, I Q; Keulemans, Y C A; Boerma, D; Bruno, M J; Schoon, E J; van der Gaag, N A; Besselink, M G H; Fockens, P; van Gulik, T M; Rauws, E A J; Busch, O R C; Gouma, D J

2016-12-01

In pancreatic cancer, preoperative biliary drainage (PBD) increases complications compared with surgery without PBD, demonstrated by a recent randomised controlled trial (RCT). This outcome might be related to the plastic endoprosthesis used. Metal stents may reduce the PBD-related complications risk. A prospective multicentre cohort study was performed including patients with obstructive jaundice due to pancreatic cancer, scheduled to undergo PBD before surgery. This cohort was added to the earlier RCT (ISRCTN31939699). The RCT protocol was adhered to, except PBD was performed with a fully covered self-expandable metal stent (FCSEMS). This FCSEMS cohort was compared with the RCT's plastic stent cohort. PBD-related complications were the primary outcome. Three-group comparison of overall complications including early surgery patients was performed. 53 patients underwent PBD with FCSEMS compared with 102 patients treated with plastic stents. Patients' characteristics did not differ. PBD-related complication rates were 24% in the FCSEMS group vs 46% in the plastic stent group (relative risk of plastic stent use 1.9, 95% CI 1.1 to 3.2, p=0.011). Stent-related complications (occlusion and exchange) were 6% vs 31%. Surgical complications did not differ, 40% vs 47%. Overall complication rates for the FCSEMS, plastic stent and early surgery groups were 51% vs 74% vs 39%. For PBD in pancreatic cancer, FCSEMS yield a better outcome compared with plastic stents. Although early surgery without PBD remains the treatment of choice, FCSEMS should be preferred over plastic stents whenever PBD is indicated. Dutch Trial Registry (NTR3142). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

New stent design for use in small coronary arteries during percutaneous coronary intervention

PubMed Central

Granada, Juan F; Huibregtse, Barbara A; Dawkins, Keith D

2010-01-01

Patients with diabetes mellitus, of female gender, increased age, and/or with peripheral vascular disease often develop coronary stenoses in small caliber vessels. This review describes treatment of these lesions with the paclitaxel-eluting 2.25 mm TAXUS® Liberté® Atom™ stent. Given the same stent composition, polymer, antirestenotic drug (paclitaxel), and release kinetics as the first-generation 2.25 mm TAXUS® Express® Atom™ stent, the second-generation TAXUS Liberté Atom stent incorporates improved stent design characteristics, including thinner struts (0.0038 versus 0.0052 inches), intended to increase conformability and deliverability. In a porcine noninjured coronary artery model, TAXUS Liberté Atom stent implantation in small vessels demonstrated complete strut tissue coverage compared with the bare metal stent control, suggesting a similar degree of tissue healing between the groups at 30, 90, and 180 days. The prospective, single-armed TAXUS ATLAS Small Vessel trial demonstrated improved instent late loss (0.28 ± 0.45 versus 0.84 ± 0.57 mm, P < 0.001), instent binary restenosis (13.0% versus 38.1%, P < 0.001), and target lesion revascularization (5.8% versus 17.6%, P < 0.001) at nine months with the TAXUS Liberté Atom stent as compared with the bare metal Express stent control, with similar safety measures between the two groups. The TAXUS Liberté Atom also significantly reduced nine-month angiographic rates of both instent late loss (0.28 ± 0.45 versus 0.44 ± 0.61 mm, P = 0.03) and instent binary restenosis (13.0% versus 25.9%, P = 0.02) when compared with the 2.25 mm TAXUS Express Atom control. The observed reduction in target lesion revascularization with the TAXUS Liberté Atom compared with the TAXUS Express Atom at nine months (5.8% versus 13.7%, P = 0.02) was sustained through three years (10.0% versus 22.1%, P = 0.008) with similar, stable safety outcomes between the groups. In conclusion, these data confirm the safety and favorable performance of the TAXUS Liberté Atom stent in the treatment of small coronary vessels. PMID:22915922

An everolimus-eluting stent versus a paclitaxel-eluting stent in small vessel coronary artery disease: a pooled analysis from the SPIRIT II and SPIRIT III trials.

PubMed

Bartorelli, Antonio L; Serruys, Patrick W; Miquel-Hébert, Karine; Yu, Shui; Pierson, Wes; Stone, Gregg W

2010-07-01

To evaluate the safety and efficacy of the XIENCE V everolimus-eluting stent compared to the TAXUS paclitaxel-eluting stent in small vessels. The XIENCE V everolimus-eluting stent (EES) has been shown to improve angiographic and clinical outcomes after percutaneous myocardial revascularization, but its performance in small coronary arteries has not been investigated. In this pooled analysis, we studied a cohort of 541 patients with small coronary vessels (reference diameter <2.765 mm) by using patient and lesion level data from the SPIRIT II and SPIRIT III studies. TAXUS Express (73% of lesions) and TAXUS Liberté (27% of lesions) paclitaxel-eluting stents (PES) were used as controls in SPIRIT II. In SPIRIT III, Taxus Express(2) PES was the control. Mean angiographic in-stent and in-segment late loss was significantly less in the EES group compared with the PES group, (0.15 +/- 0.37 mm vs. 0.30 +/- 0.44 mm; P = 0.011 for in-stent; 0.10 +/- 0.38 mm vs. 0.21 +/- 0.34 mm; P = 0.034 for in-segment). EES also resulted in a significant reduction in composite major adverse cardiac events at 1 year (19/366 [5.2%] vs. 17/159 [10.7%]; P = 0.037), due to fewer non-Q-wave myocardial infarctions and target lesion revascularizations. At 1 year, the rate of non-Q-wave myocardial infarction was significantly lower in the EES group compared with that of the PES group (6/366 [1.6%] vs. 8/159 [5.0%]; P = 0.037). In patients with small vessel coronary arteries, the XIENCE V EES was superior to the TAXUS PES. (c) 2010 Wiley-Liss, Inc.

Bridge therapy or standard treatment for urgent surgery after coronary stent implantation: Analysis of 314 patients.

PubMed

De Servi, Stefano; Morici, Nuccia; Boschetti, Enrico; Rossini, Roberta; Martina, Paola; Musumeci, Giuseppe; D'Urbano, Maurizio; Lazzari, Ludovico; La Vecchia, Carlo; Senni, Michele; Klugmann, Silvio; Savonitto, Stefano

2016-05-01

Intravenous administration of a short acting glycoprotein IIb/IIIa inhibitor has been proposed as a bridge to surgery in patients on dual antiplatelet treatment, but data in comparison with other treatment options are not available. We conducted a retrospective analysis of consecutive patients who underwent un-deferrable, non-emergency surgery after coronary stenting. The bridge therapy was performed after discontinuation of the oral P2Y12 inhibitor by using i.v. tirofiban infusion. Net Adverse Clinical Events (NACE) was the primary outcome. We analyzed 314 consecutive patients: the bridge strategy was performed in 87 patients, whereas 227 were treated with other treatment options and represent the control group. Thirty-day NACE occurred in 8% of patients in the bridge group and in 22.5% in the control group (p < 0.01). Bridge therapy was associated with decreased 30-day NACE rate [Odds ratio (OR) 0.30; 95% confidence interval (CI) 0.13-0.39; p < 0.01], particularly when the time interval between stenting and surgery was ≤ 60 days (OR 0.09, 95% CI 0.01-0.72; p = 0.02). There were no cases of stent thrombosis in the bridge group and 3 (1.3%) in the control group. Bridge therapy was associated with decreased events rates as compared to both patients with and without P2Y12 inhibitors discontinuation in the control group. After adjustment for the most relevant covariates, the favorable effect of the bridge therapy was not materially modified. In conclusion, perioperative bridge therapy using tirofiban was associated with reduced 30-day NACE rate, particularly when surgery was performed within 60 days after stent implantation.

Intraocular Pressure and Retinal Nerve Fibre Layer Thickness Changes After Carotid Artery Stenting.

PubMed

Biberoğlu, Esra; Eraslan, Muhsin; Baltacıoğlu, Feyyaz; Midi, İpek

2017-08-01

The aim of this study was to evaluate intraocular pressure (IOP) and retinal nerve fiber layer (RNFL) changes in patients with carotid artery stenosis (CAS) after carotid artery stenting. This study was conducted as a cross-sectional, non-randomised clinical case series. Fifteen male patients (mean age: 63.6±9.1) with CAS and more than 70% carotid artery narrowing were included. All of the patients were followed in the department of neurology and were operated in the interventional radiology division. Eighteen healthy male subjects (mean age: 63.7±5.3) were included in the control group. All of the healthy subjects had a detailed ophthalmological examination and subjects with any chronic eye disease were excluded from the study. All of the participants had a detailed ophthalmological examination including tonometry using Goldmann applanation tonometry and RNFL analysis using optical coherence tomography (RTVue-100 5.1). There were no ocular ischemic symptoms in any of the participants. The mean IOP value was 15.1±2.1 mmHg in the control group and 16.6±2.4 mmHg before stent implantation, 16.4±2.2 mmHg at 1 week after implantation, 16.6±2.5 mmHg at 1 month after implantation, and 16.7±2.9 mmHg at 3 months after implantation in the CAS group. Mean RNFL thickness was 105±6 µm in the control group; in the CAS group, mean RNFL thickness values were 98±27 µm before stent implantation and 103±11 µm, 101±10 µm, and 101±11 µm at 1 week, 1 month, and 3 months after stenting. There were no significant differences between the CAS group and control group regarding IOP and RNFL thickness values (p>0.05). IOP and RNFL thickness also did not show any statistically significant changes from preoperative measurements in 3 months postoperative follow-up in the CAS group (p>0.05). IOP and RNFL thickness remained unchanged after carotid stent implantation in carotid artery stenosis patients with no signs of ocular ischemic syndrome.

Intraocular Pressure and Retinal Nerve Fibre Layer Thickness Changes After Carotid Artery Stenting

PubMed Central

Biberoğlu, Esra; Eraslan, Muhsin; Baltacıoğlu, Feyyaz; Midi, İpek

2017-01-01

Objectives: The aim of this study was to evaluate intraocular pressure (IOP) and retinal nerve fiber layer (RNFL) changes in patients with carotid artery stenosis (CAS) after carotid artery stenting. Materials and Methods: This study was conducted as a cross-sectional, non-randomised clinical case series. Fifteen male patients (mean age: 63.6±9.1) with CAS and more than 70% carotid artery narrowing were included. All of the patients were followed in the department of neurology and were operated in the interventional radiology division. Eighteen healthy male subjects (mean age: 63.7±5.3) were included in the control group. All of the healthy subjects had a detailed ophthalmological examination and subjects with any chronic eye disease were excluded from the study. All of the participants had a detailed ophthalmological examination including tonometry using Goldmann applanation tonometry and RNFL analysis using optical coherence tomography (RTVue-100 5.1). Results: There were no ocular ischemic symptoms in any of the participants. The mean IOP value was 15.1±2.1 mmHg in the control group and 16.6±2.4 mmHg before stent implantation, 16.4±2.2 mmHg at 1 week after implantation, 16.6±2.5 mmHg at 1 month after implantation, and 16.7±2.9 mmHg at 3 months after implantation in the CAS group. Mean RNFL thickness was 105±6 µm in the control group; in the CAS group, mean RNFL thickness values were 98±27 µm before stent implantation and 103±11 µm, 101±10 µm, and 101±11 µm at 1 week, 1 month, and 3 months after stenting. There were no significant differences between the CAS group and control group regarding IOP and RNFL thickness values (p>0.05). IOP and RNFL thickness also did not show any statistically significant changes from preoperative measurements in 3 months postoperative follow-up in the CAS group (p>0.05). Conclusion: IOP and RNFL thickness remained unchanged after carotid stent implantation in carotid artery stenosis patients with no signs of ocular ischemic syndrome. PMID:28845322

Implantation of a new enteral stent in obstructive colorectal cancer using interventional radiology in patients over 70 years of age.

PubMed

Miłek, Tomasz; Ciostek, Piotr

2015-07-01

Colorectal cancer is the second leading cause of death due to cancer in Poland. The traditional approach to treat patients included a surgical procedure. Irrespective of the surgical method being used, surgical treatment of malignant colorectal obstruction is associated with prolonged hospitalisation, and the postoperative mortality rate is approximately 5-11%. Due to these problems, more interest has been shown in less invasive methods. Prosthesis implantation is a leading endoscopic method used currently in palliative or preoperative treatment. To compare the results of implantation of traditional stents with the results of implantation of an own stent using minimally invasive methods. Left-sided colon obstruction due to cancer was an indication for transplantation. All patients were aged over 70 years and had serious concomitant diseases. The control group included 50 patients with colorectal cancer who received traditional stents in the period 2009-2011. Our stent covers only the internal length of a tumour. It is not equipped with anti-migration flares. To minimize the risk of migration it has a system of hooks that are responsible for permanent anchorage of the stent within the tumour mass. Implantation technical and clinical success defined as effective decompression of intestinal obstruction was 100% in both groups. There were 2 cases of stent migration in the control group. It is possible to achieve a secure surgical anastomosis after intestinal decompression. Stent implantation is fast and safe thanks to the positioning system that was used. The use of labelled hooks is a secure anti-migration solution.

Evaluation of biodegradable paclitaxel-eluting nanofibre-covered metal stents for the treatment of benign cardia stricture in an experimental model.

PubMed

Zhu, Y-Q; Cui, W-G; Cheng, Y-S; Chang, J; Chen, N-W; Yan, L

2013-05-01

Benign strictures at the cardia are troublesome for patients and often require repeated endoscopic treatments. Paclitaxel can reduce fibrosis. This study evaluated a biodegradable paclitaxel-eluting nanofibre-covered metal stent for the treatment of benign cardia stricture in vitro and in vivo. Drug release was investigated in vitro at pH 7·4 and 4·0. Eighty dogs were divided randomly into four groups (each n = 20): controls (no stent), bare stent (retained for 1 week), and two drug-eluting stent (DES) groups with retention for either 1 week (DES-1w) or 4 weeks (DES-4w). Lower oesophageal sphincter pressure (LOSP) and 5-min barium height (5-mBH) were assessed before, immediately after stent deployment, at 1 week, and 1, 3 and 6 months later. Five dogs in each group were killed for histological examination at each follow-up point. Stent migration rates were similar (0 bare stent versus 2 DES; P = 0·548). The percentage and amount of paclitaxel released in vitro was higher at pH 4·0 than at pH 7·4. After 6 months, LOSP and 5-mBH were both improved in the DES-1w (P = 0·004 and P = 0·049) and DES-4w (both P < 0·001) groups compared with the bare-stent group, with better relief when the stent was retained for 4 weeks (P = 0·004 and P = 0·007). The DES was associated with a reduced peak inflammatory reaction and less scar formation compared with bare stents, especially when inserted for 4 weeks. The DES was more effective for the treatment of benign cardia stricture than bare stents in a canine model. Retention of the DES for 4 weeks led to a better clinical and pathological outcome than 1 week. © 2013 British Journal of Surgery Society Ltd. Published by John Wiley & Sons Ltd.

A Novel Self-Expandable, Radioactive Airway Stent Loaded with 125I Seeds: A Feasibility and Safety Study in Healthy Beagle Dog.

PubMed

Wang, Yong; Guo, Jin-He; Zhu, Guang-Yu; Zhu, Hai-Dong; Chen, Li; Lu, Jian; Wang, Chao; Teng, Gao-Jun

2017-07-01

Airway stent placement is an effective treatment for the immediate palliation of malignant airway obstruction. However, restenosis caused by tumor ingrowth and/or overgrowth after stenting is common. The purpose of this study was to investigate the feasibility and safety of a novel self-expandable stent loaded with 125 I seeds in healthy beagle dog. Under fluoroscopic guidance, forty-eight self-expandable airway stents loaded with 125 I seeds were perorally placed in the main trachea of 48 healthy beagle dogs, who were randomly divided into four groups (Group A: 0.3 mCi; Group B: 0.6 mCi; Group C: 0.9 mCi; Control group: 0 mCi). The estimated radiation dose was calculated using the isotropic point source approximation. Radiological follow-up examinations and histopathological examinations of stented tracheal segments and their adjacent organs and tissues were performed at 2, 4, 8, and 16 weeks following the stenting. All stents were successfully deployed in the targeted tracheal segment in the beagle dogs without procedure-related complications. Tracheal stenosis became severe gradually in all the four groups, which was not associated with the radioactivity of 125 I seeds (p > 0.05). The tracheal injury scores increased along with the higher dose of radioactive seeds which reached peak at 8 weeks and then turned back slightly at 16 weeks. The adjacent tissue did not show pathohistological changes under microscope, while mild and reversible ultrastructure changes were showed under electronic microscope. This study demonstrates that it is feasible and safe to insert this novel self-expandable airway stent loaded with 125 I seeds in healthy beagle dog.

Results of a randomized clinical trial of external beam radiation to prevent restenosis after superficial femoral artery stenting.

PubMed

Therasse, Eric; Donath, David; Elkouri, Stéphane; Lespérance, Jacques; Giroux, Marie-France; Oliva, Vincent L; Guertin, Marie-Claude; Bouchard, Louis; Perreault, Pierre; Gilbert, Patrick; Soulez, Gilles

2016-06-01

The objective of this study was to evaluate the safety and efficacy of external beam radiation (EBR) in preventing restenosis after superficial femoral artery (SFA) stenting in comparison with a control group treated with SFA stenting only. In this Institutional Review Board-approved study, patients who provided written informed consent were randomly assigned to 0 Gy or 14 Gy of EBR to the stent site 24 hours after SFA stenting. The primary end point was the angiographic binary restenosis rate 2 years after stenting. Categorical and continuous end points were respectively analyzed using logistic regression models and Wilcoxon tests. End points expressed as time to event were analyzed using a log-rank test. The study included 155 patients, 46 women and 109 men (mean age, 66 years; range, 45-85 years). In the 0 and 14 Gy groups, binary restenosis was present, respectively, in 44% (34/77) and 68% (52/76; P = .003) 2 years after stenting. Stent thrombosis occurred in 13% (10/78) of the 0 Gy group and in 33% (25/77) of the 14 Gy group (P = .003). Target lesion revascularization at 2 years was 26% (25/78) in the 0 Gy group and 30% (23/77) in the 14 Gy group (P = .56). There were no significant differences in total walking distances change from baseline to 2 years (46 ± 100 and 26 ± 79 m, respectively, in the 0 Gy and 14 Gy group; P = .25). There were no procedure-related deaths and no major amputations. A single 14 Gy dose of EBR to the SFA stenting site did not prevent in-stent restenosis. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Decreased urinary glycosaminoglycan excretion following alfuzosin treatment on ureteral stent-related symptoms: a prospective, randomized, placebo-controlled study.

PubMed

Liu, Shucheng; Yu, Ying; Gao, Yang; Yang, Xiong; Pang, Zili

2016-04-01

The objectives of the study were to evaluate changes in ureteral stent-related symptoms and urinary glycosaminoglycan (GAG) excretion after alfuzosin treatment, and to further investigate the relationship between stent-related symptoms and loss of urinary GAGs. Seventy consecutive patients scheduled for unilateral retrograde ureteroscopy with stent placement were recruited. Patients were randomly assigned to treatment with alfuzosin 10 mg/day or placebo for 3 weeks starting on the third postoperative day. The ureteral stent was removed when treatment stopped. International Prostate Symptom Score (IPSS), visual analog scale (VAS) score, and urinary GAG excretion were determined before treatment at 1, 2, and 3 weeks after treatment, and at 3 weeks after stent removal. Fifty-nine patients completed the study. IPSS, VAS score, and urinary GAG excretion were significantly lower in the alfuzosin group, compared with the placebo group, at 1, 2, and 3 weeks after treatment (P < 0.01). In both groups, IPSS, VAS score, and urinary GAG excretion were significantly lower at 3 weeks after stent removal compared with those before stent removal. No significant differences in IPSS, VAS score, or urinary GAG excretion were observed between the two groups at baseline and 3 weeks after stent removal (P > 0.05). Positive correlations were found between urinary GAG excretion (R(2) = 0.65, P < 0.001) and IPSS and between urinary GAG excretion and VAS score (R(2) = 0.33, P < 0.001). Stent placement contributes to loss of urinary GAGs. However, alfuzosin effectively reduces such loss and improves ureteral stent-related symptoms. Loss of urinary GAGs plays a role in these symptoms.

Stents Eluting 6-Mercaptopurine Reduce Neointima Formation and Inflammation while Enhancing Strut Coverage in Rabbits

PubMed Central

Ruiter, Matthijs S.; van Tiel, Claudia M.; Doornbos, Albert; Marinković, Goran; Strang, Aart C.; Attevelt, Nico J. M.; de Waard, Vivian; de Winter, Robbert J.; Steendam, Rob; de Vries, Carlie J. M.

2015-01-01

Background The introduction of drug-eluting stents (DES) has dramatically reduced restenosis rates compared with bare metal stents, but in-stent thrombosis remains a safety concern, necessitating prolonged dual anti-platelet therapy. The drug 6-Mercaptopurine (6-MP) has been shown to have beneficial effects in a cell-specific fashion on smooth muscle cells (SMC), endothelial cells and macrophages. We generated and analyzed a novel bioresorbable polymer coated DES, releasing 6-MP into the vessel wall, to reduce restenosis by inhibiting SMC proliferation and decreasing inflammation, without negatively affecting endothelialization of the stent surface. Methods Stents spray-coated with a bioresorbable polymer containing 0, 30 or 300 μg 6-MP were implanted in the iliac arteries of 17 male New Zealand White rabbits. Animals were euthanized for stent harvest 1 week after implantation for evaluation of cellular stent coverage and after 4 weeks for morphometric analyses of the lesions. Results Four weeks after implantation, the high dose of 6-MP attenuated restenosis with 16% compared to controls. Reduced neointima formation could at least partly be explained by an almost 2-fold induction of the cell cycle inhibiting kinase p27Kip1. Additionally, inflammation score, the quantification of RAM11-positive cells in the vessel wall, was significantly reduced in the high dose group with 23% compared to the control group. Evaluation with scanning electron microscopy showed 6-MP did not inhibit strut coverage 1 week after implantation. Conclusion We demonstrate that novel stents coated with a bioresorbable polymer coating eluting 6-MP inhibit restenosis and attenuate inflammation, while stimulating endothelial coverage. The 6-MP-eluting stents demonstrate that inhibition of restenosis without leaving uncovered metal is feasible, bringing stents without risk of late thrombosis one step closer to the patient. PMID:26389595

Effect of terazosin on lower urinary tract symptoms and pain due to double-J stent: a double-blind placebo-controlled randomized clinical trial.

PubMed

Mokhtari, Gholamreza; Shakiba, Maryam; Ghodsi, Sara; Farzan, Alireza; Heidari Nejad, Sayeh; Esmaeili, Samaneh

2011-01-01

We evaluated the effect of terazosin in the improvement of lower urinary tract symptoms and flank pain in patients with internal ureteral stents. In this double-blind randomized clinical trial, 73 patients with unilateral ureteral stone and hydroureteronephrosis who underwent insertion of an internal ureteral stent after transureteral lithotripsy (TUL) were randomized into two groups. 37 patients received terazosin 2 mg (once nightly) for 4 weeks and 36 patients received placebo for the same time duration. After 4 weeks, all patients were asked about the incidence of frequency, nocturia and urgency by an International Prostate Symptom Score (IPSS) questionnaire, flank pain and pain during urination by a visual analog scale (VAS) score, and hematuria. The mean VAS score was 2.21 in the terazosin group compared with 4.93 in the control group (p < 0.001). Nearly all the patients in the placebo group reported flank pain during urination but this was only reported in 54.5% of the patients in the terazosin group (p < 0.001). All criteria measured by the IPSS in the terazosin group were significantly lower than those in the placebo group (p = 0.0001). Administration of terazosin for patients with an internal ureteral stent relieved some stent-related symptoms such as flank pain, pain during voiding, frequency, nocturia and urgency, but had no effect on hematuria. Copyright © 2011 S. Karger AG, Basel.

Partially covered versus uncovered self-expandable nitinol stents with anti-migration properties for the palliation of malignant distal biliary obstruction: A randomized controlled trial.

PubMed

Yang, Min Jae; Kim, Jin Hong; Yoo, Byung Moo; Hwang, Jae Chul; Yoo, Jun Hwan; Lee, Ki Seong; Kang, Joon Koo; Kim, Soon Sun; Lim, Sun Gyo; Shin, Sung Jae; Cheong, Jae Youn; Lee, Kee Myung; Lee, Kwang Jae; Cho, Sung Won

2015-01-01

Covered self-expandable metal stents (SEMSs) are increasingly used as alternatives to uncovered SEMSs for the palliation of inoperable malignant distal biliary obstruction to counteract tumor ingrowth. We aimed to compare the outcomes of partially covered and uncovered SEMSs with identical mesh structures and anti-migration properties, such as low axial force and flared ends. One hundred and three patients who were diagnosed with inoperable malignant distal biliary obstruction between January 2006 and August 2013 were randomly assigned to either the partially covered (n = 51) or uncovered (n = 52) SEMS group. There were no significant differences in the cumulative stent patency, overall patient survival, stent dysfunction-free survival and overall adverse events, including pancreatitis and cholecystitis, between the two groups. Compared to the uncovered group, stent migration (5.9% vs. 0%, p = 0.118) and tumor overgrowth (7.8% vs. 1.9%, p = 0.205) were non-significantly more frequent in the partially covered group, whereas tumor ingrowth showed a significantly higher incidence in the uncovered group (5.9% vs. 19.2%, p = 0.041). Stent migration in the partially covered group occurred only in patients with short stenosis of the utmost distal bile duct (two in ampullary cancer, one in bile duct cancer), and did not occur in any patients with pancreatic cancer. For the palliation of malignant distal biliary obstruction, endoscopic placement of partially covered SEMSs with anti-migration designs and identical mesh structures to uncovered SEMSs failed to prolong cumulative stent patency or reduce stent migration.

A comparative evaluation of early stent occlusion among biliary conventional versus wing stents.

PubMed

Khashab, Mouen A; Hutfless, Susan; Kim, Katherine; Lennon, Anne Marie; Canto, Marcia I; Jagannath, Sanjay B; Okolo, Patrick I; Shin, Eun Ji; Singh, Vikesh K

2012-06-01

Conventional plastic stents with a lumen typically have limited patency. The lumenless wing stent was engineered to overcome this problem. The objective of this study was to compare the incidence of early stent occlusion (symptomatic occlusion/cholangitis necessitating re-insertion within 90 days) for wing stents and conventional plastic stents. Patients with biliary pathology treated with plastic biliary stenting during the period 2003-2009 comprised the study cohort. Patients who had at least one biliary wing stent placed comprised the wing stent group, whereas patients who underwent only conventional stent plastic placement comprised the conventional stent group. Patients were stratified by indication: benign biliary strictures (group 1), malignant biliary strictures (group 2), or benign biliary non-stricture pathology (group 3). The association of stent type with the occurrence of primary outcome by indication was analyzed by use of multivariable logistic regression. Three-hundred and forty-six patients underwent 612 ERCP procedures with placement of plastic biliary stent(s). On multivariate analysis, early stent occlusion did not differ between the wing and conventional groups in groups 1, 2, and 3. Among patients who achieved primary outcome in group 2, significantly fewer patients in the wing group had cholangitis (6.7% vs. 39.1%, P = 0.03). Among patients who achieved primary outcome in group 3, significantly fewer patients in the wing group had cholangitis (10% vs. 50%, P = 0.03). Early stent occlusion was similar for wing stents and conventional plastic stents. Wing stents, however, were associated with a lower incidence of cholangitis in patients with malignant biliary obstruction and benign non-stricturing biliary pathology.

Transjugular Intrahepatic Portosystemic Shunt Flow Reduction with Adjustable Polytetrafluoroethylene-Covered Balloon-Expandable Stents Using the “Sheath Control” Technique

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

Blue, Robert C., E-mail: Robert.c.blue@gmail.com; Lo, Grace C.; Kim, Edward

PurposeA complication of transjugular intrahepatic portosystemic shunts (TIPS) placement is refractory portosystemic encephalopathy (PSE) often requiring TIPS reduction. We report the results of a “sheath control technique” utilizing constraining sheaths during deployment of polytetrafluoroethylene (PTFE)-covered balloon-expandable stents, minimizing stent migration, and providing additional procedural control.MethodsTIPS reduction was performed in 10 consecutive patients for PSE using Atrium iCast covered stents (Atrium Maquet Getinge Group, Germany). Within the indwelling TIPS stent, a 9 mm × 59 mm iCast stent was deployed with 2 cm exposed from the sheath’s distal end and the majority of the stent within the sheath to create the distal hourglass shape. During balloonmore » retraction, the stent was buttressed by the sheath. The proximal portion of the stent was angioplastied to complete the hourglass configuration, and the central portion of the stent was dilated to 5 mm. Demographics, pre- and post-procedure laboratory values, and outcomes were recorded.ResultsTen patients underwent TIPS reduction with 100 % technical success. There was no stent migration during stent deployment. All patients experienced initial improvement of encephalopathy. One patient ultimately required complete TIPS occlusion for refractory PSE, and another developed TIPS occlusion 36 days post-procedure. There was no significant trend toward change in patients’ MELD scores immediately post-procedure or at 30 days (p = 0.46, p = 0.47, respectively).ConclusionTIPS reduction using Atrium iCast PTFE balloon-expandable stents using the “sheath control technique” is safe and effective, and minimizes the risk of stent migration.« less

Cost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic adenocarcinoma in a randomized controlled trial.

PubMed

Gardner, Timothy B; Spangler, Chad C; Byanova, Katerina L; Ripple, Gregory H; Rockacy, Matthew J; Levenick, John M; Smith, Kerrington D; Colacchio, Thomas A; Barth, Richard J; Zaki, Bassem I; Tsapakos, Michael J; Gordon, Stuart R

2016-09-01

The optimal type of stent for the palliation of malignant biliary obstruction in patients with pancreatic adenocarcinoma undergoing neoadjuvant chemoradiotherapy with curative intent is unknown. We performed a prospective trial comparing 3 types of biliary stents-fully covered self-expandable metal (fcSEMS), uncovered self-expandable metal (uSEMS), and plastic-to determine which best optimized cost-effectiveness and important clinical outcomes. In this prospective randomized trial, consecutive patients with malignant biliary obstruction from newly diagnosed pancreatic adenocarcinoma who were to start neoadjuvant chemoradiotherapy were randomized to receive fcSEMSs, uSEMSs, or plastic stents during the index ERCP. The primary outcomes were time to stent occlusion, attempted surgical resection, or death after the initiation of neoadjuvant therapy, and the secondary outcomes were total patient costs associated with the stent, including the index ERCP cost, downstream hospitalization cost due to stent occlusion, and the cost associated with procedural adverse event. Fifty-four patients were randomized and reached the primary end point: 16 in the fcSEMS group, 17 in the uSEMS group, and 21 in the plastic stent group. No baseline demographic or tumor characteristic differences were noted among the groups. The fcSEMSs had a longer time to stent occlusion compared with uSEMSs and plastic stents (220 vs 74 and 76 days, P < .01), although the groups had equivalent rates of stent occlusion, attempted surgical resection, and death. Although SEMS placement cost more during the index ERCP (uSEMS = $24,874 and fcSEMS = $22,729 vs plastic = $18,701; P < .01), they resulted in higher procedural AE costs per patient (uSEMS = $5522 and fcSEMS = $12,701 vs plastic = $0; P < .01). Conversely, plastic stents resulted in an $11,458 hospitalization cost per patient due to stent occlusion compared with $2301 for uSEMSs and $0 for fcSEMSs (P < .01). In a prospective trial comparing fcSEMSs, uSEMSs, and plastic stents for malignant biliary obstruction in patients undergoing neoadjuvant therapy with curative intent for pancreatic adenocarcinoma, no stent type was superior in optimizing cost-effectiveness, although fcSEMSs resulted in fewer days of neoadjuvant treatment delay and a longer time to stent occlusion. (Clincial trial registration number: NCT01038713.). Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Biological effect of microengineered grooved stents on strut healing: a randomised OCT-based comparative study in humans

PubMed Central

Vesga, Boris; Hernandez, Hector; Higuera, Sergio; Gasior, Pawel; Echeveri, Dario; Delgado, Juan A; Dager, Antonio; Arana, Camilo; Simonton, Charles; Maehara, Akiko; Palmaz, Julio; Granada, Juan F

2017-01-01

Objective To evaluate the biological effect of microengineered stent grooves (MSG) on early strut healing in humans by performing optical coherence tomography (OCT) analysis 3 weeks following the implantation. Background In the experimental setting, MSG accelerate endothelial cell migration and reduce neointimal proliferation compared with bare metal stent (BMS). Methods A total of 37 patients undergoing percutaneous coronary intervention with de novo coronary lesions were randomly assigned to either MSG (n=19) or an identical BMS controls (n=18). All patients underwent OCT imaging at 3 weeks. A total of 7959 struts were included in the final analysis. Results At 3 weeks following stent implantation, almost all struts analysed (~97%) had evidence of tissue coverage. The percentage of partially covered struts was comparable between both groups. However, the percentage of fully embedded struts was higher in the BMS group (81.22%, 49.75–95.52) compared with the MSG group (74.21%, 58.85–86.38). The stent-level analysis demonstrated reduction in neointimal formation (neointimal hyperplasia area and volume reduction of ~14% and ~19%, respectively) in the MSG versus the BMS group. In the strut-level analysis, an even greater reduction (~22% in neointimal thickness) was seen in the MSG group. Layered neointimal was present in ~6% of the OCT frames in the BMS group while it was not present in the MSG group. Conclusions MSG induced a more homogeneous and predictable pattern of surface healing in the early stages following stent implantation. The biological effect of MSG on stent healing has the potential to improve the safety profile of current generation drug-eluting stents. Classifications BMS, OCT, clinical trials. PMID:28674616

Biological effect of microengineered grooved stents on strut healing: a randomised OCT-based comparative study in humans.

PubMed

Vesga, Boris; Hernandez, Hector; Higuera, Sergio; Gasior, Pawel; Echeveri, Dario; Delgado, Juan A; Dager, Antonio; Arana, Camilo; Simonton, Charles; Maehara, Akiko; Palmaz, Julio; Granada, Juan F

2017-01-01

To evaluate the biological effect of microengineered stent grooves (MSG) on early strut healing in humans by performing optical coherence tomography (OCT) analysis 3 weeks following the implantation. In the experimental setting, MSG accelerate endothelial cell migration and reduce neointimal proliferation compared with bare metal stent (BMS). A total of 37 patients undergoing percutaneous coronary intervention with de novo coronary lesions were randomly assigned to either MSG (n=19) or an identical BMS controls (n=18). All patients underwent OCT imaging at 3 weeks. A total of 7959 struts were included in the final analysis. At 3 weeks following stent implantation, almost all struts analysed (~97%) had evidence of tissue coverage. The percentage of partially covered struts was comparable between both groups. However, the percentage of fully embedded struts was higher in the BMS group (81.22%, 49.75-95.52) compared with the MSG group (74.21%, 58.85-86.38). The stent-level analysis demonstrated reduction in neointimal formation (neointimal hyperplasia area and volume reduction of ~14% and ~19%, respectively) in the MSG versus the BMS group. In the strut-level analysis, an even greater reduction (~22% in neointimal thickness) was seen in the MSG group. Layered neointimal was present in ~6% of the OCT frames in the BMS group while it was not present in the MSG group. MSG induced a more homogeneous and predictable pattern of surface healing in the early stages following stent implantation. The biological effect of MSG on stent healing has the potential to improve the safety profile of current generation drug-eluting stents. BMS, OCT, clinical trials.

Prospective unmasked randomized evaluation of the iStent inject® versus two ocular hypotensive agents in patients with primary open-angle glaucoma

PubMed Central

Fea, Antonio M; Belda, Jose I; Rękas, Marek; Jünemann, Anselm; Chang, Lydia; Pablo, Luis; Voskanyan, Lilit; Katz, L Jay

2014-01-01

Purpose The purpose of this study was to compare outcomes of subjects with open-angle glaucoma (OAG) not controlled on one medication who underwent either implantation of two iStent inject® trabecular micro-bypass devices or received medical therapy consisting of a fixed combination of latanoprost/timolol. Patients and methods Of 192 subjects who qualified for the study and were enrolled, 94 were randomized to surgery with implantation of two iStent inject® devices in the treated eye and 98 to receive medical therapy. Results At the month 12 visit, 94.7% of eyes (89/94) in the stent group reported an unmedicated intraocular pressure (IOP) reduction of ≥20% versus baseline unmedicated IOP, and 91.8% of eyes (88/98) in the medical therapy group reported an IOP reduction ≥20% versus baseline unmedicated IOP. A 17.5% between-group treatment difference in favor of the iStent inject group was statistically significant (P=0.02) at the ≥50% level of IOP reduction. An IOP ≤18 mmHg was reported in 92.6% of eyes (87/94) in the iStent inject group and 89.8% of eyes (88/98) in the medical therapy group. Mean (standard deviation) IOP decreases from screening of 8.1 (2.6) mmHg and 7.3 (2.2) mmHg were reported in the iStent inject and medical therapy groups, respectively. A high safety profile was also noted in this study in both the iStent inject and medical therapy groups, as measured by stable best corrected visual acuity, cup-to-disc ratio, and adverse events. Conclusion These data show that the use of iStent inject is at least as effective as two medications, with the clinical benefit of reducing medication burden and assuring continuous treatment with full compliance to implant therapy as well as having a highly favorable safety profile. PMID:24855336

Comparison of diamond-like carbon-coated nitinol stents with or without polyethylene glycol grafting and uncoated nitinol stents in a canine iliac artery model

PubMed Central

Kim, J H; Shin, J H; Shin, D H; Moon, M-W; Park, K; Kim, T-H; Shin, K M; Won, Y H; Han, D K; Lee, K-R

2011-01-01

Objective Neointimal hyperplasia is a major complication of endovascular stent placement with consequent in-stent restenosis or occlusion. Improvements in the biocompatibility of stent designs could reduce stent-associated thrombosis and in-stent restenosis. We hypothesised that the use of a diamond-like carbon (DLC)-coated nitinol stent or a polyethylene glycol (PEG)-DLC-coated nitinol stent could reduce the formation of neointimal hyperplasia, thereby improving stent patency with improved biocompatibility. Methods A total of 24 stents were implanted, under general anaesthesia, into the iliac arteries of six dogs (four stents in each dog) using the carotid artery approach. The experimental study dogs were divided into three groups: the uncoated nitinol stent group (n = 8), the DLC-nitinol stent group (n = 8) and the PEG-DLC-nitinol stent group (n = 8). Results The mean percentage of neointimal hyperplasia was significantly less in the DLC-nitinol stent group (26.7±7.6%) than in the nitinol stent group (40.0±20.3%) (p = 0.021). However, the mean percentage of neointimal hyperplasia was significantly greater in the PEG-DLC-nitinol stent group (58.7±24.7%) than in the nitinol stent group (40.0±20.3%) (p = 0.01). Conclusion Our findings indicate that DLC-coated nitinol stents might induce less neointimal hyperplasia than conventional nitinol stents following implantation in a canine iliac artery model; however, the DLC-coated nitinol stent surface when reformed with PEG induces more neointimal hyperplasia than either a conventional or DLC-coated nitinol stent. PMID:21325363

Experimental evaluation of efficacy and healing response of everolimus-eluting stents in the familial hypercholesterolemic swine model: a comparative study of bioabsorbable versus durable polymer stent platforms.

PubMed

Tellez, Armando; Seifert, Paul S; Donskoy, Elina; Sushkova, Natalia; Pennington, Douglas E; Milewski, Krzysztof; Krueger, Christian G; Kaluza, Greg L; Eppihimer, Michael J; Huibregtse, Barbara A; Dawkins, Keith D; Granada, Juan F

2014-05-01

The utility of animal models for the prediction of drug-eluting stent (DES) efficacy in human clinical trials is still unclear. The familial hypercholesterolemic swine (FHS) model has been shown to induce a human-like neointimal response to bare metal stent (BMS) implantation. However, its utility to discriminate efficacy signals following DES implantation is unknown. In this study, we aimed to test the efficacy and healing response of several everolimus-eluting stent (EES) platforms in the coronary territory of the FHS. A total of 19 EES platforms (SYNERGY=6, SYNERGY½-dose=7, and PROMUS Element=6) and an identical BMS control (Element=6) were implanted into the coronary arteries of nine FHS. All implants were performed under intravascular ultrasound guidance using a 1.2 : 1 overstretch ratio. At 30 days, the vascular response to the implant was evaluated by quantitative coronary angiography, optical coherence tomography, and histology. At 28 days, all EES platforms showed a significant decrease in angiographic late lumen loss (between 27 and 37%) compared with the BMS control group. This finding was confirmed both by optical coherence tomography (mean neointimal thickness=28-42% reduction) and by histology (mean neointimal thickness=44-55% reduction). All EES platforms showed similar degrees of neointimal inhibition. The presence of moderate to severe para-strut inflammation was observed in 83% of the stent sections in the BMS group compared with 28.6% in the SYNERGY½-dose group and 0% in the SYNERGY and PROMUS groups (P=0.0002). There was a 68-95% reduction in MMP9 expression in the media in all EES platforms compared with the BMS controls. The presence of mild to moderate para-strut fibrin deposits ranged from 66.7 to 83.4% in all EES platforms compared with 16.7% in the EBMS group. The FHS coronary injury model showed the efficacy of several EES platforms compared with an identical BMS control. Everolimus eluted from different polymeric platforms showed lower levels of inflammation and slightly higher fibrin deposits compared with BMS controls.

Biocompatibility of new drug-eluting biodegradable urethral stent materials.

PubMed

Kotsar, Andres; Nieminen, Riina; Isotalo, Taina; Mikkonen, Joonas; Uurto, Ilkka; Kellomäki, Minna; Talja, Martti; Moilanen, Eeva; Tammela, Teuvo L J

2010-01-01

To investigate the effects of biodegradable stent material (poly-96L/4D-lactic acid [PLA]) on the production of cytokines and other inflammatory mediators in vitro and the biocompatibility of new drug-eluting biodegradable urethral stent materials in vivo. Indomethacin, dexamethasone, and simvastatin were used in the materials. The effects of the biodegradable stent material on cytokines and other inflammatory mediators were measured using the Human Cytokine Antibody Array and enzyme-linked immunosorbent assay in THP-1 cells, with bacterial lipopolysaccharide as a positive control. To assess the biocompatibility of the stent materials, we used muscle implantation. Biodegradable stent materials without drug-eluting properties and silicone and latex were used as controls. The measurements were done at 3 weeks and 3 months. The PLA stent material induced production of inflammatory mediators, especially interleukin-8, tumor necrosis factor-alpha, and transforming growth factor-beta, in vitro. The increase in the production of these mediators with the PLA stent material was smaller than in the cells treated with lipopolysaccharide. In vivo, the effects of the biodegradable materials did not differ at 3 weeks, although, at 3 months, dexamethasone had induced more tissue reactions than had the other materials. At 3 months, fibrosis and chronic inflammatory changes were decreased in the biodegradable material groups compared with the positive control. PLA stent material increased the production of cytokines and other inflammatory mediators less than did positive controls in vitro. The in vivo biocompatibility of the drug-eluting biodegradable materials was better than that of the positive controls. Drug-eluting biodegradable urethral stents could potentially offer a new treatment modality in the future. 2010 Elsevier Inc. All rights reserved.

Microvascular stent anastomosis using N-fibroin stents: feasibility, ischemia time, and complications.

PubMed

Smeets, Ralf; Vorwig, Oliver; Wöltje, Michael; Gaudin, Robert; Luebke, Andreas M; Beck-Broichsitter, Benedicta; Rheinnecker, Michael; Heiland, Max; Grupp, Katharina; Gröbe, Alexander; Hanken, Henning

2016-05-01

To evaluate a novel microvascular anastomosis technique using N-fibroin stents. Cylinder stents of 1 mm diameter and 5 mm length were fabricated using N-fibroin from silkworms. In 22 rats, aortas were dissected, and the stent was inserted into the two ends of the aorta and fixed using methylmethacrylate. Stent anastomosis was successful in 21 (96%) rats. The mean ischemia time was 7.4 minutes, significantly shorter than the 15.9 minutes in the control group with conventional sutures (P < .0001). After 4 months, anastomosis was functionally patent in all cases. However, elastic fibers remained interrupted in all stent anastomosis cases, and marked host rejection was evident at the stent anastomosis sites. Around the stents, thrombi were frequent (52%). Our study demonstrated the basic feasibility of stent anastomosis using N-fibroin stents and reduced ischemia time. However, thrombus formation, frequent and severe abdominal infections, and heavy host rejection remain critical issues. Copyright © 2016 Elsevier Inc. All rights reserved.

Treatment of central venous in-stent restenosis with repeat stent deployment in hemodialysis patients.

PubMed

Ronald, James; Davis, Bradley; Guevara, Carlos J; Pabon-Ramos, Waleska M; Smith, Tony P; Kim, Charles Y

2017-05-15

To report patency rates for stent deployment for treatment of in-stent stenosis of the central veins of the chest in hemodialysis patients. A retrospective analysis was performed on 29 patients who underwent 35 secondary percutaneous transluminal stent (PTS) deployments for in-stent stenosis within the central veins that were refractory to angioplasty and ipsilateral to a functioning hemodialysis access (in-stent PTS group). For comparison, patency data were acquired for 47 patients who underwent 78 successful percutaneous transluminal angioplasty (PTA) procedures for in-stent stenosis (in-stent PTA group) and 55 patients who underwent 55 stent deployments within native central vein stenosis refractory to angioplasty (native vein PTS group). The 3-, 6-, and 12-month primary lesion patency for the in-stent PTS group was 73%, 57%, and 32%, respectively. The 3-, 6-, and 12-month primary patency for the in-stent PTA group was 70%, 38%, and 17% and for the native vein PTS group was 78%, 57%, and 26%, which were similar to the in-stent PTS group (p = 0.20 and 0.41, respectively). The 3-, 6-, and 12-month secondary access patency was 91%, 73%, and 65% for the in-stent PTS group. Sub-analysis of the in-stent PTS group revealed no difference in primary (p = 0.93) or secondary patency rates (p = 0.27) of bare metal stents (n = 23) compared with stent grafts (n = 12). Stent deployment for central vein in-stent stenosis refractory to angioplasty was associated with reasonable patency rates, which were similar to in-stent PTA and native vein PTS.

Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis

PubMed Central

Sabaté, Manel; Kaiser, Christoph; Brugaletta, Salvatore; de la Torre Hernandez, Jose Maria; Galatius, Soeren; Cequier, Angel; Eberli, Franz; de Belder, Adam; Serruys, Patrick W; Ferrante, Giuseppe

2014-01-01

Objectives To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents. Design Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were used to assess the impact of stent type on outcomes. Hazard ratios with 95% confidence interval for outcomes were reported. Data sources and study selection Medline, Embase, the Cochrane Central Register of Controlled Trials. Randomised controlled trials that compared cobalt-chromium everolimus eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients. Primary outcomes The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite or probable stent thrombosis, target vessel revascularisation, and all cause death. Results The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had a significant reduction of cardiac mortality (hazard ratio 0.67, 95% confidence interval 0.49 to 0.91; P=0.01), myocardial infarction (0.71, 0.55 to 0.92; P=0.01), definite stent thrombosis (0.41, 0.22 to 0.76; P=0.005), definite or probable stent thrombosis (0.48, 0.31 to 0.73; P<0.001), and target vessel revascularisation (0.29, 0.20 to 0.41; P<0.001) at a median follow-up of 720 days. There was no significant difference in all cause death between groups (0.83, 0.65 to 1.06; P=0.14). Findings remained unchanged at multivariable regression after adjustment for the acuity of clinical syndrome (for instance, acute coronary syndrome v stable coronary artery disease), diabetes mellitus, female sex, use of glycoprotein IIb/IIIa inhibitors, and up to one year v longer duration treatment with dual antiplatelets. Conclusions This meta-analysis offers evidence that compared with bare metal stents the use of cobalt-chromium everolimus eluting stents improves global cardiovascular outcomes including cardiac survival, myocardial infarction, and overall stent thrombosis. PMID:25378023

Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis.

PubMed

Valgimigli, Marco; Sabaté, Manel; Kaiser, Christoph; Brugaletta, Salvatore; de la Torre Hernandez, Jose Maria; Galatius, Soeren; Cequier, Angel; Eberli, Franz; de Belder, Adam; Serruys, Patrick W; Ferrante, Giuseppe

2014-11-04

To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents. Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were used to assess the impact of stent type on outcomes. Hazard ratios with 95% confidence interval for outcomes were reported. Medline, Embase, the Cochrane Central Register of Controlled Trials. Randomised controlled trials that compared cobalt-chromium everolimus eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients. The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite or probable stent thrombosis, target vessel revascularisation, and all cause death. The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had a significant reduction of cardiac mortality (hazard ratio 0.67, 95% confidence interval 0.49 to 0.91; P=0.01), myocardial infarction (0.71, 0.55 to 0.92; P=0.01), definite stent thrombosis (0.41, 0.22 to 0.76; P=0.005), definite or probable stent thrombosis (0.48, 0.31 to 0.73; P<0.001), and target vessel revascularisation (0.29, 0.20 to 0.41; P<0.001) at a median follow-up of 720 days. There was no significant difference in all cause death between groups (0.83, 0.65 to 1.06; P=0.14). Findings remained unchanged at multivariable regression after adjustment for the acuity of clinical syndrome (for instance, acute coronary syndrome v stable coronary artery disease), diabetes mellitus, female sex, use of glycoprotein IIb/IIIa inhibitors, and up to one year v longer duration treatment with dual antiplatelets. This meta-analysis offers evidence that compared with bare metal stents the use of cobalt-chromium everolimus eluting stents improves global cardiovascular outcomes including cardiac survival, myocardial infarction, and overall stent thrombosis. © Valgimigli et al 2014.

Overview of evidence on emergency carotid stenting in patients with acute ischemic stroke due to tandem occlusions: a systematic review and meta-analysis.

PubMed

Coelho, Andreia; Lobo, Miguel; Gouveia, Ricardo; Silveira, Diogo; Campos, Jacinta; Augusto, Rita; Coelho, Nuno; Canedo, Alexandra

2018-01-23

Endovascular intracranial thrombectomy (IT) has established itself as the standard of care in treating large-vessel anterior circulation acute ischemic stroke (AIS). However, internal carotid artery (ICA) stenosis/occlusion hampers distal access and controversy about simultaneous emergency ICA stenting ensues. The purpose of this review was to evaluate the safety of emergency ICA stenting in combination with IT for AIS with tandem occlusions. To our knowledge this is the first meta-analysis to evaluate emergency ICA stenting in tandem occlusions, combining results from studies with a control group. A systematic review and meta-analysis was conducted according to the recommendations of the Preferred Reporting Items for Systematic reviews and Meta- Analyses (PRISMA) statement. A total of 649 potentially relevant articles were initially selected. After reviewing at title or abstract level, 87 articles were read in full and 23 were included. These studies recruited 1000 patients, 220 submitted to IT with no emergency ICA stenting and 780 to IT and emergency ICA stenting. Successful revascularization (Thrombolysis in cerebral infarction scale - TICI≥2b) was achieved in 48.6-100%. Good outcome (modified Rankin scale - mRS≤2) ranged from 18.2-100%. Symptomatic intracranial haemorrhage (sICH) ranged from 0-45.7% (overall n=168; 17.2%). Mortality at 90 days ranged from 0-45.4% (overall n=114; 11.7%). Time to recanalization was significantly longer in the stenting group with an overall mean difference of 1.76 (95% Confidence Interval: 1.59-1.93). In this meta-analysis time to recanalization was significantly longer in the emergency ICA stenting group. There was no benefit from emergency stenting in parameters such as successful revascularization (TICI≥2b), clinical outcome (mRS≤2) or 90-day mortality. Data on sICH were scarce. Emergency ICA stenting appears to increase time to revascularization and increase the risk of complications with no demonstrated clinical benefit. Furthermore, no prospective, randomized controlled trials demonstrating relative efficacy and safety of concomitant ICA stenting have been published to date. Additional studies must be undertaken to define the role of angioplasty and stenting of the extracranial carotid arteries in the early management of acute stroke in tandem occlusions. Until then, we recommend that ICA stenting concommintant to thrombectomy in acute stroke patients should be avoided.

Contrast media as carriers for local drug delivery. Successful inhibition of neointimal proliferation in the porcine coronary stent model.

PubMed

Scheller, Bruno; Speck, Ulrich; Romeike, Bernd; Schmitt, Alexander; Sovak, Milos; Böhm, Michael; Stoll, Hans Peter

2003-08-01

Lipophilic taxanes can be dissolved in contrast media at significantly higher concentration than in saline. As contrast media have occasionally been observed to delineate the contour of coronary arteries for some seconds they may serve as a matrix for an antiproliferative drug aimed at preventing restenosis. The aim of this study was to test a novel taxane-contrast agent formulation for this new approach in the setting of coronary stenting. In cell culture experiments (bovine vascular smooth muscle cells), 60-min incubation with contrast agent-taxane formulations (iopromide-paclitaxel, iopromide-protaxel) induced a significant, concentration-dependent inhibition of vascular smooth muscle cell (VSMC) proliferation over 12 days. Shorter incubation times of 10 and 3 min showed the same efficacy. For in vivo investigation, 16 stents were implanted into the coronary arteries of eight pigs using a 1.3 to 1 overstretch ratio. A control group received iopromide 370 alone while the treatment group was injected with a iopromide-protaxel formulation at a dose of 74 micromol/l, which is far below protaxel levels inducing systemic toxicity. Quantitative angiography and histomorphometry of the stented arteries asserted statistic equality of the baseline parameters between the control and treatment groups. After 28 days, the treatment group showed a marked reduction of the parameters characterizing in-stent restenosis, especially a 34% reduction of the neointimal area. First evidence is provided that using a contrast agent as solvent for a taxane constitutes a new drug delivery mechanism able to inhibit in-stent restenosis in the porcine restenosis model.

Comparative Study of Esophageal Stent and Feeding Gastrostomy/Jejunostomy for Tracheoesophageal Fistula Caused by Esophageal Squamous Cell Carcinoma

PubMed Central

Chiu, Yi-Chun; Lu, Hung-I; Huang, Cheng-Hua; Rau, Kun-Ming; Liu, Chien-Ting

2012-01-01

Background A malignant tracheoesophageal/bronchoesophageal fistula (TEF) is a life-threatening complication of esophageal squamous cell carcinoma. A feeding gastrostomy/jejunostomy had been the most common treatment method for patients with TEF before the era of stenting. The aim of this retrospective study is to compare the prognosis of esophageal squamous cell carcinoma patients with TEF treated with an esophageal metallic stent to those treated with a feeding gastrostomy/jejunostomy. Methods We retrospectively reviewed a total of 1011 patients with esophageal squamous cell carcinoma between 1996 and 2011 at Kaohsiung Chang Gung Memorial Hospital, and 86 patients with TEF (8.5%) were identified. The overall survival and other clinical data were compared between 30 patients treated with an esophageal metallic stent and 35 patients treated with a feeding gastrostomy/jejunostomy. Results Among the 65 patients receiving either an esophageal metallic stent or a feeding gastrostomy/jejunostomy, univariate analysis showed that treatment modality with an esophageal metallic stent (P = 0.007) and radiotherapy treatment after fistula diagnosis (P = 0.04) were predictive of superior overall survival. In the multivariate comparison, treatment modality with an esophageal metallic stent (P = 0.026, odds ratio: 1.859) represented the independent predictive factor of superior overall survival. There were no significant differences between groups in mean decrease in serum albumin or mean body weight loss. Compared to the feeding gastrostomy/jejunostomy group, a significantly higher proportion of patients in the stenting group (53% versus 14%, P = 0.001) were able to receive chemotherapy within 30 days after fistula diagnosis, indicating better infection control in the stenting group. Conclusions Compared with a feeding gastrostomy/jejunostomy, an esophageal metallic stent significantly improves overall survival in patients with malignant TEF in our retrospective analysis. Esophageal metallic stent placement may be considered the first-line of treatment for patients with malignant TEF. PMID:22912737

Efficacy of Tamsulosin, Oxybutynin, and their combination in the control of double-j stent-related lower urinary tract symptoms.

PubMed

Maldonado-Avila, Miguel; Garduno-Arteaga, Leopoldo; Jungfermann-Guzman, Rene; Manzanilla-Garcia, Hugo A; Rosas-Nava, Emmanuel; Procuna-Hernandez, Nestor; Vela-Mollinedo, Alejandro; Almazan-Trevino, Luis; Guzman-Esquivel, Jose

2016-01-01

Indwelling double J ureteral stents are used routinely in the resolution of ureteral obstruction caused by different etiologies. Evaluation of urinary symptoms related to double-J stent, indicate that these affect 73-90% of patients. We conducted a prospective, randomized study, to evaluate the efficacy of tamsulosin, oxybutinin and combination therapy in improving the urinary symptoms. Patients who underwent ureteral stent placement after ureterolithotripsy (total 51), were randomized into three groups: Group I: Tamsulosin 0.4 mg. Once per day(17 patients), Group II: Oxybutinin 5 mg. once per day (17 patients), Group III: Tamsulosin+ oxybutynin once per day (17 patients). All the groups received the drugs for three weeks and completed a Spanish validated Ureteral Stent Symptom Questionnaire (USSQ) at day 7 and 21. Repeated measures ANOVA showed mean urinary symptom index score was 22.3 vs. 15.5 in group three (p<0.001) at day 7 and 21 respectively. The mean work performance index was 6.6 vs 8.1 (p=0.049) favoring tamsulosin group, the mean sexual score was 0.5 vs 1.5 (p=0.03). Among additional problems the mean was 7.2 vs 6.2 (p=0.03). No significant difference was noted among pain and general health index. No side effects were reported. Combination therapy with tamsulosin and oxybutynin improved irritative symptoms and work performance as well as sexual matters. Combination therapy should be considered for patients who complained of stent related symptoms.

Endoscopic ultrasound-guided placement of plastic vs. biflanged metal stents for therapy of walled-off necrosis: a retrospective single-center series.

PubMed

Mukai, Shuntaro; Itoi, Takao; Baron, Todd H; Sofuni, Atsushi; Itokawa, Fumihide; Kurihara, Toshio; Tsuchiya, Takayoshi; Ishii, Kentaro; Tsuji, Shujiro; Ikeuchi, Nobuhito; Tanaka, Reina; Umeda, Junko; Tonozuka, Ryosuke; Honjo, Mitsuyoshi; Gotoda, Takuji; Moriyasu, Fuminori; Yasuda, Ichiro

2015-01-01

Recently, a novel fully covered and biflanged metal stent (BFMS)dedicated to the drainage of walled-off necrosis(WON) was developed. The aim of this study was to retrospectively evaluate the safety, efficacy, and cost performance of drainage of WON using the novel BFMS compared with a traditional plastic stent. A total of 70 patients with symptomatic WON were treated under endoscopic ultrasound (EUS) guidance. Initial drainage was conducted using the single gateway technique with placement of one or more plastic stents or a single BFMS.If drainage was unsuccessful,direct endoscopic necrosectomy (DEN)was performed. There were no statistically significant differences in rates of technical success, clinical success,and adverse events between plastics stents and BFMS, despite the size of WON in the BFMS group being significantly larger than that in the plastic stent group (105.6 vs. 77.1 mm; P=0.003).The mean procedure times for the first EUS-guided drainage and for re-intervention were significantly shorter in the BFMS group than in the plastic stent group (28.8±7.1 vs. 42.6±14.2, respectively,for drainage, P<0.001; and 34.9±8.5 vs.41.8±7.6, respectively, for re-intervention, P<0.001). There was no statistically significant difference in the total cost between plastic stent and BFMS use in the treatment of WON ($5352vs. $6274; P=0.25). Plastic stents and BFMS were safe and effective for the treatment of WON. In particular,BFMS placement appeared to be preferable for initial EUS-guided drainage and additional reintervention(e.g. DEN) as it reduced the procedure time. Prospective randomized controlled trials are warranted.

Coagulation and complement activation.

PubMed

Christensen, K; Larsson, R; Emanuelsson, H; Elgue, G; Larsson, A

2001-02-01

The purpose of this investigation was to assess the effect of heparin coating of a new stent construction (Stent Graft, Jomed Implantate GmbH, Germany) on platelet and coagulation activity. Stent grafts with an ePTFE membrane interfoliated between two stents were deployed in tubings to form Chandler loops. Fresh human blood with a low concentration of heparin was rotated for 1 h, then collected and used for measurements of platelet number, thrombin-antithrombin complex (TAT), CD11b, C3a and C5b-9. There were five study groups: Group 1, conventional unmodified stents (n = 8); Group 2, untreated stent grafts (n = 8); Group 3, heparin-coated stents and untreated membrane (n = 7); Group 4, heparin-coated stents and membrane (n = 8); Group 5, heparin-coated PVC tubings with no stents (n = 8). There was a significant drop in platelet count, increase in TAT-values and CD11b expression in Groups 1-3 but not in Group 4 compared to Group 5. Examination by scanning electron microscopy revealed extensive activation on non-modified stents but almost no deposition of thrombotic material on heparin-modified stent grafts. With unmodified stents and membrane there were signs of significant activation of platelets and coagulation. In contrast, the heparin-coated stent graft induced much less alterations, indicating improved blood compatibility.

Endoscopic dacryocystorhinostomy without silicone stent.

PubMed

Yeon, Je Yeob; Shim, Woo Sub

2012-06-01

In nasolacrimal duct (NLD) obstruction patients that undergo endoscopic dacryocystorhinostomy (DCR), creation of a patent rhinostomy with adequate epithelialization can be accomplished without a stent. However, in common canalicular obstruction patients, a silicone stent seems to have a beneficial role and to bear more favorable results. The aim of this study was to evaluate the surgical outcome of endoscopic DCR without the use of a silicone stent. In all, 36 patients (41 eyes) who underwent endoscopic DCR were enrolled in this study. The patients were classified into a DCR with silicone stent group and a DCR without silicone stent group. Then each of the groups was subdivided into common canalicular obstruction group and NLD obstruction group. Surgical outcomes were evaluated by postoperative symptom improvement and patency of the rhinostomy under nasal endoscopic exam. The epiphora was improved in 84.2% of the silicone stent group and 81.8% of the non-silicone stent group. Categorized by the level of obstruction, in common canalicular obstruction, the success rate was 84.5% (11/13) in the silicone stent group and 57.1% (4/7) in the no stent group. In NLD obstruction, the success rate was 83.0% (5/6) in the silicone stent group and 93.3% (14/15) in the no stent group.

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

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

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

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.

Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up

PubMed Central

Fea, Antonio Maria; Consolandi, Giulia; Zola, Marta; Pignata, Giulia; Cannizzo, Paola; Lavia, Carlo; Rolle, Teresa; Grignolo, Federico Maria

2015-01-01

Purpose. To report the long-term follow-up results in patients with cataract and primary open-angle glaucoma (POAG) randomly assigned to cataract surgery combined with micro-bypass stent implantation or phacoemulsification alone. Methods. 36 subjects with cataract and POAG were randomized in a 1 : 2 ratio to either iStent implantation and cataract surgery (combined group) or cataract surgery alone (control group). 24 subjects agreed to be evaluated again 48 months after surgery. Patients returned one month later for unmedicated washout assessment. Results. At the long-term follow-up visit we reported a mean IOP of 15,9 ± 2,3 mmHg in the iStent group and 17 ± 2,5 mmHg in the control group (p = NS). After washout, a 14,2% between group difference in favour of the combined group was statistically significant (p = 0,02) for mean IOP reduction. A significant reduction in the mean number of medications was observed in both groups compared to baseline values (p = 0,005 in the combined group and p = 0,01 in the control group). Conclusion. Patients in the combined group maintained low IOP levels after long-term follow-up. Cataract surgery alone showed a loss of efficacy in controlling IOP over time. Both treatments reduced the number of ocular hypotensive medications prescribed. This trial is registered with: NCT00847158. PMID:26587282

Comparison of self-expandable and balloon-expanding stents for hybrid ductal stenting in hypoplastic left heart complex.

PubMed

Goreczny, Sebastian; Qureshi, Shakeel A; Rosenthal, Eric; Krasemann, Thomas; Nassar, Mohamed S; Anderson, David R; Morgan, Gareth J

2017-07-01

We aimed to compare the procedural and mid-term performance of a specifically designed self-expanding stent with balloon-expandable stents in patients undergoing hybrid palliation for hypoplastic left heart syndrome and its variants. The lack of specifically designed stents has led to off-label use of coronary, biliary, or peripheral stents in the neonatal ductus arteriosus. Recently, a self-expanding stent, specifically designed for use in hypoplastic left heart syndrome, has become available. We carried out a retrospective cohort comparison of 69 neonates who underwent hybrid ductal stenting with balloon-expandable and self-expanding stents from December, 2005 to July, 2014. In total, 43 balloon-expandable stents were implanted in 41 neonates and more recently 47 self-expanding stents in 28 neonates. In the balloon-expandable stents group, stent-related complications occurred in nine patients (22%), compared with one patient in the self-expanding stent group (4%). During follow-up, percutaneous re-intervention related to the ductal stent was performed in five patients (17%) in the balloon-expandable stent group and seven patients (28%) in self-expanding stents group. Hybrid ductal stenting with self-expanding stents produced favourable results when compared with the results obtained with balloon-expandable stents. Immediate additional interventions and follow-up re-interventions were similar in both groups with complications more common in those with balloon-expandable stents.

Initial study of sediment antagonism and characteristics of silver nanoparticle-coated biliary stents in an experimental animal model.

PubMed

Tian, Yigeng; Xia, Mingfeng; Zhang, Shuai; Fu, Zhen; Wen, Qingbin; Liu, Feng; Xu, Zongzhen; Li, Tao; Tian, Hu

2016-01-01

Plastic biliary stents used to relieve obstructive jaundice are frequently blocked by sediment, resulting in loss of drainage. We prepared stents coated with silver nanoparticles (AgNPs) and compared their ability to resist sedimentation with Teflon stents in a beagle model of obstructive jaundice. AgNP-coated Teflon biliary stents were prepared by chemical oxidation-reduction and evaluated in an obstructive jaundice model that was produced by ligation of common bile duct (CBD); animals were randomized to two equal groups for placement of AgNP-coated or Teflon control stents. Liver function and inflammatory index were found to be similar in the two groups, and the obstruction was relieved. Stents were removed 21 days after insertion and observed by scanning and transmission electron microscopy. The AgNP coating was analyzed by energy dispersive X-ray analysis (EDXA), and the composition of sediment was assayed by Fourier-transform infrared (FTIR) spectroscopy. Electron microscopy revealed a black, closely adherent AgNP stent coating, with thicknesses of 1.5-6 µm. Sediment thickness and density were greater on Teflon than on AgNP-coated stents. EDXA confirmed the stability and integrity of the AgNP coating before and after in vivo animal experimentation. FTIR spectroscopy identified stent sediment components including bilirubin, cholesterol, bile acid, protein, calcium, and other substances. AgNP-coated biliary stents resisted sediment accumulation in this canine model of obstructive jaundice caused by ligation of the CBD.

Initial study of sediment antagonism and characteristics of silver nanoparticle-coated biliary stents in an experimental animal model

PubMed Central

Tian, Yigeng; Xia, Mingfeng; Zhang, Shuai; Fu, Zhen; Wen, Qingbin; Liu, Feng; Xu, Zongzhen; Li, Tao; Tian, Hu

2016-01-01

Objective Plastic biliary stents used to relieve obstructive jaundice are frequently blocked by sediment, resulting in loss of drainage. We prepared stents coated with silver nanoparticles (AgNPs) and compared their ability to resist sedimentation with Teflon stents in a beagle model of obstructive jaundice. Methods AgNP-coated Teflon biliary stents were prepared by chemical oxidation–reduction and evaluated in an obstructive jaundice model that was produced by ligation of common bile duct (CBD); animals were randomized to two equal groups for placement of AgNP-coated or Teflon control stents. Liver function and inflammatory index were found to be similar in the two groups, and the obstruction was relieved. Stents were removed 21 days after insertion and observed by scanning and transmission electron microscopy. The AgNP coating was analyzed by energy dispersive X-ray analysis (EDXA), and the composition of sediment was assayed by Fourier-transform infrared (FTIR) spectroscopy. Results Electron microscopy revealed a black, closely adherent AgNP stent coating, with thicknesses of 1.5–6 µm. Sediment thickness and density were greater on Teflon than on AgNP-coated stents. EDXA confirmed the stability and integrity of the AgNP coating before and after in vivo animal experimentation. FTIR spectroscopy identified stent sediment components including bilirubin, cholesterol, bile acid, protein, calcium, and other substances. Conclusion AgNP-coated biliary stents resisted sediment accumulation in this canine model of obstructive jaundice caused by ligation of the CBD. PMID:27217749

HDR-192Ir intraluminal brachytherapy in treatment of malignant obstructive jaundice

PubMed Central

Chen, Yi; Wang, Xiao-Lin; Yan, Zhi-Ping; Cheng, Jie-Min; Wang, Jian-Hua; Gong, Gao-Quan; Qian, Sheng; Luo, Jian-Jun; Liu, Qing-Xin

2004-01-01

AIM: To determine the feasibility and safety of intraluminal brachytherapy in treatment of malignant obstructive jaundice (MOJ) and to evaluate the clinical effect of intraluminal brachytherapy on stent patency and patient survival. METHODS: Thirty-four patients with MOJ were included in this study. Having biliary stent placed, all patients were classified into intraluminal brachytherapy group (group A, n = 14) and control group (group B, n = 20) according to their own choice. Intraluminal brachytherapy regimen included: HDR-192Ir was used in the therapy, fractional doses of 4-7 Gy were given every 3-6 d for 3-4 times, and standard points were established at 0.5-1.0 cm. Some patients of both groups received transcatheter arterial chemoembolization (TACE) after stent placement. RESULTS: In group A, the success rate of intraluminal brachytherapy was 98.0%, RTOG grade 1 acute radiation morbidity occurred in 3 patients, RTOG/EORTC grade 1 late radiation morbidity occurred in 1 patient. Mean stent patency of group A (12.6 mo) was significantly longer than that of group B (8.3 mo) (P < 0.05). There was no significant difference in the mean survival (9.4 mo vs 6.0 mo) between the two groups. CONCLUSION: HDR-192Ir intraluminal brachytherapy is a safe palliative therapy in treating MOJ, and it may prolong stent patency and has the potentiality of extending survival of patients with MOJ. PMID:15526374

Silver-nanoparticle-coated biliary stent inhibits bacterial adhesion in bacterial cholangitis in swine.

PubMed

Wen, Wei; Ma, Li-Mei; He, Wei; Tang, Xiao-Wei; Zhang, Yin; Wang, Xiang; Liu, Li; Fan, Zhi-Ning

2016-02-01

One of the major limitations of biliary stents is the stent occlusion, which is closely related to the over-growth of bacteria. This study aimed to evaluate the feasibility of a novel silver-nanoparticle-coated polyurethane (Ag/PU) stent in bacterial cholangitis model in swine. Ag/PU was designed by coating silver nanoparticles on polyurethane (PU) stent. Twenty-four healthy pigs with bacterial cholangitis using Ag/PU and PU stents were randomly divided into an Ag/PU stent group (n=12) and a PU stent group (n=12), respectively. The stents were inserted by standard endoscopic retrograde cholangiopancreatography. Laboratory assay was performed for white blood cell (WBC) count, alanine aminotransferase (ALT), interleukin-1beta (IL-1beta), tumor necrosis factor-alpha (TNF-alpha) at baseline time, 8 hours, 1, 2, 3, and 7 days after stent placements. The segment of bile duct containing the stent was examined histologically ex vivo. Implanted biliary stents were examined by a scan electron microscope. The amount of silver release was also measured in vitro. The number of inflammatory cells and level of ALT, IL-1beta and TNF-alpha were significantly lower in the Ag/PU stent group than in the PU stent group. Hyperplasia of the mucosa was more severe in the PU stent group than in the Ag/PU stent group. In contrast to the biofilm of bacteria on the PU stent, fewer bacteria adhered to the Ag/PU stent. PU biliary stents modified with silver nanoparticles are able to alleviate the inflammation of pigs with bacterial cholangitis. Silver-nanoparticle-coated stents are resistant to bacterial adhesion.

Very late outcomes of drug-eluting stents coated with biodegradable polymers: insights from the 5-year follow-up of the randomized PAINT trial

PubMed Central

Marchini, Julio F.; Gomes, Wilton F.; Moulin, Bruno; Perin, Marco A.; Oliveira, Ludmilla A.R.R.; Arruda, J. Airton; Lima, Valter C.; Lima, Antonio A.G.; Caramori, Paulo R.A.; Medeiros, Cesar R.; Barbosa, Mauricio R.; Brito, Fabio S.; Ribeiro, Expedito E.

2014-01-01

Background Few studies have examined the very long-term outcomes after implantation of drug-eluting stents (DES) coated with biodegradable polymers (BP). This report presents the 5-year clinical follow-up of patients treated with BP-DES in the randomized PAINT trial. Methods The PAINT study is a prospective, multicenter randomized controlled trial that allocated 274 patients for treatment with two BP-DES formulations [paclitaxel-eluting stents (PES) or sirolimus-eluting stents (SES)] or bare metal stents (BMS) in a 1:2:2 ratio, respectively. The primary end-point of this sub-study was defined as the composite of the major cardiac adverse events (MACE) cardiac death, myocardial infarction (MI) or ischemia-driven target vessel revascularization (TVR) at 5 years. Results The 5-year MACE rates were different among the groups: 35.3%, 22.5% and 16.9% for BMS, PES and SES, respectively (P<0.05 for both DES vs. bare stent comparisons). The primary end-point was mainly driven by TVR: 31.8%, 14.1% and 12.2% for bare stents, PES and SES, respectively (P<0.05 for both DES vs. bare stent comparisons). The incidence of stent thrombosis (ST) was null for BMS during the entire follow-up. There was no definite or probable ST in the SES group after the second year, while one patient (1.0%) presented with a definite ST episode in the PES group between 4 and 5 years. Conclusions The tested biodegradable-polymer coated stents releasing either paclitaxel or sirolimus, compared with same bare metal platform, sustained their effectiveness in reducing combined major adverse cardiac events and re-intervention without an increase in ST during 5 years of follow-up. PMID:25610805

Efficacy of Endoscopic Over 3-branched Partial Stent-in-Stent Drainage Using Self-expandable Metallic Stents in Patients With Unresectable Hilar Biliary Carcinoma.

PubMed

Uchida, Daisuke; Kato, Hironari; Muro, Shinichiro; Noma, Yasuhiro; Yamamoto, Naoki; Horiguchi, Shigeru; Harada, Ryo; Tsutsumi, Koichiro; Kawamoto, Hirofumi; Okada, Hiroyuki; Yamamoto, Kazuhide

2015-07-01

The treatment of biliary stricture is crucially important for continuing stable chemotherapy for unresectable biliary carcinoma; however, there is no consensus regarding the use of hilar biliary drainage. In this study, we examined the efficacy of endoscopic over 3-branched biliary drainage using self-expandable metallic stents (SEMSs) in patients with unresectable malignant hilar biliary stricture (HBS). A total of 77 patients with unresectable HBS treated with a SEMS and chemotherapy were retrospectively reviewed. There were 59 patients with cholangiocarcinoma and 18 patients with gallbladder carcinoma. The patients were divided into 2 groups (4- or 3-branched group and 2- or 1-branched group) and compared with respect to the duration of stent patency and overall survival. A comparison of the patients' baseline characteristics showed no significant differences between the 4- or 3-branched group and the 2- or 1-branched group. Neither the duration of patency nor survival time exhibited significant differences between the 2 groups, although, among the patients achieving disease control , the duration of patency period and survival time of the 4- or 3-branched group were significantly higher than those observed in the 2- or 1-branched group (P=0.0231 and 0.0466). The use of endoscopic over 3-branched biliary drainage with a SEMS may improve the duration of patency in patients with HBS.

Comparison of intraluminal radiofrequency ablation and stents vs. stents alone in the management of malignant biliary obstruction.

PubMed

Cui, Wei; Wang, Yu; Fan, Wenzhe; Lu, Mingjian; Zhang, Yingqiang; Yao, Wang; Li, Jiaping

2017-11-01

To retrospectively evaluate the added benefit of adding intraluminal radiofrequency ablation (RFA) to biliary metal stent placement for patients with malignant biliary obstruction (MBO). From November 2013 to December 2015, 89 patients with MBO who had undergone percutaneous intraluminal RFA and stent placement (RFA-stent group, n = 50) or stent placement only (stent group, n = 39) were included. Outcomes were compared according to the type of tumour: cholangiocarcinoma or non-cholangiocarcinoma. Primary and secondary stent patency (PSP, SSP) were significantly higher for the RFA-stent group than the stent group (PSP: 7.0 months vs. 5.0 months, p = 0.006; SSP: 10.0 months vs. 5.6 months, p < 0.001), with overall survival being comparable (5.0 months vs. 4.7 months, p = 0.068). In subgroup analysis, RFA-stent showed significant PSP benefits compared to stent alone in patients with cholangiocarcinoma (7.4 months vs. 4.3 months; p = 0.009), but with comparable outcomes in patients with non-cholangiocarcinoma (6.3 months vs. 5.2 months; p = 0.266). The SSP was improved in both subgroups (cholangiocarcinoma, 12.6 months vs. 5.0 months, p < 0.001; non-cholangiocarcinoma, 10.3 months vs. 5.5 months, p = 0.013). Technical success and clinical success were not significantly different between the two groups. The rate of complication was higher for the RFA-stent group, but tolerable when compared to the stent group. Although survival was comparable between the groups, RFA-stent confers therapeutic benefits to patients with MBO in terms of stent patency compared to stent placement alone, especially in those with cholangiocarcinoma.

Pressure Bearing Device Affects Extraction Socket Remodeling of Maxillary Anterior Tooth. A Prospective Clinical Trial.

PubMed

Jiang, Xi; Zhang, Yu; Chen, Bo; Lin, Ye

2017-04-01

Extraction socket remodeling and ridge preservation strategies have been extensively explored. To evaluate the efficacy of applying a micro-titanium stent as a pressure bearing device on extraction socket remodeling of maxillary anterior tooth. Twenty-four patients with a extraction socket of maxillary incisor were treated with spontaneous healing (control group) or by applying a micro-titanium stent as a facial pressure bearing device over the facial bone wall (test group). Two virtual models obtained from cone beam computed tomography data before extraction and 4 months after healing were 3-dimenionally superimposed. Facial bone wall resorption, extraction socket remodeling features and ridge width preservation rate were determined and compared between the groups. Thin facial bone wall resulted in marked resorption in both groups. The greatest palatal shifting distance of facial bone located at the coronal level in the control group, but middle level in the test group. Compared with the original extraction socket, 87.61 ± 5.88% ridge width was preserved in the test group and 55.09 ± 14.46% in the control group. Due to the facial pressure bearing property, the rigid micro-titanium stent might preserve the ridge width and alter the resorption features of extraction socket. © 2016 Wiley Periodicals, Inc.

Efficacy of Tamsulosin, Oxybutynin, and their combination in the control of double-j stent-related lower urinary tract symptoms

PubMed Central

Maldonado-Avila, Miguel; Garduño-Arteaga, Leopoldo; Jungfermann-Guzman, Rene; Manzanilla-Garcia, Hugo A.; Rosas-Nava, Emmanuel; Procuna-Hernandez, Nestor; Vela-Mollinedo, Alejandro; Almazan-Treviño, Luis; Guzman-Esquivel, Jose

2016-01-01

ABSTRACT Introduction and objective Indwelling double J ureteral stents are used routinely in the resolution of ureteral obstruction caused by different etiologies. Evaluation of urinary symptoms related to double-J stent, indicate that these affect 73-90% of patients. We conducted a prospective, randomized study, to evaluate the efficacy of tamsulosin, oxybutinin and combination therapy in improving the urinary symptoms. Methods Patients who underwent ureteral stent placement after ureterolithotripsy (total 51), were randomized into three groups: Group I: Tamsulosin 0.4 mg. once per day(17 patients), Group II: Oxybutinin 5 mg. once per day (17 patients), Group III: Tamsulosin+ oxybutynin once per day (17 patients). All the groups received the drugs for three weeks and completed a Spanish validated Ureteral Stent Symptom Questionnaire (USSQ) at day 7 and 21. Results Repeated measures ANOVA showed mean urinary symptom index score was 22.3 vs. 15.5 in group three (p<0.001) at day 7 and 21 respectively. The mean work performance index was 6.6 vs 8.1 (p=0.049) favoring tamsulosin group, the mean sexual score was 0.5 vs 1.5 (p=0.03). Among additional problems the mean was 7.2 vs 6.2 (p=0.03). No significant difference was noted among pain and general health index. No side effects were reported. Conclusions Combination therapy with tamsulosin and oxybutynin improved irritative symptoms and work performance as well as sexual matters. Combination therapy should be considered for patients who complained of stent related symptoms. PMID:27286111

A Nanostructured Degradable Ureteral Stent Fabricated by Electrospinning for Upper Urinary Tract Reconstruction.

PubMed

Wang, Xiaoqing; Zhang, Long; Chen, Qihui; Hou, Yuchuan; Hao, Yuanyuan; Wang, Chunxi; Shan, Hongli

2015-12-01

A degradable polycaprolactone(PCL)/poly(lactic-co-glycolic acid, LA:GA = 80:20) (PLGA) ureter tubular stent was fabricated by electrospinning. The structure and properties of the stents were investigated by the mechanical property testing, scanning electron microscopy (SEM), degradability test in vitro and MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay. The stent was transplanted to the dorsal muscle of rabbit to evaluate its tissue compatibility. It was shown that the stent has the nano-structure. The mechanical test showed that with the increase in PCL concentration, the mechanical properties of the stent gradually increased, and it could meet the demands of a urethral stent. The collapse time of different concentration of PCL/PLGA (5%, 15%, and 25%) was 28, 42, and 56 days, respectively. These results provide strong evidence that the degradation time can be increased with the increase in PCL concentration. The results of the MTT assay show that the PCL/PLGA stent had no cytotoxicity. In muscle implantation tests, acute tissue reactions due to operation trauma were seen in all specimens at 1 week. After four weeks, the number of inflammatory cells had decreased significantly. Only a few inflammatory cells were seen in the PCL/PLGA stent group after 12 weeks, and the foreign body reaction was more severe in the control group. Animal orthotopic transplantation experiments of these ureteral stents will be done to evaluate its degradable model and tissue compatibility.

Endoscopic dacryocystorhinostomy with silicone, polypropylene, and T-tube stents; randomized controlled trial of efficacy and safety.

PubMed

Okuyucu, Semsettin; Gorur, Hatice; Oksuz, Huseyin; Akoglu, Ertap

2015-01-01

To compare the efficacy and safety of endoscopic dacryocystorhinostomy (En-DCR) with different stent materials for lacrimal sac intubation in primary nasolacrimal ductal obstructions. Randomized controlled study with three parallel groups. Level of evidence is 1b. A total of 91 patients (five bilateral) with primary nasolacrimal duct obstruction (NLDO) at a tertiary referral center scheduled for En-DCR were to allocated into three stent groups with a sealed envelope and were randomized into three treatments: silicone, Prolene (polypropylene), and otologic T-tube. Ophthalmology and otolaryngology clinics evaluated the patients preoperatively and postoperatively with endoscopes, lacrimal system syringing, and dacryocystography. The success of the stents was evaluated 12 months after surgery with symptom relief and ostial patency. Complications were also noted. The overall success rate of the En-DCR in the stent groups was 78.1% (75/96); specifically, 87.5% (28/32) with silicone, 84.4% (27/32) with Prolene, and 62.5% (20/32) with T-tube. The efficacy of the procedures with the T-tube was significantly lower than that of the Prolene and silicone (p = .031, χ(2) test). There were no significant differences between the silicone and Prolene (p = .718, χ(2) test). Prolene was found to be related with orbital complications. Spontaneous loss is a particular complication of otologic T-tube and highly portends to failure. The results of our study suggest that efficacy, defined as anatomic and functional success, is equally high for silicone and Prolene stents and lower for otologic T-tube in En-DCR.

Low symptomatic premature stent occlusion of multiple plastic stents for benign biliary strictures: comparing standard and prolonged stent change intervals.

PubMed

Lawrence, Christopher; Romagnuolo, Joseph; Payne, K Mark; Hawes, Robert H; Cotton, Peter B

2010-09-01

Benign biliary strictures are typically managed endoscopically whereby an increasing size or number of plastic stents is placed at ERCP. Stents are often changed every 3 to 4 months based on the known median patency of a single biliary stent, but patency data for multiple biliary stents are lacking. To assess the incidence of occlusion-free survival of multiple plastic biliary stents and the rate of premature occlusion if left in longer than 6 months. Retrospective. Tertiary-care medical center (Charleston, SC). Consecutive patients who received multiple plastic stents for benign nonhilar biliary strictures from 1994 to 2008 were identified. Exchange of multiple plastic biliary stents within 6 months (group 1) or 6 months or longer (group 2) after placement. Symptomatic stent occlusion. Seventy-nine patients with nonhilar extrahepatic benign biliary stricture underwent 125 ERCPs with multiple plastic biliary stents. Stents were scheduled for removal/exchange within 6 months in 52 patients (86 ERCPs) compared with after 6 months in 22 patients (26 ERCPs). The median interval between multiple stent placement and removal/exchange was 90 days for group 1 and 242 days for group 2. Premature stent occlusion occurred in 4 of 52 (7.7%) patients in group 1 versus 1 of 22 (4.5%) in group 2, with significantly longer occlusion-free survival in group 2 (log-rank P < .0001). Retrospective study at a single tertiary referral center. Multiple plastic biliary stents for benign nonhilar strictures were associated with a low rate of premature symptomatic stent occlusion at more than 6 months and a longer occlusion-free survival. Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Management of endoscopic biliary stenting for choledocholithiasis: Evaluation of stent-exchange intervals.

PubMed

Tohda, Gen; Dochin, Masaki

2018-01-16

To evaluate the best management of plastic stents in patients with choledocholithiasis who were unfit for endoscopic stone removal or surgery. Between April 2007 and September 2017, 87 patients (median age 83.7 years) with symptomatic choledocholithiasis were treated with insertion of 7-Fr plastic stents because complete endoscopic stone retrieval was difficult, and their general condition was not suitable for surgery. Seventy of these patients agreed to regular stent management and stent exchange was carried out at every 6 mo (Group A, n = 35) or every 12 mo (Group B, n = 35). The remaining 17 patients did not accept regular stent exchange, and stents were replaced when clinical symptoms appeared (Group C). We evaluated the frequency of biliary complication and stent patency rate during follow-up periods. The patency rate of biliary plastic stents was 91.4% at 6 mo (Group A) and 88.6% at 12 mo (Group B), respectively. Acute cholangitis occurred in 2.9% of Group A patients and in 8.6% of Group B patients. In Group C, median stent patency was 16.3 mo, and stent exchange was carried out in 70.6% of cases because of acute cholangitis or obstructive jaundice. Although a high incidence of acute cholangitis occurred, there was no biliary-related mortality. Plastic stent exchange at 12-mo intervals is considered a safe procedure for patients with choledocholithiasis. Long-term biliary stenting increases biliary complications, but it can be an acceptable option for select patients who are medically unfit for further invasive procedures.

Self-expandable metallic stents vs. plastic stents for endoscopic biliary drainage in hepatocellular carcinoma.

PubMed

Chung, Kwang Hyun; Lee, Sang Hyub; Park, Jin Myung; Lee, Jae Min; Ahn, Dong-Won; Ryu, Ji Kon; Kim, Yong-Tae

2015-06-01

The patency of self-expandable metallic stents (SEMS) is known to be better than plastic stents in the palliation of malignant biliary obstruction. However, data are scarce for obstructive jaundice caused by hepatocellular carcinoma (HCC). This study aimed to compare SEMSs and plastic stents for the palliation of obstructive jaundice in unresectable HCC. A total of 96 patients who underwent endoscopic retrograde biliary drainage with SEMSs or plastic stents were included in this retrospective analysis. The rate of successful biliary drainage, adverse events, stent patency duration, and patient survival were compared between the SEMS (n = 36) and plastic stent (n = 60) groups. The rate of successful biliary drainage was similar between the SEMS and plastic stent groups (25/36 [69.4 %] vs. 39/60 [65.0 %]; P = 0.655). Adverse events occurred in 6 patients (16.7 %) in the SEMS group and 13 patients (21.7 %) in the plastic stent group (P = 0.552). The median patency duration was also similar between the two groups (60 vs. 68 days; P = 0.396). The median patient survival was longer in the plastic stent group than in the SEMS group (123 vs. 48 days; P = 0.005). SEMSs were not superior to plastic stents for the palliation of malignant biliary obstruction in HCC with regard to successful drainage, stent patency, and adverse events. Patient survival was better in the plastic stent group. Given the lower cost, plastic stents could be a favorable option for malignant biliary obstruction caused by HCC. © Georg Thieme Verlag KG Stuttgart · New York.

Comparison of closed-cell and hybrid-cell stent designs in carotid artery stenting: clinical and procedural outcomes

PubMed Central

Tatli, Ersan; Vatan, Mehmet Bulent; Agac, Mustafa Tarik; Gunduz, Huseyin; Akdemir, Ramazan; Kilic, Harun

2017-01-01

Introduction Carotid artery stenting (CAS) is a promising alternative to surgery in high-risk patients. However, the impact of stent cell design on outcomes in CAS is a matter of continued debate. Aim To compare the periprocedural and clinical outcomes of different stent designs for CAS with distal protection devices. Material and methods All CAS procedures with both closed- and hybrid-cell stents performed at our institution between February 2010 and December 2015 were analyzed retrospectively. Adverse events were defined as death, major stroke, minor stroke, transient ischemic attack and myocardial infarction. Periprocedural and 30-day adverse events and internal carotid artery (ICA) vasospasm rates were compared between the closed-cell and hybrid-cell stent groups. Results The study included 234 patients comprising 146 patients with a closed-cell stent (Xact stent, Abbott Vascular) (mean age: 68.5 ±8.6; 67.1% male) and 88 patients with a hybrid-cell stent (Cristallo Ideale, Medtronic) (mean age: 67.2 ±12.8; 68.2% male). There was no significant difference between the groups with respect to periprocedural or 30-day adverse event rates. While there was no difference in terms of tortuosity index between the groups, there was a higher procedural ICA vasospasm rate in the closed-cell stent group (35 patients, 23%) compared with the hybrid-cell stent group (10 patients, 11%) (p = 0.017). Conclusions The results of this study showed no significant difference in the clinical adverse event rates after CAS between the closed-cell stent group and the hybrid-cell stent group. However, procedural ICA vasospasm was more common in the closed-cell stent group. PMID:28798784

Inhibition of plaque neovascularization and intimal hyperplasia by specific targeting vascular endothelial growth factor with bevacizumab-eluting stent: an experimental study.

PubMed

Stefanadis, Christodoulos; Toutouzas, Konstantinos; Stefanadi, Elli; Lazaris, Andreas; Patsouris, Efstratios; Kipshidze, Nicholas

2007-12-01

Neovascularization is associated with destabilization of atheromatic plaques. Increased expression of vascular endothelial growth factor (VEGF) is important in the process of neovascularization. We assessed the effect of bevacizumab, a monoclonal antibody specific for VEGF, on neovascularization. We used 12 New Zealand rabbits under atherogenic diet for 3 weeks. We immersed a phosphorycholine coated stent into a solution of 4 ml bevacizumab according to previous studies. Twelve eluting stents and 12 non-eluting stents were implanted in the middle segment of the rabbit's iliac arteries. Follow-up angiography was performed at 4 weeks and tissues were obtained for histological analysis. The procedure of stent loading with bevacizumab and stent implantation was successful. There was no difference in angiographic measurements before, after implantation and at follow-up between the two groups. mean neointimal thickness (0.09+/-0.02 versus 0.12+/-0.02 mm, p<0.01), and mean neointimal area (1.08+/-0.09 versus 1.20+/-0.12 mm(2), p<0.01) were less in the bevacizumab treated segments. bevacizumab-treated arterial segments demonstrated significantly decreased microvessel density compared with the control group (1.69+/-0.06 CI: 1.65-1.73 versus 15.68+/-0.56 CI: 15.32-16.04 vessels per mm(2), p<0.001) and vegf expression was decreased in the media and adventitia of bevacizumab group. Endothelialization, inflammation and injury scores were similar between the two groups. These results suggest that bevacizumab-eluting stent implantation in rabbit iliac arteries is safe, and inhibits neovascularization without affecting the endothelialization.

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

PubMed Central

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

2015-01-01

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

[Internal drainage in cancer patients: optimizing treatment of stent-related symptoms].

PubMed

Martov, A G; Ergakov, D V; Novikov, A B; Muzhetskaya, N G; Esen'yan, G L

2016-04-01

The so-called stent-related symptoms caused mainly by detrusor overactivity due to distal ("cystic") curl of the internal stent are common among patients with this type of drainage. The need for long-term stenting makes the quality of life of cancer patients one of the challenging problems of modern urology. The aim of this study was to optimize treatment of stent-related symptoms in cancer patients with internal long-term stents by complementing the treatment regimen with m-anticholinergic solifenacin. From November 2013 to November 2015 68 cancer patients (26 males, 42 females, age 36-79 years) underwent elective internal ureteral stenting for drainage of the upper urinary tract (UUT) with special long-term stents coated with the hydrogel. The urinary tract obstruction was caused by urological (24), gynecological (26) and colorectal (18) cancers. Before deciding on urinary tract drainage, all patients were treated with radiation or chemotherapy, 28 (41.2%) patients underwent surgery, but on admission all of them had contraindications to radical surgery for different reasons. In 52 (76.5%) patients UUT stenting was performed using transurethral access, in 12 (17.6%) by percutaneous access and in another 4 (5.9%) by the combined access with patients in the supine position. Percutaneous and combined access was used in cases of impracticability (failure) of transurethral stenting. Patients in group 1 (n=32) after stent placement received standard therapy co-administered with solifenacin 5 mg daily, group 2 (n=36) - only standard therapy. The data analyzed were the technical features of the internal drainage, optimal access and registered solifenacin-related adverse events. Control examinations were scheduled once in 3 months after stent placement according to the following algorithm: ultrasound scanning, laboratory test monitoring and, if indicated, plain urography. To objectify the severity of stent-related symptoms, a survey of patients using a special questionnaire was conducted. Visual analog scale was used to measure subjectively the patients condition. After 12 months only 48 patients (26 from group 1 and 22 from group 2) completed the study. Follow-up examinations revealed that the patients in group 1 had significantly lower score of stent-related symptom severity and better ratings in visual analog scale. The greatest difference (1-2 points) was found in urgency and urinary frequency scores. The safety profile of solifenacin 5 mg corresponded to the findings of previous studies, there was no serious adverse events requiring discontinuation of the drug. Installing internal stents in UUT in cancer patients requires relevant experience in Roentgen-endoscopic operations using transurethral and percutaneous approaches and special equipment. In most cases, for preventing and eliminating supravesical obstruction in cancer patients, special internal stents for the long term placement are required. The add-on solifenacin therapy 5 mg/day resulted in almost 20% reduction in the severity of stent-related irritative symptoms and improved the quality of life in this extremely challenging category of patients.

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

PubMed

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

2015-07-01

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

Comparison of retrievable stents and permanent stents for Budd-Chiari syndrome due to obstructive inferior vena cava.

PubMed

Bi, Yonghua; Chen, Hongmei; Ding, Penxu; Ren, Jianzhuang; Han, Xinwei

2018-05-30

To compare long-term outcomes of retrievable stents and permanent stents for BCS due to long-segment obstructive IVC. Between July 2000 and August 2016, 42 patients with BCS due to long-segment obstructive IVC were treated with retrievable stents (RS) and 41 patients were treated with permanent stents (PS). The retrievable stents was removed eventually after thrombus disappeared. Patients were subsequently followed-up by color Doppler sonography or CT scanning. All retrievable stent placements were successfully, and 37 retrievable stents were retrieved 8 to 29 days later. Forty-two stents were implanted in PS Group. One failure retrieval of retrievable stents occurred, and two failures of cannulations were found in PS Group. Two deaths may procedure-related and died from acute pulmonary thromboembolism perioperatively. One patient developed acute cerebral infarction and recovered after treatment. In PS Group, minor complications were found in 3 patients. The length of IVC lesion segment, length and thickness of IVC thrombus decreased significantly, and diameter of retrocaval IVC and diaphragm IVC increased significantly in both groups. During follow up, 3 patients died from liver failure in RS Group and 2 patients died in PS Group. RS Group showed a significantly higher primary patency rate than PS Group. Cumulative 1-, 3-, and 5-year secondary patency rates were 95.2%, 89.6%, 89.6% in RS Group, and 100%, 96.6%, 96.6% in PS Group (p= 0.7109). Retrievable stents is effective for BCS due to long-segment obstructive IVC, with a higher primary patency rate. This article is protected by copyright. All rights reserved.

Unilateral versus bilateral stent insertion for malignant hilar biliary obstruction.

PubMed

Chang, Gang; Xia, Feng-Fei; Li, Hong-Fu; Niu, Su; Xu, Yuan-Shun

2017-11-01

To determine the clinical efficiency and long-term outcomes between unilateral and bilateral stent insertion in patients with malignant hilar biliary obstruction. From August 2012 to February 2016, 63 consecutive patients with malignant hilar biliary obstruction were treated with unilateral or bilateral stent insertion at our center. The bilateral stents were inserted using the side-by-side technique. The clinical efficiency and long-term outcomes were compared between the two groups. Unilateral and bilateral stent insertions were successfully performed in 31 of 33 and 27 of 30 patients, respectively (P = 0.912). No procedure-related complication occurred. Clinical success was achieved in 29 of 31 patients in the unilateral stent group and in 26 of 27 patients in the bilateral stent group (P = 0.637). During the follow-up, re-obstruction of stent occurred in five patients in the unilateral stent group and in three patients in the bilateral stent group (P = 0.58). The significant differences were not observed in the stent patency time (368 vs. 387 days, P = 0.685) and survival (200 vs. 198 days, P = 0.751) between two groups. Based on the univariate and multivariate analyses, the independent risk factors for decreasing the survival time included higher Eastern Cooperative Oncology Group performance status (P = 0.018), higher alanine aminotransferase level (P = 0.009), and absence of anticancer treatment after stent insertion (P = 0.002). Compared to bilateral stent insertion for malignant hilar biliary obstruction, unilateral stent insertion can provide comparable clinical efficiency and long-term outcomes.

Intraductal Transanastomotic Stenting in Duct-to-Duct Biliary Reconstruction after Living-Donor Liver Transplantation: A Randomized Trial.

PubMed

Santosh Kumar, K Y; Mathew, Johns Shaji; Balakrishnan, Dinesh; Bharathan, Viju Kumar; Thankamony Amma, Binoj Sivasankara Pillai; Gopalakrishnan, Unnikrishnan; Narayana Menon, Ramachandran; Dhar, Puneet; Vayoth, Sudheer Othiyil; Sudhindran, Surendran

2017-12-01

Biliary complications continue to be the "Achilles heel" of living-donor liver transplantation (LDLT). The use of biliary stents in LDLT to reduce biliary complications is a controversial issue. We performed a randomized trial to study the impact of intraductal biliary stents on postoperative biliary complications after LDLT. Of the 94 LDLTs that were performed during a period of 16 months, ABO-incompatible transplants, left lobe grafts, 3 or more bile ducts on the graft, and those requiring bilioenteric drainage were excluded. Eligible patients were randomized to either a study arm (intraductal stent, n = 31) or a control arm (no stent, n = 33) by block randomization. Stratification was done, based on the number of ducts on the graft requiring anastomosis, into single (n = 20) or 2 ducts (n = 44). Ureteric stents of 3F to 5F placed across the biliary anastomosis and exiting into the duodenum for later endoscopic removal at 3 months were used. The primary end point was postoperative bile leak. Bile leak occurred in 15 of 64 (23.4%), the incidence was higher in the stented group compared with the control group (35.5% vs 12.1%; p = 0.03). Multiplicity of bile ducts and stenting were identified as risk factors for bile leak on multivariate analysis (p = 0.031 and p = 0.032). During a median follow-up of 2 years, biliary stricture developed in 9 patients (14.1%). Postoperative bile leak is a significant risk factor for the development of biliary stricture (p = 0.003). Intraductal transanastomotic biliary stenting and multiplicity of graft ducts were identified as independent risk factors for the development of postoperative biliary complications. Copyright © 2017 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

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

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

To compare clinical effectiveness of Viabil-covered stents versus uncovered metallic Wallstents, for palliation of malignant jaundice due to extrahepatic cholangiocarcinoma, 60 patients were enrolled in a prospective and randomized study. In half of the patients a bare Wallstent was used, and in the other half a Viabil biliary stent. Patients were followed up until death. Primary patency, survival, complication rates, and mean cost were calculated in both groups. Stent dysfunction occurred in 9 (30%) patients in the bare stent group after a mean period of 133.1 days and in 4 (13.3%) patients in the covered stent group after a meanmore » of 179.5 days. The incidence of stent dysfunction was significantly lower in the covered stent group (P = 0.046). Tumor ingrowth occurred exclusively in the bare stent group (P = 0.007). Median survival was 180.5 days for the Wallstent and 243.5 days for the Viabil group (P = 0.039). Complications and mean cost were similar in the two groups. Viabil stent-grafts proved to be significantly superior to Wallstents for the palliation of malignant jaundice due to extrahepatic cholangiocarcinoma, with comparable cost and complication rates. Appropriate patient selection should be performed prior to stent placement.« less

Internal versus external ureteric stents for uretero-ileal anastomosis after laparoscopic radical cystectomy with orthotopic neobladder: A prospective comparative study.

PubMed

Abdel Hakim, Mahmoud A; Abdalla, Ahmed A; Saad, Ismail R; ElSheemy, Mohammed S; El Feel, Ahmed S; Salem, Hosni K; Abdel Hakim, Amr M

2016-06-01

To prospectively compare the use of external ureteric stents with internal JJ stenting of the uretero-ileal anastomosis in patients undergoing laparoscopic radical cystectomy (LRC) with a Y-shaped ileal orthotopic neobladder (ON). The study included 69 patients undergoing LRC with ON. Patients were grouped according to the type of uretero-ileal stents used. An external ureteric stent was used in Group A (33 patients) and a JJ stent was used in Group B (36). We prospectively compared the duration of hospital stay, the incidence of short- and intermediate-term complications in the two study groups. The mean (SD) follow-up periods were 29.18 (3.94) and 28.19 (3.37) months for patients in Groups A and B, respectively. Perioperative patient characteristics were comparable in the two study groups. The use of JJ stenting was associated with a shorter hospital stay compared with external stenting, at a mean (SD) of 14.63 (3.74) and 6.8 (3.03) days in Groups A and B, respectively (P < 0.001). The incidence of urinary leakage was comparable in the two study groups, at 6.1% in Group A vs 8.3% in Group B (P = 1.0). Strictures of the uretero-ileal anastomosis occurred in two patients (6%) in Group A and confirmed by intravenous urography. All strictures were treated with antegrade JJ fixation. JJ stents could be used as an effective alternative to external ureteric stents to support the uretero-ileal anastomosis. JJ stenting is associated with a shorter hospital stay and similar complication rates compared with external stenting in patients undergoing LRC with ON.

In vitro biocompatibility of plasma-aided surface-modified 316L stainless steel for intracoronary stents.

PubMed

Bayram, Cem; Mizrak, Alpay Koray; Aktürk, Selçuk; Kurşaklioğlu, Hurkan; Iyisoy, Atila; Ifran, Ahmet; Denkbaş, Emir Baki

2010-10-01

316L-type stainless steel is a raw material mostly used for manufacturing metallic coronary stents. The purpose of this study was to examine the chemical, wettability, cytotoxic and haemocompatibility properties of 316L stainless steel stents which were modified by plasma polymerization. Six different polymeric compounds, polyethylene glycol, 2-hydroxyethyl methacrylate, ethylenediamine, acrylic acid, hexamethyldisilane and hexamethyldisiloxane, were used in a radio frequency glow discharge plasma polymerization system. As a model antiproliferative drug, mitomycin-C was chosen for covalent coupling onto the stent surface. Modified SS 316L stents were characterized by water contact angle measurements (goniometer) and x-ray photoelectron spectroscopy. C1s binding energies showed a good correlation with the literature. Haemocompatibility tests of coated SS 316L stents showed significant latency (t-test, p < 0.05) with respect to SS 316L and control groups in each test.

Biodegradable, elastomeric coatings with controlled anti-proliferative agent release for magnesium-based cardiovascular stents.

PubMed

Gu, Xinzhu; Mao, Zhongwei; Ye, Sang-Ho; Koo, Youngmi; Yun, Yeoheung; Tiasha, Tarannum R; Shanov, Vesselin; Wagner, William R

2016-08-01

Vascular stent design continues to evolve to further improve the efficacy and minimize the risks associated with these devices. Drug-eluting coatings have been widely adopted and, more recently, biodegradable stents have been the focus of extensive evaluation. In this report, biodegradable elastomeric polyurethanes were synthesized and applied as drug-eluting coatings for a relatively new class of degradable vascular stents based on Mg. The dynamic degradation behavior, hemocompatibility and drug release were investigated for poly(carbonate urethane) urea (PCUU) and poly(ester urethane) urea (PEUU) coated magnesium alloy (AZ31) stents. Poly(lactic-co-glycolic acid) (PLGA) coated and bare stents were employed as control groups. The PCUU coating effectively slowed the Mg alloy corrosion in dynamic degradation testing compared to PEUU-coated, PLGA-coated and bare Mg alloy stents. This was confirmed by electron microscopy, energy-dispersive x-ray spectroscopy and magnesium ion release experiments. PCUU-coating of AZ31 was also associated with significantly reduced platelet adhesion in acute blood contact testing. Rat vascular smooth muscle cell (rSMC) proliferation was successfully inhibited when paclitaxel was released from pre-loaded PCUU coatings. The corrosion retardation, low thrombogenicity, drug loading capacity, and high elasticity make PCUU an attractive option for drug eluting coating on biodegradable metallic cardiovascular stents. Copyright © 2016 Elsevier B.V. All rights reserved.

Genous™ endothelial progenitor cell capturing stent vs. the Taxus Liberté stent in patients with de novo coronary lesions with a high-risk of coronary restenosis: a randomized, single-centre, pilot study

PubMed Central

Beijk, Marcel A.M.; Klomp, Margo; Verouden, Niels J.W.; van Geloven, Nan; Koch, Karel T.; Henriques, José P.S.; Baan, Jan; Vis, Marije M.; Scheunhage, Esther; Piek, Jan J.; Tijssen, Jan G.P.; de Winter, Robbert J.

2010-01-01

Aims The purpose of this study was to evaluate the GenousTM endothelial progenitor cell capturing stent vs. the Taxus Liberté paclitaxel-eluting stent in patients with de novo coronary lesions with a high-risk of coronary restenosis. Methods and results We randomly assigned 193 patients with lesions carrying a high risk of restenosis to have the Genous stent or the Taxus stent implanted. Lesions were considered high risk of restenosis if one of the following applied: chronic total occlusion, lesion length >23 mm, vessel diameter <2.8 mm, or any lesion in a diabetic patient. At 1-year, the rate of the primary end point, target vessel failure (TVF), was 17.3% in the Genous stent group when compared with 10.5% in the Taxus stent group [risk difference (RD) 6.8%, 95% CI −3.1 to 16.7%], a difference predominantly due to a higher incidence of repeat revascularization in patients treated with the Genous stent. In contrast, no stent thrombosis was observed in the Genous stent group compared to 4 stent thromboses in the Taxus stent group (RD −4.2%; 95% CI −10.3 to 0.3%). Repeat angiography between 6 and 12 months in a subgroup of patients showed a significantly higher late loss in the Genous stent compared with the Taxus stent (1.14 ± 0.64 and 0.55 ± 0.61 mm). Conclusion In patients with lesions carrying a high risk of restenosis, the Genous stent resulted in a non-significant higher rate of TVF compared with the Taxus stent mainly due to more repeat revascularizations in the Genous stent group. There were four stent thromboses with Taxus stent, none with the Genous stent. PMID:19933225

Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial.

PubMed

Camenzind, Edoardo; Wijns, William; Mauri, Laura; Kurowski, Volkhard; Parikh, Keyur; Gao, Runlin; Bode, Christoph; Greenwood, John P; Boersma, Eric; Vranckx, Pascal; McFadden, Eugene; Serruys, Patrick W; O'Neil, William W; Jorissen, Brenda; Van Leeuwen, Frank; Steg, Ph Gabriel

2012-10-20

We sought to compare the long-term safety of two devices with different antiproliferative properties: the Endeavor zotarolimus-eluting stent (E-ZES; Medtronic, Inc) and the Cypher sirolimus-eluting stent (C-SES; Cordis, Johnson & Johnson) in a broad group of patients and lesions. Between May 21, 2007 and Dec 22, 2008, we recruited 8791 patients from 36 recruiting countries to participate in this open-label, multicentre, randomised, superiority trial. Eligible patients were those aged 18 years or older undergoing elective, unplanned, or emergency procedures in native coronary arteries. Patients were randomly assigned to either receive E-ZES and C-SES (ratio 1:1). Randomisation was stratified per centre with varying block sizes of four, six, or eight patients, and concealed with a central telephone-based or web-based allocation service. The primary outcome was definite or probable stent thrombosis at 3 years and was analysed by intention to treat. Patients and investigators were aware of treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT00476957. PROTECT randomised 8791 patients, of whom 8709 provided consent to participate and were eligible: 4357 were allocated to the E-ZES group and 4352 patients to the C-SES group. At 3 years, rates of definite or probable stent thrombosis did not differ between groups (1·4% for E-ZES [predicted: 1·5%] vs 1·8% [predicted: 2·5%] for C-SES; hazard ratio [HR] 0·81, 95% CI 0·58-1·14, p=0·22). Dual antiplatelet therapy was used in 8402 (96%) patients at discharge, 7456 (88%) at 1 year, 3041 (37%) at 2 years, and 2364 (30%) at 3 years. No evidence of superiority of E-ZES compared with C-SES in definite or probable stent thrombosis rates was noted at 3 years. Time analysis suggests a difference in definite or probable stent thrombosis between groups is emerging over time, and a longer follow-up is therefore needed given the clinical relevance of stent thrombosis. Medtronic, Inc. Copyright © 2012 Elsevier Ltd. All rights reserved.

Immediate and late clinical and angiographic outcomes after GFX coronary stenting: is high-pressure balloon dilatation necessary?

PubMed

Park, S W; Hong, M K; Lee, C W; Kim, J J; Park, H K; Cho, G Y; Kang, D H; Song, J K; Park, S J

2000-08-01

The GFX stent is a balloon-expandable stent made of sinusoidal element of stainless steel. The adjunct high-pressure balloon dilatations were usually recommended in routine stenting procedure. The aim of this study was to evaluate the immediate and long-term clinical and angiographic outcomes and to investigate the necessity of high-pressure balloon dilatation during GFX stenting. In all, 172 consecutive patients underwent single 12 or 18 mm GFX stent implantation in 188 native coronary lesions. Two types of stenting technique were used: (1) stent size of a final stent-to-artery ratio of 1:1 (inflation pressure > 10 atm, high-pressure group), and (2) stent size of 0.5 mm bigger than reference vessel (inflation pressure < or = 10 atm, low-pressure group). The adjunct high-pressure balloon dilatations were performed only in cases of suboptimal results. The adjunct high-pressure balloon dilatation was required in 11 of 83 lesions (13%) in the high-pressure group and in 7 of 105 lesions (7%) in the low-pressure group (p = 0.203). Procedural success rate was 100%. There were no significant differences of in-hospital and long-term clinical events between the two groups. The overall angiographic restenosis rate was 17.7%; 18.4% in the high-pressure group and 17.1% in the low-pressure group (p = 0.991). The GFX stent is a safe and effective device with a high procedural success rate and favorable late clinical outcome for treatment of native coronary artery disease. Further randomized trials may be needed to compare stenting techniques in GFX stent implantation.

Impact of polymer formulations on neointimal proliferation after zotarolimus-eluting stent with different polymers: insights from the RESOLUTE trial.

PubMed

Waseda, Katsuhisa; Ako, Junya; Yamasaki, Masao; Koizumi, Tomomi; Sakurai, Ryota; Hongo, Yoichiro; Koo, Bon-Kwon; Ormiston, John; Worthley, Stephen G; Whitbourn, Robert J; Walters, Darren L; Meredith, Ian T; Fitzgerald, Peter J; Honda, Yasuhiro

2011-06-01

Polymer formulation may affect the efficacy of drug-eluting stents. Resolute, Endeavor, and ZoMaxx are zotarolimus-eluting stents with different stent platforms and different polymer coatings and have been tested in clinical trials. The aim of this analysis was to compare the efficacy of zotarolimus-eluting stents with different polymers. Data were obtained from the first-in man trial or first randomized trials of each stent, The Clinical RESpOnse EvaLUation of the MedTronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions (RESOLUTE), Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions (ENDEAVOR II), and ZoMaxx I trials. Follow-up intravascular ultrasound analyses (8 to 9 months of follow-up) were possible in 353 patients (Resolute: 88, Endeavor: 98, ZoMaxx: 82, Driver: 85). Volume index (volume/stent length) was obtained for vessel, stent, lumen, peristent plaque, and neointima. Cross-sectional narrowing was defined as neointimal area divided by stent area (%). Neointima-free frame ratio was calculated as the number of frames without intravascular ultrasound-detectable neointima divided by the total number of frames within the stent. At baseline, vessel, lumen, and peristent plaque volume index were not significantly different among the 4 stent groups. At follow-up, percent neointimal obstruction was significantly lower in Resolute compared with Endeavor, ZoMaxx, and Driver (Resolute: 3.7±4.0, Endeavor: 17.5±10.1, ZoMaxx: 14.6±8.1, Driver: 29.4±17.2%; P<0.001). Greater maximum cross-sectional narrowing and higher neointima-free frame ratio, suggesting less neointimal coverage, were observed in Resolute compared with other stent groups. Multiple regression analysis confirmed that the biodurable polymer used in Resolute independently correlated with neointimal suppression among 3 zotarolimus-eluting stents. The different polymer formulations significantly affect the relative amount of neointima for zotarolimus-eluting stents. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00248079.

Magnesium alloy covered stent for treatment of a lateral aneurysm model in rabbit common carotid artery: An in vivo study

NASA Astrophysics Data System (ADS)

Wang, Wu; Wang, Yong-Li; Chen, Mo; Chen, Liang; Zhang, Jian; Li, Yong-Dong; Li, Ming-Hua; Yuan, Guang-Yin

2016-11-01

Magnesium alloy covered stents have rarely been used in the common carotid artery (CCA). We evaluated the long-term efficacy of magnesium alloy covered stents in a lateral aneurysm model in rabbit CCA. Magnesium alloy covered stents (group A, n = 7) or Willis covered stents (group B, n = 5) were inserted in 12 New Zealand White rabbits and they were followed up for 12 months. The long-term feasibility for aneurysm occlusion was studied through angiograms; the changes in vessel area and lumen area were assessed with IVUS. Complete aneurysmal occlusion was achieved in all aneurysms. Angiography showed that the diameter of the stented CCA in group A at 6 and 12 months was significantly greater than the diameter immediately after stent placement. On intravascular ultrasound (IVUS) examination, the mean lumen area of the stented CCA in group A was significantly greater at 6 and 12 months than that immediately after stent placement; the mean lumen area was also significantly greater in group A than in group B at the same time points. The magnesium alloy covered stents proved to be an effective approach for occlusion of lateral aneurysm in the rabbit CCA; it provides distinct advantages that are comparable to that obtained with the Willis covered stent.

Use of double pigtail stent in hypospadias surgery.

PubMed

Chang, Paul C Y; Yeh, Ming-Lun; Chao, Chun-Chih; Chang, Chi-Jen

2011-01-01

Various types and materials of stents have been used for urinary diversion in hypospadias surgery. We evaluated whether double pigtail stents are superior to straight silicone stents. We conducted a retrospective chart review of all patients who underwent hypospadias surgery with straight silicone or double pigtail stents between November 1997 and October 2005. Comparisons were made between the two groups specifically with regard to the complication rates. A total of 86 patients were included. The complication rates in patients who received double pigtail stents were significantly reduced as compared with those who received straight silicon stents. There was less wound disruption associated with early stent dislodgement in the double pigtail group compared with the straight silicone group (3.2%vs. 17.4%, p< 0.05). The rate of urethrocutaneous fistula was also lower in the double pigtail stent group (12.7%vs. 30.4%). Subjectively, there was also improved patient comfort and parent anxiety in the double pigtail stent group. Double pigtail stent is a suitable material for urinary diversion in hypospadias surgery. It not only reduces patient discomfort, but also decreases complication rates in hypospadias surgery. Copyright © 2011 Asian Surgical Association. Published by Elsevier B.V. All rights reserved.

Self-Expandable Metallic Stent Placement in Malignant Gastric Outlet Obstruction: A Comparison Between 2 Brands of Stents.

PubMed

Ye, Bing-Wei; Lee, Kuei-Chuan; Hsieh, Yun-Cheng; Li, Chung-Pin; Chao, Yee; Hou, Ming-Chih; Lin, Han-Chieh

2015-07-01

Malignant gastric outlet obstruction is a late complication of intraabdominal malignancy. Self-expandable metallic stent placement has been a safe palliative treatment to relieve obstructive symptoms. We aimed to assess the efficacy and safety of metallic stents in our patients and analyzed the clinical outcome of different brands. Seventy-one patients with inoperable gastric outlet obstruction receiving WallFlex enteral stents (WallFlex group) or Bonastents (Bonastent group) since April 2010 were analyzed retrospectively. The overall technical and clinical success rates of stent placement were 100% and 93%, respectively. The baseline characteristics and clinical outcomes including procedure-related complications, restenosis, and reintervention rates were comparable between the 2 groups. However, the Bonastent group had a higher rate of stent fracture than the WallFlex group (13.3% vs 0%, P = 0.03). The mean duration of overall stent patency was 132.7 days. The mean duration of survival was 181.9 days. Resumption of regular diet or low residual diet at day 7 after stent insertion predicted stent patency (hazard ratio [HR]: 0.28, P = 0.01). Cancer with gastric origin (HR: 0.25, P = 0.045) and poststent chemotherapy (HR: 0.38, P = 0.006) predicted lower mortality; however, peritoneal carcinomatosis (HR: 3.09, P = 0.04) correlated with higher mortality. Metallic stent placement is a safe and effective method for relieving gastric outlet obstruction. Except higher rate of stent fracture in the Bonastent group, there is no significant difference in clinical outcomes between the Bonastent group and the WallFlex group.

Predictive factors for the failure of endoscopic stent-in-stent self-expandable metallic stent placement to treat malignant hilar biliary obstruction

PubMed Central

Sugimoto, Mitsuru; Takagi, Tadayuki; Suzuki, Rei; Konno, Naoki; Asama, Hiroyuki; Watanabe, Ko; Nakamura, Jun; Kikuchi, Hitomi; Waragai, Yuichi; Takasumi, Mika; Sato, Yuki; Hikichi, Takuto; Ohira, Hiromasa

2017-01-01

AIM To investigate the factors predictive of failure when placing a second biliary self-expandable metallic stents (SEMSs). METHODS This study evaluated 65 patients with an unresectable malignant hilar biliary obstruction who were examined in our hospital. Sixty-two of these patients were recruited to the study and divided into two groups: the success group, which consisted of patients in whom a stent-in-stent SEMS had been placed successfully, and the failure group, which consisted of patients in whom the stent-in-stent SEMS had not been placed successfully. We compared the characteristics of the patients, the stricture state of their biliary ducts, and the implemented endoscopic retrograde cholangiopancreatography (ERCP) procedures between the two groups. RESULTS The angle between the target biliary duct stricture and the first implanted SEMS was significantly larger in the failure group than in the success group. There were significantly fewer wire or dilation devices (ERCP catheter, dilator, or balloon catheter) passing the first SEMS cell in the failure group than in the success group. The cut-off value of the angle predicting stent-in-stent SEMS placement failure was 49.7 degrees according to the ROC curve (sensitivity 91.7%, specificity 61.2%). Furthermore, the angle was significantly smaller in patients with wire or dilation devices passing the first SEMS cell than in patients without wire or dilation devices passing the first SEMS cell. CONCLUSION A large angle was identified as a predictive factor for failure of stent-in-stent SEMS placement. PMID:28974893

Predictive factors for the failure of endoscopic stent-in-stent self-expandable metallic stent placement to treat malignant hilar biliary obstruction.

PubMed

Sugimoto, Mitsuru; Takagi, Tadayuki; Suzuki, Rei; Konno, Naoki; Asama, Hiroyuki; Watanabe, Ko; Nakamura, Jun; Kikuchi, Hitomi; Waragai, Yuichi; Takasumi, Mika; Sato, Yuki; Hikichi, Takuto; Ohira, Hiromasa

2017-09-14

To investigate the factors predictive of failure when placing a second biliary self-expandable metallic stents (SEMSs). This study evaluated 65 patients with an unresectable malignant hilar biliary obstruction who were examined in our hospital. Sixty-two of these patients were recruited to the study and divided into two groups: the success group, which consisted of patients in whom a stent-in-stent SEMS had been placed successfully, and the failure group, which consisted of patients in whom the stent-in-stent SEMS had not been placed successfully. We compared the characteristics of the patients, the stricture state of their biliary ducts, and the implemented endoscopic retrograde cholangiopancreatography (ERCP) procedures between the two groups. The angle between the target biliary duct stricture and the first implanted SEMS was significantly larger in the failure group than in the success group. There were significantly fewer wire or dilation devices (ERCP catheter, dilator, or balloon catheter) passing the first SEMS cell in the failure group than in the success group. The cut-off value of the angle predicting stent-in-stent SEMS placement failure was 49.7 degrees according to the ROC curve (sensitivity 91.7%, specificity 61.2%). Furthermore, the angle was significantly smaller in patients with wire or dilation devices passing the first SEMS cell than in patients without wire or dilation devices passing the first SEMS cell. A large angle was identified as a predictive factor for failure of stent-in-stent SEMS placement.

Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study.

PubMed

Schmidt, Arthur; Riecken, Bettina; Rische, Susanne; Klinger, Christoph; Jakobs, Ralf; Bechtler, Matthias; Kähler, Georg; Dormann, Arno; Caca, Karel

2015-05-01

Previous studies have shown superior patency rates for self-expandable metal stents (SEMS) compared with plastic stents in patients with malignant biliary obstruction. The aim of this study was to compare stent patency, patient survival, and complication rates between a newly designed, wing-shaped, plastic stent and SEMSs in patients with unresectable, malignant, distal, biliary obstruction. A randomized, multicenter trial was conducted at four tertiary care centers in Germany. A total of 37 patients underwent randomization between March 2010 and January 2013. Patients underwent endoscopic retrograde cholangiography with insertion of either a wing-shaped, plastic stent without lumen or an SEMS.  Stent failure occurred in 10/16 patients (62.5 %) in the winged-stent group vs. 4/18 patients (22.2 %) in the SEMS group (P = 0.034). The median time to stent failure was 51 days (range 2 - 92 days) for the winged stent and 80 days (range 28 - 266 days) for the SEMS (P = 0.002). Early stent failure (< 8 weeks after placement) occurred in 8 patients (50 %) vs. 2 patients (11.1 %), respectively (P = 0.022). After obtaining the results from this interim analysis, the study was discontinued because of safety concerns. The frequency of stent failure was significantly higher in the winged-stent group compared with the SEMS group. A high incidence of early stent failure within 8 weeks was observed in the winged-stent group. Thus, the winged, plastic stent without central lumen may not be appropriate for mid or long term drainage of malignant biliary obstruction. Study registration ClinicalTrials.gov (NCT01063634). © Georg Thieme Verlag KG Stuttgart · New York.

Metal versus plastic stents for drainage of malignant biliary obstruction before primary surgical resection.

PubMed

Song, Tae Jun; Lee, Jae Hoon; Lee, Sang Soo; Jang, Ji Woong; Kim, Jung Wook; Ok, Tae Jin; Oh, Dong Wook; Park, Do Hyun; Seo, Dong Wan; Lee, Sung Koo; Kim, Myung-Hwan; Kim, Song Cheol; Kim, Chul Nam; Yun, Sung Cheol

2016-11-01

Preoperative biliary drainage (PBD) with stent placement has been commonly used for patients with malignant biliary obstruction. In PBD, the placement of fully covered self-expandable metal stents (FCSEMSs) may provide better patency duration and a lower incidence of cholangitis compared with plastic stents. We aimed to evaluate which type of stent showed better outcomes in PBD. In this multicenter, prospective randomized trial, we compared PBD with FCSEMSs versus plastic stents in 86 patients with malignant biliary obstruction between January 2012 and December 2014. Patients with obstructive jaundice were randomly assigned to undergo PBD either with plastic stents or FCSEMS placement. Baseline characteristics were not significantly different between the 2 groups. Endoscopic stent placement was technically successful in all patients. Procedure-related adverse events were not significantly different between the 2 groups (plastic vs FCSEMS group; 16.3% vs 16.3%, P = 1.0). Reintervention was required in 16.3% of the plastic stent group and 14.0% of the FCSEMS group (P = .763). The interval to surgery after PBD (plastic vs FCSEMS group; 14.2 ± 8.3 vs 12.3 ± 6.9 days, P = .426) was not significantly different between groups. Surgery-related adverse events occurred in 43.6% of the plastic stent group and 40.0% of the FCSEMS group (P = .755). In patients with resectable malignant biliary obstruction, the outcomes of PBD with plastic stents and FCSEMSs were similar. Considering the cost-effectiveness, PBD with plastic stents may be preferable to FCSEMS placement. (Clinical trial registration number: NCT01789502.). Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis.

PubMed

Haapamäki, Carola; Kylänpää, Leena; Udd, Marianne; Lindström, Outi; Grönroos, Juha; Saarela, Arto; Mustonen, Harri; Halttunen, Jorma

2015-07-01

The use of covered self-expandable metallic stents (cSEMS) in benign biliary indications is evolving. The aim of the study was to assess the safety and feasibility of cSEMS compared with multiple plastic stents in the treatment of benign biliary stricture (BBS) caused by chronic pancreatitis. This was a prospective, multicenter, randomized study of 60 patients with BBS caused by chronic pancreatitis. All patients received an initial plastic stent before randomization. At randomization, the stent was replaced either with a single cSEMS or three plastic stents. After 3 months, the position of the cSEMS was checked or another three plastic stents were added. At 6 months after randomization, all stents were removed. Clinical follow-up including abdominal ultrasound and laboratory tests were performed at 6 months and 2 years after stent removal. Two patients dropped out of the cSEMS group before stent removal. In April 2014, the median follow-up was 40 months (range 1 - 66 months). The 2-year, stricture-free success rate was 90 % (95 % confidence interval [CI] 72 % - 97 %) in the plastic stent group and 92 % (95 %CI 70 % - 98 %) in the cSEMS group (P = 0.405). There was one late recurrence in the plastic stent group 50 months after stent removal. Stent migration occurred three times (10 %) in the plastic stent group and twice in the cSEMS group (7 %; P = 1.000). A 6-month treatment with either six 10-Fr plastic stents or with one 10-mm cSEMS produced good long-term relief of biliary stricture caused by chronic pancreatitis.Study registered at ClinicalTrials.gov (NCT01085747). © Georg Thieme Verlag KG Stuttgart · New York.

A comparison of clinical and angiographic outcomes after Excel bioabsorbable polymer versus Firebird durable polymer rapamycin-eluting stent for the treatment of coronary artery disease in a "real world" setting: six-month follow-up results.

PubMed

Liu, Hai-bo; Xu, Bo; Qiao, Shu-bin; Yang, Yue-jin; Ma, Wei-hua; Qin, Xue-wen; Yao, Min; Wu, Yong-jian; Yuan, Jin-qing; Chen, Jue; You, Shi-jie; Dai, Jun; Xia, Ran; Li, Jian-jun; Chen, Ji-lin; Gao, Run-lin

2007-04-05

Several clinical trials have shown that rapamycin-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention (PCI). The Firebird stent and the Excel stent (coated with bioabsorbable polymer) are two different types of rapamycin-eluting stents made in China, both have been recently approved for clinical use in China by State Food and Drug Administration. However, it is unclear whether there are differences in safety and efficacy between the two types of stents in daily practice. In the month of June 2006, a total of 190 consecutive patients were treated exclusively with Firebird stents (n = 93, Firebird group) or Excel stents (n = 97, Excel group) in our center and were included in this study. The frequency of major adverse cardiac events (MACE, a composite of death, myocardial infarction or target lesion revascularization), binary restenosis, and late lumen loss and stent thrombosis during a six-month follow-up period were compared between the two groups. Patient and lesion characteristics were comparable between the groups. Major adverse cardiac event rates were low in hospital and at 6 months (2.1% in the Excel group and 0% in the Firebird group, P > 0.05). The 6-month angiographic in-stent restenosis rate was 0% in both groups, with an associated late loss of (0.15 +/- 0.21) mm versus (0.14 +/- 0.20) mm (P = 0.858) and the in-segment restenosis rate was also 0% for the Excel group and the Firebird group. There was no definite stent thrombosis identified in either group during the six-month follow-up period and only one patient in the Excel group had probable stent thrombosis in hospital. Results from this mid-term, single-center study showed that both of the Firebird and the Excel rapamycin eluting stent had similar effects on reducing the incidence of MACE and the risk of restenosis (both in-stent and in-segment binary restenosis) after PCI in daily practice.

Evaluation of Polyurethane Nasolacrimal Duct Stents: In Vivo Studies in New Zealand Rabbits

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

Wilhelm, K.E., E-mail: wilhelm@uni-bonn.de; Grabolle, B.; Urbach, H.

2006-10-15

The purpose of this study was to evaluate the radiographic and biological effects of different polyurethane nasolacrimal duct stents in an animal model. Fifteen polyurethane nasolacrimal duct stents (n = 5 mushroom-type stents, n = 5 newly designed S-shaped TearLeader stents without hydrophilic coating, and n = 5 S-shaped TearLeader stents with hydrophilic coating) were implanted in the nasolacrimal ducts of eight unaffected New Zealand rabbits. One nasolacrimal system served as control. Clinical and radiographic follow-up was performed at 1-, 2-, and 4-week intervals, then after a 3-month interval, after which the animals were euthanized. All stents were implanted withoutmore » major periprocedural complications. The stents proved to be patent by the end of the procedure. During follow-up, all mushroom-type stents were occluded at 4 weeks. None of these stents opened to forced irrigation. Clinically, all rabbits demonstrated severe dacryocystitis. Three out of five TearLeader stents without hydrophilic coating were blocked at 4 weeks; one out of five was open to irrigation. Best results were observed in the stent group with hydrophilic coating. Follow-up dacryocystography demonstrated patent stents in nasolacrimal ducts of all animals after 4 weeks. In only one of five cases, the coated stent became partially occluded after 2 months. These animals were free of clinical symptoms. After 3 months, at least three out of five stents still opened to forced irrigation and only one stent was completely blocked. Dislocation of the stents was not observed. Refinement of the stent surface and stent design improves the results of nasolacrimal duct stenting in this animal model. Implantation of hydrophilic-coated S-shaped stents is highly superior to conventional mushroom-type stents and noncoated stent types. Hydrophilic coating seems to prevent foreign-body reactions, resulting in maximized stent patency.« less

Percutaneous biliary approach as a successful rescue procedure after failed endoscopic therapy for drainage in advanced hilar tumors.

PubMed

Jang, Sung Ill; Hwang, Jin-Hyeok; Lee, Kwang-Hun; Yu, Jeong-Sik; Kim, Hee Wook; Yoon, Chang Jin; Lee, Yoon Suk; Paik, Kyu Hyun; Lee, Sang Hyub; Lee, Dong Ki

2017-04-01

Palliative endoscopic or percutaneous biliary drainage is used for unresectable advanced hilar cancer (HC). The best option for drainage in Bismuth type III or IV HC has not been established. The aims of this study are to identify factors predictive of endoscopic stenting failure and evaluate the effectiveness of rescue percutaneous stenting in patients with advanced HC. Data from 110 patients with inoperable advanced HC were retrospectively reviewed. All received bilateral self-expandable metallic stents. Patients were divided into three groups: I, successful initial endoscopic stenting; II, unsuccessful initial endoscopic stenting, followed by percutaneous stenting; and III, initial percutaneous stenting. We analyzed clinical results and radiologic tumor characteristics. Baseline characteristics and clinical outcomes of all groups were similar, except the hospital stay was longer in group III than group I. Technical success rate was higher in groups II and III (100%) than in group I (72.4%). The functional success rate, stent patency time, patient survival time, and complication rate were similar between groups. Endoscopic stenting failed because of guide-wire passage failure (n = 12) or stent passage failure (n = 7). The only factor significantly associated with endoscopic failure was a smaller left intrahepatic duct-common bile duct angle. As clinical outcomes were generally similar between approaches, percutaneous stenting is recommended for patients with Bismuth type III or IV advanced HC. Acute left intrahepatic duct-common bile duct angulation predicts endoscopic stenting failure. If endoscopic stenting fails, immediate conversion to the percutaneous approach is a necessary and effective rescue method. © 2016 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Covered versus Uncovered Self-Expandable Metal Stents for Managing Malignant Distal Biliary Obstruction: A Meta-Analysis.

PubMed

Li, Jinjin; Li, Tong; Sun, Ping; Yu, Qihong; Wang, Kun; Chang, Weilong; Song, Zifang; Zheng, Qichang

2016-01-01

To compare the efficacy of using covered self-expandable metal stents (CSEMSs) and uncovered self-expandable metal stents (UCSEMSs) to treat objective jaundice caused by an unresectable malignant tumor. We performed a comprehensive electronic search from 1980 to May 2015. All randomized controlled trials comparing the use of CSEMSs and UCSEMSs to treat malignant distal biliary obstruction were included. The analysis included 1417 patients enrolled in 14 trials. We did not detect significant differences between the UCSEMS group and the CSEMS group in terms of cumulative stent patency (hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.19-4.53; p = 0.93, I2 = 0%), patient survival (HR 0.77, 95% CI 0.05-10.87; p = 0.85, I2 = 0%), overall stent dysfunction (relative ratio (RR) 0.85, M-H, random, 95% CI 0.57-1.25; p = 0.83, I2 = 63%), the overall complication rate (RR 1.26, M-H, fixed, 95% CI 0.94-1.68; p = 0.12, I2 = 0%) or the change in serum bilirubin (weighted mean difference (WMD) -0.13, IV fixed, 95% CI 0.56-0.3; p = 0.55, I2 = 0%). However, we did detect a significant difference in the main causes of stent dysfunction between the two groups. In particular, the CSEMS group exhibited a lower rate of tumor ingrowth (RR 0.25, M-H, random, 95% CI 0.12-0.52; p = 0.002, I2 = 40%) but a higher rate of tumor overgrowth (RR 1.76, M-H, fixed, 95% CI 1.03-3.02; p = 0.04, I2 = 0%). Patients with CSEMSs also exhibited a higher migration rate (RR 9.33, M-H, fixed, 95% CI 2.54-34.24; p = 0.008, I2 = 0%) and a higher rate of sludge formation (RR 2.47, M-H, fixed, 95% CI 1.36-4.50; p = 0.003, I2 = 0%). Our meta-analysis indicates that there is no significant difference in primary stent patency and stent dysfunction between CSEMSs and UCSEMSs during the period from primary stent insertion to primary stent dysfunction or patient death. However, when taking further management for occluded stents into consideration, CSEMSs is a better choice for patients with malignant biliary obstruction due to their removability.

A new self-expandable aortic valved stent deployed above native leaflets for aortic insufficiency: an in vitro study.

PubMed

Huang, H; Zhou, Y; Shao, J; Cai, J; Mei, Y; Wang, Y

2012-12-01

The aim of this paper was to develop a new self-expandable aortic valved stent following the shape of the sinus of Valsalva, which can be deployed above native leaflets for aortic regurgitation, and study it's effect on coronary artery flow when orthotopic implantation in and above native leaflets. New self-expandable aortic valved stent consist of nitinol stent and bovine pericardium, and was designed following the shape of the sinus of Valsalva, the bovine pericardium was tailed as native leaflet. Thirty-six swine hearts were divided into three equal groups of twelve. In Group A (N.=12), the new self-expandable aortic valved stents deployed in native leaflets. In Group B (N.=12), the new self-expandable aortic valved stents deployed above native leaflets. In Group C (N.=12), the cylinder-like valved stents deployed only in native leaflets. The measurements of each coronary flow rate and endoscopic inspections were repeated post-implantation. In Group A and C, valve implantation in native leaflets resulted in a significant decrease in both left and right coronary flows. In Group B, no significant change in either right or left coronary flow was found after new self-expandable aortic valved stent placement. Endoscopic inspections showed that in group A and C the native leaflets sandwiched between valved stent and aortic wall, whereas, in group B the native leaflets were under the artificial leaflets. Two kinds of stents deployed in native leaflets affect left and right coronary flows significantly. No significant effect was found when the new self-expandable aortic valved stent deployed above native leaflets. This new self-expandable aortic valved stent can be deployed above the native leaflets, which avoids the obstruction of native leaflets on coronary flow.

Biodegradable stent or balloon dilatation for benign oesophageal stricture: pilot randomised controlled trial.

PubMed

Dhar, Anjan; Close, Helen; Viswanath, Yirupaiahgari K; Rees, Colin J; Hancock, Helen C; Dwarakanath, A Deepak; Maier, Rebecca H; Wilson, Douglas; Mason, James M

2014-12-28

To undertake a randomised pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures. This British multi-site study recruited seventeen symptomatic adult patients with refractory strictures. Patients were randomised using a multicentre, blinded assessor design, comparing a biodegradable stent (BS) with endoscopic dilatation (ED). The primary endpoint was the average dysphagia score during the first 6 mo. Secondary endpoints included repeat endoscopic procedures, quality of life, and adverse events. Secondary analysis included follow-up to 12 mo. Sensitivity analyses explored alternative estimation methods for dysphagia and multiple imputation of missing values. Nonparametric tests were used. Although both groups improved, the average dysphagia scores for patients receiving stents were higher after 6 mo: BS-ED 1.17 (95%CI: 0.63-1.78) P = 0.029. The finding was robust under different estimation methods. Use of additional endoscopic procedures and quality of life (QALY) estimates were similar for BS and ED patients at 6 and 12 mo. Concomitant use of gastrointestinal prescribed medication was greater in the stent group (BS 5.1, ED 2.0 prescriptions; P < 0.001), as were related adverse events (BS 1.4, ED 0.0 events; P = 0.024). Groups were comparable at baseline and findings were statistically significant but numbers were small due to under-recruitment. The oesophageal tract has somatic sensitivity and the process of the stent dissolving, possibly unevenly, might promote discomfort or reflux. Stenting was associated with greater dysphagia, co-medication and adverse events. Rigorously conducted and adequately powered trials are needed before widespread adoption of this technology.

Biodegradable stent or balloon dilatation for benign oesophageal stricture: Pilot randomised controlled trial

PubMed Central

Dhar, Anjan; Close, Helen; Viswanath, Yirupaiahgari K; Rees, Colin J; Hancock, Helen C; Dwarakanath, A Deepak; Maier, Rebecca H; Wilson, Douglas; Mason, James M

2014-01-01

AIM: To undertake a randomised pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures. METHODS: This British multi-site study recruited seventeen symptomatic adult patients with refractory strictures. Patients were randomised using a multicentre, blinded assessor design, comparing a biodegradable stent (BS) with endoscopic dilatation (ED). The primary endpoint was the average dysphagia score during the first 6 mo. Secondary endpoints included repeat endoscopic procedures, quality of life, and adverse events. Secondary analysis included follow-up to 12 mo. Sensitivity analyses explored alternative estimation methods for dysphagia and multiple imputation of missing values. Nonparametric tests were used. RESULTS: Although both groups improved, the average dysphagia scores for patients receiving stents were higher after 6 mo: BS-ED 1.17 (95%CI: 0.63-1.78) P = 0.029. The finding was robust under different estimation methods. Use of additional endoscopic procedures and quality of life (QALY) estimates were similar for BS and ED patients at 6 and 12 mo. Concomitant use of gastrointestinal prescribed medication was greater in the stent group (BS 5.1, ED 2.0 prescriptions; P < 0.001), as were related adverse events (BS 1.4, ED 0.0 events; P = 0.024). Groups were comparable at baseline and findings were statistically significant but numbers were small due to under-recruitment. The oesophageal tract has somatic sensitivity and the process of the stent dissolving, possibly unevenly, might promote discomfort or reflux. CONCLUSION: Stenting was associated with greater dysphagia, co-medication and adverse events. Rigorously conducted and adequately powered trials are needed before widespread adoption of this technology. PMID:25561787

A cheap minimally painful and widely usable alternative for retrieving ureteral stents.

PubMed

Söylemez, Haluk; Sancaktutar, Ahmet Ali; Bozkurt, Yaşar; Atar, Murat; Penbegül, Necmettin; Yildirim, Kadir

2011-01-01

To describe a cheap, minimally painful and widely usable method for retrieving ureteral stents by using an ureteroscope. Sixty-seven patients with ureteral stents were enrolled in this study. The patients were randomized into a cystoscopic (35 patients) and a ureteroscopic (32 patients) group. All stents were retrieved by a flexible cystoscope in the first group and by a ureteroscope in the second group under local anesthesia. Patients in each group were assessed for stented time, stent side, cause of stent placement, operative time, peroperative pain, postoperative pain, irritative voiding symptoms and hematuria. Also costs of instruments were calculated. Stents were successfully retrieved in 67 patients. There were no statistical differences in the two groups regarding patient gender and age or stent side, operative time, stented time, mean operative pain score, irritative voiding symptom scores and hematuria. Total selling price was USD 20.399 for flexible instruments and USD 10.516 for rigid ones. Total maintenance price was higher in flexible instruments than in the rigid ones (USD 197.8 and 51.7 per use, respectively). Ureteroscopic stent retrieval is a minimally painful, safe and highly tolerable method under local anesthesia as well as flexible cystoscopic retrieval. Also, it is a cheap and widely usable method. Copyright © 2011 S. Karger AG, Basel.

Comparison of covered and uncovered self-expandable stents in the treatment of malignant biliary obstruction.

PubMed

Flores Carmona, Diana Yamel; Alonso Lárraga, Juan Octavio; Hernández Guerrero, Angélica; Ramírez Solís, Mauro Eduardo

2016-05-01

Drainage with metallic stents is the treatment of choice in malignant obstructive jaundice. Technical and clinical success with metallic stents is obtained in over 90% and 80% of cases, respectively. There are self-expandable metallic stents designed to increase permeability. The aim of this study was to describe the results obtained with totally covered self-expandable and uncovered self-expandable metallic stents in the palliative treatment of malignant biliary obstruction. Sixty eight patients with malignant obstructive jaundice secondary to pancreatobiliary or metastatic disease not amenable to surgery were retrospectively included. Two groups were created: group A (covered self-expandable metallic stents) (n = 22) and group B (uncovered self-expandable metallic stents) (n = 46). Serum total bilirubin, direct bilirubin, alkaline phosphatase and gamma glutamyl transferase levels decreased in both groups and no statistically significant difference was detected (p = 0.800, p = 0.190, p = 0.743, p = 0.521). Migration was greater with covered stents but it was not statistically significant either (p = 0.101). Obstruction was greater in the group with uncovered stents but it was not statistically significant either (p = 0.476). There are no differences when using covered self-expandable stents or uncovered self-expandable stents in terms of technical and clinical success or complications in the palliative treatment of malignant obstructive jaundice.

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

Alparslan, Burcu, E-mail: burcu.alparslan@gmail.com; Nas, Omer Fatih, E-mail: omerfatihnas@gmail.com; Eritmen, Ulku Turpcu, E-mail: drulkutur@hotmail.com.tr

PurposeThe aim of this study was to investigate the effect of stent cell geometry on midterm results of carotid artery stenting (CAS).Materials and MethodOne hundred fifty-five patients underwent CAS between February 2010 and December 2012. Ninety-one open- and 84 closed-cell stents were used in this non-randomized, retrospective study. Periprocedural complications were defined as the ones happened during the procedure or within 30 days afterwards. Starting from the 6th month after the procedure, in-stent restenosis was detected with multidetector computed tomography angiography and classified into four groups from focal restenosis to occlusion.ResultsEleven complications were encountered in the periprocedural period (four on themore » open- and seven on the closed-cell group). Total complication rate was 6.3 % (11/175). No significant difference was detected in terms of periprocedural complications between two groups (p = 0.643). There was statistically significant difference between stent design groups in regard to radiological findings (p = 0.002). Sixteen of open-cell stents and three of closed-cell stents had focal restenosis. One closed-cell stent had diffuse proliferative restenosis and one open-cell stent had total occlusion.ConclusionIn-stent restenosis was more common in open-cell stent group, which have larger free cell area than closed-cell stents. Although our radiologic findings promote us to use closed-cell design if ‘possible’, no difference was detected in terms of clinical outcomes.« less

Higher plasma level of STIM1, OPG are correlated with stent restenosis after PCI.

PubMed

Li, Haibin; Jiang, Zhian; Liu, Xiangdong; Yang, Zhihui

2015-01-01

Percutaneous Coronary Intervention (PCI) is one of the most effective treatments for Coronary Heart Disease (CHD), but the high rate of In Stent Restenosis (ISR) has plagued clinicians after PCI. We aim to investigate the correlation of plasma Stromal Interaction Molecular 1 (STIM1) and Osteoprotegerin (OPG) level with stent restenosis after PCI. A total of 100 consecutive patients with Coronary Heart Disease (CHD) received PCI procedure were recruited. Coronary angiography was performed 8 months after their PCI. Then patients were divided into 2 groups: observation group was composed by patients who existing postoperative stenosis after intervention; Control group was composed by patients with no postoperative stenosis. The plasma levels of STIM, OPG in all patients were tested before and after intervention. Pearson correlation and multiple linear regression analysis were performed to analysis the correlation between STIM, OPG level and postoperative stenosis. 35 cases were divided into observation group and other 65 were divided into control group. The plasma levels of STIM, OPG have no statistical difference before their PCI procedure, but we observed higher level of High-sensitivity C-reactive protein (Hs-CRP) existed in observation group. We observed higher level of plasma STIM, OPG in observation group when compared with control group after PCI procedure (P < 0.05). Regression analysis demonstrated that Hs-CRP, STIM1, OPG are independent risk factors for ISR. Elevated levels of plasma STIM1, OPG are independent risk factors for ISR in patients received PCI, which could provide useful information for the restenosis control after PCI.

Conformable covered versus uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction: a randomized prospective study.

PubMed

Lim, Sun Gyo; Kim, Jin Hong; Lee, Kee Myung; Shin, Sung Jae; Kim, Chan Gyoo; Kim, Kyung Ho; Kim, Ho Gak; Yang, Chang Heon

2014-07-01

A conformable self-expandable metallic stent was developed to overcome the limitation of previous self-expandable metallic stents. The aim of this study was to evaluate outcomes after placement of conformable covered and uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction. A single-blind, randomized, parallel-group, prospective study were conducted in 4 medical centres between March 2009 and July 2012. 134 patients with unresectable malignant gastroduodenal obstruction were assigned to a covered double-layered (n=66) or uncovered unfixed-cell braided (n=68) stent placement group. Primary analysis was performed to compare re-intervention rates between two groups. 120 patients were analysed (59 in the covered group and 61 in the uncovered group). Overall rates of re-intervention were not significantly different between the two groups: 13/59 (22.0%) in the covered group vs. 13/61 (21.3%) in the uncovered group, p=0.999. Stent migration was more frequent in the covered group than in the uncovered group (p=0.003). The tumour ingrowth rate was higher in the uncovered group than in the covered group (p=0.016). The rates of re-intervention did not significantly differ between the two stents. Conformable covered double-layered and uncovered unfixed-cell braided stents were associated with different patterns of stent malfunction. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Long-term titrated IOP control with one, two, or three trabecular micro-bypass stents in open-angle glaucoma subjects on topical hypotensive medication: 42-month outcomes

PubMed Central

Erb, Carl; Carceller Guillamet, Amadeu; Fea, Antonio M; Voskanyan, Lilit; Giamporcaro, Jane Ellen; Hornbeak, Dana M

2018-01-01

Purpose Evaluate long-term outcomes after one, two, or three trabecular micro-bypass stents implanted in a standalone procedure in eyes with open-angle glaucoma taking ocular hypotensive medication. Patients and methods Prospective randomized ongoing study of 119 subjects (109 with 42-month follow-up) with open-angle glaucoma, preoperative intraocular pressure (IOP) 18–30 mmHg on one to three glaucoma medications, and unmedicated (post-washout) IOP 22–38 mmHg. Subjects were randomized to receive one (n=38), two (n=41), or three (n=40) iStent trabecular micro-bypass stents in a standalone procedure. Postoperatively, IOP was measured with medication and annually following washout. Data included IOP, medications, gonioscopy, pachymetry, visual field, visual acuity, adverse events, and slit-lamp and fundus examinations. Results Preoperative mean medicated IOP was 19.8±1.3 mmHg on 1.71 medications in one-stent eyes, 20.1±1.6 mmHg on 1.76 medications in two-stent eyes, and 20.4±1.8 mmHg on 1.53 medications in three-stent eyes. Post-washout IOP prior to stent implantation was 25.0±1.2, 25.0±1.7, and 25.1±1.9 mmHg in the three groups, respectively. Postoperatively, Month 42 medicated IOP was 15.0±2.8, 15.7±1.0 and 14.8±1.3 mmHg in the three groups, and post-washout IOP (Months 36–37) was 17.4±0.9, 15.8±1.1 and 14.2±1.5 mmHg, respectively. IOP reduction ≥20% without medication was achieved in 89%, 90%, and 92% of one-, two-, and three-stent eyes, respectively, at Month 12; and in 61%, 91%, and 91% of eyes, respectively, at Month 42. The need for additional medication remained consistent at Months 12 and 42 in multi-stent eyes (four two-stent eyes and three three-stent eyes at both time points), whereas it increased in single-stent eyes (four eyes at Month 12 versus 18 eyes at Month 42). Safety parameters were favorable in all groups. Conclusion The standalone implantation of either single or multiple iStent® device(s) produced safe, clinically meaningful IOP and medication reductions through 42 months postoperatively, with incrementally greater and more sustained reductions in multi-stent eyes. PMID:29440867

Self-Expandable Metallic Stent Placement in Malignant Gastric Outlet Obstruction

PubMed Central

Ye, Bing-Wei; Lee, Kuei-Chuan; Hsieh, Yun-Cheng; Li, Chung-Pin; Chao, Yee; Hou, Ming-Chih; Lin, Han-Chieh

2015-01-01

Abstract Malignant gastric outlet obstruction is a late complication of intraabdominal malignancy. Self-expandable metallic stent placement has been a safe palliative treatment to relieve obstructive symptoms. We aimed to assess the efficacy and safety of metallic stents in our patients and analyzed the clinical outcome of different brands. Seventy-one patients with inoperable gastric outlet obstruction receiving WallFlex enteral stents (WallFlex group) or Bonastents (Bonastent group) since April 2010 were analyzed retrospectively. The overall technical and clinical success rates of stent placement were 100% and 93%, respectively. The baseline characteristics and clinical outcomes including procedure-related complications, restenosis, and reintervention rates were comparable between the 2 groups. However, the Bonastent group had a higher rate of stent fracture than the WallFlex group (13.3% vs 0%, P = 0.03). The mean duration of overall stent patency was 132.7 days. The mean duration of survival was 181.9 days. Resumption of regular diet or low residual diet at day 7 after stent insertion predicted stent patency (hazard ratio [HR]: 0.28, P = 0.01). Cancer with gastric origin (HR: 0.25, P = 0.045) and poststent chemotherapy (HR: 0.38, P = 0.006) predicted lower mortality; however, peritoneal carcinomatosis (HR: 3.09, P = 0.04) correlated with higher mortality. Metallic stent placement is a safe and effective method for relieving gastric outlet obstruction. Except higher rate of stent fracture in the Bonastent group, there is no significant difference in clinical outcomes between the Bonastent group and the WallFlex group. PMID:26200641

[Cost-effectiveness trial of self-expandable metal stents and plastic biliary stents in malignant biliary obstruction].

PubMed

Daróczi, Tímea; Bor, Renáta; Fábián, Anna; Szabó, Ella; Farkas, Klaudia; Bálint, Anita; Czakó, László; Rutka, Mariann; Szűcs, Mónika; Milassin, Ágnes; Molnár, Tamás; Szepes, Zoltán

2016-02-14

Self-expandable metal and plastic stents can be applied in the palliative endoscopic treatment of patients with unresectable malignant biliary obstruction. The use of metal stentsis recommended if the patient's life expectancy is more than four months. To compare the therapeutic efficacy and cost-effectiveness of metal and plastic stents in the treatment of malignant biliary obstruction. The authors retrospectively enrolled patients who received metal (37 patients) or plastic stent (37 patients). The complication rate, stent patency and cumulative cost of treatment were assessed in the two groups. The complication rate of metal stents was lower (37.84% vs. 56.76%), but the stent patency was higher compared with plastic stents (19.11 vs. 8.29 weeks; p = 0.0041). In the plastic stent group the frequency of hospitalization of patients in context with stent complications (1.18 vs. 2.32; p = 0.05) and the necessity of reintervention for stent dysfunction (17 vs. 27; p = 0.033) were substantially higher. In this group multiple stent implantation raised the stent patency from 7.68 to 10.75 weeks. There was no difference in the total cost of treatment of malignant biliary obstruction between the two groups (p = 0.848). Considering the cost of treatment and the burden of patients the authors recommend self-expandable metal sten timplantation if the life expectancy of patients is more than two months. In short survival cases multiple plastic stent implantation is recommended.

A comparison of the temporary placement of 3 different self-expanding stents for the treatment of refractory benign esophageal strictures: a prospective multicentre study

PubMed Central

2012-01-01

Background Refractory benign esophageal strictures (RBESs) have been treated with the temporary placement of different self-expanding stents with conflicting results. We compared the clinical effectiveness of 3 types of stents: self-expanding plastic stents (SEPSs), biodegradable stents, and fully covered self-expanding metal stents (FCSEMSs), for the treatment of RBES. Methods This study prospectively evaluated 3 groups of 30 consecutive patients with RBESs who underwent temporary placement of either SEPSs (12 weeks, n = 10), biodegradable stents (n = 10) or FCSEMSs (12 weeks, n = 10). Data were collected to analyze the technical success and clinical outcome of the stents as evaluated by recurrent dysphagia, complications and reinterventions. Results Stent implantation was technically successful in all patients. Migration occurred in 11 patients: 6 (60%) in the SEPS group, 2 (20%) in the biodegradable group and 3 (30%) in the FCSEMS group (P = 0.16). A total of 8/30 patients (26.6%) were dysphagia-free after the end of follow-up: 1 (10%) in the SEPS group, 3 (30%) in the biodegradable group and 4 (40%) in the FCSEMS group (P = 0.27). More reinterventions were required in the SEPS group (n = 24) than in the biodegradable group (n = 13) or the FCSEMS group (n = 13) (P = 0.24). Multivariate analysis showed that stricture length was significantly associated with higher recurrence rates after temporary stent placement (HR = 1.37; 95% CI = 1.08-1.75; P = 0.011). Conclusions Temporary placement of a biodegradable stent or of a FCSEMS in patients with RBES may lead to long-term relief of dysphagia in 30 and 40% of patients, respectively. The use of SEPSs seems least preferable, as they are associated with frequent stent migration, more reinterventions and few cases of long-term improvement. Additionally, longer strictures were associated with a higher risk of recurrence. PMID:22691296

Comparison of ADM and Connective Tissue Graft as the Membrane in Class II Furcation Defect Regeneration: A Randomized Clinical Trial

PubMed Central

Esfahanian, Vahid; Farhad, Shirin; Sadighi Shamami, Mehrnaz

2014-01-01

Background and aims. Furcally-involved teeth present unique challenges to the success of periodontal therapy and influence treatment outcomes. This study aimed to assess to compare use of ADM and connective tissue membrane in class II furcation defect regeneration. Materials and methods. 10 patient with 2 bilaterally class II furcation defects in first and/or second maxilla or man-dibular molar without interproximal furcation involvement, were selected. Four weeks after initial phase of treatment, before and thorough the surgery pocket depth (PD), clinical attachment level to stent (CAL-S), free gingival margin to stent(FGM-S) , crestal bone to stent (Crest-S), horizontal defect depth to stent (HDD-S) and vertical defect depth to stent (VDD-S) and crestal bone to defect depth measured from stent margin. Thereafter, one side randomly treated using connective tissue and DFDBA (study group) and opposite side received ADM and DFDBA (control group). After 6 months, soft and hard tissue parameters measured again in re-entry. Results. Both groups presented improvements after therapies (P & 0.05). No inter-group differences were seen in PD re-duction (P = 0.275), CAL gain (P = 0.156), free gingival margin (P = 0.146), crest of the bone (P = 0.248), reduction in horizontal defects depth (P = 0.139) and reduction in vertical defects depth (P = 0.149). Conclusion. Both treatments modalities have potential of regeneration without any adverse effect on healing process. Connective tissue grafts did not have significant higher bone fill compared to that of ADM. PMID:25093054

Experimental study on the friction effect of plastic stents for biliary stone fragmentation (with video).

PubMed

Kwon, Chang-Il; Kim, Gwangil; Jeong, Seok; Choi, Sung Hoon; Ko, Kwang Hyun; Lee, Don Haeng; Cho, Joo Young; Hong, Sung Pyo

2018-01-01

In patients with irretrievable or intractable bile duct stone, temporary insertion of a plastic stent (PS) followed by further endoscopic retrograde cholangiopancreatography (ERCP) or surgery has been recommended as a 'bridge' therapy. However, the exact mechanism of stone fragmentation has not been discovered. The aim of the present study was to evaluate whether PS shape can facilitate stone fragmentation. Using a new in vitro bile flow phantom model, we compared the friction effect among three different PS groups (straight PS group, double pigtail-shaped PS group, and screw-shaped PS group) and a control group. Each group had 10 silicon tube blocks that separately contained one stone and two PS. The control group had 10 blocks each with only a stone and no PS. We carried out analysis of the friction effect by stone weight and volume changes among the groups, excluding fragmented stones. After 8 weeks, complete fragmentation was noted in one out of 34 cholesterol stones (2.9%) and in four out of six pigmented stones (66.7%). Fragmentation tended to be more prominent in the screw-shaped PS group than in the straight PS group, double pigtail-shaped group, and control group (volume change: -11.33%, 7.94%, 4.43%, and 2.05%, respectively, P = 0.1390; weight change: -9.30%, 0.71%, -0.10%, and -1.23%, respectively, P = 0.3553). Stone fragmentation may be induced by PS friction effect. Also, screw-shaped plastic stents may improve friction effect. These results may help guide future PS development and clinical decisions. © 2017 Japan Gastroenterological Endoscopy Society.

Anchoring of a fully covered self-expandable metal stent with a 5F double-pigtail plastic stent to prevent migration in the management of benign biliary strictures.

PubMed

Park, Jong Kyu; Moon, Jong Ho; Choi, Hyun Jong; Min, Seul Ki; Lee, Tae Hoon; Cheon, Gab Jin; Cheon, Young Koog; Cho, Young Deok; Park, Sang-Heum; Kim, Sun-Joo

2011-10-01

Fully covered self-expandable metal stents (FCSEMSs) can be effectively placed in patients with benign biliary stricture (BBS). However, stent migration is an inherent problem of FCSEMSs. We evaluated the efficacy of anchoring with a 5F double-pigtail plastic stent (anchoring stent) to prevent migration of an FCSEMS in patients with BBS. Between January 2007 and December 2009, 33 of 37 consecutive patients with BBS who had experienced treatment failure of at least one plastic stent placement were prospectively enrolled in this study. The patients with BBS were randomly assigned to undergo FCSEMS placement with or without an anchoring stent (anchoring group: 16 patients; non-anchoring group: 17 patients). The main outcome measures were the stent migration rate and success rates. The technical success rate was 100% in both groups. Significantly less stent migration occurred in the anchoring group (6.3%, 1/16) than in the non-anchoring group (41.2%, 7/17; P=0.024). The median indwelling time was significantly longer in the anchoring group (154 days; range, 86-176 days) than in the non-anchoring group (114 days; range, 19-162 days; P=0.010). Improvement or resolution of the BBS was confirmed in 15 of 16 patients (93.8%) in the anchoring group, and in 12 of 17 patients (70.6%) in the non-anchoring group (P=0.101). The placement of an anchoring stent appears to be a simple and effective method of preventing premature migration of FCSEMSs in patients with BBS. Appropriately powered studies are needed to confirm this finding.

Doxazosin oral intake therapy to relieve stent - related urinary symptoms and pain: a prospective, randomized, controlled study.

PubMed

Zhang, Long; Li, Junping; Pan, Minjie; Han, Weiwei; Liu, Shucheng; Xiao, Yajun

2016-01-01

To assess the impact of Doxazosin Oral Intake Therapy on urinary symptoms and pain in patients with indwelling ureteral stents Patients and Methods: A total of 239 patients with ureteral stone-related hydronephrosis who underwent a double-J stent insertion after ureteroscopic lithotripsy were enrolled. Patients were randomized to receive doxazosin cotrolled release 4 mg once daily for 4 weeks or matching placebo. Patients completed the brief-form Chinese version Ureteric Stent Symptom Questionnaire (USSQ) and quality of life (QoL) score 2 weeks and 4 weeks after stent placement and 4 weeks after stent withdrawal. The analgesic use was also recorded during the stenting period. Patients in Doxazosin Oral Intake Therapy group, in the first 2 weeks and second 2 weeks with the stent in situ, expressed significant lower daytime frequency (p=0.028 and p=0.038), nocturia (p=0.021 and p=0.008) and urgency (p=0.012 and p=0.014), respectively. Similarly, flank pain score, QoL score and analgesic use were also significant less in the stenting period. There was no significant difference in scores of urinary symptoms, pain and QoL during the post-stent period between two cohorts. Doxazosin Oral Intake Therapy reduced stent-related urinary symptoms, pain and the negative impact on QoL. Copyright© by the International Brazilian Journal of Urology.

TACE Combined with Implantation of Irradiation Stent Versus TACE Combine with Bare Stent for HCC Complicated by IVCTT

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

Yang, Qing-hui; Zhang, Wen; Liu, Qing-xin

PurposeThis study was designed to evaluate the safety and efficacy of transarterial chemoembolization (TACE) combined with intra-IVC implantation of an irradiation stent for the treatment of hepatocellular carcinoma (HCC) complicated by inferior vena cava tumor thrombosis (IVCTT).MethodsSixty-one consecutive patients with HCC complicated by IVCTT treated by TACE combined with IVC stenting were retrospectively analysed. IVC stenting was performed using a stent loaded with {sup 125}I seeds strands (the irradiation stent) in 33 patients (Group A) and 28 patients with a bare stent (Group B). Propensity score matching eliminated the baseline differences. Overall survival, oedema related to IVC obstruction remission ratemore » and procedure-related adverse events were compared between the two groups.ResultsThe adverse effect rate was similar for both Group A and Group B patients, and complications were adequately handled by medical treatment. TACE combined with implantation of an irradiation stent showed a significant median survival benefit over TACE combined with a bare stent, with a median survival time of 203.0 ± 28.135 days versus 93.0 ± 24.341 days (p = 0.006). The propensity score-matched (24 pairs) cohort analyses (200 ± 31.231 days vs. 66 ± 23.270 days, p = 0.019). The oedema remission rate was 97.0 % in group A patients and 96.4 % in group B, respectively. TACE-irradiation stent and object tumor response were the independent prognostic factors of favorable survival.ConclusionsTACE combined with irradiation stent implantation is a safe and effective treatment modality for patients with HCC complicated by IVCTT and may extend their survival time.« less

Early Removal of Double-J Stents Decreases Urinary Tract Infections in Living Donor Renal Transplantation: A Prospective, Randomized Clinical Trial.

PubMed

Liu, S; Luo, G; Sun, B; Lu, J; Zu, Q; Yang, S; Zhang, X; Dong, J

2017-03-01

The optimal timing for stent removal after renal transplantation remains controversial. This article describes an interim analysis of a randomized, prospective, double-blind trial aimed at detecting differences in urological complications between early ureteral stent removal at 1 week and routine ureteral stent removal at 4 weeks. Between October 2010 and March 2015, 103 patients who underwent living donor renal transplantation at a single center were pre-operatively randomly assigned to the early ureteral stent removal (at 1 week) group or the routine ureteral stent removal (at 4 weeks) group. Urinary symptoms, auxiliary examination results, and obstruction events were recorded during 3 months of follow-up. A cost analysis of both the hospitalization and postoperative periods was discussed. In total, 52 patients in the 1-week stent group and 51 patients in the 4-week stent group were analyzed. No serious adverse events were reported. Three episodes of urinary tract infections (UTIs) occurred in the 1-week stent group, and 18 such episodes were recorded in the 4-week stent group (5.8% vs 29.4%; P = .002). After adjusting for age, sex, ischemia time, renal artery number, body mass index, multiple arteries, and associated medical illness, regression analysis indicated that only stent duration was associated with UTI (OR, 8.791; 95% CI, 1.984-38.943; P = .004). The results of our study demonstrate that ureteral stent removal at 1 week reduces the risk of UTIs compared with routine removal at 4 weeks. Similar effects of ureteral stent removal on complication rates are observed for these two removal times. Copyright © 2016 Elsevier Inc. All rights reserved.

Comparison of Recanalization and In-Stent Stenosis Between the Low-Profile Visualized Intraluminal Support Stent and Enterprise Stent-Assisted Coiling for 254 Intracranial Aneurysms.

PubMed

Feng, Xin; Qian, Zenghui; Liu, Peng; Zhang, Baorui; Wang, Luyao; Guo, Erkang; Wen, Xiaolong; Xu, Wenjuan; Jiang, Chuhan; Wu, Zhongxue; Li, Youxiang; Liu, Aihua

2018-01-01

To compare the rates of recanalization and in-stent stenosis between the Enterprise (EP) and low-profile visualized intraluminal support (LVIS) stent deployments for intracranial aneurysms (IAs), and the factors associated therein. Between June 2014 and July 2016, 142 patients with a total of 161 IAs were treated by LVIS stent-assisted coiling and 111 patients with a total of 142 IAs were treated by EP stent-assisted coiling at our institution. Procedure-related complications, angiographic follow-up results, and clinical outcomes were analyzed statistically. The rates of initially complete and near-complete IA occlusion immediately after the procedure were similar in the LVIS and EP groups (94.3% vs. 89.9%; P = 0.275). On follow-up, complete and near-complete occlusion rates and recanalization rates were also similar in the 2 groups (96.6% vs. 92.1%; P =0.330 and 8.0% vs. 13.5%; P = 0.245, respectively). On logistic regression analysis, a higher size ratio (SR) was significantly associated with the recanalization of aneurysms in the EP group, but not in the LVIS group. The rate of moderate to severe in-stent stenosis was lower in the LVIS group (10.2%) than in the EP group (16.8%), but the difference was not statistically significant (P = 0.198). Our data show acceptable rates of complete and near-complete occlusion with both the LVIS and EP stents. LVIS stents were associated with lower rates of recanalization and in-stent stenosis, but the difference was not significant. Higher SR (≥2) was a significant predictor of recanalization in IAs treated with EP stents, but not in those treated with LVIS stents. Copyright © 2017. Published by Elsevier Inc.

The effect of stent coating on stent deliverability: direct randomised comparison of drug eluting and bare metal stents using the same stent platform.

PubMed

Siminiak, Tomasz; Link, Rafał; Wołoszyn, Maciej; Kałmucki, Piotr; Baszko, Artur

2012-01-01

There is certain experimental and clinical evidence indicating that the covering of bare metal stents (BMS) with drug eluting polymers to produce drug eluting stents (DES) results in increased stent stiffness and modifies the mechanical properties of the stent platform. In addition, it has been speculated that the mechanical performance of DES, compared to BMS, may be related to the type of polymer used to cover stents. We aimed at evaluating the deliverability of DES with a lactate based biodegradable polymer and BMS in patients with stable coronary artery disease in a prospective randomised study. One hundred eleven consecutive patients (age: 36-77, mean 58.8 years) scheduled for routine angioplasty due to stable coronary disease were randomised to receive BMS (Chopin II(TM), Balton, Poland) or paclitaxel eluting stent (Chopin Luc(TM), Balton, Poland) using the same metal platform. Only patients scheduled for angioplasty using the direct implantation technique of a single stent were randomised. The exclusion criteria included patients 〉 80 years, multivessel disease and reference diameter of the target vessel 〉 3.5 mm. In the BMS group (n = 55; 35 males and 20 females), the mean diameter of implanted stents was 3.09 ± 0.40 and the mean length was 11.37 ± 2.80, whereas in the DES group (n = 56; 34 males and 22 females) the mean stent sizes were 3.02 ± 0.34 and 17.90 ± 7.38 mm, respectively (p 〉 0.05 for length). The groups did not significantly differ regarding the frequency of stent implantation to particular coronary vessels. The direct stenting technique was attempted and failed, leading to the stents' implantation after predilatation in five patients in the BMS group and six patients in the DES group. Failure of stent implantation and subsequent implantation of another stent type was observed in no BMS patients and in one DES patient (NS). Although stent covering with lactate based drug eluting polymer may increase its stiffness, it does not affect its deliverability in patients with stable coronary disease.

Effect of endoscopic transpapillary biliary drainage with/without endoscopic sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis in patients with biliary stricture (E-BEST): a protocol for a multicentre randomised controlled trial

PubMed Central

Kato, Shin; Kuwatani, Masaki; Sugiura, Ryo; Sano, Itsuki; Kawakubo, Kazumichi; Ono, Kota; Sakamoto, Naoya

2017-01-01

Introduction The effect of endoscopic sphincterotomy prior to endoscopic biliary stenting to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis remains to be fully elucidated. The aim of this study is to prospectively evaluate the non-inferiority of non-endoscopic sphincterotomy prior to stenting for naïve major duodenal papilla compared with endoscopic sphincterotomy prior to stenting in patients with biliary stricture. Methods and analysis We designed a multicentre randomised controlled trial, for which we will recruit 370 patients with biliary stricture requiring endoscopic biliary stenting from 26 high-volume institutions in Japan. Patients will be randomly allocated to the endoscopic sphincterotomy group or the non-endoscopic sphincterotomy group. The main outcome measure is the incidence of pancreatitis within 2 days of initial transpapillary biliary drainage. Data will be analysed on completion of the study. We will calculate the 95% confidence intervals (CIs) of the incidence of pancreatitis in each group and analyse weather the difference in both groups with 95% CIs is within the non-inferiority margin (6%) using the Wald method. Ethics and dissemination This study has been approved by the institutional review board of Hokkaido University Hospital (IRB: 016–0181). Results will be submitted for presentation at an international medical conference and published in a peer-reviewed journal. Trial registration number The University Hospital Medical Information Network ID: UMIN000025727 Pre-results. PMID:28801436

Meta-analysis of long-term outcomes of drug-eluting stent implantations for chronic total coronary occlusions.

PubMed

Ma, Jian; Yang, Weiwei; Singh, Manpreet; Peng, Tianqing; Fang, Ningyuan; Wei, Meng

2011-01-01

In the treatment of chronic total occlusions (CTOs), some uncertainty exists regarding the effect of drug-eluting stents (DESs) compared with the effects of bare mental stents (BMSs). We reviewed outcomes of DES vs. BMS implantation for CTO lesions, to evaluate the risk-benefit ratio of DES implantation. Relevant studies of long-term clinical outcomes or angiographic outcomes of both BMS and DES implantation were examined. The primary endpoint comprised major adverse cardiovascular events (MACEs), including all-cause deaths, myocardial infarctions (MIs), and target lesion revascularizations (TLRs). A fixed-effect model and random-effect model were used to analyze the pooling results. Ten studies were included according to the selection criteria. Eight were nonrandomized controlled trials, and two consisted of a randomized controlled comparison between DES and BMS implantation. No significant difference was evident for in-hospital MACE rates between the two groups (odds ratio [OR], 1.07; 95% confidence interval [CI], .53 to 2.13), but the long-term MACE rates in the DES group were significantly lower than in the BMS group (OR, .22; 95% CI, .13 to .38; P < .00001). The rates of stent restenosis and reocclusions were also significantly lower in the DES group (OR, .14; 95% CI, .09 to .20; and OR, .23; 95% CI, .12 to .41, respectively). Implantation of the DES improves long-term angiographic and clinical outcomes compared with BMS in the treatment of CTO lesions. Copyright © 2011 Elsevier Inc. All rights reserved.

Comparison of the influence of plastic and fully covered metal biliary stents on the accuracy of EUS-FNA for the diagnosis of pancreatic cancer.

PubMed

Siddiqui, Ali A; Fein, Michael; Kowalski, Thomas E; Loren, David E; Eloubeidi, Mohamad A

2012-09-01

Prior studies have reported that the presence of prior biliary stent may interfere with EUS visualization of pancreatic tumors. We aimed to compare the influence of the biliary plastic and fully covered self-expanding metal stents (CSEMS) on the accuracy of EUS-FNA cytology in patients with solid pancreatic masses. We conducted a retrospective study evaluating 677 patients with solid pancreatic head/uncinate lesions and a previous biliary stent in whom EUS-FNA was performed. The patients were stratified into two groups: (1) those with a plastic stents and (2) those with CSEMS. Performance characteristics of EUS-FNA including the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were compared between the two groups. The frequency of obtaining an adequate cytology by EUS-FNA was similar in both the CSEMS group and the plastic stent group (97 vs. 97.1 % respectively; p = 1.0). The sensitivity, specificity, and accuracy of EUS-FNA was not significantly different between patients with CSEMS and plastic stents (96.8, 100, 100 % and 97.3, 98, 99.8 %, respectively). The negative predictive value for EUS-FNA was lower in the CSEMS group compared to the plastic stent group (66.6 vs. 78.1 % respectively; p = 0.42). There was one false-positive cytology in the plastic stent group compared to none in the CSEMS group. In a retrospective cohort trial, EUS-FNA was found to be highly accurate and safe in diagnosing patients with suspected pancreatic cancer, even in the presence of a plastic or metallic biliary stent. The presence of a stent did not contribute to a higher false-positive cytology rate.

Short-term outcome after stenting versus endarterectomy for symptomatic carotid stenosis: a preplanned meta-analysis of individual patient data.

PubMed

Bonati, Leo H; Dobson, Joanna; Algra, Ale; Branchereau, Alain; Chatellier, Gilles; Fraedrich, Gustav; Mali, Willem P; Zeumer, Hermann; Brown, Martin M; Mas, Jean-Louis; Ringleb, Peter A

2010-09-25

Results from randomised controlled trials have shown a higher short-term risk of stroke associated with carotid stenting than with carotid endarterectomy for the treatment of symptomatic carotid stenosis. However, these trials were underpowered for investigation of whether carotid artery stenting might be a safe alternative to endarterectomy in specific patient subgroups. We therefore did a preplanned meta-analysis of individual patient data from three randomised controlled trials. Data from all 3433 patients with symptomatic carotid stenosis who were randomly assigned and analysed in the Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial, the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) trial, and the International Carotid Stenting Study (ICSS) were pooled and analysed with fixed-effect binomial regression models adjusted for source trial. The primary outcome event was any stroke or death. The intention-to-treat (ITT) analysis included all patients and outcome events occurring between randomisation and 120 days thereafter. The per-protocol (PP) analysis was restricted to patients receiving the allocated treatment and events occurring within 30 days after treatment. In the first 120 days after randomisation (ITT analysis), any stroke or death occurred significantly more often in the carotid stenting group (153 [8·9%] of 1725) than in the carotid endarterectomy group (99 [5·8%] of 1708, risk ratio [RR] 1·53, [95% CI 1·20-1·95], p=0·0006; absolute risk difference 3·2 [1·4-4·9]). Of all subgroup variables assessed, only age significantly modified the treatment effect: in patients younger than 70 years (median age), the estimated 120-day risk of stroke or death was 50 (5·8%) of 869 patients in the carotid stenting group and 48 (5·7%) of 843 in the carotid endarterectomy group (RR 1·00 [0·68-1·47]); in patients 70 years or older, the estimated risk with carotid stenting was twice that with carotid endarterectomy (103 [12·0%] of 856 vs 51 [5·9%] of 865, 2·04 [1·48-2·82], interaction p=0·0053, p=0·0014 for trend). In the PP analysis, risk estimates of stroke or death within 30 days of treatment among patients younger than 70 years were 43 (5·1%) of 851 patients in the stenting group and 37 (4·5%) of 821 in the endarterectomy group (1·11 [0·73-1·71]); in patients 70 years or older, the estimates were 87 (10·5%) of 828 patients and 36 (4·4%) of 824, respectively (2·41 [1·65-3·51]; categorical interaction p=0·0078, trend interaction p=0·0013]. Stenting for symptomatic carotid stenosis should be avoided in older patients (age ≥70 years), but might be as safe as endarterectomy in younger patients. The Stroke Association. Copyright © 2010 Elsevier Ltd. All rights reserved.

A decade of using intraluminal tracheal/bronchial stents in the management of tracheomalacia and/or bronchomalacia: is it better than aortopexy?

PubMed

Valerie, Evans P; Durrant, Audrey C; Forte, Vito; Wales, Paul; Chait, Peter; Kim, Peter C W

2005-06-01

We compared the efficacy and clinical outcomes of aortopexy versus tracheal stents in the management of tracheomalacia. A retrospective analysis of 25 consecutive patients undergoing aortopexy (n = 11; 8 boys, 3 girls) or tracheal stents (n = 14; 9 boys, 5 girls) between 1993 and 2003 was performed. Both treatment groups, aortopexy versus stents, were comparable in their mean age of diagnosis, timing of intervention, surgical indications ("dying spell" or failed extubation), and previous underlying conditions. The operative time (190 vs 72 minutes) and blood loss (26 vs 0 mL) were significantly greater in aortopexy group (P < .01). There were no perioperative deaths in either group. Interestingly, 4 of 11 patients in the aortopexy group developed pericardial effusion (P < .01). With stents in place for a mean of 15 (range 2-41) months, 3 of 8 patients with stent removal had significant granulation tissue requiring further dilatation. No death was observed in aortopexy group, whereas 1 stent-related death and 1 cardiac arrest requiring median sternotomy occurred during stent removal in 44 and 32 months' follow-up, respectively. Both aortopexy and tracheal stents are effective treatment modalities in the management of tracheomalacia. However, although aortopexy is associated with early perioperative complications, tracheal stents are associated with higher failure rate and more severe stent-related morbidity and mortality.

Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomised trial.

PubMed

Brilakis, Emmanouil S; Edson, Robert; Bhatt, Deepak L; Goldman, Steven; Holmes, David R; Rao, Sunil V; Shunk, Kendrick; Rangan, Bavana V; Mavromatis, Kreton; Ramanathan, Kodangudi; Bavry, Anthony A; Garcia, Santiago; Latif, Faisal; Armstrong, Ehrin; Jneid, Hani; Conner, Todd A; Wagner, Todd; Karacsonyi, Judit; Uyeda, Lauren; Ventura, Beverly; Alsleben, Aaron; Lu, Ying; Shih, Mei-Chiung; Banerjee, Subhash

2018-05-19

Few studies have examined the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure compared with bare-metal stents (BMS) in patients undergoing stenting of de-novo SVG lesions. We assessed the risks and benefits of the use of DES versus BMS in de-novo SVG lesions. Patients were recruited to our double-blind, randomised controlled trial from 25 US Department of Veterans Affairs centres. Eligible participants were aged at least 18 years and had at least one significant de-novo SVG lesion (50-99% stenosis of a 2·25-4·5 mm diameter SVG) requiring percutaneous coronary intervention with intent to use embolic protection devices. Enrolled patients were randomly assigned, in a 1:1 ratio, by phone randomisation system to receive a DES or BMS. Randomisation was stratified by presence or absence of diabetes and number of target SVG lesions requiring percutaneous coronary intervention (one or two or more) within each participating site by use of an adaptive scheme intended to balance the two stent type groups on marginal totals for the stratification factors. Patients, referring physicians, study coordinators, and outcome assessors were masked to group allocation. The primary endpoint was the 12-month incidence of target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularisation. The DIVA trial is registered with ClinicalTrials.gov, number NCT01121224. Between Jan 1, 2012, and Dec 31, 2015, 599 patients were randomly assigned to the stent groups, and the data for 597 patients were used. The patients' mean age was 68·6 (SD 7·6) years, and 595 (>99%) patients were men. The two stent groups were similar for most baseline characteristics. At 12 months, the incidence of target vessel failure was 17% (51 of 292) in the DES group versus 19% (58 of 305) in the BMS group (adjusted hazard ratio 0·92, 95% CI 0·63-1·34, p=0·70). Between-group differences in the components of the primary endpoint, serious adverse events, or stent thrombosis were not significant. Enrolment was stopped before the revised target sample size of 762 patients was reached. In patients undergoing stenting of de-novo SVG lesions, no significant differences in outcomes between those receiving DES and BMS during 12 months of follow-up were found. The study results have important economic implications in countries with high DES prices such as the USA, because they suggest that the lower-cost BMS can be used in SVG lesions without compromising either safety or efficacy. US Department of Veterans Affairs Cooperative Studies Program. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

Wang Zhongmin, E-mail: wzm0722@hotmail.com; Huang Xunbo, E-mail: huangxunbo0722@hotmail.com; Cao Jun, E-mail: caojun88888@hotmail.com

Objective: This study was designed to compare the clinical effectiveness of intraluminal radioactive stent loaded with iodine-125 seeds implantation versus covered stent alone insertion in patients with malignant esophageal stricture. Methods: We studied two groups of patients with malignant esophageal stricture. Group A comprised 28 patients (19 men and 9 women) who underwent intraluminal radioactive stent loaded with iodine-125 seeds implantation and were followed prospectively. Group B comprised 30 patients (18 men and 12 women) who had previously received covered stent alone insertion; these patients were evaluated retrospectively. There was no crossover between the two groups during follow-up. Informed consentmore » was obtained from each patient, and our institutional review board approved the study. The dysphagia score, overall survival rates, complication rates, and reintervention rates were compared in the two groups. Results: There were no significant differences between the two groups in terms of baseline characteristics. Stent placement was technically successful and well tolerated in all patients. The dysphagia score was improved in both groups after stent placement. The median survival was significantly longer in group A than in group B: 11 versus 4.9 months, respectively (P < 0.001). The complications of chest pain, esophageal reflux, and stent migration was more frequent in group B, but this difference did not reach statistical significance. There was no statistical difference in reintervention between two groups. Conclusions: Intraluminal radioactive stent loaded with iodine-125 seeds implantation was a feasible and practical management in treating malignant esophageal stricture and was superior to covered stent alone insertion, as measured by survival.« less

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

PubMed

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

2014-11-01

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

Transmyocardial drilling revascularization combined with heparinized bFGF-incorporating stent activates resident cardiac stem cells via SDF-1/CXCR4 axis

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

Zhang, Guang-Wei; Wen, Ti; Gu, Tian-Xiang, E-mail: cmugtx@sina.com

Objective: To investigate whether transmyocardial drilling revascularization combined with heparinized basic fibroblast growth factor (bFGF)-incorporating degradable stent implantation (TMDRSI) can promote myocardial regeneration after acute myocardial infarction (AMI). Methods: A model of AMI was generated by ligating the mid-third of left anterior descending artery (LAD) of miniswine. After 6 h, the animals were divided into none-treatment (control) group (n = 6) and TMDRSI group (n = 6). For TMDRSI group, two channels with 3.5 mm in diameter were established by a self-made drill in the AMI region, into which a stent was implanted. Expression of stromal cell-derived factor-1{sub {alpha}} (SDF-1{submore » {alpha}}) and CXC chemokine receptor 4 (CXCR4), cardiac stem cell (CSC)-mediated myocardial regeneration, myocardial apoptosis, myocardial viability, and cardiac function were assessed at various time-points. Results: Six weeks after the operation, CSCs were found to have differentiated into cardiomyocytes to repair the infarcted myocardium, and all above indices showed much improvement in the TMDRSI group compared with the control group (P < 0.001). Conclusions: The new method has shown to be capable of promoting CSCs proliferation and differentiation into cardiomyocytes through activating the SDF-1/CXCR4 axis, while inhibiting myocardial apoptosis, thereby enhancing myocardial regeneration following AMI and improving cardiac function. This may provide a new strategy for myocardial regeneration following AMI. -- Highlights: Black-Right-Pointing-Pointer The effects of TMDR and bFGF-stent on myocardial regeneration were studied in a pig model of AMI. Black-Right-Pointing-Pointer TMDR and bFGF-stent implantation activated CSCs via the SDF-1/CXCR4 axis. Black-Right-Pointing-Pointer CSC-mediated myocardial regeneration improved cardiac function. Black-Right-Pointing-Pointer It may be a new therapeutic strategy for AMI.« less

Fully-covered metal stents with endoscopic suturing vs. partially-covered metal stents for benign upper gastrointestinal diseases: a comparative study

PubMed Central

Ngamruengphong, Saowanee; Sharaiha, Reem; Sethi, Amrita; Siddiqui, Ali; DiMaio, Christopher J.; Gonzalez, Susana; Rogart, Jason; Jagroop, Sophia; Widmer, Jessica; Im, Jennifer; Hasan, Raza Abbas; Laique, Sobia; Gonda, Tamas; Poneros, John; Desai, Amit; Wong, Katherine; Villgran, Vipin; Brewer Gutierrez, Olaya; Bukhari, Majidah; Chen, Yen-I; Hernaez, Ruben; Hanada, Yuri; Sanaei, Omid; Agarwal, Amol; Kalloo, Anthony N.; Kumbhari, Vivek; Singh, Vikesh; Khashab, Mouen A.

2018-01-01

Background and study aims  Self-expandable metallic stents (SEMS) have been increasingly used in benign conditions (e. g. strictures, fistulas, leaks, and perforations). Fully covered SEMS (FSEMS) were introduced to avoid undesirable consequences of partially covered SEMS (PSEMS), but come with higher risk of stent migration. Endoscopic suturing (ES) for stent fixation has been shown to reduce migration of FSEMS. Our aim was to compare the outcomes of FSEMS with ES (FS/ES) versus PSEMS in patients with benign upper gastrointestinal conditions. Patients and methods  We retrospectively identified all patients who underwent stent placement for benign gastrointestinal conditions at seven US tertiary-care centers. Patients were divided into two groups: FSEMS with ES (FS/ES group) and PSEMS (PSEMS group). Clinical outcomes between the two groups were compared. Results  A total of 74 (FS/ES 46, PSEMS 28) patients were included. On multivariable analysis, there was no significant difference in rate of stent migration between FS/ES (43 %) and PSEMS (15 %) (adjusted odds ratio 0.56; 95 % CI 0.15 – 2.00). Clinical success was similar [68 % vs. 64 %; P  = 0.81]. Rate of adverse events (AEs) was higher in PSEMS group [13 (46 %) vs. 10 (21 %); P  = 0.03). Difficult stent removal was higher in the PSEMS group (n = 5;17 %) vs. 0 % in the FS/ES group; P  = 0.005. Conclusions  The proportion of stent migration of FS/ES and PSEMS are similar. Rates of other stent-related AEs were higher in the PSEMS group. PSEMS was associated with tissue ingrowth or overgrowth leading to difficult stent removal, and secondary stricture formation. Thus, FSEMS with ES for stent fixation may be the preferred modality over PSEMS for the treatment of benign upper gastrointestinal conditions. PMID:29404384

Impact of stent length on clinical outcomes of first-generation and new-generation drug-eluting stents.

PubMed

Konishi, Hirokazu; Miyauchi, Katsumi; Dohi, Tomotaka; Tsuboi, Shuta; Ogita, Manabu; Naito, Ryo; Kasai, Takatoshi; Tamura, Hiroshi; Okazaki, Shinya; Isoda, Kikuo; Daida, Hiroyuki

2016-04-01

The aim of this study is to compare first- and new-generation drug-eluting stents (DESs) which are implanted in long lesion. Stent length is known to be a predictor of adverse events after percutaneous coronary intervention (PCI), even with the first-generation DESs. The introduction of new-generation DESs has reduced the rates of adverse clinical events. However, the impact of stent length on long-term clinical outcomes is not well known. A total of 1181 consecutive patients who underwent PCI using either a first-generation DES (n = 885) or a new-generation DES (n = 296) between 2004 and 2011 were investigated. In each of the stent groups, the patients were divided into two groups by stent length (>32 and ≤32 mm) and compared. During the follow-up period, the incidence of major adverse cardiac events (MACEs) was significantly higher for patients with long stents implanted than with short stents (P < 0.01; log-rank test) in the first-generation DES group. However, there was no difference in the incidence of MACEs between the long- and short-stent groups in the new-generation DES group (P = 0.24; log-rank test). On multivariate Cox regression analysis, stent length was not associated with adverse events in the new-generation DES groups [hazard ratio (HR) 0.87; 95 % confidence interval (95 % CI) 0.71-1.04; P = 0.14]. Implanted stent length was significantly associated with a higher risk of MACEs in patients who received first-generation DESs, but not in patients who received the new-generation DESs.

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

PubMed

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

2016-02-01

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

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

PubMed

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

2015-03-01

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

Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial.

PubMed

Ali, Ziad A; Maehara, Akiko; Généreux, Philippe; Shlofmitz, Richard A; Fabbiocchi, Franco; Nazif, Tamim M; Guagliumi, Giulio; Meraj, Perwaiz M; Alfonso, Fernando; Samady, Habib; Akasaka, Takashi; Carlson, Eric B; Leesar, Massoud A; Matsumura, Mitsuaki; Ozan, Melek Ozgu; Mintz, Gary S; Ben-Yehuda, Ori; Stone, Gregg W

2016-11-26

Percutaneous coronary intervention (PCI) is most commonly guided by angiography alone. Intravascular ultrasound (IVUS) guidance has been shown to reduce major adverse cardiovascular events (MACE) after PCI, principally by resulting in a larger postprocedure lumen than with angiographic guidance. Optical coherence tomography (OCT) provides higher resolution imaging than does IVUS, although findings from some studies suggest that it might lead to smaller luminal diameters after stent implantation. We sought to establish whether or not a novel OCT-based stent sizing strategy would result in a minimum stent area similar to or better than that achieved with IVUS guidance and better than that achieved with angiography guidance alone. In this randomised controlled trial, we recruited patients aged 18 years or older undergoing PCI from 29 hospitals in eight countries. Eligible patients had one or more target lesions located in a native coronary artery with a visually estimated reference vessel diameter of 2·25-3·50 mm and a length of less than 40 mm. We excluded patients with left main or ostial right coronary artery stenoses, bypass graft stenoses, chronic total occlusions, planned two-stent bifurcations, and in-stent restenosis. Participants were randomly assigned (1:1:1; with use of an interactive web-based system in block sizes of three, stratified by site) to OCT guidance, IVUS guidance, or angiography-guided stent implantation. We did OCT-guided PCI using a specific protocol to establish stent length, diameter, and expansion according to reference segment external elastic lamina measurements. All patients underwent final OCT imaging (operators in the IVUS and angiography groups were masked to the OCT images). The primary efficacy endpoint was post-PCI minimum stent area, measured by OCT at a masked independent core laboratory at completion of enrolment, in all randomly allocated participants who had primary outcome data. The primary safety endpoint was procedural MACE. We tested non-inferiority of OCT guidance to IVUS guidance (with a non-inferiority margin of 1·0 mm 2 ), superiority of OCT guidance to angiography guidance, and superiority of OCT guidance to IVUS guidance, in a hierarchical manner. This trial is registered with ClinicalTrials.gov, number NCT02471586. Between May 13, 2015, and April 5, 2016, we randomly allocated 450 patients (158 [35%] to OCT, 146 [32%] to IVUS, and 146 [32%] to angiography), with 415 final OCT acquisitions analysed for the primary endpoint (140 [34%] in the OCT group, 135 [33%] in the IVUS group, and 140 [34%] in the angiography group). The final median minimum stent area was 5·79 mm 2 (IQR 4·54-7·34) with OCT guidance, 5·89 mm 2 (4·67-7·80) with IVUS guidance, and 5·49 mm 2 (4·39-6·59) with angiography guidance. OCT guidance was non-inferior to IVUS guidance (one-sided 97·5% lower CI -0·70 mm 2 ; p=0·001), but not superior (p=0·42). OCT guidance was also not superior to angiography guidance (p=0·12). We noted procedural MACE in four (3%) of 158 patients in the OCT group, one (1%) of 146 in the IVUS group, and one (1%) of 146 in the angiography group (OCT vs IVUS p=0·37; OCT vs angiography p=0·37). OCT-guided PCI using a specific reference segment external elastic lamina-based stent optimisation strategy was safe and resulted in similar minimum stent area to that of IVUS-guided PCI. These data warrant a large-scale randomised trial to establish whether or not OCT guidance results in superior clinical outcomes to angiography guidance. St Jude Medical. Copyright © 2016 Elsevier Ltd. All rights reserved.

Local delivery of sirolimus nanoparticles for the treatment of in-stent restenosis.

PubMed

Zago, Alexandre C; Raudales, José C; Attizzani, Guilherme; Matte, Bruno S; Yamamoto, German I; Balvedi, Julise A; Nascimento, Ludmila; Kosachenco, Beatriz G; Centeno, Paulo R; Zago, Alcides J

2013-02-01

To test the local delivery of sirolimus nanoparticles following percutaneous transluminal coronary angioplasty (PTCA) to treat in-stent restenosis (ISR) in a swine model. Coronary bare-metal stent (BMS) implantation reduces major adverse cardiac events when compared with PTCA; however, ISR rates remain high. Eighteen swine underwent BMS deployment guided by intravascular ultrasound (IVUS). Of these, 16 developed ISR (1 stent/swine) and underwent angioplasty with a noncompliant balloon (PTCA-NC). The animals were then randomized into four groups for local infusion of sirolimus nanoparticles through a porous balloon catheter, as follows: (1) PTCA-NC alone (control); (2) PTCA-NC + (polylactic acid)-based nanoparticle formulation (anionic 1); (3) PTCA-NC + (polylactic-co-glycolic acid)-based nanoparticle formulation (anionic 2); and (4) PTCA-NC + Eudragit RS nanoparticle formulation (cationic). Coronary angiography and IVUS follow-up were performed 28 days after ISR treatment. There was one episode of acute coronary occlusion with the cationic formulation. Late area loss was similar in all groups at 28 days according to IVUS. However, luminal volume loss (control = 20.7%, anionic 1 = 4.0%, anionic 2 = 6.7%, cationic = 9.6%; P = 0.01) and neointimal volume gain (control = 68.7%, anionic 1 = 17.4%, anionic 2 = 29.5%, cationic = 31.2%; P = 0.019) were significantly reduced in all treatment groups, especially in anionic 1. PTCA-NC followed by local infusion of sirolimus nanoparticles was safe and efficacious to reduce neointima in this model, and this strategy may be a promising treatment for BMS ISR. Further studies are required to validate this method in humans. Copyright © 2012 Wiley Periodicals, Inc.

Covered versus Uncovered Self-Expandable Metal Stents for Managing Malignant Distal Biliary Obstruction: A Meta-Analysis

PubMed Central

Sun, Ping; Yu, Qihong; Wang, Kun; Chang, Weilong; Song, Zifang; Zheng, Qichang

2016-01-01

Aim To compare the efficacy of using covered self-expandable metal stents (CSEMSs) and uncovered self-expandable metal stents (UCSEMSs) to treat objective jaundice caused by an unresectable malignant tumor. Methods We performed a comprehensive electronic search from 1980 to May 2015. All randomized controlled trials comparing the use of CSEMSs and UCSEMSs to treat malignant distal biliary obstruction were included. Results The analysis included 1417 patients enrolled in 14 trials. We did not detect significant differences between the UCSEMS group and the CSEMS group in terms of cumulative stent patency (hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.19–4.53; p = 0.93, I2 = 0%), patient survival (HR 0.77, 95% CI 0.05–10.87; p = 0.85, I2 = 0%), overall stent dysfunction (relative ratio (RR) 0.85, M-H, random, 95% CI 0.57–1.25; p = 0.83, I2 = 63%), the overall complication rate (RR 1.26, M-H, fixed, 95% CI 0.94–1.68; p = 0.12, I2 = 0%) or the change in serum bilirubin (weighted mean difference (WMD) -0.13, IV fixed, 95% CI 0.56–0.3; p = 0.55, I2 = 0%). However, we did detect a significant difference in the main causes of stent dysfunction between the two groups. In particular, the CSEMS group exhibited a lower rate of tumor ingrowth (RR 0.25, M-H, random, 95% CI 0.12–0.52; p = 0.002, I2 = 40%) but a higher rate of tumor overgrowth (RR 1.76, M-H, fixed, 95% CI 1.03–3.02; p = 0.04, I2 = 0%). Patients with CSEMSs also exhibited a higher migration rate (RR 9.33, M-H, fixed, 95% CI 2.54–34.24; p = 0.008, I2 = 0%) and a higher rate of sludge formation (RR 2.47, M-H, fixed, 95% CI 1.36–4.50; p = 0.003, I2 = 0%). Conclusions Our meta-analysis indicates that there is no significant difference in primary stent patency and stent dysfunction between CSEMSs and UCSEMSs during the period from primary stent insertion to primary stent dysfunction or patient death. However, when taking further management for occluded stents into consideration, CSEMSs is a better choice for patients with malignant biliary obstruction due to their removability. PMID:26859673

Safety Outcomes Using a Proximal Protection Device in Carotid Stenting of Long Carotid Stenoses

PubMed Central

Atchaneeyasakul, Kunakorn; Khandelwal, Priyank; Ambekar, Sudheer; Ramdas, Kevin; Guada, Luis; Yavagal, Dileep

2016-01-01

Background Embolic protection devices can prevent atherosclerotic emboli during carotid stenting. Newer proximal protection devices reverse flow in the internal carotid artery (ICA), leading to reduction in perioperative microemboli. The risk of stroke is high for carotid stenting of ICA lesions with a length >10 mm and/or angiographic string sign. Objective We aimed to evaluate the safety outcomes of proximal embolic protection device usage in this high-risk group. Methods This is a retrospective analysis of patients who underwent carotid stenting procedures with proximal embolic protection devices at a tertiary care center. High-risk features for adverse events with carotid stenting were identified. Peri- and postprocedural outcomes were recorded. We further compared outcomes in patients with a carotid stenosis length >10 mm to those with shorter stenosis. Results From January 2011 to December 2014, we included 27 patients; 96.3% were symptomatic and 3.7% were asymptomatic. There was a stent placement technical success rate of 100%. No major stroke or coronary events were recorded. One minor stroke event developed in one patient. A carotid lesion length >10 mm and/or angiographic string sign was noted in 21/27 patients, with an average lesion length of 14.4 mm. One patient (4.8%) in this group developed a minor stroke event. Neither a coronary nor a major stroke event was recorded in this group. There was no significant difference in the complication rate between the long lesion and the control group. Conclusion In our patient cohort, it was found that a proximal embolic protection device is safe for patients with carotid stenosis, including those with a carotid lesion length >10 mm and/or angiographic string sign. PMID:27781040

First-in-man study evaluating the safety and efficacy of a second generation biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo coronary lesions: clinical, Angiographic, and OCT outcomes of CREDIT-1.

PubMed

Wang, Geng; Sun, Zhongwei; Jin, Quanmin; Xu, Kai; Li, Yi; Wang, Xiaozeng; Ma, Yingyan; Liu, Haiwei; Zhao, Xin; Wang, Bin; Deng, Jie; Guan, Shaoyi; Ge, Meiling; Wang, Xiaoyan; Xu, Bo; Han, Yaling

2015-03-01

To evaluate the preliminary safety and efficacy of the EXCEL II stent system. Although the first biodegradable polymer drug-eluting stent (BP-DES), EXCEL, was launched nearly a decade ago, in-stent restenosis and stent thrombosis remain pertinent clinical problems in practice. A new cobalt-chromium BP-DES EXCEL II has been developed with the aim of improving stent safety and efficacy. Forty-five patients with single de novo native coronary lesions were enrolled and randomized to two groups in a 2:1 ratio, the 4-month follow-up group (n = 30) and the 12-month follow-up group (n = 15). All patients underwent percutaneous coronary intervention (PCI) with the EXCEL II stent system. Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) were used to assess coronary vasculature at the designated 4- or 12-month follow-up. The primary outcome was major adverse cardiac events (MACE) at 30 days post-PCI. No MACE, thrombotic events, or target lesion failure was found in the 45 patients during the 12-month follow-up. There was no significant difference (P > 0.05) between the two groups in terms of in-stent and in-segment late lumen loss (LLL). No in-stent and in-segment restenosis was found in either group. At follow-up, the ratio of >10% uncovered struts per lesion was 26.67% in the 4-month group and 0% in the 12-month group (P < 0.05). Neointimal coverage in the 12-month group was significantly better than in the 4-month group (98.58% vs. 93.51%, P < 0.01). This first-in-man study demonstrates promising feasibility, safety, and efficacy of EXCEL II stents. These stents were found to have rapid endothelialization and low LLL rates at 4 and 12 months after implantation. © 2015 Wiley Periodicals, Inc.

Self-expandable metallic stent as a bridge to elective surgery versus emergency surgery for acute malignant colorectal obstruction.

PubMed

Li, Zhi-Xiong; Wu, Xiao-Hua; Wu, Hai-yan; Chang, Wen-Ju; Chang, Xiu-juan; Yi, Tuo; Shi, Qiang; Chen, Jing-Wen; Feng, Qing-Yang; Zhu, De-Xiang; Wei, Ye; Zhong, Yun-Shi; Xu, Jian-Min

2016-03-01

The efficacy and safety of self-expandable metallic stents (SEMSs) as a bridge for patients with acute malignant colorectal obstructions (AMCOs) are still controversial. We conducted this study to evaluate the outcomes of patients with AMCOs treated by different strategies. From January 2010 to March 2014, a total of 171 patients with AMCOs from Zhongshan Hospital were retrospectively enrolled in this study. One hundred twenty patients successfully received stent placement followed by one-stage laparoscopic or open resection in the stent group, and 51 patients received emergency operations in the emergency group. The operation duration and postoperative hospital stay were significantly shorter in the stent group (114.51 ± 28.65 vs. 160.39 ± 58.94 min, P < 0.001; 8.00 ± 3.97 vs. 12.59 ± 9.07 days, P = 0.001). The stent group also had significantly reduced intraoperative blood loss and the incidence of postoperative complications compared with the emergency group (61.00 ± 43.70 vs. 121.18 ± 85.90 ml, P < 0.001; 16.7 vs. 37.3%, P = 0.003). Kaplan-Meier survival curves showed that the median survival time in the stent group was significantly longer than that in the emergency group (53 vs. 41 months, P = 0.034). In subgroup analysis of stent group, the stent laparoscopy group had significantly decreased postoperative complications (P = 0.025), and similar long-term survival (P = 0.81). Stent placement as a bridge to surgery is a safe and feasible procedure and provides significant advantages in terms of short-term outcomes and favorable prognoses for patients with AMCOs. Laparoscopic surgery could be considered as an optimal treatment after stent placement.

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

PubMed

Fayers, Tessa; Dolman, Peter J

2016-10-01

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

Esophageal stent fixation with endoscopic suturing device improves clinical outcomes and reduces complications in patients with locally advanced esophageal cancer prior to neoadjuvant therapy: a large multicenter experience.

PubMed

Yang, Juliana; Siddiqui, Ali A; Kowalski, Thomas E; Loren, David E; Khalid, Ammara; Soomro, Ayesha; Mazhar, Syed M; Rosé, Julian; Isby, Laura; Kahaleh, Michel; Kalra, Ankush; Sarkisian, Alex M; Kumta, Nikhil A; Nieto, Jose; Sharaiha, Reem Z

2017-03-01

Endoscopic placement of fully covered self-expanding metal stents (FCSEMS) to treat malignant dysphagia in patients with esophageal cancer significantly improves dysphagia; however, these stents have a high migration rate. To determine whether FCSEMS fixation using an endoscopic suturing device treated malignant dysphagia and prevented stent migration in patients with locally advanced esophageal cancer receiving neoadjuvant therapy when compared to patients with FCSEMS placement alone. A review of patients with locally advanced esophageal cancer who underwent FCSEMS placement at 3 centers was performed. Patients were divided into two groups: Group A (n = 26) was composed of patients who underwent FCSEMS placement with suture placement, and Group B (n = 67) was composed of patients with FCSEMS placement alone. There were no significant differences between Groups A and B in demographics, and tumor characteristics. The technical success rate for stent placement was 100 %. There was no difference between Groups A and B in the median stent diameter and stent lengths. Mean dysphagia score obtained at 1 week after stent placement had improved significantly from baseline (2.4 and 1, respectively, p < 0.001). Patients had a median follow-up of 4 months. Immediate adverse events were mild chest discomfort in 4 patients in Group A and 2 patients in Group B (p = 0.05), and significant acid reflux in 3 patient in Group A compared to 2 patients in Group B (p = 0.1). The stent migration rate was significantly lower in Group A compared to compared to Group B (7.7 vs 26.9 %, respectively, p = 0.004). There was a delayed perforation in 1 patient and 1 death due to aspiration pneumonia in Group B. Fixation of esophageal FCSEMSs by using an endoscopic suturing device in patients receiving neoadjuvant therapy was shown to be feasible, safe, and relatively effective at preventing stent migration compared to those who had stent placed alone.

The outcome of extracorporeal shockwave lithotripsy for renal pelvic stone with and without JJ stent--a comparative study.

PubMed

Mohayuddin, Nazim; Malik, Hamad Afzal; Hussain, Manzoor; Tipu, Salman Ahmed; Shehzad, Asad; Hashmi, Altaf; Naqvi, Syed Ali Anwar; Rizvi, Syed Adibul Hasan

2009-03-01

To compare the outcome of Extra corporeal shockwave lithotripsy for a renal pelvic stone with and without JJ stent. A comparative cross sectional study was carried out at Sindh Institute of Urology and Transplantation from January 2007 to January 2008. Eighty patients with renal pelvic stone measuring 2cm +/- 2mm were selected for treatment with Extra Corporeal Shockwave Lithotripsy (ESWL). All of these patients were adults with normal renal function and had unilateral renal stones with negative urine cultures. Patients with renal failure and children were excluded. They were divided into two groups of 40 each. Group A patients underwent ESWL without a JJ stent and in Group B a JJ stent was placed before ESWL. SLX F2 electromagnetic ESWL machine was used to impart shock waves. 3000 shockwaves were given in a session. Both the groups were compared for renal colic, steinstrasse, fever, lower urinary tract symptoms (LUTS) emergency room visits and hospital admissions, stone clearance, number of ESWL sessions, auxilliary procedures, (percutaneous nephrostomy or ureterorenoscopy) and cost. Ureteric colic occurred in 13 (32.5%) patients in group A and in 3 (7.5%) patient in group B. Steinstrasse developed in 4 (10%) patients with out JJ stent and in 3 (7.5%) patients with JJ stent. Fever was encountered in 1 (2.5%) patient in group A and in 3 (7.5%) patient in group B. Mean emergency room visits were 2.1 per patient in group A and 0.7 per patient in group B. Stone clearance occurred in 33 (82.5%) patients in group A and 31 (77.5%) in group B. In group B lower urinary tract symptoms were found in 50% versus 20% in group A. Auxillary procedure was performed in one (2.5%) patient each in both groups. Pre ESWL JJ stenting for a 2 cm +/- 2 mm renal stone was not beneficial in terms of steinstrasse, fever, stone clearance and number of ESWL sessions. However ureteric colic was significantly less in the stented group. Lower urinary tract symptoms (LUTS) was also significantly high in the patients having a JJ stent. The cost of the treatment doubled in the stented group which is an important factor in our country. JJ stenting does not prove to be a cost effective procedure when compared to the reduction in complications.

Endovascular image-guided treatment of in-vivo model aneurysms with asymmetric vascular stents (AVS): evaluation with time-density curve angiographic analysis and histology.

PubMed

Dohatcu, A; Ionita, C N; Paciorek, A; Bednarek, D R; Hoffmann, K R; Rudin, S

2008-01-01

In this study, we compare the results obtained from Time-Density Curve (TDC) analysis of angiographic imaging sequences with histological evaluation for a rabbit aneurysm model treated with standard stents and new asymmetric vascular stents (AVS) placed by image-guided endovascular deployment. AVSs are stents having a low-porosity patch region designed to cover the aneurysm neck and occlude blood flow inside. To evaluate the AVSs, rabbits with elastase-induced aneurysm models (n=20) were divided into three groups: the first (n=10) was treated with an AVS, the second (n=5) with a non-patch standard coronary stent, and third was untreated as a control (n=5). We used TDC analysis to measure how much contrast media entered the aneurysm before and after treatment. TDCs track contrast-media-density changes as a function of time over the region of interest in x-ray DSA cine-sequences. After 28 days, the animals were sacrificed and the explanted specimens were histologically evaluated. The first group showed an average reduction of contrast flow into the aneurysm of 95% after treatment with an AVS with fully developed thrombus at 28 days follow-up. The rabbits treated with standard stents showed an increase in TDC residency time after treatment and partial-thrombogenesis. The untreated control aneurysms displayed no reduction in flow and were still patent at follow-up. The quantitative TDC analysis findings were confirmed by histological evaluation suggesting that the new AVS has great potential as a definitive treatment for cerebro-vascular aneurysms and that angiographic TDC analysis can provide in-vivo verification.

Endovascular image-guided treatment of in-vivo model aneurysms with asymmetric vascular stents (AVS): evaluation with time-density curve angiographic analysis and histology

PubMed Central

Dohatcu, A.; Ionita, C. N.; Paciorek, A.; Bednarek, D. R.; Hoffmann, K. R.; Rudin, S.

2008-01-01

In this study, we compare the results obtained from Time-Density Curve (TDC) analysis of angiographic imaging sequences with histological evaluation for a rabbit aneurysm model treated with standard stents and new asymmetric vascular stents (AVS) placed by image-guided endovascular deployment. AVSs are stents having a low-porosity patch region designed to cover the aneurysm neck and occlude blood flow inside. To evaluate the AVSs, rabbits with elastase-induced aneurysm models (n=20) were divided into three groups: the first (n=10) was treated with an AVS, the second (n=5) with a non-patch standard coronary stent, and third was untreated as a control (n=5). We used TDC analysis to measure how much contrast media entered the aneurysm before and after treatment. TDCs track contrast-media-density changes as a function of time over the region of interest in x-ray DSA cine-sequences. After 28 days, the animals were sacrificed and the explanted specimens were histologically evaluated. The first group showed an average reduction of contrast flow into the aneurysm of 95% after treatment with an AVS with fully developed thrombus at 28 days follow-up. The rabbits treated with standard stents showed an increase in TDC residency time after treatment and partial-thrombogenesis. The untreated control aneurysms displayed no reduction in flow and were still patent at follow-up. The quantitative TDC analysis findings were confirmed by histological evaluation suggesting that the new AVS has great potential as a definitive treatment for cerebro-vascular aneurysms and that angiographic TDC analysis can provide in-vivo verification. PMID:18958295

Outcomes of Prosthetic Hemodialysis Grafts after Deployment of Bare Metal versus Covered Stents at the Venous Anastomosis

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

Kim, Charles Y., E-mail: charles.kim@duke.edu; Tandberg, Daniel J.; Rosenberg, Michael D.

2012-08-15

Purpose: To compare postintervention patency rates after deployment of bare metal versus covered stents across the venous anastomosis of prosthetic arteriovenous (AV) grafts. Methods: Review of our procedural database over a 6 year period revealed 377 procedures involving stent deployment in an AV access circuit. After applying strict inclusion criteria, our study group consisted of 61 stent deployments in 58 patients (median age 58 years, 25 men, 33 women) across the venous anastomosis of an upper extremity AV graft circuit that had never been previously stented. Both patent and thrombosed AV access circuits were retrospectively analyzed. Within the bare metalmore » stent group, 20 of 32 AV grafts were thrombosed at initial presentation compared to 18 of 29 AV grafts in the covered stent group. Results: Thirty-two bare metal stents and 29 covered stents were deployed across the venous anastomosis. The 3, 6, and 12 months primary access patency rates for bare metal stents were not significantly different than for covered stents: 50, 41, and 22 % compared to 59, 52, and 29 %, respectively (p = 0.21). The secondary patency rates were also not significantly different: 78, 78, and 68 % for bare metal stents compared to 76, 69, and 61 % for covered stents, respectively (p = 0.85). However, covered stents demonstrated a higher primary stent patency rate than bare metal stents: 100, 85, and 70 % compared to 75, 67, and 49 % at 3, 6, and 12 months (p < 0.01). Conclusion: The primary and secondary access patency rates after deployment of bare metal versus covered stents at the venous anastomosis were not significantly different. However, bare metal stents developed in-stent stenoses significantly sooner.« less

[Effect of axial stress stimulation on tibial and fibular open fractures healing after Taylor space stent fixation].

PubMed

Ge, Qihang; Wan, Chunyou; Liu, Yabei; Ji, Xu; Ma, Jihai; Cao, Haikun; Yong, Wei; Liu, Zhao; Zhang, Ningning

2017-08-01

To investigate the effect of axial stress stimulation on tibial and fibular open fractures healing after Taylor space stent fixation. The data of 45 cases with tibial and fibular open fractures treated by Taylor space stent fixation who meet the selection criteria between January 2015 and June 2016 were retrospectively analysed. The patients were divided into trial group (23 cases) and control group (22 cases) according to whether the axial stress stimulation was performed after operation. There was no significant difference in gender, age, affected side, cause of injury, type of fracture, and interval time from injury to operation between 2 groups ( P >0.05). The axial stress stimulation was performed in trial group after operation. The axial load sharing ratio was tested, and when the value was less than 10%, the external fixator was removed. The fracture healing time, full weight-bearing time, and external fixator removal time were recorded and compared. After 6 months of external fixator removal, the function of the limb was assessed by Johner-Wruhs criteria for evaluation of final effectiveness of treatment of tibial shaft fractures. There were 2 and 3 cases of needle foreign body reaction in trial group and control group, respectively, and healed after symptomatic anti allergic treatment. All the patients were followed up 8-12 months with an average of 10 months. All the fractures reached clinical healing, no complication such as delayed union, nonunion, or osteomyelitis occurred. The fracture healing time, full weight-bearing time, and external fixator removal time in trial group were significantly shorter than those in control group ( P <0.05). After 6 months of external fixator removal, the function of the limb was excellent in 13 cases, good in 6 cases, fair in 3 cases, and poor in 1 case in trial group, with an excellent and good rate of 82.6%; and was excellent in 5 cases, good in 10 cases, fair in 4 cases, and poor in 3 cases in control group, with an excellent and good rate of 68.2%, showing significant difference between 2 groups ( Z =-2.146, P =0.032). The axial stress stimulation of Taylor space stent fixation can promote the healing of tibial and fibular open fractures and promote local bone formation at fracture site.

[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.

Dynamic Y stent fractures in crescentic tracheobronchomalacia.

PubMed

Popilevsky, Frida; Al-Ajam, Mohammad R; Ly, Vanthanh; Sanchez, Lisette Delgado; Cutaia, Michael

2012-07-01

Endobronchial stents have been used occasionally to treat benign conditions such as tracheobronchomalacia (TBM). This report describes a unique case of a patient with crescentic TBM in whom Dynamic Y stent was placed on 2 separate occasions to control symptoms and resulted in identical posterior wall stent fractures within a year of stent placement, both times. A silicone Y stent was substituted for the dynamic stent, and it has been effective in controlling symptoms for 9 months without complications. A literature review of cases of fractured Dynamic Y stents is made and factors affecting the choice of stent type for crescentic TBM are explored.

Self-Expandable Nitinol Stent Placement in Homocysteinemic Porcine Aorta

PubMed Central

França, Luís Henrique Gil; Pereira, Adamastor Humberto; Perini, Sílvio César

2008-01-01

PURPOSE To compare aortic intimal thickening of normal and hyperhomocysteinemic pigs (induced with a methionine-rich diet) following placement of a self-expanding nitinol stent. METHODS Eighteen Macau pigs were used. They were older than eight weeks in age and had an average weight of 30 kg. Pigs were randomly divided into two groups. The first, Group C (control), was fed a regular diet, and the second group, Group M, was fed a methionine-rich diet for 30 days to induce hyperhomocysteinemia. The self-expandable nitinol stents were 25mm in length and 8 mm in diameter after expansion. Blood samples were collected to measure total cholesterol, triglycerides, HDL and homocysteine concentrations. All animals were subjected to angiography. Thirty days after the procedure, the animals were sacrificed, and the abdominal aorta was removed for histological and digital morphometry analysis. RESULTS Under microscopic evaluation, the intima was significantly thicker in Group C than in Group M. When groups were compared by digital morphometric analysis, intimal thickening of the vessel wall was higher in Group C than in Group M. There was no significant change in total cholesterol, triglycerides or HDL concentrations in either group. In group C the levels of plasma homocysteine ranged from 14,40 to 16,73μmol/l; in Group M, plasma homocysteine levels ranged from 17.47 to 59.80 μmol/l after 30 days of a methionine-rich diet. CONCLUSION Compared to normal pigs, less intimal hyperplasia was observed in the abdominal aortas of hyperhomocysteinemic pigs thirty days after the insertion of a self-expandable nitinol stent. PMID:18438578

Clinical benefits and oncologic equivalence of self-expandable metallic stent insertion for right-sided malignant colonic obstruction.

PubMed

Ji, Woong Bae; Kwak, Jung Myun; Kang, Dong Woo; Kwak, Han Deok; Um, Jun Won; Lee, Sun-Il; Min, Byung-Wook; Sung, Nak Song; Kim, Jin; Kim, Seon Hahn

2017-01-01

The efficacy of stenting for right-sided malignant colonic obstruction is unknown. This study aimed to evaluate the safety, feasibility, and clinical benefits of self-expandable metallic stent insertion for right-sided malignant colonic obstruction. Clinical data from patients who underwent right hemicolectomy for right colon cancer from January 2006 to July 2014 at three Korea University hospitals were retrospectively reviewed. A total of 39 patients who developed malignant obstruction in the right-sided colon were identified, and their data were analyzed. Stent insertion was attempted in 16 patients, and initial technical success was achieved in 14 patients (87.5 %). No stent-related immediate complications were reported. Complete relief from obstruction was achieved in all 14 patients. Twenty-five patients, including two patients who failed stenting, underwent emergency surgery. In the stent group, 93 % (13/14) of patients underwent elective laparoscopic surgery, and only one surgery was converted to an open procedure. All patients in the emergency group underwent emergency surgery within 24 h of admission. In the emergency group, only 12 % (3/25) of patients underwent laparoscopic surgery, with one surgery converted to an open procedure. All patients in both groups underwent either laparoscopy-assisted or open right/extended right hemicolectomy with primary anastomoses as the first operation. The operative times, retrieved lymph nodes, and pathologic stage did not differ between the two groups. Postoperative hospital stay (9.4 ± 3.4 days in the stent group vs. 12.4 ± 5.9 in the emergency group, p = 0.089) and time to resume oral food intake (3.2 ± 2.1 days in the stent group vs. 5.7 ± 3.4 in the emergency group, p = 0.019) were shorter in the stent group. And there were no significant differences in disease-free survival and overall survival between the two groups. Stent insertion appears to be safe and feasible in patients with right-sided colonic malignant obstruction. It facilitates minimally invasive surgery and may result in better short-term surgical outcomes.

A prospective randomised trial comparing the novel ridaforolimus-eluting BioNIR stent to the zotarolimus-eluting Resolute stent: six-month angiographic and one-year clinical results of the NIREUS trial.

PubMed

Paradies, Valeria; Ben-Yehuda, Ori; Jonas, Michael; Banai, Shmuel; Iñiguez, Andres; Perlman, Gidon Y; Kandzari, David E; Stone, Gregg W; Smits, Pieter C

2018-05-20

The aim of this study was to evaluate the efficacy and safety of the BioNIR stent compared with the Resolute Integrity stent for the treatment of coronary artery disease. This first-in-human, multicentre, single-blind randomised non-inferiority trial was performed in Europe and Israel. Patients with stable coronary artery disease or acute coronary syndromes were randomly assigned to treatment with BioNIR or Resolute Integrity stents in a 2:1 fashion. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Three hundred and two patients were randomised, of whom 261 (86.0%) underwent six-month angiographic follow-up. The BioNIR stent was non-inferior to the Resolute Integrity stent for the primary endpoint of in-stent LLL at six months (0.04±0.30 mm vs. 0.03±0.31 mm, respectively, pnoninferiority<0.0001). At 12-month follow-up, target lesion failure occurred in 3.4% in the BioNIR group and 5.9% in the Resolute Integrity group (p=0.22). Rates of MACE were similar between the BioNIR and Resolute Integrity groups (4.3% vs. 5.9%, respectively, p=0.45). The BioNIR stent was non-inferior to the Resolute Integrity stent for the primary endpoint of angiographic in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups.

Peri-interventional antibiotic prophylaxis only vs continuous low-dose antibiotic treatment in patients with JJ stents: a prospective randomised trial analysing the effect on urinary tract infections and stent-related symptoms.

PubMed

Moltzahn, Felix; Haeni, Katharina; Birkhäuser, Frédéric D; Roth, Beat; Thalmann, George N; Zehnder, Pascal

2013-02-01

To evaluate the antibiotic treatment regime in patients with indwelling JJ stents, the benefits and disadvantages of a peri-interventional antibiotic prophylaxis were compared with those of a continuous low-dose antibiotic treatment in a prospective randomised trial. In all, 95 patients were randomised to either receive peri-interventional antibiotic prophylaxis during stent insertion only (group A, 44 patients) or to additionally receive a continuous low-dose antibiotic treatment until stent removal (group B, 51). Evaluations for urinary tract infections (UTI), stent-related symptoms (SRSs) and drug side-effects were performed before stent insertion and consecutively after 1, 2 and 4 weeks and/or at stent withdrawal. All patients received a peri-interventional antibiotic prophylaxis with 1.2 g amoxicillin/clavulanic acid. Amoxicillin/clavulanic acid (625 mg) once daily was administered for continuous low-dose treatment (group B). Primary endpoints were the overall rates of UTIs and SRSs. Secondary endpoints were the rates and severity of drug side-effects. Neither the overall UTI rates (group A: 9% vs group B: 10%), nor the rates of febrile UTIs (group A: 7% vs group B: 6%) were different between the groups. Similarly, SRS rates did not differ (group A: 98% vs group B: 96%). Antibiotic side-effect symptoms were to be increased in patients treated with low-dose antibiotics. A continuous antibiotic low-dose treatment during the entire JJ stent-indwelling time does not reduce the quantity or severity of UTIs and has no effect on SRSs either compared with a peri-interventional antibiotic prophylaxis only. © 2012 BJU International.

Comparison of Long-Term Clinical Outcomes of Lesions Exhibiting Focal and Segmental Peri-Stent Contrast Staining.

PubMed

Tokuda, Takahiro; Yamawaki, Masahiro; Takahara, Mitsuyohi; Mori, Shinsuke; Makino, Kenji; Honda, Yosuke; Takafuji, Hiroya; Takama, Takuro; Tsutsumi, Masakazu; Sakamoto, Yasunari; Takimura, Hideyuki; Kobayashi, Norihiro; Araki, Motoharu; Hirano, Keisuke; Ito, Yoshiaki

2016-03-18

Peri-stent contrast staining (PSS) after metallic drug-eluting stent deployment is associated with target lesion revascularization and very late stent thrombosis. However, the type of PSS that influences the clinical outcomes is unknown. Therefore, we aimed to reveal which PSS type was influencing clinical outcomes. This study included 5580 de novo lesions of 4405 patients who were implanted with a first- or second-generation drug-eluting stent and who were evaluated using follow-up angiography within 12 months after stent implantation. We compared the clinical outcomes of patients divided into focal PSS and segmental PSS groups for 6 years after stent implantation. Total PSS was observed in 97 lesions (2.2%), of which 42 and 55 lesions were focal and segmental PSS, respectively. Baseline characteristics were similar between groups, except for intraoperative chronic total occlusion (segmental PSS=47.3% versus focal PSS=11.9%, P=0.0001). The incidence of segmental PSS tended to be higher in patients with a first-generation drug-eluting stent (83.6% versus 16.4%, P=0.05). The cumulative incidence of stent thrombosis in the 6 years of segmental PSS group was significantly higher than that of the focal PSS group (13.9% versus 0%, P=0.04). The cumulative incidence of overall target lesion revascularization for restenosis, excluding target lesion revascularization procedures for stent thrombosis, was significantly higher in the segmental PSS group (38.0% versus 0%, P=0.01). The incidence of segmental PSS tended to be higher in patients with a first-generation drug-eluting stent and appeared to be significantly associated with target lesion revascularization and stent thrombosis. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Percutaneous stent placement for the treatment of malignant biliary obstruction: nitinol versus elgiloy stents.

PubMed

Zurstrassen, Charles Edouard; Bitencourt, Almir Galvão Vieira; Guimaraes, Marcos Duarte; Cavalcante, Aline Cristine Barbosa Santos; Tyng, Chiang Jeng; Amoedo, Mauricio Kauark; Matsushita Junior, João Paulo Kawaoka; Szklaruk, Janio; Marchiori, Edson; Chojniak, Rubens

2017-01-01

This study aimed to compare two self-expanding stents, a nitinol stent and an elgiloy stent, both placed percutaneously, in terms of their efficacy in palliating inoperable malignant biliary obstruction. We retrospectively investigated 99 patients with unresectable malignant biliary obstruction treated with percutaneous placement of a self-expanding metallic stent at our institution between May 2007 and January 2010. Serum bilirubin and liver enzyme levels were measured before and 30 days after stenting. For all procedures using elgiloy or nitinol stents, stent occlusion and patient survival rates were calculated using Kaplan-Meyer analysis. All of the patients showed clinical improvement after stent placement, with no difference between the two groups. In both groups, the occlusion-free survival rate was 67% at 30 days, 37% at 90 days, 25% at 180 days, and 10% at 360 days, with no significant difference in relation to the type of stent. The two stents evaluated showed comparable efficacy for the percutaneous treatment of unresectable biliary malignancy, with good clinical results.

Comparison between uncovered and covered self-expandable metal stent placement in malignant duodenal obstruction.

PubMed

Kim, Ji Won; Jeong, Ji Bong; Lee, Kook Lae; Kim, Byeong Gwan; Ahn, Dong Won; Lee, Jae Kyung; Kim, Su Hwan

2015-02-07

To compare the clinical outcomes of uncovered and covered self-expandable metal stent placements in patients with malignant duodenal obstruction. A total of 67 patients were retrospectively enrolled from January 2003 to June 2013. All patients had symptomatic obstruction characterized by nausea, vomiting, reduced oral intake, and weight loss. The exclusion criteria included asymptomatic duodenal obstruction, perforation or peritonitis, concomitant small bowel obstruction, or duodenal obstruction caused by benign strictures. The technical and clinical success rate, complication rate, and stent patency were compared according to the placement of uncovered (n = 38) or covered (n = 29) stents. The technical and clinical success rates did not differ between the uncovered and covered stent groups (100% vs 96.6% and 89.5% vs 82.8%). There were no differences in the overall complication rates between the uncovered and covered stent groups (31.6% vs 41.4%). However, stent migration occurred more frequently with covered than uncovered stents [20.7% (6/29) vs 0% (0/38), P < 0.05]. Moreover, the overall cumulative median duration of stent patency was longer in uncovered than in covered stents [251 d (95%CI: 149.8 d-352.2 d) vs 139 d (95%CI: 45.5 d-232.5 d), P < 0.05 by log-rank test] The overall cumulative median survival period was not different between the uncovered stent (70 d) and covered stent groups (60 d). Uncovered stents may be preferable in malignant duodenal obstruction because of their greater resistance to stent migration and longer stent patency than covered stents.

Comparison between uncovered and covered self-expandable metal stent placement in malignant duodenal obstruction

PubMed Central

Kim, Ji Won; Jeong, Ji Bong; Lee, Kook Lae; Kim, Byeong Gwan; Ahn, Dong Won; Lee, Jae Kyung; Kim, Su Hwan

2015-01-01

AIM: To compare the clinical outcomes of uncovered and covered self-expandable metal stent placements in patients with malignant duodenal obstruction. METHODS: A total of 67 patients were retrospectively enrolled from January 2003 to June 2013. All patients had symptomatic obstruction characterized by nausea, vomiting, reduced oral intake, and weight loss. The exclusion criteria included asymptomatic duodenal obstruction, perforation or peritonitis, concomitant small bowel obstruction, or duodenal obstruction caused by benign strictures. The technical and clinical success rate, complication rate, and stent patency were compared according to the placement of uncovered (n = 38) or covered (n = 29) stents. RESULTS: The technical and clinical success rates did not differ between the uncovered and covered stent groups (100% vs 96.6% and 89.5% vs 82.8%). There were no differences in the overall complication rates between the uncovered and covered stent groups (31.6% vs 41.4%). However, stent migration occurred more frequently with covered than uncovered stents [20.7% (6/29) vs 0% (0/38), P < 0.05]. Moreover, the overall cumulative median duration of stent patency was longer in uncovered than in covered stents [251 d (95%CI: 149.8 d-352.2 d) vs 139 d (95%CI: 45.5 d-232.5 d), P < 0.05 by log-rank test] The overall cumulative median survival period was not different between the uncovered stent (70 d) and covered stent groups (60 d). CONCLUSION: Uncovered stents may be preferable in malignant duodenal obstruction because of their greater resistance to stent migration and longer stent patency than covered stents. PMID:25663777

Effect of endoscopic transpapillary biliary drainage with/without endoscopic sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis in patients with biliary stricture (E-BEST): a protocol for a multicentre randomised controlled trial.

PubMed

Kato, Shin; Kuwatani, Masaki; Sugiura, Ryo; Sano, Itsuki; Kawakubo, Kazumichi; Ono, Kota; Sakamoto, Naoya

2017-08-11

The effect of endoscopic sphincterotomy prior to endoscopic biliary stenting to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis remains to be fully elucidated. The aim of this study is to prospectively evaluate the non-inferiority of non-endoscopic sphincterotomy prior to stenting for naïve major duodenal papilla compared with endoscopic sphincterotomy prior to stenting in patients with biliary stricture. We designed a multicentre randomised controlled trial, for which we will recruit 370 patients with biliary stricture requiring endoscopic biliary stenting from 26 high-volume institutions in Japan. Patients will be randomly allocated to the endoscopic sphincterotomy group or the non-endoscopic sphincterotomy group. The main outcome measure is the incidence of pancreatitis within 2 days of initial transpapillary biliary drainage. Data will be analysed on completion of the study. We will calculate the 95% confidence intervals (CIs) of the incidence of pancreatitis in each group and analyse weather the difference in both groups with 95% CIs is within the non-inferiority margin (6%) using the Wald method. This study has been approved by the institutional review board of Hokkaido University Hospital (IRB: 016-0181). Results will be submitted for presentation at an international medical conference and published in a peer-reviewed journal. The University Hospital Medical Information Network ID: UMIN000025727 Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Temporary placement of retrievable fully covered metallic stents versus percutaneous balloon dilation in the treatment of benign biliary strictures.

PubMed

Kim, Jin Hyoung; Gwon, Dong Il; Ko, Gi-Young; Sung, Kyu-Bo; Lee, Sung Koo; Yoon, Hyun-Ki; Shin, Ji Hoon; Song, Ho-Young

2011-06-01

To compare retrospectively percutaneous transhepatic primary placement of a retrievable self-expanding metallic stent with percutaneous balloon dilation for the treatment of benign biliary strictures. From 2005-2009, 66 patients with benign biliary strictures in whom an endoscopic approach failed or in whom such an approach was inaccessible were evaluated. Of 66 patients, 31 underwent balloon dilation, and 35 underwent temporary metallic stent placement. The etiologies of the benign strictures were anastomotic stricture after surgery (n = 54), stricture secondary to intraoperative injury (n = 9), inflammatory stricture (n = 2), and stricture secondary to trauma (n = 1). The primary patency rates were significantly better in the stent group (87% at 3 years) than in the balloon group (44% at 3 years; P = .022). The indwelling period of percutaneous transhepatic biliary drainage (PTBD) catheters after the initial procedure was able to be significantly reduced in the stent group (median 2.5 months) compared with the balloon group (median 4.5 months; P = .001). Significant bleeding (associated with PTBD) occurred in one patient in the balloon group. In the stent group, stent migration occurred in two patients, and one patient underwent surgery for stent removal after failure of removal under fluoroscopic guidance. Percutaneous primary placement of a retrievable self-expanding metallic stent showed superior intermediate-term results compared with percutaneous balloon dilation for the treatment of benign biliary strictures. In addition, the indwelling period of PTBD catheters can be significantly reduced using temporary stent placement. Copyright © 2011 SIR. Published by Elsevier Inc. All rights reserved.

Comparative Study of Ureteral Stents Following Endoureterotomy in the Porcine Model: 3 vs 6 Weeks and 7F vs 14F

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

Soria, Federico; Sanchez, Francisco M.; Sun, Fei

2005-12-15

The aim of the study was to determine the optimal stent size and stenting duration following retrograde endoureterotomy of experimental ureteral strictures. Twenty healthy Large White female pigs were randomly divided into four groups, depending on stent size (7F vs 14F) and stenting duration (3 weeks vs 6 weeks). Three additional pigs were used as the control group. The internal ureteral diameter was measured 2 cm below the lower pole of the right kidney. Histopathological changes of the urinary tract, ultrasonographic and fluoroscopic studies, urine culture, and serum urea and creatine levels were analyzed during the different phases of themore » study. The study was divided into three phases. Phase I included premodel documentation of the normal urinary tract and laparoscopic ureteral stricture creation. During the second phase 1 month later, the diagnosis and endourologic treatment of strictures were performed. Phase III began 4 weeks after stent removal; follow-up imaging studies and postmortem evaluation of all animals were performed. Ureteral strictures developed in all animals 4 weeks after model creation. Results from ureteral diameter measurements and pathological studies revealed no statistically significant intergroup differences. However, prevalence of urinary infection proved to be directly related to stent size (14F) and permanence (6 weeks). The chi square results suggest a statistically significant relationship between the urinary tract infection and recurrent strictures ({alpha} = 0.046). We recommend the use of 7F stents for a period of 3 weeks or less, as these are more easily positioned and result in the reduction of secondary side effects (lower infection rate, less intramural ureteral lesions). A significant relationship between urinary tract infection and stricture recurrence was found in this experimental study.« less

Preclinical evaluation of a novel abluminal surface coated sirolimus eluting stent with biodegradable polymer matrix

PubMed Central

Doshi, Manish; Galloni, Marco; Vignolini, Christina; Vyas, Ashwin; Chevli, Bhavesh; Sheiban, Imad

2015-01-01

Background Second generation of drug eluting stents (DES) has attempted to improve safety using abluminal sirolimus drug delivery with biodegradable polymers matrix. The present preclinical study was designed to investigate the safety and efficacy profile of Abluminus™ stents (SES). This is a new coronary stent with sirolimus and biodegradable polymer matrix coated on abluminal stent and balloon surface. Methods SES were compared with two controls: bare metal stent (BMS) and BMS + polymer coated stents (PC). All devices (40 stents) were implanted in porcine coronary arteries with primary endpoint of endothelialization at 7 days and subsequent histological and morphometric evaluations at 7, 30 and 90 days. Results Early endothelialization at seven days was complete in all stents. Histology at 30 days revealed minimum inflammation in all groups and increased at 90 days in PC group while it was absent at 180 days. Thirty day morphometry showed significantly reduction of neointimal area in Abluminus™ (SES 0.96±0.48 mm2; BMS 1.83±0.34 mm2; PC 1.76±0.55 mm2; P<0.05); after 90 days neointimal area was 1.10±0.54 mm2 for SES; 1.92±0.36 mm2 for BMS; and 1.94±0.48 mm2 for PC; P<0.05). Neointimal thickness at 30 and 90 days respectively was 0.15±0.07 and 0.18±0.10 mm for SES, 0.57±0.08 and 0.61±0.09 mm for BMS and 0.52±0.09 and 0.59±0.08 mm, P<0.001 for PC group. Conclusions The most significant experimental evidence appears to be earlier endothelialization at 7 days for SES which led to safety of the device. Efficacy of the device was also observed by a reduced neointimal thickness and minimized inflammatory score at all follow-ups. Termination of antiplatelet at 30 days has not shown any further complications. Polymer thickness was almost in negligible amount at 180 days with no inflammation. PMID:26331109

A Bumpy and Winding but Right Path to Domestic Drug-Eluting Coronary Stents

PubMed Central

Cho, Jae Yeong; Ahn, Youngkeun

2013-01-01

Restenosis and stent thrombosis remain major concerns after percutaneous coronary intervention for the treatment of coronary artery disease. The present review was undertaken in order to highlight the various coronary stents that have been investigated in our Heart Research Center, and how far we have come from the first heparin-coated stent first used in the late 1990s. Thereafter, from the abciximab-coated stent to the current gene-delivery stent and other newer agents, our group has applied a range of techniques in this field. However, in groups similar to ours, the restenosis rates of such stents are still high for second-generation drug-eluting stents (DESs). Moreover, our nation imports almost all of these types of stents from other countries. Thus, we need to develop domestic coronary stents. Research into newer DESs are warranted in Korea so as to achieve improved safety and efficacy outcomes. PMID:24255648

Right Ventricular Outflow Tract Stenting in Tetralogy of Fallot Infants With Risk Factors for Early Primary Repair.

PubMed

Sandoval, Juan Pablo; Chaturvedi, Rajiv R; Benson, Lee; Morgan, Gareth; Van Arsdell, Glen; Honjo, Osami; Caldarone, Christopher; Lee, Kyong-Jin

2016-12-01

Tetralogy of Fallot with cyanosis requiring surgical repair in early infancy reflects poor anatomy and is associated with more clinical instability and longer hospitalization than those who can be electively repaired later. We bridged symptomatic infants with risk factors for early primary repair by right ventricular outflow tract stenting (stent). Four groups of tetralogy of Fallot with confluent central pulmonary arteries were studied: stent group (n=42), primary repair (aged <3 months) with pulmonary stenosis (early-PS group; n=44), primary repair (aged <3 months) with pulmonary atresia (early-PA group; n=49), and primary repair between 3 and 11 months of age (surg>3mo group; n=45). Stent patients had the smallest pulmonary arteries with a median (95% credible intervals) Nakata index (mm 2 /m 2 ) of 79 (66-85) compared with the early-PA 139 (129-154), early-PS 136 (121-153), and surg>3mo 167 (153-200) groups. Only stent infants required unifocalization of aortopulmonary collaterals (17%). Stent and early-PA infants had younger age and lower weight than early-PS infants. Stent infants had the most multiple comorbidities. Stenting allowed deferral of complete surgical repair to an age (6 months), weight (6.3 [5.8-7.0] kg), and Nakata index (147 [132-165]) similar to the low-risk surg>3mo group. The 3 early treatment groups had similar intensive care unit/hospital stays and high reintervention rates in the first 12 months after repair, compared with the surg>3mo group. Right ventricular outflow tract stenting of symptomatic tetralogy of Fallot with poor anatomy (small pulmonary arteries) and adverse factors (multiple comorbidities, low weight) relieves cyanosis and defers surgical repair. This allowed pulmonary arterial and somatic growth with clinical results comparable to early surgical repair in more favorable patients. © 2016 American Heart Association, Inc.

Periprocedural use of tirofiban in elective percutaneous coronary intervention for long coronary lesions in stable patients with overlapping drug-eluting stents--the PETITION study: a prospective, randomized, multicenter study.

PubMed

Zhang, Qi; Wang, Xiao Long; Liao, Min Lei; Hu, Jian; Yang, Zhen Kun; Ding, Feng Hua; Zhang, Jian Sheng; Du, Run; Zhu, Tian Qi; Shen, Wei Feng; Zhang, Rui Yan

2015-03-01

Patients are at risk of developing periprocedural myonecrosis after percutaneous coronary intervention (PCI). We investigated whether the use of the platelet glycoprotein (GP) IIb/IIIa receptor inhibitor tirofiban could reduce periprocedural myocardial infarction (PMI) in patients with stable coronary artery disease undergoing elective PCI with overlapping stent implantation for long lesions. A total of 748 stable angina patients with long lesions (≥ 40 mm in length) treated with overlapping stent implantation were randomly assigned to receive tirofiban (tirofiban group; n = 373) or conventional therapy (control group; n = 375). Intravenous tirofiban was initiated before PCI and maintained for 12 hr after the procedure. The primary endpoint was PMI, defined as an elevation in CK-MB > 3 times the upper limit of normal 12 hr after the index procedure. The secondary endpoint was major adverse cardiac events (MACE), including cardiac death, target vessel revascularization, and recurrent MI (re-MI), at one-year of clinical follow-up. The safety end-points included Thrombolysis in Myocardial Infarction (TIMI) major bleeding and stent thrombosis. Despite comparable angiographic and procedural characteristics, in the intention-to-treatment analysis, the primary endpoint was significantly reduced in the tirofiban group (4.0% vs. 11.5%, P < 0.001). Multivariate analysis revealed that the adjunctive use of tirofiban was the only negative predictor of PMI (OR 0.41, 95% CI 0.28-0.81, P < 0.01). At one-year of clinical follow-up, the overall occurrence of MACE was significantly lower in the tirofiban group (13.4% vs. 22.7%, P = 0.001). The rate of TIMI major bleeding and stent thrombosis did not differ significantly between the two groups. Our results show that the adjunctive use of tirofiban reduces the occurrence of PMI and MACE at one year in stable coronary artery disease patients undergoing elective PCI for long lesions with overlapping stent implantation. © 2015 Wiley Periodicals, Inc.

Induction of biliary cholangiocarcinoma cell apoptosis by 103Pd cholangial radioactive stent gamma-rays.

PubMed

He, Gui-jin; Sun, Dan-dan; Ji, Da-wei; Sui, Dong-ming; Yu, Fa-qiang; Gao, Qin-yi; Dai, Xian-wei; Gao, Hong; Jiang, Tao; Dai, Chao-liu

2008-06-05

In recent years, interventional tumor therapy, involving implantation of intra-cholangial metal stents through percutaneous trans-hepatic punctures, has provided a new method for treating cholangiocarcinoma. (103)Pd cholangial radioactive stents can concentrate high radioactive dosages into the malignant tumors and kill tumor cells effectively, in order to prevent re-stenosis of the lumen caused by a relapsed tumor. The aim of the present study was to investigate the efficacy of gamma-rays released by the (103)Pd biliary duct radioactive stent in treating cholangiocarcinoma via induction of biliary cholangiocarcinoma cell apoptosis. A group of biliary duct cancer cells was collectively treated with a dose of gamma-rays. Cells were then examined by the 3-(4, 5-dimethyl thiazol-2-yl)-2, 5-diphenyl terazolium-bromide (MTT) technique for determining the inhibition rate of the biliary duct cancer cells, as well as with other methods including electron microscopy, DNA agarose gel electrophoresis, and flow cytometry were applied for the evaluation of their morphological and biochemical characteristics. The growth curve and the growth inhibition rate of the cells were determined, and the changes in the ultrastructure of the cholangiocarcinoma cells and the DNA electrophoresis bands were examined under a UV-lamp. The gamma-ray released by (103)Pd inhibited cholangiocarcinoma cell growth, as demonstrated when the growth rate of the cells was stunned by a gamma-ray with a dosage larger than 197.321 MBq. Typical features of cholangiocarcinoma cell apoptosis were observed in the 197.321 MBq dosage group, while cell necrosis was observed when irradiated by a dosage above 245.865 MBq. DNA agarose gel electrophoresis results were different between the 197.321 MBq irradiation dosage group, the 245.865 MBq irradiation dosage group, and the control group. (103)Pd radioactive stents which provide a radioactive dosage of 197.321 MBq are effective in the treatment of cholangiocarcinoma; (103)Pd radioactive stents should be useful for the clinical treatment of cholangiocarcinoma.

Self-expanding metallic stent as a bridge to surgery in the treatment of left colon cancer obstruction: Cost-benefit analysis and oncologic results.

PubMed

Flor-Lorente, Blas; Báguena, Gloria; Frasson, Matteo; García-Granero, Alvaro; Cervantes, Andrés; Sanchiz, Vicente; Peña, Andres; Espí, Alejandro; Esclapez, Pedro; García-Granero, Eduardo

2017-03-01

The use of a self-expanding metallic stent as a bridge to surgery in acute malignant left colonic obstruction has been suggested as an alternative treatment to emergency surgery. The aim of the present study was to compare the morbi-mortality, cost-benefit and long-term oncological outcomes of both therapeutic options. This is a prospective, comparative, controlled, non-randomized study (2005-2010) performed in a specialized unit. The study included 82 patients with left colon cancer obstruction treated by stent as a bridge to surgery (n=27) or emergency surgery (n=55) operated with local curative intention. The main outcome measures (postoperative morbi-mortaliy, cost-benefit, stoma rate and long-term oncological outcomes) were compared based on an "intention-to-treat" analysis. There were no significant statistical differences between the two groups in terms of preoperative data and tumor characteristics. The technically successful stenting rate was 88.9% (11.1% perforation during stent placement) and clinical success was 81.4%. No difference was observed in postoperative morbi-mortality rates. The primary anastomosis rate was higher in the bridge to surgery group compared to the emergency surgery group (77.8% vs. 56.4%; P=.05). The mean costs in the emergency surgery group resulted to be €1,391.9 more expensive per patient than in the bridge to surgery group. There was no significant statistical difference in oncological long-term outcomes. The use of self-expanding metalllic stents as a bridge to surgery is a safe option in the urgent treatment of obstructive left colon cancer, with similar short and long-term results compared to direct surgery, inferior mean costs and a higher rate of primary anastomosis. Copyright © 2017 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Extraction Strings for Ureteric Stents: Is There an Increased Risk for Urinary Tract Infections?

PubMed

Fröhlich, Maryna; Fehr, Jan; Sulser, Tullio; Eberli, Daniel; Mortezavi, Ashkan

To evaluate urinary tract infections associated with placement of ureteric stents, we performed a retrospective study and compared rates between patients with and patients without an extraction string attached to the ureteric stent. Indwelling ureteric stents are routinely removed by cystoscopy. If an extraction string has been connected to the stent at the time of placement, however, the removal can be performed without an invasive procedure. Concerns exist regarding the risk for an unintentional dislocation, increased stent-related discomfort, or an increase of the post-operative urinary tract infection rate. All elective transurethral ureteric stent placements performed between November 2011 and December 2012 in our department were included for this investigation. Urinary tract infection was defined according to the Centers for Disease Control and Prevention (CDC)/National Healthcare Safety Network (NHSN) surveillance definition of health-care-associated infections. Patients with an existing urinary tract infection at the time of admission were excluded from the analysis. A total of 342 patients receiving ureteric stents were evaluated regarding post-operative urinary tract infections. Of these patients, 127 (37.1%) had an extraction string and 215 (62.9%) a stent without a string. The total urinary tract infection rate was 6.4% with no significant difference between the two groups (7.9% vs. 5.6%, p = 0.49). In the present study, we did not observe an increased rate of post-operative urinary tract infections in patients with an extraction string attached to the ureteral stent. Extraction string is a good option for patients to avoid cystoscopic stent removal.

Air cholangiography in endoscopic bilateral stent-in-stent placement of metallic stents for malignant hilar biliary obstruction.

PubMed

Lee, Jae Min; Lee, Sang Hyub; Jang, Dong Kee; Chung, Kwang Hyun; Park, Jin Myung; Paik, Woo Hyun; Lee, Jun Kyu; Ryu, Ji Kon; Kim, Yong-Tae

2016-03-01

Although endoscopic bilateral stent-in-stent (SIS) placement of self-expandable metallic stents (SEMS) is one of the major palliative treatments for unresectable malignant hilar biliary obstruction, post-endoscopic retrograde cholangiopancreatography (ERCP) cholangitis can occur frequently due to inadequate drainage, especially after contrast injection into the biliary tree. The aim of this study is to evaluate the efficacy and safety of air cholangiography-assisted stenting. This study included 47 patients with malignant hilar biliary obstruction who underwent endoscopic bilateral SEMS placement using the SIS technique. They were divided into two groups, air (n = 23) or iodine contrast (n = 24) cholangiography. We retrospectively compared comprehensive clinical and laboratory data of both groups. There were no significant differences found between the two groups with respect to technical success (87% versus 87.5%, air versus contrast group, respectively), functional success (95% versus 95.2%), 30-day mortality (8.3% versus 8.7%) and stent patency. Post-ERCP adverse events occurred in 5 (21.7%) of the patients in the air group and 8 (33.3%) of the patients in the contrast group. Among these, the rate of cholangitis was significantly lower in the air group (4.8% versus 29.2%, p = 0.048). In multivariate analysis, air cholangiography, technical success and a shorter procedure time were significantly associated with a lower incidence of post-ERCP cholangitis. Air cholangiography-assisted stenting can be a safe and effective method for endoscopic bilateral SIS placement of SEMS in patients with malignant hilar biliary obstruction.

The influence of stents on microbial colonization of the airway in children after slide tracheoplasty: a 14-year single-center experience.

PubMed

Rijnberg, Friso M; Butler, Colin R; Speggiorin, Simone; Fierens, Anja; Wallis, Colin; Nouraei, Reza; McLaren, Clare A; Roebuck, Derek J; Hewitt, Richard; Elliott, Martin J

2015-01-01

This study describes the microbial colonization profile of the airway in children after slide tracheoplasty (STP) with and without stents, and compares colonization to children undergoing cardiothoracic surgical procedures without airway related disease. A 14-year retrospective single case note review was performed on patients undergoing STP and stent insertion. Nose and throat (NT) and bronchoalveolar lavage (BAL) specimens were analyzed for microbial profile and expressed as cumulative mean microorganisms per patient (MMP). Forty-three patients (median age ± SD 15.02 ± 31.76 months) underwent STP and 141 patients underwent cardiothoracic but no airway surgery (median age ± SD 31.7 ± 47.2 months). Sixteen patients required a stent after STP. One-hundred seventy-two positive microbial specimens were identified. The predominant 6 microorganisms were (1) Staphylococcus aureus; (2) Pseudomonas aeruginosa; (3) Haemophilus influenzae not type B; (4) Coliforms; (5) Streptococcus pneumoniae; and (6) Candida Albicans, and accounted for 128 (74%) of all positive specimens found. Children with stents had more MMP compared to children without stents after STP [4.06 ± 2.38 and 2.04 ± 2.24 MMP (P < 0.001), respectively]. Both groups of children after STP had more MMP compared to the control group (P < 0.001). Children with stents had more microbial colonization of their lower respiratory tract compared to their upper respiratory tract (3.36 ± 2.02 and 1.36 ± 0.93 MMP (P < 0.01) respectively). Staphylococcus aureus colonization of the lower respiratory tract was significantly higher in children with stents compared to children without stents after STP [0.5 and 0.15 MMP (P < 0.05) respectively]. This study indicates airway surgery and the subsequent use of stents to be a significant risk factor for microbial colonization of the airway in children. More specifically airway stents appear to increase colonization in the distal airway, which appears unrelated to that of the upper respiratory tract. © 2014 Wiley Periodicals, Inc.

Minimizing the Number of Urological Complications After Kidney Transplant: A Comparative Study of Two Types of External Ureteral Stents.

PubMed

Ooms, Liselotte S S; Spaans, Laura G; Betjes, Michiel G H; Ijzermans, Jan N M; Terkivatan, Türkan

2017-04-01

The aim of this study was to evaluate the effects of 2 types of external ureteral stents on the number of urological complications after kidney transplant. Data were retrospectively collected from 366 consecutive transplants performed between January 2013 and January 2015 in our hospital, in which an external ureteral stent was placed during surgery and removed after 9 days. Urological complications were defined as urinary leakage or ureteral stenosis requiring percutaneous nephrostomy placement. A total of 197 patients received a straight stent with 2 larger side holes (type A; 8F "Covidien" tube; Covidien, Dublin, Ireland) and 169 patients received a single J stent with 7 smaller side holes (type B; 7F "Teleflex" single J stent; Teleflex Medical, Athlone, Ireland). We found a significantly higher number of percutaneous nephrostomy placements with type A stents, with 34 (17%) versus 16 (9%) in type B (P = .030). Reason for percutaneous nephrostomy placement, occurrence of stent dysfunction, and need for early removal (< 8 days) were equal in both groups (P = .397), whereas incidence of rejection and urinary tract infection were higher in type B stent group. Patient and graft survival did not differ between the groups. Use of the type B stent was associated with less urological complications compared with the type A stent.

Comparison of cardiovascular risk of noncardiac surgery following coronary angioplasty with versus without stenting.

PubMed

Leibowitz, David; Cohen, Maurice; Planer, David; Mosseri, Morris; Rott, David; Lotan, Chaim; Weiss, A Teddy

2006-04-15

Previous studies have shown a high incidence of cardiovascular complications when noncardiac surgery (NCS) is performed after coronary stenting. No study has compared the outcomes of NCS after stenting compared with percutaneous transluminal coronary angioplasty (PTCA) alone. The records of all patients who underwent NCS within 3 months of percutaneous coronary intervention at our institution were reviewed for adverse clinical events with the end points of acute myocardial infarction, major bleeding, and death < or = 6 months after NCS. A total of 216 consecutive patients were included in the study. Of these, 122 (56%) underwent PTCA and 94 (44%) underwent stenting. A total of 26 patients (12%) died, 13 in the stent group (14%) and 13 in the PTCA group (11%), a nonsignificant difference. The incidence of acute myocardial infarction and major bleeding was 7% and 16% in the stent group and 6% and 13% in the PTCA group (p = NS), respectively. Significantly more events occurred in the 2 groups when NCS was performed within 2 weeks of percutaneous coronary intervention. In conclusion, our study has demonstrated high rates of perioperative morbidity and mortality after NCS in patients undergoing PTCA alone, as well as stenting. These findings support the current guidelines regarding the risk of NCS after stenting but suggest they be extended to PTCA as well.

Evaluation of Ureteral Stent Colonization in Live-Donor Renal Transplant Recipients.

PubMed

Sarier, M; Demir, M; Duman, I; Yuksel, Y; Demirbas, A

2017-04-01

Ureteral stent insertion during kidney transplantation is a matter of debate. Stenting has been proven to reduce the risk of surgical complications. In addition, it has been reported to increase risks such as urinary tract infections especially after operation. Ureteral stent colonization (USC) is known to play a role in the pathogenesis of stent related-infections. The aim of this study was (1) to assess the frequency of USC and values of urine cultures in identifying colonizing bacteria; (2) to assess the importance of indwelling time for USC in live-donor renal transplant recipients; and (3) to evaluate the biomarker role of neutrophil-to-lymphocyte ratio (NLR) on USC. A total of 107 live-donor kidney transplant patients were included in the study (76 men and 31 women). The mean age was 43.7 years, and average indwelling time of the ureteral stent was 24.7 days. Patients were divided into three groups according to indwelling stent time as group 1: 15 to 21 days (3rd week), group 2: 22 to 28 days (4th week), and group 3: 29 to 35 days (5th week). The decision to remove the stent was primarily based on clinical judgment. Ureteral stents were removed with the use of flexible cystoscopy. Midstream urine for urine culture and blood samples for NLR were taken prior to stent removal. The removed stents were divided into three parts and taken for bacteriological investigation. Of 107 patients, USC was detected in 24 (22.4%) patients, whereas urinary proliferation was observed in 8 (7.4%) patients. The most common microorganisms found in USC was the Enterecoccus species. The most common microorganisms in urinary culture were Enterecoccus spp. and Klebsiella pnemoniae. All patients with isolated microorganisms in the urine had USC (P < .001). On the other hand, proliferation in urinary culture was observed only in 30% of patients. Urine culture was not significant in identification of USC (P = .063). The three patient groups that were determined according to indwelling stent time were compared in terms of USC, proliferation in urine culture, and NLR. The highest incidence of USC was found in group 3 (44%) and the least in group 2 (11%) (P < .05). No significant difference was found between the groups in terms of urine culture (P = .546). Although no significant difference was found between groups 1 and 2 in NLR values (P = .755), NLR was significantly higher in group 3 (P = .026). Colonization is common in ureteral stents inserted in live-donor kidney transplant patients, although routine urine culture is insufficient in identfying this colonization. The most common microorganism detected in ureteral stent colonization was Enterecoccus spp. The 4th week was the most convenient time for stent removal time in terms of USC among the 3rd, 4th, and 5th weeks. In addition, increased NLR might have value as a biomarker for USC. Copyright © 2017 Elsevier Inc. All rights reserved.

Very late stent thrombosis with second generation drug eluting stents compared to bare metal stents: Network meta-analysis of randomized primary percutaneous coronary intervention trials.

PubMed

Philip, Femi; Stewart, Susan; Southard, Jeffrey A

2016-07-01

The relative safety of drug-eluting stents (DES) and bare-metal stents (BMS) in primary percutaneous coronary intervention (PPCI) in ST elevation myocardial infarction (STEMI) continues to be debated. The long-term clinical outcomes between second generation DES and BMS for primary percutaneous coronary intervention (PCI) using network meta-analysis were compared. Randomized controlled trials comparing stent types (first generation DES, second generation DES, or BMS) were considered for inclusion. A search strategy used Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion criteria, and sample characteristics were extracted. Network meta-analysis was used to pool direct (comparison of second generation DES to BMS) and indirect evidence (first generation DES with BMS and second generation DES) from the randomized trials. Twelve trials comparing all stents types including 9,673 patients randomly assigned to treatment groups were analyzed. Second generation DES was associated with significantly lower incidence of definite or probable ST (OR 0.59, 95% CI 0.39-0.89), MI (OR 0.59, 95% CI 0.39-0.89), and TVR at 3 years (OR 0.50: 95% CI 0.31-0.81) compared with BMS. In addition, there was a significantly lower incidence of MACE with second generation DES versus BMS (OR 0.54, 95% CI 0.34-0.74) at 3 years. These were driven by a higher rate of TVR, MI and stent thrombosis in the BMS group at 3 years. There was a non-significant reduction in the overall and cardiac mortality [OR 0.83, 95% CI (0.60-1.14), OR 0.88, 95% CI (0.6-1.28)] with the use of second generation DES versus BMS at 3 years. Network meta-analysis of randomized trials of primary PCI demonstrated lower incidence of MACE, MI, TVR, and stent thrombosis with second generation DES compared with BMS. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Protection or nonprotection in carotid stent angioplasty: the influence of interventional techniques on outcome data from the SPACE Trial.

PubMed

Jansen, Olav; Fiehler, Jens; Hartmann, Marius; Brückmann, Hartmut

2009-03-01

The use of protection devices (PDs) and stents with different cell designs in carotid artery stenting (CAS) is a subject of controversy, and no data on their benefit are available from independently controlled multi-center studies. We analyzed data from the prospective randomized SPACE trial, which included 563 patients randomized to CAS and treated per protocol. A total of 145 patients were treated with a PD and 418 without. Of the patients, 436 were treated with an open cell stent and 127 with a closed cell stent. Use of PDs and choice of device was chosen at the individual discretion of the interventionalist. The outcome event (OE) of the analysis (ipsilateral stroke or ipsilateral stroke death within 30 days) was reached in 26/418 patients (6.2%, 95% CI: 4.1 to 9.0%) in the nonprotection [corrected] group and in 12/145 (8.3%, 95% CI: 4.3 to 14.0%) patients in the protection [corrected] group (P=0.40). The OE rate was significantly lower in patients treated with a closed cell stent (5.6% [95% CI: 3.7 to 8.2%]) than in those treated with an open cell stent.(11.0%, 95% CI: 6.2 to 17.8%; P=0.029). Predilatation showed a tendency to but no significant reduction of OE rate. Overall, 49% of all OEs occurred directly periinterventionally, 10% during the navigation procedure and 41% postinterventionally, including 10% of hyperperfusion syndromes. Time point of the event was not influenced by the use of a PD. This secondary analysis of data from the SPACE trial does not support the need for a PD in CAS. Stent design seems to have an impact on the OE rate. Our analysis demonstrates that the choice of the interventional material may have an impact on the periprocedural complication rate in CAS and that the development of more specific stent systems for the treatment of carotid stenosis may reduce the complication rate significantly.

Stenting for symptomatic vertebral artery stenosis: The Vertebral Artery Ischaemia Stenting Trial.

PubMed

Markus, Hugh S; Larsson, Susanna C; Kuker, Wilhelm; Schulz, Ursula G; Ford, Ian; Rothwell, Peter M; Clifton, Andrew

2017-09-19

To compare in the Vertebral Artery Ischaemia Stenting Trial (VIST) the risks and benefits of vertebral angioplasty and stenting with best medical treatment (BMT) alone for symptomatic vertebral artery stenosis. VIST was a prospective, randomized, open-blinded endpoint clinical trial performed in 14 hospitals in the United Kingdom. Participants with symptomatic vertebral stenosis ≥50% were randomly assigned (1:1) to vertebral angioplasty/stenting plus BMT or to BMT alone with randomization stratified by site of stenosis (extracranial vs intracranial). Because of slow recruitment and cessation of funding, recruitment was stopped after 182 participants. Follow-up was a minimum of ≥1 year for each participant. Three patients did not contribute any follow-up data and were excluded, leaving 91 patients in the stent group and 88 in the medical group. Mean follow-up was 3.5 (interquartile range 2.1-4.7) years. Of 61 patients who were stented, stenosis was extracranial in 48 (78.7%) and intracranial in 13 (21.3%). No periprocedural complications occurred with extracranial stenting; 2 strokes occurred during intracranial stenting. The primary endpoint of fatal or nonfatal stroke occurred in 5 patients in the stent group vs 12 in the medical group (hazard ratio 0.40, 95% confidence interval 0.14-1.13, p = 0.08), with an absolute risk reduction of 25 strokes per 1,000 person-years. The hazard ratio for stroke or TIA was 0.50 ( p = 0.05). Stenting in extracranial stenosis appears safe with low complication rates. Large phase 3 trials are required to determine whether stenting reduces stroke risk. ISRCTN95212240. This study provides Class I evidence that for patients with symptomatic vertebral stenosis, angioplasty with stenting does not reduce the risk of stroke. However, the study lacked the precision to exclude a benefit from stenting. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

Iliocaval Confluence Stenting for Chronic Venous Obstructions

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

Graaf, Rick de, E-mail: r.de.graaf@mumc.nl; Wolf, Mark de, E-mail: markthewolf@gmail.com; Sailer, Anna M., E-mail: anni.sailer@mumc.nl

PurposeDifferent techniques have been described for stenting of venous obstructions. We report our experience with two different confluence stenting techniques to treat chronic bi-iliocaval obstructions.Materials and MethodsBetween 11/2009 and 08/2014 we treated 40 patients for chronic total bi-iliocaval obstructions. Pre-operative magnetic resonance venography showed bilateral extensive post-thrombotic scarring in common and external iliac veins as well as obstruction of the inferior vena cava (IVC). Stenting of the IVC was performed with large self-expandable stents down to the level of the iliocaval confluence. To bridge the confluence, either self-expandable stents were placed inside the IVC stent (24 patients, SECS group) ormore » high radial force balloon-expandable stents were placed at the same level (16 patients, BECS group). In both cases, bilateral iliac extensions were performed using nitinol stents.ResultsRecanalization was achieved for all patients. In 15 (38 %) patients, a hybrid procedure with endophlebectomy and arteriovenous fistula creation needed to be performed because of significant involvement of inflow vessels below the inguinal ligament. Mean follow-up was 443 ± 438 days (range 7–1683 days). For all patients, primary, assisted-primary, and secondary patency rate at 36 months were 70, 73, and 78 %, respectively. Twelve-month patency rates in the SECS group were 85, 85, and 95 % for primary, assisted-primary, and secondary patency. In the BECS group, primary patency was 100 % during a mean follow-up period of 134 ± 118 (range 29–337) days.ConclusionStenting of chronic bi-iliocaval obstruction shows relatively high patency rates at medium follow-up. Short-term patency seems to favor confluence stenting with balloon-expandable stents.« less

The applicability of using straight ureteral stents for the treatment of ureteral stones in presumably non-compliant patients.

PubMed

Mydlo, J H; Streater, S

2001-01-01

There have been many reports describing the complications of retained ureteral stents following stone treatment. We wanted to evaluate the practicality of definitive treatment of poorly compliant patients who present with ureteral stones using a straight stent connected to a urethral catheter alone and compared these to patients treated with double-J stents alone. We treated 23 patients (12 in group I and 11 patients in group II) who had a ureteral stone of 6 mm or less, with an indwelling straight stent and a double-J stent, respectively, while on oral antibiotics. We followed these patients 1 week later with an abdominal X-ray prior to removing the stent. Eleven patients in group I and 9 patients in group II passed their stones spontaneously. Three patients required surgical intervention with a ureterscope and laser lithotripsy. There were no cases of infection or pyelonephritis. Although each of the straight-stent-treated patients returned to our clinic for follow-up, only 5 of the 11 double-J stent patients returned for follow-up. The remaining 6 patients had to be contacted to remind them that they still had an internal stent. Although technologic advances now allow many urologists to definitively treat ureteral stones, some urologists may lack the proper equipment and/or assistance to treat the stone at the time of presentation, or may deal with non-compliant patients. Therefore, in these certain circumstances, treatment of small ureteral stones in non-compliant patients using a straight stent connected to a leg bag, as either definitive or initial treatment, may be of practical use and avoid the risk of retained double-J ureteral stents. Copyright 2001 S. Karger AG, Basel

Patient-Centered Tablet Application for Improving Medication Adherence after a Drug-Eluting Stent.

PubMed

Shah, Vicki; Dileep, Anandu; Dickens, Carolyn; Groo, Vicki; Welland, Betty; Field, Jerry; Baumann, Matthew; Flores, Jose D; Shroff, Adhir; Zhao, Zhongsheng; Yao, Yingwei; Wilkie, Diana J; Boyd, Andrew D

2016-01-01

This study's objective was to evaluate a patient-centered educational electronic tablet application, "My Interventional Drug-Eluting Stent Educational App" (MyIDEA) to see if there was an increase in patient knowledge about dual antiplatelet therapy (DAPT) and medication possession ratio (MPR) compared to treatment as usual. In a pilot project, 24 elderly (≥50 years old) research participants were recruited after a drug-eluting stent. Eleven were randomized to the control arm and 13 to the interventional arm. All the participants completed psychological and knowledge questionnaires. Adherence was assessed through MPR, which was calculated at 3 months for all participants who were scheduled for second and third follow-up visits. Relative to control, the interventional group had a 10% average increase in MPR. As compared to the interventional group, more patients in the control group had poor adherence (<80% MPR). The psychological data revealed a single imbalance in anxiety between the control and interventional groups. On average, interventional participants spent 21 min using MyIDEA. Consumer health informatics has enabled us to engage patients with their health data using novel methods. Consumer health technology needs to focus more on patient knowledge and engagement to improve long-term health. MyIDEA takes a unique approach in targeting DAPT from the onset. MyIDEA leverages patient-centered information with clinical care and the electronic health record highlighting the patients' role as a team member in their own health care. The patients think critically about adverse events and how to solve issues before leaving the hospital.

Pancreatic stents for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis should be inserted up to the pancreatic body or tail.

PubMed

Sugimoto, Mitsuru; Takagi, Tadayuki; Suzuki, Rei; Konno, Naoki; Asama, Hiroyuki; Sato, Yuki; Irie, Hiroki; Watanabe, Ko; Nakamura, Jun; Kikuchi, Hitomi; Waragai, Yuichi; Takasumi, Mika; Hikichi, Takuto; Ohira, Hiromasa

2018-06-14

To investigate the location to which a pancreatic stent should be inserted to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Over a ten-year period at our hospital, 296 patients underwent their first ERCP procedure and had a pancreatic stent inserted; this study included 147 patients who had ERCP performed primarily for biliary investigation and had a pancreatic stent inserted to prevent PEP. We divided these patients into two groups: 131 patients with a stent inserted into the pancreatic head (head group) and 16 patients with a stent inserted up to the pancreatic body or tail (body/tail group). Patient characteristics and ERCP factors were compared between the groups. Pancreatic amylase isoenzyme (p-AMY) levels in the head group were significantly higher than those in the body/tail group [138.5 (7.0-2086) vs 78.5 (5.0-1266.5), P = 0.03] [median (range)]. No cases of PEP were detected in the body/tail group [head group, 12 (9.2%)]. Of the risk factors for post-ERCP hyperamylasemia (≥ p-AMY median, 131 IU/L), procedure time ≥ 60 min [odds ratio (OR) 2.65, 95%CI: 1.17-6.02, P = 0.02) and stent insertion into the pancreatic head (OR 3.80, 95%CI: 1.12-12.9, P = 0.03) were identified as independent risk factors by multivariate analysis. Stent insertion up to the pancreatic body or tail reduces the risk of post-ERCP hyperamylasemia and may reduce the risk of PEP.

Preliminary Assessment of a New Antireflux Ureteral Stent Design in Swine Model.

PubMed

Soria, Federico; Morcillo, Esther; Serrano, Alvaro; Rioja, Jorge; Budia, Alberto; Moreno, Jesús; Sanchez-Margallo, Francisco M

2015-08-01

To assess a new antireflux ureteral stent in animal model. The design expects to reduce morbidity associated with JJ ureteral stents. Twelve pigs were used in this study. The study began with a nephrosonographic assessment and excretory urography. Afterward, measurement of the internal diameter of both ureteropelvic junctions (UPJ) by retrograde ureteropyelography was performed. A 3 Fr (ARS group) antireflux ureteral stent was placed in the right kidney and a JJ 4 Fr (JJ group) stent was placed in the left. Follow-ups were performed at 3-6 weeks; both stents were removed at 6 weeks. The final follow-up was completed at 5 months. This includes the above-mentioned diagnostic methods and an anatomopathological study. There were no significant differences in UPJ diameter evolution between groups. During renal damage assessment, significant differences at 3 and 6 weeks were found, renal dilation being larger in JJ group. The JJ group shows a higher degree of vesicoureteral reflux at 3 and 6 weeks. After assessment of ureteral orifice, significant differences between groups were found at 3 weeks, 6 weeks, and 5 months, damage being more severe in the JJ group. After anatomopathological assessment, no statistical significance at UPJ was observed. However, statistical significance was found at ureterovesical junction, damage being more severe in the JJ group. The antireflux ureteral stent design dilates the upper urinary tract without affecting ureterovesical junction, and consequently reduces morbidity associated with JJ ureteral stents. Therefore, its patient tolerance will possibly be better than that to existent designs. Copyright © 2015 Elsevier Inc. All rights reserved.

Safety and benefits of self-expandable metallic stents with chemotherapy for malignant gastric outlet obstruction.

PubMed

Miyabe, Katsuyuki; Hayashi, Kazuki; Nakazawa, Takahiro; Sano, Hitoshi; Yamada, Tomonori; Takada, Hiroki; Naitoh, Itaru; Shimizu, Shuya; Kondo, Hiromu; Nishi, Yuji; Yoshida, Michihiro; Umemura, Shuichiro; Hori, Yasuki; Kato, Akihisa; Ohara, Hirotaka; Joh, Takashi

2015-07-01

The influence of chemotherapy on placement of self-expandable metallic stents (SEMS) for malignant gastric outlet obstruction (MGOO) has not been evaluated extensively. We investigated the influence of chemotherapy on the clinical outcomes of SEMS placement for MGOO. A total of 152 cancer patients with MGOO from a university hospital and affiliate hospitals were included. The patients were classified according to chemotherapy status and evaluated for palliative efficacy and safety of SEMS placement. Technical success rate, time to oral intake, and parameters indicating improvement of physical condition did not differ between the with- and without-chemotherapy groups after stent placement. Re-intervention and stent migration were significantly more frequent in the with-chemotherapy group than in the without-chemotherapy group after stent placement (re-intervention, 32.4% vs 7.8%, P = 0.0005; stent migration, 13.5% vs 1.7%, P = 0.0097). The frequency of adverse events did not differ between the with- and without-chemotherapy groups. Although chemotherapy after stent placement was an independent predictive factor for shortening the stent patency period (hazard ratio [HR], 3.10; P = 0.0264), the use of additional stents facilitated uneventful recovery and further prolonged survival time (HR, 0.60; P = 0.0132). Various cancer patients with MGOO can undergo SEMS placement safely regardless of chemotherapy, and concurrent chemotherapy after stent placement can prolong survival time, although re-intervention and stent migration may be increased. © 2015 The Authors. Digestive Endoscopy © 2015 Japan Gastroenterological Endoscopy Society.

Direct implantation of rapamycin-eluting stents with bioresorbable drug carrier technology utilising the Svelte coronary stent-on-a-wire: the DIRECT II study.

PubMed

Verheye, Stefan; Khattab, Ahmed A; Carrie, Didier; Stella, Pieter; Slagboom, Ton; Bartunek, Jozef; Onuma, Yoshinobu; Serruys, Patrick W

2016-08-05

Our aim was to demonstrate the safety and efficacy of the Svelte sirolimus-eluting coronary stent-on-a-wire Integrated Delivery System (IDS) with bioresorbable drug coating compared to the Resolute Integrity zotarolimus-eluting stent with durable polymer in patients with de novo coronary artery lesions. Direct stenting, particularly in conjunction with transradial intervention (TRI), has been associated with reduced bleeding complications, procedure time, radiation exposure and contrast administration compared to conventional stenting with wiring and predilatation. The low-profile Svelte IDS is designed to facilitate TRI and direct stenting, reducing the number of procedural steps, time and cost associated with coronary stenting. DIRECT II was a prospective, multicentre trial which enrolled 159 patients to establish non-inferiority of the Svelte IDS versus Resolute Integrity using a 2:1 randomisation. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Target vessel failure (TVF), as well as secondary clinical endpoints, will be assessed annually up to five years. At six months, in-stent LLL was 0.09±0.31 mm in the Svelte IDS group compared to 0.13±0.27 mm in the Resolute Integrity group (p<0.001 for non-inferiority). TVF at one year was similar across the Svelte IDS and Resolute Integrity groups (6.5% vs. 9.8%, respectively). DIRECT II demonstrated the non-inferiority of the Svelte IDS to Resolute Integrity with respect to in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups.

Outcomes with the paclitaxel-eluting stent in patients with acute coronary syndromes: analysis from the TAXUS-IV trial.

PubMed

Moses, Jeffrey W; Mehran, Roxana; Nikolsky, Eugenia; Lasala, John M; Corey, Woodrow; Albin, Glenn; Hirsch, Cary; Leon, Martin B; Russell, Mary E; Ellis, Stephen G; Stone, Gregg W

2005-04-19

We sought to investigate the outcomes of paclitaxel-eluting stent implantation in patients with unstable angina or non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI). Whether the paclitaxel-eluting stent is safe and effective in patients with acute coronary syndromes (ACS) is unknown. In the TAXUS-IV trial, 1,314 patients with stable or unstable ischemic syndromes undergoing PCI were randomized to treatment with either the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or a bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). The results were stratified by the acuity of the presenting clinical syndrome. Acute coronary syndromes were present in 450 patients (34.2%), 237 of whom were assigned to paclitaxel-eluting stents and 213 to bare-metal stents. The baseline and procedural characteristics were well matched between the groups. Clinical outcomes at 30 days were similar with both stents. At one-year follow-up, patients with ACS assigned to the paclitaxel-eluting stent compared to the control stent had strikingly lower rates of target lesion revascularization (TLR) (3.9% vs. 16.0%, p < 0.0001) and major adverse cardiac events (11.1 vs. 21.7%, p = 0.002). By multivariate analysis, ACS was an independent predictor of in-stent restenosis in the cohort treated with bare-metal stents (hazard ratio [HR] = 2.03 [95% confidence interval (CI) 1.05 to 3.92], p = 0.035), while among patients randomized to the paclitaxel-eluting stents, ACS was an independent predictor of freedom from restenosis (HR = 0.27 [95% CI 0.08 to 0.97], p = 0.04). The use of the paclitaxel-eluting TAXUS stent was safe in patients with unstable ischemic syndromes, and was associated with marked reduction of ischemia-driven TLR and adverse cardiac events at one year.

Development and evaluation of a centralised computerised registry for ureteric stents: completing the audit cycle.

PubMed

Davis, N F; Murray, G; O'Connor, T; Browne, C; MacCraith, E; Galvin, D; Mulvin, D; Quinlan, D; Lennon, G

2017-11-01

A forgotten ureteric stent may result in severe renal impairment leading to nephrectomy. To compare the effectiveness of a centralised computerised registry for monitoring ureteric stent activity with a previously established theatre stent logbook system. This prospective audit was performed in two 9-monthly intervals. During the first interval, insertion/removal of a ureteric stent was documented in a specific theatre stent logbook. In the second interval, an electronic centralised computerised registry was developed to document insertion/removal of a ureteric stent onto an accessible hospital server. A computerised traffic-light system was also developed to identify patients with an indwelling stent for >3 months. The primary outcome variable was the number of prolonged indwelling ureteric stents in both groups. During the first time interval, 188 ureteric stents were inserted and 182 (96%) were removed or changed. Six (4%) patients underwent insertion of a ureteric stent for a prolonged period of time (>6 months). This subgroup required complex endourological intervention for stent removal due to encrustation. During the second time interval, 157 ureteric stents were inserted and all patients had their stent removed or changed within 6 months. No patients in this group were lost to follow-up. This study demonstrates that a centralised computerised ureteric stent registry is superior to a conventional logbook for monitoring ureteric stent activity. We propose the introduction a centralised nationalised ureteric stent registry for eliminating the potential for prolonged or forgotten ureteric stents.

Is hypertension the fate of aortic coarctation patients treated with Cheatham Platinum (CP) stent?

PubMed

Baykan, Ali; Demiraldi, Ayse G; Tasci, Onur; Pamukcu, Ozge; Sunkak, Suleyman; Uzum, Kazım; Sezer, Sadettin; Narin, Nazmi

2018-04-01

The aim of this study is to address the presence of hypertension and risk for cardiovascular diseases in patients with Coarctation of the Aorta (CoA) who were treated with endovascular stent placement. Twenty patients (mean age: 14.2 ± 3.9 years) who were treated with stent and 20 age- and sex-matched controls were included to the study. Structure and functions of left ventricle were assessed by echocardiography. Carotid intima media (CIM) thickness was measured by using sonography as a marker for detecting cardiovascular risk. As indirect marker of arterial stiffness, pulse wave velocity, and augmentation index were recorded by ambulatory blood pressure monitorization/arteriography device. By ambulatory blood pressure monitorization, 24 h and daytime systolic and mean arterial pressure values were found to be significantly higher in patient group. Based on percentile values, 15% and 5% of patients were pre-hypertensive and hypertensive, respectively. Pulse wave velocity and cardiac output values were found to be significantly higher than control group. CIM thickness was also found to be significantly higher in patient group when compared to controls. It was shown that hypertension incidence as demonstrated by ambulatory blood pressure monitorization and risk for cardiovascular diseases as indicated by CIM thickness and Pulse wave velocity were higher than those in healthy population even after CoA is corrected. © 2017, Wiley Periodicals, Inc.

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

PubMed

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

2013-11-01

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

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

Kim, Young Il; Chung, Jin Wook, E-mail: chungjw@snu.ac.kr; Kim, Hyun Beom

PurposeThis study was designed to investigate the effects of stenting across the branching arteries on the patency and stent-tissue responses over the branching arterial orifices. Methods: Thirteen dogs were observed after placing aortic stents across the celiac arteries (CA), superior mesenteric arteries (SMA), and renal arteries (RA). The animals were grouped according to stent types: large-cell group (n = 6) and small-cell group (n = 7). Angiography was performed to evaluate the branching artery patency at 2, 6, and 12 months after stent insertion, and the stent-tissue responses covering the orifices were evaluated on histopathologic examination. Results: All branching arteriesmore » were patent on follow-up angiography; however, three patterns of stent-tissue responses over the orifices were observed: neointimal layering, bridging septa, and papillary hyperplasia. Although neointimal layering and bridging septa were evenly observed, severe papillary hyperplasia was more frequent at SMA and CA than RA. Four RA showed less than 50% ostial patency, and localized infarct was observed in six kidneys (24%). The ostial patency tended to decrease with small-cell stent during the follow-up period. Conclusions: Various stent-tissue responses over the branching artery orifices are induced by the aortic stent covering the branching arteries and may not be easily detected by conventional angiography. Subclinical renal infarct also may occur despite patent renal angiography.« less

Internal or External Stenting of the Ureterovesical Anastomosis in Renal Transplantation.

PubMed

Fockens, M Matthijs; Alberts, Victor P; Bemelman, Frederike J; Laguna Pes, M Pilar; Idu, Mirza M

2016-01-01

Stenting of the ureterovesical anastomosis reduces the incidence of urological complications (UCs) after renal transplantation, but there are multiple stenting techniques, and there is no consensus regarding which technique is preferred. The aim of this study was to compare an internal versus an external stenting technique on the incidence of UCs. This is a retrospective analysis of 419 deceased donor renal transplantations performed between January 2008 and December 2013. Until 2011, 183 patients received an external stent through the ureterovesical anastomosis placed by suprapubic bladder puncture (SP stent). From 2011, 236 recipients received an internal double-J (JJ) stent. The rate of UC was 3.8% in JJ stents, compared to 9.3% in SP stents (p = 0.021). No difference in surgical ureter revision rate was observed between the groups (2.1 vs. 5.5%; p = 0.068). Urinary tract infection (UTI) rate and graft function were comparable between both groups. Internal JJ stenting significantly decreased the incidence of UC compared to an external SP stent. There was no difference in surgical ureter revision rate, UTI or graft function. © 2015 S. Karger AG, Basel.

Evidence-Based Recommendations on Colorectal Stenting: A Report from the Stent Study Group of the Korean Society of Gastrointestinal Endoscopy

PubMed Central

Lee, Kwang Jae; Kim, Sang Woo; Kim, Tae Il; Lee, Jong-Hoon; Lee, Bo-In; Keum, Bora; Cheung, Dae Young

2013-01-01

Recently, placement of self-expandable metallic stents has been used for the treatment of colorectal obstruction. As domestic awareness of colorectal cancer has increased, the number of colorectal stenting procedures performed has also increased. We aimed to provide evidence-based recommendations for colorectal stenting to aid gastroenterologists in making informed decisions regarding the management of patients who present with colorectal obstruction. The working group consisted of eight gastroenterologists who actively practice and conduct research in the field of colorectal stenting and are the members of the Stent Study Group of the Korean Society of Gastrointestinal Endoscopy. A literature search was conducted using the PubMed, Embase, KoreaMed, and the Cochrane Library databases to identify relevant articles published between January 2001 and June 2012. Based on the modified Delphi process, 10 recommendation statements regarding indications, usefulness, methodology and complications of colorectal stenting, and alternative treatments for malignant colorectal obstruction were determined. The contents will be widely distributed, and periodically revised to reflect the latest knowledge. These evidence-based recommendations for colorectal stenting will provide gastroenterologists and patients with appropriate and balanced information, and will improve the quality of care. PMID:23964332

Impact of Rhenium-188, Gemcitabine, and 5-Fluorouracil on Cholangiocellular Carcinoma Cells: An In Vitro Study

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

Wiesinger, Benjamin, E-mail: Benjamin.wiesinger@med.uni-tuebingen.de; Farkas, Emese; Kehlbach, Rainer

2009-07-15

The purpose of this study was to compare the beneficial effects of radioactive stents and radioactive stents plus additional chemotherapy in the palliative treatment of cholangiocellular carcinomas. Cholangiocellular carcinoma cells (TFK-1 cells) were treated either with 8 Gy (RTB group) or 16 Gy (RTA group) {sup 188}Re or with {sup 188}Re irradiation (8 Gy) combined with either gemcitabine (8 Gy/Gem) or 5-fluorouracil (8 Gy/5-FU) at a dosage of 20 {mu}g/ml medium for 4 days and subsequently compared with an untreated control group. Proliferation kinetics were assessed on days 4, 7, 11, 18, 25, and 32. Colony formation assays were performedmore » on days 7, 18, and 32 and cell cycle distribution was examined on days 4, 7, 11, 15, 25, and 39. Cell proliferation kinetics showed the lowest cell numbers in the 8 Gy/5-FU group (control, 15,390,000; RTA group, 8,394,000; RTB group, 5,609,000; 8 Gy/Gem group, 423,000; and 8 Gy/5-FU group, 297,667). In contrast, clonogenic activity on day 32 was lower in the 8 Gy/Gem group (control, 29.3 colonies; RTB group, 23.1 colonies; 8 Gy/5-FU group, 21.5 colonies; 8 Gy/Gem, 3.3 colonies; and even augmented in the RTA group, with 37.7 colonies). Cell cycle distribution showed similar curves for all groups on slightly different levels except for the 8 Gy/5-FU group, which showed a relatively augmented percentage of cells on day 7 in the G2 M cycle phase and on day 4 in the S phase. In conclusion, irradiation (8 Gy) with {sup 188}Re administered, e.g., via coated stents, combined with Gem could be a valid option for the treatment of CCCs.« less

Airway complications after covered stent placement for malignant esophageal stricture: special reference to radiation therapy.

PubMed

Park, Ji Yeon; Shin, Ji Hoon; Song, Ho-Young; Yi, Seong Yoon; Kim, Jin Hyoung

2012-02-01

The purpose of this study was to evaluate the characteristics of airway complications and survival with special reference to radiation therapy in the care of patients undergoing covered stent placement for malignant esophageal strictures. A total of 208 patients who underwent stent placement with or without palliative radiation therapy for inoperable esophageal cancer were included. The endpoints were frequency, type, and management of airway complications; association between occurrence of airway complications and radiation therapy history; and differences in stent-to-complication interval and survival period after esophageal stenting between patients who underwent radiation therapy before and those who underwent radiation therapy after stent placement. Airway complications occurred in 23 patients (11.1%): 18 (78.3%) had esophagorespiratory fistula, three (13.0%) had airway narrowing, and two (8.7%) had both complications. The frequency of airway complications was significantly greater among patients who underwent RT than those who did not (p = 0.005) but was not significantly different between the radiation before stenting and radiation after stenting groups (p = 0.158). The median stent-to-complication interval and survival period after esophageal stenting were significantly shorter in the radiation before stenting group than in the radiation after stenting group (p = 0.002, p = 0.001). Esophagorespiratory fistula is much more common than airway narrowing as an airway complication. The rate of complications increases significantly in association with radiation therapy among patients with malignant esophageal stricture. Clinicians need to be aware of earlier airway complications and poorer prognosis among patients who undergo radiation therapy before placement of an esophageal stent than in patients who undergo radiation after stent placement.

A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus: The RESERVOIR Clinical Trial.

PubMed

Romaguera, Rafael; Gómez-Hospital, Joan A; Gomez-Lara, Josep; Brugaletta, Salvatore; Pinar, Eduardo; Jiménez-Quevedo, Pilar; Gracida, Montserrat; Roura, Gerard; Ferreiro, Jose L; Teruel, Luis; Montanya, Eduard; Fernandez-Ortiz, Antonio; Alfonso, Fernando; Valgimigli, Marco; Sabate, Manel; Cequier, Angel

2016-01-11

The aim of this study was to compare the efficacy of amphilimus-eluting stents (AES) with that of everolimus-eluting stents (EES) in patients with diabetes mellitus (DM). The AES is a polymer-free drug-eluting stent that elutes sirolimus formulated with an amphiphilic carrier from laser-dug wells. This technology could be associated with a high efficacy in patients with DM. This was a multicenter, randomized, noninferiority trial. Patients with DM medically treated with oral glucose-lowering agents or insulin and de novo coronary lesions were randomized in a 1:1 fashion to AES or EES. The primary endpoint was the neointimal (NI) volume obstruction assessed by optical coherence tomography at 9-month follow-up. A total of 116 lesions in 112 patients were randomized. Overall, 40% were insulin-treated patients, with a median HbA1c of 7.3% (interquartile range: 6.7% to 8.0%). The primary endpoint, NI volume obstruction, was 11.97 ± 5.94% for AES versus 16.11 ± 18.18% for EES, meeting the noninferiority criteria (p = 0.0003). Pre-specified subgroup analyses showed a significant interaction between stent type and glycemic control (p = 0.02), with a significant reduction in NI hyperplasia in the AES group in patients with the higher HbA1c (p = 0.03). By quantitative coronary angiography, in-stent late loss was 0.14 ± 0.24 for AES versus 0.24 ± 0.57 mm for EES (p = 0.27), with a larger minimal lumen diameter at follow-up for AES (p = 0.02), mainly driven by 2 cases of occlusive restenosis in the EES group. AES are noninferior to EES for the coronary revascularization of patients with DM. These results suggest a high efficacy of the AES and may support the potential benefit of this stent in patients with DM. (A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus [RESERVOIR]; NCT01710748). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Spontaneously removed biliary stent drainage versus T-tube drainage after laparoscopic common bile duct exploration.

PubMed

Xu, Yakun; Dong, Chengyong; Ma, Kexin; Long, Fei; Jiang, Keqiu; Shao, Ping; Liang, Rui; Wang, Liming

2016-09-01

Several studies have shown the safety and feasibility of laparoscopic common bile duct exploration (LCBDE) as a minimally invasive treatment options for choledocholithiasis. Use of T-tube or biliary stent drainage tube placement after laparoscopic choledochotomy for common bile duct (CBD) stones is still under debate. This study tried to confirm the safety of spontaneously removable biliary stent in the distal CBD after LCBDE to allow choledochus primary closure. A total of 47 patients with choledocholithiasis underwent LCBDE with primary closure and internal drainage using a spontaneously removable biliary stent drainage tube (stent group, N = 22) or T-tube (T-tube group, N = 25). Operative parameters and outcomes are compared. Surgical time, intraoperative blood loss, length of hospital stay, drainage tube removal time, postoperative intestinal function recovery, and cost of treatment were all significantly lower in the stent group as compared to that in the T-tube group (P < 0.05 for all). Otherwise, Bile leakage between the two groups had no significant difference (P > 0.05). The biliary stent drainage tube was excreted spontaneously 4 to 14 days after surgery with the exception of one case, where endoscopic removal of biliary tube was required due to failure of its spontaneous discharge. LCBDE with primary closure and use of spontaneously removable biliary stent drainage showed advantage over the use of traditional T-tube drainage in patients with choledocholithiasis.

Long-term clinical follow-up of the multicentre, randomized study to test immunosuppressive therapy with oral prednisone for the prevention of restenosis after percutaneous coronary interventions: Cortisone plus BMS or DES veRsus BMS alone to EliminAte Restenosis (CEREA-DES).

PubMed

Ribichini, Flavio; Tomai, Fabrizio; Pesarini, Gabriele; Zivelonghi, Carlo; Rognoni, Andrea; De Luca, Giuseppe; Boccuzzi, Giacomo; Presbitero, Patrizia; Ferrero, Valeria; Ghini, Anna S; Marino, Paolo; Vassanelli, Corrado

2013-06-01

To analyse the clinical outcome at 4 years in patients with coronary artery disease treated with bare metal stents (BMS) vs. BMS and oral prednisone, or drug-eluting stents (DES), all assuming similar adjunctive medical treatment. Five Italian hospitals enrolled 375 non-diabetic, ischaemic patients without contraindications to dual anti-platelet treatment or corticosteroid therapy in a randomized controlled study. The primary endpoint was the event-free survival of cardiovascular death, myocardial infarction, and recurrence of ischaemia needing repeated target vessel revascularization at 1 year, and this was significantly lower in the BMS group (80.8%) compared with the prednisone (88.0%) and DES group (88.8%, P = 0.04 and 0.006, respectively). The long-term analysis of the primary endpoint was a pre-specified aim of the trial, and was performed at 1447 days (median, IQ range = 1210-1641). Patients receiving BMS alone had significantly lower event-free survival (75.3%) compared with 84.1% in the prednisone group (HR: 0.447; 95% CI: 0.25-0.80, P = 0.007) and 80.6% in DES patients (HR: 0.519; 95% CI: 0.29-0.93, P = 0.03). Prednisone-treated patients did not develop new treatment-related clinical problems. Drug-eluting stents patients suffered more very late stent thrombosis as a cause of spontaneous myocardial infarction. The need for target vessel revascularization remained lower in the prednisone and DES groups (13.6 and 15.2%, respectively), compared with BMS (23.2%). The clinical benefits of prednisone compared with BMS only persisted almost unchanged at 4 years. Drug-eluting stents performed better than BMS at long-term, although the advantages observed at 1 year were in part attenuated because of the occurrence of very late stent thrombosis and late revascularizations. Clinical Trial NCT 00369356.

Effects of antibacterial nanostructured composite films on vascular stents: hemodynamic behaviors, microstructural characteristics, and biomechanical properties.

PubMed

Cheng, Han-Yi; Hsiao, Wen-Tien; Lin, Li-Hsiang; Hsu, Ya-Ju; Sinrang, Andi Wardihan; Ou, Keng-Liang

2015-01-01

The purpose of this research was to investigate stresses resulting from different thicknesses and compositions of hydrogenated Cu-incorporated diamond-like carbon (a-C:H/Cu) films at the interface between vascular stent and the artery using three-dimensional reversed finite element models (FEMs). Blood flow velocity variation in vessels with plaques was examined by angiography, and the a-C:H/Cu films were characterized by transmission electron microscopy to analyze surface morphology. FEMs were constructed using a computer-aided reverse design system, and the effects of antibacterial nanostructured composite films in the stress field were investigated. The maximum stress in the vascular stent occurred at the intersections of net-like structures. Data analysis indicated that the stress decreased by 15% in vascular stents with antibacterial nanostructured composite films compared to the control group, and the stress decreased with increasing film thickness. The present results confirmed that antibacterial nanostructured composite films improve the biomechanical properties of vascular stents and release abnormal stress to prevent restenosis. The results of the present study offer the clinical benefit of inducing superior biomechanical behavior in vascular stents. © 2014 Wiley Periodicals, Inc.

Comparison of results of endovascular stenting and bypass grafting for TransAtlantic Inter-Society (TASC II) type B, C and D iliac occlusive disease

PubMed Central

Benetis, Rimantas; Antusevas, Aleksandras; Kaupas, Rytis Stasys; Inciura, Donatas; Kinduris, Sarunas

2016-01-01

Introduction The priority use of endovascular techniques in the management of aortoiliac occlusive disease has increased in the last decade. The aim of the present article is to report 1- and 2-year results of iliac artery stenting (IAS) and aortoiliac grafting in the management of patients with TASC II type B, C and D iliac lesions and chronic limb ischaemia. Material and methods In this prospective, non-randomised, one-centre clinical study, iliac artery stents and vascular grafts used for the treatment of patients with symptomatic lesions in the iliac artery were evaluated. This study enrolled 2 groups: 54 patients in the stent group and 47 patient in the surgery group. Results The primary patency rates at 1 and 2 years were 83% and 79.9% after IAS and 97.1% and 97.1% after surgical reconstruction, respectively (p = 0.015). The assisted primary stent patency at 1 and 2 years was 87.9% and 78.2%, respectively. The complication rate was 7.4% in the stent group and 6.3% in the surgery group. There was no perioperative mortality in either group. Conclusions Our results reveal that patients with severe aortoiliac occlusive disease (TASC II types B, C and D) can be treated with IAS or surgically with satisfactory results. Iliac artery stenting is associated with decreased primary patency compared with the surgery group. Iliac artery stenting should be considered with priority in elderly patients or in patients with severe comorbidities. PMID:27186180

Chemotherapy versus self-expanding metal stent as primary treatment of severe dysphagia from unresectable oesophageal or gastro-oesophageal junction cancer.

PubMed

Touchefeu, Yann; Archambeaud, Isabelle; Landi, Bruno; Lièvre, Astrid; Lepère, Céline; Rougier, Philippe; Mitry, Emmanuel

2014-03-01

To compare chemotherapy first (group 1) versus self-expanding metal stent first (group 2) for the management of malignant dysphagia in unresectable oesophageal or gastro-oesophageal junction cancer. Patients from two university hospitals with severe malignant dysphagia (dysphagia score ≥ 2) uneligible for surgery or radiochemotherapy were evaluated retrospectively. Forty-two patients were included in group 1, and 29 in group 2. After 4 weeks, dysphagia scores improved by at least 1 point in 67% of patients in group 1 versus 93% in group 2 (p=0.01); 48% of patients in group 1 were able to eat solid food versus 68% in group 2 (p=0.054). In group 1, a self-expanding metal stent was secondarily placed in 18 patients (42.9%), whereas in group 2 dysphagia required a second self-expanding metal stent placement in 33.3% of patients. Chemotherapy as the first treatment may be a valid option, avoiding self-expanding metal stent insertion in half of the patients. Copyright © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Endoscopic biliary stenting in irretrievable common bile duct stones: stent exchange or expectant management-tertiary-centre experience and systematic review.

PubMed

Mohammed, Noor; Pinder, Matthew; Harris, Keith; Everett, Simon M

2016-07-01

Conventional endoscopic duct clearance may not be possible in up to 10%-15% of common bile duct stones (CBDS). Sphincterotomy and biliary drainage by endoprosthesis have for many years been the mainstay of management in irretrievable stones. Recent years have seen the advent of sphincteroplasty or cholangioscopically-guided electrohydraulic lithotripsy (EHL) permitting duct clearance in majority of cases. However, when bile duct clearance is not possible, options include long-term stenting followed by elective stent exchange (ESE) 6-12 monthly or permanent stent insertion (PSI) in selected cases, but it is not clear which management strategy among ESE and PSI is preferable. A retrospective review of all patients in Leeds Teaching Hospitals NHS Trust who underwent plastic stent insertion for biliary access for difficult CBDS from January 2006 to December 2011 was undertaken. Adult patients with irretrievable CBDS who had plastic stent insertions throughout the follow-up period were included. Patients who underwent PSI and ESE annually were retrospectively reviewed to determine the long-term outcomes. A detailed systematic review was also performed, examining the outcomes of CBDS managed with stents. During the study period, 674 patients underwent 1769 biliary-stent-related procedures; of which, 246 patients met our inclusion criteria. 201 patients had subsequent duct clearance. 45 patients were, therefore, included in the final analysis, 28 of whom underwent annual ESEs and 17 PSIs. Patients in the PSI group had higher American Society of Anesthesiologists (ASA) scores compared with the ESE group. In the PSI group, 9/17 patients presented acutely with blocked stents, 5 of whom presented within 12 months. 2/9 patients were severely ill and died within a fortnight following the repeat endoscopic retrograde cholangiopancreatography (ERCP). In the ESE group, 4/28 patients had duct clearance in subsequent ERCPs, 1/28 patient presented with a blocked stent, and no biliary-related deaths were observed. The mean numbers of ERCPs performed were 0.52 and 1.95 in the PSI and ESE groups, respectively. Over 50% of patients treated with long-term stenting re-presented acutely with stent blockage, though many of these were before 12 months, meaning planned stent exchange would not have affected the outcome. Duct clearance using all possible modalities is the preferred option, but where not possible, management with biliary stenting either with elective exchange or permanent stenting remains a possibility for carefully selected patients, though maybe best suited to those with limited life expectancy.

The Impact of Preoperative α-Adrenergic Antagonists on Ureteral Access Sheath Insertion Force and the Upper Limit of Force Required to Avoid Ureteral Mucosal Injury: A Randomized Controlled Study.

PubMed

Koo, Kyo Chul; Yoon, Jun-Ho; Park, No-Cheol; Lee, Hye Sun; Ahn, Hyun Kyu; Lee, Kwang Suk; Kim, Do Kyung; Cho, Kang Su; Chung, Byung Ha; Hong, Chang Hee

2018-06-01

Excessive bulking force during primary access of the ureteral access sheath may induce ureteral injury. We investigated the efficacy of preoperative α-blockade to reduce ureteral access sheath insertion force and determine the upper limit required to avoid ureteral injury. In this randomized controlled trial 135 patients from a single institution who had ureteropelvic junction or renal pelvis stones and were scheduled to undergo retrograde intrarenal surgery were prospectively enrolled from December 2015 to January 2017. Of the patients 41 and 42 were randomly assigned to the control and experimental groups, respectively. The experimental group received α-blockade preoperatively. The 21 patients who were pre-stented were assessed separately. We developed a homemade device to measure maximal ureteral access sheath insertion force. Our ureteral access sheath insertion force measurement device showed excellent reproducibility. Higher insertion velocity resulted in greater maximal sheath insertion force. Maximal insertion force in the α-blockade group was significantly lower than in the control group at the ureterovesical junction (p = 0.008) and the proximal ureter (p = 0.036). Maximal insertion force in the α-blockade group was comparable to that in pre-stented patients. Female patients and patients 70 years old or older showed a lower maximal ureteral access sheath insertion force than their counterparts. The rate of grade 2 or greater ureteral injury was lower in the α-blockade group than in controls (p = 0.038). No injury occurred in any case in which ureteral access sheath insertion force did not exceed 600 G. Preoperative α-blockade and slow sheath placement may reduce maximal ureteral access sheath insertion force. If the force exceeds 600 G, a smaller diameter sheath may be an alternative. Alternatively the procedure can be terminated and followed later by pre-stented retrograde intrarenal surgery. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis.

PubMed

Palmerini, Tullio; Biondi-Zoccai, Giuseppe; Della Riva, Diego; Stettler, Christoph; Sangiorgi, Diego; D'Ascenzo, Fabrizio; Kimura, Takeshi; Briguori, Carlo; Sabatè, Manel; Kim, Hyo-Soo; De Waha, Antoinette; Kedhi, Elvin; Smits, Pieter C; Kaiser, Christoph; Sardella, Gennaro; Marullo, Antonino; Kirtane, Ajay J; Leon, Martin B; Stone, Gregg W

2012-04-14

The relative safety of drug-eluting stents and bare-metal stents, especially with respect to stent thrombosis, continues to be debated. In view of the overall low frequency of stent thrombosis, large sample sizes are needed to accurately estimate treatment differences between stents. We compared the risk of thrombosis between bare-metal and drug-eluting stents. For this network meta-analysis, randomised controlled trials comparing different drug-eluting stents or drug-eluting with bare-metal stents currently approved in the USA were identified through Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes was extracted. 49 trials including 50,844 patients randomly assigned to treatment groups were analysed. 1-year definite stent thrombosis was significantly lower with cobalt-chromium everolimus eluting stents (CoCr-EES) than with bare-metal stents (odds ratio [OR] 0·23, 95% CI 0·13-0·41). The significant difference in stent thrombosis between CoCr-EES and bare-metal stents was evident as early as 30 days (OR 0·21, 95% CI 0·11-0·42) and was also significant between 31 days and 1 year (OR 0·27, 95% CI 0·08-0·74). CoCr-EES were also associated with significantly lower rates of 1-year definite stent thrombosis compared with paclitaxel-eluting stents (OR 0·28, 95% CI 0·16-0·48), permanent polymer-based sirolimus-eluting stents (OR 0·41, 95% CI 0·24-0·70), phosphorylcholine-based zotarolimus-eluting stents (OR 0·21, 95% CI 0·10-0·44), and Resolute zotarolimus-eluting stents (OR 0·14, 95% CI 0·03-0·47). At 2-year follow-up, CoCr-EES were still associated with significantly lower rates of definite stent thrombosis than were bare-metal (OR 0·35, 95% CI 0·17-0·69) and paclitaxel-eluting stents (OR 0·34, 95% CI 0·19-0·62). No other drug-eluting stent had lower definite thrombosis rates compared with bare-metal stents at 2-year follow-up. In randomised studies completed to date, CoCr-EES has the lowest rate of stent thrombosis within 2 years of implantation. The finding that CoCr-EES also reduced stent thrombosis compared with bare-metal stents, if confirmed in future randomised trials, represents a paradigm shift. The Cardiovascular Research Foundation. Copyright © 2012 Elsevier Ltd. All rights reserved.

Comparison of the 9-month intra-stent conditions and 2-year clinical outcomes after Resolute zotarolimus-eluting stent implantation between 3-month and standard dual antiplatelet therapy.

PubMed

Fujimoto, Wataru; Sawada, Takahiro; Toba, Takayoshi; Takahashi, Yu; Miyata, Taishi; Oishi, Shogo; Osue, Tsuyoshi; Onishi, Tetsuari; Takaya, Tomofumi; Shimane, Akira; Taniguchi, Yasuyo; Kawai, Hiroya; Yasaka, Yoshinori

2018-07-01

The use of short-duration dual antiplatelet therapy (DAPT) remains controversial. To investigate efficacy and safety of short-duration DAPT, we performed a detailed comparison of intra-stent conditions by optical coherence tomography (OCT) after second-generation drug-eluting stent implantation with short-term and standard DAPT. Eighty-two consecutive patients with stable angina pectoris who received Resolute zotarolimus-eluting stents (R-ZESs; Medtronic Cardiovascular, Santa Rosa, CA, USA) were enrolled. Patients were assigned to 3-month (3M group: 41 patients) and standard (standard group: 41 patients) DAPT. In the 3M group, clopidogrel was discontinued 3 months after stent implantation. In the standard group, DAPT was maintained until follow-up OCT. At 9 months, neointimal proliferation was significantly larger in the 3M group, but there were no significant between-group differences in the proportion of uncovered and malapposed strut. The prevalence of abnormal intra-stent tissue (AIT) at 9 months was equivalent between groups. A multiple regression analysis revealed malapposition at 9 months as the strongest independent predictor of AIT at 9 months, and the prevalence of AIT was not associated with DAPT duration. Over 2 years, cardiac events were equal between groups; however, major bleeding was higher tendency in the standard group than in the 3M group. This OCT study indicated that reducing DAPT's duration may provide acceptable arterial healing in patients with implanted R-ZESs. Copyright © 2018 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Coronary In-Stent Restenosis: Assessment with Corrected Coronary Opacification Difference across Coronary Stents Measured with CT Angiography.

PubMed

Gao, Yang; Lu, Bin; Hou, Zhi Hui; Yu, Fang Fang; Yin, Wei Hua; Wang, Zhi Qiang; Wu, Yong Jian; Mu, Chao Wei; Meinel, Felix G; McQuiston, Andrew D; Schoepf, U Joseph

2015-05-01

To determine whether changes in coronary opacification normalized to the aorta (corrected coronary opacification [CCO]) across stents can help identify in-stent restenosis (ISR) severity with use of invasive coronary angiography as the standard of reference. This study was approved by the institutional review board, and the requirement to obtain informed consent was waived. The authors retrospectively analyzed 106 patients (88 men, 18 women; mean age, 59.6 years ± 10.4; age range, 36-84 years) who had previously undergone stent implantation within 3 months of coronary computed tomographic (CT) angiography. Attenuation values in the coronary lumen were measured proximal and distal to the stents and normalized to the descending aorta. The CCO difference across the stent was compared with the severity of ISR. One-way analysis of variance least significant difference was used for comparison. A total of 141 stents were assessed. Seventy-six stents were normally patent, 18 had ISR of less than 50%, 28 had ISR of 50%-99%, and 19 were fully occluded. The median CCO differences in the four groups were 0.078, 0.163, 0.346, and 0.606, respectively. There was no significant difference between stents with an ISR of at least 50% and those with total occlusion (P = .056), although the other groups had significant differences at pairwise comparison (P < .01 for all). For stents smaller than 3 mm in diameter, the median CCO differences in the four groups were 0.086, 0.136, 0.390, and 0.471, respectively. The CCO differences across normal stents and stents with ISR of less than 50% were significantly less than those across stents with an ISR of at least 50% and those with total occlusion (P < .01 for all). There were no significant differences between stents with no ISR and those with an ISR of less than 50% (P = .821) and between stents with an ISR of at least 50% and those with an ISR of 100% (P = .836). The CCO difference across coronary stents is related to ISR severity in obstructive ISR in stents smaller than 3 mm in diameter. © RSNA, 2014.

Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents.

PubMed

Win, Htut K; Caldera, Angel E; Maresh, Kelly; Lopez, John; Rihal, Charanjit S; Parikh, Manish A; Granada, Juan F; Marulkar, Sachin; Nassif, Deborah; Cohen, David J; Kleiman, Neal S

2007-05-09

Clinical trials that have excluded patients at high risk for cardiac events have led to commercial labeling approval of drug-eluting stents; nevertheless, such high-risk patients commonly undergo stent placement in clinical practice. The degree to which they experience cardiac events at a higher rate than non-high-risk patients is unclear. To assess the rates of major adverse cardiac events during the index admission and 1 year after the implantation of drug-eluting stents in patients with high-risk angiographic and clinical features. From July 2004 to September 2005, consecutive patients who underwent attempted stent placement at 42 different hospitals throughout the United States were enrolled in a prospective multicenter registry. We analyzed outcomes of 3323 patients who received at least 1 drug-eluting stent for a reason other than acute ST-segment elevation myocardial infarction. The study population was divided into 2 groups based on presence of at least 1 of 9 off-label characteristics based on the current US Food and Drug Administration-approved indications for sirolimus- and paclitaxel-eluting stents. The composite clinical outcomes of death, myocardial infarction, or target vessel revascularization during the index admission and death, myocardial infarction, or target lesion revascularization at 1 year were evaluated. Of the 3323 patients, 1817 (54.7%) had at least 1 off-label characteristic. During the index hospitalization, the composite clinical outcome occurred in 198 (10.9%) of patients in the off-label group and 76 (5.0%) of patients in the on-label group (adjusted odds ratio, 2.32; 95% confidence interval [CI], 1.75-3.07; P<.001). At 1 year, the composite clinical outcome occurred more often in the off-label group compared with the on-label group; 309 (17.5%) vs 131 (8.9%) (adjusted hazard ratio [HR], 2.16; 95% CI, 1.74-2.67; P<.001). Stent thrombosis also occurred more frequently among patients in the off-label group during the initial hospitalization (8 [0.4%] vs 0) and at 1 year: 29 (1.6%) vs 13 (0.9%), adjusted HR, 2.29 (95% CI, 1.02-5.16; P = .05). Compared with on-label use, off-label use of drug-eluting stents is associated with a higher rate of adverse outcomes during the index admission and at 1 year. Stent thrombosis occurred predominantly in patients who underwent off-label drug-eluting stent implantation. Clinicians should be cautious about extrapolating the benefits of drug-eluting stents over bare-metal stents observed in randomized clinical trials to higher-risk clinical settings that have not been assessed.

Outcomes of secondary self-expandable metal stents versus surgery after delayed initial palliative stent failure in malignant colorectal obstruction.

PubMed

Yoon, Jin Young; Park, Soo Jung; Hong, Sung Pil; Kim, Tae Il; Kim, Won Ho; Cheon, Jae Hee

2013-01-01

When re-intervention is required due to an occluded first colorectal self-expanding metal stent for malignant colorectal obstruction, serious controversies exist regarding whether to use endoscopic re-stenting or surgery. To compare the clinical outcomes in patients who underwent stent re-insertion versus palliative surgery as a second intervention. A total of 115 patients who received either self-expandable metal stent (SEMS) insertion or palliative surgery for treatment of a second occurrence of malignant colorectal obstruction after the first SEMS placement were retrospectively studied between July 2005 and December 2009. The median overall survival (8.2 vs. 15.5 months) and progression-free survival (4.0 vs. 2.7 months) were not significantly different between the stent and surgery groups (p = 0.895 and 0.650, respectively). The median lumen patency in the stent group was 3.4 months and that in the surgery group was 7.9 months (p = 0.003). The immediate complication rate after second stent insertion was 13.9% and late complication rate was observed in 12 of 79 (15.2%) patients. There was no mortality related to the SEMS procedure. The complication and mortality rates associated with palliative surgery were 3.5% (2/57) and 12.3% (7/57), respectively. Although there is no significant difference in the overall survival between stenting and surgery, a secondary stent insertion had a lower mortality rate despite a shorter duration of temporary colorectal decompression compared to that of palliative surgery.

Aggressive plaque modification with rotational atherectomy and cutting balloon for optimal stent expansion in calcified lesions

PubMed Central

Tang, Zhe; Bai, Jing; Su, Shao-Ping; Lee, Pui-Wai; Peng, Liang; Zhang, Tao; Sun, Ting; Nong, Jing-Guo; Li, Tian-De; Wang, Yu

2016-01-01

Objective To evaluate the factors affecting optimal stent expansion in calcified lesions treated by aggressive plaque modification with rotational atherectomy (RA) and a cutting balloon (CB). Methods From January 2014 to May 2015, 92 patients with moderate to severe coronary calcified lesions underwent rotational atherectomy and intravascular ultrasound imaging at Chinese PLA General Hospital (Beijing, China) were included in this study. They were divided into a rotational artherectomy combined with cutting balloon (RACB) group (46 patients treated with RA followed by CB angioplasty) and an RA group (46 patients treated with RA followed by plain balloon angioplasty). Another 40 patients with similar severity of their calcified lesions treated with plain old balloon angioplasty (POBA) were demographically matched to the other groups and defined as the POBA group. All patients received a drug-eluting stent after plaque preparation. Lumen diameter and lumen diameter stenosis (LDS) were measured by quantitative coronary angiography at baseline, after RA, after dilatation, and after stenting. Optimal stent expansion was defined as the final LDS < 10%. Results The initial and post-RA LDS values were similar among the three groups. However, after dilatation, the LDS significantly decreased in the RACB group (from 54.5% ± 8.9% to 36.1% ± 7.1%) but only moderately decreased (from 55.7% ± 7.8% to 46.9% ± 9.4%) in the RA group (time × group, P < 0.001). After stenting, there was a higher rate of optimal stent expansion in the RACB group (71.7% in the RACB group, 54.5% in the RA group, and 15% in the POBA group, P < 0.001), and the final LDS was significantly diminished in the RACB group compared to the other two groups (6.0% ± 2.3%, 10.8% ± 3.3%, 12.7% ± 2.1%, P < 0.001). Moreover, an LDS ≤ 40% after plaque preparation (OR = 2.994, 95% CI: 1.297–6.911) was associated with optimal stent expansion, which also had a positive correlation with the appearance of a calcified ring split (r = 0.581, P < 0.001). Conclusions Aggressive plaque modification with RA and CB achieve more optimal stent expansion. An LDS ≤ 40% after plaque modification was a predictive factor for optimal stent expansion in calcified lesions. This parameter was also associated with the presence of calcified ring split. PMID:28321242

Comparison of in-hospital and long-term outcomes between a Cypher stent and a Taxus stent in Chinese diabetic patients with coronary artery disease.

PubMed

Yang, Yue-jin; Xu, Bo; Kang, Sheng; Pei, Wei-dong; Chen, Ji-lin; Qiao, Shu-bin; Qin, Xue-wen; Yao, Min; Chen, Jue; Wu, Yong-jian; Liu, Hai-Bo; You, Shi-Jie; Li, Jian-Jun; Dai, Jun; Gao, Run-Lin

2007-11-05

The sirolimus and paclitaxel distribution patterns and tissue residence time may be modified in atherosclerotic lesions for patients with diabetes, and the biological mechanisms of action for these agents differ significantly. Previous clinical trials have yielded discrepant results of major adverse cardiac events and restenosis between a sirolimus-eluting stent and a paclitaxel-eluting stent in coronary artery disease. Therefore, this study was conducted to compare in-hospital and long-term clinical outcomes between patients receiving sirolimus-eluting stent (Cypher or Cypher Select stent) and paclitaxel-eluting stent (Taxus Express stent) after percutaneous intervention (PCI) in Chinese patients with diabetes. One hundred and sixty-four consecutive diabetic patients underwent PCI in Fuwai Hospital from April 2004 to December 2004. Of them, 101 patients received Cypher or Cypher Select stents (Cypher group, 145 stents) and 63 patients received Taxus Express stents (Taxus group, 129 stents). Repeat coronary angiography was performed at 6-month and clinical outcomes were evaluated at 1- and 3-year follow-up. Stent thrombosis was classified according to Academic Research Consortium (ARC). The two groups did not differ significantly with respect to cardiac death, recurrent myocardial infarction (re-MI), target vessel revascularization (TVR) and occurrence of major adverse cardiac events (MACE). And the MACE-free cumulative survival at 1- and 3-year follow-up and early, late and very late thrombosis rates were also similar in the two groups (all P > 0.05). There was a trend favoring PES over SES with regard to reducing cardiac death (0 vs 2.0%, P = 0.524), re-MI (0 vs 2.0%, P = 0.524), the composite of the cardiac death and re-MI (0 vs 4.0%, P = 0.299) and very late thrombosis (0 vs 3.0%, P = 0.295) between 1-year and 3-year follow-up. The study indicates that PCI with either Cypher or Taxus stents is associated with similar efficacy and safety in the small population of Chinese diabetic patients during long-term follow-up.

Randomized comparison of deliverability and in-hospital complications in implantation of BxSonic(R), Express(R), and Flexmaster(R) coronary stents.

PubMed

Thuesen, Leif; Galløe, Anders; Thayssen, Per; Rasmussen, Klaus; Kelbæk, Henning; Lassen, Jens Flensted; Hansen, Peter Riis; Pedersen, Knud Erik; Ravkilde, Jan; Helquist, Steffen; Abildgaard, Ulrik; Andersen, Henning Rud; Bøtker, Hans Erik; Kristensen, Steen Dalby; Hjort, Jacob; Krusell, Lars Romer

2005-11-01

To compare deliverability and in-hospital complications in implantation of BxSonic(R), Express(R), and Flexmaster(R) coronary stents in a randomized multicenter trial in five Danish interventional centres. Patients with planned stenting of at least one stenotic lesion in a native coronary artery were included in the study. There were 494 (664) patients (treated lesions) in the BxSonic(R), 499 (657) in the Express(R) and 500 (658) in the Flexmaster(R) groups. The groups were well matched with regard to age, sex, diabetes, smoking, hypercholesterolemia, hypertension, indication for PCI and coronary artery lesion complexity. The study stents were implanted with or without predilatation according to ordinary -clinical practice.Rates of successful stent implantation and in-hospital stent thrombosis, re-intervention, non-fatal myocardial infarction or death. The BxSonic(R), Express(R) and Flexmaster(R) stents were successfully implanted in 92,2%, 89,3% and 91,6% of all lesions (ns). There were no in-hospital deaths and the rates of in-hospital complications were similar in the three stent groups. We found similar deliverability and in-hospital complication rates of the BxSonic(R), Express(R) and Flexmaster(R) stents.

The glider balloon: a useful device for the treatment of bifurcation lesions.

PubMed

Briguori, Carlo; Visconti, Gabriella; Donahue, Michael; Chiariello, Giovanni Alfonso; Focaccio, Amelia

2013-10-09

Final kissing balloon dilatation (FKBD) is a recommended final step in case of treatment of bifurcation lesions by two stents approaches. Furthermore, dilatation of the side branch (SB) may be necessary following main vessel (MV) stenting. Occasionally, recrossing the stent struts with a balloon is hampered because the tip hits a stent strut. The Glider (TriReme Medical, Pleasanton, CA) is a dedicated balloon designed for crossing through struts of deployed stents toward a SB. From October 2010 to January 2012, FKBD was attempted in 236 consecutive bifurcation lesions treated in our Institution. FKBD was successfully performed by conventional balloon catheters in 221 (93.5%) lesions (Conventional group). In the remaining 15 (6.5%) lesions, where a conventional balloon failed to cross the stent strut, the Glider balloon was attempted (Glider group). The angle beta (between the axis of the MV after the branch point and the SB axis at the point of divergence) was wider in the Glider group (83±17° versus 65±27°; p=0.032). A trend toward an higher rate of the true bifurcation lesions was observed in the Glider group (93% versus 70.5%; p=0.07). The Glider balloon successfully crossed through MV stent struts toward a SB in 12 patients (80%), whereas failed in the remaining 3 patients. The Glider balloon represents an unique bail-out device which offers an effective rescue strategy for recrossing stent struts during complex bifurcation stenting. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Is pre-shock wave lithotripsy stenting necessary for ureteral stones with moderate or severe hydronephrosis?

PubMed

El-Assmy, Ahmed; El-Nahas, Ahmed R; Sheir, Khaled Z

2006-11-01

We performed a prospective, randomized clinical trial to evaluate the outcome of ureteral stents for solitary ureteral stones 2 cm or less in moderately or severely obstructed systems using shock wave lithotripsy. Between 2001 and 2004, 186 patients who met study criteria were randomized into 2 groups. Group 1 received a pre-shock wave lithotripsy 6Fr Double-J stent and group 2 had no stent. Patients were treated with a Dornier MFL 5000 lithotripter. Results were compared in terms of clearance rates, number of shock waves and sessions, irritative voiding symptoms, incidence of complications and secondary interventions. Failure was defined as the need for additional procedure(s) for stone extraction. Overall 164 patients (88.2%) became stone-free after shock wave lithotripsy. Complete stone fragmentation was achieved after 1 to 3 and more than 3 session in 108 (58.1%), 30 (16.1%), 13 (7%) and 14 patients (7.5%), respectively. Ureteral stent insertion did not affect the stone-free rate, which was 84.9% and 91.4% in groups 1 and 2, respectively (p = 0.25). There was no statistical difference in the re-treatment rate, flank pain or temperature in the 2 groups. However, all patients in the stented group significantly complained of side effects attributable to the stent, including dysuria, suprapubic pain, hematuria, pyuria and positive urinary culture. Pretreatment stenting provides no advantage over in situ shock wave lithotripsy for significantly obstructing ureteral calculi. Shock wave lithotripsy is reasonable initial therapy for ureteral stones 2 cm or less that cause moderate or severe hydronephrosis.

Comparison of in-hospital and follow-up results of directional atherectomy and stenting for ostial lesions of the left anterior descending coronary artery.

PubMed

Gambhir, D S; Batra, R; Singh, S; Sudha, R; Trehen, V; Arora, R

1998-01-01

Lesions at the ostium of the left anterior descending coronary artery constitute a distinct group because of suboptimal results and higher restenosis rate after balloon angioplasty. Several non-balloon devices have been used to improve the outcome of dilatation of such lesions. We retrospectively compared the in-hospital and follow-up results of directional coronary artherectomy and stents for the treatment of ostial lesions of the left anterior descending artery. Out of 37 patients, 12 underwent directional coronary atherectomy and 25, stent implantation. The two strategies were deployed at different periods over the past five years. The baseline clinical and angiographic characteristics were comparable in the two groups. Directional coronary atherectomy was done using 7Fr atherocath with adjunctive balloon angioplasty in all. All the stents were deployed using moderate to high pressure balloon inflation after adequate predilatation. While the pre-procedure luminal diameter stenosis was similar in the two groups (87.3 +/- 8.8% vs 89.3 +/- 7.2%; p = NS), the residual stenosis was significantly lower in the stent group (5 +/- 2.8%) compared to directional coronary atherectomy (18.7 +/- 9.8; p = 0.02). There was no significant difference in the primary success rate between the two devices (91.6% directional coronary atherectomy vs 100% stent; p = NS). One patient in the directional coronary atherectomy group developed acute closure followed by emergency coronary artery bypass graft surgery and death. No major complication was observed in the stent group. Over a mean follow-up of 9.9 +/- 11.6 months following directional coronary atherectomy and 8.6 +/- 4.4 months after stenting, significantly higher number of patients (60%) developed recurrence of angina or any event following directional coronary atherectomy compared to stent (15.8%; p < 0.02). There was no myocardial infarction, coronary artery bypass graft surgery or death in either group on follow-up. The need for target lesion revascularisation was significantly higher in the directional coronary atherectomy group (50%) compared to stenting (10.5%; p < 0.02). Comparing directional coronary atherectomy with stent, the event-free survival was 80 percent vs 94.7 percent at three months and 50 percent vs 84.7 percent, both at six and nine months, respectively. In conclusion, stenting of the left anterior descending artery ostial lesion results in a significantly lesser post-procedure residual stenosis, improved in-hospital outcome, a lesser need for target lesion revascularisation and much improved event-free survival on follow-up as compared to directional coronary atherectomy. Therefore, stenting appears to be a more favourable treatment option compared to directional coronary atherectomy for the treatment of ostial lesions in the left anterior descending artery.

Dual chamber stent prevents organ malperfusion in a model of donation after cardiac death.

PubMed

Tillman, Bryan W; Chun, Youngjae; Cho, Sung Kwon; Chen, Yanfei; Liang, Nathan; Maul, Timothy; Demetris, Anthony; Gu, Xinzhu; Wagner, William R; Tevar, Amit D

2016-10-01

The paradigm for donation after cardiac death subjects donor organs to ischemic injury. A dual-chamber organ perfusion stent would maintain organ perfusion without affecting natural cardiac death. A center lumen allows uninterrupted cardiac blood flow, while an external chamber delivers oxygenated blood to the visceral vessels. A prototype organ perfusion stent was constructed from commercial stents. In a porcine model, the organ perfusion stent was deployed, followed by a simulated agonal period. Oxygenated blood perfused the external stent chamber. Organ perfusion was compared between controls (n = 3) and organ perfusion stent (n = 6). Finally, a custom, nitinol, dual chamber organ perfusion stent was fabricated using a retrievable "petal and stem" design. Endovascular organ perfusion stent deployment achieved visceral isolation without adverse impact on cardiac parameters. Visceral oxygen delivery was 4.8-fold greater compared with controls. During the agonal period, organs in organ perfusion stent-treated animals appeared well perfused in contrast with the malperfused controls. A custom nitinol and polyurethane organ perfusion stent was recaptured easily with simple sheath advancement. An organ perfusion stent maintained organ perfusion during the agonal phase in a porcine model of donation after cardiac death organ donation without adversely affecting cardiac function. Ultimately, the custom retrievable design of this study may help resolve the critical shortage of donor organs for transplant. Copyright © 2016 Elsevier Inc. All rights reserved.

Endoscopic Stenting as Bridge to Surgery versus Emergency Resection for Left-Sided Malignant Colorectal Obstruction: An Updated Meta-Analysis

PubMed Central

Ceresoli, Marco; Fugazzola, Paola; Ansaloni, Luca

2017-01-01

Introduction Emergency resection represents the traditional treatment for left-sided malignant obstruction. However, the placement of self-expanding metallic stents and delayed surgery has been proposed as an alternative approach. The aim of the current meta-analysis was to review the available evidence, with particular interest for the short-term outcomes, including a recent multicentre RCT. Methods We considered randomized controlled trials comparing stenting as a bridge to surgery and emergency surgery for the management of left-sided malignant large bowel obstruction, performing a systematic review in MEDLINE, PubMed database, and the Cochrane libraries. Results We initially identified a total of 2543 studies. After the elimination of duplicates and the screening of titles and abstracts, seven studies, for a total of 448 patients, were considered. The current meta-analysis revealed no difference in the mortality rate between the stent group and the emergency surgery group; the postoperative complication rate (37.84% versus 54.87%, P = 0.02), the stoma rate (28.8% versus 46.02%, P < 0.0001), and the incidence of wound infection (8.11% versus 15.49%, P = 0.01) were reduced after stent as a bridge to surgery. Conclusion Colonic stenting as a bridge to surgery appears to be a safe approach to malignant large bowel obstruction. Possible advantages of this treatment can be identified in a reduced incidence of postoperative complications and a lower stoma rate. Further RCTs considering long-term outcomes and cost-effectiveness analysis are needed. PMID:28761765

Is early removal of prophylactic ureteric stents beneficial in live donor renal transplantation?

PubMed Central

Indu, K. N.; Lakshminarayana, G.; Anil, M.; Rajesh, R.; George, K.; Ginil, K.; Georgy, M.; Nair, B.; Sudhindran, S.; Appu, T.; Unni, V. N.; Sanjeevan, K. V.

2012-01-01

Prophylactic ureteric stenting has been shown to reduce ureteric leaks and collecting system obstruction following renal transplantation and is in widespread use. However, the optimal time for removal of ureteric stents after renal transplantation remains unclear. Aim of this study was to compare the result of early versus late removal of ureteric stents after kidney transplantation of the laparoscopically retrieved live related donor grafts. Eligible patients were live donor kidney transplant recipients with normal urinary tracts. All recipients underwent extravesical Lich–Gregoire ureteroneocystostomy over 4F/160 cm polyurethane double J stents by a uniform technique. They were randomized on seventh postoperative day for early removal of stents on postoperative day 7 (Group I), or for late removal on postoperative day 28 (Group II). The incidence of urinary tract infections, asymptomatic bacteriuria, and urological complications were compared. Between 2007 and 2009, 130 kidney transplants were performed at one centre of which 100 were enrolled for the study, and 50 each were randomized into the two groups. Donor and recipient age, sex, native renal disease, immunosupression, number of rejection episodes, and antirejection therapy were similar in the two groups. The occurrence of symptomatic urinary tract infection during the follow-up period of 6 months was significantly less in the early stent removal group [5 out of 50 (10%) in Group I, vs 50 out of 15 (30%) in Group II, P=0.02]. Asymptomatic bacteriuria was documented in 2 out of 50 (4%) in Group I and 4 out of 50 (8%) in Group II (P=0.3). There was no statistically significant difference in the rate of ureteric leak, ureteric obstruction, or hematuria in the two groups (P=1.0). We conclude that, in kidney transplant recipients of laparoscopically retrieved live donor grafts, early stent removal at the end of first week reduces the incidence of urinary tract infection without increasing the rate of urine leak or ureteric obstruction. PMID:23162271

Endoscopic stenting for hilar cholangiocarcinoma: efficacy of unilateral and bilateral placement of plastic and metal stents in a retrospective review of 480 patients

PubMed Central

2012-01-01

Background Endoscopic biliary drainage of hilar cholangiocarcinoma is controversial with respect to the optimal types of stents and the extent of drainage. This study evaluated endoscopic palliation in patients with hilar cholangiocarcinoma using self-expandable metallic stents (SEMS) and plastic stents (PS).We also compared unilateral and bilateral stent placement according to the Bismuth classification. Methods Data on 480 patients receiving endoscopic biliary drainage for hilar cholangiocarcinoma between September 1995 and December 2010 were retrospectively reviewed to evaluate the following outcome parameters: technical success (TS), functional success (FS), early and late complications, stent patency and survival. Patients were followed from stent insertion until death or stent occlusion. Patients were divided into 3 groups according to the Bismuth classification (Group 1, type I; Group 2, type II; Group 3, type > III). Results The initial stent insertion was successful in 450 (93.8%) patients. TS was achieved in 204 (88.3%) patients treated with PS and in 246 (98.8%) patients palliated with SEMS (p < 0.001). In the intention-to-treat (ITT) analysis, the FS in patients treated with SEMS (97.9%) was significantly higher than in patients treated with PS (84.8%) (p < 0.001). Late complications occurred in 115 (56.4%) patients treated with PS and 60 (24.4%) patients treated with SEMS (p < 0.001). The median duration of stent patency in weeks (w) were as follows: 20 w in patients palliated with PS and 27 w in patients treated with SEMS (p < 0.0001). In Group 2, the median duration of PS patency was 17 w and 18 w for unilateral and bilateral placement, respectively (p = 0.0004); the median duration of SEMS patency was 24 w and 29 w for unilateral and bilateral placement, respectively (p < 0.0001). Multivariate analysis using the Poisson regression showed that SEMS placement (B = 0.48; P < 0.01) and bilateral deployment (B = 0.24; P < 0.01) were the only independent prognostic factors associated with stent patency. Conclusions SEMS insertion for the palliation of hilar cholangiocarcinoma offers higher technical and clinical success rates in the ITT analysis as well as lower complication rates and a superior cumulative stent patency when compared with PS placement in all Bismuth classifications. The cumulative patency of bilateral SEMS or PS stents was significantly higher than that of unilateral SEMS or PS stents, with lower occlusion rates in Bismuth II patients. PMID:22873816

Stent Design Affects Femoropopliteal Artery Deformation.

PubMed

MacTaggart, Jason; Poulson, William; Seas, Andreas; Deegan, Paul; Lomneth, Carol; Desyatova, Anastasia; Maleckis, Kaspars; Kamenskiy, Alexey

2018-03-23

Poor durability of femoropopliteal artery (FPA) stenting is multifactorial, and severe FPA deformations occurring with limb flexion are likely involved. Different stent designs result in dissimilar stent-artery interactions, but the degree of these effects in the FPA is insufficiently understood. To determine how different stent designs affect limb flexion-induced FPA deformations. Retrievable markers were deployed into n = 28 FPAs of lightly embalmed human cadavers. Bodies were perfused and CT images were acquired with limbs in the standing, walking, sitting, and gardening postures. Image analysis allowed measurement of baseline FPA foreshortening, bending, and twisting associated with each posture. Markers were retrieved and 7 different stents were deployed across the adductor hiatus in the same limbs. Markers were then redeployed in the stented FPAs, and limbs were reimaged. Baseline and stented FPA deformations were compared to determine the influence of each stent design. Proximal to the stent, Innova, Supera, and SmartFlex exacerbated foreshortening, SmartFlex exacerbated twisting, and SmartControl restricted bending of the FPA. Within the stent, all devices except Viabahn restricted foreshortening; Supera, SmartControl, and AbsolutePro restricted twisting; SmartFlex and Innova exacerbated twisting; and Supera and Viabahn restricted bending. Distal to the stents, all devices except AbsolutePro and Innova exacerbated foreshortening, and Viabahn, Supera, Zilver, and SmartControl exacerbated twisting. All stents except Supera were pinched in flexed limb postures. Peripheral self-expanding stents significantly affect limb flexion-induced FPA deformations, but in different ways. Although certain designs seem to accommodate some deformation modes, no device was able to match all FPA deformations.

Fifty shades of gradients: does the pressure gradient in venous sinus stenting for idiopathic intracranial hypertension matter? A systematic review.

PubMed

McDougall, Cameron M; Ban, Vin Shen; Beecher, Jeffrey; Pride, Lee; Welch, Babu G

2018-03-02

OBJECTIVE The role of venous sinus stenting (VSS) for idiopathic intracranial hypertension (IIH) is not well understood. The aim of this systematic review is to attempt to identify subsets of patients with IIH who will benefit from VSS based on the pressure gradients of their venous sinus stenosis. METHODS MEDLINE/PubMed was searched for studies reporting venous pressure gradients across the stenotic segment of the venous sinus, pre- and post-stent pressure gradients, and clinical outcomes after VSS. Findings are reported according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. RESULTS From 32 eligible studies, a total of 186 patients were included in the analysis. Patients who had favorable outcomes had higher mean pressure gradients (22.8 ± 11.5 mm Hg vs 17.4 ± 8.0 mm Hg, p = 0.033) and higher changes in pressure gradients after stent placement (19.4 ± 10.0 mm Hg vs 12.0 ± 6.0 mm Hg, p = 0.006) compared with those with unfavorable outcomes. The post-stent pressure gradients between the 2 groups were not significantly different (2.8 ± 4.0 mm Hg vs 2.7 ± 2.0 mm Hg, p = 0.934). In a multivariate stepwise logistic regression controlling for age, sex, body mass index, CSF opening pressure, pre-stent pressure gradient, and post-stent pressure gradient, the change in pressure gradient with stent placement was found to be an independent predictor of favorable outcome (p = 0.028). Using a pressure gradient of 21 as a cutoff, 81/86 (94.2%) of patients with a gradient > 21 achieved favorable outcomes, compared with 82/100 (82.0%) of patients with a gradient ≤ 21 (p = 0.022). CONCLUSIONS There appears to be a relationship between the pressure gradient of venous sinus stenosis and the success of VSS in IIH. A randomized controlled trial would help elucidate this relationship and potentially guide patient selection.

Impact of Paclitaxel Dose on Tissue Pharmacokinetics and Vascular Healing: A Comparative Drug-Coated Balloon Study in the Familial Hypercholesterolemic Swine Model of Superficial Femoral In-Stent Restenosis.

PubMed

Gongora, Carlos A; Shibuya, Masahiko; Wessler, Jeffrey D; McGregor, Jenn; Tellez, Armando; Cheng, Yanping; Conditt, Gerard B; Kaluza, Greg L; Granada, Juan F

2015-07-01

This study sought to compare the effect of paclitaxel-coated balloon (PCB) concentration on tissue levels and vascular healing using 3 different PCB technologies (In.Pact Pacific = 3 μg/mm(2), Lutonix = 2 μg/mm(2) and Ranger = 2 μg/mm(2)) in the experimental setting. The optimal therapeutic dose for PCB use has not been determined yet. Paclitaxel tissue levels were measured up to 60 days following PCB inflation (Ranger and In.Pact Pacific) in the superficial femoral artery of healthy swine (18 swine, 36 vessels). The familial hypercholesterolemic swine model of superficial femoral artery in-stent restenosis (6 swine, 24 vessels) was used in the efficacy study. Two weeks following bare-metal stent implantation, each in-stent restenosis site was randomly treated with a PCB or an uncoated control balloon (Sterling). Quantitative vascular analysis and histology evaluation was performed 28 days following PCB treatment. All PCB technologies displayed comparable paclitaxel tissue levels 4 h following balloon inflation. At 28 days, all PCB had achieved therapeutic tissue levels; however, the In.Pact PCB resulted in higher tissue concentrations than did the other PCB groups at all time points. Neointimal inhibition by histology was decreased in all PCB groups compared with the control group, with a greater decrease in the In.Pact group. However, the neointima was more mature and contained less peri-strut fibrin deposits in both 2-μg/mm(2) PCB groups. Compared with the clinically established PCB dose, lower-dose PCB technologies achieve lower long-term tissue levels but comparable degrees of neointimal inhibition and fewer fibrin deposits. The impact of these findings in restenosis reduction and clinical outcomes needs to be further investigated. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Use of XenX™, the latest ureteric occlusion device with guide wire utility: results from a prospective multicentric comparative study.

PubMed

Sanguedolce, Francesco; Montanari, Emanuele; Alvarez-Maestro, Mario; Macchione, Nicola; Hruby, Stephan; Papatsoris, Athanasios; Kallidonis, Panagiotis; Villa, Luca; Honeck, Patrick; Traxer, Olivier; Greco, Francesco

2016-11-01

This is a prospective multicentric comparative study evaluating the performance of XenX-a new dual-purpose device for the prevention of stone fragments migration during ureteroscopic lithotripsy (URS). Between March 2014 and January 2015, 41 patients undertaking URS + XenX were matched with 41 patients undergoing standard URS. Patients included had unilateral ureteric stone(s) of 0.5-1.5 cm in maximum size. Demographics, complication rates and surgical outcomes were recorded for comparison. A Likert-like 5-grade scoring system was used for surgeons' evaluation of XenX properties. Cost analysis was performed by comparing weighted mean costs of the relevant procedures. Patients' characteristics between the two groups were comparable. Lasering time was longer for XenX group (13.59 vs. 5.17 min; p = 0.0001) whilst use of basket and need of JJ stent insertion was more frequent in control group (19.5 vs. 97.6 %; p = 0.0001 and 22 vs. 35 %; p = 0.001, respectively). Intra-operative SFR was significantly higher for XenX group (100 vs. 85.4 %; p = 0.0001), but not at 4-week follow-up, after ancillary procedures were needed in 17.1 % of the control group. Surgeons' evaluations for XenX were suboptimal for "Ease of Basketing" (2/5) and "Advancement of double J stent" (3/5). The use of XenX increased costs of procedures, but spared the costs associated to ancillary procedures and stent removals. XenX confirmed to be a safe and effective device especially for the treatment of upper ureteric tract stones; moreover, XenX may reduce the risk for the need of auxiliary procedures and for the insertion of a JJ stent.

Assessment of percutaneous transhepatic portal vein embolization with portal vein stenting for perihilar cholangiocarcinoma with severe portal vein stenosis.

PubMed

Hyodo, Ryota; Suzuki, Kojiro; Ebata, Tomoki; Komada, Tomohiro; Mori, Yoshine; Yokoyama, Yukihiro; Igami, Tsuyoshi; Sugawara, Gen; Naganawa, Shinji; Nagino, Masato

2015-04-01

The aim of the present study was to assess the clinical efficiency of portal vein (PV) stenting when performed with preoperative percutaneous transhepatic portal vein embolization (PTPVE) in patients with severe PV stenosis due to tumor invasion. Between 2007 and 2013, four consecutive patients (one male, three females; mean age, 52 years; age range, 25-73 years) with perihilar cholangiocarcinoma and PV stenosis underwent PTPVE and PV stenting. Patients were analyzed with regard to the procedure, hypertrophy of the future remnant liver (FRL), and plasma clearance rate of indocyanine green by the FRL (ICGK-F). Further, the %FRL volume increase in PTPVE was compared between the stenting group and the usual PTPVE group who have perihilar cholangiocarcinomas without PV stenosis. Preoperative PTPVE with PV stenting was successfully performed and portal flow to the FRL improved after stenting in all four patients. The %FRL volume increase was 18-60% (mean, 34%) in the stenting group and was 12-51% (mean, 21%) in the usual PTPVE group. The ICGK-F value after PTPVE exceeded 0.05 in all four patients. All patients achieved R0 resection. Preoperative PTPVE with PV stenting appears to be feasible in cases of severe PV tumor invasion and stenosis. This procedure may allow a broader indication for surgery. © 2014 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

Comparison of partially covered nitinol stents with partially covered stainless stents as a historical control in a multicenter study of distal malignant biliary obstruction: the WATCH study.

PubMed

Isayama, Hiroyuki; Mukai, Tsuyoshi; Itoi, Takao; Maetani, Iruru; Nakai, Yousuke; Kawakami, Hiroshi; Yasuda, Ichiro; Maguchi, Hiroyuki; Ryozawa, Shomei; Hanada, Keiji; Hasebe, Osamu; Ito, Kei; Kawamoto, Hirofumi; Mochizuki, Hitoshi; Igarashi, Yoshinori; Irisawa, Atsushi; Sasaki, Tamito; Togawa, Osamu; Hara, Taro; Kamada, Hideki; Toda, Nobuo; Kogure, Hirofumi

2012-07-01

Covered self-expandable metal stents (CSEMSs) were developed to prevent tumor ingrowth, but stent migration is one of the problems with CSEMSs. To evaluate a new, commercially available CSEMS with flared ends and low axial force compared with a commercially available CSEMS without the anti-migration system and high axial force. Multicenter, prospective study with a historical cohort. Twenty Japanese referral centers. This study involved patients with unresectable distal malignant biliary obstruction. Placement of a new, commercially available, partially covered SEMS. Recurrent biliary obstruction rate, time to recurrent biliary obstruction, stent-related complications, survival. Between April 2009 and March 2010, 141 patients underwent partially covered nitinol stent placement, and between May 2001 and January 2007, 138 patients underwent placement of partially covered stainless stents as a historical control. The silicone cover of the partially covered nitinol stents prevented tumor ingrowth. There were no significant differences in survival (229 vs 219 days; P = .250) or the rate of recurrent biliary obstruction (33% vs 38%; P = .385) between partially covered nitinol stents and partially covered stainless stents. Stent migration was less frequent (8% vs 17%; P = .019), and time to recurrent biliary obstruction was significantly longer (373 vs 285 days; P = .007) with partially covered nitinol stents. Stent removal was successful in 26 of 27 patients (96%). Nonrandomized, controlled trial. Partially covered nitinol stents with an anti-migration system and less axial force demonstrated longer time to recurrent biliary obstruction with no tumor ingrowth and less stent migration. Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

A prospective randomized study for efficacy of an uncovered double bare metal stent compared to a single bare metal stent in malignant biliary obstruction.

PubMed

Lee, Hyun Jik; Chung, Moon Jae; Park, Jeong Yup; Park, Seung Woo; Nam, Chung Mo; Song, Si Young; Bang, Seungmin

2017-08-01

A biliary self-expandable metal stent (SEMS) is commonly used to relieve malignant biliary obstruction. The aim of this study was to compare the efficacy of a conventional uncovered SEMS with that of a newly developed uncovered double bare metal stent in reducing the risk of stent occlusion caused by tumor ingrowth. We performed a prospective, open-labeled, randomized trial in 71 patients at Severance Hospital, Yonsei University College of Medicine from June 2013 to June 2014. Patients with inoperable malignant biliary obstruction were included and randomized to receive an uncovered single bare metal stent (SBSs; S&G Biotech Inc.), an uncovered single bare metal stent (SBSt; Taewoong Medical), or an uncovered double bare metal stent (DBS; S&G Biotech Inc.). The mean age was 66.6 years (range, 35-83), and 42 (59.2%) were male. The mean duration of stent patency was 212 days (±152) in the DBS group (n = 24) compared with 124 days (±98) in the SBSs group (n = 23; P = 0.022 for noninferiority) and 116 days (±79) in the SBSt group (n = 24; P = 0.010 for noninferiority). There were no differences in the incidences of early and delayed complications or migration. The newly developed DBS is noninferior to the conventional uncovered SEMSs on duration of stent patency and tumor ingrowth occurred less frequently in the DBS group. This might decrease the need for reintervention and offer a better quality of life. The trial is registered with Clinicaltrials.gov no: NCT01869894.

In vitro comparison of intracranial stent visibility using various concentrations of gadolinium contrast agent under 1.5 T and 3 T MR angiography.

PubMed

Chiang, Chen-Hua; Tseng, Ying-Chi; Chen, Ai-Chi; Huang, Yen-Lin; Chen, David Yen-Ting; Chen, Chi-Jen; Lin, Yen-Kuang; Hsu, Hui-Ling

2017-04-01

MR angiography (MRA) is an increasingly used evaluation method following intracranial stenting. However, the various artifacts created by the stent limit this technique. The purpose of this study was to investigate the effects of various concentrations of gadolinium contrast agent on the visibility and signal characteristics of two stents using the a contrast enhanced MRA technique. Two intracranial stents (Enterprise and Helistent) were placed in polyvinyl chloride tubes as vascular phantoms. They were filled with six different doses of gadolinium contrast agent (1.0, 2.0, 4.0, 6.0, 8.0, and 10.0 mmol/L dimeglumine gadopentetate, respectively) and imaged using 3 T and 1.5 T MR systems. Relative in-stent signal (RIS) was calculated and artificial luminal narrowing (ALN) was obtained using pixel by pixel analysis. The Enterprise stent, performed in both 1.5 T and 3 T MR systems, showed mean RIS values much less than those for the Helistent for all different doses of gadolinium solution. Increased gadolinium concentration resulted in a gradual reduction in RIS values in the Enterprise group. Also, ALN in the Enterprise group showed no or little change with various gadolinium doses. The Enterprise stent demonstrated good luminal visibility regardless of gadolinium concentration. The relative in-stent signals were more predictable in the Enterprise stent with various doses of gadolinium. Therefore, the Enterprise stent has been shown to provide better in-stent visibility compared with the Helistent using various gadolinium doses. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Long-term Postprocedural Outcomes of Palliative Emergency Stenting vs Stoma in Malignant Large-Bowel Obstruction.

PubMed

Abelson, Jonathan S; Yeo, Heather L; Mao, Jialin; Milsom, Jeffrey W; Sedrakyan, Art

2017-05-01

Colonic stenting was introduced for palliation of malignant large-bowel obstruction (MLBO) more than 20 years ago but remains controversial. To compare outcomes after palliative stenting vs stoma creation in patients with MLBO requiring emergency management. This observational cohort study assessed 345 patients from New York State with an urgent or emergency admission to the hospital for obstruction secondary to colorectal cancer and who underwent stenting or stoma creation from October 1, 2009, through December 31, 2013. Patients were excluded if they underwent resection within 1 year of the index admission. Palliative stenting vs stoma creation. Primary outcomes included subsequent operation and readmission within 90-day and 1-year follow-up. Secondary outcomes were in-hospital death, major medical and surgical complications, length of stay, total charges, and discharge dispositions. Multivariable hierarchical analyses and propensity score matching were used to compare outcomes between the exposure groups. The cohort included 345 patients (mean [SD] age, 69.9 [14.4] years in the stoma group and 70.9 [16.8] years in the stent group; 87 men [50.3%] in the stoma group and 90 [52.3%] in the stent group; and 114 non-Hispanic white patients [65.9%] in the stoma group and 90 [52.3%] in the stent group). Most patients undergoing stenting were treated at high-volume (104 [60.5%]) vs medium-volume (42 [24.4%]) or low-volume (26 [15.1%]) hospitals (P < .001). Patients undergoing stenting were significantly less likely to experience prolonged length of stay (odds ratio [OR], 0.50; 95% CI, 0.26-0.97; P = .04), more likely to be discharged to their usual residence (OR, 0.14; 95% CI, 0.07-0.28; P < .001), and tended to have similar or fewer complications (major events: OR, 0.81; 95% CI, 0.30-2.18; P = .68; procedural complications: OR, 0.57; 95% CI, 0.11-1.22; P = .10). There was no significant difference between the groups in terms of 90-day and 1-year readmission to the hospitals (90 days: OR, 0.93; 95% CI, 0.49-1.78; P = .83; 1 year: OR, 0.72; 95% CI, 0.38-1.37; P = .30). Subsequent operation at 90 days was also not different between the groups (OR, 1.34; 95% CI, 0.26-6.89; P = .72), but there was a higher chance of subsequent operation at 1 year after the stenting procedure (OR, 2.93; 95% CI, 1.12-7.68; P = .03), with most subsequent operations being restenting. In patients with MLBO and if resection is not part of the treatment plan, stenting is safe and improves the efficiency of care with obvious quality-of-life benefits. It should be offered at experienced centers, and patients should be counseled regarding increased risk of subsequent stenting within 1 year.

75 FR 54637 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-08

... infarction, treatment of in-stent restenosis and/or post-deployment stent expansion. Cutting/scoring PTCA... of in-stent restenosis and/or post- deployment stent expansion, be reclassified from class III to... PTCA catheters for the treatment of in-stent restenosis and/or post-deployment stent expansion, but not...

Endoscopic Biliary Stenting Versus Percutaneous Transhepatic Biliary Stenting in Advanced Malignant Biliary Obstruction: Cost-effectiveness Analysis.

PubMed

Sun, Xin Rong; Tang, Cheng Wu; Lu, Wen Ming; Xu, Yong Qiang; Feng, Wen Ming; Bao, Yin; Zheng, Yin Yuan

2014-05-01

This study aims to compare the clinical outcomes and costs between endoscopic biliary stenting (EBS) and percutaneous transhepatic biliary stenting (PTBS). We randomly assigned 112 patients with unresectable malignant biliary obstruction 2006 and 2011 to receive EBS or PTBS with self-expandable metal stent (SEMS) as palliative treatment. PTBS was successfully performed in 55 patients who formed the PTBS group (failed in 2 patients). EBS was successfully performed in 52 patients who formed the EBS group (failed in 3 patients). The effectiveness of biliary drainage, hospital stay, complications, cost, survival time and mortality were compared. Patients in PTBS group had shorter hospital stay and lower initial and overall expense than the BBS group (P < 0.05). There was no significant difference in effectiveness of biliary drainage (P = 0.9357) or survival time between two groups (P = 0.6733). Early complications occurred in PTBS group was significantly lower than in EBS group (3/55 vs 11/52, P = 0.0343). Late complications in the EBS group did not differ significantly from PTBS group (7/55 vs 9/52, P = 0.6922). The survival curves in the two groups showed no significant difference (P = 0.5294). Conclusions: 3.

Microparticles and blood cells induce procoagulant activity via phosphatidylserine exposure in NSTEMI patients following stent implantation.

PubMed

Wang, Lixiu; Bi, Yayan; Cao, Muhua; Ma, Ruishuang; Wu, Xiaoming; Zhang, Yan; Ding, Wenbo; Liu, Yan; Yu, Qian; Zhang, Yingqian; Jiang, Hua; Sun, Yingchun; Tong, Dongxia; Guo, Li; Dong, Zengxiang; Tian, Ye; Kou, Junjie; Shi, Jialan

2016-11-15

Relatively little is known about the role of phosphatidylserine (PS) in procoagulant activity (PCA) in patients with non-ST-elevated myocardial infarction (NSTEMI) after stent implantation. This study was designed to evaluate whether exposed PS on microparticles (MPs) and blood cells were involved in the hypercoagulable state in NSTEMI patients with stent implantation. NSTEMI patients (n=90) and healthy controls (n=20) were included in our study. PS exposure on MPs and blood cells was analyzed with flow cytometer and confocal microscope. PCA was evaluated by clotting time, purified coagulation complex assays and fibrin production assays. Baseline levels of MPs and PS + blood cells were significantly higher (P<0.001) in the patients than in controls. After stent implantation, a remarkable increase was observed in both MPs and PS + blood cells. Specifically, PS + MPs, PS + platelets and erythrocytes peaked at 18h following stent implantation, while PS + leukocytes peaked on day 2. In addition, circulating MPs (mostly derived from platelets, leukocytes, erythrocytes and endothelial cells) cooperating with PS + blood cells, contributed to markedly shortened coagulation time and markedly increased FXa/thrombin/fibrin (all P<0.01) generation in patient group. Moreover, blockade of exposed PS on MPs and cells with lactadherin inhibited PCA by approximately 70%. Our results suggest that PS + MPs and blood cells play a procoagulant role in NSTEMI patients following stent implantation. Blockade of PS could become a novel therapeutic modality for the prevention of thrombosis in these patients. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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.

Provisional vs. two-stent technique for unprotected left main coronary artery disease after ten years follow up: A propensity matched analysis.

PubMed

D'Ascenzo, Fabrizio; Iannaccone, Mario; Giordana, Francesca; Chieffo, Alaide; Connor, Stephen O; Napp, L Christian; Chandran, SujaySubash; de la Torre Hernández, José María; Chen, Shao-Liang; Varbella, Ferdinando; Omedè, Pierluigi; Taha, Salma; Meliga, Emanuele; Kawamoto, Hiroyoshi; Montefusco, Antonio; Chong, Mervyn; Garot, Philippe; Sin, Lin; Gasparetto, Valeria; Abdirashid, Mohamed; Cerrato, Enrico; Biondi-Zoccai, Giuseppe; Gaita, Fiorenzo; Escaned, Javier; Hiddick Smith, David; Lefèvre, Thierry; Colombo, Antonio; Sheiban, Imad; Moretti, Claudio

2016-05-15

There is uncertainty on which stenting approach confers the best long-term outlook for unprotected left main (ULM) bifurcation disease. This is a non-randomized, retrospective study including all consecutive patients with 50% stenosis of the left main involving at least 1 of the arteries stemming from the left main treated with drug-eluting stents (DES) in 9 European centers between 2002 and 2004. Patients were divided into two groups: those treated with provisional stentings vs. those treated with two stent strategy. The outcomes of interest were 10-year rates of target lesion revascularization (TLR), major adverse cardiac events (MACE), and their components (cardiovascular death, myocardial infarction [MI], or repeat revascularization), along with stent thrombosis (ST). A total of 285 patients were included, 178 (62.5%) in the provisional stenting group and 87 (37.5%) in the two stent group. After 10 years, no differences in TLR were found at unadjusted analysis (19% vs 25%, p>0.05) nor after propensity score matching (25% vs 28%, p>0.05). Similar rates of MACE (60% vs 66%, p>0.05), death (34% vs 43%, p>0.05), MI (9% vs 14%, p>0.05) and ST were also disclosed at propensity-based analysis. Even after 10 year follow-up, patients treated with provisional stenting on left main showed comparable rates of target lesion revascularization compared to two stent strategy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

MIGS: therapeutic success of combined Xen Gel Stent implantation with cataract surgery.

PubMed

Hohberger, Bettina; Welge-Lüßen, Ulrich-Christoph; Lämmer, Robert

2018-03-01

Glaucoma, a common disease in the elderly population, is frequently coexistent with cataract. While the combination of filtration surgery and cataract surgery is a challenging topic with limited success, minimal invasive glaucoma surgery (MIGS), such as Xen Gel Stents, seems to provide promising results. The aim of this study was to investigate the complete and qualified therapeutic success of Xen Gel Stent implantation with (XenPhaco) and without cataract surgery. One hundred and eleven open-angle glaucoma eyes underwent implantation of Xen45 Gel Stent (AqueSys, Inc.) with or without cataract operation. Complete therapeutic success was defined as target intraocular pressure (IOP) < 18 mmHg at any time point within 6 months of follow-up without local antiglaucomatous therapy or further surgical interventions. Qualified success was defined as target IOP <18 mmHg with additional 1-2 local antiglaucomatous eye drops. Failure included all cases with the necessity of at least three local antiglaucomatous eye drops or additional glaucoma surgery. Combined implantation of Xen Gel Stent with cataract surgery was performed in 30 eyes and stand-alone Xen Gel Stent implantation was performed in 81 eyes. A complete therapeutic success was achieved in 46.9% of single Xen Gel Stent implantation, whereas 53.3% was reached with combined XenPhaco. Qualified success was seen in 2.5% in the eyes of the single Xen Gel Stent implantation group and in 3.3% of the combined surgery group. Therapeutic failure rate was 49.4% in the stand-alone group vs 46.7% in the combined group. Data were not significantly different for group and subgroup analyses. Complete and qualified therapeutic success is similar for the combination of Xen Gel Stent implantation with and without cataract surgery in open-angle glaucoma patients. MIGS using Xen Gel Stent can be recommended in situations if glaucoma surgery is indicated besides coexisting cataract.

Comparing the effectiveness and safety between triple antiplatelet therapy and dual antiplatelet therapy in type 2 diabetes mellitus patients after coronary stents implantation: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Bundhun, Pravesh Kumar; Qin, Tao; Chen, Meng-Hua

2015-10-09

Since antiplatelet therapy in type 2 diabetes mellitus (T2DM) patients is very important after intracoronary stenting, and because the most commonly used therapies have been the dual antiplatelet therapy (DAPT) consisting of aspirin and clopidogrel and the triple antiplatelet therapy (TAPT) consisting of aspirin, clopidogrel and cilostazol, we aim to compare the effectiveness and safety between triple antiplatelet therapy and dual antiplatelet therapy in T2DM patients. Systematic literature search was done from the databases of PubMed, Cochrane, Embase, China National Knowledge Infrastructure (CNKI) and WanFang. Randomized controlled trials (RCTs) comparing the effectiveness and safety between triple therapy and dual therapy in T2DM patients after coronary stents placement were included. Endpoints included major adverse cardiac effects (MACEs), target lesion revascularization (TLR), target vessel revascularization (TVR), death, stent thrombosis, bleeding and adverse drug reactions during a 9-12 months period, as well as platelet activities. Four studies including 1005 patients reporting the adverse clinical outcomes and six studies including 519 patients reporting the platelet activities, with a total of 1524 patients have been analyzed in this meta-analysis. The pooling analysis shows that TAPT has significantly decreased the occurrence of MACEs (RR: 0.55; 95 % CI: 0.36-0.86, P = 0.009), TLR (RR 0.41; 95 % CI: 0.21-0.80, P = 0.008), TVR (RR 0.55; 95 % CI: 0.34-0.88, P = 0.01) and the overall incidence of Death/ Myocardial Infarction (MI)/TVR (RR 0.54; 95 % CI: 0.31-0.94, P = 0.03) during this 9 to 12 months follow up period after stents implantation. Stent thrombosis was almost similar in both groups. Bleeding seemed to favor DAPT but the result was not statistically significant. Platelet aggregation, platelet reactivity index (PRI) and platelet reactivity unit (PRU) were also reduced with Weight Mean Difference (WMD) of (-13.80; 95 % CI: -17.03 to -10.56, P < 0.00001), (-22.87; 95 % CI: -23.66 to -22.07, P < 0.00001) and (-44.17; 95 % CI: -58.56 to -29.77, P < 0.00001) respectively. Since MACEs have been significantly decreased in the triple group, TAPT appears to be more effective than DAPT in T2DM patients after intracoronary stenting. No significant difference in stent thrombosis and bleeding risks between these 2 groups shows TAPT to be almost as safe as DAPT in these diabetic patients.

The C4280A (rs5705) gene polymorphism of the renin (REN) gene is associated with risk of developing coronary artery disease, but not with restenosis after coronary stenting.

PubMed

Fragoso, Jose Manuel; Alvarez-León, Edith; Delgadillo-Rodríguez, Hilda; Arellano-González, Marva; López-Pacheco, Filogonio Caín; Cruz-Robles, David; Peña-Duque, Marco Antonio; Pérez-Méndez, Oscar; Martínez-Ríos, Marco Antonio; Vargas-Alarcón, Gilberto

2015-08-01

The aim of the present study was to evaluate the role of AGT and REN gene polymorphisms as susceptibility markers for coronary artery disease (CAD) and/or restenosis after coronary stent placement in a group of Mexican patients. Five polymorphisms of the AGT (rs699, rs4762, rs5051, rs5049, rs5046) and two of the REN (rs5707, rs5705) genes were analyzed by 5' exonuclease TaqMan genotyping assays in 240 patients with CAD who underwent coronary artery stenting (76 with restenosis and 164 without restenosis). A group of 610 individuals without clinical and familial antecedents of cardiovascular diseases were included as controls. The results showed that the distribution of AGT and REN polymorphisms were similar in patients with and without restenosis. However, when the whole group of patients (with and without restenosis) was compared to healthy controls, under co-dominant, dominant, heterozygous and additive models, the REN A4280C (rs5705) polymorphism was associated with increased risk of CAD (OR=1.76, PCo-dom=0.006, OR=1.81, PDom=0.001, OR=1.75, PHet=0.003 and OR=1.59, PAdd=0.003, respectively). All models were adjusted for age, gender, diabetes, dyslipidemia, hypertension and smoking habit. The TC haplotype of the REN gene was associated with increased risk of CAD (OR=1.53, P=0.014). The data suggest that the REN C4280A (rs5705) polymorphism plays an important role in the risk of developing CAD with the highest risk for C allele, but do not support its role as a risk factor for developing restenosis after coronary stenting. Copyright © 2015. Published by Elsevier Inc.

Palliative treatment with radiation-emitting metallic stents in unresectable Bismuth type III or IV hilar cholangiocarcinoma.

PubMed

Lu, Jian; Guo, Jin-He; Zhu, Hai-Dong; Zhu, Guang-Yu; Wang, Yong; Zhang, Qi; Chen, Li; Wang, Chao; Pan, Tian-Fan; Teng, Gao-Jun

2017-01-01

The emerging data for stenting in combination with brachytherapy in unresectable hilar cholangiocarcinoma are encouraging. The aim of this study was to evaluate the efficacy and safety of radiation-emitting metallic stents (REMS) for unresectable Bismuth type III or IV hilar cholangiocarcinoma. Consecutive patients who underwent percutaneous placement with REMS or uncovered self-expandable metallic stent (SEMS) for unresectable Bismuth type III or IV hilar cholangiocarcinoma between September 2011 and April 2016 were identified into this retrospective study. Data on patient demographics and overall survival, functional success, stent patency and complications were collected at the authors' hospital. A total of 59 patients were included: 33 (55.9%) in the REMS group and 26 (44.1%) in the SEMS group. The median overall survival was 338 days in the REMS group and 141 days in the SEMS group (p<0.001). The median stent patency time was 385 days for REMS and 142 days for SEMS (p<0.001). The functional success rate (87.9% vs 84.6%, p=0.722) and incidence of overall complications (27.3% vs 26.9%, p=0.999) did not differ in the two groups. Placement with REMS is safe and effective in palliation for unresectable Bismuth type III or IV hilar cholangiocarcinoma, and seems to prolong survival as well as patency of stent in these patients.

Fully covered stents versus partially covered stents for palliative treatment of esophageal cancer: Is there a difference?

PubMed

Alonso Lárraga, J O; Flores Carmona, D Y; Hernández Guerrero, A; Ramírez Solís, M E; de la Mora Levy, J G; Sánchez Del Monte, J C

2018-02-26

Malignant dysphagia is difficulty swallowing resulting from esophageal obstruction due to cancer. The goal of palliative treatment is to reduce the dysphagia and improve oral dietary intake. Self-expandable metallic stents are the current treatment of choice, given that they enable the immediate restoration of oral intake. The aim of the present study was to describe the results of using totally covered and partially covered esophageal stents for palliating esophageal cancer. A retrospective study was conducted on patients with inoperable esophageal cancer treated with self-expandable metallic stents. The 2 groups formed were: group A, which consisted of patients with a fully covered self-expandable stent (SX-ELLA ® ), and group B, which was made up of patients with a partially covered self-expandable stent (Ultraflex ® ). Of the 69-patient total, 50 were included in the study. Group A had 19 men and 2 women and their mean age was 63.6 years (range 41-84). Technical success was achieved in 100% (n=21) of the cases and clinical success in 90.4% (n=19). Group B had 24 men and 5 women and their mean age was 67.5 years (range 43-92). Technical success was achieved in 100% (n=29) of the cases and clinical success in 89.6% (n=26). Complications were similar in both groups (33.3 vs. 51.7%). There was no difference between the 2 types of stent for the palliative treatment of esophageal cancer with respect to technical success, clinical success, or complications. Copyright © 2018 Asociación Mexicana de Gastroenterología. Publicado por Masson Doyma México S.A. All rights reserved.

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

PubMed

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

2017-07-15

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

Predictors of acute and persisting ischemic brain lesions in patients randomized to carotid stenting or endarterectomy.

PubMed

Rostamzadeh, Ayda; Zumbrunn, Thomas; Jongen, Lisa M; Nederkoorn, Paul J; Macdonald, Sumaira; Lyrer, Philippe A; Kappelle, L Jaap; Mali, Willem P Th M; Brown, Martin M; van der Worp, H Bart; Engelter, Stefan T; Bonati, Leo H

2014-02-01

We investigated predictors for acute and persisting periprocedural ischemic brain lesions among patients with symptomatic carotid stenosis randomized to stenting or endarterectomy in the International Carotid Stenting Study. We assessed acute lesions on diffusion-weighted imaging 1 to 3 days after treatment in 124 stenting and 107 endarterectomy patients and lesions persisting on fluid-attenuated inversion recovery after 1 month in 86 and 75 patients, respectively. Stenting patients had more acute (relative risk, 8.8; 95% confidence interval, 4.4-17.5; P<0.001) and persisting lesions (relative risk, 4.2; 95% confidence interval, 1.6-11.1; P=0.005) than endarterectomy patients. Acute lesion count was associated with age (by trend), male sex, and stroke as the qualifying event in stenting; high systolic blood pressure in endarterectomy; and white matter disease in both groups. The rate of conversion from acute to persisting lesions was lower in the stenting group (relative risk, 0.4; 95% confidence interval, 0.2-0.8; P=0.007), and was only predicted by acute lesion volume. Stenting caused more acute and persisting ischemic brain lesions than endarterectomy. However, the rate of conversion from acute to persisting lesions was lower in the stenting group, most likely attributable to lower acute lesion volumes. Clinical Trial Registration -URL: www.isrctn.org. Unique identifier: ISRCTN25337470.

Carotid Artery Stenting: Single-Center Experience Over 11 Years

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

Nolz, Richard, E-mail: richard.nolz@meduniwien.ac.at; Schernthaner, Ruediger Egbert, E-mail: ruediger.schernthaner@meduniwien.ac.a; Cejna, Manfred, E-mail: manfred.cejna@lkhf.a

2010-04-15

This article reports the results of carotid artery stenting during an 11-year period. Data from 168 carotid artery stenting procedures (symptomatic, n = 55; asymptomatic, n = 101; symptoms not accessible, n = 12) were retrospectively collected. Primary technical success rate, neurological events in-hospital, access-site complications, and contrast-induced nephropathy (n = 118) were evaluated. To evaluate the influence of experience in carotid artery stenting on intraprocedural neurologic complications, patients were divided into two groups. Group 1 included the first 80 treated patients, and group 2 the remainder of the patients (n = 88). In-stent restenoses at last-follow-up examinations (n =more » 89) were assessed. The overall primary technical success rate was 95.8%. The in-hospital stroke-death rate was 3.0% (n = 5; symptomatic, 5.4%; asymptomatic, 2.0%; p = 0.346). Neurologic complications were markedly higher in group 1 (4.2%; three major strokes; symptomatic, 2.8%, asymptomatic, 1.4%) compared to group 2 (2.4%; one major and one minor stroke-symptomatic, 1.2%, asymptomatic 1.2%), but this was not statistically significant. Further complications were access-site complications in 12 (7.1%), with surgical revision required in 1 (0.6%) and mild contrast-induced nephropathy in 1 (0.85%). Twenty-one (23.6%) patients had >50% in-stent restenosis during a mean follow-up of 28.2 months. In conclusion, advanced experience in carotid artery stenting leads to an acceptable periprocedural stroke-death rate. In-stent restenosis could be a critical factor during the follow-up course.« less

Effects of specific alpha-1A/1D blocker on lower urinary tract symptoms due to double-J stent: a prospectively randomized study.

PubMed

Wang, Chung-Jing; Huang, Shi-Wei; Chang, Chien-Hsing

2009-06-01

The aim of our study was to evaluate the effect of tamsulosin in improving symptoms in patients with indwelling double-J ureteral stents. This prospective study lasted from April 2006 to March 2008. All the patients with symptomatic lower ureteral stones with <15 mm diameter were enrolled, and were prospectively randomized (random numbers table) into two groups. A total of 154 patients, with insertion of a double-J ureteral stent after ureteroscopic stone removal. In group 1, 75 patients were enrolled and received placebo for 2 weeks. Group 2 included 79 patients who received 0.4 mg of tamsulosin, once daily for 2 weeks. All patients completed the validated ureteral stent symptom questionnaire (USSQ) and quality of life of international prostate symptom scale (IPSS) for evaluating the symptoms of double-J stents and quality of life after double-J stent insertion and removal, respectively. The analysis of the questionnaire at W1 revealed a significant difference in the main score index of urinary symptoms, body pain and general health between groups 1 and 2. When comparing W1 evaluation with that of W4 after double-J removal, both groups showed significant worsening of urinary symptoms, body pain, general health and work performance, except sexual performance. The mean score of quality of life in IPSS was 4.21 in group 1 and 1.6 in group 2. Tamsulosin can improve a subset of stent-related urinary symptoms and quality of life effectively and may be applied in routine clinical practice.

A comparative study of short- and medium-term outcomes comparing emergent surgery and stenting as a bridge to surgery in patients with acute malignant colonic obstruction.

PubMed

Kavanagh, Dara O; Nolan, Blathnaid; Judge, Ciaran; Hyland, John M P; Mulcahy, Hugh E; O'Connell, P Ronan; Winter, Des C; Doherty, Glen A

2013-04-01

The use of self-expanding metal stents as a bridge to surgery in the setting of malignant colorectal obstruction has been advocated as an acceptable alternative to emergency surgery. However, concerns about the safety of stenting have been raised following recent randomized studies. The aim of the current study was to compare outcomes. This was an observational, comparative study. This study was conducted at a tertiary referral center and university teaching hospital. Patients with malignant colonic obstruction (n = 49) treated by either emergency surgery (n = 26) or with stent placement (n = 23) as a bridge to surgery were identified and followed. Short-term outcomes including stoma rates and postoperative morbidity and medium-term oncological outcomes were compared based on an "intention-to-treat" analysis. Patients in both groups were well matched on clinicopathological parameters. Technical and clinical successful stent deployment was achieved in 91% and 83%. This did not adversely impact cancer-specific and overall survival (log rank = nonsignificant). No difference was observed in stoma rates, primary anastomosis rates, perioperative mortality rates, or reoperation rates between the 2 groups. Significantly fewer patients underwent total colectomy in the stent group in comparison with the emergency surgery group (1/23 vs 6/26: p = 0.027). There was no difference in postoperative morbidity (59% vs 66%: p = 0.09). There was a significant reduction in readmission rates in the stent group (5/26 vs 0/23: p = 0.038). The small sample size of this study could lead to type II error. In addition, the study was nonrandomized and demonstrated a limited length of follow-up. Despite a high rate of technical and clinical success in selected patients with colonic obstruction, stenting has no impact on stoma rates. Despite concerns about the rate of stent-associated perforation, stenting does not adversely impact disease progression or survival. Future comparative trials are essential to better define the role of stenting in this setting and to ensure that we are not using costly technology to create an elective operative situation without concomitant patient benefits.

A randomized study to compare bioactive titanium stents and everolimus-eluting stents in diabetic patients (TITANIC XV): 1-year results.

PubMed

López-Mínguez, José R; Nogales-Asensio, Juan M; Doncel-Vecino, Luis J; Merchán-Herrera, Antonio; Pomar-Domingo, Francisco; Martínez-Romero, Pedro; Fernández-Díaz, José A; Valdesuso-Aguilar, Raúl; Moreu-Burgos, José; Díaz-Fernández, José

2014-07-01

Up to 25% of patients who undergo a percutaneous coronary intervention show some limitation in the use of drug-eluting stents. The aim of this study was to evaluate if titanium-nitride-oxide-coated stents could be a good alternative to everolimus-eluting stents in diabetic patients. A total of 173 diabetic patients with lesions at moderate risk of restenosis (exclusion criteria: diameter < 2.5 mm or length > 28 mm in vessels < 3mm, chronic occlusion) were randomized to a titanium group (83 patients) or an everolimus group (90 patients). Baseline characteristics were well balanced; 28.3% of patients were insulin dependent. At 1 year, the incidence of major adverse cardiac events (death, nonfatal myocardial infarction, stroke, or repeat target vessel revascularization) was significantly higher in the titanium group than in the everolimus group (total, 14.5% vs 4.4%; P = .02; noninsulin-dependent subgroup, 9.7% vs 3.2%; P = .14; insulin-dependent subgroup, 28.6% vs 7.1%; P = .04). The incidence of death, nonfatal myocardial infarction, stroke, or any revascularization was 16.9% in the titanium group and 7.8% in the everolimus group (P = .06). Target lesion and vessel revascularizations occurred in 8.4% compared with 3.3% (P = .15) and in 13.3% compared with 3.3% (P = .01) in the titanium and everolimus groups, respectively. Angiographic follow-up at 9 months showed significantly less late lumen loss in the everolimus group (in-segment, 0.52 [standard deviation, 0.58) mm vs -0.05 [0.32] mm; in-stent, 0.76 [0.54] mm vs 0.13 [0.31] mm; P < .0001). The everolimus-eluting stent is superior to the titanium stent for clinical and angiographic end points in diabetic patients with lesions at moderate risk of restenosis. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial.

PubMed

Suwannasom, Pannipa; Sotomi, Yohei; Ishibashi, Yuki; Cavalcante, Rafael; Albuquerque, Felipe N; Macaya, Carlos; Ormiston, John A; Hill, Jonathan; Lang, Irene M; Egred, Mohaned; Fajadet, Jean; Lesiak, Maciej; Tijssen, Jan G; Wykrzykowska, Joanna J; de Winter, Robbert J; Chevalier, Bernard; Serruys, Patrick W; Onuma, Yoshinobu

2016-06-27

The study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clinical events at 1-year follow-up. Mechanical properties of a fully BVS are inherently different from those of permanent metallic stent. The ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial compared the BVS and metallic EES in the treatment of a de novo coronary artery stenosis. Protocol-mandated intravascular ultrasound imaging was performed pre- and post-procedure in 470 patients (162 metallic EES and 308 BVS). Asymmetry index (AI) was calculated per lesion as: (1 - minimum scaffold/stent diameter/maximum scaffold/stent diameter). Expansion index and optimal scaffold/stent expansion followed the definition of the MUSIC (Multicenter Ultrasound Stenting in Coronaries) study. Eccentricity index (EI) was calculated as the ratio of minimum and maximum scaffold/stent diameter per cross section. The incidence of device-oriented composite endpoint (DoCE) was collected. Post-procedure, the metallic EES group was more symmetric and concentric than the BVS group. Only 8.0% of the BVS arm and 20.0% of the metallic EES arm achieved optimal scaffold/stent expansion (p < 0.001). At 1 year, there was no difference in the DoCE between both devices (BVS 5.2% vs. EES 3.1%; p = 0.29). Post-procedural devices asymmetry and eccentricity were related to higher event rates while there was no relevance to the expansion status. Subsequent multivariate analysis identified that post-procedural AI >0.30 is an independent predictor of DoCE (hazard ratio: 3.43; 95% confidence interval: 1.08 to 10.92; p = 0.037). BVS implantation is more frequently associated with post-procedural asymmetric and eccentric morphology compared to metallic EES. Post-procedural devices asymmetry were independently associated with DoCE following percutaneous coronary intervention. However, this approach should be viewed as hypothesis generating due to low event rates. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Comparison of outcomes among secondary covered metallic, uncovered metallic, and plastic biliary stents in treating occluded primary metallic stents in malignant distal biliary obstruction.

PubMed

Cho, Jae Hee; Jeon, Tae Joo; Park, Jeong Youp; Kim, Hee Man; Kim, Yoon Jae; Park, Seung Woo; Chung, Jae Bock; Song, Si Young; Bang, Seungmin

2011-02-01

The self-expandable metallic stent (SEMS) has been widely used for unresectable malignant biliary obstruction but eventually becomes occluded by tumor ingrowth/overgrowth and sludge. Therefore, we aimed to determine the therapeutic effectiveness of secondary stents and to find differences according to various combinations of the first and second stents for the management of occluded SEMSs in patients with malignant distal biliary obstruction. Between 1999 and November 2008, 77 patients with malignant biliary obstruction underwent secondary biliary stent placement as "stent-in-stent" at three university hospitals in Korea (40 covered, 26 uncovered, and 11 plastic stents). The membrane of the covered SEMS was regarded as the barrier against tumor ingrowth. We categorized the patients into three groups based on whether the covered SEMS was either the first or the second stent: membrane-SEMS (18 covered-covered; 9 covered-uncovered; 22 uncovered-covered SEMS), bare-SEMS (17 uncovered-uncovered SEMS), and plastic stent (3 covered-plastic; 8 uncovered-plastic). The median patency of second stents was 138, 109, and 88 days (covered, uncovered, and plastic stents). The second covered SEMSs had a significantly longer patency than plastic stents (p=0.047). In a multivariate analysis including membrane-SEMS, bare-SEMS, and plastic stent groups, the bare-SEMS had a worse cumulative stent patency (HR=2.04, CI=1.08-3.86) and survival time (HR=2.37, CI=1.25-4.49) than the membrane-SEMS. Patients with ampulla of Vater cancer had better stent patency (HR=0.27, CI=0.08-0.98) and survival (HR=0.17, CI=0.04-0.77) than those with other pancreatobiliary malignancies. In addition, antitumor treatment prolonged survival time (HR=0.50, CI=0.26-0.99). The placement of additional biliary stents using the "stent-in-stent" method is an effective treatment for an occluded metallic primary stent. In addition, double biliary SEMS placement using at least one covered SEMS (in the primary and/or secondary procedure) might provide longer cumulative stent patency and survival than using uncovered SEMSs in both procedures.

Self-expandable metal stents for malignant esophageal obstruction: a comparative study between extrinsic and intrinsic compression.

PubMed

Rhee, K; Kim, J-H; Jung, D H; Han, J W; Lee, Y C; Lee, S K; Shin, S K; Park, J C; Chung, H S; Park, J J; Youn, Y H; Park, H

2016-04-01

Self-expandable metal stents (SEMSs) are effective for malignant esophageal obstruction, but usefulness of SEMSs in extrinsic lesions is yet to be elucidated. This study is aimed at evaluating the clinical usefulness of SEMSs in the extrinsic compression compared with intrinsic. A retrospective review was conducted for 105 patients (intrinsic, 85; extrinsic, 20) with malignant esophageal obstruction who underwent endoscopic SEMSs placement. Technical and clinical success rates were evaluated and clinical outcomes were compared between extrinsic and intrinsic group. Extrinsic group was mostly pulmonary origin. Overall technical and clinical success rate was 100% and 91%, respectively, without immediate complications. Extrinsic and intrinsic group did not differ significantly in clinical success rate. The median stent patency time was 131.3 ± 85.8 days in intrinsic group while that of extrinsic was 54.6 ± 45.1 due to shorter survival after stent insertion. The 4-, 8-, and 12-week patency rates were 90.5%, 78.8%, and 64.9% respectively in intrinsic group, while stents of extrinsic group remained patent until death. Uncovered, fully covered, and double-layered stent were used evenly and the types did not influence patency in both groups. In conclusion, esophageal SEMSs can safely and effectively be used for malignant extrinsic compression as well as intrinsic. © 2015 International Society for Diseases of the Esophagus.

The comparation of effects and security of double-J stent retention and ureteroscopy lithotripsy in the treatment of symptomatic ureteral calculi during pregnancy.

PubMed

Tan, Shu-Tao; Chen, Xiaonan; Sun, Ming; Wu, Bin

2018-06-01

To describe the efficacy of double-J stent retention and ureteroscopy lithotripsy, we performed a study to evaluate the management of symptomatic ureteral calculi during pregnancy. From January 2005 and June 2015, 53 pregnant women with symptomatic ureteral calculi were admitted and treated in our hospital. According to the treatment techniques, there were divided into two groups: double-J stent retention group (30 cases) and ureteroscopy lithotripsy group (23 cases). We collected the characteristics and treatment outcome of the patients. Double-J stent retention was performed on 30 patients. And the stents were successfully inserted in 25 patients (83.3%). 4 cases got complication in double-J group (16%). The mean operating time, medical cost and hospitalization time of double-J group were 20.6 min, 1632 yuan and 1.3 days. Ureteroscopy lithotripsy was performed on 23 patients. 20 patients were operated successfully (87.0%). 2 cases got complication in ureteroscopy group (10.0%). The mean operating time, medical cost and hospitalization time of ureteroscopy group were 41.5 min, 2792 yuan and 6.0 days. In summary, both double-J stent retention and ureteroscopy lithotripsy are effective and safe in the managation of ureteral calculi during pregnancy. Copyright © 2018 Elsevier B.V. All rights reserved.

Efficacy and safety of aspirin, clopidogrel, and warfarin after coronary artery stenting in Korean patients with atrial fibrillation.

PubMed

Suh, Soon Yong; Kang, Woong Chol; Oh, Pyung Chun; Choi, Hanul; Moon, Chan Il; Lee, Kyounghoon; Han, Seung Hwan; Ahn, Taehoon; Choi, In Suck; Shin, Eak Kyun

2014-09-01

There are limited data on the optimal antithrombotic therapy for patients with atrial fibrillation (AF) who undergoing coronary stenting. We reviewed 203 patients (62.6 % men, mean age 68.3 ± 10.1 years) between 2003 and 2012, and recorded clinical and demographic characteristics of the patients. Clinical follow-up included major adverse cardiac and cerebrovascular events (MACCE) (cardiac death, myocardial infarction, target lesion revascularization, and stroke), stent thrombosis, and bleeding. The most commonly associated comorbidities were hypertension (70.4 %), diabetes mellitus (35.5 %), and congestive heart failure (26.6 %). Sixty-three percent of patients had stroke risk higher than CHADS2 score 2. At discharge, dual-antiplatelet therapy (aspirin, clopidogrel) was used in 166 patients (81.8 %; Group I), whereas 37 patients (18.2 %) were discharged with triple therapy (aspirin, clopidogrel, warfarin; Group II). The mean follow-up period was 42.0 ± 29.0 months. The mean international normalized ratio (INR) in group II was 1.83 ± 0.41. The total MACCE was 16.3 %, with stroke in 3.4 %. Compared with the group II, the incidence of MACCE (2.7 % vs 19.3 %, P = 0.012) and cardiac death (0 % vs 11.4 %, P = 0.028) were higher in the group I. Major and any bleeding, however, did not differ between the two groups. In multivariate analysis, no warfarin therapy (odds ratio 7.8, 95 % confidence interval 1.02-59.35; P = 0.048) was an independent predictor of MACCE. By Kaplan-Meier survival analysis, warfarin therapy was associated with a lower risk of MACCE (P = 0.024). In patients with AF undergoing coronary artery stenting, MACCE were reduced by warfarin therapy without increased bleeding, which might be related to tighter control with a lower INR value.

Endoscopic management of occluded metal biliary stents: Metal versus 10F plastic stents

PubMed Central

Yoon, Won Jae; Ryu, Ji Kon; Lee, Jung Won; Ahn, Dong-Won; Kim, Yong-Tae; Yoon, Yong Bum; Woo, Sang Myung; Lee, Woo Jin

2010-01-01

AIM: To compare the efficacy of self-expandable metal stents (SEMSs) with 10F plastic stents (PSs) in the endoscopic management of occluded SEMSs. METHODS: We retrospectively reviewed the medical records of 56 patients who underwent SEMS insertion for palliation of unresectable malignant biliary obstruction between 2000 and 2007 and subsequent endoscopic retrograde biliary drainage (ERBD) with SEMS or PS for initial SEMS occlusion between 2000 and 2008. RESULTS: Subsequent ERBD with SEMS was performed in 29 patients and with PS in 27. The median time to stent occlusion after subsequent ERBD was 186 d in the SEMS group and 101 d in the PS group (P = 0.118). Overall median stent patency was 79 d for the SEMS group and 66 d for the PS group (P = 0.379). The mean number of additional biliary drainage procedures after subsequent ERBD in patients that died (n = 50) during the study period was 2.54 ± 4.12 for the SEMS group and 1.85 ± 1.95 for the PS group (P = 0.457). The mean total cost of additional biliary drainage procedures after the occlusion of subsequent SEMS or PS was $410.04 ± 692.60 for the SEMS group and $630.16 ± 671.63 for the PS group (P = 0.260). Tumor ingrowth as the cause of initial SEMS occlusion was the only factor associated with a shorter time to subsequent stent occlusion (101 d for patients with tumor ingrowth vs 268 d for patients without tumor ingrowth, P = 0.008). CONCLUSION: Subsequent ERBD with PSs offered similar patency and number of additional biliary drainage procedures compared to SEMSs in the management of occluded SEMS. PMID:21072899

Endoscopic management of occluded metal biliary stents: metal versus 10F plastic stents.

PubMed

Yoon, Won Jae; Ryu, Ji Kon; Lee, Jung Won; Ahn, Dong-Won; Kim, Yong-Tae; Yoon, Yong Bum; Woo, Sang Myung; Lee, Woo Jin

2010-11-14

To compare the efficacy of self-expandable metal stents (SEMSs) with 10F plastic stents (PSs) in the endoscopic management of occluded SEMSs. We retrospectively reviewed the medical records of 56 patients who underwent SEMS insertion for palliation of unresectable malignant biliary obstruction between 2000 and 2007 and subsequent endoscopic retrograde biliary drainage (ERBD) with SEMS or PS for initial SEMS occlusion between 2000 and 2008. Subsequent ERBD with SEMS was performed in 29 patients and with PS in 27. The median time to stent occlusion after subsequent ERBD was 186 d in the SEMS group and 101 d in the PS group (P = 0.118). Overall median stent patency was 79 d for the SEMS group and 66 d for the PS group (P = 0.379). The mean number of additional biliary drainage procedures after subsequent ERBD in patients that died (n = 50) during the study period was 2.54 ± 4.12 for the SEMS group and 1.85 ± 1.95 for the PS group (P = 0.457). The mean total cost of additional biliary drainage procedures after the occlusion of subsequent SEMS or PS was $410.04 ± 692.60 for the SEMS group and $630.16 ± 671.63 for the PS group (P = 0.260). Tumor ingrowth as the cause of initial SEMS occlusion was the only factor associated with a shorter time to subsequent stent occlusion (101 d for patients with tumor ingrowth vs 268 d for patients without tumor ingrowth, P = 0.008). Subsequent ERBD with PSs offered similar patency and number of additional biliary drainage procedures compared to SEMSs in the management of occluded SEMS.

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.

Preoperative biliary drainage by plastic or self-expandable metal stents in patients with periampullary tumors: results of a randomized clinical study

PubMed Central

Olsson, Greger; Frozanpor, Farshad; Lundell, Lars; Enochsson, Lars; Ansorge, Christoph; Del Chiaro, Marco; Reuterwall-Hansson, Marcus; Shetye, Alysha; Arnelo, Urban

2017-01-01

Background and study aims  Preoperative biliary drainage in patients with periampullary tumors and jaundice has been popularized to improve the quality of life and minimize the risks associated with subsequent radical surgery. The aim of this study was to investigate the possible superiority of self-expandable metal stents (SEMS) over plastic stents, by comparing the amount of bacteria in intraoperatively collected bile and using this variable as a proxy for the efficacy of the respective biliary drainage modalities. Patients and methods  In this randomized clinical trial, 92 patients with obstructive jaundice were enrolled; 45 were allocated to the plastic stent group and 47 to the SEMS group. The primary outcome was the extent and magnitude of biliary bacterial growth at the time of surgical exploration. Secondary outcomes were: macroscopic grading of inflammation of the stented bile ducts, occurrence of adverse events after stenting, stent dysfunction, recognized surgical complexities, and incidence of postoperative complications. Results  The patients were well matched regarding clinical and disease-specific characteristics. At surgery, there were no group differences in the bacterial amount and composition of the bile cultures or the perceived difficulty of surgical dissection. During the preoperative biliary drainage period, more instances of stent dysfunction requiring stent replacement were recorded in the plastic stent group (19 % vs. 0 %; P  = 0.03). Postoperative complications in patients who underwent curative surgery were more common in patients with plastic stents (72 % vs. 52 %), among which clinically significant leakage from the pancreatic anastomoses seemed to predominate (12 % vs. 3.7 %); however, none of these differences in postoperative adverse events reached statistical significance. Conclusion  This randomized clinical study was unable to demonstrate any superiority of SEMS in the efficacy of preoperative bile drainage, as assessed by the amount of bacteria in the intraoperatively collected bile. However, some data in favor of SEMS were observed among the clinical secondary outcomes variables (preoperative stent exchange rates) without increases in local inflammatory reactions. PMID:28879225

To stent or not to stent: the use of transanastomotic biliary stents in liver transplantation and patient outcomes.

PubMed

Ong, Michelle; Slater, Kellee; Hodgkinson, Peter; Dunn, Nathan; Fawcett, Jonathan

2018-06-01

There is no substantial evidence for the use of biliary stents in bile duct reconstruction during liver transplantation. A longitudinal, retrospective cohort study was performed to compare biliary complications between stented and non-stented patients between 2011 and 2015 at the Princess Alexandra Hospital, Brisbane, Australia. We found no significant difference in biliary complications between stented and non-stented groups. Stented patients were 3.31 times as likely to require subsequent intervention, mainly in the form of stent removal. These results suggest that there is limited benefit in the placement of endobiliary stents in liver transplantation. Given that this was purely an observational study, causality cannot be proven and a prospective cohort trial would be beneficial in further defining these relationships. © 2018 Royal Australasian College of Surgeons.

Combined Arterial Infusion and Stent Implantation Compared with Metal Stent Alone in Treatment of Malignant Gastroduodenal Obstruction

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

Wang Zhongmin, E-mail: wzm0722@hotmail.co; Chen Kemin, E-mail: ckm0722@hotmail.co; Gong Ju

Many patients with malignant gastroduodenal obstruction have an unresectable primary lesion and distant metastases, which may prompt palliative management to allow the patient to eat and to improve the quality of life. Intraluminal metallic stent implantation (MSI) under fluoroscopic guidance has been reported to be an effective option for symptomatic relief in these patients, with a good safety record. An alternative, dual interventional therapy (DIT), has been used during the last decade, in which prosthesis insertion is followed by intra-arterial chemotherapy via the tumor-feeding arteries. The aim of this study was to compare success rates, complication rates, and survival timemore » between MSI and DIT in patients who presented with gastroduodenal obstruction from advanced upper gastrointestinal tract cancer. All consecutive patients with malignant gastroduodenal obstruction seen at our center between October 2002 and August 2007 were retrospectively studied. Patients were treated palliatively by either MSI or DIT by the patient's or the next of kin's decision. Outcomes included technical and clinical success, complication rates, and survival. Of the 164 patients with malignant gastric and duodenal outlet obstructions, 80 (49%) underwent stent insertion as the primary therapy, while the remaining 84 (51%) received DIT. Clinical characteristics were similar between the two groups. In the MSI cohort initial stent implantation was successful in 73 patients (91%), two stents were used in 5 patients, and delayed additional stent insertion for stent obstruction related to tumor overgrowth was required in 3 patients during follow-up. In the DIT cohort the technical success rate was 94%, 3 patients required two stents, and stent obstruction occurred in 2 patients after initial stent placement. Early postprocedural clinical success, indicated by average dysphagia score, improved significantly in both groups: MSI group, from 4.56 to 1.51 (P < 0.01); and DIT group, from 4.38 to 1.48 (p < 0.01). There were no short-term complications. Late complications including hematemesis (n = 3), migration (n = 12), and stent occlusion due to tumor overgrowth (n = 5) were evenly distributed between the groups. In the DIT group chemotherapy-induced neutropenia and transient renal dysfunction were detected in six patients, which improved after symptomatic management. Mean survival time after the procedure was 5.9 and 11.1 months for MSI and DIT, respectively (P < 0.001). In conclusion, both MSI and DIT offer effective palliation for malignant gastroduodenal obstruction, but DIT appears to offer superior survival over MSI alone. Ideally, a prospective randomized trial comparing these two techniques should be carried out to validate this result.« less

Third generation drug eluting stent (DES) with biodegradable polymer in diabetic patients: 5 years follow-up.

PubMed

Wiemer, Marcus; Stoikovic, Sinisa; Samol, Alexander; Dimitriadis, Zisis; Ruiz-Nodar, Juan M; Birkemeyer, Ralf; Monsegu, Jacques; Finet, Gérard; Hildick-Smith, David; Tresukosol, Damras; Novo, Enrique Garcia; Koolen, Jacques J; Barbato, Emanuele; Danzi, Gian Battista

2017-02-10

To report the long-term safety and efficacy data of a third generation drug eluting stent (DES) with biodegradable polymer in the complex patient population of diabetes mellitus after a follow-up period of 5 years. After percutaneous coronary intervention patients with diabetes mellitus are under higher risk of death, restenosis and stent thrombosis (ST) compared to non-diabetic patients. In 126 centers worldwide 3067 patients were enrolled in the NOBORI 2 registry, 888 patients suffered from diabetes mellitus (DM), 213 of them (14%) being insulin dependent (IDDM). Five years follow-up has been completed in this study. At 5 years, 89.3% of the patients were available for follow-up. The reported target lesion failure (TLF) rates at 5 years were 12.39% in DM group and 7.34% in non-DM group; (p < 0.0001). In the DM group, the TLF rate in patients with IDDM was significantly higher than in the non-IDDM subgroup (17.84 vs. 10.67%; p < 0.01). The rate of ST at 5 years was not different among diabetic versus non-diabetic patients or IDDM versus NIDDM. Only 10 (<0.4%) very late stent thrombotic events beyond 12 months occurred. The Nobori DES performed well in patients with DM. As expected patients with DM, particularly those with IDDM, had worse outcomes. However, the very low rate of very late stent thrombosis in IDDM patients might have significant clinical value in the treatment of these patients. Clinical trial registration ISRCTN81649913; http://www.controlled-trials.com/isrctn/search.html?srch=81649913&sort=3&dir=desc&max=10.

A randomized controlled trial of a middle meatal silastic stent for reducing adhesions and middle turbinate lateralization following endoscopic sinus surgery.

PubMed

Chan, Chun L; Elmiyeh, Behrad; Woods, Charmaine; Ullah, Shahid; Gunawardena, Indunil; Carney, A Simon; Ooi, Eng H

2015-06-01

Endoscopic sinus surgery (ESS) is indicated for patients with recalcitrant chronic rhinosinusitis symptoms. However, surgical revision can be required because of adhesion formation and middle turbinate lateralization. We investigate the efficacy of a middle meatal silastic stent in reducing these complications after ESS. Thirty-six patients were randomized to receive a silastic stent in the middle meatus unilaterally after ESS. The surgeon was blinded to the side receiving the stent until completion of the ESS. The contralateral side, with no stent, was the control side. Patients completed a 7-day, postoperative, visual analog scale symptom diary and were blinded to the stent side until its removal at the first postoperative visit. Patients were followed up after 2, 8, and 24 weeks. Endoscopic video of the sinus cavities were recorded at all visits and 2 blinded, independent ear/nose/throat (ENT) surgeons assessed the videos using a modified Lund-Kennedy scoring system. Thirty-five of 36 patients completed 6-months' follow-up. Middle turbinate lateralization was observed in 13 sides without a stent vs 1 side with a stent. There was a significant reduction in adhesions at weeks 2 and 8 (p < 0.001) and crusting (p < 0.01) in the stent side compared to control. Video scores at 6 months after surgery for stent and control sides remained unchanged from the 8-week visit. There was no difference between sides for symptom scores, edema, or nasal discharge. Middle meatal silastic stents are well tolerated by patients and effective in reducing middle turbinate lateralization, adhesions, and crusting postoperatively in ESS. © 2015 ARS-AAOA, LLC.

Carotid artery stenting with double cerebral embolic protection in asymptomatic patients - a diffusion-weighted MRI controlled study.

PubMed

Vuruskan, Ertan; Saracoglu, Erhan; Ergun, Ugur; Poyraz, Fatih; Duzen, İrfan Veysel

2017-01-01

The aim of this study was to compare the simultaneous double-protection method (proximal balloon plus distal filter) with distal-filter protection or proximal-balloon protection alone in asymptomatic patients during carotid artery stenting. 119 consecutive patients were investigated for carotid artery stentings in the extracranial internal carotid artery with the use of distal filters (n = 41, 34.4 %), proximal balloon (MoMa) protection (n = 40, 33.6 %) or double protection (n = 38, 31.9 %). Magnetic resonance imaging (MRI) was performed on all patients before the procedure, and control diffusion-weighted MRI (DW-MRI) was obtained within 24-48 h after the procedure. Procedural data, complications, success rate, major adverse cardiovascular events, and MRI findings were collected. New cerebral high-intensity (HI) lesions were observed in 47 (39.4 %) patients. HI lesions were observed in 22 (53.6 %), 15 (37.5 %), and 10 (26.3 %) of the patients with distal filters, proximal protection, and double protection, respectively (p = 0.004). The average number of HI lesions on DW-MRI was 1.80 in the distal-filter group, 0.90 in the proximal-balloon group, and 0.55 in the double-protection group (p < 0.001). Procedure and fluoroscopy times were slightly longer in the double-protection group compared to the distal- or proximal-protection groups (p = 0.001). The double (proximal plus distal) cerebral embolic protection technique is safe and effective for minimizing the risk of cerebral embolization, even in patients with asymptomatic carotid artery stenosis, despite slightly longer procedure and fluoroscopy times.
.

Effectiveness of early ureteric stenting for urosepsis associated with urinary tract calculi.

PubMed

Nishiguchi, Sho; Branch, Joel; Suganami, Yu; Kitagawa, Izumi; Tokuda, Yasuharu

2014-01-01

Patients with urosepsis associated with urinary tract calculi occasionally require drainage, primarily via ureteric stenting. Such patients require longer hospitalization. However, the indications for early ureteric stenting for this condition have not been clearly defined. To compare the length of stay (LOS) in the hospital between patients treated with earlier ureteric stenting versus those with delayed ureteric stenting. Design: Retrospective cohort study. Setting: An acute care teaching hospital in Japan. Length of hospital stay in days. Patients Patients with urosepsis associated with urinary tract calculi. Among a total of 30 patients (mean age, 72; 13 men), the mean number of days from emergency room admission to ureteric stenting was 3.5 days (range, 1-14 days), and the overall mean LOS was 36 days (range, 8-102 days). The early stenting group (mean LOS, 21 days) had a significantly shorter LOS than the delayed stenting group (mean LOS, 50 days), with an adjusted beta coefficient of -26 days [95% confidence interval (CI), -46, -6]. In patients with urosepsis associated with urinary tract calculi, performing early stenting within two days of admission may reduce the LOS in the hospital.

Chemoembolization and stenting combined with iodine-125 seed strands for the treatment of hepatocellular carcinoma with inferior vena cava obstruction

PubMed Central

LI, WENHUI; DAI, ZHENYU; YAO, LIZHENG; LUO, JIANJUN; YAN, ZHIPING

2015-01-01

The aim of the present study was to investigate the efficacy and safety of stenting combined with radioactive iodine-125 seed strands following chemoembolization for the treatment of patients with hepatocellular carcinoma and inferior vena cava (IVC) obstruction. A retrospective analysis was conducted of 52 hepatocellular carcinoma patients with IVC obstruction. All patients received chemoembolization of tumor-supplying arteries and IVC stents, and 18 patients additionally received iodine-125 seed strands, which were fixed to the stents. Improvement of IVC obstruction and the tumor response rates were compared between the two groups with a median follow-up time of 2.5 months. In both groups the stents were successfully deployed. At the 2-month post-procedural follow-up, the mean diameter of the IVC obstruction site, the mean pressure difference between the distal IVC obstructive segment and the right atrium as well as the obstruction scoring did not differ significantly between the two groups. By contrast, the tumor response rate of the iodine-125 seed strand group was 94.4%, whereas for the group without iodine-125 seed strands it was 35.3% (P<0.001). The combination of stent and iodine-125 seed strands was effective and safe for the treatment of hepatocellular carcinoma with IVC obstruction. PMID:26622424

Stent fabric fatigue of grafts supported by Z-stents versus ringed stents: an in vitro buckling test.

PubMed

Lin, Jing; Wang, Lu; Guidoin, Robert; Nutley, Mark; Song, Ge; Zhang, Ze; Du, Jia; Douville, Yvan

2014-03-01

Stent-grafts externally fitted with a Z-shaped stents were compared to devices fitted with ringed stents in an in vitro oscillating fatigue machine at 200 cycles per minute and a pressure of 360 mmHg for scheduled durations of up to 1 week. The devices fitted with Z-stents showed a considerably lower endurance limit to buckling compared to the controls. The contact between the apexes of adjacent Z-stents resulted in significant damage to the textile scaffolds and polyester fibers due to the sharp angle of the Z-stents. The ringed stents did not cause any fraying in the textile scaffolds.

Biological effect on restenosis and vascular healing of encapsulated paclitaxel nanocrystals delivered via coated balloon technology in the familial hypercholesterolaemic swine model of in-stent restenosis.

PubMed

Cheng, Yanping; Shibuya, Masahiko; McGregor, Jenn; Conditt, Gerard B; Yi, Geng-Hua; Kaluza, Greg L; Gray, William; Doshi, Manish; Sojitra, Prakash; Granada, Juan F

2016-10-20

The aim of this study was to evaluate the biological efficacy of a novel lower-dose (2.5 µg/mm2) encapsulated paclitaxel nanocrystal-coated balloon (Nano-PCB) in the familial hypercholesterolaemic swine (FHS) model of iliofemoral in-stent restenosis. Nano-PCB pharmacokinetics were assessed in 20 femoral arteries (domestic swine). Biological efficacy was evaluated in ten FHS: 14 days following bare metal stent implantation each stent segment was randomised to a clinically available PCB (IN.PACT, n=14), the Nano-PCB (n=14) or an uncoated balloon (n=12). Angiographic, optical coherence tomography and histological evaluation was performed at 28 days after treatment. Arterial paclitaxel concentration was 120.7 ng/mg at one hour and 7.65 ng/mg of tissue at 28 days with the Nano-PCB. Compared to the control uncoated group, both PCBs significantly reduced percent area stenosis (Nano-PCB: 36.0±14.2%, IN.PACT: 29.3±9.2% vs control: 67.9±15.1%, p<0.001). Neointimal distribution in the entire stent length was more homogenous in the Nano-PCB. Histological evaluation showed comparable degrees of neointimal proliferation in both PCBs; however, the Nano-PCB showed slightly higher levels of neointimal maturity and endothelialisation. Lower-dose encapsulated paclitaxel nanocrystals delivered via a coated balloon displayed comparable biological efficacy with superior healing features compared to a clinically validated PCB technology.

Biliary plastic stent does not influence the accuracy of endoscopic ultrasound-guided sampling of pancreatic head masses performed with core biopsy needles.

PubMed

Antonini, Filippo; Fuccio, Lorenzo; Giorgini, Sara; Fabbri, Carlo; Frazzoni, Leonardo; Scarpelli, Marina; Macarri, Giampiero

2017-08-01

While the presence of biliary stent significantly decreases the accuracy of endoscopic ultrasound (EUS) for pancreatic head cancer staging, its impact on the EUS-guided sampling accuracy is still debated. Furthermore, data on EUS-fine needle biopsy (EUS-FNB) using core biopsy needles in patients with pancreatic mass and biliary stent are lacking. The aim of this study was to evaluate the influence of biliary stent on the adequacy and accuracy of EUS-FNB in patients with pancreatic head mass. All patients who underwent EUS-guided sampling with core needles of solid pancreatic head masses causing obstructive jaundice were retrospectively identified in a single tertiary referral center. Adequacy, defined as the rate of cases in which a tissue specimen for proper examination was achieved, with and without biliary stent, was the primary outcome measure. The diagnostic accuracy and complication rate were the secondary outcome measures. A total of 130 patients with pancreatic head mass causing biliary obstruction were included in the study: 74 cases of them were sampled without stent and 56 cases with plastic stent in situ. The adequacy was 96.4% in the stent group and 90.5% in the group without stent (p=0.190). No significant differences were observed for sensitivity (88.9% vs. 85.9%), specificity (100% for both groups), and accuracy (89.3% vs. 86.5%) between those with and without stent, respectively. The accuracy was not influenced by the timing of stenting (<48h or ≥48h before EUS). No EUS-FNB related complications were recorded. The presence of biliary stent does not influence the tissue sampling adequacy, the diagnostic accuracy and the complication rate of EUS-FNB of pancreatic head masses performed with core biopsy needles. Copyright © 2017 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Durability of renal artery stents in patients with transrenal abdominal aortic endografts.

PubMed

Baril, Donald T; Lookstein, Robert A; Jacobs, Tikva S; Won, Jamie; Marin, Michael L

2007-05-01

The management of renal artery stenosis in patients with abdominal aortic aneurysms continues to be complex and technically challenging despite advances in endovascular therapy. There is growing concern about the durability of renal artery stents in the setting of transrenal abdominal aortic endografts. This study reports a single-center experience of renal artery stenting with transrenal abdominal aortic endografts for patients with renal artery stenosis. All patients undergoing endovascular abdominal aortic aneurysm repair preceded or followed by renal artery stent placement between January 1999 and December 2005 were retrospectively reviewed from a prospectively gathered endovascular database. Patients were surveyed after renal stent procedures with multidetector computed tomography angiography or duplex sonography. The surveillance data were analyzed for primary patency of the renal artery stent at 6 months, incidence of complications, need for secondary interventions, and changes in creatinine clearance (CrCl). Sixty-two renal artery stents were placed in 56 patients (44 men, 12 women) with a mean age of 77.3 years (range, 61 to 94 years). Forty-one were placed before the endograft procedure, eight were placed during the endograft procedure, and 13 were placed postoperatively. There were no major or minor complications related to the renal artery stent procedures. Transrenal aortic endografts were used in 44 of the 56 patients, and 12 had devices with infrarenal fixation. The mean follow-up was 18.5 months (range, 1 to 73 months). The 6-month primary patency, which could be evaluated for 51 renal artery stents, was 97.4% (37/38) in patients with transrenal fixation and 84.6% (11/13) in patients with infrarenal fixation. The overall rate of in-stent restenosis was 8.5% (4/47) in the transrenal fixation group and 20.0% (3/15) in the infrarenal fixation group. The overall occlusion rate was 2.1% (1/47) in the transrenal fixation group and 0% (0/15) in infrarenal fixation group. Five (83.3%) of six patients underwent successful treatment of in-stent restenosis with placement of a new stent in all five cases. CrCl decreased in the total group by 4.2 +/- 11.8 mL/min, by 4.7 +/- 12.0 mL/min in patients with transrenal fixation, and by 2.2 +/- 11.0 mL/min in patients with infrarenal fixation. The presence of a transrenal aortic endograft did not affect the outcome of the renal artery revascularization procedure in this cohort. Renal artery stenting in the presence of transrenal abdominal aortic endografts appears to be a safe procedure without adverse effect on renal artery stent patency or renal function.

Comparison of resorbable poly-L-lactic acid-polyglycolic acid and internal Palmaz stents for the surgical correction of severe tracheomalacia.

PubMed

Sewall, Gregory K; Warner, Thomas; Connor, Nadine P; Hartig, Gregory K

2003-06-01

Tracheomalacia (TM) is associated with expiratory airway collapse and potentially fatal respiratory distress. Internal and external tracheal stents and, recently, resorbable biopolymers have been used to treat this condition. In this study, the efficacy and biocompatibility of internal Palmaz stents and external poly-L-lactic acid-polyglycolic acid (PLPG) stents were compared in a model of severe TM induced in piglets. The tracheas were repaired with one of two stenting methods, and the animals survived for up to 16 weeks. Weight gain, adverse respiratory signs and symptoms, tracheal or lung histopathologic changes, and internal and external tracheal diameters were measured. The animals in the PLPG group uniformly were free of respiratory distress and tracheal stenosis or inflammation, whereas all animals in the Palmaz group developed respiratory distress as a result of pneumonia or tracheal stenosis caused by intraluminal granulation tissue. In conclusion, superior efficacy of external, resorbable PLPG stents was found relative to internal Palmaz stents for the surgical repair of severe TM.

Use of biliary stent in laparoscopic common bile duct exploration.

PubMed

Lyon, Matthew; Menon, Seema; Jain, Abhiney; Kumar, Harish

2015-05-01

It is well supported in the literature that laparoscopic common bile duct exploration (LCBDE) for choledocholithiasis has equal efficacy when compared to ERCP followed by laparoscopic cholecystectomy. Decompression after supra-duodenal choledochotomy is common practice as it reduced the risk of bile leaks. We conducted a prospective non-randomized study to compare outcomes and length of stay in patients undergoing biliary stent insertion versus T-tube drainage following LCBDE via choledochotomy. The study involved 116 patients with choledocholithiasis who underwent LCBDE and decompression of the biliary system by either ante-grade biliary stent or T-tube insertion. A 7 French straight/duodenal curve biliary Diagmed™ stent (9-11 cm) was placed in 82 patients (Biliary Stent Group). T-tube insertion was used for 34 patients (T-tube group). The length of hospital stay and complications for the selected patients were recorded. All trans-cystic common bile duct explorations were excluded from the study. The mean hospital stay for patients who underwent ante-grade biliary stent or T-tube insertion after LBCDE were 1 and 3.4 days, respectively. This is a statistically significant result with a p value of less than 0.001. Of the T-tube group, two patients required laparoscopic washout due to bile leaks, one had ongoing biliary stasis and one reported ongoing pain whilst the T-tube was in situ. A complication rate of 11.2%, this was a significant finding. There were no complications or concerns reported for the Biliary Stent Group. Our results show that there is a significant reduction in length of hospital stay and morbidity for patients that have ante-grade biliary stent decompression of the CBD post laparoscopic choledochotomy when compared T-tube drainage. This implies that ante-grade biliary stent insertion is likely to reduce costs and increase overall patient satisfaction. We support the use of ante-grade biliary stent insertion during LCBDE when primary closure is not preferred.

Stent placement vs. balloon angioplasty for popliteal artery treatment: two-year results of a prospective, multicenter, randomized trial.

PubMed

Rastan, Aljoscha; Krankenberg, Hans; Baumgartner, Iris; Blessing, Erwin; Müller-Hülsbeck, Stefan; Pilger, Ernst; Scheinert, Dierk; Lammer, Johannes; Beschorner, Ulrich; Noory, Elias; Neumann, Franz-Josef; Zeller, Thomas

2015-02-01

To investigate the 2-year technical and clinical results of primary nitinol stent placement in comparison with percutaneous transluminal angioplasty (PTA) in the treatment of de novo lesions of the popliteal artery. The ETAP study (Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions: balloon angioplasty vs. primary stenting; www.ClinicalTrials.gov identifier NCT00712309) is a prospective, randomized trial that enrolled 246 patients (158 men; mean age 72 years) who were randomly assigned to receive a nitinol stent (n=119) or PTA (n=127) for lesions averaging 42.3 mm in length. The results of the primary study endpoint were published. Secondary outcome measures and endpoints included primary patency (freedom from duplex-detected target lesion restenosis), target lesion revascularization (TLR), secondary patency, changes in ankle-brachial index and Rutherford class, and event-free survival (freedom from target limb amputation, TLR, myocardial infarction, and death). In total, 183 patients (89 stent and 94 PTA) were available for the 2-year analysis. The primary patency rate was significantly higher in the stent group (64.2%) than in the PTA group (31.3%, p=0.0001). TLR rates were 22.4% and 59.5%, respectively (p=0.0001). When provisional stent placement in the PTA arm was not considered as TLR and loss in patency, the differences prevailed between the study groups but were not significant (64.2% vs. 56.1% for primary patency, respectively; p=0.44). A significant improvement in ABI and Rutherford category was observed at 2 years in both groups. In treatment of obstructive popliteal artery lesions, provisional stenting reveals equivalent patency in comparison to primary stenting. However, the 2-year results of this trial suggest the possibility of a shift toward higher patency rates in favor of primary stenting. © The Author(s) 2015.

A bridging stent to surgery in patients with esophageal and gastroesophageal junction cancer has a dramatic negative impact on patient survival: A retrospective cohort study through data acquired from a prospectively maintained national database.

PubMed

Kjaer, D W; Nassar, M; Jensen, L S; Svendsen, L B; Mortensen, F V

2017-02-01

This study aimed to assess the impact of esophageal stenting on postoperative complications and survival in patients with obstructing esophageal and gastroesophageal junction (GEJ) cancer. All patients treated without neoadjuvant therapy that had an R0-resection performed for esophageal and GEJ cancer between January 2003 and December 2010 were identified from a prospectively maintained database. Data on stenting, postoperative mortality, morbidity, recurrence-free survival, complications, and length of hospital stay were collected. Kaplan-Meier plots for survival and recurrence-free survival curves were constructed for R0 resected patients. Data were compared between the stent and no-stent group by nonparametric tests. Two hundred seventy three consecutive R0 resected patients with esophageal or GEJ cancer were identified. Of these patients, 63 had a stent as a bridge to surgery. The male/female ratio was 2.64 (198/75) with a median age in the stent group (SG) of 65.1 versus 64.3 in the no stent group (NSG). Patients were comparable with respect to gender, age, smoking, TNM-classification, oncological treatment, hospital stay, tumor location, and histology. The median survival in the SG was 11.6 months compared with 21.3 months for patients treated without a bridging stent (P < 0.001). There were no statistically significant differences in 30-day mortality between the two groups, but NSG patients exhibited a significantly better two-year survival (P = 0.017). The median recurrence-free survival was 9.1 months for the SG compared with 15.2 months for the NSG. The use of a stent as a bridging procedure to surgery in patients treated without neaoadjuvant therapy for an esophageal or GEJ cancer that later underwent R0 resection decreased the two year survival and the recurrence-free survival. © 2016 International Society for Diseases of the Esophagus.

Recanalization of acute carotid stent occlusion using Penumbra 4Max aspiration catheter: technical report and review of rescue strategies for acute carotid stent occlusion.

PubMed

Munich, Stephan; Moftakhar, Roham; Lopes, Demetrius

2014-10-01

Carotid artery stenting (CAS) has become a widely used treatment for carotid artery stenosis, especially in high-risk patients. Acute in-stent and distal protection device occlusion are potentially catastrophic complications of this procedure. Previously described rescue strategies have included administration of antiplatelet agents (eg, abciximab) with/without thrombolytics and removal of the filter. Here we describe the successful resolution of in-stent occlusion by mechanical thrombolysis using the Penumbra 4Max aspiration catheter. Distal flow was subsequently restored with minimal residual stenosis. The patient did not suffer any consequent neurological deficits. The different strategies that could be used in this critical situation are reviewed. 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.

Biodegradable Polymer Biolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents in Patients With Coronary Artery Disease: Final 5-Year Report From the COMPARE II Trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent).

PubMed

Vlachojannis, Georgios J; Smits, Pieter C; Hofma, Sjoerd H; Togni, Mario; Vázquez, Nicolás; Valdés, Mariano; Voudris, Vassilis; Slagboom, Ton; Goy, Jean-Jaques; den Heijer, Peter; van der Ent, Martin

2017-06-26

This analysis investigates the 5-year outcomes of the biodegradable polymer biolimus-eluting stent (BP-BES) and durable polymer everolimus-eluting stent (DP-EES) in an all-comers population undergoing percutaneous coronary intervention. Recent 1- and 3-year results from randomized trials have indicated similar safety and efficacy outcomes of BP-BES and DP-EES. Whether benefits of the biodegradable polymer device arise over longer follow-up is unknown. Moreover, in-depth, prospective, long-term follow-up data on metallic drug-eluting stents with durable or biodegradable polymers are scarce. The COMPARE II trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent) was a prospective, randomized, multicenter, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BP-BES or DP-EES. The pre-specified endpoint at 5 years was major adverse cardiac events, a composite of cardiac death, nonfatal myocardial infarction, or target vessel revascularization. Five-year follow-up was available in 2,657 patients (98%). At 5 years, major adverse cardiac events occurred in 310 patients (17.3%) in the BP-BES group and 142 patients (15.6%) in the DP-EES group (p = 0.26). The rate of the combined safety endpoint all-cause death or myocardial infarction was 15.0% in the BP-BES group versus 14.8% in the DP-EES group (p = 0.90), whereas the efficacy measure target vessel revascularization was 10.6% versus 9.0% (p = 0.18), respectively. Interestingly, definite stent thrombosis rates did not differ between groups (1.5% for BP-BES vs. 0.9% for DP-EES; p = 0.17). The 5-year analysis comparing biodegradable polymer-coated BES and the durable polymer-coated EES confirms the initial early- and mid-term results regarding similar safety and efficacy outcomes in this all-comers percutaneous coronary intervention population. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Comparison between gastrostomy feeding and self-expandable metal stent insertion for patients with esophageal cancer and dysphagia.

PubMed

Min, Yang Won; Jang, Eun Young; Jung, Ji Hey; Lee, Hyuk; Min, Byung-Hoon; Lee, Jun Haeng; Rhee, Poong-Lyul; Kim, Jae J

2017-01-01

Self-expandable metal stent (SEMS) insertion and percutaneous gastrostomy (PG) feeding are commonly used for patients with esophageal cancer and dysphagia. This study aimed to compare outcomes between SEMS insertion and PG feeding for them. We retrospectively analyzed 308 patients with esophageal cancer who underwent fully covered SEMS insertion (stent group) or PG (gastrostomy group) for dysphagia due to tumor. Patients with other causes of dysphagia, such as radiation-induced or postoperative stricture, were excluded from the study. Clinical outcomes were compared between the two groups, including overall survival and need for additional intervention and postprocedural nutritional status. At baseline, the stent group (n = 169) had more stage IV patients, less cervical cancers, and received radiotherapy and esophagectomy less often than the gastrostomy group (n = 64). The Kaplan-Meier curves showed higher overall survival in the gastrostomy group than in the stent group. Multivariate analysis revealed that PG was associated with better survival compared with SEMS insertion (hazard ratio 0.541, 95% confidence interval 0.346-0.848, p = 0.007). In addition, the gastrostomy group needed additional intervention less often (3.1% vs. 21.9%, p < 0.001) and experienced less decrease in serum albumin levels (-0.15 ± 0.56 g/dL vs. -0.39 ± 0.58 g/dL, p = 0.011) than the stent group after procedure. Our data suggested that, compared with SEMS insertion, PG is associated with better overall survival in patients with esophageal cancer and dysphagia. Stabilized nutritional status by PG may play a role in improving patient survival.

A Meta-Analysis of the Effect of Preoperative Biliary Stenting on Patients With Obstructive Jaundice

PubMed Central

Sun, Chengyi; Yan, Guirong; Li, Zhiming; Tzeng, Chi-Meng

2014-01-01

Abstract The goal of this study was to systematically review the effects of biliary stenting on postoperative morbidity and mortality of patients with obstructive jaundice. PubMed, Embase, Cochrane Library, and other relevant databases were searched by computer and manually for published and unpublished studies on the impact of preoperative biliary drainage on patients with obstructive jaundice from 2000 to the present day. Two investigators independently selected the studies according to the inclusion and exclusion criteria, extracted the data, and assessed the quality of the selected studies. Meta-analysis was performed to compare postoperative morbidity and mortality of patients between the drainage and nondrainage groups. Compared with the nondrainage group, the overall mortality, overall morbidity, infectious morbidity, incidence of wound infection, intra-abdominal abscess, pancreatic fistulas, bile leak, and delayed gastric emptying in the drainage group were not significantly different. Compared with the nondrainage group, the drainage group had a drainage time of <4 weeks with an increased overall morbidity by 7% to 23%; however, the overall morbidity of the drainage group with a drainage time >4 weeks was not significantly different. Compared with the nondrainage group, the overall mortality of the drainage group using metal stents and plastic stents as internal drainage devices was reduced by 0.5% to 6%, whereas that of the drainage group using plastic stent devices was not significantly different. In summary, preoperative drainage should be applied selectively. The drainage time should be >4 weeks, and metal stents should be used for internal drainage. PMID:25474436

Does the novel delivery system for the STENTYS self-apposing coronary stent increase the risk of stent edge dissections? Optical coherence tomography post stent findings.

PubMed

Lu, Huangling; Kalkman, Deborah N; Grundeken, Maik J; Tijssen, Jan G P; Wykrzykowska, Joanna J; de Winter, Robbert J; Koch, Karel T

2018-02-01

With optical coherence tomography (OCT), details of arterial injuries during percutaneous coronary intervention can be assessed accurately. There might be an increased risk of stent edge dissections with the novel delivery system for the STENTYS stent. We evaluated the prevalence of stent edge dissections using the novel Xposition delivery device as compared with the conventional delivery device. A total of 38 patients who were treated with the self-apposing STENTYS stent and with OCT assessment at our center were retrospectively analysed. Twenty patients were treated using the Xposition- and 18 using the conventional delivery device. OCT was performed according to study protocol. Frames with poor quality were excluded. A total of 12(18%) dissections were detected, 7(20%) in the Xposition delivery device group, and 5(15%) in the conventional group (p = 1). Using the Xposition delivery device 4(33%) dissections were found proximally, using the conventional delivery device 3(25%) (p = ns). Mean longitudinal dissection length was 2.07 ± 1.80mm, 8(67%) appeared as flaps, 4(33%) as cavities. Morphometric parameters were comparable in both groups. Detailed OCT assessment of stent edge dissections was possible, which revealed no large differences using the Xposition delivery device as compared with conventional delivery device, however large studies are warranted.

Site-specific gene delivery to stented arteries using magnetically guided zinc oleate-based nanoparticles loaded with adenoviral vectors

PubMed Central

Chorny, Michael; Fishbein, Ilia; Tengood, Jillian E.; Adamo, Richard F.; Alferiev, Ivan S.; Levy, Robert J.

2013-01-01

Gene therapeutic strategies have shown promise in treating vascular disease. However, their translation into clinical use requires pharmaceutical carriers enabling effective, site-specific delivery as well as providing sustained transgene expression in blood vessels. While replication-deficient adenovirus (Ad) offers several important advantages as a vector for vascular gene therapy, its clinical applicability is limited by rapid inactivation, suboptimal transduction efficiency in vascular cells, and serious systemic adverse effects. We hypothesized that novel zinc oleate-based magnetic nanoparticles (MNPs) loaded with Ad would enable effective arterial cell transduction by shifting vector processing to an alternative pathway, protect Ad from inactivation by neutralizing factors, and allow site-specific gene transfer to arteries treated with stent angioplasty using a 2-source magnetic guidance strategy. Ad-loaded MNPs effectively transduced cultured endothelial and smooth muscle cells under magnetic conditions compared to controls and retained capacity for gene transfer after exposure to neutralizing antibodies and lithium iodide, a lytic agent causing disruption of free Ad. Localized arterial gene expression significantly stronger than in control animal groups was demonstrated after magnetically guided MNP delivery in a rat stenting model 2 and 9 d post-treatment, confirming feasibility of using Ad-loaded MNPs to achieve site-specific transduction in stented blood vessels. In conclusion, Ad-loaded MNPs formed by controlled precipitation of zinc oleate represent a novel delivery system, well-suited for efficient, magnetically targeted vascular gene transfer.—Chorny, M., Fishbein, I., Tengood, J. E., Adamo, R. F., Alferiev, I. S., Levy, R. J. Site-specific gene delivery to stented arteries using magnetically guided zinc oleate-based nanoparticles loaded with adenoviral vectors. PMID:23407712

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

PubMed

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

2014-03-01

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

Cost-utility analysis of stenting versus endarterectomy in the International Carotid Stenting Study.

PubMed

Morris, Stephen; Patel, Nishma V; Dobson, Joanna; Featherstone, Roland L; Richards, Toby; Luengo-Fernandez, Ramon; Rothwell, Peter M; Brown, Martin M

2016-06-01

The International Carotid Stenting Study was a multicenter randomized trial in which patients with symptomatic carotid artery stenosis were randomly allocated to treatment by carotid stenting or endarterectomy. Economic evidence comparing these treatments is limited and inconsistent. We compared the cost-effectiveness of stenting versus endarterectomy using International Carotid Stenting Study data. We performed a cost-utility analysis estimating mean costs and quality-adjusted life years per patient for both treatments over a five-year time horizon based on resource use data and utility values collected in the trial. Costs of managing stroke events were estimated using individual patient data from a UK population-based study (Oxford Vascular Study). Mean costs per patient (95% CI) were US$10,477 ($9669 to $11,285) in the stenting group (N = 853) and $9669 ($8835 to $10,504) in the endarterectomy group (N = 857). There were no differences in mean quality-adjusted life years per patient (3.247 (3.160 to 3.333) and 3.228 (3.150 to 3.306), respectively). There were no differences in adjusted costs between groups (mean incremental costs for stenting versus endarterectomy $736 (95% CI -$353 to $1826)) or adjusted outcomes (mean quality-adjusted life years gained -0.010 (95% CI -0.117 to 0.097)). The incremental net monetary benefit for stenting versus endarterectomy was not significantly different from zero at the maximum willingness to pay for a quality-adjusted life year commonly used in the UK. Sensitivity analyses showed little uncertainty in these findings. Economic considerations should not affect whether patients with symptomatic carotid stenosis undergo stenting or endarterectomy. © 2016 World Stroke Organization.

Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial.

PubMed

Derdeyn, Colin P; Chimowitz, Marc I; Lynn, Michael J; Fiorella, David; Turan, Tanya N; Janis, L Scott; Montgomery, Jean; Nizam, Azhar; Lane, Bethany F; Lutsep, Helmi L; Barnwell, Stanley L; Waters, Michael F; Hoh, Brian L; Hourihane, J Maurice; Levy, Elad I; Alexandrov, Andrei V; Harrigan, Mark R; Chiu, David; Klucznik, Richard P; Clark, Joni M; McDougall, Cameron G; Johnson, Mark D; Pride, G Lee; Lynch, John R; Zaidat, Osama O; Rumboldt, Zoran; Cloft, Harry J

2014-01-25

Early results of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis trial showed that, by 30 days, 33 (14·7%) of 224 patients in the stenting group and 13 (5·8%) of 227 patients in the medical group had died or had a stroke (percentages are product limit estimates), but provided insufficient data to establish whether stenting offered any longer-term benefit. Here we report the long-term outcome of patients in this trial. We randomly assigned (1:1, stratified by centre with randomly permuted block sizes) 451 patients with recent transient ischaemic attack or stroke related to 70-99% stenosis of a major intracranial artery to aggressive medical management (antiplatelet therapy, intensive management of vascular risk factors, and a lifestyle-modification programme) or aggressive medical management plus stenting with the Wingspan stent. The primary endpoint was any of the following: stroke or death within 30 days after enrolment, ischaemic stroke in the territory of the qualifying artery beyond 30 days of enrolment, or stroke or death within 30 days after a revascularisation procedure of the qualifying lesion during follow-up. Primary endpoint analysis of between-group differences with log-rank test was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT 00576693. During a median follow-up of 32·4 months, 34 (15%) of 227 patients in the medical group and 52 (23%) of 224 patients in the stenting group had a primary endpoint event. The cumulative probability of the primary endpoints was smaller in the medical group versus the percutaneous transluminal angioplasty and stenting (PTAS) group (p=0·0252). Beyond 30 days, 21 (10%) of 210 patients in the medical group and 19 (10%) of 191 patients in the stenting group had a primary endpoint. The absolute differences in the primary endpoint rates between the two groups were 7·1% at year 1 (95% CI 0·2 to 13·8%; p=0·0428), 6·5% at year 2 (-0·5 to 13·5%; p=0·07) and 9·0% at year 3 (1·5 to 16·5%; p=0·0193). The occurrence of the following adverse events was higher in the PTAS group than in the medical group: any stroke (59 [26%] of 224 patients vs 42 [19%] of 227 patients; p=0·0468) and major haemorrhage (29 [13%]of 224 patients vs 10 [4%] of 227 patients; p=0·0009). The early benefit of aggressive medical management over stenting with the Wingspan stent for high-risk patients with intracranial stenosis persists over extended follow-up. Our findings lend support to the use of aggressive medical management rather than PTAS with the Wingspan system in high-risk patients with atherosclerotic intracranial arterial stenosis. National Institute of Neurological Disorders and Stroke (NINDS) and others. Copyright © 2014 Elsevier Ltd. All rights reserved.

Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial

PubMed Central

Derdeyn, Colin P; Chimowitz, Marc I; Lynn, Michael J; Fiorella, David; Turan, Tanya N; Janis, L Scott; Montgomery, Jean; Nizam, Azhar; Lane, Bethany F; Lutsep, Helmi L; Barnwell, Stanley L; Waters, Michael F; Hoh, Brian L; Hourihane, J Maurice; Levy, Elad I; Alexandrov, Andrei V; Harrigan, Mark R; Chiu, David; Klucznik, Richard P; Clark, Joni M; McDougall, Cameron G; Johnson, Mark D; Pride, G Lee; Lynch, John R; Zaidat, Osama O; Rumboldt, Zoran; Cloft, Harry J

2014-01-01

Summary Background Early results of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis trial showed that, by 30 days, 33 (14·7%) of 224 patients in the stenting group and 13 (5·8%) of 227 patients in the medical group had died or had a stroke (percentages are product limit estimates), but provided insufficient data to establish whether stenting offered any longer-term benefit. Here we report the long-term outcome of patients in this trial. Methods We randomly assigned (1:1, stratified by centre with randomly permuted block sizes) 451 patients with recent transient ischaemic attack or stroke related to 70–99% stenosis of a major intracranial artery to aggressive medical management (antiplatelet therapy, intensive management of vascular risk factors, and a lifestyle-modification programme) or aggressive medical management plus stenting with the Wingspan stent. The primary endpoint was any of the following: stroke or death within 30 days after enrolment, ischaemic stroke in the territory of the qualifying artery beyond 30 days of enrolment, or stroke or death within 30 days after a revascularisation procedure of the qualifying lesion during follow-up. Primary endpoint analysis of between-group differences with log-rank test was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT 00576693. Findings During a median follow-up of 32·4 months, 34 (15%) of 227 patients in the medical group and 52 (23%) of 224 patients in the stenting group had a primary endpoint event. The cumulative probability of the primary endpoints was smaller in the medical group versus the percutaneous transluminal angioplasty and stenting (PTAS) group (p=0·0252). Beyond 30 days, 21 (10%) of 210 patients in the medical group and 19 (10%) of 191 patients in the stenting group had a primary endpoint. The absolute differences in the primary endpoint rates between the two groups were 7·1% at year 1 (95% CI 0·2 to 13·8%; p=0·0428), 6·5% at year 2 (−0·5 to 13·5%; p=0·07) and 9·0% at year 3 (1·5 to 16·5%; p=0·0193). The occurrence of the following adverse events was higher in the PTAS group than in the medical group: any stroke (59 [26%] of 224 patients vs 42 [19%] of 227 patients; p=0·0468) and major haemorrhage (29 [13%] of 224 patients vs 10 [4%] of 227 patients; p=0·0009). Interpretation The early benefit of aggressive medical management over stenting with the Wingspan stent for high-risk patients with intracranial stenosis persists over extended follow-up. Our findings lend support to the use of aggressive medical management rather than PTAS with the Wingspan system in high-risk patients with atherosclerotic intracranial arterial stenosis. PMID:24168957

Randomized multicentre trial comparing external and internal pancreatic stenting during pancreaticoduodenectomy.

PubMed

Jang, J-Y; Chang, Y R; Kim, S-W; Choi, S H; Park, S J; Lee, S E; Lim, C-S; Kang, M J; Lee, H; Heo, J S

2016-05-01

There is no consensus on the best method of preventing postoperative pancreatic fistula (POPF) after pancreaticoduodenectomy (PD). This multicentre, parallel group, randomized equivalence trial investigated the effect of two ways of pancreatic stenting after PD on the rate of POPF. Patients undergoing elective PD or pylorus-preserving PD with duct-to-mucosa pancreaticojejunostomy were enrolled from four tertiary referral hospitals. Randomization was stratified according to surgeon with a 1 : 1 allocation ratio to avoid any related technical factors. The primary endpoint was clinically relevant POPF rate. Secondary endpoints were nutritional index, remnant pancreatic volume, long-term complications and quality of life 2 years after PD. A total of 328 patients were randomized to the external (164 patients) or internal (164) stent group between August 2010 and January 2014. The rates of clinically relevant POPF were 24·4 per cent in the external and 18·9 per cent in the internal stent group (risk difference 5·5 per cent). As the 90 per cent confidence interval (-2·0 to 13·0 per cent) did not fall within the predefined equivalence limits (-10 to 10 per cent), the clinically relevant POPF rates in the two groups were not equivalent. Similar results were observed for patients with soft pancreatic texture and high fistula risk score. Other postoperative outcomes were comparable between the two groups. Five stent-related complications occurred in the external stent group. Multivariable analysis revealed that soft pancreatic texture, non-pancreatic disease and high body mass index (23·3 kg/m 2 or above) predicted clinically relevant POPF. External stenting after PD was associated with a higher rate of clinically relevant POPF than internal stenting. Registration number: NCT01023594 (https://www.clinicaltrials.gov). © 2016 BJS Society Ltd Published by John Wiley & Sons Ltd.

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

PubMed

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

2016-06-25

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

Recent Advances in Drug Eluting Stents

PubMed Central

Puranik, Amey S.; Dawson, Eileen R.; Peppas, Nicholas A.

2013-01-01

One of the most common medical interventions to reopen an occluded vessel is the implantation of a coronary stent. While this method of treatment is effective initially, restenosis, or the re-narrowing of the artery frequently occurs largely due to neointimal hyperplasia of smooth muscle cells. Drug eluting stents were developed in order to provide local, site-specific, controlled release of drugs that can inhibit neointima formation. By implementing a controlled release delivery system it may be possible to control the time release of the pharmacological factors and thus be able to bypass some of the critical events associated with stent hyperplasia and prevent the need for subsequent intervention. However, since the advent of first-generation drug eluting stents, long-term adverse effects have raised concerns regarding their safety. These limitations in safety and efficacy have triggered considerable research in developing biodegradable stents and more potent drug delivery systems. In this review, we shed light on the current state-of-the-art in drug eluting stents, problems related to them and highlight some of the ongoing research in this area. PMID:23117022

Safety of 6-month duration of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndromes: Rationale and design of the Smart Angioplasty Research Team-safety of 6-month duration of Dual Antiplatelet Therapy after percutaneous coronary intervention in patients with acute coronary syndromes (SMART-DATE) prospective multicenter randomized trial.

PubMed

Lee, Joo Myung; Cho, Deok-Kyu; Hahn, Joo-Yong; Song, Young Bin; Park, Taek Kyu; Oh, Ju-Hyeon; Lee, Jin Bae; Doh, Joon-Hyung; Kim, Sang-Hyun; Yang, Jeong Hoon; Choi, Jin-Ho; Choi, Seung-Hyuck; Lee, Sang Hoon; Gwon, Hyeon-Cheol

2016-12-01

Dual antiplatelet therapy (DAPT) is a fundamental treatment that optimizes clinical outcomes after percutaneous coronary intervention, especially in patients with acute coronary syndrome (ACS). Although current international guidelines recommend DAPT for at least 12 months after implantation of a drug-eluting stent in patients with ACS, these recommendations are not based on randomized controlled trials dedicated to ACS population. The SMART-DATE trial is a prospective, multicenter, randomized, and open-label study to demonstrate the noninferiority of 6-month DAPT compared with 12 months or longer DAPT in patients with ACS undergoing percutaneous coronary intervention. A total of 2,700 patients will undergo prospective, random assignment to either of the DAPT duration groups. To minimize the bias from different stent devices, the type of stents will be randomly assigned (everolimus-eluting stents, zotarolimus-eluting stents, or biolimus A9-eluting stents). The primary end point is a composite of all-cause death, myocardial infarction, and cerebrovascular events at 18 months after the index procedure. The major secondary end points are definite/probable stent thrombosis defined by the Academic Research Consortium and bleeding defined by Bleeding Academic Research Consortium type 2-5. The SMART-DATE randomized trial is the first study exploring the safety of 6-month DAPT compared with conventional 12-month or longer DAPT dedicated to patients with ACS after second-generation drug-eluting stent implantation. Copyright © 2016 Elsevier Inc. All rights reserved.

Endoscopic removal and trimming of distal self-expandable metallic biliary stents

PubMed Central

Ishii, Kentaro; Itoi, Takao; Sofuni, Atsushi; Itokawa, Fumihide; Tsuchiya, Takayoshi; Kurihara, Toshio; Tsuji, Shujiro; Ikeuchi, Nobuhito; Umeda, Junko; Moriyasu, Fuminori; Tsuchida, Akihiko

2011-01-01

AIM: To evaluate the efficacy and safety of endoscopic removal and trimming of self-expandable metallic stents (SEMS). METHODS: All SEMS had been placed for distal biliary strictures. Twenty-seven endoscopic procedures were performed in 19 patients in whom SEMS (one uncovered and 18 covered) removal had been attempted, and 8 patients in whom stent trimming using argon plasma coagulation (APC) had been attempted at Tokyo Medical University Hospital. The APC settings were: voltage 60-80 W and gas flow at 1.5 L/min. RESULTS: The mean stent indwelling period for all patients in whom stent removal had been attempted was 113.7 ± 77.6 d (range, 8-280 d). Of the 19 patients in whom removal of the SEMS had been attempted, the procedure was successful in 14 (73.7%) without procedure-related adverse events. The indwelling period in the stent removable group was shorter than that in the unremovable group (94.9 ± 71.5 d vs 166.2 ± 76.2 d, P = 0.08). Stent trimming was successful for all patients with one minor adverse event consisting of self-limited hemorrhage. Trimming time ranged from 11 to 16 min. CONCLUSION: Although further investigations on larger numbers of cases are necessary to accumulate evidence, the present data suggested that stent removal and stent trimming is feasible and effective for stent-related complications. PMID:21677835

Ureteral stents increase risk of postoperative acute kidney injury following colorectal surgery.

PubMed

Hassinger, Taryn E; Mehaffey, J Hunter; Mullen, Matthew G; Michaels, Alex D; Elwood, Nathan R; Levi, Shoshana T; Hedrick, Traci L; Friel, Charles M

2018-07-01

Ureteral stents are commonly placed before colorectal resection to assist in identification of ureters and prevent injury. Acute kidney injury (AKI) is a common cause of morbidity and increased cost following colorectal surgery. Although previously associated with reflex anuria, prophylactic stents have not been found to increase AKI. We sought to determine the impact of ureteral stents on the incidence of AKI following colorectal surgery. All patients undergoing colon or rectal resection at a single institution between 2005 and 2015 were reviewed using American College of Surgeons National Surgical Quality Improvement Program dataset. AKI was defined as a rise in serum creatinine to ≥ 1.5 times the preoperative value. Univariate and multivariate regression analyses were performed to identify independent predictors of AKI. 2910 patients underwent colorectal resection. Prophylactic ureteral stents were placed in 129 patients (4.6%). Postoperative AKI occurred in 335 (11.5%) patients during their hospitalization. The stent group demonstrated increased AKI incidence (32.6% vs. 10.5%; p < 0.0001) with bilateral having a higher rate than unilateral stents. Hospital costs were higher in the stent group ($23,629 vs. $16,091; p < 0.0001), and patients with bilateral stents had the highest costs. Multivariable logistic regression identified predictors of AKI after colorectal surgery including age, procedure duration, and ureteral stent placement. Prophylactic ureteral stents independently increased AKI risk when placed prior to colorectal surgery. These data demonstrate increased morbidity and hospital costs related to usage of stents in colorectal surgery, indicating that placement should be limited to patients with highest potential benefit.

Fatigue and durability of Nitinol stents.

PubMed

Pelton, A R; Schroeder, V; Mitchell, M R; Gong, Xiao-Yan; Barney, M; Robertson, S W

2008-04-01

Nitinol self-expanding stents are effective in treating peripheral artery disease, including the superficial femoral, carotid, and renal arteries. However, fracture occurrences of up to 50% have been reported in some stents after one year. These stent fractures are likely due to in vivo cyclic displacements. As such, the cyclic fatigue and durability properties of Nitinol-based endovascular stents are discussed in terms of an engineering-based experimental testing program. In this paper, the combined effects of cardiac pulsatile fatigue and stent-vessel oversizing are evaluated for application to both stents and stent subcomponents. In particular, displacement-controlled fatigue tests were performed on stent-like specimens processed from Nitinol microtubing. Fatigue data were collected with combinations of simulated oversizing conditions and pulsatile cycles that were identified by computer modeling of the stent that mimic in vivo deformation conditions. These data are analyzed with non-linear finite element computations and are illustrated with strain-life and strain-based constant-life diagrams. The utility of this approach is demonstrated in conjunction with 10 million cycle pulsatile fatigue tests of Cordis SMART Control((R)) Nitinol self-expanding stents to calculate fatigue safety factors and thereby predict in vivo fatigue resistance. These results demonstrate the non-linear constant fatigue-life response of Nitinol stents, whereby, contrary to conventional engineering materials, the fatigue life of Nitinol is observed to increase with increasing mean strain.

Comparative Study of Esophageal Self-expandable Metallic Stent Insertion and Gastrostomy Feeding for Dysphagia Caused by Lung Cancer.

PubMed

Kim, Jihye; Min, Yang Won; Lee, Hyuk; Min, Byung Hoon; Lee, Joon Haeng; Rhee, Poong Lyul; Kim, Jae J

2018-03-25

Dysphagia is encountered in a large proportion of patients with lung cancer and is associated with malnutrition and a poor quality of life. This study compared the clinical outcomes of self-expandable metallic stent (SEMS) insertion and percutaneous gastrostomy (PG) feeding for patients with lung cancer and dysphagia. A total of 261 patients with lung cancer, who underwent either SEMS insertion (stent group) or PG (gastrostomy group) as an initial treatment procedure for dysphagia between July 1997 and July 2015 at the Samsung Medical Center, were reviewed retrospectively, and 84 patients with esophageal obstruction were identified. The clinical outcomes, including the overall survival, additional intervention, complications, and post-procedural nutritional status in the two groups, were compared. Among the 84 patients finally analyzed, 68 patients received SEMS insertion and 16 had PG. The stent group had less cervical obstruction and more mid-esophageal obstruction than the gastrostomy group. The Kaplan-Meier curves revealed similar overall survival in the two groups. Multivariate analysis showed that the two modalities had similar survival rates (PG compared with SEMS insertion, hazard ratio 0.682, p=0.219). Fifteen patients (22.1%) in the stent group received additional intervention, whereas there was no case in the gastrostomy group (p=0.063). The decrease in the serum albumin level after the procedure was lower in the gastrostomy group than in the stent group (-0.20±0.54 g/dL vs. -0.65±0.57 g/dL, p=0.013). SEMS insertion and PG feeding for relieving dysphagia by lung cancer had a comparable survival outcome. On the other hand, PG was associated with a better nutritional status.

Safety of carotid endarterectomy in patients concurrently on clopidogrel.

PubMed

Fleming, Mark D; Stone, William M; Scott, Paul; Chapital, Alyssa B; Fowl, Richard J; Money, Samuel R

2009-01-01

Clopidogrel (Plavix) usage is increasing, primarily for the management of patients with cerebrovascular symptoms and for those receiving drug-eluting coronary artery stents. A significant percentage of these patients will require carotid endarterectomy (CEA) while they are receiving clopidogrel. Recent data have demonstrated an increased incidence of coronary stent thrombosis when clopidogrel is discontinued. The objective of this study was to determine if CEA could be performed safely while patients are continued on clopidogrel therapy. A retrospective cohort design was employed to review consecutive patients who underwent CEA over a 24-month period ending March 2007. Patients were divided into two groups based on the perioperative use of clopidogrel. Preoperative demographics and postoperative results were compared between the two groups and statistically analyzed. Of the 100 patients who underwent CEA, 19 were taking clopidogrel within 5 days of surgery. This comprised the study group. The control group consisted of the 81 patients who did not receive clopidogrel. Heparin anticoagulation was routinely utilized prior to clamping in both groups. Demographics were similar between the groups. There were no statistical differences in morbidity or mortality between the control group and the clopidogrel group. Combined stroke/death rates were equivalent between the two groups (1.2% control vs. 0% clopidogrel). One hematoma developed in the control group, which did not require operative intervention. In this series, our results suggest that patients concurrently on clopidogrel can safely undergo CEA without increased risk of hematoma or neurological complications. In view of recent data demonstrating adverse outcomes in patients discontinuing clopidogrel, this study is useful in optimally managing this group of patients.

Temporary placement of stent grafts in postsurgical benign biliary strictures: a single center experience.

PubMed

Vellody, Ranjith; Willatt, Jonathon M; Arabi, Mohammad; Cwikiel, Wojciech B

2011-01-01

To evaluate the effect of temporary stent graft placement in the treatment of benign anastomotic biliary strictures. Nine patients, five women and four men, 22-64 years old (mean, 47.5 years), with chronic benign biliary anastomotic strictures, refractory to repeated balloon dilations, were treated by prolonged, temporary placement of stent-grafts. Four patients had strictures following a liver transplantation; three of them in bilio-enteric anastomoses and one in a choledocho-choledochostomy. Four of the other five patients had strictures at bilio-enteric anastomoses, which developed after complications following laparoscopic cholecystectomies and in one after a Whipple procedure for duodenal carcinoma. In eight patients, balloon-expandable stent-grafts were placed and one patient was treated by insertion of a self-expanding stent-graft. In the transplant group, treatment of patients with bilio-enteric anastomoses was unsuccessful (mean stent duration, 30 days). The patient treated for stenosis in the choledocho-choledochostomy responded well to consecutive self-expanding stent-graft placement (total placement duration, 112 days). All patients with bilio-enteric anastomoses in the non-transplant group were treated successfully with stent-grafts (mean placement duration, 37 days). Treatment of benign biliary strictures with temporary placement of stent-grafts has a positive effect, but is less successful in patients with strictures developed following a liver transplant.

Sirolimus- versus paclitaxel-eluting stents in patients with stenosis in a native coronary artery.

PubMed

Doggrell, Sheila A

2004-06-01

With stenting, restenosis occurs in approximately 25% of patients and the incidence is even higher in patients with diabetes, small coronary vessels and long lesions. The sirolimus-eluting balloon-expandable stent in the treatment of patients with de novo native coronary-artery lesions (SIRIUS) trial, enrolled patients with more challenging conditions, including a higher frequency of diabetes, more complex lesion morphology and longer lesions and showed benefits in all groups. After 240 days, the frequency of stenosis of at least 50% of the luminal diameter was 3.2 and 35.4% in the sirolimus and standard stents groups, respectively. The TAXUS-IV trial was the first large-scale trial on the safety and efficacy of paclitaxel-eluting stents in a broad population of patients and lesions, and established the safety and effectiveness of this agent. After 9 months, there was a mean stenosis of 17% in the paclitaxel group compared to 37% of patients treated with a bare stent. Thus, the local delivery of potent cell cycle inhibitors (sirolimus, paclitaxel) from stents being used for revascularisation dramatically decreases the incidence of restenosis in the populations of patients studied so far and represents a major advancement in the treatment of coronary artery disease.

Comparison of Covered Versus Uncovered Stents for Benign Superior Vena Cava (SVC) Obstruction.

PubMed

Haddad, Mustafa M; Simmons, Benjamin; McPhail, Ian R; Kalra, Manju; Neisen, Melissa J; Johnson, Matthew P; Stockland, Andrew H; Andrews, James C; Misra, Sanjay; Bjarnason, Haraldur

2018-05-01

To identify whether long-term symptom relief and stent patency vary with the use of covered versus uncovered stents for the treatment of benign SVC obstruction. We retrospectively identified all patients with benign SVC syndrome treated to stent placement between January 2003 and December 2015 (n = 59). Only cases with both clinical and imaging follow-up were included (n = 47). In 33 (70%) of the patients, the obstruction was due to a central line or pacemaker wires, and in 14 (30%), the cause was fibrosing mediastinitis. Covered stents were placed in 17 (36%) of the patients, and 30 (64%) patients had an uncovered stent. Clinical and treatment outcomes, complications, and the percent stenosis of each stent were evaluated. Technical success was achieved in all cases at first attempt. Average clinical and imaging follow-up in years was 2.7 (range 0.1-11.1) (covered) and 1.7 (range 0.2-10.5) (uncovered), respectively. There was a significant difference (p = 0.044) in the number of patients who reported a return of symptoms between the covered (5/17 or 29.4%) and uncovered (18/30 or 60%) groups. There was also a significant difference (p = < 0.001) in the mean percent stenosis after stent placement between the covered [17.9% (range 0-100) ± 26.2] and uncovered [48.3% (range 6.8-100) ± 33.5] groups. No significant difference (p = 0.227) was found in the time (days) between the date of the procedure and the date of clinical follow-up where a return of symptoms was reported [covered: 426.6 (range 28-1554) ± 633.9 and uncovered 778.1 (range 23-3851) ± 1066.8]. One patient in the uncovered group had non-endovascular surgical intervention (innominate to right atrial bypass), while none in the covered group required surgical intervention. One major complication (SIR grade C) occurred that consisted of a pericardial hemorrhagic effusion after angioplasty that required covered stent placement. There were no procedure-related deaths. Both covered and uncovered stents can be used for treating benign SVC syndrome. Covered stents, however, may be a more effective option at providing symptom relief and maintaining stent patency if validated by further studies.

Can a brief period of double J stenting improve the outcome of extracorporeal shock wave lithotripsy for renal calculi sized 1 to 2 cm?

PubMed

Sharma, Rakesh; Choudhary, Arpan; Das, Ranjit Kumar; Basu, Supriya; Dey, Ranjan Kumar; Gupta, Rupesh; Deb, Partha Pratim

2017-03-01

Extracorporeal shock wave lithotripsy (ESWL) is an established modality for renal calculi. Its role for large stones is being questioned. A novel model of temporary double J (DJ) stenting followed by ESWL was devised and outcomes were assessed. The study included 95 patients with renal calculi sized 1 to 2 cm. Patients were randomized into 3 groups. Group 1 received ESWL only, whereas group 2 underwent stenting followed by ESWL. In group 3, a distinct model was applied in which the stent was kept for 1 week and then removed, followed by ESWL. Procedural details, analgesic requirements, and outcome were analyzed. Eighty-eight patients (male, 47; female, 41) were available for analysis. The patients' mean age was 37.9±10.9 years. Stone profile was similar among groups. Group 3 received fewer shocks (mean, 3,155) than did group 1 (mean, 3,859; p=0.05) or group 2 (mean, 3,872; p=0.04). The fragmentation rate was similar in group 3 (96.7%) and groups 1 (81.5%, p=0.12) and 2 (87.1%, p=0.16). Overall clearance in group 3 was significantly improved (83.3%) compared with that in groups 1 (63.0%, p=0.02) and 2 (64.5%, p=0.02) and was maintained even in lower pole stones. The percentage successful outcome in groups 1, 2, and 3 was 66.7%, 64.5%, and 83.3%, respectively (p=0.21). The analgesic requirement in group 2 was higher than in the other groups (p=0.00). Group 2 patients also had more grade IIIa (2/3) and IIIB (1/2) complications. Stenting adversely affects stone clearance and also makes the later course uncomfortable. Our model of brief stenting followed by ESWL provided better clearance, comfort, and a modest improvement in outcome with fewer sittings and steinstrasse in selected patients with large renal calculi.

Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study)

PubMed Central

van Hooft, Jeanin E; Bemelman, Willem A; Breumelhof, Ronald; Siersema, Peter D; Kruyt, Philip M; van der Linde, Klaas; Veenendaal, Roeland A; Verhulst, Marie-Louise; Marinelli, Andreas W; Gerritsen, Josephus JGM; van Berkel, Anne-Marie; Timmer, Robin; Grubben, Marina JAL; Scholten, Pieter; Geraedts, Alfons AM; Oldenburg, Bas; Sprangers, Mirjam AG; Bossuyt, Patrick MM; Fockens, Paul

2007-01-01

Background Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion. Methods/design Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS). Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures analysis of variance. Mortality will be compared using Kaplan-Meier curves and log-rank statistics. Discussion The Stent-in 2 study is a randomized controlled multicenter trial that will provide evidence whether or not colonic stenting as bridge to surgery is to be performed in patients with acute left-sided colonic obstruction. Trial registration Current Controlled Trials ISRCTN46462267. PMID:17608947

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.

Comparison between gastrostomy feeding and self-expandable metal stent insertion for patients with esophageal cancer and dysphagia

PubMed Central

Jung, Ji Hey; Lee, Hyuk; Min, Byung-Hoon; Lee, Jun Haeng; Rhee, Poong-Lyul; Kim, Jae J.

2017-01-01

Background Self-expandable metal stent (SEMS) insertion and percutaneous gastrostomy (PG) feeding are commonly used for patients with esophageal cancer and dysphagia. This study aimed to compare outcomes between SEMS insertion and PG feeding for them. Methods We retrospectively analyzed 308 patients with esophageal cancer who underwent fully covered SEMS insertion (stent group) or PG (gastrostomy group) for dysphagia due to tumor. Patients with other causes of dysphagia, such as radiation-induced or postoperative stricture, were excluded from the study. Clinical outcomes were compared between the two groups, including overall survival and need for additional intervention and postprocedural nutritional status. Results At baseline, the stent group (n = 169) had more stage IV patients, less cervical cancers, and received radiotherapy and esophagectomy less often than the gastrostomy group (n = 64). The Kaplan-Meier curves showed higher overall survival in the gastrostomy group than in the stent group. Multivariate analysis revealed that PG was associated with better survival compared with SEMS insertion (hazard ratio 0.541, 95% confidence interval 0.346–0.848, p = 0.007). In addition, the gastrostomy group needed additional intervention less often (3.1% vs. 21.9%, p < 0.001) and experienced less decrease in serum albumin levels (-0.15 ± 0.56 g/dL vs. -0.39 ± 0.58 g/dL, p = 0.011) than the stent group after procedure. Conclusions Our data suggested that, compared with SEMS insertion, PG is associated with better overall survival in patients with esophageal cancer and dysphagia. Stabilized nutritional status by PG may play a role in improving patient survival. PMID:28632744

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

PubMed

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

2017-04-01

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

Endoscopic stenting versus surgical colostomy for the management of malignant colonic obstruction: comparison of hospital costs and clinical outcomes.

PubMed

Varadarajulu, Shyam; Roy, Ann; Lopes, Tercio; Drelichman, Ernesto R; Kim, Micheline

2011-07-01

Although stent placement is increasingly performed, colostomy still is considered the gold standard for emergent relief of malignant colonic obstruction (MCO). This study aimed to compare hospital costs and clinical outcomes between patients undergoing colostomy and those undergoing stenting for the management of MCO. A retrospective claims analysis of the Medicare Provider Analysis and Review (MedPAR) data set was conducted to identify inpatient hospitalizations for colostomy or stent placement for the treatment of colon cancer (2007-2008). The outcomes evaluated using MedPAR compared the total length of hospital stay (LOS) and the costs associated with both techniques. Because MedPAR is a claims data set that does not provide outcomes at a patient level, a single-institution retrospective case-control study was conducted in which each stent placement patient was matched with two colostomy patients during the same period. Outcome measures (institutional data) were used to compare rates of treatment success, postprocedure LOS, and reinterventions between the two cohorts. The MedPAR data evaluated 778 stent placements and 5,868 colostomy hospitalizations. There were no differences in gender, age distribution, or comorbidity between the two groups. Compared with colostomy, the median LOS (8 vs. 12 days; p<0.0001) and the median cost ($15,071 vs. $24,695; p<0.001) per claim were significantly less for stent placement. Stent placement was more commonly performed at urban versus rural hospitals (84% vs. 16%; p<0.0001), teaching versus nonteaching hospitals (56% vs. 44%; p=0.0058) and larger versus smaller institutions (mean bed capacity, 331 vs. 227; p<0.0001). The institution data included 12 patients who underwent stent placement and 24 who underwent colostomy. Although both methods were technically successful, the median postprocedure LOS (2.17 vs. 10.58 days; p=0.0004) and the rate of readmissions for complications (0% vs. 25%; p=0.01) were significantly lower for stent placement. Although the technical and clinical outcomes for colostomy and stent placement appear comparable, stent placement is less costly and associated with shorter LOS and fewer complications. Dissemination of stent placement beyond large teaching hospitals located in urban areas as a treatment for MCO is important given its implications for patient care and resource use.

Flow diverter effect of LVIS stent on cerebral aneurysm hemodynamics: a comparison with Enterprise stents and the Pipeline device.

PubMed

Wang, Chao; Tian, Zhongbin; Liu, Jian; Jing, Linkai; Paliwal, Nikhil; Wang, Shengzhang; Zhang, Ying; Xiang, Jianping; Siddiqui, Adnan H; Meng, Hui; Yang, Xinjian

2016-07-02

The aim of this study was to quantify the effect of the new Low-profile Visualized Intraluminal Support (LVIS®D) device and the difference of fluid diverting effect compared with the Pipeline device and the Enterprise stent using computational fluid dynamics (CFD). In this research, we simulated three aneurysms constructed from 3D digital subtraction angiography (DSA). The Enterprise, LVIS and the Pipeline device were virtually conformed to fit into the vessel lumen and placed across the aneurysm orifice. Computational fluid dynamics analysis was performed to compare the hemodynamic differences such as WSS, Velocity and Pressure among these stents. Control referred to the unstented model, the percentage of hemodynamic changes were all compared to Control. A single LVIS stent caused more wall shear stress reduction than double Enterprise stents (39.96 vs. 30.51 %) and velocity (23.13 vs. 18.64 %). Significant reduction in wall shear stress (63.88 %) and velocity (46.05 %) was observed in the double-LVIS stents. A single Pipeline showed less reduction in WSS (51.08 %) and velocity (37.87 %) compared with double-LVIS stent. The double-Pipeline stents resulted in the most reduction in WSS (72.37 %) and velocity (54.26 %). Moreover, the pressure increased with minuscule extent after stenting, compared with the unstented model. This is the first study analyzing flow modifications associated with LVIS stents. We found that the LVIS stent has certain hemodynamic effects on cerebral aneurysms: a single LVIS stent caused more flow reductions than the double-Enterprise stent but less than a Pipeline device. Nevertheless, the double-LVIS stent resulted in a better flow diverting effect than a Pipeline device.

Fully covered self-expanding metal stents versus lumen-apposing fully covered self-expanding metal stent versus plastic stents for endoscopic drainage of pancreatic walled-off necrosis: clinical outcomes and success.

PubMed

Siddiqui, Ali A; Kowalski, Thomas E; Loren, David E; Khalid, Ammara; Soomro, Ayesha; Mazhar, Syed M; Isby, Laura; Kahaleh, Michel; Karia, Kunal; Yoo, Joseph; Ofosu, Andrew; Ng, Beverly; Sharaiha, Reem Z

2017-04-01

Endoscopic transmural drainage/debridement of pancreatic walled-off necrosis (WON) has been performed using double-pigtail plastic (DP), fully covered self-expanding metal stents (FCSEMSs), or the novel lumen-apposing fully covered self-expanding metal stent (LAMS). Our aim was to perform a retrospective cohort study to compare the clinical outcomes and adverse events of EUS-guided drainage/debridement of WON with DP stents, FCSEMSs, and LAMSs. Consecutive patients in 2 centers with WON managed by EUS-guided debridement were divided into 3 groups: (1) those who underwent debridement using DP stents, (2) debridement using FCSEMSs, (3) debridement using LAMSs. Technical success (ability to access and drain a WON by placement of transmural stents), early adverse events, number of procedures performed per patient to achieve WON resolution, and long-term success (complete resolution of the WON without need for further reintervention at 6 months after treatment) were evaluated. From 2010 to 2015, 313 patients (23.3% female; mean age, 53 years) underwent WON debridement, including 106 who were drained using DP stents, 121 using FCSEMSs, and 86 using LAMSs. The 3 groups were matched for age, cause of the pancreatitis, WON size, and location. The cause of the patients' pancreatitis was gallstones (40.6%), alcohol (30.7%), idiopathic (13.1%), and other causes (15.6%). The mean cyst size was 102 mm (range, 20-510 mm). The mean number of endoscopy sessions was 2.5 (range, 1-13). The technical success rate of stent placement was 99%. Early adverse events were noted in 27 of 313 (8.6%) patients (perforation in 6, bleeding in 8, suprainfection in 9, other in 7). Successful endoscopic therapy was noted in 277 of 313 (89.6%) patients. When comparing the 3 groups, there was no difference in the technical success (P = .37). Early adverse events were significantly lower in the FCSEMS group compared with the DP and LAMS groups (1.6%, 7.5%, and 9.3%; P < .01). At 6-month follow-up, the rate of complete resolution of WON was lower with DP stents compared with FCSEMSs and LAMSs (81% vs 95% vs 90%; P = .001). The mean number of procedures required for WON resolution was significantly lower in the LAMS group compared with the FCSEMS and DP groups (2.2 vs 3 vs 3.6, respectively; P = .04). On multivariable analysis, DP stents remain the sole negative predictor for successful resolution of WON (odds ratio [OR], 0.18; 95% confidence interval, 0.06-0.53; P = .002) after adjusting for age, sex, and WON size. Although there was no significant difference between FCSEMSs and LAMSs for WON resolution, the LAMS was more likely to have early adverse events (OR, 6.6; P = .02). EUS-guided drainage/debridement of WON using FCSEMSs and LAMSs is superior to DP stents in terms of overall treatment efficacy. The number of procedures required for WON resolution was significantly lower with LAMSs compared with FCSEMSs and DP stents. Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial.

PubMed

Vlachojannis, Georgios J; Smits, Pieter C; Hofma, Sjoerd H; Togni, Mario; Vázquez, Nicolás; Valdés, Mariano; Voudris, Vassilis; Puricel, Serban; Slagboom, Ton; Goy, Jean-Jacques; den Heijer, Peter; van der Ent, Martin

2015-07-01

The aim of this analysis was to compare the long-term safety and efficacy of the biodegradable polymer biolimus-eluting stent (BES) with that of the durable polymer everolimus-eluting stent (EES). The COMPARE II study was a prospective, randomised, multicentre, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BES or EES. The pre-specified endpoint at three years was major adverse cardiac events (MACE), a composite of cardiac death, non-fatal myocardial infarction (MI), or target vessel revascularisation (TVR). Moreover, the combined endpoint all-cause death or MI was analysed as a safety, and TVR as an efficacy measure. Three-year follow-up was available in 2,683 patients (99.1%). At three years, MACE occurred in 213 patients (11.9%) in the BES group and in 101 patients (11.1 %) in the EES group (p=0.57). The rate of the combined safety endpoint all-cause death or MI was 9.3% in the BES group vs. 8.4% (p=0.52), while the efficacy measure TVR was 7.6% in BES vs. 6.5% (p=0.27). Interestingly, definite stent thrombosis rates did not differ between groups (1.2% for BES vs. 0.8%, p=0.33). At three-year follow-up, MACE as well as safety and efficacy measures including stent thrombosis were not statistically different between the biodegradable polymer-coated BES and the durable polymer-coated EES. ClinicalTrials.gov Identifier: NCT01233453.

Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study.

PubMed

Belle, Loic; Motreff, Pascal; Mangin, Lionel; Rangé, Grégoire; Marcaggi, Xavier; Marie, Antoine; Ferrier, Nadine; Dubreuil, Olivier; Zemour, Gilles; Souteyrand, Géraud; Caussin, Christophe; Amabile, Nicolas; Isaaz, Karl; Dauphin, Raphael; Koning, René; Robin, Christophe; Faurie, Benjamin; Bonello, Laurent; Champin, Stanislas; Delhaye, Cédric; Cuilleret, François; Mewton, Nathan; Genty, Céline; Viallon, Magalie; Bosson, Jean Luc; Croisille, Pierre

2016-03-01

Delayed stent implantation after restoration of normal epicardial flow by a minimalist immediate mechanical intervention aims to decrease the rate of distal embolization and impaired myocardial reperfusion after percutaneous coronary intervention. We sought to confirm whether a delayed stenting (DS) approach (24-48 hours) improves myocardial reperfusion, versus immediate stenting, in patients with acute ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. In the prospective, randomized, open-label minimalist immediate mechanical intervention (MIMI) trial, patients (n=140) with ST-segment-elevation myocardial infarction ≤12 hours were randomized to immediate stenting (n=73) or DS (n=67) after Thrombolysis In Myocardial Infarction 3 flow restoration by thrombus aspiration. Patients in the DS group underwent a second coronary arteriography for stent implantation a median of 36 hours (interquartile range 29-46) after randomization. The primary end point was microvascular obstruction (% left ventricular mass) on cardiac magnetic resonance imaging performed 5 days (interquartile range 4-6) after the first procedure. There was a nonsignificant trend toward lower microvascular obstruction in the immediate stenting group compared with DS group (1.88% versus 3.96%; P=0.051), which became significant after adjustment for the area at risk (P=0.049). Median infarct weight, left ventricular ejection fraction, and infarct size did not differ between groups. No difference in 6-month outcomes was apparent for the rate of major cardiovascular and cerebral events. The present findings do not support a strategy of DS versus immediate stenting in patients with ST-segment-elevation infarction undergoing primary percutaneous coronary intervention and even suggested a deleterious effect of DS on microvascular obstruction size. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360242. © 2016 American Heart Association, Inc.

Partially covered metal stents have longer patency than uncovered and fully covered metal stents in the management of distal malignant biliary obstruction: a retrospective study.

PubMed

Yokota, Yudai; Fukasawa, Mitsuharu; Takano, Shinichi; Kadokura, Makoto; Shindo, Hiroko; Takahashi, Ei; Hirose, Sumio; Kawakami, Satoshi; Fukasawa, Yoshimitsu; Sato, Tadashi; Enomoto, Nobuyuki

2017-10-11

Self-expandable metal stents (SEMSs) are widely used for malignant biliary obstructions. Nitinol-covered SEMSs have been developed to improve stent patency. Currently, SEMSs may be uncovered, partially covered, or fully covered; however, there is no consensus on the best stent type for the management of malignant distal biliary obstruction (MDBO). Patients with unresectable MDBO receiving SEMS (Wallflex™) were retrospectively analyzed. Time to recurrent biliary obstruction (TRBO) and survival time were compared among the three types of SEMSs. Univariate and multivariate analyses were performed to identify risk factors for stent dysfunction. In total, 101 patients received SEMSs for unresectable MDBO (44 uncovered, 28 partially covered, and 29 fully covered SEMSs). Median survival time was 200, 168, and 276 days in the uncovered, partially covered, and fully covered SEMSs groups, respectively. There were no differences in survival among the three groups. Median TRBO was 199, 444, and 194 days in the uncovered, partially covered, and fully covered SEMSs groups, respectively. Partially covered SEMSs had longer TRBO than uncovered (p = 0.013) and fully covered (p = 0.010) SEMSs. Tumor ingrowth occurred only with uncovered SEMSs and stent migration occurred only with fully covered SEMSs. Multivariate analyses confirmed that partially covered SEMSs have lower risk of dysfunction. Partially covered SEMSs with a proximal uncovered flared end have longer patency than uncovered and fully covered SEMSs by preventing tumor ingrowth and stent migration.

Improvement of postoperative cognitive dysfunction and attention network function of patients with ischemic cerebrovascular disease via dexmedetomidine.

PubMed

Zhang, Jingchao; Wang, Guoliang; Zhang, Fangxiang; Zhao, Qian

2018-03-01

The protective effect of dexmedetomidine on cognitive dysfunction and decreased attention network function of patients with ischemic cerebrovascular disease after stenting was investigated. Fifty-eight patients with ischemic cerebrovascular disease undergoing stenting in Guizhou Provincial People's Hospital were selected and randomly divided into control group (n=29) and dexmedetomidine group (n=29). The dexmedetomidine group was treated with dexmedetomidine before induced anesthesia, while the control group was given the same dose of normal saline; and the normal volunteers of the same age were selected as the normal group (n=29). At 3 days after operation, the levels of serum S100B and nerve growth factor (NGF) in each group were detected using the enzyme-linked immunosorbent assay, and the level of brain-derived neurotrophic factor (BDNF) was detected via western blotting. Montreal cognitive assessment (MoCA) and attention network test (ANT) were performed. Moreover, the cognitive function and attention network function, and the effects of dexmedetomidine on cognitive function and attention network function were evaluated. The concentrations of serum S100B and NGF in dexmedetomidine group was lower than those in control group (P<0.01). The results of western blotting showed that the levels of serum BDNF in control group and dexmedetomidine group were significantly lower than that in normal group (P<0.01), and it was higher in dexmedetomidine group than that in control group (P<0.01). Besides, both MoCA and ANT results revealed that the visual space and executive function scores, attention scores, delayed memory scores, targeted network efficiency and executive control network efficiency in dexmedetomidine group were obviously higher than those in control group (P<0.01). The cognitive function and attention network function of patients with ischemic cerebrovascular disease have a certain degree of damage, and the preoperative administration of dexmedetomidine can effectively improve the patient's cognitive dysfunction and attention network function after operation.

Does antegrade JJ stenting affect the total operative time during laparoscopic pyeloplasty?

PubMed

Bolat, Mustafa Suat; Çınar, Önder; Akdeniz, Ekrem

2017-12-01

We aimed to show the effect of retrograde JJ stenting and intraoperative antegrade JJ stenting techniques on operative time in patients who underwent laparoscopic pyeloplasty. A total of 34 patients were retrospectively investigated (15 male and 19 female) with ureteropelvic junction obstruction. Of the patients stentized under local anesthesia preoperatively, as a part of surgery, 15 were retrogradely stentized at the beginning of the procedure (Group 1), and 19 were antegradely stentized during the procedure (Group 2). A transperitoneal dismembered pyeloplasty technique was performed in all patients. The two groups were retrospectively compared in terms of complications, the mean total operative time, and the mean stenting times. The mean ages of the patients were 31.5±15.5 and 33.2±15.5 years (p=0.09), and the mean body mass indexes were 25.8±5.6 and 26.2.3±8.4 kg/m 2 in Group 1 and Group 2, respectively. The mean total operative times were 128.9±38.9 min and 112.7±21.9 min (p=0.04); the mean stenting times were 12.6±5.4 min and 3.5±2.4 min (p=0.02); and the mean rates of catheterization-to-total surgery times were 0.1 and 0.03 (p=0.01) in Group 1 and 2, respectively. The mean hospital stays and the mean anastomosis times were similar between the two groups (p>0.05). Antegrade JJ stenting during laparoscopic pyeloplasty significantly decreased the total operative time.

Effect of platelet inhibition with cangrelor during PCI on ischemic events.

PubMed

Bhatt, Deepak L; Stone, Gregg W; Mahaffey, Kenneth W; Gibson, C Michael; Steg, P Gabriel; Hamm, Christian W; Price, Matthew J; Leonardi, Sergio; Gallup, Dianne; Bramucci, Ezio; Radke, Peter W; Widimský, Petr; Tousek, Frantisek; Tauth, Jeffrey; Spriggs, Douglas; McLaurin, Brent T; Angiolillo, Dominick J; Généreux, Philippe; Liu, Tiepu; Prats, Jayne; Todd, Meredith; Skerjanec, Simona; White, Harvey D; Harrington, Robert A

2013-04-04

The intensity of antiplatelet therapy during percutaneous coronary intervention (PCI) is an important determinant of PCI-related ischemic complications. Cangrelor is a potent intravenous adenosine diphosphate (ADP)-receptor antagonist that acts rapidly and has quickly reversible effects. In a double-blind, placebo-controlled trial, we randomly assigned 11,145 patients who were undergoing either urgent or elective PCI and were receiving guideline-recommended therapy to receive a bolus and infusion of cangrelor or to receive a loading dose of 600 mg or 300 mg of clopidogrel. The primary efficacy end point was a composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 hours after randomization; the key secondary end point was stent thrombosis at 48 hours. The primary safety end point was severe bleeding at 48 hours. The rate of the primary efficacy end point was 4.7% in the cangrelor group and 5.9% in the clopidogrel group (adjusted odds ratio with cangrelor, 0.78; 95% confidence interval [CI], 0.66 to 0.93; P=0.005). The rate of the primary safety end point was 0.16% in the cangrelor group and 0.11% in the clopidogrel group (odds ratio, 1.50; 95% CI, 0.53 to 4.22; P=0.44). Stent thrombosis developed in 0.8% of the patients in the cangrelor group and in 1.4% in the clopidogrel group (odds ratio, 0.62; 95% CI, 0.43 to 0.90; P=0.01). The rates of adverse events related to the study treatment were low in both groups, though transient dyspnea occurred significantly more frequently with cangrelor than with clopidogrel (1.2% vs. 0.3%). The benefit from cangrelor with respect to the primary end point was consistent across multiple prespecified subgroups. Cangrelor significantly reduced the rate of ischemic events, including stent thrombosis, during PCI, with no significant increase in severe bleeding. (Funded by the Medicines Company; CHAMPION PHOENIX ClinicalTrials.gov number, NCT01156571.).

Are Everolimus-Eluting Stents Associated With Better Clinical Outcomes Compared to Other Drug-Eluting Stents in Patients With Type 2 Diabetes Mellitus?

PubMed Central

Bundhun, Pravesh Kumar; Pursun, Manish; Teeluck, Abhishek Rishikesh; Long, Man-Yun

2016-01-01

Abstract Controversies still exist with the use of Everolimus-Eluting Stents (EES) compared to other Drug-Eluting Stents (DES) in patients with Type 2 Diabetes Mellitus (T2DM). Therefore, in order to solve this issue, we aim to compare the 1-year adverse clinical outcomes between EES and non-EE DES with a larger number of patients with T2DM. Medline, EMBASE, PubMed databases, as well as the Cochrane library were searched for randomized controlled trials (RCTs) and observational studies (OS) comparing EES and non-EE DES in patients with T2DM. One-year adverse outcomes were considered as the clinical endpoints in this study. Odd ratios (OR) with 95% confidence interval (CI) were used to express the pooled effect on discontinuous variables and the pooled analyses were performed with RevMan 5.3. Ten studies consisting of a total of 11,981 patients with T2DM (6800 patients in the EES group and 5181 in the non-EE DES group) were included in this meta-analysis. EES were associated with a significantly lower major adverse cardiac events (MACEs) with OR: 0.83, 95% CI: 0.70–0.98, P = 0.03. Revascularization including target vessel revascularization (TVR) and target lesion revascularization (TLR) were also significantly lower in the EES group with OR: 0.62, 95% CI: 0.40–0.94, P = 0.03 and OR: 0.74, 95% CI: 0.57–0.95, P = 0.02, respectively. Also, a significantly lower rate of stent thrombosis with OR: 0.63, 95% CI: 0.46–0.86, P = 0.003 was observed in the EES group. However, a similar mortality rate was reported between the EES and non-EE DES groups. During this 1-year follow-up period, EES were associated with significantly better clinical outcomes compared to non-EE DES in patients suffering from T2DM. However, further research comparing EES with non-EE DES in insulin-treated and noninsulin-treated patients with T2DM are recommended. PMID:27057888

Amniotic membrane grafts for the prevention of esophageal stricture after circumferential endoscopic submucosal dissection.

PubMed

Barret, Maximilien; Pratico, Carlos Alberto; Camus, Marine; Beuvon, Frédéric; Jarraya, Mohamed; Nicco, Carole; Mangialavori, Luigi; Chaussade, Stanislas; Batteux, Frédéric; Prat, Frédéric

2014-01-01

The prevention of esophageal strictures following circumferential mucosal resection remains a major clinical challenge. Human amniotic membrane (AM) is an easily available material, which is widely used in ophthalmology due to its wound healing, anti-inflammatory and anti-fibrotic properties. We studied the effect of AM grafts in the prevention of esophageal stricture after endoscopic submucosal dissection (ESD) in a swine model. In this prospective, randomized controlled trial, 20 swine underwent a 5 cm-long circumferential ESD of the lower esophagus. In the AM Group (n = 10), amniotic membrane grafts were placed on esophageal stents; a subgroup of 5 swine (AM 1 group) was sacrificed on day 14, whereas the other 5 animals (AM 2 group) were kept alive. The esophageal stent (ES) group (n = 5) had ES placement alone after ESD. Another 5 animals served as a control group with only ESD. The prevalence of symptomatic strictures at day 14 was significantly reduced in the AM group and ES groups vs. the control group (33%, 40% and 100%, respectively, p = 0.03); mean esophageal diameter was 5.8±3.6 mm, 6.8±3.3 mm, and 2.6±1.7 mm for AM, ES, and control groups, respectively. Median (range) esophageal fibrosis thickness was 0.87 mm (0.78-1.72), 1.19 mm (0.28-1.95), and 1.65 mm (0.7-1.79) for AM 1, ES, and control groups, respectively. All animals had developed esophageal strictures by day 35. The anti-fibrotic effect of AM on esophageal wound healing after ESD delayed the development of esophageal stricture in our model. However, this benefit was of limited duration in the conditions of our study.

Preliminary investigation of the effects of surface treatments on biological response to shape memory NiTi stents.

PubMed

Trépanier, C; Leung, T K; Tabrizian, M; Yahia, L H; Bienvenu, J G; Tanguay, J F; Piron, D L; Bilodeau, L

1999-01-01

Nickel-titanium (NiTi) offers many advantages for the fabrication of coronary stents: shape memory, superelasticity, and radiopacity. However, many authors highlighted the selective dissolution of Ni from the alloy during the corrosion process that could lead to potential toxicity. The improvement of the NiTi stent's corrosion resistance by different surface treatments (electropolishing, heat treatment, and nitric acid passivation) was reported in a previous article. In the present study a comparative biocompatibility evaluation of such stents was performed through in vitro and in vivo assays. A cell proliferation test was completed to evaluate the cytotoxicity of surface treated NiTi using human fibroblasts. Then a stent implantation was performed in rabbit paramuscular muscle to study the inflammatory response generated by the same implants. Cell proliferation tests generally indicated an in vitro biocompatibility of our samples similar to the control group. An in vivo implantation study demonstrated the gradual overall reduction with time of the fibrocellular capsule thickness surrounding the implants. After a 12-week implantation period, the fibrous capsules surrounding the different implants tended toward the same value of 0.07 mm, which suggested that all surface treatments produced a similar biological response. This low value of the fibrocellular capsule indicated that our NiTi surface treated implants were relatively inert.

Initial clinical experience with the trabecular micro-bypass stent in patients with glaucoma.

PubMed

Spiegel, Detlev; Wetzel, Wolfgang; Haffner, David S; Hill, Richard A

2007-01-01

This study was undertaken to evaluate the efficiency of a trabecular micro-bypass stent designed to allow direct aqueous drainage from the anterior chamber into Schlemm's canal in patients with glaucoma. In this prospective case series of 6 patients with open-angle glaucoma, the microstent was inserted ab interno under local anesthesia in an ophthalmic operating room. Patients were seen postoperatively at 1 to 2 d, 1 wk, and 1, 2, 6, and 12 mo. All stents were successfully placed within Schlemm's canal. Mean intraocular pressure (IOP) at preoperative baseline was 20.2+/-6.3 mm Hg (range, 14-31 mm Hg). Mean IOP decreased during the immediate postoperative period to approximately 12 to 13 mm Hg and was stabilized at 14 to 15 mm Hg with reduction of medication throughout 1 y of follow-up. No major complications occurred. According to observations reported in this feasibility study, the microstent was effective in reducing IOP and in decreasing the number of glaucoma medications required to control IOP. Implantation procedures were safe, and stents remained in place throughout the follow-up period. None of the complications traditionally associated with filtering surgery were reported. Further research on this stent in a larger group of patients is needed to assess its role in glaucoma therapy.

To kiss or not to kiss? Impact of final kissing-balloon inflation on early and long-term results of percutaneous coronary intervention for bifurcation lesions.

PubMed

Biondi-Zoccai, Giuseppe; Sheiban, Imad; De Servi, Stefano; Tamburino, Corrado; Sangiorgi, Giuseppe; Romagnoli, Enrico

2014-11-01

Final kissing-balloon inflation is often recommended for percutaneous coronary intervention (PCI) of bifurcation lesions. However, randomized trials focusing on kissing inflation have not confirmed its beneficial impact. We compared outcomes of kissing inflation for PCI of bifurcation lesions, explicitly stratifying results according to stenting strategy. Patients undergoing bifurcation PCI were retrospectively enrolled. Subjects receiving final kissing inflation were compared with those not undergoing kissing inflation, after stratification for a single-stent technique. The primary end point was the long-term rate of major adverse cardiac events (MACE, i.e., death, myocardial infarction, or target lesion revascularization (TLR)). A total of 4314 patients were included: 1176 (27.3 %) treated with a single stent and kissing inflation, 1637 (37.9 %) with a single stent but no kissing, 1072 (24.8 %) with two stents and kissing, and 429 (9.9 %) with two stents but no kissing. At unadjusted analyses kissing was associated with fewer short-term MACE and deaths in the two-stent group, and with fewer long-term MACE, cardiac deaths, and side-branch TLR in the two-stent group (all P < 0.05). Conversely, kissing appeared detrimental after single stenting. However, after multivariable analyses, kissing no longer significantly affected the risk of adverse events, with the exception of the risk of side-branch TLR, which was lower in those receiving two stents and final kissing inflation (hazard ratio = 0.52, 95 % confidence interval 0.30–0.90, P = 0.020). Kissing inflation can be avoided in bifurcation lesions uneventfully treated with single-stent PCI. However, final kissing-balloon inflation appears beneficial in reducing the risk of side-branch repeat revascularization after using a two-stent strategy.

Randomised comparison of drug-eluting versus bare-metal stenting in patients with non-ST elevation myocardial infarction.

PubMed

Remkes, Wouter S; Badings, Erik A; Hermanides, Renicus S; Rasoul, Saman; Dambrink, Jan-Henk E; Koopmans, Petra C; The, Salem Hk; Ottervanger, Jan Paul; Gosselink, A T Marcel; Hoorntje, Jan Ca; Suryapranata, Harry; van 't Hof, Arnoud Wj

2016-01-01

The superiority of drug-eluting stents (DES) over bare-metal stents (BMS) in patients with ST elevation myocardial infarction (STEMI) is well studied; however, randomised data in patients with non-ST elevation myocardial infarction (NSTEMI) are lacking. The objective of this study was to investigate whether stenting with everolimus-eluting stents (EES) safely reduces restenosis in patients with NSTEMI as compared to BMS. ELISA-3 patients were asked to participate in the angiographic substudy and were randomised to DE (Xience V) or BM (Vision) stenting (ELISA-3 group). The primary end point was minimal luminal diameter (MLD) at 9-month follow-up angiography. In addition, 296 patients with NSTEMI who were excluded or did not want to participate in the ELISA-3 trial (RELI group) were randomised to DE or BM stenting and underwent clinical follow-up only (major adverse cardiac events (MACE), stent thrombosis (ST)). A pooled analysis was performed to assess an effect on clinical outcome. 178 of 540 ELISA-3 patients participated in the angiographic substudy. MLD at 9 months angiography was 2.37±0.63 mm (DES) versus 1.84±0.62 mm (BMS), p<0.001. Binary restenosis occurred in 1.9% in the DES group versus 16.7% in the BMS group (RR 0.11, 95% CI 0.02 to 0.84, p=0.007). In the pooled analysis, the incidence of MACE, target vessel revascularisation and ST at 2 years follow-up in the DES versus BMS group was 12.5% versus 16.0% (p=0.28), 4.0% versus 10.4% (p=0.009) and 1.3% versus 3.0% (p=0.34), respectively. In patients with NSTEMI, use of EES is safe and decreases both angiographic and clinical restenosis as compared to BMS http://www.isrctn.com/search?q=39230163. 39230163; Post-results.

Randomised comparison of drug-eluting versus bare-metal stenting in patients with non-ST elevation myocardial infarction

PubMed Central

Remkes, Wouter S; Badings, Erik A; Hermanides, Renicus S; Rasoul, Saman; Dambrink, Jan-Henk E; Koopmans, Petra C; The, Salem HK; Ottervanger, Jan Paul; Gosselink, A T Marcel; Hoorntje, Jan CA; Suryapranata, Harry; van 't Hof, Arnoud WJ

2016-01-01

Objective The superiority of drug-eluting stents (DES) over bare-metal stents (BMS) in patients with ST elevation myocardial infarction (STEMI) is well studied; however, randomised data in patients with non-ST elevation myocardial infarction (NSTEMI) are lacking. The objective of this study was to investigate whether stenting with everolimus-eluting stents (EES) safely reduces restenosis in patients with NSTEMI as compared to BMS. Methods ELISA-3 patients were asked to participate in the angiographic substudy and were randomised to DE (Xience V) or BM (Vision) stenting (ELISA-3 group). The primary end point was minimal luminal diameter (MLD) at 9-month follow-up angiography. In addition, 296 patients with NSTEMI who were excluded or did not want to participate in the ELISA-3 trial (RELI group) were randomised to DE or BM stenting and underwent clinical follow-up only (major adverse cardiac events (MACE), stent thrombosis (ST)). A pooled analysis was performed to assess an effect on clinical outcome. Results 178 of 540 ELISA-3 patients participated in the angiographic substudy. MLD at 9 months angiography was 2.37±0.63 mm (DES) versus 1.84±0.62 mm (BMS), p<0.001. Binary restenosis occurred in 1.9% in the DES group versus 16.7% in the BMS group (RR 0.11, 95% CI 0.02 to 0.84, p=0.007). In the pooled analysis, the incidence of MACE, target vessel revascularisation and ST at 2 years follow-up in the DES versus BMS group was 12.5% versus 16.0% (p=0.28), 4.0% versus 10.4% (p=0.009) and 1.3% versus 3.0% (p=0.34), respectively. Conclusions In patients with NSTEMI, use of EES is safe and decreases both angiographic and clinical restenosis as compared to BMS http://www.isrctn.com/search?q=39230163. Trial registration number 39230163; Post-results. PMID:27933192

Stent-based nitric oxide delivery reducing neointimal proliferation in a porcine carotid overstretch injury model.

PubMed

Hou, Dongming; Narciso, Hugh; Kamdar, Kirti; Zhang, Ping; Barclay, Bruce; March, Keith L

2005-01-01

The effects of nitric acid (NO) on vessel response to injury include the inhibition of platelet adhesion, platelet aggregation, leukocyte adhesion and smooth muscle cell proliferation. Releasing NO from a stent might reduce the clinical problem of restenosis. The present study was designed to examine whether an NO-eluting covered stent can prevent neointimal formation in a porcine carotid overstretch injury model. The interior of a self-expanding polytetrafluoroethylene (ePTFE)-covered aSpire stent was coated with silicone, which contained 23.6 microg or 54.5 microg sodium nitroprusside (SNP, NO-releasing compound). The stent was implanted into carotid artery. Six pigs were implanted with stents, one high-dose SNP and one uncoated control, following balloon overstretch injury of the carotid artery with a balloon-to-artery ratio of 1.3:1. No local or systemic toxicity was evidenced in the six pigs after carotid artery implantation with either low- or high-dose stents within a week. At day 28, the mean intimal thickness was 0.12 +/- 0.05 mm for NO-eluting stents and 0.43 +/- 0.09 mm for uncoated stents (p = 0.008). The mean neointimal area was reduced from 2.40 +/- 0.39 mm2 for control stents to 0.49 +/- 0.16 mm2 for NO-eluting stents (p < 0.0001), which resulted in a 24% reduction of angiographic vessel narrowing. The NO-eluting ePTFE-covered stent is feasible and effectively reduces in-stent neointimal hyperplasia at 28 days in a porcine carotid overstretch model.

New-generation stents compared with coronary bypass surgery for unprotected left main disease: A word of caution.

PubMed

Benedetto, Umberto; Taggart, David P; Sousa-Uva, Miguel; Biondi-Zoccai, Giuseppe; Di Franco, Antonino; Ohmes, Lucas B; Rahouma, Mohamed; Kamel, Mohamed; Caputo, Massimo; Girardi, Leonard N; Angelini, Gianni D; Gaudino, Mario

2018-05-01

With the advent of bare metal stents and drug-eluting stents, percutaneous coronary intervention has emerged as an alternative to coronary artery bypass grafting surgery for unprotected left main disease. However, whether the evolution of stents technology has translated into better results after percutaneous coronary intervention remains unclear. We aimed to compare coronary artery bypass grafting with stents of different generations for left main disease by performing a Bayesian network meta-analysis of available randomized controlled trials. All randomized controlled trials with at least 1 arm randomized to percutaneous coronary intervention with stents or coronary artery bypass grafting for left main disease were included. Bare metal stents and drug-eluting stents of first- and second-generation were compared with coronary artery bypass grafting. Poisson methods and Bayesian framework were used to compute the head-to-head incidence rate ratio and 95% credible intervals. Primary end points were the composite of death/myocardial infarction/stroke and repeat revascularization. Nine randomized controlled trials were included in the final analysis. Six trials compared percutaneous coronary intervention with coronary artery bypass grafting (n = 4654), and 3 trials compared different types of stents (n = 1360). Follow-up ranged from 6 months to 5 years. Second-generation drug-eluting stents (incidence rate ratio, 1.3; 95% credible interval, 1.1-1.6), but not bare metal stents (incidence rate ratio, 0.63; 95% credible interval, 0.27-1.4), and first-generation drug-eluting stents (incidence rate ratio, 0.85; 95% credible interval, 0.65-1.1) were associated with a significantly increased risk of death/myocardial infarction/stroke when compared with coronary artery bypass grafting. When compared with coronary artery bypass grafting, the highest risk of repeat revascularization was observed for bare metal stents (hazard ratio, 5.1; 95% confidence interval, 2.1-14), whereas first-generation drug-eluting stents (incidence rate ratio, 1.8; 95% confidence interval, 1.4-2.4) and second-generation drug-eluting stents (incidence rate ratio, 1.8; 95% confidence interval, 1.4-2.4) were comparable. The introduction of new-generation drug-eluting stents did not translate into better outcomes for percutaneous coronary intervention when compared with coronary artery bypass grafting. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Stenting for symptomatic intracranial vertebrobasilar artery stenosis: 30-day results in a high-volume stroke center.

PubMed

Liu, Lian; Zhao, Xiaojing; Mo, Dapeng; Ma, Ning; Gao, Feng; Miao, Zhongrong

2016-04-01

Symptomatic intracranial vertebrobasilar artery stenosis (IVBS) carries a high annual risk of recurrent stroke. Endovascular therapy was a promising technique but recent trials suggest it may carry a risk of periprocedual complications especially in inexperienced hands. This prospective study was to evaluate the safety of endovascular therapy for severe symptomatic IVBS in a high volume stroke centre. Patients with symptomatic IVBS caused by 70-99% stenosis despite medical treatment of at least one antiplatelet agent and statin were enrolled. The patients were treated either with balloon-mounted stent or balloon pre-dilation plus self-expanding stent as determined by the operators following a guideline. The primary outcome was 30-day stroke, transient ischemic attack (TIA) and death after stenting. The secondary outcome was successful stent deployment. The baseline characteristics and outcomes of patients with basilar artery (BA) lesions and patients with vertebral artery V4 segment lesions (BA group vs V4 group) were compared. And the outcome of different Mori type lesions was also compared. From September 2013 to September 2014, 105 patients with stroke or TIA due to intracranial IVBS were screened and 97 patients were treated by stenting, including 52 patients with BA stenosis and 45 patients with V4 stenosis. The rate of 30-day stroke, TIA and death was 7.1%. All the three strokes happened in the BA group and were perforator strokes. The successful stent deployment rate was 100%. General anesthesia was more preferred in the BA group than in the V4 groups (96.2% vs 75.6%, p=0.005). The Apollo stent was used more for Mori A lesions (30.5% vs 7.9%, p=0.011) and had lower degree of residual stenosis (8.6% vs 12.6%, p=0.014) than Wingspan stent. Mori C lesions were more likely to have higher degree of residual stenosis than Mori A lesion (15.3% vs 7.4%, p=0.005). The short-term safety of endovascular stenting for patients with severe symptomatic IVBS in a high volume stroke centre was acceptable. Mori A lesions may have lower residual stenosis rate than the Mori C type lesions. Copyright © 2016. Published by Elsevier B.V.

Cost effectiveness of drug eluting coronary artery stenting in a UK setting: cost-utility study.

PubMed

Bagust, A; Grayson, A D; Palmer, N D; Perry, R A; Walley, T

2006-01-01

To assess the cost effectiveness of drug eluting stents (DES) compared with conventional stents for treatment of symptomatic coronary artery disease in the UK. Cost-utility analysis of audit based patient subgroups by means of a simple economic model. Tertiary care. 12 month audit data for 2884 patients receiving percutaneous coronary intervention with stenting at the Cardiothoracic Centre Liverpool between January 2000 and December 2002. Risk of repeat revascularisation within 12 months of index procedure and reduction in risk from use of DES. Economic modelling was used to estimate the cost-utility ratio and threshold price premium. Four factors were identified for patients undergoing elective surgery (n = 1951) and two for non-elective surgery (n = 933) to predict risk of repeat revascularisation within 12 months. Most patients fell within the subgroup with lowest risk (57% of the elective surgery group with 5.6% risk and 91% of the non-elective surgery group with 9.9% risk). Modelled cost-utility ratios were acceptable for only one group of high risk patients undergoing non-elective surgery (only one patient in audit data). Restricting the number of DES for each patient improved results marginally: 4% of stents could then be drug eluting on economic grounds. The threshold price premium justifying 90% substitution of conventional stents was estimated to be 112 pound sterling (212 USD, 162 pound sterling) (sirolimus stents) or 89 pound sterling (167 USD, 130 pound sterling) (paclitaxel stents). At current UK prices, DES are not cost effective compared with conventional stents except for a small minority of patients. Although the technology is clearly effective, general substitution is not justified unless the price premium falls substantially.

Serial Versus Direct Dilation of Small Diameter Stents Results in a More Predictable and Complete Intentional Transcatheter Stent Fracture: A PICES Bench Testing Study.

PubMed

Crystal, Matthew A; Morgan, Gareth J; Danon, Saar; Gray, Robert G; Gruenstein, Daniel H; Gordon, Brent M; Goldstein, Bryan H

2018-01-01

Balloon-expandable stents, implanted in infants and children with congenital heart disease (CHD), often require redilation to match somatic growth. Small diameter stents may eventually require longitudinal surgical transection to prevent iatrogenic vascular stenosis. Intentional transcatheter stent fracture (TSF) is an emerging alternative approach to stent transection, but little is known about the optimal stent substrate and best protocol to improve the likelihood of successful TSF. Bench testing was performed with a stent dilation protocol. After recording baseline characteristics, stents were serially or directly dilated using ultra-high-pressure balloons (UHPB) until fracture occurred or further stent dilation was not possible. Stent characteristics recorded were as follows: cell design, metallurgy, mechanism, and uniformity of fracture. Stents tested included bare-metal coronary stents, premounted small diameter stents, and ePTFE-covered small diameter premounted stents. Ninety-four stents representing 9 distinct models were maximally dilated, with 80 (85%) demonstrating evidence of fracture. Comprehensive fracture details were recorded in 64 stents: linear and complete in 34/64 stents (53.1%), linear and incomplete in 9/64 stents (14.1%), transverse/complex and complete in 6/64 stents (9.4%), and transverse/complex and incomplete in 15/64 stents (23.4%). Stent fracture was not accomplished in some stent models secondary to significant shortening, i.e., "napkin-ring" formation. Serial dilation resulted in evidence of fracture in 62/67 (92.5%) stents compared with 18/27 (66.7%) stents in the direct dilation group (p = 0.003). Intentional TSF is feasible in an ex vivo model. Serial dilation more reliably expanded the stent and allowed for ultimate stent fracture, whereas direct large diameter dilation of stents was more likely to generate a "napkin-ring" configuration, which may be more resistant to fracture. In vivo animal and human testing is necessary to better understand the response to attempted TSF for newly developed stents as well as those currently in use.

Automated stent defect detection and classification with a high numerical aperture optical system

NASA Astrophysics Data System (ADS)

Bermudez, Carlos; Laguarta, Ferran; Cadevall, Cristina; Matilla, Aitor; Ibañez, Sergi; Artigas, Roger

2017-06-01

Stent quality control is a highly critical process. Cardiovascular stents have to be inspected 100% so as no defective stent is implanted in a human body. However, this visual control is currently performed manually and every stent could need tenths of minutes to be inspected. In this paper, a novel optical inspection system is presented. By the combination of a high numerical aperture (NA) optical system, a rotational stage and a line-scan camera, unrolled sections of the outer and inner surfaces of the stent are obtained and image-processed at high speed. Defects appearing in those surfaces and also in the edges are extremely contrasted due to the shadowing effect of the high NA illumination and acquisition approach. Therefore by means of morphological operations and a sensitivity parameter, defects are detected. Based on a trained defect library, a binary classifier sorts each kind of defect through a set of scoring vectors, providing the quality operator with all the required information to finally take a decision. We expect this new approach to make defect detection completely objective and to dramatically reduce the time and cost of stent quality control stage.

Renal Sympathetic Denervation System via Intraluminal Ultrasonic Ablation: Therapeutic Intravascular Ultrasound Design and Preclinical Evaluation.

PubMed

Chernin, Gil; Szwarcfiter, Iris; Bausback, Yvonne; Jonas, Michael

2017-05-01

To assess the safety and performance of a nonfocused and nonballooned ultrasonic (US) catheter-based renal sympathetic denervation (RDN) system in normotensive swine. RDN with the therapeutic intravascular US catheter was evaluated in 3 experiments: (i) therapeutic intravascular US RDN vs a control group of untreated animals with follow-up of 30, 45, and 90 days (n = 6; n = 12 renal arteries for each group); (ii) therapeutic intravascular US RDN vs radiofrequency (RF) RDN in the contralateral artery in the same animal (n = 2; n = 4 renal arteries); and (iii) therapeutic intravascular US RDN in a recently stent-implanted renal artery (n = 2; n = 4 renal arteries). In the first experiment, therapeutic intravascular US RDN was safe, without angiographic evidence of dissection or renal artery stenosis. Neuronal tissue vacuolization, nuclei pyknosis, and perineuronal inflammation were evident after RDN, without renal artery wall damage. Norepinephrine levels were significantly lower after therapeutic intravascular US RDN after 30, 45, and 90 days compared with the control group (200.17 pg/mg ± 63.35, 184.75 pg/mg ± 44.51, and 203.43 pg/mg ± 58.54, respectively, vs 342.42 pg/mg ± 79.97). In the second experiment, deeper neuronal ablation penetrance was found with therapeutic intravascular US RDN vs RF RDN (maximal penetrance from endothelium of 7.0 mm vs 3.5 mm, respectively). There was less damage to the artery wall after therapeutic intravascular US RDN than with RF RDN, after which edema and injured endothelium were seen. In the third experiment, denervation inside the stent-implanted segments was feasible without damage to the renal artery wall or stent. The therapeutic intravascular US system performed safely and reduced norepinephrine levels. Deeper penetrance and better preservation of vessel wall were observed with therapeutic intravascular US RDN vs RF RDN. Neuronal ablations were observed in stent-implanted renal arteries. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

Stenting or not prior to extracorporeal shockwave lithotripsy for ureteral stones? Results of a prospective randomized study.

PubMed

Sfoungaristos, Stavros; Polimeros, Nikolaos; Kavouras, Adamantios; Perimenis, Petros

2012-06-01

To determine the need for pre-treatment stenting in patients undergoing extracorporeal shockwave lithotripsy (ESWL) for ureteral stones sized 4-10 mm. A prospective randomized study was conducted between September 2009 and March 2011. Included 156 patients randomized in stented and non-stented groups and underwent a maximum of 3 ESWL sessions. Radiographic follow-up was used to assess the stone fragmentation and clearance. Results were compared in terms of stone-free rates, post-treatment morbidity and complications. Overall efficacy was 76.9%. Stone-free rates were statistically significantly lower (P = 0.026) in the stented group (68.6%) compared to the non-stented ones (83.7%). Furthermore, stenting was significantly correlated with post-treatment lower urinary tract symptoms (P ≤ 0.001), need for more ESWL sessions (P = 0.019) and possibility for operation due to ESWL failure (P = 0.026). A multivariate analysis was conducted to identify the parameters which may predict complete stone removal after ESWL. Stone size (P = 0.026), stone location (P = 0.011) and stenting (P = 0.007) were the most significant factors. ESWL is an efficient and safe treatment for 4- to 10-mm ureteral stones. Pre-treatment stenting is limiting stone-free rates and is significantly influencing post-ESWL morbidity and quality of life in a negative manner, while it contributes minimally to the prophylaxis of complications.

Securing stent during multi-stage laryngotracheoplasty--an evolved technique.

PubMed

Siegel, Bianca; Bent, John P

2015-09-01

Multi-stage laryngotracheoplasty (LTP) typically requires a stent be secured to the airway for 2-6 weeks. Our technique has evolved over time to securing the stent to the strap muscles and tying a series of knots long enough to leave the suture tail protruding through the skin incision, which simplifies stent removal. Retrospective chart review. Twenty-four patients underwent multi-stage LTP at our institution from 2007 to 2013. Eight patients were excluded from the study because they either did not have a stent placed (n=4), or they had a t-tube placed which was not sutured in place (n=4). Of the remaining 16 patients, 62.5% (n=10) had their stent secured via sutures which were buried below the skin, and 37.5% (n=6) via a long suture tail which was left protruding through the end of the skin incision. An incision was required for stent removal 100% of buried sutures patients, and 33% of exposed suture patients (p=0.0009). Average operative time for stent removal was 60min in the buried sutures group, and 25min in the exposed sutures group (p=0.0075). Securing stents via an exposed suture technique decreases the need for making a skin incision during the second stage of the operation, and significantly decreases the operative time of the second stage. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Efficacy of a dual-ring wound protector for prevention of incisional surgical site infection after Whipple's procedure (pancreaticoduodenectomy) with preoperatively-placed intrabiliary stents: protocol for a randomised controlled trial.

PubMed

Bressan, Alexsander K; Roberts, Derek J; Edwards, Janet P; Bhatti, Sana U; Dixon, Elijah; Sutherland, Francis R; Bathe, Oliver; Ball, Chad G

2014-08-21

Among surgical oncology patients, incisional surgical site infection is associated with substantially increased morbidity, mortality and healthcare costs. Moreover, while adults undergoing pancreaticoduodenectomy with preoperative placement of an intrabiliary stent have a high risk of this type of infection, and wound protectors may significantly reduce its risk, no relevant studies of wound protectors yet exist involving this patient population. This study will evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among adults undergoing pancreaticoduodenectomy with preoperatively-placed intrabiliary stents. This study will be a parallel, dual-arm, randomised controlled trial that will utilise a more explanatory than pragmatic attitude. All adults (≥18 years) undergoing a pancreaticoduodenectomy at the Foothills Medical Centre in Calgary, Alberta, Canada with preoperative placement of an intrabiliary stent will be considered eligible. Exclusion criteria will include patient age <18 years and those receiving long-term glucocorticoids. The trial will employ block randomisation to allocate patients to a commercial dual-ring wound protector (the Alexis Wound Protector) or no wound protector and the current standard of care. The main outcome measure will be the rate of surgical site infection as defined by the Centers for Disease Control and Prevention criteria within 30 days of the index operation date as determined by a research assistant blinded to treatment allocation. Outcomes will be analysed by a statistician blinded to allocation status by calculating risk ratios and 95% CIs and compared using Fisher's exact test. This will be the first randomised trial to evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among patients undergoing pancreaticoduodenectomy. Results of this study are expected to be available in 2016/2017 and will be disseminated using an integrated and end-of-grant knowledge translation strategy. ClinicalTrials.gov identifier NCT01836237. 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.

Influence of Prior Coronary Stenting on the Immediate and Mid-term Outcome of Isolated Coronary Artery Bypass Surgery.

PubMed

Pliam, Michael B; Zapolanski, Alex; Anastassiou, Peter; Ryan, Colman J; Manila, Louis L; Shaw, Richard E; Pira, Bob-Kenneth

2007-09-01

: There has been little emphasis on the possible consequences of prior stent placement on the outcome of coronary bypass surgery (CABG). We compared the results of isolated CABG patients who had prior stents with those who had not with respect to preoperative status, operative procedure, and postoperative immediate and long-term outcome. : Records of 1471 patients undergoing isolated CABG at our institution between January 1, 2000, and March 31, 2005, were reviewed. Patients were divided into three groups. Group I had no stents (n = 1317). Group II had one to three stents (n = 137). Group III had more than three stents (n = 17). Groups were compared with respect to preoperative risk factors, operative procedures, and postoperative results. Long-term survival data were obtained on 97.6% of patients with a mean follow-up, 4.1 ± 2.3 years. : Stented patients were younger (66.1 ± 10.8 vs. 69.1 ± 10.8 years, P = 0.006), had more unstable angina (68.2% vs. 58.9%, P = 0.02), hypercholesterolemia (83.8% vs. 61.2%, P = 0.00), chronic obstructive pulmonary disease (13.6% vs. 8.4%, P = 0.03), peripheral vascular disease (15.2% vs. 8.4%, P = 0.00), and previous CABG (10.1% vs. 4.2%, P = 0.00), fewer low ejection fractions (1.3% vs. 5.2%, P = 0.02), left main disease (25.3% vs. 32.6%, P = 0.04), diabetes (31.2% vs. 40.8%, P = 0.01), or diffuse disease (19.5 ± 10.5 vs. 22.5 ± 10.9, P = 0.00), had more off pump procedures (53.2% vs. 45.3%, P = 0.03), fewer internal thoracic artery grafts (80.5% vs. 86.6%, P = 0.03), fewer grafts placed (>3: 52.6% vs. 61.8%, P = 0.02), more complications (76.5% vs. 42.6%, P = 0.005), atrial fibrillation (47.1% vs. 19.7%, P = 0.011), longer hospital stays (12.2 vs. 8.3 days, P = 0.019). Percentage survival for groups I, II, and III at 60 months was 82.1%, 84.7%, and 72.6%, respectively. : Stents placed before surgery in isolated CABG patients may be associated with higher preoperative risk, altered operative procedures, more postoperative complications, longer hospitalizations, and more readmissions. Overall, stented patients experienced more preoperative hospitalizations, catheterizations, and percutaneous coronary interventions (PCIs) than nonstented patients. Survival for those with more than three stents may be diminished.

Prevention of stent thrombosis: challenges and solutions

PubMed Central

Reejhsinghani, Risheen; Lotfi, Amir S

2015-01-01

Stent thrombosis is an uncommon but serious complication which carries with it significant mortality and morbidity. This review analyzes the entity of stent thrombosis from a historical and clinical perspective, and chronicles the evolution of this condition through the various generations of stent development, from bare metal to first-generation, second-generation, and third-generation drug-eluting stents. It also delineates the specific risk factors associated with stent thrombosis and comprehensively examines the literature related to each of these risks. Finally, it highlights the preventative strategies that can be garnered from the existing data, and concludes that a multifactorial approach is necessary to combat the occurrence of stent thrombosis, with higher risk groups, such as patients with ST segment elevation myocardial infarction, meriting further research. PMID:25657588

A review of the iStent® trabecular micro-bypass stent: safety and efficacy

PubMed Central

Wellik, Sarah R; Dale, Elizabeth A

2015-01-01

There is a significant demand for procedures that can effectively treat glaucoma with low risk and good visual outcomes. To fill this void, procedures termed “minimally invasive glaucoma surgery”, are gaining in popularity. This review will focus on the safety and efficacy of one such minimally invasive glaucoma surgery procedure, the trabecular micro-bypass stent. This stent is intended to lower intraocular pressure by directly cannulating Schlemm’s canal and thereby enhancing aqueous outflow. Recent randomized controlled trials and case series have demonstrated the micro-bypass stent to be a relatively safe procedure, with limited complications and no serious adverse sequelae. The most common complication across all studies was stent obstruction or malposition, which generally did not result in any adverse outcome in vision or pressure control. In addition, increased rates of hypotony, choroidal hemorrhage, or infection were not seen with the micro-bypass stent in comparison to cataract surgery alone. PMID:25931808

Preventive effects of 125I seeds on benign restenosis following esophageal stent implantation in a dog model

PubMed Central

GAN, ZHEN; JING, JIAN; ZHU, GUANGYU; QIN, YONGLIN; TENG, GAOJUN; GUO, JINHE

2015-01-01

The present study aimed to evaluate the effects of iodine-125 (125I) seeds on the proliferation of primary esophageal fibroblasts in dogs, and to assess the safety and preventive efficacy of 125I seed-pre-loaded esophageal stents in benign restenosis following implantation. Primary fibroblasts were cultured with various 125I seed activities, which were then evaluated using cell proliferation and apoptosis assays as well as cell cycle analysis using Annexin V/propidium iodide (PI) double staining and PI staining. Prior to sacrification, animals were submitted to esophageal radiography under digital subtraction angiography. Esophageal tissues were collected and examined for macroscopic, microscopic and pathological alterations. The results demonstrated a significant and dose-dependent inhibition of fibroblast proliferation and increased apoptosis following exposure to 125I seeds. G0/G1 fibroblast populations increased in a dose-dependent manner following treatment with 125I seeds, in contrast to cells in S phase. Four weeks following implantation, α-smooth muscle actin and proliferating cell nuclear antigen expression levels in the experimental group were significantly lower compared with those in the control group; in addition, eight weeks following implantation, esophageal inner diameters were increased in the experimental group. 125I seeds inhibited proliferation of dog esophageal fibroblasts via cell cycle arrest and apoptosis. In conclusion, 125I seed-pre-loaded esophageal stents inhibited benign hyperplasia in the upper edge of the stent to a certain extent, which relieved benign restenosis following implantation with a good safety profile. PMID:25543838

Circulating endothelial progenitor cells are inversely correlated with in-stent restenosis in patients with non-ST-segment elevation acute coronary syndromes treated with EPC-capture stents (JACK-EPC trial).

PubMed

Wojakowski, W; Pyrlik, A; Król, M; Buszman, P; Ochała, A; Milewski, K; Smolka, G; Kawecki, D; Rudnik, A; Pawłowski, T; Jadczyk, T; Wyderka, R; Cybulski, W; Dworowy, S; Tendera, M

2013-06-01

Aim of the study was to evaluate the association between circulating endothelial progenitor cells (EPCs) and angiographic outcomes after implantation of GenousTM stent in patients with non-ST-segment elevation acute coronary syndromes (ACS) (NSTE-ACS) undergoing urgent percutaneous coronary intervention (PCI). Sixty patients treated with EPC-capture stent (N.=30) or bare metal stents (BMS) (N.=30) receiving 80 mg atorvastatin and dual antiplatelet therapy (DAT) for 12 months. Restenosis was assessed after 6 months by quantitative coronary angiography (QCA) and major acute coronary events (MACE) evaluated after 6 and 12 months. de novo lesion >70% in native vessel, diameter 2.5-4 mm, lesion length <30 mm. diabetes, previous revascularization, significant left main stenosis, chronic total occlusions (CTO) and multivessel disease. Majority of patients in EPC-capture stent and BMS groups presented with NSTEMI (73.3% and 70%, respectively). Mean stent length was 20.1±8 and 19.9±10 mm, diameter 3±0.97 and 3.1±0.88 mm in respective groups. The binary restenosis was significantly lower in GenousTM (13 vs. 26.6%, P=0.04). Risk of MACE after 6 and 12 months were comparable in both groups. There was no stent thrombosis. Numbers of circulating EPCs were significantly approximately 2-fold higher during the ACS than after 6 months. Mobilization of EPCs during acute ischemia was significantly lower in patients who developed restenosis after 6 months (3 vs. 4.5 cells/μL, P=0.002) and it was negatively correlated with late-loss after 6 months (R=-0.42; P<0.03). Use of GenousTM stents in NSTE-ACS is associated with lower restenosis rate than BMS at 6 months. There was no ST through 1 year. The number of circulating EPCs is inversely correlated with in-stent late loss (LL).

Age modifies the relative risk of stenting versus endarterectomy for symptomatic carotid stenosis--a pooled analysis of EVA-3S, SPACE and ICSS.

PubMed

Bonati, L H; Fraedrich, G

2011-02-01

Recent randomised controlled trials comparing carotid artery stenting (CAS) with endarterectomy (CEA) for the treatment of symptomatic carotid stenosis were not powered to investigate differences in risks in specific patient subgroups. We therefore performed a pooled analysis of individual patient data from the Symptomatic Severe Carotid Stenosis trial (EVA-3S), the Stent-Protected Angioplasty versus Carotid Endarterectomy trial (SPACE), and the International Carotid Stenting Study (ICSS). Individual data from all 3433 patients randomised and analysed in these trials were pooled and analysed with fixed-effect binomial regression models adjusted for source trial. The primary outcome event was any stroke or death. In the first 120 days after randomisation (ITT analysis), the primary outcome event occurred in 153/1725 patients in the CAS group (8.9%) compared with 99/1708 patients in the CEA group (5.8%, risk ratio [RR] 1.53, 95% confidence interval [CI] 1.20-1.95, p = 0.0006; absolute risk difference 3.2, 95% CI 1.4-4.9). Age was the only subgroup variable which significantly modified the treatment effect: in patients <70 years old (the median age), the 120-day stroke or death risk was 5.8% in CAS and 5.7% in CEA (RR 1.00, 0.68-1.47); in patients 70 years or older, there was an estimated two-fold increase in risk with CAS over CEA (12.0% vs. 5.9%, RR 2.04, 1.48-2.82, interaction p = 0.0053). Endarterectomy was safer in the short-term than stenting, because of an increased risk of stroke associated with stenting in patients over the age of 70 years. Stenting should be avoided in older patients, but may be as safe as endarterectomy in younger patients. Determination of the efficacy and ultimate balance between the two procedures requires further data on long-term stroke recurrence. Copyright © 2011 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Does the use of ureteral stents with extraction strings increase urinary infection rates?

PubMed

Freifeld, Yuval; Goldin, Demitry; Khalili, Luai; Friedman, Boris; Boyarsky, Leonid; Klein, Ilan; Gazy, Faris; Stein, Avi; Dekel, Yoram

2017-05-01

To assess the effect of ureteral stents with extraction string on the rate of postoperative UTI after ureteroscopies. Retrospective analysis of patient records who underwent ureteroscopy from January 2011 to August 2014 was performed. Patients were grouped into three groups according to postoperative stent status: non-stented or ureteral catheter for up to 24 h (NS), ureteral stent without extraction string (US) and ureteral stent with an extraction string (US-E). There were 144, 133 and 282 cases in the NS, US and US-E groups, respectively. Overall infection rate was 4.7%; NS-2.1%, US-3.0% and US-E-6.7% (p = 0.057). Four percentage of men and 6.6% of women had postoperative UTI (p = 0.22). Within the group of men infection rates were 0, 2.4 and 6.4% for the NS, US and US-E groups, respectively (p = 0.01). For women, UTI rates were 7.5, 4.0 and 8.5% in the NS, US and US-E groups, respectively (p = 0.6). Infection rates were 20 and 3.9% (p = 0.001) for patients with extraction strings for >8 and <8 days. In multivariate analysis the presence of an extraction string was found to be a risk factor for infection OR 7.7 (1.01-58.9, 95% CI, p = 0.049) along with renal stone location OR 5.09 (2.1-12.05, 95% CI, p < 0.001). No statistically significant difference was found between overall infections rates for patients with and without extraction strings, and such difference was found within the male group, suggesting extraction strings in men may increase the risk of infection.

Colonic stenting as a bridge to surgery for obstructive colorectal cancer: advantages and disadvantages.

PubMed

Haraguchi, Naotsugu; Ikeda, Masataka; Miyake, Masakazu; Yamada, Takuya; Sakakibara, Yuko; Mita, Eiji; Doki, Yuichiro; Mori, Masaki; Sekimoto, Mitsugu

2016-11-01

To clarify the advantages and disadvantages of stenting as a bridge to surgery (BTS) by comparing the clinical features and outcomes of patients who underwent BTS with those of patients who underwent emergency surgery (ES). We assessed technical success, clinical success, surgical procedures, stoma formation, complications, clinicopathological features, and Onodera's prognostic nutritional index (OPNI) in patients who underwent BTS and those who underwent ES. Twenty-six patients underwent stenting, which was successful in 22 (BTS group). The remaining four patients with unsuccessful stenting underwent emergency surgery. A total of 22 patients underwent emergency surgery (ES group). The rates of technical and clinical success were 85.0 and 81.0 %, respectively. The proportion of patients able to be treated by laparoscopic surgery (P = 0.0001) and avoid colostomy (P = 0.0042) was significantly higher in the BTS group. Although the incidence of anastomotic leakage in the two groups was not significantly different, it was significantly reduced by colonoscopic evaluation of obstructive colitis (P = 0.0251). The mean number of harvested lymph nodes (P = 0.0056) and the proportion of D3 lymphadenectomy (P = 0.0241) were significantly greater in the BTS group. Perineural invasion (PNI) was noted in 59.1 and 18.2 % of the BTS group and ES group patients, respectively (P = 0.0053). OPNI and serum albumin decreased significantly after stenting (P = 0.0084). The advantages of stenting as a BTS were that it avoided colostomy and allowed for laparoscopic surgery and lymphadenectomy, whereas its disadvantage lay in the decreased PNI and OPNI levels. A larger study including an analysis of prognosis is warranted.

An in Vitro Twist Fatigue Test of Fabric Stent-Grafts Supported by Z-Stents vs. Ringed Stents.

PubMed

Lin, Jing; Guidoin, Robert; Du, Jia; Wang, Lu; Douglas, Graeham; Zhu, Danjie; Nutley, Mark; Perron, Lygia; Zhang, Ze; Douville, Yvan

2016-02-16

Whereas buckling can cause type III endoleaks, long-term twisting of a stent-graft was investigated here as a mechanism leading to type V endoleak or endotension. Two experimental device designs supported with Z-stents having strut angles of 35° or 45° were compared to a ringed control under accelerated twisting. Damage to each device was assessed and compared after different durations of twisting, with focus on damage that may allow leakage. Stent-grafts with 35° Z-stents had the most severe distortion and damage to the graft fabric. The 45° Z-stents caused less fabric damage. However, consistent stretching was still seen around the holes for sutures, which attach the stents to the graft fabric. Larger holes may become channels for fluid percolation through the wall. The ringed stent-graft had the least damage observed. Stent apexes with sharp angles appear to be responsible for major damage to the fabrics. Device manufacturers should consider stent apex angle when designing stent-grafts, and ensure their devices are resistant to twisting.

An in Vitro Twist Fatigue Test of Fabric Stent-Grafts Supported by Z-Stents vs. Ringed Stents

PubMed Central

Lin, Jing; Guidoin, Robert; Du, Jia; Wang, Lu; Douglas, Graeham; Zhu, Danjie; Nutley, Mark; Perron, Lygia; Zhang, Ze; Douville, Yvan

2016-01-01

Whereas buckling can cause type III endoleaks, long-term twisting of a stent-graft was investigated here as a mechanism leading to type V endoleak or endotension. Two experimental device designs supported with Z-stents having strut angles of 35° or 45° were compared to a ringed control under accelerated twisting. Damage to each device was assessed and compared after different durations of twisting, with focus on damage that may allow leakage. Stent-grafts with 35° Z-stents had the most severe distortion and damage to the graft fabric. The 45° Z-stents caused less fabric damage. However, consistent stretching was still seen around the holes for sutures, which attach the stents to the graft fabric. Larger holes may become channels for fluid percolation through the wall. The ringed stent-graft had the least damage observed. Stent apexes with sharp angles appear to be responsible for major damage to the fabrics. Device manufacturers should consider stent apex angle when designing stent-grafts, and ensure their devices are resistant to twisting. PMID:28787913

A systematic review of biodegradable biliary stents: promising biocompatibility without stent removal.

PubMed

Siiki, Antti; Sand, Juhani; Laukkarinen, Johanna

2018-05-18

Biodegradable self-expanding stents are an emerging alternative to standard biliary stents as the development of endoscopic insertion devices advances. The aim was to systematically review the existing literature on biodegradable biliary stents. In-vivo studies on the use of biodegradable stents in the biliary duct were systematically reviewed from 1990 to 2017. Despite extensive research on the biocompatibility of stents, the experience so far on their clinical use is limited. A few favorable reports have recently been presented on endoscopically and percutaneously inserted self-expanding biodegradable polydioxanone stents in benign biliary strictures. Another potential indication appears to be postcholecystectomy leak of the cystic duct. The main benefit of biodegradable stents is that stent removal can be avoided. The biocompatibility of the current biodegradable stent materials, most prominently polydioxanone, is well documented. In the few studies currently available, biodegradable stents are reported to be feasible and safe, also in humans. The initial results of the endoscopic use of these stents in benign biliary stricture management and for treating postcholecystectomy bile leaks are promising. Further controlled studies on long-term clinical results and cost-effectiveness are needed.

The Primary Patency and Fracture Rates of Self-Expandable Nitinol Stents Placed in the Popliteal Arteries, Especially in the P2 and P3 Segments, in Korean Patients

PubMed Central

Chang, Il Soo; Park, Sang Woo; Yun, Ik Jin; Hwang, Jae Joon; Lee, Song Am; Kim, Jun Seok; Chang, Seong-Hwan; Jung, Hong Geun

2011-01-01

Objective We wanted to evaluate the status of self-expandable nitinol stents implanted in the P2 and P3 segments of the popliteal artery in Korean patients. Materials and Methods We retrospectively analyzed 189 consecutive patients who underwent endovascular treatment for stenoocclusive lesions in the femoropopliteal artery from July 2003 to March 2009, and 18 patients who underwent stent placement in popliteal arterial P2 and P3 segments were finally enrolled. Lesion patency was evaluated by ultrasound or CT angiography, and stent fracture was assessed by plain X-rays at 1, 3, 6 and 12 months and annually thereafter. Results At the 1-month follow-up, stent fracture (Type 2) was seen in one limb (up to P3, 1 of 18, 6%) and it was identified in seven limbs at the 3-month follow-up (Type 2, Type 3, Type 4) (n = 1: up to P2; n = 6: P3). At the 6-month follow-up, one more fracture (Type 1) (up to P3) was noted. At the 1-year follow-up, there were no additional stent fractures. Just four limbs (up to P2) at the 2-year follow-up did not have stent fracture. The primary patency was 94%, 61% and 44% at 1, 3 and 6 months, respectively, and the group with stent implantation up to P3 had a higher fracture rate than that of the group that underwent stenting up to P2 (p < 0.05). Conclusion We suggest that stent placement up to the popliteal arterial P3 segment and over P2 in an Asian population can worsen the stent patency owing to stent fracture. It may be necessary to develop a stent design and structure for the Asian population that can resist the bending force in the knee joint. PMID:21430937

Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).

PubMed

Dippel, Eric J; Makam, Prakash; Kovach, Richard; George, Jon C; Patlola, Raghotham; Metzger, D Christopher; Mena-Hurtado, Carlos; Beasley, Robert; Soukas, Peter; Colon-Hernandez, Pedro J; Stark, Matthew A; Walker, Craig

2015-01-01

The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR). Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging. The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.S. centers. Patients with Rutherford Class 1 to 4 and lesions of target lesion length ≥4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days post-procedure. Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12.0 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. ELA + PTA subjects demonstrated superior procedural success (93.5% vs. 82.7%; p = 0.01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (p < 0.005), and 30-day major adverse event rates were 5.8% versus 20.5% (p < 0.001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74). The EXCITE ISR trial is the first large, prospective, randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR. (Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis [EXCITE ISR]; NCT01330628). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Covered duodenal self-expandable metal stents prolong biliary stent patency in double stenting: The largest series of bilioduodenal obstruction.

PubMed

Hori, Yasuki; Naitoh, Itaru; Hayashi, Kazuki; Kondo, Hiromu; Yoshida, Michihiro; Shimizu, Shuya; Hirano, Atsuyuki; Okumura, Fumihiro; Ando, Tomoaki; Jinno, Naruomi; Takada, Hiroki; Togawa, Shozo; Joh, Takashi

2018-03-01

Endoscopic biliary and duodenal stenting (DS; double stenting) is widely accepted as a palliation therapy for malignant bilioduodenal obstruction. The aim of the current study was to investigate the patency and adverse events of duodenal and biliary stents in patients with DS. Patients who underwent DS from April 2004 to March 2017 were analyzed retrospectively with regard to clinical outcomes and predictive factors of recurrent biliary and duodenal obstruction (recurrent biliary obstruction [RBO] and recurrent duodenal obstruction [RDO]). A total of 109 consecutive patients was enrolled. Technical success of DS was achieved in 108 patients (99.1%). Symptoms due to biliary and duodenal obstruction were improved in 89 patients (81.7%). RBO occurred in 25 patients (22.9%) and RDO in 13 (11.9%). The median times to RBO and RDO from DS were 87 and 76 days, respectively. Placement of a duodenal uncovered self-expandable metal stent (U-SEMS) was significantly associated with RBO in the multivariable analysis (P = 0.007). Time to RBO was significantly longer in the duodenal covered self-expandable metal stent group than in the U-SEMS group (P = 0.003). No predictive factors of RDO were detected, and duodenal stent type was not associated with the time to RDO (P = 0.724). Double stenting was safe and effective for malignant bilioduodenal obstruction. Duodenal U-SEMS is a risk factor for RBO. The covered self-expandable metal stent is the preferred type of duodenal SEMS in patients with DS (Clinical trial registration number: UMIN000027606). © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Radiologic Placement of Uncovered Stents for the Treatment of Malignant Colonic Obstruction Proximal to the Descending Colon

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

Yoon, Jehong; Kwon, Se Hwan, E-mail: Kwon98@khu.ac.kr; Lee, Chang-Kyun

PurposeTo evaluate the safety, feasibility, and patency rates of radiologic placement of uncovered stents for the treatment of malignant colonic obstruction proximal to the descending colon.Materials and MethodsThis was a retrospective, single-center study. From May 2003 to March 2015, 53 image-guided placements of uncovered stents (44 initial placements, 9 secondary placements) were attempted in 44 patients (male:female = 23:21; mean age, 71.8 years). The technical and clinical success, complication rates, and patency rates of the stents were also evaluated. Technical success was defined as the successful deployment of the stent under fluoroscopic guidance alone and clinical success was defined as the relief of obstructivemore » symptoms or signs within 48 h of stent deployment.ResultsIn total, 12 (27.3 %) patients underwent preoperative decompression, while 32 (72.7 %) underwent decompression with palliative intent. The technical success rate was 93.2 % (41/44) for initial placement and 88.9 % (8/9) for secondary placement. Secondary stent placement in the palliative group was required in nine patients after successful initial stent placement due to stent obstruction from tumor ingrowth (n = 7) and stent migration (n = 2). The symptoms of obstruction were relieved in all successful cases (100 %). In the palliative group, the patency rates were 94.4 % at 1 month, 84.0 % at 3 months, 64.8 % at 6 months, and 48.6 % at 12 months.ConclusionsThe radiologic placement of uncovered stents for the treatment of malignant obstruction proximal to the descending colon is feasible and safe, and provides acceptable clinical results.« less

ABSORB II randomized controlled trial: a clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: rationale and study design.

PubMed

Diletti, Roberto; Serruys, Patrick W; Farooq, Vasim; Sudhir, Krishnankutty; Dorange, Cecile; Miquel-Hebert, Karine; Veldhof, Susan; Rapoza, Richard; Onuma, Yoshinobu; Garcia-Garcia, Hector M; Chevalier, Bernard

2012-11-01

Currently, no data are available on the direct comparison between the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) and conventional metallic drug-eluting stents. The ABSORB II study is a randomized, active-controlled, single-blinded, multicenter clinical trial aiming to compare the second-generation Absorb BVS with the XIENCE everolimus-eluting metallic stent. Approximately 501 subjects will be enrolled on a 2:1 randomization basis (Absorb BVS/XIENCE stent) in approximately 40 investigational sites across Europe and New Zealand. Treated lesions will be up to 2 de novo native coronary artery lesions, each located in different major epicardial vessels, all with an angiographic maximal luminal diameter between 2.25 and 3.8 mm as estimated by online quantitative coronary angiography (QCA) and a lesion length of ≤48 mm. Clinical follow-up is planned at 30 and 180 days and at 1, 2, and 3 years. All subjects will undergo coronary angiography, intravascular ultrasound (IVUS) and IVUS-virtual histology at baseline (pre-device and post-device implantation) and at 2-year angiographic follow-up. The primary end point is superiority of the Absorb BVS vs XIENCE stent in terms of vasomotor reactivity of the treated segment at 2 years, defined as the QCA quantified change in the mean lumen diameter prenitrate and postnitrate administration. The coprimary end point is the noninferiority (reflex to superiority) of the QCA-derived minimum lumen diameter at 2 years postnitrate minus minimum lumen diameter postprocedure postnitrate by QCA. In addition, all subjects allocated to the Absorb BVS group will undergo multislice computed tomography imaging at 3 years. The ABSORB II randomized controlled trial (ClinicalTrials.gov NCT01425281) is designed to compare the safety, efficacy, and performance of Absorb BVS against the XIENCE everolimus-eluting stent in the treatment of de novo native coronary artery lesions. Copyright © 2012 Mosby, Inc. All rights reserved.

Configuration affects parallel stent grafting results.

PubMed

Tanious, Adam; Wooster, Mathew; Armstrong, Paul A; Zwiebel, Bruce; Grundy, Shane; Back, Martin R; Shames, Murray L

2018-05-01

A number of adjunctive "off-the-shelf" procedures have been described to treat complex aortic diseases. Our goal was to evaluate parallel stent graft configurations and to determine an optimal formula for these procedures. This is a retrospective review of all patients at a single medical center treated with parallel stent grafts from January 2010 to September 2015. Outcomes were evaluated on the basis of parallel graft orientation, type, and main body device. Primary end points included parallel stent graft compromise and overall endovascular aneurysm repair (EVAR) compromise. There were 78 patients treated with a total of 144 parallel stents for a variety of pathologic processes. There was a significant correlation between main body oversizing and snorkel compromise (P = .0195) and overall procedural complication (P = .0019) but not with endoleak rates. Patients were organized into the following oversizing groups for further analysis: 0% to 10%, 10% to 20%, and >20%. Those oversized into the 0% to 10% group had the highest rate of overall EVAR complication (73%; P = .0003). There were no significant correlations between any one particular configuration and overall procedural complication. There was also no significant correlation between total number of parallel stents employed and overall complication. Composite EVAR configuration had no significant correlation with individual snorkel compromise, endoleak, or overall EVAR or procedural complication. The configuration most prone to individual snorkel compromise and overall EVAR complication was a four-stent configuration with two stents in an antegrade position and two stents in a retrograde position (60% complication rate). The configuration most prone to endoleak was one or two stents in retrograde position (33% endoleak rate), followed by three stents in an all-antegrade position (25%). There was a significant correlation between individual stent configuration and stent compromise (P = .0385), with 31.25% of retrograde stents having any complication. Parallel stent grafting offers an off-the-shelf option to treat a variety of aortic diseases. There is an increased risk of parallel stent and overall EVAR compromise with <10% main body oversizing. Thirty-day mortality is increased when more than one parallel stent is placed. Antegrade configurations are preferred to any retrograde configuration, with optimal oversizing >20%. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

A New Fully Covered Self-Expandable Metal Stent for the Treatment of Postsurgical Benign Biliary Strictures.

PubMed

Wu, Jun; Zhou, Dong-Xun; Wang, Tian-Tian; Gao, Dao-Jian; Hu, Bing

2017-09-01

Endotherapy with plastic stent (PS) placement is the main modality for treating benign biliary strictures (BBSs). Fully covered self-expandable metal stents (FCSEMSs) are being increasingly used for BBS management, with high stricture resolution. However, traditional metal tents are associated with high migration, causing treatment failure. We investigated the efficacy and safety of a new FCSEMS for postsurgical BBS treatment and compared these parameters between the FCSEMS and PS treatment through retrospective analysis. The primary outcome measurements included stricture resolution, stricture recurrence, and complications. In total, 69 patients were included, of whom 32 underwent FCSEMS treatment and 37 underwent PS treatment. The technical success rate and the number of endoscopic retrograde cholangiopancreatography procedures were similar between the groups. The median stenting duration was 5.2 months (range 1.5-15.3) in the FCSEMS group and 10.7 months (range 2.5-22.6) in the PS group (P < 0.01). The stents removal rate was 96.9% in the FCSEMS group and 94.6% in the PS group. The stricture resolution rate based on intention-to-treat analysis was 83.8% in the PS group and 84.4% (27/32) in the FCSEMS group (P = 0.947), whereas the rates from per-protocol analysis were 88.6% (31/35) and 87.1% (27/31), respectively (P = 0.574). Early and late complications were similar between the groups. The median follow-up time was 43 months (range 13-71). The stricture recurrence rate was 11.1% (3/27) in the FCSEMS group and 16.1% (5/31) in the PS group (P = 0.435). The new FCSEMS and the PS approach showed similar efficacy and safety in postsurgical BBS treatment. However, the FCSEMS required fewer procedural steps and shorter stenting time, making it an effective alternative modality.

Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial.

PubMed

Lemos, Pedro A; Abizaid, Alexandre A C; Meireles, George C; Sarmento-Leite, Rogério; Prudente, Mauricio; Cantarelli, Marcelo; Dourado, Adriano D; Mariani, Jose; Perin, Marco A; Costantini, Costantino; Costa, Ricardo A; Costa, José Ribamar; Chamie, Daniel; Campos, Carlos A; Ribeiro, Expedito

2015-12-01

To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups. The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent. © 2015 John Wiley & Sons Ltd.

Timing of silicone stent removal in patients with post-tuberculosis bronchial stenosis.

PubMed

Eom, Jung Seop; Kim, Hojoong; Park, Hye Yun; Jeon, Kyeongman; Um, Sang-Won; Koh, Won-Jung; Suh, Gee Young; Chung, Man Pyo; Kwon, O Jung

2013-10-01

In patients with post-tuberculosis bronchial stenosis (PTBS), the severity of bronchial stenosis affects the restenosis rate after the silicone stent is removed. In PTBS patients with incomplete bronchial obstruction, who had a favorable prognosis, the timing of stent removal to ensure airway patency is not clear. We evaluated the time for silicone stent removal in patients with incomplete PTBS. A retrospective study examined PTBS patients who underwent stenting and removal of a silicone stent. Incomplete bronchial stenosis was defined as PTBS other than total bronchial obstruction, which had a luminal opening at the stenotic segment on bronchoscopic intervention. The duration of stenting was defined as the interval from stent insertion to removal. The study included 44 PTBS patients and the patients were grouped at intervals of 6 months according to the duration of stenting. Patients stented for more than 12 months had a significantly lower restenosis rate than those stented for less than 12 months (4% vs. 35%, P = 0.009). Multiple logistic regression revealed an association between stenting for more than 12 months and a low restenosis rate (odds ratio 12.095; 95% confidence interval 1.097-133.377). Moreover, no restenosis was observed in PTBS patients when the stent was placed more than 14 months previously. In patients with incomplete PTBS, stent placement for longer than 12 months reduced restenosis after stent removal.

Effect on Intimal Hyperplasia of Dexamethasone Released from Coated Metal Stents Compared with Non-Coated Stents in Canine Femoral Arteries

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

Strecker, Ernst-Peter; Gabelmann, Andreas; Boos, Irene

1998-11-15

Purpose: Polymer-coated, dexamethasone (DXM)-releasing stents were tested in order to assess the efficacy of DXM released locally for the prevention of stent restenosis due to intimal hyperplasia. Methods: Strecker stents coated with a biodegradable membrane containing DXM were implanted percutaneously into the femoral artery in 14 dogs. The contralateral artery received a conventional non-coated stent serving as control. The drugs are eluted by degradation of the carrier membrane. Follow-up intraarterial digital subtraction angiography (DSA) was obtained at 3, 6, 9, 12, and 24 weeks with subsequent autopsy. Specimens for gross and microscopic pathology were obtained and histomorphometry was performed. Results:more » Four of 14 DXM-coated stents showed thrombotic occlusion within the first 3 weeks; ten DXM-coated stents remained patent. At follow-up DSA, DXM-coated stents showed a significantly wider lumen than the non-coated stents. At morphometry there was less intimal hyperplasia over DXM-coated stents than over non-coated stents (p < 0.05). Conclusion: DXM-coated stents reduce neointimal hyperplasia in dogs when compared with non-coated stents.« less

Cost analysis of iliac stenting performed in the operating room and the catheterization lab: A case-control study.

PubMed

Kim, Sooyeon; Kramer, Sage P; Dugan, Adam J; Minion, David J; Gurley, John C; Davenport, Daniel L; Ferraris, Victor A; Saha, Sibu P

2016-12-01

Iliac arterial stenting is performed both in the operating room (OR) and the catheterization lab (CL). To date, no analysis has compared resource utilization between these locations. Consecutive patients (n = 105) treated at a single center were retrospectively analyzed. Patients included adults with chronic, symptomatic iliac artery stenosis with a minimum Rutherford classification (RC) of 3, treated with stents. Exclusion criteria were prior stenting, acute ischemia, or major concomitant procedures. Immediate and two-year outcomes were observed. Patient demographics, perioperative details, physician billings, and hospital costs were recorded. Multivariable regression was used to adjust costs by patient and perioperative cost drivers. Fifty-one procedures (49%) were performed in the OR and 54 (51%) in the CL. Mean age was 57, and 44% were female. Severe cases were more often performed in the OR (RC ≥ 4; 42% vs. 11%, P < 0.001) and were associated with increased total costs (P < 0.01). OR procedures more often utilized additional stents (stents ≥ 2; 61% vs. 46%, P = 0.214), thrombolysis (12% vs. 0%, P = 0.011), cut-down approach (8% vs. 0%, P = 0.052), and general anesthesia (80% vs. 0%, P < 0.001): these were all associated with increased costs (P < 0.05). After multivariable regression, location was not a predictor of procedure room or total costs but was associated with increased professional fees. Same-stay (5%) and post-discharge reintervention (33%) did not vary by location. The OR was associated with increased length of stay, more ICU admissions, and increased total costs. However, OR patients had more severe disease and therefore often required more aggressive intervention. After controlling for these differences, procedure venue per se was not associated with increased costs, but OR cases incurred increased professional fees due to dual-provider charges. Given the similar clinical results between venues, it seems reasonable to perform most stenting in the CL or utilize conscious sedation in the OR. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Plastic biliary stent patency in patients with locally advanced pancreatic adenocarcinoma receiving downstaging chemotherapy.

PubMed

Ge, Phillip S; Hamerski, Christopher M; Watson, Rabindra R; Komanduri, Srinadh; Cinnor, Birtukan B; Bidari, Kiran; Klapman, Jason B; Lin, Cui L; Shah, Janak N; Wani, Sachin; Donahue, Timothy R; Muthusamy, V Raman

2015-02-01

Plastic stents in patients with biliary obstruction caused by pancreatic adenocarcinoma are typically exchanged at 3-month intervals. Plastic stents may have reduced durability in patients receiving chemotherapy. To determine the duration of plastic biliary stent patency in patients undergoing chemotherapy for pancreatic adenocarcinoma. Retrospective, multicenter cohort study. Three tertiary academic referral centers. A total of 173 patients receiving downstaging chemotherapy for locally advanced or borderline resectable pancreatic adenocarcinoma from 1996 to 2013. Placement of 10F or larger plastic biliary stents. Primary outcome was overall duration of stent patency. Secondary outcomes included the incidence of premature stent exchange (because of cholangitis or jaundice) and hospitalization rates. A total of 233 plastic stents were placed, and the overall median duration of stent patency was 53 days (interquartile range [IQR] 25-99 days). Eighty-seven stents were removed at the time of surgical resection, and 63 stents were exchanged routinely per protocol. The remaining 83 stent exchanges were performed for worsening liver function test results, jaundice, or cholangitis, representing a 35.6% rate of premature stent exchange. The median stent patency duration in the premature stent exchange group was 49 days (IQR 25-91 days) with a 44.6% hospitalization rate. The overall rate of cholangitis was 15.0% of stent exchanges, occurring a median of 56 days after stent placement (IQR 26-89 days). Retrospective study. Plastic biliary stents placed during chemotherapy/chemoradiation for pancreatic adenocarcinoma have a shorter-than-expected patency duration, and a substantial number of patients will require premature stent exchange. Consideration should be given to shortening the interval for plastic biliary stent exchange. Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

[Prospective evaluation of pain associated with indwelling JJ stents following ureterorenoscopic lithotripsy].

PubMed

Dudek, Przemysław; Gołabek, Tomasz; Jaskulski, Jarosław; Orłowski, Paweł; Bukowczan, Jakub; Szopiński, Tomasz; Chłosta, Piotr

2013-01-01

Routine placement of JJ ure teric stents, following uncomplicated endoscopic removal of a ureteral stone, still remains debatable. Indwelling JJ stents are not without any risks. They often can cause marked discomfort, or even pain. The aim of this study was to prospectively evaluate patient's perceived pain due to renal colic and indwelling JJ stent left following ure terorenoscopic lithotripsy (URSL). 54 patients with colicky pain due to distal ureteric stone, and who underwent uncompli cated ureterorenoscopic lithotripsy, were included in the study. Follow ing URSL, patients were randomly selected to have either JJ stent left in situ (Group I), or remain without a stent (Group II). Among all study par ticipants levels of pain prior, as well as 14 days after the procedure were evalu ated with the use of a visual analogue pain scale. Pain perception at the time of colic did not vary between men and women (6.30 +/- 1.33 and 6.38 +/- 1.11, respectively, p=0.293). Similarly, no differences in perceived pain were noted 14 days following URSL. Mean pain score in patients with indwelling JJ stent was 2.12 +/- 1.23 as compared to 2.15 +/- 0.67 in those without it (p=0.148). No increase in pain levels due to indwelling JJ stent could be observed. Further research to allow for better assessment of discomfort and pain caused by an indwelling JJ stent on a larger cohort, and which could also discriminate patients' psy chosomatic symptoms, is needed.

Stented ureterovesical anastomosis in renal transplantation: does it influence the rate of urinary tract infections?

PubMed

Mathe, Zoltan; Treckmann, J W; Heuer, M; Zeiger, A; Sauerland, S; Witzke, O; Paul, A

2010-01-01

Our objective was to evaluate the impact of routine use of double-J stents on the incidence of urinary tract infection after renal transplantation. We conducted a retrospective-comparative single-centre study in 310 consecutive adult deceased donor kidney recipients transplanted from 2002 to 2006. Patients were divided in two groups, with or without urinary stent implantation. To evaluate the predictive factors for UTI, donor and recipients pre- and post-transplantation data were analysed. Early urological complications and renal function within 12 months of transplantation were included as well. A total of 157 patients were enrolled to a stent (ST) and 153 patients to a no-stent (NST) group. The rate of urinary tract infection at three months was similar between the two groups (43.3% ST vs. 40.1% NST, p = 0.65). Of the identified pathogens Enterococcus and Escherichia coli were the most common species. In multivariate analysis neither age nor immunosuppressive agents, BMI or diabetes seemed to have influence on the rate of UTI. When compared to males, females had a significantly higher risk for UTI (54.0% vs. 33.5%). Prophylactic stenting of the ureterovesical anastomosis does not increase the risk of urinary tract infection in the early postoperative period.

Stented ureterovesical anastomosis in renal transplantation: does it influence the rate of urinary tract infections?

PubMed Central

2010-01-01

Objective Our objective was to evaluate the impact of routine use of double-J stents on the incidence of urinary tract infection after renal transplantation. Methods We conducted a retrospective-comparative single-centre study in 310 consecutive adult deceased donor kidney recipients transplanted from 2002 to 2006. Patients were divided in two groups, with or without urinary stent implantation. To evaluate the predictive factors for UTI, donor and recipients pre- and post-transplantation data were analysed. Early urological complications and renal function within 12 months of transplantation were included as well. Results A total of 157 patients were enrolled to a stent (ST) and 153 patients to a no-stent (NST) group. The rate of urinary tract infection at three months was similar between the two groups (43.3% ST vs. 40.1% NST, p = 0.65). Of the identified pathogens Enterococcus and Escherichia coli were the most common species. In multivariate analysis neither age nor immunosuppressive agents, BMI or diabetes seemed to have influence on the rate of UTI. When compared to males, females had a significantly higher risk for UTI (54.0% vs. 33.5%). Conclusion Prophylactic stenting of the ureterovesical anastomosis does not increase the risk of urinary tract infection in the early postoperative period. PMID:20696641

Treatment strategies for coronary in-stent restenosis: systematic review and hierarchical Bayesian network meta-analysis of 24 randomised trials and 4880 patients

PubMed Central

Giacoppo, Daniele; Gargiulo, Giuseppe; Aruta, Patrizia; Capranzano, Piera; Tamburino, Corrado

2015-01-01

Study question What is the most safe and effective interventional treatment for coronary in-stent restenosis? Methods In a hierarchical Bayesian network meta-analysis, PubMed, Embase, Scopus, Cochrane Library, Web of Science, ScienceDirect, and major scientific websites were screened up to 10 August 2015. Randomised controlled trials of patients with any type of coronary in-stent restenosis (either of bare metal stents or drug eluting stents; and either first or recurrent instances) were included. Trials including multiple treatments at the same time in the same group or comparing variants of the same intervention were excluded. Primary endpoints were target lesion revascularisation and late lumen loss, both at six to 12 months. The main analysis was complemented by network subanalyses, standard pairwise comparisons, and subgroup and sensitivity analyses. Study answer and limitations Twenty four trials (4880 patients), including seven interventional treatments, were identified. Compared with plain balloons, bare metal stents, brachytherapy, rotational atherectomy, and cutting balloons, drug coated balloons and drug eluting stents were associated with a reduced risk of target lesion revascularisation and major adverse cardiac events, and with reduced late lumen loss. Treatment ranking indicated that drug eluting stents had the highest probability (61.4%) of being the most effective for target lesion vascularisation; drug coated balloons were similarly indicated as the most effective treatment for late lumen loss (probability 70.3%). The comparative efficacy of drug coated balloons and drug eluting stents was similar for target lesion revascularisation (summary odds ratio 1.10, 95% credible interval 0.59 to 2.01) and late lumen loss reduction (mean difference in minimum lumen diameter 0.04 mm, 95% credible interval −0.20 to 0.10). Risks of death, myocardial infarction, and stent thrombosis were comparable across all treatments, but these analyses were limited by a low number of events. Trials had heterogeneity regarding investigation periods, baseline characteristics, and endpoint reporting, with a lack of information at long term follow-up. Direct and indirect evidence was also inconsistent for the comparison between drug eluting stents and drug coated balloons. What this study adds Compared with other currently available interventional treatments for coronary in-stent restenosis, drug coated balloons and drug eluting stents are associated with superior clinical and angiographic outcomes, with a similar comparative efficacy. Funding, competing interests, data sharing This study received no external funding. The authors declare no competing interests. No additional data available. PMID:26537292

A Spanner in the works: the use of a new temporary urethral stent to relieve bladder outflow obstruction after prostate brachytherapy.

PubMed

Henderson, Alastair; Laing, Robert W; Langley, Stephen E M

2002-01-01

Assessment of the Spanner, a new temporary urethral stent to relieve bladder outflow obstruction and urinary symptoms after brachytherapy. Five patients with unusually severe urinary morbidity after (125)I brachytherapy were recruited. The mean time after implant was 40 days (range 25-90). Spanner intraprostatic stents were introduced using topical anesthetic without complication. All patients were able to void spontaneously with no post-void residual volume of urine. The flow rates increased in all cases (p=0.03) and the International Prostate Symptom Scores were significantly improved after stent insertion in all patients (p=0.03). All patients experienced some degree of pain or dysuria during stent use. Bladder outflow obstruction was effectively treated with the Spanner intraprostatic stent, however pain limited the use of the device in the early post-brachytherapy patient group. Pharmacotherapy, stent design modification, or smaller stent diameter may increase the utility of stents after brachytherapy.

Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures. Final order.

PubMed

2016-07-13

The Food and Drug Administration (FDA) is classifying the metallic biliary stent system for benign strictures into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the metallic biliary stent system for benign strictures' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

An Unusual Case of Stent Migration After Celiac Trunk Endovascular Revascularization

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

Negri, Silvia; Ferraro, Stefania; Piffaretti, Gabriele, E-mail: gabriele.piffaretti@uninsubria.it

2012-08-15

A 61-year-old woman underwent celiac trunk stenting to treat abdominal angina. Three months later, she was readmitted for recurrent symptoms. Computed tomography control revealed the migration of the stent into the splenic artery. No sign of vessel injury or end-organ ischemia was detected. Repeat stenting of the celiac trunk was performed; the postoperative course was uneventful. 12 months later, the patient was asymptomatic with the second stent in its correct position, and she was asymptomatic for mesenteric ischemia.

Anesthetic exposure in the treatment of symptomatic urinary calculi in pregnant women.

PubMed

Rivera, Marcelino E; McAlvany, Kelly L; Brinton, Thomas S; Gettman, Matthew T; Krambeck, Amy E

2014-12-01

To assess the duration and total number of anesthetic exposures required for the treatment of urolithiasis during pregnancy, specifically comparing temporizing measures with active treatment because urolithiasis and its management may pose potential theoretical risks for the mother and fetus. We retrospectively reviewed patients with a confirmed diagnosis of urolithiasis during pregnancy who underwent surgical intervention from 1997 to 2012 at our institution. The number and duration of anesthetic exposures were assessed. We identified 26 women with urolithiasis during pregnancy, of which 15 (58%) were treated with temporizing stents and 11 (42%) with ureteroscopic stone extraction. In the ureteroscopy group, the median number of anesthetic exposures was 1.18 (interquartile range [IQR], 1-2), and the median total anesthetic time was 80 minutes (IQR, 37-126 minutes). In the stent group, 6 (40%) required multiple stent exchanges for a median of 1.47 (IQR, 1-3) anesthetic events and a median total anesthetic time of 70 minutes (IQR, 29-208 minutes). In the ureteral stent group, 7 women (47%) were induced before spontaneous labor due to inability to tolerate the stent. There was no difference in the number of anesthetic events (P = .208) or anesthesia time (P = .503) between stenting and ureteroscopy. Women undergoing ureteroscopic surgical intervention during pregnancy were at no greater risk in the number or cumulative duration of anesthesia exposure than women managed with temporizing ureteral stent placement and subsequent exchanges. Copyright © 2014 Elsevier Inc. All rights reserved.

Safety and efficacy of a novel plastic stent coated with stone-dissolving agents for the treatment of biliary stones in a porcine model.

PubMed

Cai, Xiao Bo; Zhang, Wei Xing; Zhang, Ru Ling; Dong Yuan, Xiao; Yang, Qin; Qi, Xiao Shen; Li, Bai Wen; Qin Qian, Yue; Wang, Xing Peng; Lu, Lun Gen; Xu, Zheng Jie; Wan, Xin Jian

2015-05-01

We previously reported on a plastic stent that was coated with ethylenediaminetetraacetic acid (EDTA) and sodium cholate, which dissolved common bile duct (CBD) stones ex vivo. The aim of this study was to investigate the safety and efficacy of such stents on biliary stones in a live porcine model. Stents without coating or with degradable membranes containing 0 % or 50 % EDTA and sodium cholate were inserted together with human CBD stones into the porcine CBD. Serum laboratory variables, histological examinations of the bile duct, and the weight change in stones were compared during and after stent placement for 6 months. A total of 16 pigs were included (5 no coating, 5 0 % coating, 6 50 % coating). Biliary stones showed decreased weight in all groups; however, stones in the group with 50 % coated stents showed a greater reduction in weight compared with the no coating and the 0 % coating groups (269 ± 66 mg vs. 179 ± 51 mg [P = 0.09]; 269 ± 66 mg vs. 156 ± 26 mg [P = 0.01], respectively). The plastic stent coated with 50 % agent enhanced CBD stone dissolution in vivo and may be a promising tool for patients with difficult biliary stones. © Georg Thieme Verlag KG Stuttgart · New York.

Percutaneous coronary intervention with second-generation paclitaxel-eluting stents versus everolimus-eluting stents in United States contemporary practice (REWARDS TLX Trial).

PubMed

Waksman, Ron; Ghali, Magdi; Goodroe, Randy; Ryan, Thomas; Turco, Mark; Ring, Michael; McGarry, Thomas; Dobies, David; Shammas, Nicolas; Steinberg, Daniel H; Swymelar, Stacy; Kaneshige, Kimberly; Torguson, Rebecca

2012-10-15

Registry Experience at the Washington Hospital Center, DES - Taxus Liberte Versus Xience V (REWARDS TLX) is a physician-initiated, retrospective, real-world, multicenter, observational study for all patients >18 years of age subjected to percutaneous coronary intervention with everolimus-eluting stents (EESs) or paclitaxel-eluting stents (PESs). Outcomes of patients receiving a TAXUS Liberté or XIENCE V drug-eluting stent were compared. Baseline clinical, procedural, and follow-up data at 12 months were collected from 10 clinical centers by an electronic data capture system. The study's primary end point was major adverse cardiac events: a composite of all-cause death, Q-wave myocardial infarction, target vessel revascularization, and stent thrombosis. The trial is registered with http://www.clinicaltrials.gov (NCT01134159). Data were entered for 1,195 patients (PES, n = 595; EES, n = 600). Baseline clinical characteristics were similar except for higher dyslipidemia, systemic hypertension, and family history of coronary artery disease in the EES group. In-hospital outcome was similar between groups, with an overall in-hospital stent thrombosis rate of 0.2%. The primary end point at 12 months was similar (EES 7.8% vs 10.8%, p = 0.082). Overall stent thrombosis rate was lower in the EES group (0.3% vs 1.2%, respectively, p = 0.107); however, target lesion revascularization was similar (PES, hazard ratio 1.46, 95% confidence interval 0.98 to 2.19, p = 0.064). There was no difference in overall mortality between groups. In conclusion, second-generation EESs and PESs demonstrated similar efficacy and safety profiles for broadened patient and lesion subsets compared to a selected population from the pivotal trials. However, for composite efficacy and safety end points, EESs outperformed second-generation PESs. Copyright © 2012 Elsevier Inc. All rights reserved.

Impact of biliary stent-related events in patients diagnosed with advanced pancreatobiliary tumours receiving palliative chemotherapy.

PubMed

Lamarca, Angela; Rigby, Christina; McNamara, Mairéad G; Hubner, Richard A; Valle, Juan W

2016-07-14

To determine the impact (morbidity/mortality) of biliary stent-related events (SRE) (cholangitis or stent obstruction) in chemotherapy-treated pancreatico-biliary patients. All consecutive patients with advanced pancreatobiliary cancer and a biliary stent in-situ prior to starting palliative chemotherapy were identified retrospectively from local electronic case-note records (Jan 13 to Jan 15). The primary end-point was SRE rate and the time-to-SRE (defined as time from first stenting before chemotherapy to date of SRE). Progression-free survival and overall survival were measured from the time of starting chemotherapy. Kaplan-Meier, Cox and Fine-Gray regression (univariate and multivariable) analyses were employed, as appropriate. For the analysis of time-to-SRE, death was considered as a competing event. Ninety-six out of 693 screened patients were eligible; 89% had a metal stent (the remainder were plastic). The median time of follow-up was 9.6 mo (range 2.2 to 26.4). Forty-one patients (43%) developed a SRE during follow-up [cholangitis (39%), stent obstruction (29%), both (32%)]. There were no significant differences in baseline characteristics between the SRE group and no-SRE groups. Recorded SRE-consequences were: none (37%), chemotherapy delay (24%), discontinuation (17%) and death (22%). The median time-to-SRE was 4.4 mo (95%CI: 3.6-5.5). Patients with severe comorbidities (P < 0.001) and patients with ≥ 2 baseline stents/biliary procedures [HR = 2.3 (95%CI: 1.2-4.44), P = 0.010] had a shorter time-to-SRE on multivariable analysis. Stage was an independent prognostic factor for overall survival (P = 0.029) in the multivariable analysis adjusted for primary tumour site, performance status and development of SRE (SRE group vs no-SRE group). SREs are common and impact on patient's morbidity. Our results highlight the need for prospective studies exploring the role of prophylactic strategies to prevent/delay SREs.

Impact of biliary stent-related events in patients diagnosed with advanced pancreatobiliary tumours receiving palliative chemotherapy

PubMed Central

Lamarca, Angela; Rigby, Christina; McNamara, Mairéad G; Hubner, Richard A; Valle, Juan W

2016-01-01

AIM: To determine the impact (morbidity/mortality) of biliary stent-related events (SRE) (cholangitis or stent obstruction) in chemotherapy-treated pancreatico-biliary patients. METHODS: All consecutive patients with advanced pancreatobiliary cancer and a biliary stent in-situ prior to starting palliative chemotherapy were identified retrospectively from local electronic case-note records (Jan 13 to Jan 15). The primary end-point was SRE rate and the time-to-SRE (defined as time from first stenting before chemotherapy to date of SRE). Progression-free survival and overall survival were measured from the time of starting chemotherapy. Kaplan-Meier, Cox and Fine-Gray regression (univariate and multivariable) analyses were employed, as appropriate. For the analysis of time-to-SRE, death was considered as a competing event. RESULTS: Ninety-six out of 693 screened patients were eligible; 89% had a metal stent (the remainder were plastic). The median time of follow-up was 9.6 mo (range 2.2 to 26.4). Forty-one patients (43%) developed a SRE during follow-up [cholangitis (39%), stent obstruction (29%), both (32%)]. There were no significant differences in baseline characteristics between the SRE group and no-SRE groups. Recorded SRE-consequences were: none (37%), chemotherapy delay (24%), discontinuation (17%) and death (22%). The median time-to-SRE was 4.4 mo (95%CI: 3.6-5.5). Patients with severe comorbidities (P < 0.001) and patients with ≥ 2 baseline stents/biliary procedures [HR = 2.3 (95%CI: 1.2-4.44), P = 0.010] had a shorter time-to-SRE on multivariable analysis. Stage was an independent prognostic factor for overall survival (P = 0.029) in the multivariable analysis adjusted for primary tumour site, performance status and development of SRE (SRE group vs no-SRE group). CONCLUSION: SREs are common and impact on patient’s morbidity. Our results highlight the need for prospective studies exploring the role of prophylactic strategies to prevent/delay SREs. PMID:27468198

Comparison of the long-term safety and efficacy of drug-eluting and bare-metal stent implantation in saphenous vein grafts.

PubMed

Latib, Azeem; Ferri, Luca; Ielasi, Alfonso; Cosgrave, John; Godino, Cosmo; Bonizzoni, Erminio; Romagnoli, Enrico; Chieffo, Alaide; Valgimigli, Marco; Penzo, Carlo; Carlino, Mauro; Michev, Iassen; Sangiorgi, Giuseppe M; Montorfano, Matteo; Airoldi, Flavio; Colombo, Antonio

2010-06-01

Concerns about the long-term safety of drug-eluting stents (DES) in saphenous vein grafts has become an area of controversy and uncertainty. In this retrospective registry, we compared the outcomes in 127 patients (143 lesions) treated with DES from April 2002 to June 2006 (DES group) with 131 patients (160 lesions) treated with bare-metal stents in the preceding 36 months (bare-metal stent group). End points analyzed were cumulative death, myocardial infarction, and target vessel revascularization at 2 years after stent implantation. The DES group was significantly (P<0.05) more complex with a greater frequency of diabetes (33.1%versus 15.3%), older grafts (11.6+/-5.3 years versus 9.6+/-5.2 years), restenotic lesions (23.8% versus 4.4%), total occlusions (7.7% versus 1.2%), and smaller grafts (3.16+/-0.66 mm versus 3.44+/-0.76 mm) treated with longer stents (34.1+/-25.1 mm versus 22.7+/-11.6 mm). At 2 years, there was no statistical difference in death (8.7% versus 7.8%), myocardial infarction (6.3% versus 9.4%), or target vessel revascularization (19.7% versus 24.2%) between DES and bare-metal stents, respectively. A propensity analysis to adjust for baseline differences suggested that there was no observed association between DES and increased mortality (hazard ratio, 0.72; 95% CI, 0.21 to 2.44; P=0.60) but possibly an association with a reduction in target vessel revascularization (hazard ratio, 0.31; 95% CI, 0.14 to 0.66; P=0.002). Despite being implanted in patients and lesions more complex than the bare-metal stent group, there was no observed association between DES implantation in saphenous vein grafts and an increase in late mortality. DES may maintain their efficacy in reducing revascularization rates in diseased saphenous vein grafts over a 2-year follow-up period.

Randomized trial in malignant biliary obstruction: Plastic vs partially covered metal stents

PubMed Central

Moses, Peter L; AlNaamani, Khalid M; Barkun, Alan N; Gordon, Stuart R; Mitty, Roger D; Branch, M Stanley; Kowalski, Thomas E; Martel, Myriam; Adam, Viviane

2013-01-01

AIM: To compare efficacy and complications of partially covered self-expandable metal stent (pcSEMS) to plastic stent (PS) in patients treated for malignant, infrahilar biliary obstruction. METHODS: Multicenter prospective randomized clinical trial with treatment allocation to a pcWallstent® (SEMS) or a 10 French PS. Palliative patients aged ≥ 18, for infrahilar malignant biliary obstruction and a Karnofsky performance scale index > 60% from 6 participating North American university centers. Primary endpoint was time to stent failure, with secondary outcomes of death, adverse events, Karnofsky performance score and short-form-36 scale administered on a three-monthly basis for up to 2 years. Survival analyses were performed for stent failure and death, with Cox proportional hazards regression models to determine significant predictive characteristics. RESULTS: Eighty-five patients were accrued over 37 mo, 42 were randomized to the SEMS group and 83 patients were available for analyses. Time to stent failure was 385.3 ± 52.5 d in the SEMS and 153.3 ± 19.8 d in the PS group, P = 0.006. Time to death did not differ between groups (192.3 ± 23.4 d for SEMS vs 211.5 ± 28.0 d for PS, P = 0.70). The only significant predictor was treatment allocation, relating to the time to stent failure (P = 0.01). Amongst other measured outcomes, only cholangitis differed, being more common in the PS group (4.9% vs 24.5%, P = 0.029). The small number of patients in follow-up limits longitudinal assessments of performance and quality of life. From an initially planned 120 patients, only 85 patients were recruited. CONCLUSION: Partially covered SEMS result in a longer duration till stent failure without increased complication rates, yet without accompanying measurable benefits in survival, performance, or quality of life. PMID:24379581

[Comparison of the therapeutic effects of PTBD and PTBS in treatment of malignant obstructive jaundice].

PubMed

Bai, Ai-Guo; Zheng, Chuan-Sheng; Zhou, Guo-Feng; Liang, Hui-Min; Feng, Gan-Sheng

2010-06-01

To summarize and compare the short-term and long-term clinical efficacy of percutaneous transhepatic biliary drainage (PTBD) and percutaneous transhepatic biliary stent (PTBS) in the treatment of malignant obstructive jaundice. 210 cases of malignant obstructive jaundice underwent interventional therapy, of which 161 cases of drainage catheters placement and 49 cases of metallic stent implantation. Follow-up information was obtained through telephone review or check-up records. The technical success rate of technique was 100%. At 3 - 5 days after treatment, the serum total bilirubin in 15 metallic stent-treated patients was decreased by (178.04 +/- 42.32) micromol/L, and direct bilirubin by (83.97 +/- 23.63) micromol/L. Compared with those of 28 cases treated with drainage catheters: (95.67 +/- 34.28) micromol/L and (49.84 +/- 28.21) micromol/L, there were statistically significant differences between the two groups (P = 0.017 and P = 0.035). At 6 - 9 days after treatment, the serum total bilirubin in 28 cases of metallic stent group was decreased by (188.22 +/- 79.90) micromol/L, and that in 126 cases of drainage catheter group decreased by (141.39 +/- 65.32) micromol/L. The difference was statistically significant (P = 0.014). But the decline value of direct bilirubin had no significant difference. The median patency period and the median survival time of the drainage catheter group were 60 and 148 days, respectively, those of metallic stent group were 197 days and 245 days. There were statistically significant differences between the two groups (P < 0.05). The results of this study indicate that the short-term and long-term efficacies of metallic stent implantation are better than those of catheter drainage technique.

Comparison of the utility of covered metal stents versus uncovered metal stents in the management of malignant biliary strictures in 749 patients.

PubMed

Lee, Jeffrey H; Krishna, Somashekar G; Singh, Amanpal; Ladha, Harshad S; Slack, Rebecca S; Ramireddy, Srinivas; Raju, Gottumukkala S; Davila, Marta; Ross, William A

2013-08-01

Self-expandable metal stents (SEMSs) are used to relieve malignant biliary obstruction. To compare outcomes between covered self-expandable metal stents (CSEMSs) and uncovered self-expandable metal stents (USEMSs) in malignant biliary obstruction. Retrospective cohort study. Tertiary cancer center. Patients with malignant biliary obstruction. Placement of CSEMS or USEMS. Time to recurrent biliary obstruction (TRO), overall survival (OS), and adverse events. From January 2000 to June 2011, 749 patients received SEMSs: 171 CSEMSs and 578 USEMSs. At 1 year, there was no significant difference in the percentage of patients with recurrent obstruction (CSEMSs, 35% vs USEMSs, 38%) and survival (CSEMSs, 45% vs USEMSs, 49%). There was no significant difference in the median OS (CSEMSs, 10.4 months vs USEMSs, 11.8 months; P = .84) and the median TRO (CSEMSs, 15.4 months vs USEMSs, 26.3 months; P = .61). The adverse event rate was 27.5% for the CSEMS group and 27.7% for the USEMS group. Although tumor ingrowth with recurrent obstruction was more common in the USEMS group (76% vs 9%, P < .001), stent migration (36% vs 2%, P < .001) and acute pancreatitis (6% vs 1%, P < .001) were more common in the CSEMS group. Retrospective study. There was no significant difference in the patency rate or overall survival between CSEMSs and USEMSs for malignant distal biliary strictures. The CSEMS group had a significantly higher rate of migration and pancreatitis than the USEMS group. No significant SEMS-related adverse events were observed in patients undergoing neoadjuvant chemoradiation or surgical resection. Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Comparison of Bile Drainage Methods after Laparoscopic CBD Exploration.

PubMed

Kwon, Seong Uk; Choi, In Seok; Moon, Ju Ik; Ra, Yu Mi; Lee, Sang Eok; Choi, Won Jun; Yoon, Dae Sung; Min, Hyun Sik

2011-05-01

T-tube is a major procedure that prevents complication by biliary decompression, but which is accompanied by complications. Therefore, several procedures such as ENBD, PTBD, and antegrade biliary stent have been attempted, but with controversies as to which procedure is superior. Also, there are no standard procedures after laparoscopic CBD exploration. We performed this study to ascertain the most appropriate biliary drainage procedure after laparoscopic CBD exploration. From March 2001 to December 2009, 121 patients who underwent Laparoscopic CBD exploration in Gunyang University were included for retrospective analysis. The patients were divided to 4 groups according to type of procedure, and we compared clinical parameters including age and gender, operation time, hospital stay, start of post-operative diet, and complications. There was no difference in age, gender, mean operation time, postoperative diet between the 4 groups. Hospital stay in the Stent group was shorter than T-tube group. There were 10 (7%) complications that occurred. Two 2 occurred in the T-tube, 3 in PTBD, and 5 in the Antegrade stent group. There were more complications in Stent group but no significant statistical difference. In 5 cases with remnant CBD stone, a total of 4 (3 PTBD, 1 Stent) was performed by endoscopic CBD stone removal. One T-tube case was removed easily by choledochoscopy through the T-tube. Three migrated and the impacted stents were removed by additional endoscopy. Perioperative biliary leakage (1) and peritonitis (1) post t-tube removal were resolved by conservative treatment. T-tube appears to be an appropriate method to patients who are suspected to have remnant CBD stones. Multiple procedures may be performed on a case by case basis such as performing PTBD first in a suspected cholangitis patient.

Percutaneous Endovascular Radiofrequency Ablation for Malignant Portal Obstruction: An Initial Clinical Experience

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

Wu, Tian-Tian, E-mail: matthewwu1979@126.com; Li, Hu-Cheng, E-mail: hucheng-li-surgery@126.com; Zheng, Fang, E-mail: fang-zheng-surgery@126.com

PurposeThe Habib™ VesOpen Catheter is a new endovascular radiofrequency ablation (RFA) device used to treat malignant portal obstruction. The purpose of this study was to evaluate the clinical feasibility and safety of RFA with this device.MethodsWe collected the clinical records and follow-up data of patients with malignant portal obstruction treated with percutaneous endovascular portal RFA using the Habib™ VesOpen Catheter. Procedure-related complications, improvement of symptoms, portal patency, survival, and postoperative biochemical tests were investigated.ResultsThe 31 patients enrolled in the study underwent 41 successful endovascular portal RFA procedures. Patients were divided into a portal-stenting (PS) group (n = 13), which underwent subsequent portalmore » stenting with self-expandable metallic stents, and a non-stenting (NS) group (n = 18), which did not undergo stenting. No procedure-related abdominal hemorrhage or portal rupture occurred. Postablation complications included abdominal pain (n = 26), fever (n = 13), and pleural effusion (n = 15). Improvements in clinical manifestations were observed in 27 of the 31 patients. Of the 17 patients experiencing portal restenosis, 10 underwent successful repeat RFA. The rate of successful repeat RFA was significantly higher in the NS group than in the PS group. Median portal patency was shorter in the PS group than in the NS group. No mortality occurred during the 4 weeks after percutaneous endovascular portal RFA.ConclusionsPercutaneous endovascular portal RFA is a feasible and safe therapeutic option for malignant portal obstruction. Prospective investigations should be performed to evaluate clinical efficacy, in particular, the need to evaluate the necessity for subsequent portal stenting.« less

Randomized Comparison of Paclitaxel-Eluting Balloon and Stenting Versus Plain Balloon Plus Stenting Versus Directional Atherectomy for Femoral Artery Disease (ISAR-STATH).

PubMed

Ott, Ilka; Cassese, Salvatore; Groha, Philipp; Steppich, Birgit; Hadamitzky, Martin; Ibrahim, Tareq; Kufner, Sebastian; Dewitz, Karl; Hiendlmayer, Regina; Laugwitz, Karl-Ludwig; Schunkert, Heribert; Kastrati, Adnan; Fusaro, Massimiliano

2017-06-06

Atherosclerosis in the superficial femoral artery is common in patients suffering from peripheral artery disease. Paclitaxel-eluting balloon (PEB) angioplasty, stenting, and directional atherectomy (DA) have provided new options for the treatment of superficial femoral artery disease; however, the comparative efficacy of these interventional strategies remains uncertain. One hundred and fifty-five patients with symptomatic peripheral artery disease due to de novo superficial femoral artery stenotic or occlusive lesions were randomized to treatment with plain balloon angioplasty (BA) followed by PEB angioplasty and stenting (n=48), BA and stenting (n=52), or DA with distal protection and bailout stenting (n=55). The primary end point of the study was percentage diameter stenosis after 6 months measured by angiography. Other end points included target lesion revascularization, thrombosis, ipsilateral amputation, binary restenosis, and all-cause mortality at 6 and 24 months. Baseline and lesion characteristics were comparable in all groups with a mean lesion length of 65.9±46.8 mm and 56% total occlusions. At 6 months angiography, the percent diameter stenosis was significantly lower in patients treated by PEB angioplasty and stenting (34±31%) as compared with BA angioplasty and stenting (56±29%, P =0.009) or DA (55±29%, P =0.007). Similarly, binary restenosis was significantly lower after treatment with PEB and stenting as compared with BA and stenting or DA. Clinical follow-up at 24 months revealed a lower risk for target lesion revascularization after PEB angioplasty and stenting as compared with BA and stenting or DA. We found no difference in terms of target lesion thrombosis and mortality among groups, and no patient underwent amputation. Treatment of de novo superficial femoral artery lesions with PEB angioplasty and stenting is superior to BA angioplasty and stenting or DA in terms of angiographic diameter stenosis at 6 months and target lesion revascularization at 24 months. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00986752. © 2017 American Heart Association, Inc.

Hepatocellular Carcinoma Complicated by Gastroduodenal Obstruction: Palliative Treatment with Metallic Stent Placement

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

Lee, Ye Jin; Kim, Jin Hyoung, E-mail: m1fenew@daum.net; Song, Ho-Young

Purpose: To evaluate the clinical effectiveness of self-expandable metallic stents in seven patients with malignant gastroduodenal obstruction caused by inoperable hepatocellular carcinoma (HCC). Methods: Seven patients with gastroduodenal obstruction caused by advanced HCC underwent metallic stent placement from 2003 to 2010. These patients had total dysphagia (n = 5) or were able to eat only liquids (n = 2) before stent placement. Patients had Eastern Cooperative Oncology Group performance scores of 2 or 3, and Child-Pugh classification B or C. Results: Stent placement was technically successful in all seven patients (100%) and clinically successful in six (86%). Five patients couldmore » eat a soft diet, and one patient tolerated regular diet after stent placement. Stent-related obstructive jaundice occurred in one patient. One patient had hematemesis 11 days after stent placement. Overall mean survival was 51 days (range, 10-119 days). Stent patency was preserved in six patients with clinical success until death. Conclusion: Placement of a covered self-expandable metallic stent may offer good palliation in patients with gastroduodenal obstruction due to advanced HCC.« less

Results of celiac trunk stenting during fenestrated or branched aortic endografting.

PubMed

Wattez, Hélène; Martin-Gonzalez, Teresa; Lopez, Benjamin; Spear, Rafaëlle; Clough, Rachel E; Hertault, Adrien; Sobocinski, Jonathan; Haulon, Stéphan

2016-12-01

Endovascular repair of aortic aneurysms involving the visceral segment of the aorta often requires placement of a covered bridging stent in the celiac axis (CA). The median arcuate ligament (MAL) is a fibrous arch that unites the diaphragmatic crura on either side of the aortic hiatus. The ligament may compress and distort the celiac artery and result in difficult cannulation, or stenosis and occlusion of the vessel. This study evaluated the influence of the MAL compression on the technical success and the patency of the celiac artery after branched and fenestrated endovascular aortic repair. We retrospectively analyzed a cohort of consecutive patients treated electively for complex aneurysms with branched and fenestrated endovascular aortic repair between January 2007 and April 2014. All data were collected prospectively. Analysis of preoperative computed tomography angiography on a three-dimensional workstation determined the presence of MAL compression. Patency of the CA bridging stent was assessed during follow-up by computed tomography angiography and duplex ultrasound evaluation. Statistical analysis was performed to compare the outcomes of patients with MAL (MAL+) and without MAL (MAL-) compression. Of 315 patients treated for aortic disease involving the visceral segment during the study period, 113 had endografts designed with a branch (n = 57) or fenestration (n = 56) for the CA. In 45 patients (39.8%), asymptomatic compression of the CA by the MAL was depicted (MAL+). Complex endovascular techniques were required in this group to access the CA in 16 (14.2%) patients (vs none in the MAL- group; P = .003), which lead to a failed bridging stent implantation in seven patients (6.2%). Increased operative time and dose area product were observed in the MAL+ group, but this did not reach statistical significance. In the MAL+ group, no thrombosis of the CA bridging stents were observed during follow-up; an external compression of the CA bridging stent was depicted in six patients but without hemodynamic effect on duplex ultrasound imaging. In the MAL- group, one CA bridging stent occlusion occurred owing to an embolus from a cardiac source. MAL compression is associated with good celiac trunk bridging stent patency during follow-up, but with a higher rate of technical difficulties and failed bridging stent implantation during the procedure. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Stent-protected carotid angioplasty using a membrane stent: a comparative cadaver study.

PubMed

Müller-Hülsbeck, Stefan; Gühne, Albrecht; Tsokos, Michael; Hüsler, Erhard J; Schaffner, Silvio R; Paulsen, Friedrich; Hedderich, Jürgen; Heller, Martin; Jahnke, Thomas

2006-01-01

To evaluate the performance of a prototype membrane stent, MembraX, in the prevention of acute and late embolization and to quantify particle embolization during carotid stent placement in human carotid explants in a proof of concept study. Thirty human carotid cadaveric explants (mild stenoses 0-29%, n = 23; moderate stenoses 30-69%, n = 3; severe stenoses 70-99%, n = 2) that included the common, internal and external carotid arteries were integrated into a pulsatile-flow model. Three groups were formed according to the age of the donors (mean 58.8 years; sample SD 15.99 years) and randomized to three test groups: (I) MembraX, n = 9; (II) Xpert bare stent, n = 10; (III) Xpert bare stent with Emboshield protection device, n = 9. Emboli liberated during stent deployment (step A), post-dilatation (step B), and late embolization (step C) were measured in 100 microm effluent filters. When the Emboshield was used, embolus penetration was measured during placement (step D) and retrieval (step E). Late embolization was simulated by compressing the area of the stented vessel five times. Absolute numbers of particles (median; >100 microm) caught in the effluent filter were: (I) MembraX: A = 7, B = 9, C = 3; (II) bare stent: A = 6.5, B = 6, C = 4.5; (III) bare stent and Emboshield: A = 7, B = 7, C.=.5, D = 8, E = 10. The data showed no statistical differences according to whether embolic load was analyzed by weight or mean particle size. When summing all procedural steps, the Emboshield caused the greatest load by weight (p = 0.011) and the largest number (p = 0.054) of particles. On the basis of these limited data neither a membrane stent nor a protection device showed significant advantages during ex vivo carotid angioplasty. However, the membrane stent seems to have the potential for reducing the emboli responsible for supposed late embolization, whereas more emboli were observed when using a protection device. Further studies are necessary and warranted.

Clinical Outcomes of Self-Expandable Metal Stents for Malignant Rectal Obstruction.

PubMed

Lee, Hyun Jung; Hong, Sung Pil; Cheon, Jae Hee; Kim, Tae Il; Kim, Won Ho; Park, Soo Jung

2018-01-01

Self-expandable metal stents are widely used to treat malignant colorectal obstruction. However, data on clinical outcomes of stent placement for rectal obstruction specifically are lacking. We aimed to investigate the clinical outcomes of self-expandable metal stents in malignant rectal obstruction in comparison with those in left colonic obstruction and to identify factors associated with clinical failure and complication. This was a retrospective study. The study was conducted at a tertiary care center. Between January 2005 and December 2013, medical charts of patients who underwent stent placement for malignant rectal or left colonic obstruction were reviewed retrospectively. Study intervention included self-expandable metal stent placement. Technical success, clinical success, and complications were measured. Technical success rates for the 2 study groups (rectum vs left colon, 93.5% vs 93.1%; p = 0.86) did not differ significantly; however, the clinical success rate was lower in patients with rectal obstruction (85.4% vs 92.1%; p = 0.02). In addition, the complication rate was higher in patients with rectal obstruction (37.4% vs 25.1%; p = 0.01). Patients with rectal obstruction showed higher rates of obstruction because of extracolonic malignancy (33.8% vs 15.8%; p < 0.001) and stent use for palliation (78.6% vs 56.3%; p < 0.001). Multivariate analysis indicated obstruction attributed to extracolonic malignancy and covered stent usage to be independent risk factors for clinical failure. Factors predictive of complications in the palliative group were total obstruction, obstruction because of extracolonic malignancy, and covered stent usage. This was a retrospective, single-center study. The efficacy and safety of stent placement for malignant rectal obstruction were comparable with those for left colonic obstruction. However, obstruction attributed to extracolonic malignancy, use of covered stents, and total obstruction negatively impacted clinical outcomes of self-expandable metal stent placement and must be considered by endoscopists. See Video Abstract at http://links.lww.com/DCR/A417.

[How to prevent tissue overgrowth and incrustation of metal stents in the urinary tract in patients with pelvic malignancy] b ].

PubMed

Marković, Z; Masulović, D; Markovic, B; Anojcić, P; Mladenović, A

2009-01-01

At the current level of stent application in urology each irreversible urostasis contraindicated for surgical therapy implies consideration of indications for metal stent insertion. Stent incrustation which leads directly into a new uroobstruction is a characteristic complication of this method. Available experience in different uroobstructive conditions has shown that very different clinical aspects of stent usage may directly determine the possibility of their incrustation. Stent incrustation may occur in the early postprocedural course or several months later. After that, prevention of stent incrustation starts with postprocedural evaluation, selection of the stent type, and it is subsequently continued by insertion technique and lasts practically permanently after the insertion (infection control, promotion of diuresis and maintenance of normal urodynamics). Authors present own experianse in clinical aplication of metal stents in uroradiology strictures for period of last 15 years.

Tracheomalacia treatment using a large-diameter, custom-made airway stent in a case with mounier-kuhn syndrome.

PubMed

Ozdemir, Cengiz; Sökücü, Sinem Nedime; Karasulu, Levent; Altın, Sedat; Dalar, Levent

2014-01-01

Mounier-Kuhn Syndrome (MKS) is a rare congenital disease that presents with abnormal enlargement in the central airways. In MKS, tracheomegaly is accompanied by difficulty in expelling recurrent lung infections and bronchiectasia. We presented a patient with MKS where commercially made stents were inadequate for stabilization and a custom-made, self-expandable metallic stent with a diameter of 28 mm and length of 100 mm was used. Chest pain that was thought to develop due to the stent and that disappeared after stent removal may be considered the main complication leading to stent removal. Continuous positive airway pressure therapy (CPAP) therapy was planned for the control of symptoms, which re-emerged after stent removal. This case is presented as an example that complications developing due to the stent as well as patient noncompliance may lead to stent removal, even when useful results are obtained from treatment of MKS.

Biodegradable stents for the treatment of refractory or recurrent benign esophageal stenosis.

PubMed

Imaz-Iglesia, Iñaki; García-Pérez, Sonia; Nachtnebel, Anna; Martín-Águeda, Belén; Sánchez-Piedra, Carlos; Karadayi, Bilgehan; Demirbaş, Ali Rıza

2016-06-01

Esophageal stents are used for the treatment of refractory and recurrent dyphagias. In 2007, esophageal biodegradable stents (EBS) were authorised as an alternative to existing metal and plastic stents in Europe. The advantages claimed for EBS are fewer complications concerning tissue ingrowth, stent migration and stent removal. We performed a systematic review to evaluate the efficacy and safety of EBS compared to fully-covered self-expanding metal stents, self-expanding plastic stents, and esophageal dilation for the treatment of refractory or recurrent benign esophageal stenosis. Three comparative studies (one randomized controlled trial and two cohort studies) were assessed. The studies used different inclusion criteria, had a very small (sample) size and the quality of the evidence was very low. Expert commentary: The current evidence is insufficient to determine the relative efficacy or safety of esophageal biodegradable stents. The results of this systematic review should be updated once new evidence is available.

Preventing intra-urethral migration of a guidewire during antegrade placement of a JJ stent: a technical modification.

PubMed

Bansal, Ankur; Gupta, Piyush; Dalela, Disha; Dalela, Diwakar

2016-03-07

A JJ stent is usually inserted in antegrade fashion after percutaneous renal surgery. We describe a new technical modification for antegrade stent insertion that prevents intraoperative intra-urethral migration of the guidewire and saves operative time and cost. 2016 BMJ Publishing Group Ltd.

Fluoroscopic Placement of Double-Pigtail Ureteral Stents

PubMed Central

Chen, Gregory L.

2001-01-01

Purpose: Double-pigtail ureteral stent is placed cystoscopically after ureteroscopy. We describe a technique for fluoroscopic placement of ureteral stents and demonstrate its use in a non-randomized prospective study. Materials and methods: Double-pigtail stents were placed either fluoroscopically or cystoscopically in 121 consecutive patients. In the fluoroscopic method, the stent was placed over a guide wire using a stent pusher without the use of cystoscopy. Conversely, stents were placed through the working channel of the cystoscope under vision. The procedure, stent length, width, type, method, ureteral dilation, and use of a retrieval string were noted. Results: A wide range of stent sizes were used. The success with fluoroscopic placement of double-pigtail ureteral stents was 100% (89 of 89 cases). No stents migrated or required replacement. Stents were placed after ureteroscopic laser lithotripsy (53/89) and ureteroscopic tumor treatment (22/89). Cystoscopic visualization was used in 32 additional procedures requiring precise control (15 ureteral strictures and nine retrograde endopyelotomy). Conclusions: The fluoroscopic placement of ureteral stents is a safe and simple technique with a very high success rate. We have used cystoscopic placement only after incisional procedures such as retrograde endopyelotomy, stricture or ureterotomy. PMID:18493562

Comparison of femoropopliteal artery stents under axial and radial compression, axial tension, bending, and torsion deformations.

PubMed

Maleckis, Kaspars; Deegan, Paul; Poulson, William; Sievers, Cole; Desyatova, Anastasia; MacTaggart, Jason; Kamenskiy, Alexey

2017-11-01

High failure rates of Peripheral Arterial Disease (PAD) stenting appear to be associated with the inability of certain stent designs to accommodate severe biomechanical environment of the femoropopliteal artery (FPA) that bends, twists, and axially compresses during limb flexion. Twelve Nitinol stents (Absolute Pro, Supera, Lifestent, Innova, Zilver, Smart Control, Smart Flex, EverFlex, Viabahn, Tigris, Misago, and Complete SE) were quasi-statically tested under bench-top axial and radial compression, axial tension, bending, and torsional deformations. Stents were compared in terms of force-strain behavior, stiffness, and geometrical shape under each deformation mode. Tigris was the least stiff stent under axial compression (6.6N/m axial stiffness) and bending (0.1N/m) deformations, while Smart Control was the stiffest (575.3N/m and 105.4N/m, respectively). Under radial compression Complete SE was the stiffest (892.8N/m), while Smart Control had the lowest radial stiffness (211.0N/m). Viabahn and Supera had the lowest and highest torsional stiffness (2.2μNm/° and 959.2μNm/°), respectively. None of the 12 PAD stents demonstrated superior characteristics under all deformation modes and many experienced global buckling and diameter pinching. Though it is yet to be determined which of these deformation modes might have greater clinical impact, results of the current analysis may help guide development of new stents with improved mechanical characteristics. Copyright © 2017 Elsevier Ltd. All rights reserved.

Validation of the Spanish version of Ureteral Stent Symptom Questionnaire: prevalence of symptoms in a tertiary care center in Mexico.

PubMed

Olvera-Posada, Daniel; Suárez-Santos, Myrna; Castillejos-Molina, Ricardo; Gabilondo-Navarro, Fernando; Méndez-Probst, Carlos Enrique

2014-03-01

To develop and to validate the Spanish version of the Ureteral Stent Symptom Questionnaire (USSQ). Describe the prevalence of symptoms associated with the presence of ureteral stent in a Spanish-speaking population. We developed and delivered the Spanish USSQ version to patients who underwent ureteral stent placement after endourological procedures. We determined the internal consistency and the instrument's sensitivity to change. Results of the patients were compared with a control group of healthy individuals. We analyzed the prevalence of symptoms in the six domains of the questionnaire and the overall quality of life. We compared the means of the results by gender to find significant differences in associated symptoms. We obtained good internal consistency values of the instrument. Significant differences were obtained after sensitivity to change analysis in the scores of all domains except sexual performance. The correlation between the domains of urinary symptoms, pain, and general health was high. The analysis of specific symptoms showed important affection in all domains, being more significant in urinary symptoms and pain. The ureteral catheter also affected the daily life and work performance. There were no significant differences when comparing the symptoms by gender or age. Spanish version of the USSQ is appropriate for assessing the symptoms associated with ureteral stent in the Spanish-speaking population. The ureteral catheter significantly affects the various aspects of life in this population.

Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial.

PubMed

Kandzari, David E; Mauri, Laura; Koolen, Jacques J; Massaro, Joseph M; Doros, Gheorghe; Garcia-Garcia, Hector M; Bennett, Johan; Roguin, Ariel; Gharib, Elie G; Cutlip, Donald E; Waksman, Ron

2017-10-21

The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention. BIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent or to a durable polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946. Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with bioresorbable polymer sirolimus-eluting stents (n=884) or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the bioresorbable polymer sirolimus-eluting stent group and 41 (10%) of 427 patients in the durable polymer everolimus-eluting stent group met the 12-month primary endpoint of target lesion failure (95% CI -6·84 to -0·29, p=0·0399), with differences in target vessel myocardial infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0·0155). The posterior probability that the bioresorbable polymer sirolimus-eluting stent is non-inferior to the durable polymer everolimus-eluting stent was 100% (Bayesian analysis, difference in target lesion failure frequency -2·6% [95% credible interval -5·5 to 0·1], non-inferiority margin 3·85%, n=2208). The outperformance of the ultrathin, bioresorbable polymer sirolimus-eluting stent over the durable polymer everolimus-eluting stent in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next generation drug-eluting stent technology. BIOTRONIK. Copyright © 2017 Elsevier Ltd. All rights reserved.

Current Opinion on Catheter-based Hemorrhage Control in Trauma Patients

DTIC Science & Technology

2014-01-01

catheter-based interventions. Similar guidelines for competency/credentialing of practitioners to per- form endovascular stent grafting of the thoracic...practitioners to perform endovascular stent -grafting of the thoracic aorta. J Thorac Cardiovasc Surg. 2006;131: 530 532. 30. Rosenfield KM. Clinical...competence statement on carotid stenting : train- ing and credentialing for carotid stenting multispecialty consensus rec- ommendations. J Vasc Surg. 2005;41

Timing of silicone stent removal in patients with post-tuberculosis bronchial stenosis

PubMed Central

Eom, Jung Seop; Kim, Hojoong; Park, Hye Yun; Jeon, Kyeongman; Um, Sang-Won; Koh, Won-Jung; Suh, Gee Young; Chung, Man Pyo; Kwon, O. Jung

2013-01-01

CONTEXT: In patients with post-tuberculosis bronchial stenosis (PTBS), the severity of bronchial stenosis affects the restenosis rate after the silicone stent is removed. In PTBS patients with incomplete bronchial obstruction, who had a favorable prognosis, the timing of stent removal to ensure airway patency is not clear. AIMS: We evaluated the time for silicone stent removal in patients with incomplete PTBS. SETTINGS AND DESIGN: A retrospective study examined PTBS patients who underwent stenting and removal of a silicone stent. METHODS: Incomplete bronchial stenosis was defined as PTBS other than total bronchial obstruction, which had a luminal opening at the stenotic segment on bronchoscopic intervention. The duration of stenting was defined as the interval from stent insertion to removal. The study included 44 PTBS patients and the patients were grouped at intervals of 6 months according to the duration of stenting. RESULTS: Patients stented for more than 12 months had a significantly lower restenosis rate than those stented for less than 12 months (4% vs. 35%, P = 0.009). Multiple logistic regression revealed an association between stenting for more than 12 months and a low restenosis rate (odds ratio 12.095; 95% confidence interval 1.097-133.377). Moreover, no restenosis was observed in PTBS patients when the stent was placed more than 14 months previously. CONCLUSIONS: In patients with incomplete PTBS, stent placement for longer than 12 months reduced restenosis after stent removal. PMID:24250736

Evidence-Based Recommendations on Upper Gastrointestinal Tract Stenting: A Report from the Stent Study Group of the Korean Society of Gastrointestinal Endoscopy

PubMed Central

Jee, Sam Ryong; Kim, Kyung Ho; Kim, Sang Gyun; Cho, Jun-Hyung

2013-01-01

Endoscopic stents have evolved dramatically over the past 20 years. With the introduction of uncovered self-expanding metal stents in the early 1990s, they are primarily used to palliate symptoms of malignant obstruction in patients with inoperable gastrointestinal (GI) cancer. At present, stents have emerged as an effective, safe, and less invasive alternative for the treatment of malignant GI obstruction. Clinical decisions about stent placement should be made based on the exact understanding of the patient's condition. These recommendations based on a critical review of the available data and expert consensus are made for the purpose of providing endoscopists with information about stent placement. These can be helpful for management of patients with inoperable cancer or various nonmalignant conditions in the upper GI tract. PMID:23964331

Randomized Comparison of Ridaforolimusand Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease

PubMed Central

Kandzari, David E.; Smits, Pieter C.; Love, Michael P.; Ben-Yehuda, Ori; Banai, Shmuel; Rob-inson, Simon D.; Jonas, Michael; Kornowski, Ran; Bagur, Rodrigo; Iniguez, Andres; Danenberg, Haim; Feldman, Robert; Jauhar, Rajiv; Chandna, Harish; Parikh, Manish; Perlman, Gidon Y.; Balcells, Mer-cedes; Markham, Peter; Ozan, Melek Ozgu; Genereux, Philippe; Edelman, Elazer R.; Leon, Martin B.; Stone, Gregg W.

2018-01-01

BACKGROUND The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. METHODS A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. RESULTS Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, Pnoninferiority=0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P=0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm (Pnoninferiority=0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively (Pnoninferiority=0.01). CONCLUSIONS In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01995487. PMID:28794001

Improved biocompatibility of poly(lactic-co-glycolic acid) orv and poly-L-lactic acid blended with nanoparticulate amorphous calcium phosphate in vascular stent applications.

PubMed

Zheng, Xiaoxin; Wang, Yujue; Lan, Zhiyuan; Lyu, Yongnan; Feng, Gaoke; Zhang, Yipei; Tagusari, Shizu; Kislauskis, Edward; Robich, Michael P; McCarthy, Stephen; Sellke, Frank W; Laham, Roger; Jiang, Xuejun; Gu, Wei Wang; Wu, Tim

2014-06-01

Biodegradable polymers used as vascular stent coatings and stent platforms encounter a major challenge: biocompatibility in vivo, which plays an important role in in-stent restenosis (ISR). Co-formulating amorphous calcium phosphate (ACP) into poly(lactic-co-glycolic acid) (PLGA) or poly-L-lactic acid (PLLA) was investigated to address the issue. For stent coating applications, metal stents were coated with polyethylene-co-vinyl acetate/poly-n-butyl methacrylate (PEVA/PBMA), PLGA or PLGA/ACP composites, and implanted into rat aortas for one and three months. Comparing with both PEVA/PBMA and PLGA groups after one month, the results showed that stents coated with PLGA/ACP had significantly reduced restenosis (PLGA/ACP vs. PEVA/PBMA vs. PLGA: 21.24 +/- 2.59% vs. 27.54 +/- 1.19% vs. 32.12 +/- 3.93%, P < 0.05), reduced inflammation (1.25 +/- 0.35 vs. 1.77 +/- 0.38 vs. 2.30 +/- 0.21, P < 0.05) and increased speed of re-endothelialization (1.78 +/- 0.46 vs. 1.17 +/- 0.18 vs. 1.20 +/- 0.18, P < 0.05). After three months, the PLGA/ACP group still displayed lower inflammation score (1.33 +/- 0.33 vs. 2.27 +/- 0.55, P < 0.05) and higher endothelial scores (2.33 +/- 0.33 vs. 1.20 +/- 0.18, P < 0.05) as compared with the PEVA/PBMA group. Moreover, for stent platform applications, PLLA/ACP stent tube significantly reduced the inflammatory cells infiltration in the vessel walls of rabbit iliac arteries relative to their PLLA cohort (NF-kappaB-positive cells: 23.31 +/- 2.33/mm2 vs. 9.34 +/- 1.35/mm2, P < 0.05). No systemic biochemical or pathological evidence of toxicity was found in either PLGA/ACP or PLLA/ACP. The co-formulation of ACP into PLGA and PLLA resulted in improved biocompatibility without systemic toxicity.

Reduction of Late In-Stent Stenosis in a Porcine Coronary Artery Model by Cobalt Chromium Stents with a Nanocoat of Polyphosphazene (Polyzene-F)

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

Stampfl, Ulrike; Sommer, Christof-Matthias; Thierjung, Heidi

2008-11-15

The purpose of this study was to investigate the potential of nanoscale coating with the highly biocompatible polymer Polyzene-F (PZF), in combination with cobalt chromium and stainless steel stents, to reduce in-stent stenosis, thrombogenicity, and vessel wall injury and inflammation. One bare cobalt chromium, PZF-nanocoated stainless steel or PZF-nanocoated cobalt chromium stent was implanted in right coronary artery of 30 mini-pigs (4- or 12-week follow-up). Primary study end points were in-stent stenosis and thrombogenicity. Secondary study end points were vessel wall injury and inflammation as evaluated by microscopy and a new immunoreactivity score applying C-reactive protein (CRP), tumor-necrosis factor alphamore » (TNF{alpha}), and TGF{beta}. At 12 weeks, angiography showed a significantly lower average loss in lumen diameter (2.1% {+-} 3.05%) in PZF-nanocoated cobalt chromium stents compared with stents in the other groups (9.73% {+-} 4.93% for bare cobalt chromium stents and 9.71% {+-} 7% for PZF-nanocoated stainless steel stents; p = 0.04), which was confirmed at microscopy (neointima 40.7 {+-} 16 {mu}m in PZF-nanocoated cobalt chromium stents, 74.7 {+-} 57.6 {mu}m in bare cobalt chromium stents, and 141.5 {+-} 109 {mu}m in PZF-nanocoated stainless steel stents; p = 0.04). Injury and inflammation scores were low in all stents and were without significant differences. PZF-nanocoated cobalt chromium stents provided the highest efficacy in reducing in-stent stenosis at long-term follow-up. The PZF nanocoat proved to be biocompatible with respect to thromboresistance and inflammation. Our data suggest that its combination with cobalt chromium stents might provide an interesting passive stent platform.« less

Long-term outcome of self expandable metal stents for biliary obstruction in chronic pancreatitis.

PubMed

Waldthaler, Alexander; Schütte, Kerstin; Weigt, Jochen; Kropf, Siegfried; Malfertheiner, Peter; Kahl, Stefan

2013-01-10

Insertion of a self-expandable metal stent is still controversial for treatment of benign common bile duct stenosis but can be a valuable alternative to surgical treatment. Aim of our study was to analyze the efficacy of covered and uncovered self-expandable metal stent in patients with chronic pancreatitis and common bile duct stenosis. Twenty patients with common bile duct stenosis due to alcoholic chronic pancreatitis were retrospective analyzed. All patients had advanced chronic pancreatitis, presenting with calcifications in pancreatic head. Uncovered self-expandable metal stent (uSEMS) were used in 11 patients (3 females, 8 males) while in 9 patients (3 females, 6 males) partially covered self-expandable metal stent (cSEMS) were inserted. All patients treated with self-expandable metal stent had contraindications for surgery. Overall mean follow up time was 155 weeks: 206 (52-412) weeks in uSEMS, and 93 (25-233) weeks in cSEMS, respectively. Stent patency was in mean 118 weeks: 159 (44-412) weeks in uSEMS and 67 (25-150) weeks in cSEMS (P=0.019). In the uSEMS group, reintervention was necessary in 5 patients (45%) due to stent obstruction, whereas in the cSEMS group 4 patients (44%) needed reintervention (2 obstructions, 2 migration). Stent migration is an early complication, compared to obstruction (P<0.05), and in cSEMS obstruction occurred significantly earlier compared to uSEMS (P<0.05). Patency of uSEMS was significantly longer compared to partially cSEMS. Available self-expandable metal stent, unfortunately, do not meet the demands on successful treatment of benign common bile duct stenosis.

The Use of Biodegradable Stents in Malignant Oesophageal Strictures for the Treatment of Dysphagia Before Neoadjuvant Treatment or Radical Radiotherapy: A Feasibility Study

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

Krokidis, Miltiadis, E-mail: mkrokidis@hotmail.com; Burke, Chris; Spiliopoulos, Stavros

PurposeTo evaluate the clinical results of the use of biodegradable oesophageal stents in malignant strictures.MethodsEleven patients were included in this prospective analysis in which a woven polydioxanone biodegradable oesophageal stent was used. The inclusion criterion was that the patient underwent neoadjuvant treatment or radical radiotherapy after the stent insertion. Primary end points were dysphagia score at discharge, stent patency, and complication rate. Secondary end points were overall survival and surgical outcome of surgery.ResultsThere was a 100 % procedure technical success rate. Early complications occurred in three patients resulting in failure to restore oral nutrition. In the remaining eight patients, dysphagiamore » was significantly improved at discharge. Mean stent patency rate in this group was 71.5 days. Stent dysfunction occurred in five of eight patients (62.5 %); in two of five patients this was due to local inflammatory reaction, and in three of five patients it was due to tumour growth after a mean time of 97.8 days, and a new metallic stent was consequently placed in four of five patients. One patient was successfully treated with esophagectomy. At the end of follow-up (mean time 102.1 days), three of eight stents were patent. The overall patient survival rate was 81.8 %.ConclusionAlthough short-term dysphagia scores improved, biodegradable stents do not appear to offer a clear beneficial effect in most cases of malignant strictures, particularly due to a local inflammatory reaction that may be induced. Technical improvement of the device and delineation of the patient group that would benefit from its use is necessary if further studies are to be conducted in the future.« less

Local Delivery of Gene Vectors From Bare-Metal Stents by Use of a Biodegradable Synthetic Complex Inhibits In-Stent Restenosis in Rat Carotid Arteries

PubMed Central

Fishbein, Ilia; Alferiev, Ivan; Bakay, Marina; Stachelek, Stanley J.; Sobolewski, Peter; Lai, Meizan; Choi, Hoon; Chen, I.-W.; Levy, Robert J.

2012-01-01

Background Local drug delivery from polymer-coated stents has demonstrated efficacy for preventing in-stent restenosis; however, both the inflammatory effects of polymer coatings and concerns about late outcomes of drug-eluting stent use indicate the need to investigate innovative approaches, such as combining localized gene therapy with stent angioplasty. Thus, we investigated the hypothesis that adenoviral vectors (Ad) could be delivered from the bare-metal surfaces of stents with a synthetic complex for reversible vector binding. Methods and Results We synthesized the 3 components of a gene vector binding complex: (1) A polyallylamine bisphosphonate with latent thiol groups (PABT), (2) a polyethyleneimine (PEI) with pyridyldithio groups for amplification of attachment sites [PEI(PDT)], and (3) a bifunctional (amine- and thiol-reactive) cross-linker with a labile ester bond (HL). HL-modified Ad attached to PABT/PEI(PDT)-treated steel surfaces demonstrated both sustained release in vitro over 30 days and localized green fluorescent protein expression in rat arterial smooth muscle cell cultures, which were not sensitive to either inhibition by neutralizing anti-Ad antibodies or inactivation after storage at 37°C. In rat carotid studies, deployment of steel stents configured with PABT/PEI(PDT)/HL-tethered adenoviral vectors demonstrated both site-specific arterial AdGFP expression and adenovirus-luciferase transgene activity per optical imaging. Rat carotid stent delivery of adenovirus encoding inducible nitric oxide synthase resulted in significant inhibition of restenosis. Conclusions Reversible immobilization of adenovirus vectors on the bare-metal surfaces of endovascular stents via a synthetic complex represents an efficient, tunable method for sustained release of gene vectors to the vasculature. PMID:18413497

Late adverse events after implantation of sirolimus-eluting stent and bare-metal stent: long-term (5-7 years) follow-up of the Coronary Revascularization Demonstrating Outcome study-Kyoto registry Cohort-2.

PubMed

Natsuaki, Masahiro; Morimoto, Takeshi; Furukawa, Yutaka; Nakagawa, Yoshihisa; Kadota, Kazushige; Yamaji, Kyohei; Ando, Kenji; Shizuta, Satoshi; Shiomi, Hiroki; Tada, Tomohisa; Tazaki, Junichi; Kato, Yoshihiro; Hayano, Mamoru; Abe, Mitsuru; Tamura, Takashi; Shirotani, Manabu; Miki, Shinji; Matsuda, Mitsuo; Takahashi, Mamoru; Ishii, Katsuhisa; Tanaka, Masaru; Aoyama, Takeshi; Doi, Osamu; Hattori, Ryuichi; Kato, Masayuki; Suwa, Satoru; Takizawa, Akinori; Takatsu, Yoshiki; Shinoda, Eiji; Eizawa, Hiroshi; Takeda, Teruki; Lee, Jong-Dae; Inoko, Moriaki; Ogawa, Hisao; Hamasaki, Shuichi; Horie, Minoru; Nohara, Ryuji; Kambara, Hirofumi; Fujiwara, Hisayoshi; Mitsudo, Kazuaki; Nobuyoshi, Masakiyo; Kita, Toru; Kimura, Takeshi

2014-04-01

Late adverse events such as very late stent thrombosis (VLST) or late target-lesion revascularization (TLR) after first-generation sirolimus-eluting stents (SES) implantation have not been yet fully characterized at long term in comparison with those after bare-metal stent (BMS) implantation. Among 13 058 consecutive patients undergoing first percutaneous coronary intervention in the Coronary REvascularization Demonstrating Outcome study-Kyoto registry Cohort-2, 5078 patients were treated with SES only, and 5392 patients were treated with BMS only. During 7-year follow-up, VLST and late TLR beyond 1 year after SES implantation occurred constantly and without attenuation at 0.24% per year and at 2.0% per year, respectively. Cumulative 7-year incidence of VLST was significantly higher in the SES group than that in the BMS group (1.43% versus 0.68%, P<0.0001). However, there was no excess of all-cause death beyond 1 year in the SES group as compared with that in the BMS group (20.8% versus 19.6%, P=0.91). Cumulative incidences of late TLR (both overall and clinically driven) were also significantly higher in the SES group than in the BMS group (12.0% versus 4.1%, P<0.0001 and 8.5% versus 2.6%, P<0.0001, respectively), leading to late catch-up of the SES group to the BMS group regarding TLR through the entire 7-year follow-up (18.8% versus 25.2%, and 10.6% versus 10.2%, respectively). Clinical presentation as acute coronary syndrome was more common at the time of late SES TLR compared with early SES TLR (21.2% and 10.0%). Late catch-up phenomenon regarding stent thrombosis and TLR was significantly more pronounced with SES than that with BMS. This limitation should remain the target for improvements of DES technology.

Restrictive bare stent prevents distal stent graft-induced new entry in endovascular repair of type B aortic dissection.

PubMed

Zhao, Yang; Yin, Henghui; Chen, Yitian; Wang, Mian; Zheng, Liang; Li, Zilun; Chang, Guangqi

2018-01-01

Distal stent graft-induced new entry (SINE) can occur after thoracic endovascular aortic repair (TEVAR) of type B aortic dissection. This study investigated the mechanism of distal SINE and its prevention using a restrictive bare stent (RBS) technique. From January 2013 to December 2014, 68 consecutive type B aortic dissection patients received endovascular repair at our center. The RBS technique was used with distal oversizing (between the diameter of the thoracic stent graft and the descending aorta true lumen diameter at the level of the intended distal edge of the thoracic stent graft) >20%. Twenty-three patients received TEVAR with a single thoracic stent graft (TEVAR group, n = 23); the rest received TEVAR combined with the RBS technique (TEVAR + RBS group, n = 45). Four distal SINEs occurred in the TEVAR group. Distal oversizing (69.7% ± 35.5% vs 31.2% ± 24.5%; P = .005) and expansion mismatch ratio (132.2% ± 16.9% vs 106.5% ± 11.6%; P < .05) were significantly higher in the SINE patients. Compared with standard TEVAR, TEVAR + RBS was associated with significantly lower distal oversizing (TEVAR vs TEVAR + RBS group, 59.8% ± 24.7% vs 16.7% ± 7.6%; P < .05), lower expansion mismatch ratio (113.8% ± 14.6% vs 103.8% ± 11.7%; P = .012), and lower distal SINE rate (4/23 [17.4%] vs 0/45 [0%]; P = .011). Compared with the TEVAR group, the false lumen was reduced significantly at the level of the RBS distal edge (P = .029). Excessive distal oversizing and distal expansion mismatch ratio may contribute to the occurrence of distal SINE. The RBS technique reduced the incidence of distal SINE. Based on our midterm and long-term observations, implantation of an RBS may improve aortic remodeling. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

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.

Onset and extent of platelet inhibition by clopidogrel loading in patients undergoing elective coronary stenting: the Plavix Reduction Of New Thrombus Occurrence (PRONTO) trial.

PubMed

Gurbel, Paul A; Cummings, Charles C; Bell, Christopher R; Alford, Amanda B; Meister, Andrew F; Serebruany, Victor L

2003-02-01

Despite the common practice of clopidogrel loading for coronary stenting, the time dependence and degree of platelet inhibition after this therapy are not well defined. We sought to establish an optimal clopidogrel dosing regimen for sustained platelet inhibition in stented patients. Platelets were assessed by conventional aggregation with 5 micromol/L adenosine diphosphate (ADP), 1 microg/mL collagen (COLL), and 750 micromol/L arachidonic acid; whole blood aggregation by 1 microg/mL collagen (WBA); shear-induced closure time (CT); contractile force (CF); and expression of 9 surface receptors by flow cytometry in 100 patients undergoing elective stent placement without glycoprotein (GP) IIb/IIIa receptor antagonists. Blood was obtained at baseline and serially over 5 days poststenting after different clopidogrel loading regimens: 300 mg 24 hours before (Group A), 12 hours before (Group B), 3 to 6 hours before (Group C), and 75 mg at the time of intervention (Group D). Before stenting, ADP, COLL, CT, and WBA were reduced by clopidogrel loading (P <.05). CF was not affected by clopidogrel. Before stenting, GP IIb/IIIa expression increased in groups A through C (P <.05), whereas PECAM-1 and CD107a were reduced (P <.05). At 2 hours and 2 days poststenting, platelets, in general, exhibited an increase in activity that was most inhibited by clopidogrel loading. Clopidogrel inhibited GP Ib, platelet/endothelial cell adhesion molecule-1, CD 107a, CD 151, and GP IIb/IIIa expression at day 5 poststenting. A 300 mg clopidogrel load given 3 to 24 hours before stenting inhibits platelets at the time of the procedure and reduces poststent activity more than a 75 mg dose given at the time of the procedure. The inhibition of adhesive molecule expression may also contribute an antithrombotic effect. Poststent activation of platelets may warrant higher periprocedural dosing.

A novel high nitrogen nickel-free coronary stents system: evaluation in a porcine model.

PubMed

Zhang, Bin; Chen, Ming; Zheng, Bo; Wang, Xin Gang; Wang, Xi Ting; Fan, Yuan Yuan; Huo, Yong

2014-04-01

To study the safety of the novel high nitrogen nickel-free austenitic stainless steel bare metal stents (BMS) in a recognized porcine coronary model and to select a better grid structure of it. Three types of stents were randomly implanted in different coronary arteries of the same pig: 316 L stainless steel BMS (316 L-BMS) (n=12), novel high nitrogen nickel-free stents Grid A (NF-A-BMS) (n=12) and novel high nitrogen nickel-free stents Grid B (NF-B-BMS) (n=12). In total, eighteen animals underwent successful random placement of 36 oversized stents in the coronary arteries. Coronary angiography was performed after 36 d of stents implantation. Nine animals were respectively sacrificed after 14 d and 36 d for histomorphologic analysis. Quantitative coronary angiography (QCA) showed similar luminal loss (LL) in the three groups: (0.21 ± 0.17) mm for 316 L-BMS, (0.16 ± 0.12) mm for NF-A-BMS, (0.24 ± 0.15) mm for NF-B-BMS (P>0.05). Histomorphomeric analysis after 15 d and 36 d revealed that there was also no significant difference among the three groups in neointimal area (NA) with similar injury scores respectively. High magnification histomorphologic examination showed similar inflammation scores in the three groups, but NF-A-BMS group had poorer endothelialization scores compared with NF-B-BMS group, 2.00 ± 0.63 vs. 2.83 ± 0.41 (P=0.015) at 15 d, which also could be proved by the scanning electron microscope. However, the difference could not been observed at 36 d. The novel NF-BMS showed similar safety as 316 L-BMS during the short-term study. NF-B-BMS had better endothelialization than NF-A-BMS and this may owe to the specific strut units. Copyright © 2014 The Editorial Board of Biomedical and Environmental Sciences. Published by China CDC. All rights reserved.

Long-term angiographic outcome of stent-assisted coiling compared to non-assisted coiling of intracranial saccular aneurysms

PubMed Central

Ozretić, David; Radoš, Marko; Pavliša, Goran; Poljaković, Zdravka

2015-01-01

Aim To compare angiographic result at long-term follow-up, and rates of progressive occlusion, recurrence, and retreatment of stent-assisted coiled (SAC) and non-assisted coiled (NAC) intracranial saccular aneurysms. Methods Retrospective evaluation of department records identified 260 patients with 283 saccular intracranial aneurysms who had long-term angiographic follow-up (more than 12 months) and were successfully treated with SAC (89 aneurysms) or NAC (194 aneurysms) at the University Hospital Center Zagreb from June 2005 to July 2012. Initial and control angiographic results in both groups were graded using Roy/Raymond scale, converted to descriptive terms, and the differences between them were evaluated for statistical significance. A multivariate analysis was performed to identify factors related to progression of aneurysm occlusion and recurrence at follow-up, and those related to aneurysm retreatment. Results There were more progressively occluded aneurysms in SAC group (38 of 89 aneurysms, 42.7%) than in NAC group (46 of 194, 23.7%) (P = 0.002), but there were no significant differences in the rates of recanalization, regrowth, and stable result. Multivariate logistic regression identified the use of stent as the most important factor associated with progressive occlusion (P = 0.015, odds ratio 2.22, 95% confidence interval 1.17-4.21), and large aneurysm size and posterior circulation location as most predictive of aneurysm recurrence and retreatment. Conclusion The use of stent is associated with delayed occlusion of initially incompletely coiled aneurysms during follow-up, but does not reduce the rate of recurrence and retreatment compared to coiling alone. Long-term angiographic follow-up is needed for both SAC and NAC aneurysms. PMID:25727039

Impact of Paclitaxel-Eluting Balloons Compared to Second-Generation Drug-Eluting Stents for of In-Stent Restenosis in a Primarily Acute Coronary Syndrome Population

PubMed Central

Marquis-Gravel, Guillaume; Matteau, Alexis; Potter, Brian J; Gobeil, François; Noiseux, Nicolas; Stevens, Louis-Mathieu; Mansour, Samer

2017-01-01

Background The place of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) is not well-defined, particularly in a population of all-comers with acute coronary syndromes (ACS). Objective Compare the clinical outcomes of DEB with second-generation drug-eluting stents (DES) for the treatment of ISR in a real-world population with a high proportion of ACS. Methods A retrospective analysis of consecutive patients with ISR treated with a DEB compared to patients treated with a second-generation DES was performed. The primary endpoint was a composite of major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, and target lesion revascularization). Comparisons were performed using Cox proportional hazards multivariate adjustment and Kaplan-Meier analysis with log-rank. Results The cohort included 91 patients treated with a DEB and 89 patients treated with a DES (74% ACS). Median follow-up was 26 months. MACE occurred in 33 patients (36%) in the DEB group, compared to 17 patients (19%) in the DES group (p log-rank = 0.02). After multivariate adjustment, there was no significant difference between the groups (HR for DEB = 1.45 [95%CI: 0.75-2.83]; p = 0.27). Mortality rates at 1 year were 11% with DEB, and 3% with DES (p = 0.04; adjusted HR = 2.85 [95%CI: 0.98-8.32]; p = 0.06). Conclusion In a population with a high proportion of ACS, a non-significant numerical signal towards increased rates of MACE with DEB compared to second-generation DES for the treatment of ISR was observed, mainly driven by a higher mortality rate. An adequately-powered randomized controlled trial is necessary to confirm these findings. PMID:28977052

New Variable Porosity Flow Diverter (VPOD) Stent Design for Treatment of Cerebrovascular Aneurysms

PubMed Central

Ionita, Ciprian; Baier, Robert; Rudin, Stephen

2012-01-01

Using flow diverting Stents for intracranial aneurysm repair has been an area of recent active research. While current commercial flow diverting stents rely on a dense mesh of braided coils for flow diversion, our group has been developing a method to selectively occlude the aneurysm neck, without endangering nearby perforator vessels. In this paper, we present a new method of fabricating the low porosity patch, a key element of such asymmetric vascular stents (AVS). PMID:22254507

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis: Results From a Patient-Level Pooled Analysis of the RIBS IV and V Trials.

PubMed

Alfonso, Fernando; Pérez-Vizcayno, María José; García Del Blanco, Bruno; García-Touchard, Arturo; López-Mínguez, José-Ramón; Masotti, Mónica; Zueco, Javier; Melgares, Rafael; Mainar, Vicente; Moreno, Raul; Domínguez, Antonio; Sanchís, Juan; Bethencourt, Armando; Moreu, José; Cequier, Angel; Martí, Vicens; Otaegui, Imanol; Bastante, Teresa; Gonzalo, Nieves; Jiménez-Quevedo, Pilar; Cárdenas, Alberto; Fernández, Cristina

2016-07-01

Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled. A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) and RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) randomized trials was performed using patient-level data to compare the efficacy of EES in bare-metal stent ISR and DES-ISR. Inclusion and exclusion criteria were identical in both trials. Results of 94 patients treated with EES for bare-metal stent ISR were compared with those of 155 patients treated with EES for DES-ISR. Baseline characteristics were more adverse in patients with DES-ISR, although they presented later and more frequently with a focal pattern. After intervention, minimal lumen diameter (2.22±0.5 versus 2.38±0.5 mm, P=0.01) was smaller in the DES-ISR group. Late angiographic findings (89.3% of eligible patients), including minimal lumen diameter (2.03±0.7 versus 2.36±0.6 mm, P<0.001) and diameter stenosis (23±22 versus 13±17%, P<0.001) were poorer in patients with DES-ISR. Results were consistent in the in-segment and in-lesion analyses. On multiple linear regression analysis, minimal lumen diameter at follow-up remained significantly smaller in patients with DES-ISR. Finally, at 1-year clinical follow-up (100% of patients), mortality (2.6 versus 0%, P<0.01) and need for target vessel revascularization (8 versus 2%, P=0.03) were higher in the DES-ISR group. This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EES provide favorable outcomes in patients with ISR. However, the results of EES are less satisfactory in patients with DES-ISR than in those with bare-metal stent ISR. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01239953 and NCT01239940. © 2016 American Heart Association, Inc.

Air Embolism During TEVAR: Carbon Dioxide Flushing Decreases the Amount of Gas Released from Thoracic Stent-Grafts During Deployment.

PubMed

Rohlffs, Fiona; Tsilimparis, Nikolaos; Saleptsis, Vasilis; Diener, Holger; Debus, E Sebastian; Kölbel, Tilo

2017-02-01

To investigate the amount of gas released from Zenith thoracic stent-grafts using standard saline flushing vs the carbon dioxide flushing technique. In an experimental bench setting, 20 thoracic stent-grafts were separated into 2 groups of 10 endografts. One group of grafts was flushed with 60 mL saline and the other group was flushed with carbon dioxide for 5 minutes followed by 60 mL saline. All grafts were deployed into a water-filled container with a curved plastic pipe; the deployment was recorded and released gas was measured using a calibrated setup. Gas was released from all grafts in both study groups during endograft deployment. The average amount of released gas per graft was significantly lower in the study group with carbon dioxide flushing (0.79 vs 0.51 mL, p=0.005). Thoracic endografts release significant amounts of air during deployment if flushed according to the instructions for use. Application of carbon dioxide for the flushing of thoracic stent-grafts prior to standard saline flush significantly reduces the amount of gas released during deployment. The additional use of carbon dioxide should be considered as a standard flush technique for aortic stent-grafts, especially in those implanted in proximal aortic segments, to reduce the risk of air embolism and stroke.

Randomized Comparison of Ridaforolimus- and Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: Primary Results From the BIONICS Trial (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis).

PubMed

Kandzari, David E; Smits, Pieter C; Love, Michael P; Ben-Yehuda, Ori; Banai, Shmuel; Robinson, Simon D; Jonas, Michael; Kornowski, Ran; Bagur, Rodrigo; Iniguez, Andres; Danenberg, Haim; Feldman, Robert; Jauhar, Rajiv; Chandna, Harish; Parikh, Manish; Perlman, Gidon Y; Balcells, Mercedes; Markham, Peter; Ozan, Melek Ozgu; Genereux, Philippe; Edelman, Elazer R; Leon, Martin B; Stone, Gregg W

2017-10-03

The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, P noninferiority =0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P =0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm ( P noninferiority =0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively ( P noninferiority =0.01). In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01995487. © 2017 American Heart Association, Inc.

Aspirin Use Is Associated With Reduced Risk of Occlusion of Metallic Biliary Stents.

PubMed

Jang, Sunguk; Stevens, Tyler; Parsi, Mansour A; Lopez, Rocio; Vargo, John J

2017-03-01

Biliary self-expandable metallic stents (SEMSs) are widely used to treat malignant and benign conditions of bile duct. Despite their lower rate of occlusion and longer patency than plastic stents, SEMSs still have significant rates of occlusion. We aimed to identify factors associated with occlusion of biliary SEMS. We performed a retrospective study of consecutive patients who underwent endoscopic retrograde cholangiopancreatography with biliary SEMS placement at the Cleveland Clinic Foundation from March 2011 to April 2016. We collected clinical, endoscopic, radiographic, and surgical data from medical records and performed multivariable analysis to identify factors associated with SEMS patency. Subjects that received minimal daily dose of 81 mg at the time of stent placement until the end of follow-up were assigned to the aspirin exposure group (n = 157) and compared with subjects with no aspirin exposure (n = 436). Patients were followed for a median 81 days. The primary outcome was hazard ratio for SEMS occlusion requiring an interventional maneuver for biliary drainage. We analyzed data from patients receiving a total of 593 biliary SEMS for treatment of malignant and benign conditions of bile duct. Stent occlusion was observed in 126 cases. Multivariable analysis showed that daily use of aspirin (81 mg or more) was associated with 51% lower risk of stent occlusion than in patients without daily use of aspirin (hazard ratio, 0.49; 95% confidence interval, 0.32-0.75). Furthermore, SEMSs had a longer duration of stent patency in patients in the aspirin exposure group (434.4 days) versus the no aspirin exposure group (339.9 days) (P < .001). Stricture location limited to distal bile duct (in comparison with strictures involving proximal extrahepatic duct) was associated with lower risk of stent occlusion (hazard ratio, 0.39; 95% CI, 0.22-0.71). In an analysis of a large cohort of subjects with metallic biliary stent placement for malignant and benign conditions of bile duct, we associated daily use of aspirin (81 mg or more) with lower risk of SEMS occlusion and longer stent patency duration. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

The trabecular bypass stent in a pseudophakic glaucoma patient: A 1-year follow-up

PubMed Central

Fea, Antonio M; Dogliani, Monica; Machetta, Federica; Lale-Lacroix, Gabriella; Brogliatti, Beatrice; Grignolo, Federico M

2008-01-01

Purpose To describe the 1-year success of a trabecular stent implant in a pseudophakic glaucoma patient. The stent is implanted through a small corneal incision under gonioscopic control. Intraocular pressure control was reported in cultured human anterior segment. Design Observational case report. Methods We report the case of a patient who was implanted and followed-up for 1 year at the Dipartimento di Fisiopatologia Clinica. The main outcome measures were intraocular pressure and visual field. Results The patient’s intraocular pressure was controlled with topical beta-blockers for 6 months and without therapy for 6 months. Two diurnal curves demonstrated achievement of target pressure during the day. The 1-year visual field was unchanged. Conclusions We are not aware of previous reports of trabecular stent implantation in pseudophakic patients. The trabecular stent had minimal peri-operative morbidity. Identification of the implantation site is challenging and reduction of efficacy over time may occur. PMID:19668446

Impact of vessel curvature on neointimal healing after stent implantation as assessed by optical coherence tomography.

PubMed

Fu, Yandong; Zhang, Shaotao; Du, Hongwei; Li, Lulu; Wang, Chao; Zheng, Gonghui; Wang, Yan; Dong, Hui; Jia, Haibo; Yu, Bo

2018-04-01

Previous studies have indicated that stent implantation could alter the vessel geometry, which may impact the neointimal healing process. Curvature is an important parameter for evaluating vessel geometry. The purpose of our study was to investigate the relationship between vessel curvature and neointimal healing after stent implantation. Fifty-nine patients with acute coronary syndrome (ACS) who underwent stent implantation were enrolled in the study. According to the post-percutaneous coronary intervention vessel curvature measured by quantitative coronary angiography, patients were divided into high (n = 30) and low (n = 29) curvature groups. Neointimal thickness and area together with the neointimal type were assessed by optical coherence tomography at a 6-month follow-up. Baseline clinical characteristics were comparable between the 2 groups. The vessel curvature at pre- and 6-month follow-up was significantly higher in the high curvature group than the low curvature group. At 6-month follow-up, neointimal thickness (0.22 [0.08-0.32] mm vs. 0.10 [0.07-0.16] mm, P = .043) and neointimal area (1.86 [0.66-2.66] vs. 0.82 [0.60-1.41] mm, P = .030) were significantly higher in the high curvature group than the low curvature group. In the high curvature group, the incidence of the heterogeneous neointimal type was higher than that in the low curvature group (50.00% vs. 17.20%, respectively, P = .004), whereas the frequency of the homogeneous neointimal type was lower (43.30% vs. 82.80%, respectively, P = .004) in the high curvature group than the low curvature group. Higher vessel curvature after stent implantation may potentially have an impact on the neointimal healing with a higher incidence of heterogeneous neointimal.

Long-term efficacy and safety of biodegradable-polymer biolimus-eluting stents: main results of the Basel Stent Kosten-Effektivitäts Trial-PROspective Validation Examination II (BASKET-PROVE II), a randomized, controlled noninferiority 2-year outcome trial.

PubMed

Kaiser, Christoph; Galatius, Soeren; Jeger, Raban; Gilgen, Nicole; Skov Jensen, Jan; Naber, Christoph; Alber, Hannes; Wanitschek, Maria; Eberli, Franz; Kurz, David J; Pedrazzini, Giovanni; Moccetti, Tiziano; Rickli, Hans; Weilenmann, Daniel; Vuillomenet, André; Steiner, Martin; Von Felten, Stefanie; Vogt, Deborah R; Wadt Hansen, Kim; Rickenbacher, Peter; Conen, David; Müller, Christian; Buser, Peter; Hoffmann, Andreas; Pfisterer, Matthias

2015-01-06

Biodegradable-polymer drug-eluting stents (BP-DES) were developed to be as effective as second-generation durable-polymer drug-eluting stents (DP-DES) and as safe >1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should no longer appear. To address these early and late aspects, 2291 patients presenting with acute or stable coronary disease needing stents ≥3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9-eluting BP-DES, second-generation everolimus-eluting DP-DES, or thin-strut silicon-carbide-coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute risk difference, 0.78%; -1.93% to 3.50%; P for noninferiority 0.042; per protocol P=0.09) and superior to BMS (absolute risk difference, -5.16; -8.32 to -2.01; P=0.0011). The 3 stent groups did not differ in the combined safety end point, with no decrease in events >1 year, particularly VLST with BP-DES. In large vessel stenting, BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS, but without evidence for better safety nor lower VLST rates >1 year. Findings challenge the concept that durable polymers are key in VLST formation. http://www.clinicaltrials.gov. Unique identifier: NCT01166685. © 2014 American Heart Association, Inc.

Fabrication of Small Caliber Stent-grafts Using Electrospinning and Balloon Expandable Bare Metal Stents.

PubMed

Uthamaraj, Susheil; Tefft, Brandon J; Jana, Soumen; Hlinomaz, Ota; Kalra, Manju; Lerman, Amir; Dragomir-Daescu, Dan; Sandhu, Gurpreet S

2016-10-26

Stent-grafts are widely used for the treatment of various conditions such as aortic lesions, aneurysms, emboli due to coronary intervention procedures and perforations in vasculature. Such stent-grafts are manufactured by covering a stent with a polymer membrane. An ideal stent-graft should have a biocompatible stent covered by a porous, thromboresistant, and biocompatible polymer membrane which mimics the extracellular matrix thereby promoting injury site healing. The goal of this protocol is to manufacture a small caliber stent-graft by encapsulating a balloon expandable stent within two layers of electrospun polyurethane nanofibers. Electrospinning of polyurethane has been shown to assist in healing by mimicking native extracellular matrix, thereby promoting endothelialization. Electrospinning polyurethane nanofibers on a slowly rotating mandrel enabled us to precisely control the thickness of the nanofibrous membrane, which is essential to achieve a small caliber balloon expandable stent-graft. Mechanical validation by crimping and expansion of the stent-graft has shown that the nanofibrous polyurethane membrane is sufficiently flexible to crimp and expand while staying patent without showing any signs of tearing or delamination. Furthermore, stent-grafts fabricated using the methods described here are capable of being implanted using a coronary intervention procedure using standard size guide catheters.

Analysis of Iliac Artery Geometric Properties in Fenestrated Aortic Stent Graft Rotation.

PubMed

Doyle, Matthew G; Crawford, Sean A; Osman, Elrasheed; Eisenberg, Naomi; Tse, Leonard W; Amon, Cristina H; Forbes, Thomas L

2018-04-01

A complication of fenestrated endovascular aneurysm repair is the potential for stent graft rotation during deployment causing fenestration misalignment and branch artery occlusion. The objective of this study is to demonstrate that this rotation is caused by a buildup of rotational energy as the device is delivered through the iliac arteries and to quantify iliac artery geometric properties associated with device rotation. A retrospective clinical study was undertaken in which iliac artery geometric properties were assessed from preoperative imaging for 42 cases divided into 2 groups: 27 in the nonrotation group and 15 in the rotation group. Preoperative computed tomography scans were segmented, and the iliac artery centerlines were determined. Iliac artery tortuosity, curvature, torsion, and diameter were calculated from the centerline and the segmented vessel geometry. The total iliac artery net torsion was found to be higher in the rotation group compared to the nonrotation group (23.5 ± 14.7 vs 14.6 ± 12.8 mm -1 ; P = .05). No statistically significant differences were found for the mean values of tortuosity, curvature, torsion, or diameter between the 2 groups. Stent graft rotation occurred in 36% of the cases considered in this study. Cases with high iliac artery total net torsion were found to be more likely to have stent graft rotation upon deployment. This retrospective study provides a framework for prospectively studying the influence of iliac artery geometric properties on fenestrated stent graft rotation.

Ureteric stents vs percutaneous nephrostomy for initial urinary drainage in children with obstructive anuria and acute renal failure due to ureteric calculi: a prospective, randomised study.

PubMed

ElSheemy, Mohammed S; Shouman, Ahmed M; Shoukry, Ahmed I; ElShenoufy, Ahmed; Aboulela, Waseem; Daw, Kareem; Hussein, Ahmed A; Morsi, Hany A; Badawy, Hesham

2015-03-01

To compare percutaneous nephrostomy (PCN) tube vs JJ ureteric stenting as the initial urinary drainage method in children with obstructive calcular anuria (OCA) and post-renal acute renal failure (ARF) due to bilateral ureteric calculi, to identify the selection criteria for the initial urinary drainage method that will improve urinary drainage, decrease complications and facilitate the subsequent definitive clearance of stones, as this comparison is lacking in the literature. A series of 90 children aged ≤12 years presenting with OCA and ARF due to bilateral ureteric calculi were included from March 2011 to September 2013 at Cairo University Pediatric Hospital in this randomised comparative study. Patients with grade 0-1 hydronephrosis, fever or pyonephrosis were excluded. No patient had any contraindication for either method of drainage. Stable patients (or patients stabilised by dialysis) were randomised (non-blinded, block randomisation, sealed envelope method) into PCN-tube or bilateral JJ-stent groups (45 patients for each group). Initial urinary drainage was performed under general anaesthesia and fluoroscopic guidance. We used 4.8-6 F JJ stents or 6-8 F PCN tubes. The primary outcomes were the safety and efficacy of both groups for the recovery of renal functions. Both groups were compared for operative and imaging times, complications, and the period required for a return to normal serum creatinine levels. The secondary outcomes included the number of subsequent interventions needed for clearance of stones. Additional analysis was done for factors affecting outcome within each group. All presented patients completed the study with intention-to-treat analysis. There was no significant difference between the PCN-tube and JJ-stent groups for the operative and imaging times, period for return to a normal creatinine level and failure of insertion. There were significantly more complications in the PCN-tube group. The stone size (>2 cm) was the only factor affecting the rates of mucosal complications, operative time and failure of insertion in the JJ-stent group. The degree of hydronephrosis significantly affected the operative time for PCN-tube insertion. Grade 2 hydronephrosis was associated with all cases of insertion failure in the PCN-tube group. The total number of subsequent interventions needed to clear stones was significantly higher in the PCN-tube group, especially in patients with bilateral stones destined for chemolytic dissolution (alkalinisation) or extracorporeal shockwave lithotripsy (ESWL). We recommend the use of JJ stents for initial urinary drainage for stones that will be subsequently treated with chemolytic dissolution or ESWL, as this will lower the total number of subsequent interventions needed to clear the stones. This is also true for stones destined for ureteroscopy (URS), as JJ-stent insertion will facilitate subsequent URS due to previous ureteric stenting. Mild hydronephrosis will prolong the operative time for PCN-tube insertion and may increase the incidence of insertion failure. We recommend the use of PCN tube if the stone size is >2 cm, as there was a greater risk of possible iatrogenic ureteric injury during stenting with these larger ureteric stones in addition to prolongation of operative time with an increased incidence of failure. © 2014 The Authors. BJU International © 2014 BJU International.

Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation.

PubMed

Camenzind, Edoardo; Wijns, William; Mauri, Laura; Boersma, Eric; Parikh, Keyur; Kurowski, Volkhard; Gao, Runlin; Bode, Christoph; Greenwood, John P; Gershlick, Anthony; O'Neill, William; Serruys, Patrick W; Jorissen, Brenda; Steg, P Gabriel

2009-12-01

Drug-eluting stents (DES) reduce restenosis rates compared to bare-metal stents. Most trials using DES enrolled selected patient and lesion subtypes, and primary endpoint focused on angiographic metrics or relatively short-term outcomes. When DES are used in broader types of lesions and patients, important differences may emerge in long-term outcomes between stent types, particularly the incidence of late stent thrombosis. PROTECT is a randomized, open-label trial comparing the long-term safety of the zotarolimus-eluting stent and the sirolimus-eluting stent. The trial has enrolled 8,800 patients representative of those seen in routine clinical practice, undergoing elective, unplanned, or emergency procedures in native coronary arteries in 196 centers in 36 countries. Indications for the procedure and selection of target vessel and lesion characteristics were at the operator's discretion. Procedures could be staged, but no more than 4 target lesions could be treated per patient. Duration of dual antiplatelet therapy was prespecified to achieve similar lengths of treatment in both study arms. The shortest predefined duration was 3 months, as per the manufacturer's instructions. The primary outcome measure is the composite rate of definite and probable stent thrombosis at 3 years, centrally adjudicated using Academic Research Consortium definitions. The main secondary end points are 3-year all-cause mortality, cardiac death, large nonfatal myocardial infarction, and all myocardial infarctions. This large, international, randomized, controlled trial will provide important information on comparative rates of stent thrombosis between 2 different DES systems and safety as assessed by patient-relevant long-term clinical outcomes.

[Stent-assisted recanalization of femoropopliteal arterial occlusive disease. Influence of stent design on patency rates].

PubMed

Treitl, M; Reiser, M F; Treitl, K M

2016-03-01

Despite enormous technical progress the results of endovascular treatment of the femoropopliteal vasculature are unsatisfactory and its role is still controversially discussed. In the past decade numerous new stent designs have come onto the market but it is unclear whether they have benefits with respect to patency rates. Comparison of published data on patency rates and target lesion revascularization rates after use of different stent designs in the femoropopliteal vasculature. Analysis of 25 published studies and registries from 2006 to 2015 for classical open-cell stents, interwoven stents and partially or fully covered stents. The published data are heterogeneous and comparative studies for different stent designs are completely missing. Over the past decade the patency rates after femoropopliteal stenting could be improved. According to available data stenting of short lesions < 5 cm does not show any benefit compared to isolated balloon angioplasty. Primary stenting is now recommended for intermediate and longer lesions > 6.4 cm. Due to the heterogeneity of published data a clear benefit for a specific stent design is not obvious; however, data for interwoven stents are promising and show a tendency towards improved patency, at least for certain lesions. Randomized controlled comparative trials are needed to confirm this result.

A cost analysis of stenting in uncomplicated semirigid ureteroscopic stone removal.

PubMed

Seklehner, Stephan; Sievert, Karl-Dietrich; Lee, Richard; Engelhardt, Paul F; Riedl, Claus; Kunit, Thomas

2017-05-01

To evaluate the outcome and the costs of stenting in uncomplicated semirigid ureteroscopic stone removal. A decision tree model was created to evaluate the economic impact of routine stenting versus non-stenting strategies in uncomplicated ureteroscopy (URS). Probabilities of complications were extracted from twelve randomized controlled trials. Stone removal costs, costs for complication management, and total costs were calculated using Treeage Pro (TreeAge Pro Healthcare version 2015, Software, Inc, Williamstown Massachusetts, USA). Stone removal costs were higher in stented URS (€1512.25 vs. €1681.21, respectively). Complication management costs were higher in non-stented procedures. Both for complications treated conservatively (€189.43 vs. €109.67) and surgically (€49.26 vs. €24.83). When stone removal costs, costs for stent removal, and costs for complication management were considered, uncomplicated URS with stent placement yielded an overall cost per patient of €1889.15 compared to €1750.94 without stent placement. The incremental costs of stented URS were €138.25 per procedure. Semirigid URS with stent placement leads to higher direct procedural costs. Costs for managing URS-related complications are higher in non-stented procedures. Overall, a standard strategy of deferring routine stenting uncomplicated ureteroscopic stone removal is more cost efficient.

Nitinol Esophageal Stents: New Designs and Clinical Indications

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

Strecker, Ernst-Peter; Boos, Irene; Vetter, Sylvia

1996-11-15

Purpose: To evaluate the clinical use of covered and noncovered, knitted nitinol stents in patients presenting new stent indications. Methods: Self-expandable, knitted nitinol stents were implanted in four patients for treatment of dysphagia. In two patients who had malignant strictures and had esophago-respiratory fistulae and in one patient with an esophagocutaneous fistula, polytetrafluoroethylene (PTFE)-covered stents were implanted. One patient received a noncovered stent, but a retrograde approach through a percutaneous endoscopic gastrostomy (PEG) fistula had to be chosen for recanalization of an esophageal occlusion. Two patients received stents for treatment of benign strictures. Results: Recanalization of the stricture and stentmore » implantation were performed under fluoroscopic control without any procedure-related morbidity or mortality. Dysphagia improved in all patients and the esophageal fistulae could be sealed off by covered stents. During a maximum follow-up of 18 months, there was no stent migration or esophageal perforation. Complications observed were stent stenosis due to food impaction (1/4) and benign stent stenosis (2/2). Most complications could be treated by the interventional radiologist. Conclusion: Self-expandable, covered Nitinol stents provide an option for the treatment of dysphagia combined with esophageal fistulae. In combination with interventional radiology techniques, even complex strictures are accessible. For benign strictures, the value of stent treatment has not yet been proven.« less

Repair of a common bile duct defect with a decellularized ureteral graft

PubMed Central

Cheng, Yao; Xiong, Xian-Ze; Zhou, Rong-Xing; Deng, Yi-Lei; Jin, Yan-Wen; Lu, Jiong; Li, Fu-Yu; Cheng, Nan-Sheng

2016-01-01

AIM To evaluate the feasibility of repairing a common bile duct defect with a decellularized ureteral graft in a porcine model. METHODS Eighteen pigs were randomly divided into three groups. An approximately 1 cm segment of the common bile duct was excised from all the pigs. The defect was repaired using a 2 cm long decellularized ureteral graft over a T-tube (T-tube group, n = 6) or a silicone stent (stent group, n = 6). Six pigs underwent bile duct reconstruction with a graft alone (stentless group). The surviving animals were euthanized at 3 mo. Specimens of the common bile ducts were obtained for histological analysis. RESULTS The animals in the T-tube and stent groups survived until sacrifice. The blood test results were normal in both groups. The histology results showed a biliary epithelial layer covering the neo-bile duct. In contrast, all the animals in the stentless group died due to biliary peritonitis and cholangitis within two months post-surgery. Neither biliary epithelial cells nor accessory glands were observed at the graft sites in the stentless group. CONCLUSION Repair of a common bile duct defect with a decellularized ureteral graft appears to be feasible. A T-tube or intraluminal stent was necessary to reduce postoperative complications. PMID:28082809

Magnetoelastic galfenol as a stent material for wirelessly controlled degradation rates.

PubMed

DeRouin, Andrew; Guillory, Roger; He, Weilue; Frost, Megan; Goldman, Jeremy; Ong, Keat Ghee

2018-03-23

The gold standard of care for coronary artery disease, a leading cause of death for in the world, is balloon angioplasty in conjunction with stent deployment. However, implantation injuries and long-term presence of foreign material often promotes significant luminal tissue growth, leading to a narrowing of the artery and severely restricted blood flow. A promising method to mitigate this process is the use of biodegradable metallic stents, but thus far they have either degraded too slowly (iron) or disappeared prematurely (magnesium). The present work investigates the use of a unique type of magnetic material, galfenol (iron-gallium), for postoperative wireless control of stent degradation rates. Due to its magnetoelastic property, galfenol experiences longitudinal micron-level elongations when exposed to applied magnetic fields, allowing generation of a microstirring effect that affect its degradation behavior. In vitro indirect cytotoxicity tests on primary rat aortic smooth muscle cells indicated that galfenol byproducts must be concentrated approximately seven times from collected 60 day degradation medium to cause ∼15% of death from all cells. Surface and cross-sectional characterization of the material indicate that galfenol (Fe 80 Ga 20 ) degradation rates (∼0.55% per month) are insufficient for stenting applications. While this material may not be ideal for comprising the entire stent, there is potential for use in combination with other materials. Furthermore, the ability to control degradation rates postimplantation opens new possibilities for biodegradable stents; additional magnetoelastic materials should be investigated for use in stenting applications. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2018. © 2018 Wiley Periodicals, Inc.

Fluoroscopy-assisted vs fluoroless endoscopic ultrasound-guided transmural drainage of pancreatic fluid collections: A comparative study.

PubMed

Consiglieri, Claudia F; Gornals, Joan B; Busquets, Juli; Peláez, Nuria; Secanella, Lluis; De-La-Hera, Meritxell; Sanzol, Resurrección; Fabregat, Joan; Castellote, José

2018-01-01

The need for fluoroscopy guidance in patients undergoing endoscopic ultrasound-guided transmural drainage (EUS-TMD) of peripancreatic fluid collections (PFCs) remains unclear. The aim of this study was to compare general outcomes of EUS-TMD of PFCs under fluoroscopy (F) vs fluoroless (FL). This is a comparative study with a retrospective analysis of a prospective and consecutive inclusion database at a tertiary centre, from 2009 to 2015. All patients were symptomatic pseudocyst (PSC) and walled-off pancreatic necrosis (WON). Two groups were assigned depending on availability of fluoroscopy. The groups were heterogeneous in terms of their demographic characteristics, PFCs and procedure. The main outcome measures included technical and clinical success, incidences, adverse events (AEs), and follow-up. Fifty EUS-TMD of PFCs from 86 EUS-guided drainages were included during the study period. Group F included 26 procedures, PSC 69.2%, WON 30.8%, metal stents 61.5% (46.1% lumen-apposing stent) and plastic stents 38.5%. Group FL included 24 procedures, PSC 37.5%, WON 62.5%, and metal stents 95.8% (lumen-apposing stents). Technical success was 100% in both groups, and clinical success was similar (F 88.5%, FL 87.5%). Technical incidences and intra-procedure AEs were only described in group F (7.6% and 11.5%, respectively) and none in group FL. Procedure time was less in group FL (8min, p=0.0341). Fluoroless in the EUS-TMD of PFCs does not involve more technical incidences or intra-procedure AEs. Technical and clinical success was similar in the two groups. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

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

PubMed Central

Bishu, Kalkidan; Armstrong, Ehrin J

2015-01-01

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

[Immediate and Long-term Results of the First in Russia of IntrocoronaryMetal Stent in the Coronary Artery].

PubMed

Babunashvili, A M; Navtsishvili, Z G; Konstantinov, B A

2016-02-01

The authors present immediate and long term results of the first in Russia implantation in coronary artery of Palmaz-Shatz metal stent. Indications for stenting were urgent after complicated dissection as a result of balloon dilation of discrete bifurcational stenosis of anterior interventricular artery (IVA). Immediate angiographic and clinical result was good. At control angiography after 13 years their was no restenosis in stented IVA. However novel narrowing was found in left main coronary artery (LMCA) in which drug eluting stent was implanted. Coronary angiography carried out after 7.5 years after stenting of LMCA and in 20 years after stent implantation in IVA revealed good patency of both stented segments without signs of restenosis. This case report demonstrates possibility of long term preservation of angiographic and clinical effect of staged endovascular treatment of coronary atherosclerosis.

Effectiveness of presurgical nasoalveolar molding therapy on unilateral cleft lip nasal deformity

PubMed Central

Kinouchi, Nao; Horiuchi, Shinya; Yasue, Akihiro; Kuroda, Yuko; Kawai, Nobuhiko; Watanabe, Keiichiro; Izawa, Takashi; Hashimoto, Ichiro; Hassan, Ali H.; Tanaka, Eiji

2018-01-01

Objectives: To evaluate the effectiveness of pre-surgical nasoalveolar molding (PNAM) in patients with unilateral cleft lip nasal deformities. Methods: This was a retrospective study involving 29 patients with unilateral cleft lip and palate defects, of whom 13 were treated with palatal devices with nasal stents (PNAM group) and 16 were treated with palatal devices without nasal stents or surgical tapes (control group). Submental oblique photographs and orthodontic models were longitudinally obtained at the initial visit (T1) and immediately before (T2) and after cheiloplasty (T3). Asymmetry of the external nose, degree of columellar shifting, nasal tip/ala nose ratio, nasal base angle, interalveolar gap, and the sagittal difference in the alveolar gap were measured. The study was conducted in the Orthodontic Clinic at Tokushima University Hospital, Tokushima, Japan between 1997 and 2012. Results: At T1, there were no significant intergroup differences in the first 4 asymmetry parameters. At T2, the PNAM group showed a significant improvement in all values compared to the control group. At T3, the PNAM group showed significant improvement in nasal asymmetry and columellar shifting. Model analysis showed significantly greater changes in the inter-alveolar gap and the sagittal difference of the alveolar cleft gap from T1 to T2 in the PNAM group. Conclusion: The use of PNAM is indispensable for pre-surgical orthodontic treatment at the early postnatal age. PMID:29436566

Effectiveness of presurgical nasoalveolar molding therapy on unilateral cleft lip nasal deformity.

PubMed

Kinouchi, Nao; Horiuchi, Shinya; Yasue, Akihiro; Kuroda, Yuko; Kawai, Nobuhiko; Watanabe, Keiichiro; Izawa, Takashi; Hashimoto, Ichiro; Hassan, Ali H; Tanaka, Eiji

2018-02-01

To evaluate the effectiveness of pre-surgical nasoalveolar molding (PNAM) in patients with unilateral cleft lip nasal deformities. Methods: This was a retrospective study involving 29 patients with unilateral cleft lip and palate defects, of whom 13 were treated with palatal devices with nasal stents (PNAM group) and 16 were treated with palatal devices without nasal stents or surgical tapes (control group). Submental oblique photographs and orthodontic models were longitudinally obtained at the initial visit (T1) and immediately before (T2) and  after cheiloplasty (T3). Asymmetry of the external nose, degree of columellar shifting, nasal tip/ala nose ratio, nasal base angle, interalveolar gap, and the sagittal difference in the alveolar gap were measured. The study was conducted in the Orthodontic Clinic at Tokushima University Hospital, Tokushima, Japan between 1997 and 2012. Results: At T1, there were no significant intergroup differences in the first 4 asymmetry parameters. At T2, the PNAM group showed a significant improvement in all values compared to the control group. At T3, the PNAM group showed significant improvement in nasal asymmetry and columellar shifting. Model analysis showed significantly greater changes in the inter-alveolar gap and the sagittal difference of the alveolar cleft gap from T1 to T2 in the PNAM group. Conclusion: The use of PNAM is indispensable for pre-surgical orthodontic treatment at the early postnatal age.

Control of Fibrinogen Assembly by Changing a Polarity of Surfaces

NASA Astrophysics Data System (ADS)

Koo, Jaseung; Liu, Ying; Snow, Sara; Rambhia, Pooja; Koga, Tadanori; Rafailovich, Miriam; Galanakis, Dennis

2009-03-01

Thrombogenesis causes various problems associated with an interruption in the blood flow (e.g., myocardial and cerebral infarction), and a hindrance to use of blood-contact vascular biomaterials (e.g., hemodialysis and cardiopulmonary bypass) with long-term patency since undesired adsorption of blood components occurs on vessels or biomaterials, such as surface-induced thrombosis. we showed that this clotting procedure can be occurred on hydrophobic polymeric surfaces without thrombin cleavage. However, the fibrinogen fibers were not formed on the polar surface such as spun-cast polymer film with pyridine and phenol groups. We also found that αC domains play an important role in initiation of polymerization on surface. Therefore, molecular association was inhibited on the polar surfaces due to confinement of αC chains on the surfaces. These findings were directly applied to stent surface modification. The commercial stent consist of Co-Cr alloy forms undesired fiber formation. However, PS-r-PVPh (13% phenol) coated stent surfaces completely prevent fiber formation.

Surface modification of metallic cardiovascular stents by strongly adhering aliphatic polyester coatings.

PubMed

Jérôme, Christine; Aqil, Abdelhafid; Voccia, Samuël; Labaye, David-Emmanuel; Maquet, Véronique; Gautier, Sandrine; Bertrand, Olivier F; Jérôme, Robert

2006-03-01

This article reports on a novel two-step strategy for the coating of cardiovascular stents by strongly adhering biocompatible and biodegradable aliphatic polyesters. First, a precoating of poly(ethylacrylate) (PEA) was electrografted onto the metallic substrate by cathodic reduction of the parent monomer in dimethylformamide (DMF). The electrodeposition of PEA, in a good solvent of it, was confirmed by both Infra-red and Raman spectroscopies. The pendant ester groups of PEA were then chemically reduced into aluminum alkoxides, able to initiate the ring-opening polymerization (ROP) of either D,L-lactide (LA) or epsilon-caprolactone (CL). Growth of biodegradable PLA or PCL coatings from the adhering precoating was confirmed by both Infra-red and Raman spectroscopies, and directly observed by scanning electron microscopy (SEM). This type of coating can act as an anchoring layer for the subsequent casting of drug-loaded polyester films allowing the controlled release of antiproliferative agents for the treatment of in-stent restenosis. (c) 2005 Wiley Periodicals, Inc.

Composite self-expanding bioresorbable prototype stents with reinforced compression performance for congenital heart disease application: Computational and experimental investigation.

PubMed

Zhao, Fan; Xue, Wen; Wang, Fujun; Liu, Laijun; Shi, Haoqin; Wang, Lu

2018-08-01

Stents are vital devices to treat vascular stenosis in pediatric patients with congenital heart disease. Bioresorbable stents (BRSs) have been applied to reduce challenging complications caused by permanent metal stents. However, it remains almost a total lack of BRSs with satisfactory compression performance specifically for children with congenital heart disease, leading to importantly suboptimal effects. In this work, composite bioresorbable prototype stents with superior compression resistance were designed by braiding and annealing technology, incorporating poly (p-dioxanone) (PPDO) monofilaments and polycaprolactone (PCL) multifilament. Stent prototype compression properties were investigated. The results revealed that novel composite prototype stents showed superior compression force compared to the control ones, as well as recovery ability. Furthermore, deformation mechanisms were analyzed by computational simulation, which revealed bonded interlacing points among yarns play an important role. This research presents important clinical implications in bioresorbable stent manufacture and provides further study with an innovative stent design. Copyright © 2018 Elsevier Ltd. All rights reserved.

Tracheomalacia Treatment Using a Large-Diameter, Custom-Made Airway Stent in a Case with Mounier-Kuhn Syndrome

PubMed Central

Özdemir, Cengiz; Sökücü, Sinem Nedime; Karasulu, Levent; Altın, Sedat; Dalar, Levent

2014-01-01

Mounier-Kuhn Syndrome (MKS) is a rare congenital disease that presents with abnormal enlargement in the central airways. In MKS, tracheomegaly is accompanied by difficulty in expelling recurrent lung infections and bronchiectasia. We presented a patient with MKS where commercially made stents were inadequate for stabilization and a custom-made, self-expandable metallic stent with a diameter of 28 mm and length of 100 mm was used. Chest pain that was thought to develop due to the stent and that disappeared after stent removal may be considered the main complication leading to stent removal. Continuous positive airway pressure therapy (CPAP) therapy was planned for the control of symptoms, which re-emerged after stent removal. This case is presented as an example that complications developing due to the stent as well as patient noncompliance may lead to stent removal, even when useful results are obtained from treatment of MKS. PMID:25276462

Plastic or metal stents for benign extrahepatic biliary strictures: a systematic review

PubMed Central

2009-01-01

Background Benign biliary strictures may be a consequence of surgical procedures, chronic pancreatitis or iatrogenic injuries to the ampulla. Stents are increasingly being used for this indication, however it is not completely clear which stent type should be preferred. Methods A systematic review on stent placement for benign extrahepatic biliary strictures was performed after searching PubMed and EMBASE databases. Data were pooled and evaluated for technical success, clinical success and complications. Results In total, 47 studies (1116 patients) on outcome of stent placement were identified. No randomized controlled trials (RCTs), one non-randomized comparative studies and 46 case series were found. Technical success was 98,9% for uncovered self-expandable metal stents (uSEMS), 94,8% for single plastic stents and 94,0% for multiple plastic stents. Overall clinical success rate was highest for placement of multiple plastic stents (94,3%) followed by uSEMS (79,5%) and single plastic stents (59.6%). Complications occurred more frequently with uSEMS (39.5%) compared with single plastic stents (36.0%) and multiple plastic stents (20,3%). Conclusion Based on clinical success and risk of complications, placement of multiple plastic stents is currently the best choice. The evolving role of cSEMS placement as a more patient friendly and cost effective treatment for benign biliary strictures needs further elucidation. There is a need for RCTs comparing different stent types for this indication. PMID:20017920

Renal embolic protection devices improve blood flow after stenting for atherosclerotic renal artery stenosis.

PubMed

Paul, Timir K; Lee, John H; White, Christopher J

2012-11-15

We sought to measure angiographic renal frame counts (RFC), as a quantitative angiographic assessment of renal blood flow, to evaluate microvascular compromise due to atheroembolism associated with RAS. Atheroembolism associated with renal artery stenting (RAS) has been implicated as a cause for worsening renal function following successful intervention. Use of a distal embolic protection device (EPD) during RAS has been shown to be safe with debris capture in a high percentage of cases. However, objective benefit for renal function with EPD has been difficult to demonstrate. A control group of 30 consecutive patients (33 kidneys) who underwent RAS without EPD were compared with 33 consecutive patients (33 kidneys) who underwent RAS with EPD using RFC measurement. The prestent and poststent mean RFC for the control group was 30.4 ± 12.1 vs. 23.7 ± 9.9 (P = 0.002) and for the EPD group it was 42.6 ± 12.6 vs. 28.3 ± 9.2 (P < 0.0001). The EPD group had a greater improvement in renal blood flow, manifested by a greater reduction of the RFC (Δ RFC) 14.2 ± 15.2 vs. 6.7 ± 11.7 (P = 0.03) compared with the control group. The use of an EPD was associated with a much larger improvement in renal blood flow (lower RFC) following RAS. This suggests that EPD's may be effective in preventing renal atheroembolic injury and that a controlled trial measuring the impact of EPD's on renal blood flow following RAS should be performed. Copyright © 2012 Wiley Periodicals, Inc.

Titanium-nitride-oxide-coated coronary stents: insights from the available evidence.

PubMed

Karjalainen, Pasi P; Nammas, Wail

2017-06-01

Coating of stent surface with a biocompatible material is suggested to improve stent safety profile. A proprietary process was developed to coat titanium-nitride-oxide on the stent surface, based on plasma technology that uses the nano-synthesis of gas and metal. Preclinical in vitro and in vivo investigation confirmed blood compatibility of titanium (nitride-) oxide films. Titanium-nitride-oxide-coated stents demonstrated a better angiographic outcome, compared with bare-metal stents at mid-term follow-up; however, they failed to achieve non-inferiority for angiographic outcome versus second-generation drug-eluting stents. Observational studies showed adequate clinical outcome at mid-term follow-up. Non-randomized studies showed an outcome of titanium-nitride-oxide-coated stents comparable to - or better than - first-generation drug-eluting stents at long-term follow-up. Two randomized controlled trials demonstrated comparable efficacy outcome, and a better safety outcome of titanium-nitride-oxide-coated stents versus drug-eluting stents at long-term follow-up. Evaluation by optical coherence tomography at mid-term follow-up revealed better neointimal strut coverage associated with titanium-nitride-oxide-coated stents versus drug-eluting stents; yet, neointimal hyperplasia thickness was greater. Key messages Stents coated with titanium-nitride-oxide demonstrated biocompatibility in preclinical studies: they inhibit platelet and fibrin deposition, and reduce neointimal growth. In observational and non-randomized studies, titanium-nitride-oxide-coated stents were associated with adequate safety and efficacy outcome. In randomized trials of patients with acute coronary syndrome, titanium-nitride-oxide-coated stents were associated with a better safety outcome, compared with drug-eluting stents; efficacy outcome was comparable.

Stent implantation into the tracheo-bronchial system in rabbits: histopathologic sequelae in bare metal vs. drug-eluting stents.

PubMed

Sigler, Matthias; Klötzer, Julia; Quentin, Thomas; Paul, Thomas; Möller, Oliver

2015-12-01

Stent implantation into the tracheo-bronchial system may be life-saving in selected pediatric patients with otherwise intractable stenosis of the upper airways. Following implantation, significant tissue proliferation may occur, requiring re-interventions. We sought to evaluate the effect of immunosuppressive coating of the stents on the extent of tissue proliferation in an animal model. Bare metal and sirolimus-coated stents (Bx Sonic and Cypher Select, Johnson & Johnson, Cordis) were implanted into non-stenotic lower airways of New Zealand white rabbits (weight 3.1 to 4.8 kg). Three stents with sirolimus coating and six bare metal stents could be analyzed by means of histology and immunohistochemistry 12 months after implantation. On a macroscopic evaluation, all stents were partially covered with a considerable amount of whitish tissue. Histologically, these proliferations contained fiber-rich connective tissue and some fibromuscular cells without significant differences between both stent types. The superficial tissue layer was formed by typical respiratory epithelium and polygonal cells. Abundant lymphocyte infiltrations and moderate granulocyte infiltrations were found in both groups correspondingly, whereas foreign-body reaction was more pronounced around sirolimus-eluting stents. After stent implantation in the tracheo-bronchial system of rabbits, we found tissue reactions comparable to those seen after stent implantation into the vascular system. There was no difference between coated and uncoated stents with regard to quality and quantity of tissue proliferation. We found, however, a significantly different inflammatory reaction with a more pronounced foreign-body reaction in sirolimus-coated stents. In our small series, drug-eluting stents did not exhibit any benefit over bare metal stents in an experimental setting.

Amniotic Membrane Grafts for the Prevention of Esophageal Stricture after Circumferential Endoscopic Submucosal Dissection

PubMed Central

Barret, Maximilien; Pratico, Carlos Alberto; Camus, Marine; Beuvon, Frédéric; Jarraya, Mohamed; Nicco, Carole; Mangialavori, Luigi; Chaussade, Stanislas; Batteux, Frédéric; Prat, Frédéric

2014-01-01

Background and Aims The prevention of esophageal strictures following circumferential mucosal resection remains a major clinical challenge. Human amniotic membrane (AM) is an easily available material, which is widely used in ophthalmology due to its wound healing, anti-inflammatory and anti-fibrotic properties. We studied the effect of AM grafts in the prevention of esophageal stricture after endoscopic submucosal dissection (ESD) in a swine model. Animals and Methods In this prospective, randomized controlled trial, 20 swine underwent a 5 cm-long circumferential ESD of the lower esophagus. In the AM Group (n = 10), amniotic membrane grafts were placed on esophageal stents; a subgroup of 5 swine (AM 1 group) was sacrificed on day 14, whereas the other 5 animals (AM 2 group) were kept alive. The esophageal stent (ES) group (n = 5) had ES placement alone after ESD. Another 5 animals served as a control group with only ESD. Results The prevalence of symptomatic strictures at day 14 was significantly reduced in the AM group and ES groups vs. the control group (33%, 40% and 100%, respectively, p = 0.03); mean esophageal diameter was 5.8±3.6 mm, 6.8±3.3 mm, and 2.6±1.7 mm for AM, ES, and control groups, respectively. Median (range) esophageal fibrosis thickness was 0.87 mm (0.78–1.72), 1.19 mm (0.28–1.95), and 1.65 mm (0.7–1.79) for AM 1, ES, and control groups, respectively. All animals had developed esophageal strictures by day 35. Conclusions The anti-fibrotic effect of AM on esophageal wound healing after ESD delayed the development of esophageal stricture in our model. However, this benefit was of limited duration in the conditions of our study. PMID:24992335

Fourth update on CT angiography of coronary stents: in vitro evaluation of 24 novel stent types.

PubMed

Hickethier, Tilman; Wenning, Justus; Doerner, Jonas; Maintz, David; Michels, Guido; Bunck, Alexander C

2017-01-01

Background Non-invasive evaluation of coronary stent patency by coronary computed tomography angiography (cCTA) remains challenging. Multiple studies showed that CT technology but also individual stent design strongly influence the assessability of coronary stents by cCTA. Purpose To expand the available data on cCTA characteristics of coronary stents by 24 novel types to help interpreting examinations of patients after stent placement and selecting which stents are suitable for assessment by cCTA. Material and Methods Twenty-four novel coronary stents (17 cobalt-chromium, six stainless-steel, one platinum-chromium) were examined in a coronary phantom. Standard cCTA parameters with stent-specific algorithms were used. Image quality was quantified for each stent using established parameters (in-stent attenuation alteration and visible lumen diameter). Results Most stents (n = 14) showed lumen visibilities of 45-55%. No severe restriction of lumen visibility (>60%) was found. The majority of stents (n = 13) caused only small intraluminal attenuation deviations and no severe alterations (>20%) were found. When grouped by manufacturing material, no significant differences were found between cobalt-chromium and stainless-steel with identical mean visible diameters (1.52 ± 0.17 mm vs. 1.52 ± 0.13 mm) and comparable attenuation alterations (35.04 ± 16.56 HU vs. 21.25 ± 14.60 HU). The only platinum-chromium stent showed a smaller visible diameter (1.23 mm) and higher attenuation alteration (41.70 HU), but was also deemed to be assessable by cCTA. Conclusion All 24 novel evaluated stents are eligible for non-invasive evaluation by cCTA without significant differences between cobalt-chromium and stainless-steel stents. This updated catalogue of CT appearances of current coronary stents may serve as reference when taking care of patients with stents in need of coronary imaging.

Biliary sphincteroplasty facilitates retrieval of proximally migrated plastic biliary stent.

PubMed

Shah, Dharmesh K; Jain, Samit S; Somani, Piyush O; Rathi, Pravin M

2014-01-01

Proximal migration of biliary stents presents a technical challenge for the therapeutic endoscopist. It may require multiple, complicated corrective procedures resulting in significant morbidity to the patients. In this study we evaluated the utility of balloon biliary sphincteroplasty with CRE (Controlled Radial Expansion) Balloon Dilator on retrieval of proximally migrated biliary stents. We identified patients from our ERCP database who presented with proximal migration of biliary stent, between August 2011 and October 2013. Patients in whom the stent could not be retrieved with conventional methods, balloon sphincteroplasty was performed with a 12 mm CRETM Balloon Dilator (Boston Scientific). Stent removal was attempted with extraction balloon or basket thereafter. We identified 28 patients with proximal migration of biliary stents, placed for benign diseases of the common bile duct. Stent removal was successful in 18 patients (64.28%) with help of an extraction balloon or basket. Of the remaining 10 patients, balloon sphincteroplasty was successfully followed by stent removal in eight patients. Balloon biliary sphincteroplasty increases the success rate of retrieving proximally migrated biliary stents. The procedure is safe, technically easy and yields a good success rate in our experience.

[Changes of brain function and cognitive function after carotid artery stenting].

PubMed

Lu, Z X; Deng, G; Wei, H L; Zhao, G F; Wen, L Z; Chen, X

2017-10-24

Objective: To investigate the effect of carotid artery stenting(CAS) on cognitive function and brain function based on changes of a battery of neuropsychological tests and magnetic resonance imaging. Methods: Thirty-three patients were included with 17 in the stent-placement group and 16 in the control group (receiving medical treatment), among whom, the unilateral or bilateral severe internal carotid artery stenosis was confirmed by cerebral vascular angiography in the department of Interventional Radiology and Vascular Surgery of Zhongda Hospital Southeast University from June 2015 to September 2016.Neuropsychological tests and rest-state blood oxygenation level dependent fMRI were performed at the baseline and six months follow-up.The baseline characteristics and follow-up changes were compared in each group. Results: The overall cognitive function of the stent-placement group was statistically significantly improved ( P <0.05) compared with control group, mainly in the executive function, memory, attention and other aspects.The value of amplitude of low-frequency fluctuation(ALFF) showed statistically significant increase ( P <0.05, Alphasim correction) in left prefrontal cortex ( t =5.861 3, P <0.05), the somatosensory association cortex in left superior parietal lobe( t =5.601 2, P <0.05) and bilateral motor cortical area in posterior frontal lobe ( t =5.288 5, P <0.05). The ALFF showed statistically significant decrease ( P <0.05, Alphasim correction) in left retrosplenial cingulate cortex( t =-5.590 4, P <0.05), left insular cortex ( t =-6.340 8, P <0.05), right insular cortex ( t =-8.129 9, P <0.05) and left dorsal anterior cingulate cortex ( t =-5.584 8, P <0.05). There was no statistically significant difference ( P >0.05, Alphasim correction)between baseline and follow-up results in control group.Besides, the ALFF changes of the left insular cortex ( r =-0.591, P =0.033) and bilateral motor cortical area ( r =-0.659, P =0.014) were negatively correlated with auditory verb learning test (AVLT) score changes.The ALFF change of bilateral motor cortical area was negatively correlated with the AVLT-delay score change ( r =-0.588, P =0.034). And the ALFF change on right insular cortex and the frontal assessment battery (FAB) score change was positively correlated ( r =0.638, P =0.025). Conclusions: The overall cognitive function of patients with carotid artery stenosis significantly improve after CAS compared with medical treatment.The change of ALFF value in related brain area is also statistically significant.ALFF Change most in area of Default Mode Network may suggest a mechanism of postoperative neurological recovery in patients with carotid artery stenosis.

Experimental Evaluation of a New Tubular Coronary Stent (V-Flexª).

PubMed

Shun; Wang; Zhou; Verbeken; Ping; Szilard; Yanming; Jianhua; De Scheerder IK

1998-11-01

The safety, efficacy, angiographic and histological effects of a new 316 L, SS seamless stainless steel tubular stent (V-Flexª, Global Therapeutics, Broomfield, Colorado) was evaluated in a porcine coronary and peripheral artery model. Implantation in the right coronary artery was successful in all 16 pigs. Eight pigs were angiographically controlled after 6 weeks and then sacrificed for morphometric analysis. All stented coronary vessels were widely patent at this moment and morphometric analysis showed only a mild fibromuscular neointimal hyperplasia resulting in a neointimal hyperplasia of 1.15 +/- 0.38 mm2. The remaining 8 pigs were controlled and sacrificed at 12 weeks. At that time, all stented vessels were patent and neointimal hyperplasia was 1.22 +/- 0.34 mm2. Comparison with the Palmaz-Schatzª coronary stent (Cordis, Miami, Florida) in a porcine peripheral artery model demonstrated significantly less neointimal hyperplasia at 6 weeks (1.11 +/- 0.73 vs. 2.40 +/- 0.36, p = 0.001) and at 12 weeks (1.53 +/- 0.42 vs. 2.47 +/- 0.63, p = 0.003) for the V-Flex stent. In conclusion, V-Flex coronary stent implantation in a porcine coronary and peripheral arteries results in a high procedural success rate without subacute thrombotic occlusions, despite no further anticoagulation nor antiplatelet therapy. Six and 12 week histopathological and morphometric evaluation demonstrated only a mild fibromuscular neointimal hyperplasia. Comparison with the Palmaz-Schatz coronary stent in a peripheral artery model showed significantly less neointimal hyperplasia in the V-Flex stent.

Surrogate and clinical endpoints in interventional cardiology: are statistics the brakes?

PubMed

Waliszewski, Matthias; Rittger, Harald

2016-10-01

Randomized controlled trials are the gold standard for demonstrating safety and efficacy of coronary devices with or without accompanying drug treatments in interventional cardiology. With the advent of last-generation drug-eluting stents having enhanced technical attributes and long-term clinical benefits, the proof of incremental angiographic or long-term clinical efficacy becomes more challenging. The purpose of this review is to provide an overview of the most common and alternative study endpoints in interventional cardiology and their potential reimbursement value. Moreover, we intend to describe the statistical limitations in order to demonstrate differences between potential treatment groups. Furthermore, careful endpoint recommendations for a given patient number are offered for future study designs. The number of patients per treatment group was estimated for various study designs such as noninferiority test hypotheses with hard clinical endpoints and various surrogate endpoints. To test for differences in various surrogate endpoint scenarios, the corresponding patient group sizes were explored. To evaluate these endpoints in terms of their reimbursement impact, preferred endpoints for technical appraisals in interventional cardiology at the National Institute of Health and Care Excellence (NICE) were used. Even with the most stringent experimental control to reduce bias-introducing factors, studies with hard primary clinical endpoints such as the occurrence of major adverse cardiac events (MACE) or target-lesion revascularization (TLR) rates remain the gold standard, with numbers reaching into the 300-700 patient range per group. Study designs using loss in fractional-flow reserve (FFR) or stent-strut-coverage rates can be statistically formulated; however, the clinical ramifications for the patient remain to be discussed. Nonrandomized study designs with intrapatient angiographic controls in nontarget vessels may merit further thoughts and explorations. From a reimbursement impact, the primary endpoints MACE and TLR are the best choices for a moderately sized study population of 500 patients per group. Angiographic endpoints, in particular minimal lumen diameter (MLD), are not useful in this context. The emerging endpoints such as loss in FFR or stent coverage require smaller patient populations. However, their impact on reimbursement-related decisions is limited. © The Author(s), 2016.

Surrogate and clinical endpoints in interventional cardiology: are statistics the brakes?

PubMed Central

Waliszewski, Matthias; Rittger, Harald

2016-01-01

Background: Randomized controlled trials are the gold standard for demonstrating safety and efficacy of coronary devices with or without accompanying drug treatments in interventional cardiology. With the advent of last-generation drug-eluting stents having enhanced technical attributes and long-term clinical benefits, the proof of incremental angiographic or long-term clinical efficacy becomes more challenging. The purpose of this review is to provide an overview of the most common and alternative study endpoints in interventional cardiology and their potential reimbursement value. Moreover, we intend to describe the statistical limitations in order to demonstrate differences between potential treatment groups. Furthermore, careful endpoint recommendations for a given patient number are offered for future study designs. Methods: The number of patients per treatment group was estimated for various study designs such as noninferiority test hypotheses with hard clinical endpoints and various surrogate endpoints. To test for differences in various surrogate endpoint scenarios, the corresponding patient group sizes were explored. To evaluate these endpoints in terms of their reimbursement impact, preferred endpoints for technical appraisals in interventional cardiology at the National Institute of Health and Care Excellence (NICE) were used. Results: Even with the most stringent experimental control to reduce bias-introducing factors, studies with hard primary clinical endpoints such as the occurrence of major adverse cardiac events (MACE) or target-lesion revascularization (TLR) rates remain the gold standard, with numbers reaching into the 300–700 patient range per group. Study designs using loss in fractional-flow reserve (FFR) or stent-strut-coverage rates can be statistically formulated; however, the clinical ramifications for the patient remain to be discussed. Nonrandomized study designs with intrapatient angiographic controls in nontarget vessels may merit further thoughts and explorations. Conclusions: From a reimbursement impact, the primary endpoints MACE and TLR are the best choices for a moderately sized study population of 500 patients per group. Angiographic endpoints, in particular minimal lumen diameter (MLD), are not useful in this context. The emerging endpoints such as loss in FFR or stent coverage require smaller patient populations. However, their impact on reimbursement-related decisions is limited. PMID:27378486

Spontaneous passage of ureteral stones in patients with indwelling ureteral stents.

PubMed

Baumgarten, Lee; Desai, Anuj; Shipman, Scott; Eun, Daniel D; Pontari, Michel A; Mydlo, Jack H; Reese, Adam C

2017-10-01

To determine rates of spontaneous ureteral stone passage in patients with indwelling ureteral stents, and to identify factors associated with the spontaneous passage of stones while a ureteral stent is in place. From our institutional database, we identified patients who underwent ureteroscopic procedures for stone disease between January 1, 2013 and March 1, 2015. We compared the rates of spontaneous stone passage between patients who had previously undergone ureteral stent placement and those who had not. In patients with indwelling stents, multivariate logistic regression was performed to identify factors associated with spontaneous stone passage. A total of 194 patients met inclusion criteria. Spontaneous stone passage rates were similar in the stented (17/119, 14%) and non-stented (15/75, 20%) groups (p = 0.30). In bivariate analysis of stented patients, smaller stone size (p < 0.001) and distal stone location (p = 0.01) were significantly associated with spontaneous stone passage. Multivariate logistic regression analysis of stented patients showed that only small stone size was significantly associated with the likelihood of stone passage (p = 0.01), whereas stent duration, stone location, and stone laterality were not. A small, but clinically significant percentage of ureteral stones pass spontaneously with a ureteral stent in place. Small stone size is associated with an increased likelihood of spontaneous passage in patients with indwelling stents. These findings may help to identify patients who can potentially avoid additional surgical procedures for definitive stone removal after ureteral stent placement.

A retrospective analysis of early and late outcome of biodegradable stent placement in the management of refractory anastomotic colorectal strictures.

PubMed

Repici, A; Pagano, N; Rando, G; Carlino, A; Vitetta, E; Ferrara, E; Strangio, G; Zullo, A; Hassan, C

2013-07-01

Benign colorectal strictures are treated conventionally by endoscopic dilation. Experience using SEMS for benign colonic strictures is limited, and outcomes to date have been disappointing. Refractory colorectal strictures remain challenging to be treated with surgery. Polydioxanone-based stent are biodegradable (BD) stent CE approved for esophageal strictures. This study was designed to investigate retrospectively the safety and the efficacy of these stents for the management of strictures refractory to multiple sessions of dilation. Patients with postsurgical benign strictures located within 20 cm from anal verge, refractory to mechanical or pneumatic dilation (at least 3 sessions) were included in this analysis. Clinical success was defined as the absence of occlusive symptoms and the ability to pass through the stricture with a regular size colonoscope. All patients were predilated before stent placement. Stents were released under fluoroscopic control. All patients were under stool softeners for 3 months. Follow-up was scheduled with endoscopic and fluoroscopic controls within 90 days from stent deployment and afterwards by telephone interview and/or ambulatory consultation. Eleven patients (7 males, mean age 62.3 ± 8.5 years) were included. Technical success was achieved in all the patients. Stent migration was observed in four patients within the first 2 weeks after stent placement. Stent migration was followed by recurrence of stricture and obstructive symptoms in all the cases. Among the seven patients who completed the process of stent biodegradation, five of them had complete resolution of the stricture and relief of symptoms. Two of 11 patients required surgical treatment during the follow-up period (mean 19.8 (range 42-15) months). The overall success rate of the BD stent was 45 %. This retrospective analysis of a limited number of patients demonstrated that nondedicated esophageal BD stents are associated with high risk of migration and clinical success in less than 50 % of patients. Dedicated stents with large diameter and antimigration findings could potentially improve the outcome of patients with refractory benign colorectal strictures.

Suppressive effects of standard-dose rosuvastatin therapy on the progression of coronary atherosclerosis in Japanese patients: the APOLLO study.

PubMed

Amemiya, Kisaki; Yokoi, Hiroyoshi; Domei, Takenori; Shirai, Shinichi; Ando, Kenji; Goya, Masahiko; Iwabuchi, Masashi

2014-01-01

We used quantitative coronary angiography (QCA) to investigate whether coronary plaque progression can be inhibited by controlling lipids with rosuvastatin at Japanese standard doses following elective percutaneous coronary intervention (PCI). A total of 143 patients who underwent elective PCI were randomized to either the rosuvastatin (5 or 2.5mg/day) or non-statin group. Changes from baseline in the minimal lumen diameter (MLD) and average lumen diameter (ALD) measured using QCA were analyzed in both target and non-target lesions. The changes in MLD and ALD from baseline to 24 months in the non-target lesions were significantly smaller in the rosuvastatin group than in the non-statin group (-0.079 ± 0.014 mm vs.-0.135 ± 0.019 mm, p=0.022; -0.062 ± 0.012 mmvs. -0.109 ± 0.016mm, p=0.025). The changes in MLD from six to 24 months in the target lesions were significantly lower in the rosuvastatin group than in the non-statin group among the patients treated with drug-eluting stents (-0.046 ± 0.108 mm vs. -0.133 ± 0.108 mm, p=0.009) versus those treated with bare-metal stents (-0.011 ± 0.094 mm vs. -0.015 ± 0.040 mm, p=0.255). The present study demonstrated that the administration of a standard dose of rosuvastatin slows coronary plaque progression and may prevent the late catch-up phenomenon associated with drug-eluting stents in patients who undergo elective PCI.

Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the International Carotid Stenting Study (ICSS) randomised trial

PubMed Central

Bonati, Leo H; Dobson, Joanna; Featherstone, Roland L; Ederle, Jörg; van der Worp, H Bart; de Borst, Gert J; Mali, Willem P Th M; Beard, Jonathan D; Cleveland, Trevor; Engelter, Stefan T; Lyrer, Philippe A; Ford, Gary A; Dorman, Paul J; Brown, Martin M

2015-01-01

Summary Background Stenting is an alternative to endarterectomy for treatment of carotid artery stenosis, but long-term efficacy is uncertain. We report long-term data from the randomised International Carotid Stenting Study comparison of these treatments. Methods Patients with symptomatic carotid stenosis were randomly assigned 1:1 to open treatment with stenting or endarterectomy at 50 centres worldwide. Randomisation was computer generated centrally and allocated by telephone call or fax. Major outcomes were assessed by an independent endpoint committee unaware of treatment assignment. The primary endpoint was fatal or disabling stroke in any territory after randomisation to the end of follow-up. Analysis was by intention to treat ([ITT] all patients) and per protocol from 31 days after treatment (all patients in whom assigned treatment was completed). Functional ability was rated with the modified Rankin scale. This study is registered, number ISRCTN25337470. Findings 1713 patients were assigned to stenting (n=855) or endarterectomy (n=858) and followed up for a median of 4·2 years (IQR 3·0–5·2, maximum 10·0). Three patients withdrew immediately and, therefore, the ITT population comprised 1710 patients. The number of fatal or disabling strokes (52 vs 49) and cumulative 5-year risk did not differ significantly between the stenting and endarterectomy groups (6·4% vs 6·5%; hazard ratio [HR] 1·06, 95% CI 0·72–1·57, p=0·77). Any stroke was more frequent in the stenting group than in the endarterectomy group (119 vs 72 events; ITT population, 5-year cumulative risk 15·2% vs 9·4%, HR 1·71, 95% CI 1·28–2·30, p<0·001; per-protocol population, 5-year cumulative risk 8·9% vs 5·8%, 1·53, 1·02–2·31, p=0·04), but were mainly non-disabling strokes. The distribution of modified Rankin scale scores at 1 year, 5 years, or final follow-up did not differ significantly between treatment groups. Interpretation Long-term functional outcome and risk of fatal or disabling stroke are similar for stenting and endarterectomy for symptomatic carotid stenosis. Funding Medical Research Council, Stroke Association, Sanofi-Synthélabo, European Union. PMID:25453443

Results of the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) study to treat symptomatic stenoses at 2 years: a multinational, prospective, randomised trial.

PubMed

Eckstein, Hans-Henning; Ringleb, Peter; Allenberg, Jens-Rainer; Berger, Jürgen; Fraedrich, Gustav; Hacke, Werner; Hennerici, Michael; Stingele, Robert; Fiehler, Jens; Zeumer, Hermann; Jansen, Olav

2008-10-01

The SPACE trial is a multinational, prospective, randomised study to test the hypothesis that carotid artery stenting is not inferior to carotid endarterectomy for treating patients with severe symptomatic carotid artery stenosis. We did not prove non-inferiority of carotid artery stenting compared with carotid endarterectomy for the 30-day complication rate, and we now report the results at 2 years. Between March, 2001, and February, 2006, patients with symptomatic, severe (>or=70%) carotid artery stenosis were recruited to this non-inferiority trial and randomly assigned with a block randomisation design to have carotid artery angioplasty with stenting or carotid artery endarterectomy. 2-year endpoints include several clinical endpoints and the incidence of recurrent carotid stenosis of at least 70%. Clinical and vascular follow-up was done by a certified neurologist. Analyses were by intention to treat and per protocol. This trial is registered with ISRCTN, number 57874028.12. 1 214 patients were randomly assigned (613 were randomly assigned to carotid angioplasty with stenting and 601 were randomly assigned to carotid endarterectomy). In both the intention-to-treat and per-protocol analyses the Kaplan-Meier estimates of ipsilateral ischaemic strokes up to 2 years after the procedure and any periprocedural stroke or death do not differ between the carotid artery stenting and the carotid endarterectomy groups (intention to treat 9.5%vs 8.8%; hazard ratio (HR) 1.10, 95%CI 0.75 to 1.61; log-rank p=0.62; per protocol 9.4%vs 7.8%; HR 1.23, 95%CI 0.82 to 1.83; log-rank p=0.31). In both the intention-to-treat and per-protocol populations, recurrent stenosis of 70% or more is significantly more frequent in the carotid artery stenting group compared with the carotid endarterectomy group, with a life-table estimate of 10.7% versus 4.6% (p=0.0009) and 11.1% versus 4.6% (p=0.0007), respectively. Only two incidences of recurrent stenoses after carotid artery stenting led to neurological symptoms. After 2 years' follow-up, the rate of recurrent ipsilateral ischaemic strokes reported in the SPACE trial is similar for both treatment groups. The incidence of recurrent carotid stenosis at 2 years, as defined by ultrasound, is significantly higher after carotid artery stenting. However, it cannot be excluded that the degree of in-stent stenosis is slightly overestimated by conventional ultrasound criteria.

Comparison of Technical and Clinical Outcome of Transjugular Portosystemic Shunt Placement Between a Bare Metal Stent and a PTFE-Stentgraft Device.

PubMed

Lauermann, J; Potthoff, A; Mc Cavert, M; Marquardt, S; Vaske, B; Rosenthal, H; von Hahn, T; Wacker, F; Meyer, B C; Rodt, Thomas

2016-04-01

To analyse technical and clinical success of transjugular intrahepatic portosystemic shunt (TIPS) in patients with portal hypertension and compare a stent and a stentgraft with regard to clinical and technical outcome and associated costs. 170 patients (56 ± 12 years, 32.9% females) treated with TIPS due to portal hypertension were reviewed. 80 patients received a stent (group 1) and 83 a stentgraft (group 2), and seven interventions were unsuccessful. Technical data, periprocedural imaging, follow-up ultrasound and clinical data were analysed with focus on technical success, patency, clinical outcome and group differences. Cost analysis was performed. Portal hypertension was mainly caused by ethyltoxic liver cirrhosis with ascites as dominant symptom (80%). Technical success was 93.5% with mean portosystemic gradient decrease from 16.1 ± 4.8 to 5.1 ± 2.1 mmHg. No significant differences in technical success and portosystemic gradient decrease between the groups were observed. Kaplan-Meier analysis yielded significant differences in primary patency after 14 days, 6 months and 2 years in favour of the stentgraft. Both groups showed good clinical results without significant difference in 1-year survival and hepatic encephalopathy rate. Costs to establish TIPS and to manage 2-year follow-up with constant patency and clinical success were 8876 € (group 1) and 9394 € (group 2). TIPS is a safe and effective procedure to manage portal hypertension. Stent and stentgraft enabled good technical and clinical results with a low complication rate. Primary patency rates are clearly in favour of the stentgraft, whereas the stent was more cost effective with similar clinical results in both groups.

Efficacy of therapy for hepatocellular carcinoma with portal vein tumor thrombus

PubMed Central

Chuan-Xing, Li; Xu, He; Bao-Shan, Hu; Yong, Li; Pei-Jian, Shao; Xian-Yi, Yu; Xiao-Ning, Luo

2011-01-01

The purpose of this study is to analyze the safety and clinical efficacy of transcatheter arterial chemoembolization (TACE) combined with portal vein stent and 125I implantation for the treatment of portal vein tumor thrombus (PVTT) in hepatocellular carcinoma. Fifty-six patients from our department diagnosed with advanced hepatocellular carcinoma with PVTT between January 2008 and December 30, 2010 were divided into two groups. Patients in Group A were treated with TACE and portal vein stent; patients in Group B were treated with TACE, portal vein stent and 125I implantation. The success rate of TACE with portal vein stent and 125I implantation was 100%, with no severe surgery-related complications. After an 8 mo follow-up, the total clinical benefit rates were 56.7 and 88.5% for Groups A and B, respectively (p < 0.05). The median survival times (mOS) for the two groups were 5.7 and 8.9 mo, respectively (p < 0.05). The median time of progression (mTTP) of the two groups were 5.3 and 7.9 mo, respectively (p < 0.05). The 2, 6, 8, 12 and 18 mo patency rates in Group A were 100, 93.3, 83.3, 53.3 and 36.6%. Those in Group B were 100, 100, 92.3, 84.6 and 80.7%. The 2, 6 and 8 mo patency rates showed no statistical differences (p > 0.05), but the 12 and 18 mo rates did (p < 0.05). Our results suggest that TACE combined with portal vein stent and 125I implantation are both safe and effective, and 125I implantation can further postpone the restenosis of the portal vein effectively. PMID:22037354

Comparison of Technical and Clinical Outcome of Transjugular Portosystemic Shunt Placement Between a Bare Metal Stent and a PTFE-Stentgraft Device

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

Lauermann, J., E-mail: jostlauermann@gmail.com; Potthoff, A.; Mc Cavert, M.

PurposeTo analyse technical and clinical success of transjugular intrahepatic portosystemic shunt (TIPS) in patients with portal hypertension and compare a stent and a stentgraft with regard to clinical and technical outcome and associated costs.Materials and Methods170 patients (56 ± 12 years, 32.9 % females) treated with TIPS due to portal hypertension were reviewed. 80 patients received a stent (group 1) and 83 a stentgraft (group 2), and seven interventions were unsuccessful. Technical data, periprocedural imaging, follow-up ultrasound and clinical data were analysed with focus on technical success, patency, clinical outcome and group differences. Cost analysis was performed.ResultsPortal hypertension was mainly caused by ethyltoxicmore » liver cirrhosis with ascites as dominant symptom (80 %). Technical success was 93.5 % with mean portosystemic gradient decrease from 16.1 ± 4.8 to 5.1 ± 2.1 mmHg. No significant differences in technical success and portosystemic gradient decrease between the groups were observed. Kaplan–Meier analysis yielded significant differences in primary patency after 14 days, 6 months and 2 years in favour of the stentgraft. Both groups showed good clinical results without significant difference in 1-year survival and hepatic encephalopathy rate. Costs to establish TIPS and to manage 2-year follow-up with constant patency and clinical success were 8876 € (group 1) and 9394 € (group 2).ConclusionTIPS is a safe and effective procedure to manage portal hypertension. Stent and stentgraft enabled good technical and clinical results with a low complication rate. Primary patency rates are clearly in favour of the stentgraft, whereas the stent was more cost effective with similar clinical results in both groups.« less

Incidence and Clinical Outcomes of Stent Fractures on the Basis of 6,555 Patients and 16,482 Drug-Eluting Stents From 4 Centers.

PubMed

Kan, Jing; Ge, Zhen; Zhang, Jun-Jie; Liu, Zhi-Zhong; Tian, Nai-Liang; Ye, Fei; Li, Sui-Ji; Qian, Xue-Song; Yang, Song; Chen, Meng-Xuan; Rab, Tanveer; Chen, Shao-Liang

2016-06-13

The present study aimed to analyze the incidence of SF and its correlation with clinical events after DES implantation and the outcome of re-intervention for symptomatic in-stent restenosis (ISR) induced by stent fracture (SF). SF is associated with a high rate of clinical events after the implantation of drug-eluting stents (DES). However, the chronological rate of SF and the effect of SF on clinical outcomes from a large patient population remain underreported. A total of 6,555 patients with 16482 DES in 10751 diseased vessels and surveillance angiography between November 2003 and January 2014 were prospectively studied. The primary endpoints included the incidence of SF, in-stent restenosis (ISR), target lesion revascularization (TLR), and definite stent thrombosis (ST) at the end of follow-up before and after propensity score matching. Clinical outcomes after TLR were also followed up. The SF rate was detected in 803 (12.3%) patients, 3,630 (22.0%) stents, and 1,852 (17.2%) diseased vessels. SF increased over time. SF was associated with higher unadjusted rates of ISR (42.1%), TLR (24.8%, n = 379), and definite ST (4.6%) compared with stents without fracture (10.7%, 6.6%, and 1.03%, all p < 0.001), and the differences remained significant after propensity score matching (all p < 0.05). There was no significant difference in any-cause or cardiac mortality between patients with and without SF. After 1,523 days of follow-up since the first surveillance angiography, repeat ISR was detected in 90 of 379 (23.8%) stents after reintervention, and 6 (7.5%) stents required repeat TLR. SF is more frequently observed after DES implantation. TLR was required in almost one-fourth of fractured stents. Increased events in the SF group did not translate into a difference in mortality compared with the non-SF group. Reintervention was associated with acceptable clinical results. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Stent-Protected Carotid Angioplasty Using a Membrane Stent: A Comparative Cadaver Study

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

Mueller-Huelsbeck, Stefan, E-mail: muehue@rad.uni-kiel.de; Guehne, Albrecht; Tsokos, Michael

2006-08-15

Purpose. To evaluate the performance of a prototype membrane stent, MembraX, in the prevention of acute and late embolization and to quantify particle embolization during carotid stent placement in human carotid explants in a proof of concept study. Methods. Thirty human carotid cadaveric explants (mild stenoses 0-29%, n = 23; moderate stenoses 30-69%, n = 3; severe stenoses 70-99%, n = 2) that included the common, internal and external carotid arteries were integrated into a pulsatile-flow model. Three groups were formed according to the age of the donors (mean 58.8 years; sample SD 15.99 years) and randomized to three testmore » groups: (I) MembraX, n 9; (II) Xpert bare stent, n = 10; (III) Xpert bare stent with Emboshield protection device, n = 9. Emboli liberated during stent deployment (step A), post-dilatation (step B), and late embolization (step C) were measured in 100 {mu}m effluent filters. When the Emboshield was used, embolus penetration was measured during placement (step D) and retrieval (step E). Late embolization was simulated by compressing the area of the stented vessel five times. Results. Absolute numbers of particles (median; >100 {mu}m) caught in the effluent filter were: (I) MembraX: A = 7, B = 9, C = 3; (II) bare stent: A 6.5, B = 6, C = 4.5; (III) bare stent and Emboshield: A = 7, B = 7, C.=.5, D = 8, E = 10. The data showed no statistical differences according to whether embolic load was analyzed by weight or mean particle size. When summing all procedural steps, the Emboshield caused the greatest load by weight (p 0.011) and the largest number (p = 0.054) of particles. Conclusions. On the basis of these limited data neither a membrane stent nor a protection device showed significant advantages during ex vivo carotid angioplasty. However, the membrane stent seems to have the potential for reducing the emboli responsible for supposed late embolization, whereas more emboli were observed when using a protection device. Further studies are necessary and warranted.« less

[EFFECTIVENESS OF VAGINOPLASTY WITH ACELLULAR DERMAL MATRIX AND MIXED PARTICLES GRAFT].

PubMed

Zhou, Yu; Li, Qiang; Ll, Senkai; Zhou, Chuande; Li, Fengyong; Cao, Yujiao; Zhang, Siya; Wei, Shuyi; Zhao, Yang

2015-06-01

To evaluate the effectiveness or acellular dermal matrix (ADM) with autologous buccal micro mucosa and micro skin graft in vaginoplasty. A retrospective analysis was made on the clinical data of 67 patients with vaginal agenesis treated between July 2006 and June 2013. ADM and mixed particles were used in 20 cases (ADM group) and mixed particles graft in 47 cases (control group) in vaginoplasty. There was no significant difference in age between 2 groups (t=0.233, P=0.816). The depth, diameter, and volume of neovagina, epithelization time, stent needing time, and female sexual function index (FSFI) score were compared between 2 groups. There was no significant difference in operation time and amount of bleeding between 2 groups (t = -1.922, P = 0.059; t = 0.398, P = 0.692). The patients were followed up 11-38 months (mean, 16.08 months). Fifteen cases in ADM group and 29 cases in control group had sexual life after operation. Bleeding after operation occurred in 6 cases (2 in ADM group and 4 in control group). No stenosis was observed. Difference in epithelization time was not statistically significant (t = -1.938, P = 0.057). However, the stent needing time of ADM group was significantly shorter than that of control group (t = 7.020, P = 0.000). The neovagina was ideal in wetness degree, smoothness, flexibility, and hairlessness during follow-up. The depth, diameter, and volume of vagina had no significant difference between 2 groups (P > 0.05) at last follow-up, which were close to normal vagina. The other patients had normal sexual function except 1 patient whose FSFI score was less than 23; no statistically significant difference was found in FSFI score between 2 groups (P > 0.05). On the basis of mixed particles grafting, the ADM could improve trestle structure for resisting contracture. The effectiveness is better than merely mixed particles graft. The procedure has satisfactory anatomical and functional results.

Fabrication of Small Caliber Stent-grafts Using Electrospinning and Balloon Expandable Bare Metal Stents

PubMed Central

Uthamaraj, Susheil; Tefft, Brandon J.; Jana, Soumen; Hlinomaz, Ota; Kalra, Manju; Lerman, Amir; Dragomir-Daescu, Dan; Sandhu, Gurpreet S.

2016-01-01

Stent-grafts are widely used for the treatment of various conditions such as aortic lesions, aneurysms, emboli due to coronary intervention procedures and perforations in vasculature. Such stent-grafts are manufactured by covering a stent with a polymer membrane. An ideal stent-graft should have a biocompatible stent covered by a porous, thromboresistant, and biocompatible polymer membrane which mimics the extracellular matrix thereby promoting injury site healing. The goal of this protocol is to manufacture a small caliber stent-graft by encapsulating a balloon expandable stent within two layers of electrospun polyurethane nanofibers. Electrospinning of polyurethane has been shown to assist in healing by mimicking native extracellular matrix, thereby promoting endothelialization. Electrospinning polyurethane nanofibers on a slowly rotating mandrel enabled us to precisely control the thickness of the nanofibrous membrane, which is essential to achieve a small caliber balloon expandable stent-graft. Mechanical validation by crimping and expansion of the stent-graft has shown that the nanofibrous polyurethane membrane is sufficiently flexible to crimp and expand while staying patent without showing any signs of tearing or delamination. Furthermore, stent-grafts fabricated using the methods described here are capable of being implanted using a coronary intervention procedure using standard size guide catheters. PMID:27805589

Urethra sparing - potential of combined Nickel-Titanium stent and intensity modulated radiation therapy in prostate cancer.

PubMed

Thomsen, Jakob Borup; Arp, Dennis Tideman; Carl, Jesper

2012-05-01

To investigate a novel method for sparing urethra in external beam radiotherapy of prostate cancer and to evaluate the efficacy of such a treatment in terms of tumour control using a mathematical model. This theoretical study includes 20 patients previously treated for prostate cancer using external beam radiotherapy. All patients had a Nickel-Titanium (Ni-Ti) stent inserted into the prostate part of urethra. The stent has been used during the treatment course as an internal marker for patient positioning prior to treatment. In this study the stent is used for delineating urethra while intensity modulated radiotherapy was used for lowering dose to urethra. Evaluation of the dose plans were performed using a tumour control probability model based on the concept of uniform equivalent dose. The feasibility of the urethra dose reduction method is validated and a reduction of about 17% is shown to be possible. Calculations suggest a nearly preserved tumour control probability. A new concept for urethra dose reduction is presented. The method relies on the use of a Ni-Ti stent as a fiducial marker combined with intensity modulated radiotherapy. Theoretical calculations suggest preserved tumour control. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Complications and management of forgotten long-term biliary stents.

PubMed

Sohn, Se Hoon; Park, Jae Hyun; Kim, Kook Hyun; Kim, Tae Nyeun

2017-01-28

To evaluate complications and management outcomes of retained long-term plastic biliary stents. Endoscopic plastic biliary stent placement was performed in 802 patients at Yeungnam University Hospital between January 2000 and December 2014. Follow-up loss with a subsequently forgotten stent for more than 12 mo occurred in 38 patients. We retrospectively examined the cause of biliary stent insertion, status of stents, complications associated with biliary stents and management outcomes of long-term plastic biliary stents. Continuous variables were analyzed using the t test. Observed frequencies in subsets of the study population were compared using Fisher's exact test and χ 2 tests. Statistical significance was defined as P < 0.05 (two-tailed). Mean age of patients was 73.7 ± 12 years and male-to-female ratio was 2.2:1. Indications of plastic biliary stent insertion were bile duct stones (63.2%, 24/38) and benign bile duct stricture (52.6%, 20/38). Mean duration of retained plastic stent was 22.6 ± 12.2 mo, and in 10 cases (26.3%), stents were retained for more than 24 mo. Common bile duct (CBD) stones or sludge were found in most cases (92.1%, 35/38). The most common complication was acute cholangitis (94.7%, 36/38). Stent removal by endoscopic approach was successfully performed in 92.1% (35/38) of the cases. In 3 cases, an additional plastic stent was inserted alongside the previous stent due to failure of the stent removal. Endoscopic removal of bile duct stones was successful in 73.7% (28/38) of the cases. When patients were divided into two groups by duration of stent placement (12 to 24 mo vs over 24 mo), there were no differences in the development of cholangitis, presence of biliary stones, and success rate of endoscopic removal of stones and biliary stents. The most common complication of retained long-term plastic biliary stents was acute cholangitis associated with CBD stones. Endoscopic management was successfully performed in most cases.

Radioactive self-expanding stents for palliative management of unresectable esophageal cancer: a systematic review and meta-analysis.

PubMed

Chen, Hong-Lin; Shen, Wang-Qin; Liu, Kun

2017-05-01

Stent insertion is a feasible and safe palliative management for advanced unresectable esophageal cancer. The aim of this study is to assess the efficacy of radioactive stent for unresectable esophageal cancer compared with conventional stent. Systematic searches of the PubMed and Web of science are dated from their beginning to January 25, 2016. Studies that compared radioactive stent with conventional stent for unresectable esophageal cancer were included. The outcomes were postimplantation survival, relief of dysphagia, and complications related to stent implant. Six studies with 539 patients were included. All of them used stent equipped with radioactive iodine beads as a radioactive stent. The pooled weighted mean difference for median survival was 2.734 months (95% CI 1.710-3.775; Z = 5.21, P = 0.000) between two groups. The 1,3,6 month survival rates were higher in radioactive stents than conventional stent, with the pooled ORs 3.216 (95% CI 1.293-7.999; Z = 2.51, P = 0.012), 3.095 (95% CI 1.908-5.020; Z = 4.58, P = 0.000), and 7.503 (95% CI 2.206- 25.516; Z = 3.23, P = 0.001, respectively). The pooled hazard ratio was 0.464 (95% CI 0.328-0.655; Z = 4.35, P = 0.000) between two groups. For relief of dysphagia, two stents all have good relief of the dysphagia effect, but radioactive stent showed a better effect at 3, 6 months follow-up after implantation. For complications related to stent implant, no significant differences were found between two stents in terms of severe chest pain (30.0% vs. 35.7%, OR 0.765, 95% CI 0.490-1.196), gastroesophageal reflux (18.6% vs. 16.1%, OR 1.188, 95% CI 0.453-3.115), fever (12.1% vs. 12.1%, OR 1.014, 95% CI 0.332-3.097), bleeding (16.7% vs. 14.2%, OR 1.201, 95% CI 0.645-2.236), perforation or fistula (6.1% vs. 9.0%, OR 0.658, 95% CI 0.291-1.486), pneumonia (10.7% vs. 14.1%, OR 0.724, 95% CI 0.343-1.526), stent migration (7.0% vs. 10.2%, OR 0.651, 95% CI 0.220-1.924), and restenosis (24.2% vs. 20.6%, OR 1.228, 95% CI 0.674-2.239). Radioactive stent insertion had potential benefits for palliative management for patients with unresectable esophageal cancer. This method prolonged survival and dysphagia relief period without more complications. However, this conclusion should be confirmed by more trials. © International Society for Diseases of the Esophagus 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Fluoroscopically guided placement of self-expandable metallic stents and stent-grafts in the treatment of acute malignant colorectal obstruction.

PubMed

Kim, Honsoul; Kim, Seung Hyoung; Choi, Sun Young; Lee, Kwang-Hun; Won, Jong Yoon; Lee, Do Yun; Lee, Jong Tae

2008-12-01

To evaluate the technical feasibility and clinical effectiveness of fluoroscopically guided placement of self-expandable metallic stents and stent-grafts for acute malignant colorectal obstruction. Radiologic images and clinical reports of 42 patients (22 men, 20 women; age range, 28-93 years; median age, 65.5 years) who underwent fluoroscopically guided colorectal stent insertion without endoscopic assistance for acute malignant obstruction were reviewed retrospectively. Eighteen patients received bare stents as a bridge to surgery. Twenty-four patients received 27 insertions of either a bare stent (n = 15) or a stent-graft (n = 12) for palliation. The obstruction was located in the rectum (n = 8), sigmoid (n = 17), descending colon (n = 8), splenic flexure (n = 3), and transverse colon (n = 6). Clinical success, defined as more than 50% dilatation of the stent with subsequent symptomatic improvement, was achieved in 41 of the 42 patients (98%). No major procedure-related complications occurred. Minor complications occurred in eight of the 45 procedures (18%). No perioperative mortalities occurred within 1 month after surgery. In the palliative group, the median stent patency was 62 days (range, 0-1,014 days). There was no statistically significant difference in stent patency between the bare stents (range, 0-855 days; median, 68 days) and stent-grafts (range, 1-1,014 days; median, 81 days). Fluoroscopically guided placement of self-expandable metallic stents and stent-grafts for the relief of acute malignant colorectal obstruction was technically feasible without endoscopic assistance-even in lesions proximal to the splenic flexure and transverse colon-and clinically effective in both bridge to surgery and palliative management.

Preoperative biliary decompression preceding pancreaticoduodenectomy with plastic or self-expandable metallic stent.

PubMed

Haapamäki, C; Seppänen, H; Udd, M; Juuti, A; Halttunen, J; Kiviluoto, T; Sirén, J; Mustonen, H; Kylänpää, L

2015-06-01

The rainage (PBD) prior to pancreaticoduodenectomy (PD) is controversial. If PBD is required, large bore self-expandable metallic stents (SEMS) are thought to maintain better drainage and have fewer postoperative complications than plastic stents. The confirming evidence is scarce. The aim of the study was to compare outcomes of surgery in patients who underwent PBD with SEMS or plastic stents deployed at endoscopic retrograde cholangiopancreatography (ERCP). This is a retrospective study of 366 patients having had PD during 2000-2009. Preceding endoscopic PBD was performed in 191 patients and nine had had percutaneous transhepatic drainage (PTD). At the time of operation, 163 patients had a plastic stent and 28 had SEMS. Due to stent exchanges, 176 plastic stents and 29 SEMS were placed in all. The stent failure rate was 7.4% for plastic stents and 3.4% for SEMS (p = 0.697). A bilirubin level under 50 µmol/L was reached by 80% of the patients with plastic stents and by 61% of the patients with SEMS (p = 0.058). A postoperative infection complication and/or a pancreatic fistula was found in 26% while using plastic stents and in 25% using SEMS (p = 1.000). In unstented patients with biliary obstruction, the bile juice was sterile significantly more often than in endoscopically stented patients (100% vs 1%, p < 0.001). When the stented and unstented patients were compared regarding postoperative infection complications, there was no significant difference between the groups (p = 0.365). Plastic stents did not differ from SEMS regarding the stent failure rate, bilirubin level decrease, amount of bacteria in the bile juice, or postoperative complications when used for PBD. The significantly higher price of SEMS suggests their use in selected cases only. © The Finnish Surgical Society 2014.

Metabolic Syndrome and Coronary Artery Disease in Ossabaw Compared with Yucatan Swine

PubMed Central

Neeb, Zachary P; Edwards, Jason M; Alloosh, Mouhamad; Long, Xin; Mokelke, Eric A; Sturek, Michael

2010-01-01

Metabolic syndrome (MetS), a compilation of associated risk factors, increases the risk of type 2 diabetes and coronary artery disease (CAD, atherosclerosis), which can progress to the point of artery occlusion. Stents are the primary interventional treatment for occlusive CAD, and patients with MetS and hyperinsulinemia have increased restenosis. Because of its thrifty genotype, the Ossabaw pig is a model of MetS. We tested the hypothesis that, when fed high-fat diet, Ossabaw swine develop more features of MetS, greater native CAD, and greater stent-induced CAD than do Yucatan swine. Animals of each breed were divided randomly into 2 groups and fed 2 different calorie-matched diets for 40 wk: control diet (C) and high-fat, high-cholesterol atherogenic diet (H). A bare metal stent was placed in the circumflex artery, and pigs were allowed to recover for 3 wk. Characteristics of MetS, macrovascular and microvascular CAD, in-stent stenosis, and Ca2+ signaling in coronary smooth muscle cells were evaluated. MetS characteristics including, obesity, glucose intolerance, hyperinsulinemia, and elevated arterial pressure were elevated in Ossabaw swine compared to Yucatan swine. Ossabaw swine with MetS had more extensive and diffuse native CAD and in-stent stenosis and impaired coronary blood flow regulation compared with Yucatan. In-stent atherosclerotic lesions in Ossabaw coronary arteries were less fibrous and more cellular. Coronary smooth muscle cells from Ossabaw had impaired Ca2+ efflux and intracellular sequestration versus cells from Yucatan swine. Therefore, Ossabaw swine are a superior model of MetS, subsequent CAD, and cellular Ca2+ signaling defects, whereas Yucatan swine are leaner and relatively resistant to MetS and CAD. PMID:20819380

Gender difference on five-year outcomes of EXCEL biodegradable polymer-coated sirolimus-eluting stents implantation: results from the CREATE study.

PubMed

Zhang, Lei; Qiao, Bing; Han, Ya-Ling; Li, Yi; Xu, Kai; Zhang, Quan-Yu; Yang, Li-Xia; Liu, Hui-Liang; Xu, Bo; Gao, Run-Lin

2013-03-01

The gender difference on long-term outcome in unselected patients after percutaneous coronary intervention (PCI) has not yet been fully investigated. This study aimed to evaluate the gender difference on five-year outcomes following EXCEL biodegradable polymer-coated sirolimus-eluting stenting in patients with coronary disease. A total of 2077 "all comers", consisting of 1528 (73.6%) men and 549 (26.4%) women, who were exclusively treated with EXCEL coronary stents were enrolled in the prospective CREATE study at 59 centers from four countries. After propensity score matching, the baseline characteristics of the two groups were well matched. Recommended antiplatelet regimen was clopidogrel and aspirin for six months followed by chronic aspirin therapy. The primary outcome that was the rate of major adverse cardiac events (MACE), defined as a composite of cardiac mortality, non-fatal myocardial infarction (MI) and target lesion revascularization (TLR), and stent thrombosis (ST) at five years were compared between the two gender groups. In the two groups, women had higher proportions of clinical risk factors, such as being elderly, diabetes mellitus, hypertension and hyperlipidemia, compared to men. Besides, the mean target vessel number per patient was higher and the mean reference vessel diameter smaller for women. Men had higher risks of cardiac death (3.7% vs. 1.6%, P = 0.021) and MACE (8.4% vs. 4.7%, P = 0.004) at five years compared with women. However, the cumulative hazards of non-fatal MI and TLR were similar between men and women. The incidence of Academic Research Consortium (ARC) definite or probable stent thrombosis was similar between the two groups (1.3% vs. 1.0%, P = 0.639). Prolonged clopidogrel therapy (>6 months) did not reduce the cumulative hazards of ST from six months to five years in both men (χ(2) = 0.098, log rank P = 0.754) and women (χ(2) = 2.043, log rank P = 0.153) patients. Women had a lower MACE and cardiac death rate than men after biodegradable polymer-coated sirolimus-eluting stenting in long term follow-up. Effects of prolonged dual antiplatelet therapy (DAPT) in preventing stent thrombosis was similar with six-month DAPT after EXCEL stent implantation in both men and women groups.

Early double J stent removal in renal transplant patients to prevent urinary tract infection - systematic review and meta-analysis of randomized controlled trials.

PubMed

Yahav, Dafna; Green, Hefziba; Eliakim-Raz, Noa; Mor, Eytan; Husain, Shahid

2018-04-01

Ureteral stents are routinely used in renal transplant and are associated with reduced urological complications but increased urinary tract infections (UTIs). There is no agreement on the preferred time to removal of stents after transplantation. We performed a systematic review and meta-analysis of all randomized controlled trials (RCTs) comparing stent duration of <14 days vs > =14 days. Electronic databases were searched to identify RCTs that compared early vs late stent removal. Primary outcome was urinary tract infections. Secondary outcomes included various urological complications. No significant difference in UTI rates was demonstrated between short and long stent duration (relative risk (RR) 0.85, 95% confidence interval (CI) 0.44-1.64), with significant heterogeneity (I 2  = 86%). Sensitivity analysis evaluating studies with low risk of bias for allocation concealment demonstrated statistically significant lower rates of UTI with short stent duration (RR 0.48, 95% CI 0.32-0.71) with no heterogeneity. No significant difference was demonstrated for the outcome of major urological complications (RR 0.72, 95% CI 0.50-1.05), without heterogeneity. Ureteral stenosis rates were significantly lower in the short duration arm (RR 0.42, 95% CI 0.18-0.98). Early removal of ureteral stents after renal transplant may be associated with reduced rates of UTI and ureteral stenosis. Additional RCTs are needed.

Current evidence for the safety and efficacy of the bio-engineered dual therapy COMBO stent.

PubMed

Kalkman, Deborah N; Chandrasekhar, Jaya; de Winter, Robbert J; Mehran, Roxana

2018-06-01

The novel dual-therapy COMBO stent aims to promote vessel healing after percutaneous coronary intervention (PCI) in patients with coronary artery disease. The pro-healing technique consists of an anti-CD34+ antibody layer that attracts circulating endothelial progenitor cells (EPCs), which bind to the stent surface and allow rapid endothelialization by differentiation of the EPCs into normal endothelial cells. The COMBO stent combines this pro-healing technique with an abluminal drug elution of sirolimus. The promise of this dual-therapy stent is that it may safely allow a shortened duration of dual-antiplatelet therapy (DAPT) after stent placement. Moreover, with a mature endothelial layer, lower rates of in-stent restenosis may be expected. Clinical outcomes after COMBO stent implantation have been recently evaluated in both randomized trials and large, prospective, multicenter registries, showing low clinical event rates of in-stent restenosis and stent thrombosis. Randomized clinical trials (HARMONEE and RECOVERY) have demonstrated the non-inferiority of COMBO versus "first in class" second generation and newer generation drug-eluting stents. Safety and efficacy of 3 months of DAPT after COMBO stent placement in patients presenting with acute coronary syndrome has been evaluated in the large REDUCE randomized controlled trial, showing non-inferiority to standard duration of 12-month DAPT. In this review we provide an overview of the current pre-clinical and clinical evidence for the performance of the COMBO stent.

True coronary bifurcation lesions: meta-analysis and review of literature.

PubMed

Athappan, Ganesh; Ponniah, Thirumalaikolundiusubramanian; Jeyaseelan, Lakshmanan

2010-02-01

Percutaneous intervention of true coronary bifurcation lesions is challenging. Based on the results of randomized trials and registry data, the approach of stenting of main vessel only with balloon dilatation of the side branch has become the default approach for false bifurcation lesions except when a complication occurs or in cases of suboptimal result. However, the optimal stenting strategy for true coronary bifurcation lesions - to stent or not to stent the side branch - is still a matter of debate. The purpose of this study was, therefore, to compare the clinical and angiographic outcomes of the double stent technique (stenting of the main branch and side branch) over the single stent technique (stenting of main vessel only with balloon dilatation of the side branch) for treatment of true coronary bifurcation lesions, with drug-eluting stents (DES). Comparative studies published between January 2000 and February 2009 of the double stent technique vs. single stent technique with DES for true coronary bifurcations were identified using an electronic search and reviewed using a random effects model. The primary endpoints of our study were side-branch and main-branch restenoses, all-cause mortality, myocardial infarction (MI) and target lesion revascularization (TLR) at longest available follow-up. The secondary endpoints of our analysis were postprocedural minimal luminal diameter (MLD) of the side branch and main branch, follow-up MLD of side branch and main branch and stent thrombosis. Heterogeneity was assessed and sensitivity analysis was performed to test the robustness of the overall summary odds ratios (ORs). Five studies comprising 1145 patients (616 single stent and 529 double stent) were included in the analysis. Three studies were randomized comparisons between the two techniques for true coronary bifurcation lesions. Incomplete reporting of data in the primary studies was common. The lengths of clinical and angiographic follow-up ranged between 6 and 12 months and 6 and 7 months, respectively. Postprocedural MLD of the side branch was significantly smaller in the single stent group [standardized mean difference (SMD) -0.71, 95% CI -0.88 to -0.54, P < 0.000, I2 = 0%]. The odds of side-branch restenosis (OR 1.11, 95% CI 0.47-2.67, P = 0.81, I2 = 76%), main-branch restenois (OR 0.88, 95% CI 0.56-1.39, P = 0.58, I = 0%), all-cause mortality (OR 0.52, 95% CI 0.11-2.45, P = 0.41, I2 = 0%), MI (OR 0.92, 95% CI 0.34-2.54, P = 0.87, I = 49%) and TLR (OR 0.87, 95% CI 0.46-1.65, P = 0.68, I2 = 0%) were similar between the two groups. Postprocedural MLD of the main branch [standardized mean difference (SMD) -0.08, 95% CI -0.42 to -0.26, P < 0.65, I2 = 67%], follow-up MLD of side branch (SMD -0.19, 95% CI -0.40 to 0.01, P < 0.31, I2 = 15%) and main branch MLD (SMD 0.17, 95% CI -0.18 to 0.542, P < 0.35, I2 = 65%) were also similar between the two groups. In patients undergoing percutaneous coronary intervention (PCI) for true coronary bifurcations, there is no added advantage of stenting both branches as compared with a conventional one-stent strategy. The results, however, need to be interpreted considering the poor study methods and/or poor quality of reporting in publications. We propose to move forward and consider the conduct of more systematic, well-designed and scientific trials to investigate the treatment of true coronary bifurcation lesions.

Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI.

PubMed

Giustino, Gennaro; Chieffo, Alaide; Palmerini, Tullio; Valgimigli, Marco; Feres, Fausto; Abizaid, Alexandre; Costa, Ricardo A; Hong, Myeong-Ki; Kim, Byeong-Keuk; Jang, Yangsoo; Kim, Hyo-Soo; Park, Kyung Woo; Gilard, Martine; Morice, Marie-Claude; Sawaya, Fadi; Sardella, Gennaro; Genereux, Philippe; Redfors, Bjorn; Leon, Martin B; Bhatt, Deepak L; Stone, Gregg W; Colombo, Antonio

2016-10-25

Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p < 0.0001). Compared with short-term DAPT, long-term DAPT yielded significant reductions in MACE in the complex PCI group (adjusted HR: 0.56; 95% CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95% CI: 0.75 to 1.35; p interaction  = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (p interaction  = 0.96). Results were consistent by per-treatment landmark analysis. Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

The Effect of Cilostazol on the Angiographic Outcome of Drug-Eluting Coronary Stents Angiographic Analysis of the CILON-T (Influence of CILostazol-Based Triple Antiplatelet Therapy ON Ischemi Complication after Drug-Eluting StenT Implantation) Trial.

PubMed

Suh, Jung-Won; Lee, Seung-Pyo; Park, KyungWoo; Kang, Hyun-Jae; Koo, Bon-Kwon; Cho, Young-Seok; Youn, Tae-Jin; Chae, In-Ho; Choi, Dong-Ju; Rha, Seung-Woon; Bae, Jang-Ho; Kwon, Taek-Geun; Bae, Jang-Whan; Cho, Myeong-Chan; Kim, Hyo-Soo

2017-12-12

It is not clear if anti-restonotic effect of cilostazol is consistent for different types of drug-eluting stents (DES).The purpose of this study was to compare the anti-proliferative effect of cilostazol between DAT and TAT with consideration of confounding influences of DES type.Nine hundred and fifteen patients were randomized to either dual antiplatelet therapy (DAT; aspirin and clopidogrel) or triple antiplatelet therapy (TAT; aspirin, clopidogrel, and cilostazol) in the previous CILON-T trial. After excluding 70 patients who received both or neither stents, we analyzed 845 patients who received exclusively PES or ZES, and compared in-stent late loss at 6 months between both antiplatelet regimens (DAT versus TAT).Baseline angiographic and clinical characteristics were similar between the DAT (656 lesions in 425 patients) and the TAT group (600 lesions in 420 patients). The 6-month follow-up angiography was completed in 745 patients (88.2%). Quantitative coronary angiography showed that TAT significantly reduced in-stent late loss (DAT 0.62 ± 0.62 mm versus TAT 0.54 ± 0.49 mm, P = 0.015). Stent type, diabetes or lesion length did not interact with difference of late loss. However, reduction of late loss by cilostazol did not lead to a significant reduction in the rate of target lesion revascularization (TLR) (DAT 7.8% versus TAT 6.9%, P = 0.69) due to a nonlinear relationship found between late loss and TLR.The TAT group showed less in-stent late loss as compared to the DAT group. This was consistently observed regardless of DES type, lesion length, or diabetic status. However, reduction of late loss by cilostazol did not lead to a significant reduction in TLR.

Comparing Percutaneous Transluminal Angioplasty and Stent Placement for Treatment of Subclavian Arterial Occlusive Disease: A Systematic Review and Meta-Analysis

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

Ahmed, Ahmed T., E-mail: Ahmed.Ahmed1@mayo.edu; Mohammed, Khaled, E-mail: Mohammed.Khaled@mayo.edu; Chehab, Monzer, E-mail: moe.chehab@beumont.edu

Background and PurposeSubclavian artery occlusive disease (SAOD) is often associated with cerebrovascular symptoms such as subclavian steal syndrome and stroke. We conducted a systematic review and meta-analysis to compare percutaneous transluminal angioplasty (PTA) and stent placement for the treatment of SAOD.Materials and MethodsWe searched Medline, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus through October 16, 2014. From each study, we abstracted baseline patient characteristics, study design variables, and outcome data including rates of technical success, primary patency (≤2 and >2 years follow-up), symptom resolution, and complications. Meta-analysis was performed using a random-effects model.ResultsA total ofmore » 35 non-comparative studies with 1726 patients were included. Technical success rate was significantly higher in the stent group than the PTA group (92.8 vs 86.8 %, p = 0.007). Long-term primary patency rates (76.9 vs 79.6 %, p = 0.729) and symptom resolution rates (82.2 vs 73.0 %, p = 0.327) were not statistically different. There was no statistically significant difference in the rates of stroke or death.ConclusionStent placement for treatment of SAOD may be associated with higher rates of technical success but similar rates of symptom resolution and long-term outcomes. The confidence in the available estimates is low. Further comparative studies are needed to guide patients and clinicians in shared decision making.« less

Scanning Electron Microscopic Features of Nasolacrimal Silastic Stents Retained for Prolong Durations Following Dacryocystorhinostomy.

PubMed

Ali, Mohammad Javed; Baig, Farhana; Lakshman, Mekala; Naik, Milind N

2016-01-01

The aims of this study were to examine the scanning electron microscopic features of silastic nasolacrimal duct stents retained for long durations following a dacryocystorhinostomy. A prospective interventional study was performed on stents retrieved from patients who were lost to follow up after a dacryocystorhinostomy with Crawford stent insertion. Long duration was defined as stents retrieved at a minimum of 1 year following a dacryocystorhinostomy. None of the patients had any evidence of postoperative infection. After removal, the stent segments were subjected to biofilm and physical deposit analysis using standard protocols of scanning electron microscopy. These stent segments were compared against sterile stents which acted as controls. A total of 7 stents were studied. Five were consecutive patient samples, and 2 were sterile stents. All the 5 stents were retrieved from patients who were lost to follow up for a minimum of 12 months following surgery. The mean duration of intubation at retrieval was 21 months. All the stents demonstrated evidence of biofilm formation and physical deposits. However, as the duration of retention increased, the deposits and biofilms were noted to be progressively denser, multilayered and extensive. Certain areas demonstrated thick biofilm integration with the deposits. Polymicrobial communities were noted within the exopolysaccharide matrix. This is the first study to exclusively report on scanning electron microscopic features of lacrimal stents retained for long durations. Further studies on physical elements within the deposits and protein analysis would provide more insights into stent-tissue interactions.

Self-expandable metal stents for relieving malignant colorectal obstruction: short-term safety and efficacy within 30 days of stent procedure in 447 patients.

PubMed

Meisner, Søren; González-Huix, Ferran; Vandervoort, Jo G; Goldberg, Paul; Casellas, Juan A; Roncero, Oscar; Grund, Karl E; Alvarez, Alberto; García-Cano, Jesús; Vázquez-Astray, Enrique; Jiménez-Pérez, Javier

2011-10-01

The self-expandable metal stent (SEMS) can alleviate malignant colonic obstruction and avoid emergency decompressive surgery. To document performance, safety, and effectiveness of colorectal stents used per local standards of practice in patients with malignant large-bowel obstruction to avoid palliative stoma surgery in incurable patients (PAL) and facilitate bowel decompression as a bridge to surgery for curable patients (BTS). Prospective clinical cohort study. Two global registries with 39 academic and community centers. This study involved 447 patients with malignant colonic obstruction who received stents (255 PAL, 182 BTS, 10 no indication specified). Colorectal through-the-scope SEMS placement. The primary endpoint was clinical success at 30 days, defined as the patient's ability to maintain bowel function without adverse events related to the procedure or stent. Secondary endpoints were procedural success, defined as successful stent placement in the correct position, symptoms of persistent or recurrent colonic obstruction, and complications. The procedural success rate was 94.8% (439/463), and the clinical success rates were 90.5% (313/346) as assessed on a per protocol basis and 71.6% (313/437) as assessed on an intent-to-treat basis. Complications included 15 (3.9%) perforations, 3 resulting in death, 7 (1.8%) migrations, 7 (1.8%) cases of pain, and 2 (0.5%) cases of bleeding. No control group. No primary endpoint analysis data for 25% of patients. This largest multicenter, prospective study of colonic SEMS placement demonstrates that colonic SEMSs are safe and highly effective for the short-term treatment of malignant colorectal obstruction, allowing most curable patients to have 1-step resection without stoma and providing most incurable patients minimally invasive palliation instead of surgery. The risk of complications, including perforation, was low. Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Use of flow-diverting stents as salvage treatment following failed stent-assisted embolization of intracranial aneurysms.

PubMed

Heiferman, Daniel M; Billingsley, Joshua T; Kasliwal, Manish K; Johnson, Andrew K; Keigher, Kiffon M; Frudit, Michel E; Moftakhar, Roham; Lopes, Demetrius K

2016-07-01

Flow-diverting stents, including the Pipeline embolization device (PED) and Silk, have been beneficial in the treatment of aneurysms previously unable to be approached via endovascular techniques. Recurrent aneurysms for which stent-assisted embolization has failed are a therapeutic challenge, given the existing intraluminal construct with continued blood flow into the aneurysm. We report our experience using flow-diverting stents in the repair of 25 aneurysms for which stent-assisted embolization had failed. Nineteen (76%) of these aneurysms at the 12-month follow-up showed improved Raymond class occlusion, with 38% being completely occluded, and all aneurysms demonstrated decreased filling. One patient developed a moderate permanent neurologic deficit. Appropriate stent sizing, proximal and distal construct coverage, and preventing flow diverter deployment between the previously deployed stent struts are important considerations to ensure wall apposition and prevention of endoleak. Flow diverters are shown to be a reasonable option for treating previously stented recurrent cerebral aneurysms. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Intra-stent tissue evaluation within bare metal and drug-eluting stents > 3 years since implantation in patients with mild to moderate neointimal proliferation using optical coherence tomography and virtual histology intravascular ultrasound.

PubMed

Kitabata, Hironori; Loh, Joshua P; Pendyala, Lakshmana K; Omar, Alfazir; Ota, Hideaki; Minha, Sa'ar; Magalhaes, Marco A; Torguson, Rebecca; Chen, Fang; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

2014-04-01

We aimed to compare neointimal tissue characteristics between bare-metal stents (BMS) and drug-eluting stents (DES) at long-term follow-up using optical coherence tomography (OCT) and virtual histology intravascular ultrasound (VH-IVUS). Neoatherosclerosis in neointima has been reported in BMS and in DES. Thirty patients with 36 stented lesions [BMS (n=17) or DES (n=19)] >3years after implantation were prospectively enrolled. OCT and VH-IVUS were performed and analyzed independently. Stents with ≥70% diameter stenosis were excluded. The median duration from implantation was 126.0months in the BMS group and 60.0months in the DES group (p <0.001). Lipid-laden intima (58.8% vs. 42.1%, p=0.317), thrombus (17.6% vs. 5.3%, p=0.326), and calcification (35.3% vs. 26.3%, p=0.559) did not show significant differences between BMS and DES. When divided into 3 time periods, the cumulative incidence of lipid-laden neointima from >3years to <9years was similar between BMS and DES (42.9% vs. 42.1%, p=1.000). Furthermore, it continued to gradually increase over time in both groups. OCT-derived thin-cap fibroatheroma (TCFA) was observed in 17.6% of BMS- and 5.3% of DES-treated lesions (p=0.326). No stents had evidence of intimal disruption. The percentage volume of necrotic core (16.1% [9.7, 20.3] vs. 9.7% [7.0, 16.5], p=0.062) and dense calcium (9.5% [3.8, 13.6] vs. 2.7% [0.4, 4.9], p=0.080) in neointima tended to be greater in BMS-treated lesions. Intra-stent VH-TCFA (BMS vs. DES 45.5% vs. 18.2%, p=0.361) did not differ significantly. At long-term follow-up beyond 3 years after implantation, the intra-stent neointimal tissue characteristics appeared similar for both BMS and DES. Copyright © 2014 Elsevier Inc. All rights reserved.

Pancreatic stent insertion after an unintentional guidewire cannulation of the pancreatic duct during ERCP.

PubMed

García-Cano, Jesús; Viñuelas Chicano, Miriam; Del Moral Martínez, María; Muñiz Muñoz, Marta; Murillo Matamoros, Claudio; Suárez Matías, Miguel; Valiente González, Laura; Martínez Pérez, Teresa; Martínez Fernández, Raquel; Gómez Ruiz, Carmen Julia; Pérez García, José Ignacio; Morillas Ariño, Julia

2018-04-24

the guidewire (GW) may enter the pancreatic duct during common bile duct (CBD) cannulation attempts in endoscopic retrograde cholangiopancreatography (ERCP). After GW passage into the pancreas, the most effective maneuver for CBD cannulation and pancreatitis prevention has not been determined. to study CBD cannulation and post-ERCP pancreatitis rates when a pancreatic stent is inserted after an unintentional GW cannulation of the pancreatic duct. a retrospective analysis of patients undergoing ERCP for biliary drainage that were included prospectively into a database. After unintentional GW cannulation of the pancreatic duct, a straight 5-Fr and 4-cm long plastic stent was inserted. The stents had no internal flaps to facilitate expulsion. CBD cannulation attempts were made above the stent. A pancreatic sphincterotomy was performed in patients older than 60 years before stent insertion. a total of 46 pancreatic stents were inserted during 154 ERCP (29.8%) procedures. In the stent group, CBD cannulation was accomplished in 44/46 (95.6%) subjects. A total of 21/46 (45.6%) pancreatic sphincterotomies were performed. Only 1/46 (2.17%) mild pancreatitis cases were observed and most stents were spontaneously expelled. in this study, the CBD was eventually reached with the insertion of a plastic pancreatic stent after an unintentional GW passage into the pancreatic duct while attempting a CBD cannulation. No adverse events were observed following pancreatic stent insertion.

Percutaneous intraductal radiofrequency ablation for clearance of occluded metal stent in malignant biliary obstruction: feasibility and early results.

PubMed

Pai, Madhava; Valek, Vlastimil; Tomas, Andrasina; Doros, Attila; Quaretti, Pietro; Golfieri, Rita; Mosconi, Cristina; Habib, Nagy

2014-02-01

The major complication occurring with biliary stents is stent occlusion, frequently seen because of tumour in-growth, epithelial hyperplasia, and sludge deposits, resulting in recurrent jaundice and cholangitis. We report a prospective study with the results of first in man percutaneous intraductal radiofrequency (RF) ablation to clear the blocked metal stents in patients with malignant biliary obstruction using a novel bipolar RF catheter. Nine patients with malignant biliary obstruction and blocked metal stents were included. These patients underwent intraductal biliary RF ablation through the blocked metal stent following external biliary decompression with an internal-external biliary drainage. All nine patients had their stent patency restored successfully without the use of secondary stents. Following this intervention, there was no 30-day mortality, haemorrhage, bile duct perforation, bile leak, or pancreatitis. Of the nine patients, six are alive and three patients are dead with a median follow-up of 122 (range 50-488) days and a median stent patency of 102.5 (range 50-321) days. Six patients had their stent patent at the time of last follow-up or death. Three patients with stent blockage at 321, 290, and 65 days postprocedure underwent percutaneous transhepatic drain insertion and repeat ablation. In this selective group of patients, it appears that this new approach is safe and feasible. Efficacy remains to be proven in future, randomized, prospective studies.

Risk of stent thrombosis among bare-metal stents, first-generation drug-eluting stents, and second-generation drug-eluting stents: results from a registry of 18,334 patients.

PubMed

Tada, Tomohisa; Byrne, Robert A; Simunovic, Iva; King, Lamin A; Cassese, Salvatore; Joner, Michael; Fusaro, Massimiliano; Schneider, Simon; Schulz, Stefanie; Ibrahim, Tareq; Ott, Ilka; Massberg, Steffen; Laugwitz, Karl-Ludwig; Kastrati, Adnan

2013-12-01

This study sought to compare the risk of stent thrombosis among patients treated with bare-metal stents (BMS), first-generation drug-eluting stents (G1-DES), and second-generation drug-eluting stents (G2-DES) for a period of 3 years. In patients undergoing coronary stenting, there is a scarcity of long-term follow-up data on cohorts large enough to compare rates of stent thrombosis across the stent generations. A total of 18,334 patients undergoing successful coronary stent implantation from 1998 to 2011 at 2 centers in Munich, Germany, were included in this study. Patients were stratified into 3 groups according to treatment with BMS, G1-DES, and G2-DES. The cumulative incidence of definite stent thrombosis at 3 years was 1.5% with BMS, 2.2% with G1-DES, and 1.0% with G2-DES. On multivariate analysis, G1-DES compared with BMS showed a significantly higher risk of stent thrombosis (odds ratio [OR]: 2.05; 95% confidence interval [CI]: 1.47 to 2.86; p < 0.001). G2-DES were associated with a similar risk of stent thrombosis compared with BMS (OR: 0.82; 95% CI: 0.56 to 1.19; p = 0.30). Beyond 1 year, the risk of stent thrombosis was significantly increased with G1-DES compared with BMS (OR: 4.72; 95% CI: 2.01 to 11.1; p < 0.001), but not with G2-DES compared with BMS (OR: 1.01; 95% CI: 0.32 to 3.25; p = 0.98). In a large cohort of unselected patients undergoing coronary stenting, compared with BMS, there was a significant excess risk of stent thrombosis at 3 years with G1-DES, driven by an increased risk of stent thrombosis events beyond 1 year. G2-DES were associated with a similar risk of stent thrombosis compared with BMS. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Comparison of early-phase arterial repair following cobalt-chrome everolimus-eluting stent and slow-release zotarolimus-eluting stent: an angioscopic study.

PubMed

Ishihara, Takayuki; Iida, Osamu; Fujita, Masashi; Masuda, Masaharu; Okamoto, Shin; Nanto, Kiyonori; Kanda, Takashi; Tsujimura, Takuya; Sunaga, Akihiro; Awata, Masaki; Nanto, Shinsuke; Uematsu, Masaaki

2018-04-01

Whether arterial repair following implantation of drug-eluting stents (DES) of the second generation differs among stent types remains unknown. We examined 41 DES placed in 28 patients (age 72 ± 7 years, male 89%) presenting with stable angina pectoris due to de novo lesions in native coronary arteries. Coronary angioscopy was performed 4 ± 1 months after stent implantation. Patients were divided into two groups based on the DES types: 22 cobalt-chrome everolimus-eluting stents (CoCr-EES) in 13 patients and 19 slow-release zotarolimus-eluting stents (R-ZES) in 15 patients. Neointimal coverage (NIC) was graded as: grade 0, stent struts exposed; grade 1, struts bulging into the lumen, although covered; grade 2, struts embedded in the neointima, but translucent; grade 3, struts fully embedded and invisible. NIC was defined as heterogeneous when the NIC grade variation was ≥1. Presence of thrombus was also investigated. Distribution of dominant NIC grade (CoCr-EES: grade 0, 9%; grade 1, 77%; grade 2, 9%; grade 3, 5%; R-ZES: grade 0, 16%; grade 1: 47%; grade 2, 37%; grade 3, 0%, P = 0.38) and heterogeneity of NIC (P = 0.43) were similar between CoCr-EES and R-ZES groups. Existence of thrombus was not significantly different in CoCr-EES and R-ZES (18 versus 42%, P = 0.17). Arterial repair occurred without significant differences between CoCr-EES and R-ZES 4 months after implantation.

Comparison of cost of care for tethered versus non-tethered ureteric stents in the management of uncomplicated upper urinary tract stones.

PubMed

Okullo, Alfin; Yuminaga, Yuigi; Ziaziaris, William; Ende, David; Lau, Howard; Brooks, Andrew; Patel, Manish I; Bariol, Simon

2017-06-01

Many surgeons use a stent after ureteroscopic lithotripsy (URSL). For short-term stenting purposes, a surgeon has the choice of either a tethered or a non-tethered stent. Stents may be associated with complications that entail an additional cost to their use. There is a paucity of data on the direct healthcare cost of using stent type after either primary or secondary URSL. We retrospectively reviewed medical records for patients who underwent URSL for uncomplicated urolithiasis between January 2013 and December 2013 at two tertiary referral hospitals. Costs data was sourced from the costing department with complete data available for 134 patients. The overall medical care cost was estimated by computing the cost of surgery, stent-related emergency department presentations, re-admissions and stent removal. A total of 113 patients had tethered stents and 21 had non-tethered stents, with similar age and gender composition between the two groups and complications rates. The mean cost of URSL and stent placement was A$3071.7 ± A$906.8 versus A$3423.8 ± A$808.4 (P = 0.049), mean cost of managing complications was A$309.4 ± A$1744.8 versus A$31.3 ± A$98.9 (P = 0.096), mean cost of out-patient clinic stent removal was A$222.5 ± A$60 versus A$1013.6 ± A$75.4 (P < 0.001) for endoscopic stent removal, overall mean cost of care was A$3603.6 ± A$1896.7 versus A$4468.1 ± A$820.8 (P = 0.042) for tethered and non-tethered stents, respectively. It is cheaper to use a tethered ureteric stent compared with non-tethered stents for short-term stenting after uncomplicated URSL, with a mean cost saving of A$864.5. © 2017 Royal Australasian College of Surgeons.

Stent Coating Integrity of Durable and Biodegradable Coated Drug Eluting Stents.

PubMed

Yazdani, Saami K; Sheehy, Alexander; Pacetti, Stephen; Rittlemeyer, Brandon; Kolodgie, Frank D; Virmani, Renu

2016-10-01

Coatings consisting of a polymer and drug are widely used in drug-eluting stents (DES) and are essential in providing programmable drug release kinetics. Among other factors, stent coating technologies can influence blood compatibility, affect acute and sub-acute healing, and potentially trigger a chronic inflammatory response. The aim of this study was to investigate the short-term (7 and 28 days) and long-term (90 and 180 days) coating integrity of the Xience Prime Everolimus-Eluting Stent (EES), Resolute Zotarolimus-Eluting Stent (ZES), Taxus Paclitaxel-Eluting Stent (PES), and Nobori Biolimus A9-Eluting Stent (BES) in a rabbit ilio-femoral stent model. Stented arteries (n = 48) were harvested and the tissue surrounding the implanted stents digested away with an enzymatic solution. Results demonstrated that the majority of struts of EES were without any coating defects with a few struts showing minor defects. Similarly, for the ZES, most of the struts were without coating defects at all time points except at 180 days. The majority of PES demonstrated mostly webbing and uneven coating. In the BES group, the majority of strut coating showed polymer cracking. Overall, the EES and ZES had fewer coating defects than the PES and BES. Coating defects, however increase over time for the ZES, whereas the percent of coating irregularities remained constant for the EES. These results provide, for the first time, a comparison of the long-term durability of these drug-eluting stent coatings in vivo. © 2016, Wiley Periodicals, Inc.

Threaded biliary inside stents are a safe and effective therapeutic option in cases of malignant hilar obstruction.

PubMed

Inatomi, Osamu; Bamba, Shigeki; Shioya, Makoto; Mochizuki, Yosuke; Ban, Hiromitsu; Tsujikawa, Tomoyuki; Saito, Yasuharu; Andoh, Akira; Fujiyama, Yoshihide

2013-02-14

Although endoscopic biliary stents have been accepted as part of palliative therapy for cases of malignant hilar obstruction, the optimal endoscopic management regime remains controversial. In this study, we evaluated the safety and efficacy of placing a threaded stent above the sphincter of Oddi (threaded inside plastic stents, threaded PS) and compared the results with those of other stent types. Patients with malignant hilar obstruction, including those requiring biliary drainage for stent occlusion, were selected. Patients received either one of the following endoscopic indwelling stents: threaded PS, conventional plastic stents (conventional PS), or metallic stents (MS). Duration of stent patency and the incident of complication were compared in these patients. Forty-two patients underwent placement of endoscopic indwelling stents (threaded PS = 12, conventional PS = 17, MS = 13). The median duration of threaded PS patency was significantly longer than that of conventional PS patency (142 vs. 32 days; P = 0.04, logrank test). The median duration of threaded PS and MS patency was not significantly different (142 vs. 150 days, P = 0.83). Stent migration did not occur in any group. Among patients who underwent threaded PS placement as a salvage therapy after MS obstruction due to tumor ingrowth, the median duration of MS patency was significantly shorter than that of threaded PS patency (123 vs. 240 days). Threaded PS are safe and effective in cases of malignant hilar obstruction; moreover, it is a suitable therapeutic option not only for initial drainage but also for salvage therapy.

Early Strut Coverage in Patients Receiving Drug-Eluting Stents and its Implications for Dual Antiplatelet Therapy: A Randomized Trial.

PubMed

Lee, Seung-Yul; Kim, Jung-Sun; Yoon, Hyuck-Jun; Hur, Seung-Ho; Lee, Sang-Gon; Kim, Jin Won; Hong, Young Joon; Kim, Ki-Seok; Choi, So-Yeon; Shin, Dong-Ho; Nam, Chung-Mo; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong-Ki

2018-02-09

This study sought to measure early strut coverage in patients receiving drug-eluting stents (DESs) and to explore the feasibility of short-term dual antiplatelet therapy (DAPT) based on the degree of early strut coverage. Data for early strut coverage in patients receiving new-generation DESs, and its implications for DAPT continuation were limited. A randomized, multicenter trial was conducted in 894 patients treated with DESs. Patients were randomly assigned to everolimus-eluting stent (EES) (n = 444) or biolimus-eluting stent (BES) (n = 450) groups and optical coherence tomography (OCT)-guided (n = 445) or angiography-guided (n = 449) implantation groups using a 2-by-2 factorial design. Early strut coverage was measured as the percentage of uncovered struts on 3-month follow-up OCT examination. The primary outcome was the difference in early strut coverage between EES and BES groups and between OCT- and angiography-guided implantation groups. The secondary outcome was a composite of cardiac death, myocardial infarction, stent thrombosis, and major bleeding during the first 12 months post-procedure in patients receiving 3-month DAPT based on the presence of early strut coverage (≤6% uncovered) on 3-month follow-up OCT. Three-month follow-up OCT data were acquired for 779 patients (87.1%). The median percentage of uncovered struts at 3 months was 8.9% and 8.2% in the EES and BES groups, respectively (p = 0.69) and was lower in the OCT-guided group (7.5%) than in the angiography-guided group (9.9%; p = 0.009). Favorable early strut coverage (≤6% uncovered strut) was observed in 320 of 779 patients (41.1%). At 12 months, the composite event rarely occurred in the 3-month (0.3%) or 12-month (0.2%) DAPT groups (p = 0.80). OCT-guided DES implantation improved early strut coverage compared with angiography-guided DES implantation, with no difference in strut coverage between EES and BES groups. Short-term DAPT may be feasible in selected patients with favorable early strut coverage (Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents [DETECT-OCT]; NCT01752894). Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Effectiveness of two-year clopidogrel + aspirin in abolishing the risk of very late thrombosis after drug-eluting stent implantation (from the TYCOON [two-year ClOpidOgrel need] study).

PubMed

Tanzilli, Gaetano; Greco, Cesare; Pelliccia, Francesco; Pasceri, Vincenzo; Barillà, Francesco; Paravati, Vincenzo; Pannitteri, Gaetano; Gaudio, Carlo; Mangieri, Enrico

2009-11-15

It remains unclear whether dual antiplatelet therapy >12 months might carry a better prognosis after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs). To address the hypothesis that in the real world the risk of very late thrombosis after PCI with DESs can be decreased by an extended use of clopidogrel, we set up the Two-Year ClOpidOgrel Need (TYCOON) registry and prospectively investigated the impact on very late thrombosis of 12- versus 24-month dual antiplatelet regimens in an unselected population. The registry enrolled 897 consecutive patients who underwent PCI with stenting from January 1, 2003, to December 31, 2004, and had dual antiplatelet therapy. All patients had a 4-year clinical follow-up. In the 447 patients with DES implantation, the dual antiplatelet regimen after PCI was given for 12 months in the 173 patients treated in 2003 (12-month group) and for 24 months in the 274 patients treated in 2004 (24-month group). Comparison between groups did not reveal any significant difference in baseline clinical characteristics, angiographic and procedural features, and major adverse cardiac events. During follow-up, there were 5 cases of stent thrombosis after PCI in the 12-month DES group and 1 case in the 24-month DES group (p = 0.02). Specifically, there were 2 cases of subacute thrombosis (1 in each group), no case of late thrombosis, and 4 cases of very late thrombosis occurring at 13, 15, 17, and 23 months after DES implantation in the 12-month group only. In conclusion, a 2-year dual antiplatelet regimen with aspirin and clopidogrel can prevent the occurrence of very late stent thrombosis after PCI with DESs.

Endoluminal stenting for the management of leak following sleeve gastrectomy and loop duodenojejunal bypass with sleeve gastrectomy.

PubMed

Tsai, Ying-Nan; Wang, Hsiu-Po; Huang, Chih-Kun; Chang, Po-Chin; Lin, I-Chang; Tai, Chi-Ming

2018-01-01

Postoperative leak is a serious complication of bariatric surgery and often results in significant morbidity and mortality. Stent placement is a less invasive alternative to surgery for the treatment of bariatric surgical leak. We evaluated the efficacy and complications of covered self-expandable metal stents (SEMS) in the treatment of post-bariatric surgical leak. We retrospectively reviewed patients who underwent stent placement for leak after bariatric surgery. Leak was diagnosed by upper gastrointestinal series or was visualized during the endoscopy. We examined the timing of stent placement, size of the leak, stent migration and its complications, total stent treatment duration, and treatment outcome. Between January 2011 and April 2015, seven patients underwent covered SEMS placement for leak after bariatric surgery, including laparoscopic sleeve gastrectomy (LSG) (n = 5) and laparoscopic loop duodenojejunal bypass with sleeve gastrectomy (LDJB-SG) (n = 2). A stent was placed in one patient for infection control and bridging to revisional surgery. Among the other six patients, one patient who received stent placement one year after leak diagnosis failed to achieve leak closure, and five patients with early stent placement achieved leak closure. Three patients with small leak achieved leak closure more quickly. Stent migration was found in six patients, and associated ulcers occurred in five patients. We conclude that stenting is effective in the management of staple-line leaks following LSG and LDJB-SG. Stent migration and associated ulcers are common after stent placement. Early stent removal can be achieved in patients with small leaks. Copyright © 2017. Published by Elsevier Taiwan.

The Glider registry.

PubMed

Secco, Gioel Gabrio; Rittger, Harald; Hoffmann, Stefan; Richardt, Gert; Abdel-Wahab, Mohamed; Reinecke, Holger; Lotan, Chaim; Werner, Gerald; Sievert, Horst; Foin, Nicolas; Di Mario, Carlo

2017-01-01

Provisional stenting of the side-branch (SB) is the universally accepted gold standard while there is still controversy on the usefulness of routine dilatation of the SB ostium. Recrossing the struts of a previously deployed stent with a wire and a balloon can prove challenging and is occasionally unsuccessful, mainly because the balloon tip hits a stent strut. This prospective multicenter international registry tested the crossing ability procedural results of a new-dedicated ultrashort balloon specifically designed for side branch dilatation (Glider, TriReme Medical, Pleasanton, CA, USA). One hundred and twenty five patients (for a total of 131 bifurcation lesions) were enrolled in the registry between January 2009 and May 2012. The Glider was used as first choice in alternative to conventional balloon (group I, 72%) or as bail-out after unsuccessful previous attempt at crossing with small conventional low-profile balloons (group II, 28%). Postprocedural coronary artery dissections and in-hospital MACE (death, myocardial infarction and repeat revascularization) were assessed. Technical success was defined as the ability of the Glider to recross the struts of a previously deployed stent while procedural success was defined as less of residual 50% diameter stenosis at the origin of the SB with a final TIMI 3 and/or freedom from in-hospital MACE. Technical success was achieved, respectively, in 92% (group I), and 83% (group II). Clinical and angiographic procedural success was achieved in 98% of the lesions. In Group II, no other balloon of the same size could cross in cases where Glider could not. A total of 13 complications were observed, including nine ostial SB dissection four of which needed a second stent on the SB, one stent loss, two severe coronary spasms, and two by thrombus formation. The unique possibility offered by this short dedicated balloon to orientate its beveled tip provides an effective strategy for recrossing stent struts when conventional low profile balloons fail achieving greater SB ostial expansion thus reducing the incidence of strut malapposition during provisional treatment of bifurcational lesions. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

A Comparison of Bilateral Side-by-Side Metal Stents Deployed Above and Across the Sphincter of Oddi in the Management of Malignant Hilar Biliary Obstruction.

PubMed

Cosgrove, Natalie; Siddiqui, Ali A; Adler, Douglas G; Shahid, Haroon; Sarkar, Avik; Sharma, Ashish; Kowalski, Thomas E; Loren, David; Warndorf, Matthew; Chennat, Jennifer; Munigala, Satish; Papachristou, Georgios I

2017-07-01

The optimal method for endoscopic placement of bilateral self-expanding metal stents (SEMS) for the management of malignant hilar biliary obstruction has not been determined. The aim of this study was to compare the efficacies and complication rates between SEMS placed above and across the sphincter of Oddi (SO) in patients with malignant hilar biliary obstruction. A retrospective review of patients with malignant hilar strictures who underwent bilateral SEMS placement at 3 centers was performed. Patients were divided into 2 groups: group A (above SO, n=52) or B (across SO, n=120). Patient demographics, technical success (successful SEMS placement across the stricture), functional success (decrease in pretreatment bilirubin level), complications, stent occlusion, and patient survival in the 2 groups were evaluated. We identified 172 patients with malignant hilar biliary obstruction (106 males, mean age 67 y). Significantly more early complications (1.9% vs. 11.7%, P=0.04) were seen in group B, mainly post-endoscopic retrograde cholangio-pancreatography pancreatitis. Mean SEMS patency periods were 33 weeks for group A and 29.6 weeks for group B (P=0.3). Occlusion rates were 50% and 45% for groups A and B (P=0.61); occlusion was due to tumor in-growth or overgrowth in all patients. SEMS occlusion was successfully treated endoscopically in 85% (22/26) patients in group A and 96% (52/54) in group B (P=0.24). The median survival time was 26 weeks in the group A and 29 weeks in group B (P=0.49). Bilateral side-by-side SEMS placement above or below the SO results in similar success rates, stent patency duration, and stent occlusion rates. Significantly fewer complications, with a trend toward lower rates of pancreatitis, were observed for SEMS placed above the SO.

Inverse Relationship between Serum VEGF Levels and Late In-Stent Restenosis of Drug-Eluting Stents

PubMed Central

Shen, Li; Ji, Meng; Cai, Sishi; Chen, Jiahui; Yao, Zhifeng

2017-01-01

Late in-stent restenosis (ISR) has raised concerns regarding the long-term efficacy of drug-eluting stents (DES). The role of vascular endothelial growth factor (VEGF) in the pathological process of ISR is controversial. This retrospective study aimed to investigate the relationship between serum VEGF levels and late ISR in patients with DES implantation. A total of 158 patients who underwent angiography follow-up beyond 1 year after intervention were included. The study population was classified into ISR and non-ISR groups. The ISR group was further divided according to follow-up duration and Mehran classification. VEGF levels were significantly lower in the ISR group than in the non-ISR group [96.34 (48.18, 174.14) versus 179.14 (93.59, 307.74) pg/mL, p < 0.0001]. Multivariate regression revealed that VEGF level, procedure age, and low-density lipoprotein cholesterol were independent risk factors for late ISR formation. Subgroup analysis demonstrated that VEGF levels were even lower in the very late (≥5 years) and diffuse ISR group (Mehran patterns II, III, and IV) than in the late ISR group (1–4 years) and the focal ISR group (Mehran pattern I), respectively. Furthermore, significant difference was found between diffuse and focal ISR groups. Serum VEGF levels were inversely associated with late ISR after DES implantation. PMID:28373989

Comparative Study between Standard and Totally Tubeless Percutaneous Nephrolithotomy.

PubMed

Yun, Sung Il; Lee, Yoon Hyung; Kim, Jae Soo; Cho, Sung Ryong; Kim, Bum Soo; Kwon, Joon Beom

2012-11-01

Several recent studies have reported the benefits of tubeless percutaneous nephrolithotomy (PNL). Postoperatively, tubeless PNL patients have an indwelling ureteral stent placed, which is often associated with stent-related morbidity. We have performed totally tubeless (tubeless and stentless) PNL in which no nephrostomy tube or ureteral stent is placed postoperatively. We evaluated the safety, effectiveness, and feasibility of totally tubeless PNL. From March 2008 to February 2012, 57 selected patients underwent standard or totally tubeless PNL. Neither a nephrostomy tube nor a ureteral stent was placed in the totally tubeless PNL group. We compared patient and stone characteristics, operation time, length of hospitalization, analgesia requirements, stone-free rate, blood loss, change in creatinine, and perioperative complications between the standard and totally tubeless PNL groups. There were no significant differences in preoperative patient characteristics, postoperative complications, or the stone-free rate between the two groups, but the totally tubeless PNL group showed a shorter hospitalization and a lesser analgesic requirement compared with the standard PNL group. Blood loss and change in creatinine were not significantly different between the two groups. Totally tubeless PNL appears to be a safe and effective alternative for the management of renal stone patients and is associated with a decrease in length of hospital stay.

Comparative Study between Standard and Totally Tubeless Percutaneous Nephrolithotomy

PubMed Central

Yun, Sung Il; Lee, Yoon Hyung; Kim, Jae Soo; Cho, Sung Ryong; Kim, Bum Soo

2012-01-01

Purpose Several recent studies have reported the benefits of tubeless percutaneous nephrolithotomy (PNL). Postoperatively, tubeless PNL patients have an indwelling ureteral stent placed, which is often associated with stent-related morbidity. We have performed totally tubeless (tubeless and stentless) PNL in which no nephrostomy tube or ureteral stent is placed postoperatively. We evaluated the safety, effectiveness, and feasibility of totally tubeless PNL. Materials and Methods From March 2008 to February 2012, 57 selected patients underwent standard or totally tubeless PNL. Neither a nephrostomy tube nor a ureteral stent was placed in the totally tubeless PNL group. We compared patient and stone characteristics, operation time, length of hospitalization, analgesia requirements, stone-free rate, blood loss, change in creatinine, and perioperative complications between the standard and totally tubeless PNL groups. Results There were no significant differences in preoperative patient characteristics, postoperative complications, or the stone-free rate between the two groups, but the totally tubeless PNL group showed a shorter hospitalization and a lesser analgesic requirement compared with the standard PNL group. Blood loss and change in creatinine were not significantly different between the two groups. Conclusions Totally tubeless PNL appears to be a safe and effective alternative for the management of renal stone patients and is associated with a decrease in length of hospital stay. PMID:23185671