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Objective: The aim of this study was to assess clinical outcomes and target vessel patency through 2 years following thoracoabdominal aortic aneurysms (TAAA) repair with the off-the-shelf Zenith t-Branch Thoracoabdominal Endovascular Graft (William Cook Europe)., Methods: This post-market observational study was conducted at three European sites with ambispective enrollment from 2012 to 2017. Patients underwent endovascular TAAA repair with the t-Branch graft and bridging stent grafts (BSGs) for the celiac (CA), superior mesenteric (SMA), left renal (LRA), and/or right renal (RRA) arteries. Follow-up was through 2 years, per sites' standard of care. Procedural and 1-year results were reported previously., Results: Eighty patients (mean age, 71.0±7.4 years; 70.0% men) were enrolled; six patients had symptomatic TAAAs, and 15 patients had contained ruptures. Technical success was achieved in 98.8% of patients (79/80). Median follow-up was 22.2 months (interquartile range, 9.2-25.1 months). At 24 months, Kaplan-Meier (KM) freedom from all-cause and aneurysm-related mortality were 78.5% and 98.6%, respectively. Beyond 12 months, 38 adverse events occurred in 20 patients, including two aortic ruptures (one study aneurysm and one non-study aneurysm) and six deaths (none aneurysm-related, as reported by the site). Compared with postprocedure, maximum aneurysm diameter decreased (>5 mm) in 84.6% (44/52), remained unchanged in 3.8% (2/52), and increased (>5 mm) in 11.5% (6/52) of patients with imaging follow-up after 12 months. No conversions to open repair, and no t-Branch graft or other endograft component migration or integrity issues were reported. No loss of patency was reported in the t-Branch or iliac limb grafts throughout the study. Throughout study duration, four patients had five imaging-reported BSG compressions, none of which required secondary intervention. KM freedom from secondary intervention was 76.3% at 24 months. Fourteen target vessel-related secondary interventions were performed, primarily consisting of stent placement for endoleak, stenosis, or occlusion. KM freedom from loss of primary patency was 94.8%, 100%, 91.3%, and 89.3% for the CA, SMA, LRA, and RRA, respectively, at 24 months. KM freedom from loss of secondary patency in the CA, SMA, LRA, and RRA were 96.3%, 100%, 98.2%, and 98.3% at 24 months, respectively. A total of 298 vessels were targeted, of which 12 were occluded over the study period., Conclusions: Primary and secondary target vessel patency rates through 2 years demonstrated durable repair with the t-Branch graft in patients treated for symptomatic or asymptomatic thoracoabdominal aortic aneurysms., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: We have reported the short-term outcomes regarding the safety of the off-the-shelf Zenith t-Branch multibranched thoracoabdominal stent-graft (William Cook Europe ApS, Bjaeverskov, Denmark) in a postmarket, multicenter study., Methods: Patients who had been treated with the t-Branch device from September 2012 to November 2017 at three European centers were either prospectively or retrospectively enrolled in the present study. Device implantation and postprocedural follow-up were performed according to the standard of care at each center. The primary objectives of the present study were to assess the procedure-related mortality and morbidity at 30 days and 1 year and to assess the presence of endoleaks, device integrity, and stent-graft and branch vessel patency., Results: A total of 80 patients were included in the present study (mean age, 71.0 ± 7.4 years; 70.0% male). Most (n = 77) had been treated for thoracoabdominal aortic aneurysms (TAAAs) and the rest for dissection (n = 3). Most TAAAs were stable (72.7%; 56 of 77). The remaining TAAAs were symptomatic (7.8%; 6 of 77) or had a contained rupture (19.5%; 15 of 77). The t-Branch device was successfully deployed in 79 patients. In one patient, the delivery system of the device could not be advanced through the iliac artery. Within 30 days, one patient had died (1.3%). At 1 year, seven patients had died (8.8%), and no aortic rupture or conversion to open surgery had been reported. The 30-day neurologic events included stroke in three patients (3.8%), paraplegia in one (1.3%), and paraparesis in six patients (7.5%). Secondary interventions were required in nine patients (11.3%) during follow-up. Postoperative endoleaks were observed in 37 of 72 patients (51.4%), including type II endoleak in 30, type Ia in 4, and type III endoleak in 6 patients. At 1 year, endoleaks had been reported in 20 patients (16 with type II and 4 with type III). The t-Branch main body graft patency was 100% throughout the 1-year follow-up period. At 30 days after the procedure, all celiac and superior mesenteric artery branches were patent and one left renal and one right renal branch were occluded. At 1 year, occlusion had developed in three bridging stent-grafts for the celiac artery, one for the left renal artery, and two for the right renal artery., Conclusions: The t-Branch device appears safe, with good 30-day and 1-year mortality and morbidity in the present study, including both stable and symptomatic cases., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the 2-year performance of a polymer-based drug-eluting stent (DES) for the treatment of complex femoropopliteal lesions., Background: Despite the promising early outcomes of the Eluvia DES, the long-term safety and efficacy of the device in a real-world scenario remain unclear., Methods: Between March 2016 and December 2018, 130 patients (137 lesions) with symptomatic femoropopliteal disease were included in this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization, freedom from surgical conversion, and overall mortality and morbidity were additionally analyzed., Results: The majority of patients presented with lifestyle-limiting claudication (n = 90 [69%]). The mean lesion length was 194 ± 108 mm, 74% of the lesions (n = 101) were chronic total occlusions, and 72% (n = 99) were calcified. Moderate to severe calcification (Peripheral Arterial Calcium Scoring Scale score 3 or 4) was observed in 48% of the treated vessels (n = 67). At 24 months, the Kaplan-Meier estimate of primary patency was 71%, whereas both the secondary patency rate and freedom from target lesion revascularization were 80%. Overall survival amounted to 85%. Freedom from major amputation was 98%, while freedom from surgical conversion was 89%. Degeneration of the vessel wall was observed in 27 lesions (20%)., Conclusions: In this study, use of the Eluvia polymer-based DES for the treatment of complex femoropopliteal disease showed promising 2-year results. Nonetheless, a relatively high rate of vessel wall degeneration was observed after DES deployment., Competing Interests: Funding Support and Author Disclosures This study was supported by a scientific grant from Boston Scientific. Dr. Stavroulakis is a consultant for Phillips, Shockwave, and Terumo; and has received honoraria from Medtronic, Boston Scientific, and Biotronik. Dr. Bisdas is a consultant for Boston Scientific, Medtronic, Bard, and Cook Medical. Dr. Bosiers has received honoraria from Medtronic, Terumo, Penumbra, Cook, Bard, and Boston Scientific; and is a consultant for Cook., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate 1-year safety and efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS)., Background: Small clinical studies evaluating 1-year outcomes of CAS performed with 2 available DLS, Roadsaver (RS) (Terumo Corp., Tokyo, Japan) and CGuard (CG) (InspireMD, Boston, Massachusetts), have been published., Methods: The authors performed an individual patient-level meta-analysis including studies enrolling more than 100 CAS with DLS. The primary endpoint was the death and stroke rate; secondary endpoints were restenosis and in-stent thrombosis rates at 1 year., Results: Patients were divided into 2 groups according to DLS (RS n = 250; CG n = 306). At 1 year, 11 patients died (1.97%), 7 patients in the group RS (2.8%) and 4 patients in the CG one (1.31%); and 10 strokes occurred, 4 in the group RS (1.6%) and 6 in the CG one (1.96%). Overall death and stroke rate was 3.77% (n = 21), 11 events in the group RS group (4.4%) and 10 in the CG group (3.27%). Symptomatic status was the only predictor of death and or stroke. At 1 year, restenosis occurred in 12 patients (2.1%), 10 in the group RS (4%) and 2 in the CG one (0.65%) (p = 0.007). In-stent thrombosis occurred in 1 patient (0.18%) in the CG group (0.32%). RS use was the only independent predictor of restenosis., Conclusions: This study suggests that DLS use for CAS is associated with a low 1-year death and stroke rate, and the specific DLS stent used could affect the restenosis rate., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The goal of this study was to evaluate the 5-year follow-up data of the IN.PACT DEEP (Randomized IN.PACT Amphirion Drug-Coated Balloon [DCB] vs. Standard Percutaneous Transluminal Angioplasty [PTA] for the Treatment of Below-the-Knee Critical Limb Ischemia [CLI]) trial., Background: Initial studies from randomized controlled trials have shown comparable short-term outcomes of DCB angioplasty versus PTA in patients with CLI with infrapopliteal disease. However, the long-term safety and effectiveness of DCB angioplasty remain unknown in this patient population., Methods: IN.PACT DEEP was an independently adjudicated prospective, multicenter, randomized controlled trial that enrolled 358 subjects with CLI. Subjects were randomized 2:1 to DCB angioplasty or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, amputation, and all-cause death. Additional assessments were conducted to identify risk factors for death and major amputation, including paclitaxel dose tercile., Results: Freedom from clinically driven target lesion revascularization through 5 years was 70.9% and 76.0% (log-rank p = 0.406), and the incidence of the safety composite endpoint was 59.8% and 57.5% (log-rank p = 0.309) in the DCB angioplasty and PTA groups, respectively. The rate of major amputation was 15.4% for DCB angioplasty compared with 10.6% for PTA (log-rank p = 0.108). Given the recent concern regarding a late mortality signal in patients treated with paclitaxel-coated devices, additional analyses from this study showed no increase in all-cause mortality with DCB angioplasty (39.4%) compared with PTA (44.9%) (log-rank p = 0.727). Predictors of mortality included age, Rutherford category >4, and previous revascularization but not paclitaxel by dose tercile., Conclusions: Tibial artery revascularization in patients with CLI using DCB angioplasty resulted in comparable long-term safety and effectiveness as PTA. Paclitaxel exposure was not related to increased risk for amputation or all-cause mortality at 5-year follow-up. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733)., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective/background: Endovascular abdominal aortic aneurysm repair (EVAR) is commonly used to treat abdominal aortic aneurysm (AAA). However, the incidence of long-term complications and the need for re-interventions after EVAR remain a concern. Newer generation stent grafts have encouraging short and mid-term outcomes, but thorough analysis of their long-term performance is necessary., Methods: The ENGAGE registry includes a total of 1263 patients with AAA enrolled from March 2009 to April 2011 at 79 centres across 30 countries. The aim of this study is to present standard EVAR outcomes in the registry after five years., Results: A significant proportion of the ENGAGE patients presented with challenging features, such as 15.2% with an AAA diameter >7 cm, 12.0% with proximal neck lengths <15 mm, and 10.2% with infrarenal neck angles >60°. Of the 1263 enrolled subjects, 17.8% were implanted outside of the instructions for use for the device. At the five year follow up, the Kaplan-Meier overall survival rate was 67.4% and the freedom from aneurysm related mortality was 97.8%. Freedom from aneurysm rupture, secondary procedures, and conversion to open repair at five years were 98.6%, 84.3%, and 97.9% respectively. The five year freedom from type IA endoleaks was 95.2% and for type III endoleaks 97.4%. Aneurysm sac diameter at five years was observed to have either decreased ≥5 mm in diameter or remained stable in 89.4% of the patients., Conclusion: Five year follow up of patients in the ENGAGE registry demonstrates sustained safety, effectiveness, and durability in an international cohort that is reflective of real world experience. Additional follow up is expected through to 10 years., (Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.)

Objectives: The aim of this study was to evaluate the clinical efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS)., Background: The need to minimize the risk for plaque debris prolapsing between stent struts following CAS has resulted in the development of DLS. Small clinical studies evaluating 2 available devices, Roadsaver and CGuard, have been recently published; none of these studies is sufficiently powered to test the role of common risk factors on the occurrence of stroke at 30 days post-CAS., Methods: A search was performed of multiple electronic databases for studies larger than 100 cases of CAS with DLS. Four single-arm prospective studies were identified, and individual patient data were collected. The primary endpoint was the occurrence of stroke at 30 days; secondary endpoints were technical and procedural success, periprocedural stroke, and in-hospital and 30-day rates of death., Results: The Roadsaver and CGuard stents were used in similar proportions, and technical success was achieved in all procedures (100% [n = 556]). There were 6 periprocedural strokes (1.08%; all minor). During 30-day follow-up, there was 1 death (0.17%) from myocardial infarction and 1 additional minor stroke (0.17%). The cumulative 30-day mortality rate was 0.17%, and the incidence of stroke at 30 days was 1.25%. No predictors of stroke at 30 days could be identified., Conclusions: This meta-analysis suggests that DLS can be safely used for CAS, and their use minimizes the incremental risk related to symptomatic status and other risk factors., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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

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

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

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

Background: To evaluate the 24-month outcome of stenting in Trans-Atlantic Inter-Society Consensus (TASC) A & B and TASC C & D iliac lesions in a controlled setting., Methods: The BRAVISSIMO study is a prospective, nonrandomized, multicenter, multinational, monitored registry including 325 patients with aortoiliac lesions. The end point is the primary patency at 24 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio >2.0). A separate analysis for TASC A & B versus TASC C & D population is performed., Results: Between July 2009 and September 2010, 190 patients with TASC A or B and 135 patients with TASC C or D aortoiliac lesions were included. The demographic data were comparable for TASC A & B cohort and TASC C & D cohort. Technical success was 100%. Significantly more balloon-expandable stents were deployed in TASC A & B lesions, and considerably more self-expanding stents were placed in TASC C & D (P = 0.01). The 24-month primary patency rate after 24 months for the total population was 87.9% (88.0% for TASC A, 88.5% for TASC B, 91.9% for TASC C, and 84.8% for TASC D). No statistically significant difference was shown when comparing these groups. The 24-month primary patency rates were 92.1% for patients treated with the self-expanding stent, 85.2% for patients treated with the balloon-expandable stent, and 75.3% for patients treated with a combination of both stents (P = 0.06). Univariate and multivariable regression analyses using Cox proportional hazards model identified only kissing stent configuration (P = 0.0012) and obesity (P = 0.0109) as independent predictors of restenosis (primary patency failure). Interestingly, as all TASC groups enjoyed high levels of patency, neither TASC category nor lesion length was predictive of restenosis., Conclusion: The 24-month data from this large, prospective, multicenter study confirm that endovascular therapy may be considered the preferred first-line treatment option of iliac lesions, irrespectively of TASC lesion category., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate the safety and efficacy of the Lutonix drug-coated balloon (DCB) coated with 2 μg/mm(2)paclitaxel and a polysorbate/sorbitol carrier for treatment of femoropopliteal lesions., Background: Percutaneous treatment of peripheral vascular disease is associated with a high recurrence. Paclitaxel-coated balloons at 3 μg/mm(2) formulated differently have shown promising results with reduced restenosis. Methods Subjects at 9 centers with Rutherford class 2 to 5 femoropopliteal lesions were randomized between June 2009 and December 2009 to treatment with Lutonix DCB (n = 49) versus uncoated balloons (control group [n = 52]), stratified by whether balloon-only treatment (n = 75) or stenting (n = 26) was intended. The primary endpoint was angiographic late lumen loss at 6 months. Secondary outcomes included adjudicated major adverse events (death, amputation, target lesion thrombosis, reintervention), functional outcomes, and pharmacokinetics., Results: Demographic, peripheral vascular disease, and lesion characteristics were matched, with mean lesion length of 8.1 3.8 cm and 42% total occlusions. At 6 months, late lumen loss was 58% lower for the Lutonix DCB group (0.46 1.13 mm) than for the control group (1.09 1.07 mm; p = 0.016). Composite 24-month major adverse events were 39% for the DCB group, including 15 target lesion revascularizations, 1 amputation, and 4 deaths versus 46% for uncoated balloon group, with 20 target lesion revascularizations, 1 thrombosis, and 5 deaths. Pharmacokinetics showed biexponential decay with peak concentration (Cmax) of 59 ng/ml and total observed exposure (AUC(all)) of 73 ng h/ml. For successful DCB deployment excluding 8 malfunctions, 6-month late lumen loss was 0.39 mm and the 24-month target lesion revascularization rate was 24%., Conclusions: Treatment of femoropopliteal lesions with the low-dose Lutonix DCB reduced late lumen loss with safety comparable to that of control angioplasty. (LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis; NCT00930813), (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

We report the case of a 68-year-old woman who was referred to our clinic due to a contained-ruptured type III thoracoabdominal aortic aneurysm 9 cm in diameter. The patient was not a candidate for an open repair because of her comorbid conditions, including dialysis, heart insufficiency requiring pacemaker support, chronic obstructive pulmonary disease, coronary artery disease, and previous abdominal aortic repair. Owing to her hemodynamic instability, we performed a totally endovascular repair with off-the-shelf devices by means of the sandwich technique. An intraoperative gutters-associated endoleak occurred but resolved after 2 months. The 1-year follow-up confirmed the safety of the technique, showing aneurysm shrinkage, absence of any endoleak, and patent visceral vessels., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: Angioplasty and stenting are options for revascularization of symptomatic femoral popliteal disease. Although angioplasty alone is effective in short lesions, longer lesions are often treated with stents. Multiple overlapping stents are expensive and may be associated with stent fracture. This trial evaluated the safety and efficacy of a single self-expanding stent up to 20 cm in length in patients with atherosclerotic disease of the superficial femoral artery (SFA) and proximal popliteal artery., Methods: Patients with lesions >4 cm and <18 cm were enrolled in this nonrandomized, prospective, multicenter trial that evaluated the Protégé EverFlex Self-Expanding Peripheral Stent System (Covidien, Plymouth, Minn). The study's primary end points were the 30-day major adverse event rate and duplex ultrasound-assessed patency at 1 year. These were compared with published performance goals. A preplanned analysis was conducted for the primary effectiveness end points at 1 year. Follow-up, including history, ankle-brachial index, patient-reported outcomes, duplex ultrasound assessment, and radiographs, is planned through 3 years. There was core laboratory review of angiograms, ultrasound scans, and plain radiographs. A subgroup of patients was studied with graded treadmill testing., Results: The study enrolled 287 patients (66% male; mean age, 68 years) with stenotic, restenotic, or occluded lesions of the SFA at 44 investigational sites in the United States and Europe. Systemic comorbidities included hypertension (88%), hyperlipidemia (86%), diabetes (43%), and prior SFA intervention (41%). The mean lesion length measured by the core laboratory was 89 mm. The mean normal-to-normal lesion length measured by sites was 110 mm. A total of 303 stents were implanted, and 95% of patients received a single stent. No major adverse events occurred at 30 days. At 1 year, primary outcome of duplex ultrasound stent patency was 67.7% in evaluable patients, and among 1-year secondary outcomes, the mean ankle-brachial index increased by 0.25. Walking Improvement Questionnaire scores improved in pain by 33.7, distance by 37.1, speed by 18.6, and stair climbing by 24.7. The Kaplan-Meier estimate of primary patency was 77.2%, primary assisted patency was 86.9%, and secondary patency was 87.3%. Rutherford clinical category improved in 83.5% of patients. Stent fracture rate was 0.4%. Matched absolute claudication distance was 412 feet greater and was not statistically different in this subgroup of 29 individuals., Conclusions: The results of DURABILITY II (StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protégé EverfLex NitInol Stent SYstem II) suggest that a new single stent strategy is safe and effective for the treatment of long lesions of the SFA and proximal popliteal arteries at 1 year., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: Critical limb ischemia, the most severe form of peripheral arterial disease, results in extremity amputation if left untreated. Endovascular recanalization of stenotic or occluded infrapopliteal arteries has recently emerged as an effective form of therapy, although the duration of patency is typically limited by restenosis. Recently, it has been suggested that drug-eluting stents originally developed for the coronary arteries might also be effective in preventing restenosis in the infrapopliteal arteries. This prospective, randomized, controlled clinical trial tested the hypothesis that treatment of infrapopliteal arterial occlusive lesions with an everolimus-eluting stent (Xience V) would provide superior patency to treatment with a bare-metal stent (Multi-Link Vision)., Methods: A sample size of 140 patients was planned to be enrolled at five European investigative sites. The primary end point was arterial patency at 12 months, defined as the absence of ≥50% restenosis based on quantitative analysis of contrast angiography., Results: Between March of 2008 and September of 2009, 74 patients were treated with Xience V and 66 patients were treated with Vision. After 12 months, the primary patency rate after treatment with Xience V was 85% compared with 54% after treatment with Vision (P = .0001). Treatment with Xience V significantly reduced mean in-stent diameter stenosis (21% ± 21% vs 47% ± 27%; P < .0001) and mean in-stent late lumen loss (0.78 ± 0.63 vs 1.41 ± 0.89 mm; P = .001). There were no differences in the percentage of patients receiving a designation of Rutherford class 0 or 1 at the 12-month follow-up visit (56% for Vision, vs 60% for Xience V; P = .68). Major extremity amputations were rare in both groups (two for Vision and one for Xience V). The use of the Xience V stent significantly reduced the need for repeat intervention: freedom from target lesion revascularization was 91% for Xience V vs 66% for Vision (P = .001)., Conclusions: Treatment of the infrapopliteal occlusive lesions of critical limb ischemia with everolimus-eluting stents reduces restenosis and the need for reintervention compared with bare metal stents., (Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objectives: This study investigated the results with primary stenting using the Protégé EverFlex 200-mm-long self-expanding nitinol stent (ev3 Endovascular Inc, Plymouth, Minn) in femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C and D lesions of at least 150 mm in length., Methods: Between March 2008 and June 2009, 100 patients (66 men) presenting with 100 symptomatic TASC C and D femoropopliteal lesions were treated with at least one 200-mm-long Protégé EverFlex stent. The intention of this study was to treat all lesions with as few stents as possible. The primary study end point was primary patency at 12 months, defined as the absence of hemodynamically significant stenosis on duplex ultrasound imaging (systolic velocity ratio <2.4) at the target lesion and without target lesion revascularization (TLR) ≤12 months. Stent fracture occurrence was assessed at the 12-month follow-up by conventional x-ray imaging., Results: Average patient age was 70 years. Preoperative symptom assessment reported 71 patients (71%) had claudication vs 29 (29%) with critical limb ischemia. Average lesion length was 242 mm (range, 160-450 mm), and 27 patients (27%) presented with popliteal involvement. A total of 158 Protégé EverFlex stents were used to treat 100 lesions. Kaplan-Meier estimation reported a 12-month freedom from target lesion revascularization of 68.2% and a primary patency rate of 64.8%. Stent fractures occurred in six patients (6.0%) when x-ray images taken immediately after the procedure were compared with those taken after 1 year., Conclusions: The results of our Durability-200 study show an acceptable primary patency rate after 1 year was obtained in this patient cohort with TASC C and D femoropopliteal lesions., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: A novel self-expanding drug-eluting stent was designed to slowly release everolimus to prevent restenosis following peripheral arterial intervention. The purpose of the first-in-human Superficial Femoral Artery Treatment with Drug-Eluting Stents (STRIDES) trial was to evaluate the safety and efficacy of this device for the treatment of symptomatic superficial femoral and proximal popliteal arterial occlusive disease., Methods and Results: One hundred four patients were enrolled at 11 European investigative centers in a prospective, nonrandomized, single-arm trial. The patients had severe symptomatic vascular disease, including a significant proportion of patients with critical limb ischemia (17%), diabetes (39%), and single-vessel outflow (26%). The mean lesion length was 9.0 ± 4.3 cm. Ninety-nine percent of patients were available for 12-month follow-up, including duplex imaging in 90% and arteriography in 83%. Clinical improvement, defined as a sustained decrease in Rutherford-Becker clinical category, was achieved in 80% of patients. Primary patency (freedom from ≥50% in-stent restenosis) was 94 ± 2.3% and 68 ± 4.6% at 6 and 12 months, respectively. Plain radiographic examination of 122 implanted devices at 12 months revealed no evidence for stent fracture., Conclusions: The everolimus-eluting self-expanding nitinol stent can be successfully implanted in patients with severe peripheral arterial disease with favorable outcomes and clinical improvements observed in the majority of patients., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: To compare the safety and efficacy of a rotational aspiration atherectomy system (Jetstream) for the treatment of infrainguinal arteries in diabetic versus nondiabetic patients., Methods: A total of 172 patients with Rutherford stage 1-5 lower limb ischemia were treated with rotational aspiration atherectomy between February 2006 and February 2007. Of these, 80 patients with type 2 diabetes mellitus (DM: 46.5%) were compared with 92 nonDM (53.5%) patients. Overall, 210 target lesions (99 DM; 111 nonDM) were treated, located in the superficial femoral (67% DM; 61% nonDM), popliteal (25% DM; 30% nonDM), and tibial (8% DM; 9% nonDM) arteries. Lesion characteristics were comparable in both groups, mean lesion length was 28.5 mm (DM) and 26.2 mm (nonDM); total occlusions were present in 29% (DM) and 32% (nonDM), and 15% (DM) and 14% (nonDM) were restenotic., Results: In the entire cohort, device success was 99% (all but two lesions). The major adverse event (MAE) rate (death, index limb amputation, myocardial infarction, target lesion revascularization [TLR] and target vessel revascularization) in DM at 30 days was 2.5% (n = 2 planned amputations) and 0% in nonDM. At 6 and 12 months, MAE in DM was seen in 13.8% (11/80) and 25% (20/80) compared with 21.7% (20/92) and 31.5% (29/92) in nonDM, respectively. TLR rate through 12 months was 20% (16/80) in DM and 28% in nonDM (26/92). Overall, 1 year restenosis rate was 38.2% based on duplex. The ankle-brachial index, mean Rutherford categories, and walking impairment questionnaire did not differ between groups at baseline and were increased significantly in both study cohorts at 12 months., Conclusion: Jetstream-assisted atherectomy in infrainguinal arteries is safe and effective in DM compared with nonDM patients. In this short-lesion cohort, vessel patency in diabetics was as good as for non-DM at 1 year. TLR and MAE were higher by trend in nonDM, although planned amputations were seen only in DM. The clinical benefit was similar in both groups., (Copyright © 2011. Published by Elsevier Inc.)

Objective: Data regarding the long-term efficacy of carotid artery stenting (CAS) are still scarce. As demonstrated by several major randomized controlled trials (RCT) comparing the efficacy of carotid endarterectomy (CEA) vs medical therapy, even after successful carotid revascularization late ipsilateral stroke occurs in 5-13% at 5 years. Therefore, major concerns also remain about the durability of the CAS procedure in terms of stroke prevention. The purpose of this study was to review long-term results after carotid stent implantation in a large cohort of patients., Methods: This retrospective investigation involved 3179 CAS procedures performed at four European carotid high-volume centers. Echo-duplex scan using modified velocity criteria to recognize in-stent restenosis (ISR) and neurological examinations of all patients were carried out every 6 months after the procedure. Life-table analysis was used to determine freedom from mortality, stroke-related death, ipsilateral fatal/major stroke, and any ipsilateral stroke. Freedom from ISR and from reintervention were also reported. The secondary aim was to identify predictive risk factors for neurological complications and ISR., Results: At 5 years freedom from mortality, stroke-related death, ipsilateral fatal/major stroke, and any stroke rate were 82%, 93.5%, 93.3%, and 91.9%, respectively. The only predictor for neurological complications was the presence of neurological symptoms before CAS (hazard ratio 1.38 [CI 1.05, 1.82] P = .02). Freedom from restenosis at 1, 3, and 5 years was, respectively, 98.4%, 96.1%, and 94%. Uni- and multi-variate analyses showed that stent characteristics (material/design/free-cell area) were not significantly associated with time to in-stent restenosis or time to reintervention., Conclusion: Our long-term results in a large cohort of patients validated CAS as a durable procedure for stroke prevention. The annual rate of neurological complications after CAS was comparable to that of conventional surgery as demonstrated by large RCTs involving both symptomatic patients (North American Symptomatic Carotid Endarterectomy Trial [NASCET] and European Carotid Surgery Trial [ECST]) and asymptomatic patients (Asymptomatic Carotid Atherosclerosis Study [ACAS] and Asymptomatic Carotid Surgery Trial [ACST]).

The importance of angioplasty and stenting in the treatment of carotid artery disease cannot be underestimated. Successful carotid stenting does not only depend of the operator's skills and experience, but also an adequate selection of cerebral protection devices and carotid stents can help avoiding neurological complications. A broad spectrum of carotid devices is currently on the market and since all have their assets and downsides, it is virtually impossible to acclaim one specific device as being the best. The individual characteristics of each specific protection system or stent may make it an attractive choice in one circumstance, but render it a less desirable option in others situations. The applicability depends primarily on the arterial anatomy and the specific details of the lesion being treated. But certainly, personal preferences and familiarity with a specific device may legitimately influence the decision to choose one over another.

Objectives: The goal of this study was to review our experience with embolic protection devices (EPDs) during carotid artery stenting (CAS). Specifically, we aimed to verify their clinical effectiveness and to compare clinical outcomes between specific devices and types of EPDs., Methods: The CAS databases at four participating centers were reviewed. Adverse events were defined as death, stroke (>24 hours), or transient ischemic attack (TIA) (<24 hours). We compared the risk of procedural and 30-day events between patients treated with and without an EPD. We also compared these risks between different EPDs and between the different types of EPDs., Results: A total of 3160 CAS procedures using nine EPDs were analyzed. The risk of a procedural adverse event was 0.9% in protected and 2.3% in unprotected procedures (P = .12). Compared with the most frequently used device (FilterWire, Boston Scientific, Natick, Mass), there was no significant difference in the risk of procedural adverse events for any of the other EPDs. There was, however, an increased risk of 30-day adverse events with the Accunet (Abbott Vascular, Redwood, Calif) filter compared with the FilterWire (relative risk [RR] 2.67, confidence interval [CI] 1.41 to 5.04, P = .005). Pairwise comparison of proximal occlusion balloons to filters, distal occlusion balloons to filters, and proximal to distal occlusion balloons revealed no significant difference in the risk of procedural or 30-day adverse events. There was no significant difference in risk of procedural events between eccentric and concentric filters, however, the relative risk of eccentric compared with concentric filters at 30 days was 0.59 (unadjusted, CI 0.38 to 0.92, P = .04). This difference was still apparent after adjustment for risk factors (RR 0.61, CI 0.39 to 0.95, P = .06), but not after adjustment for risk factors and stent-type [(open-cell vs closed-cell) RR 0.76, CI 0.47 to 1.22, P = .51]., Conclusion: The use of EPDs is associated with a low risk of procedural adverse events. We were unable to detect significant differences in risks of procedural adverse events between different devices or types of devices. We speculate that the observed differences seen at 30 days are largely attributable to differences in stent-type used.

Objectives: To identify if carotid stent design, especially free cell area, impacts on the 30-day rates for stroke, death and TIA after carotid artery stenting (CAS)., Material and Methods: A CAS database of 3179 consecutive CAS patients was retrospectively assessed. The distribution of neurological complications were analysed for association with the different stent types and designs. Events where subdivided into procedural and postprocedural events., Results: The overall combined rate of TIA, stroke and death was 2.8% at 30 days (late events 1.9%). The post-procedural event rate analyzed for differences stents varied from 1.2% using BSCI Carotid Wallstent to 5.9% using Medtronic Exponent. The late event rates varied from 1.2% to 3.4% for free cell areas <2.5mm(2) and >7.5mm(2) respectively (p<0.05). Post-procedural event rate was 1.3% for closed cells and 3.4% for open cells. All these differences were highly pronounced among symptomatic patients (p<0.0001)., Conclusions: After carotid stenting, complication rates vary according to stent type, free cell area and cell design. In the symptomatic population (and also in the total population), post-procedural complication rates are highest for the open cell types and increase with larger free cell area.

Objectives: The study was conducted to identify patient and procedural parameters that negatively impact the 30-day rates for stroke, death and transient ischemic attack (TIA) after carotid artery stenting (CAS) and that might be modified or further studied in future efforts to improve CAS., Methods: This was a retrospective investigation of a dual-center CAS database of 701 consecutive CAS patients (414 men; mean age, 72.4 +/- 8.4). A subset of patient-related, lesion-related, or procedure-related variables (age >or=80, left sided lesion, symptomatic, nicotine abuse, hypertension, diabetes mellitus, other peripheral vascular disease, hypercholesterolemia, embolic protection devices usage, predilation, ulcerated lesion, echolucent plaque, restenosis after surgery) were analyzed for association with occurrence of stroke, death, or TIA

Objective: Several prosthetic materials have been used for femoropopliteal bypass grafting in patients with peripheral vascular disease in whom a venous bypass is not possible. Expanded polytetrafluoroethylene (ePTFE) is the most commonly used, but patency results have not always equaled those achieved with vein, especially in below-knee reconstructions. This study assessed the performance of a new heparin-bonded ePTFE vascular graft that was designed to provide resistance to thrombosis and thereby decrease early graft failures and possibly prolong patency., Method: From June 2002 to June 2003, 86 patients (62 men and 24 women; mean age, 70 years; 99 diseased limbs) were enrolled prospectively in a nonrandomized, multicenter study of the heparin-bonded ePTFE graft. Fifty-five above-knee and 44 below-knee (including 21 femorocrural) procedures were performed. Follow-up evaluations consisted of clinical examinations, ultrasonographic studies, and distal pulse assessments. Patency and limb salvage rates were assessed by using life-table analyses., Results: All grafts were patent immediately after implantation. There were no graft infections or episodes of prolonged anastomotic bleeding. During the 1-year follow-up, 10 patients died, 15 grafts occluded, and 5 major amputations were performed. The overall primary and secondary 1-year patency rates were 82% and 97%, respectively. The limb salvage rate in patients with critical limb ischemia (n = 41) was 87%. Primary patency rates according to bypass type were 84%, 81%, and 74% for above-knee femoropopliteal, below-knee femoropopliteal, and femorocrural bypasses, respectively; the corresponding secondary patency rates were 96%, 100%, and 100%., Conclusions: In this study, the heparin-bonded ePTFE graft provided promising early patency and limb salvage results, with no device-related complications, in patients with occlusive vascular disease. Longer-term and randomized studies are warranted to determine whether this graft provides results superior to those achieved with other prostheses, especially in patients at increased risk of early graft failure, such as those undergoing below-knee bypass and those with poor run-off or advanced vascular disease.

Objectives: Neurologic complications during carotid artery stenting (CAS) are most clearly associated with embolization of visible debris. Distal filter devices may provide cerebral protection by capturing clinically significant debris. However, they increase procedural time and expense and have their own set of complications. The current study was undertaken to identify the clinical factors predictive for the presence or absence of visible debris captured by distal filter devices during CAS., Methods: Patients undergoing CAS with use of a distal filter device (n = 279) were prospectively entered into an investigational carotid registry. Recorded variables were classified as patient-, lesion-, or procedure-related. The filter was assessed for visible debris in each case. The odds ratio (OR) and 95% confidence interval (CI) were determined for each variable to predict visible debris. The ability of each variable to predict the absence of visible debris was assessed by calculating the individual negative predictive value (NPV)., Results: Visible debris was present in 169 filters (60.3%). There was an increased risk of visible debris found with several variables (OR, 95% CI): hypertension (2.9, 1.7 to 5.2), hypercholesterolemia (2.3, 1.4 to 3.9), stent diameter >9 mm (16.6, 9.0 to 30.0), and any neurologic event (4.2, 1.5 to 9.9). The NPV failed to exceed 0.80 (80%) for any variable. The NPV of the variables with a significantly elevated OR was as follows: hypertension (0.60), hypercholesterolemia (0.52), stent diameter >9 mm (0.75), and any neurologic event (0.38)., Conclusions: Several clinical variables are associated with the presence of visible debris captured by distal filter devices. The current study failed to identify any variables capable of consistently predicting the absence of visible debris. These findings support the routine rather than the selective use of cerebral protection during CAS.

Background: The purpose of this study was to assess the safety and efficacy of translating into national practice methodology for infrainguinal excimer laser-assisted angioplasty, for the treatment of critical limb ischemia in poor surgical bypass candidates., Methods: A prospective five centre Belgian registry enrolled 48 patients, who presented with 51 chronic critically ischemic limbs (Rutherford category 4, 5 or 6) and were poor candidates for bypass surgery. Treatment included crossing the occlusion or stenosis by conventional guidewire followed by excimer laser angioplasty with, or without, adjunctive balloon angioplasty or stenting. A step-by-step technique was used in cases where the guidewire could not pass the occluded site. The primary endpoint was limb salvage, at 6 months, of the treated limb., Results: Initial treatment was successful in all 51 limbs. By 6 months there had been six deaths, six minor and four major amputations and further intervention was required in four patients. Among survivors, limb salvage rate at 6 month was 38/42 (90.5%), with freedom from critical limb ischemia in 86%., Conclusions: This Belgian study of excimer laser assisted angioplasty, in high-risk patients who were poor candidates for surgical re-vascularisation, had a low incidence of surgical re-interventions and limb salvage rate in excess of 90%.