One year outcomes of the United States regulatory trial of the Endurant Stent Graft System.

To report the 1-year outcomes of the United States (US) regulatory trial of the Endurant Stent Graft System (Medtronic Vascular), a new device for the treatment of abdominal aortic aneurysms (AAA). This was a prospective, single arm, multicenter trial conducted at 26 sites in the US. From April 2008 to May 2009, 150 patients with AAA were treated with the Endurant bifurcated stent graft. The main inclusion criteria were an AAA diameter >5 cm, proximal neck length ≥ 10 mm, bilateral iliac fixation length ≥ 15 mm, and a neck angulation of ≤ 60 degrees. A clinical events committee (CEC) adjudicated all adverse events except blood loss, and a core laboratory reviewed all imaging. The primary safety endpoint was freedom from major adverse events at 30 days, and the primary effectiveness endpoint was successful aneurysm treatment at 12 months. One hundred forty-nine patients (99.3%) had a successful stent graft implant, 83.3% under general anesthesia. One failure was due to inability to cannulate the contralateral gate. One patient developed a neck rupture during the procedure, but was still treated successfully. Patients were predominantly male (91.3%), elderly (mean age, 73.1 years) with significant comorbidities. Mean estimated blood loss was 185 mL (range, 0-1450 mL), with blood transfusion required in one patient. Average hospital stay was 2.1 days. At 1 month, the major adverse events rate was only 4% with no operative mortality. Serious adverse events were recorded in 43 of 150 (28.7%) patients. Cardiac (8.7%), fever (6%), urological (4.7%), pulmonary (4%), and vascular events (4%) were the most frequent. Through 12 months of follow up, there were no migrations, ruptures, or conversions. No type I or III endoleaks were identified during the first year. Fifteen of 129 patients (11.6%) had endoleaks at 6 months and 13 of 130 (10%) at 1 year, all type II except for one indeterminate endoleak. One Type II endoleak proved to be a Type IB on later angiography. Ten aneurysm related reinterventions were performed during the first year of follow up, mostly for limb thrombosis or stenosis (5) or for type II endoleak (2). Four of the procedures were endovascular. Aneurysm sac diameter decreased >5 mm at 1 year in 47% of patients and remained stable in 53%. No sac showed an increase of >5 mm. None of seven late deaths (range, 90-458 days post-implant) was adjudicated to be aneurysm related. Early results of the Endurant pivotal trial are quite encouraging and suggest a safe and effective new device for the treatment of abdominal aortic aneurysms.

Makaroun MS ，Tuchek M ，Massop D ，Henretta J ，Rhee R ，Buckley C ，Mehta M ，Ellozy S ，Endurant US Pivotal Trial Investigators ... -  《-》

One-year multicenter results of 100 abdominal aortic aneurysm patients treated with the Endurant stent graft.

The Endurant (Medtronic, Minneapolis, Minn) is a new stent graft specifically designed to make more patients anatomically eligible for endovascular aneurysm (EVAR). This study presents the 1-year results of 100 consecutive patients with abdominal aortic aneurysms (AAAs) treated with the Endurant stent graft in real-life practice. All clinical preoperative, operative, postoperative, and 1-year follow-up data of patients with the Endurant stent graft from three tertiary centers were prospectively collected. Patients underwent computed tomographic angiography (CTA) preoperatively, at 1 month, and at 1-year post-EVAR. The first 100 patients with an implantation date at least 1 year before our date of analysis and complete information were included. Clinical data, AAA characteristics, presence of endoleaks, graft migration, and other EVAR-related complications were noted. All values are stated as mean ± SD (range). This study included 100 patients with AAAs (88 men) with a mean age of 73 ± 8 years (47 to 87 years), an AAA size of 61 ± 10 mm (31 to 93 mm), an AAA volume of 210 ± 122 mL (69 to 934 mL), a proximal neck length of 33 ± 14 mm (9 to 82 mm), and an infrarenal angulation of 44 ± 25° (0°-108°). Nineteen of the 100 included patients had at least one anatomic characteristic that was considered a violation of the instructions for use (IFU) of the Endurant stent graft. A primary technical success was achieved in 98% of the patients (one additional stent placement in renal artery was required; one unplanned aorto-uni-iliac device placed), with no primary type I or III endoleaks or conversions. A secondary technical success was achieved in all cases. The 30-day mortality was 2% and the first postoperative CTA documented 16 endoleaks (16%; 16 type II). One-year follow-up showed three iliac limb occlusions (3%), one infected stent graft (causing a type Ia endoleak), and five endovascular reinterventions (5%; three to treat iliac limb occlusions, one proximal extension cuff; and one stent in the renal artery). The 1-year all-cause mortality rate was 12% (12 patients) and the AAA-related mortality was 3%. The mean AAA size was significantly smaller after 1 year (diameter, 54 ± 11.8 [32-80] mm; P < .01; volume, 173 ± 119 [42-1028] mL; P < .01), and one graft migration >5 mm and 13 endoleaks were noted (12 type II, 1 type I [neck dilatation]). The treatment of patients with AAAs with the Endurant stent graft seems to be successful and durable during the first year after EVAR. Despite the wider inclusion criteria for the Endurant, and with 19% of our patients treated outside the IFU, the AAA-related mortality, number of type I or III endoleaks, and reintervention rates are comparable to the results of other stent grafts.

van Keulen JW ，de Vries JP ，Dekker H ，Gonçalves FB ，Moll FL ，Verhagen HJ ，van Herwaarden JA ... -  《-》

Final results of the Endurant Stent Graft System in the United States regulatory trial.

To report the 5-year outcomes from the Endurant Stent Graft System in the U.S. regulatory trial (bifurcated Endurant; Medtronic Santa Rosa, Calif). The study was a prospective, multicenter, regulatory trial performed at 26 U.S. sites. From June 2008 to April 2009, 150 patients with abdominal aortic aneurysms (AAAs) were treated with the Endurant bifurcated graft. The main inclusion criteria included AAA diameter >5 cm (or 4-5 cm in diameter where the size increased more than 5 mm within the previous 6 months), neck length ≥10 mm, and neck angulation ≤60 degrees. A clinical events committee adjudicated all untoward events, and a core laboratory reviewed available imaging at 1, 6, 12, 24, and 60 months. Outcomes were compared with the Talent enhanced Low Profile System (eLPS) study for regulatory purposes. At 5 years, clinical follow-up was available on 94% and imaging on 87% of 101 eligible patients. At 5 years, all-cause mortality estimate by Kaplan-Meier was 17.7%, and freedom from aneurysm-related mortality was 99.2%. One aneurysm-related mortality was noted in a patient that refused treatment for a type I endoleak and died in year 4 from rupture. There were no endograft migrations, fractures, or open conversions. At 5 years, endoleaks were identified in 7/83 patients (8.4%) and included six type II endoleaks and one of indeterminate origin. Maximum AAA diameter decreased by more than 5 mm in 53/83 patients (63.9%), remained stable in 25/83 (30.1%), and increased >5 mm in 5/83 (6.0%). Eighteen AAA-related secondary interventions were required in 15 patients (11%): 12 for endoleak management, 4 for limb occlusions, 1 for stenosis, and 1 for thromboembolism. Four of 5 limb occlusions reported were in the first 6 months. Survival and reintervention rates were better than the Talent eLPS study, which was conducted under similar inclusion exclusion criteria. The 5-year outcomes of the Endurant Stent Graft System in the U.S. regulatory trial continue to be positive. The device appears to be durable with limited adverse events through 5 years. Comparison with an older generation device suggests improving outcomes with newer devices.

Singh MJ ，Fairman R ，Anain P ，Jordan WD ，Maldonado T ，Samson R ，Makaroun MS ，Endurant U.S. Pivotal Trial Investigators ... -  《-》

One-year outcomes from an international study of the Ovation Abdominal Stent Graft System for endovascular aneurysm repair.

This study evaluated 1-year safety and effectiveness outcomes of the United States regulatory trial for the Ovation Abdominal Stent Graft System (TriVascular Inc, Santa Rosa, Calif) for endovascular repair of abdominal aortic aneurysms (AAAs). This prospective, multicenter, single-arm trial was conducted at 36 sites in the United States, Germany, and Chile to evaluate the safety and effectiveness of the Ovation stent graft. From November 2009 to May 2011, 161 patients (88% males; mean age, 73 ± 8 years) with AAAs (mean diameter, 54 ± 9 mm) were treated with the Ovation stent graft. The main body is a modular two-docking limb device with a 14F outer diameter delivery system, active suprarenal fixation, and polymer-filled proximal rings that accommodate the aortic neck for seal. Main inclusion criteria included proximal aortic neck length ≥ 7 mm, inner neck diameter between 16 and 30 mm, distal iliac landing zones length ≥ 10 mm, and diameter between 8 and 20 mm. Patients were treated under a common protocol, including clinical and imaging follow-up at discharge, 30 days, 6 months, and annually through 5 years. A Clinical Events Committee adjudicated adverse events, an independent imaging core laboratory analyzed imaging, and a Data Safety and Monitoring Board provided study oversight. Complete 1-year follow-up data were available for this report. The Ovation stent graft was implanted successfully in 161 patients (100%), including 69 (42.9%) by percutaneous access. General anesthesia was used in 106 patients (65.8%). Technical success was 100%, and mean procedure time was 110 minutes. Median procedural blood loss was 150 mL, and median hospital stay was 1 day. The 30-day major adverse event rate was 2.5%. At 1 year, AAA-related and all-cause mortality were 0.6% and 2.5%, respectively. Major adverse event and serious adverse event rates through 1 year were 6.2% and 38.5%, respectively. The 1-year treatment success rate was 99.3%. The imaging core laboratory reported no stent graft migration or type I, III, or IV endoleaks. At 1 year, type II endoleaks were identified in 34% of patients, and AAA enlargement was identified in one patient (0.7%). No AAA rupture or conversion to open surgery was reported. AAA-related secondary procedures were performed in 10 patients (6.2%) for 12 findings, including endoleak (six), aortic main body stenosis (three), and iliac limb stenosis or occlusion (three). The 1-year results of the Ovation Abdominal Stent Graft System demonstrate excellent safety and effectiveness in treatment of patients with AAAs, particularly in patients with challenging anatomic characteristics, including short aortic necks and narrow iliac arteries. Longer-term follow-up is needed.

Mehta M ，Valdés FE ，Nolte T ，Mishkel GJ ，Jordan WD ，Gray B ，Eskandari MK ，Botti C ，A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation Abdominal Stent Graft System Investigators ... -  《-》

Secure fixation following EVAR with the Powerlink XL System in wide aortic necks: results of a prospective, multicenter trial.

Jordan WD Jr ，Moore WM Jr ，Melton JG ，Brown OW ，Carpenter JP ，Endologix Investigators ... -  《-》