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 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 ... -  《-》

Comparison of midterm results for the Talent and Endurant stent graft.

Stent graft evolution is often addressed as a cause for improved outcomes of endovascular aneurysm repair for patients with an abdominal aortic aneurysm. In this study, we directly compared the midterm result of Endurant stent graft with its predecessor, the Talent stent graft (both Medtronic, Santa Rosa, Calif). Patient treated from January 2005 to December 2010 in a single tertiary center in The Netherlands with a Talent or Endurant stent graft were eligible for inclusion. Ruptured abdominal aortic aneurysms or patients with previous aortic surgery were excluded. The primary end point was the Kaplan-Meier estimated freedom from secondary interventions. Secondary end points were perioperative outcomes and indications for secondary interventions. In total, 221 patients were included (131 Endurant and 90 Talent). At baseline, the median aortic bifurcation was narrower for the Endurant (30 mm vs 39 mm; P < .001). Median follow-up was 64.1 ± 37.9 months and 59.2 ± 25.3 months for Talent and Endurant, respectively. The estimated freedom from secondary interventions at 30 days, 1 year, 5 years, and 7 years was 94.3%, 89.4%, 72.2%, and 64.1% for Talent and 96.8%, 89.3%, 75.2%, and 69.2% for Endurant (P = .528). The indication for secondary interventions does differ; more patients required an intervention for a proximal neck-related complication (type Ia endoleak or migration) in the Talent group (18.2% vs 4.8%; P = .001), whereas more interventions for iliac limb stenosis were seen in the Endurant group (0.0% vs 4.8%; P = .044). In a binomial regression analysis, suprarenal angulation, infrarenal neck length, and type of stent graft were independent predictors of neck-related complications. Evolution from the Talent stent graft into the Endurant has resulted in significant reduction of infrarenal neck-related complications; on the other hand, iliac interventions increased. The overall midterm secondary intervention rate was comparable.

't Mannetje YW ，Cuypers PWM ，Saleem BR ，Bode AS ，Teijink JAW ，van Sambeek MRHM ... -  《-》

Results of endovascular repair of infrarenal aortic aneurysms using the Endurant stent graft.

Recent reports showed that the Endurant stent graft (Medtronic Cardiovascular, Santa Rosa, Calif) is safe and effective for endovascular repair of abdominal aortic aneurysms (AAAs). However, due to its relatively recent introduction, only short-term follow-up data are available. This study presents the 4-year results using this device. All clinical data, including detailed anatomic information of the first 100 consecutive patients treated with the Endurant stent graft for an infrarenal AAA in three Dutch high-volume hospitals, were prospectively collected. Computed tomography angiography was routinely performed before the procedure, ≤ 1 month, and at 1 year post-endovascular aneurysm repair. Thereafter, the imaging modality during yearly follow-up was individualized (duplex ultrasound imaging or computed tomography angiography). Patients were classified as within or outside the instructions for use (IFU) for analysis. Study end points were primary clinical success, overall and AAA-related mortality, and sac morphology changes and endoleak during follow-up. Estimates were obtained using Kaplan-Meier plots. The study included 100 consecutive patients (88 men) with a median age of 74 years (interquartile range [IQR], 67-79 years) and median AAA diameter of 58 mm (IQR, 55-65 mm), between December 2007 and March 2009. Twenty patients (20%) were treated outside the IFU (18, outside proximal neck IFU, one outside iliac IFU, and one outside both IFUs). Median follow-up was 48 months (IQR, 36-53 months), and no patients were lost. One contained rupture was observed after 1.5 months due to graft infection. No patients had graft migration. Two type Ia endoleaks, 5 type Ib endoleaks, and 15 type II endoleaks were found. Primary clinical success was 97%, 90%, 84% and 77% at 1, 2, 3, and 4 years, respectively. Primary clinical success was comparable for patients treated within or outside IFU (P = .20), although both patients outside iliac IFU needed a secondary iliac intervention. Over time, maximum aneurysm diameter decreased ≥ 5 mm, remained stable, and increased ≥ 5 mm in 58%, 32%, and 10% of the patients, respectively. All-cause mortality was 20% at 4 years, with a 3% AAA-related mortality. The 4-year follow-up data of the Endurant stent graft for AAA treatment shows its use results in a low AAA-related mortality with adequate prevention of rupture or aneurysm growth. Although patients with very challenging anatomy were treated in our series, primary clinical success rates were comparable for patients treated within and outside the IFU. However, both patients outside the iliac IFU needed a secondary iliac intervention. The knowledge of the present results may aid in improving outcomes in the future.

Zandvoort HJ ，Gonçalves FB ，Verhagen HJ ，Werson DA ，Moll FL ，de Vries JP ，van Herwaarden JA ... -  《-》