Endovascular abdominal aortic aneurysm repair using an anatomical fixation technique and concomitant suprarenal orientation: results of a prospective, multicenter trial.

Endovascular repair of abdominal aortic aneurysms with the Endologix Powerlink System has been shown to be a safe and effective alternative to open surgery in patients having an aortic neck diameter of up to 26 mm. We report the mid-term outcomes of an endovascular repair approach wherein the infrarenal bifurcated stent graft was placed at the aortoiliac bifurcation, with concomitant placement of a proximal extension having suprarenal orientation for proximal sealing. Between 2006 and 2008, eight US sites enrolled 44 consecutive eligible patients presenting with abdominal aortic aneurysm in a prospective, single arm pivotal trial approved by the Food and Drug Administration. Each patient received a Powerlink infrarenal bifurcated stent graft through anatomical fixation at the aortoiliac bifurcation and a suprarenal extension to achieve proximal sealing. Analysis of the primary endpoint (proximal type I endoleak) was evaluated using contrast-enhanced computed tomography scans at 30 days, with on-going long-term follow-up for safety and treatment effectiveness. Patients (89% male) presented at a mean age of 70 ± 10 years with mean maximal aneurysm sac diameter of 5.5 cm. Challenging infrarenal aortic neck anatomy was present in 93% of patients. Technical success was 100% over a mean procedure time of 129 minutes. No aneurysm-related deaths, conversions, ruptures, migrations, or type III or IV endoleaks have been observed. The majority of endoleaks (80%) observed to date are type II. Currently, the primary clinical success rate is 93%. Two endovascular secondary procedures have been performed for resolution of type IA or type IB endoleak, and one surgical intervention was performed for resolution of limb occlusion. Significant reduction in sac diameter is observed to up to 2 years. The combination of an anatomically-fixed Powerlink infrarenal bifurcated stent graft and a suprarenal proximal extension safely and effectively excludes aneurysms in eligible patients. Longer term follow-up will determine the durability of these findings.

Harlin SA ，Beasley RE ，Feldman RL ，Thompson CS ，Williams JB ... -  《-》

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 ... -  《-》

From clinical trials to clinical practice: 612 cases treated with the Powerlink stent-graft for endovascular repair of AAA.

Qu L ，Raithel D 《JOURNAL OF CARDIOVASCULAR SURGERY》

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 ... -  《-》

Long-term outcomes of Palmaz stent placement for intraoperative type Ia endoleak during endovascular aneurysm repair.

Perioperative proximal endoleaks during endovascular aneurysm repair potentiate graft migration, aneurysm sac expansion, and stent-graft failure. Adjunctive placement of a Palmaz stent at the proximal landing zone can improve proximal seal and eliminate perigraft flow; however, the long-term sequelae associated with this maneuver are unknown. We sought to evaluate the effect of Palmaz stent placement for type Ia endoleaks on delayed endoleak formation, graft migration, and aneurysm expansion. A retrospective cohort review of a prospectively maintained database was performed. Between 2000 and 2005, all consecutive patients who had undergone infrarenal endovascular aneurysm repair were evaluated for a type I endoleak that was treated with Palmaz stent placement. Fenestrated, juxtarenal, and investigational devices were excluded from the analysis. Postoperative and follow-up axial imaging were analyzed for the following three primary endpoints: type I endoleak formation, stent-graft migration, and aneurysm sac expansion. In addition, a paired analysis was performed comparing suprarenal aortic diameters, infrarenal aortic neck diameters, aortic neck lengths, and proximal seal zones. In all, 36 consecutive patients were identified with intraoperative type I endoleaks that were treated with Palmaz stenting. Five patients with ruptured abdominal aortic aneurysms died before discharge; the remaining 31 patients comprised the cohort for analysis. During a median follow-up period of 53 months (interquartile range: 14-91 months), no type I endoleak developed after Palmaz stent placement. Despite patients experiencing shortening of aortic neck length (26%) and loss of the proximal seal zone (35%), no stent-graft migration was seen in this population. Continued aortic degeneration accounted for proximal seal zone loss. At a distance 15 mm below the lowest renal artery, the mean aortic diameter increased by 3.2 mm (95% confidence interval: 0.4-6, p < 0.5), and 63% of patients demonstrated an increase of >10%. Mean aortic sac regression was 5.8 mm (95% confidence interval: 0.5-11.0, p < 0.05). Overall, at the final follow-up evaluation, aortic sac regression was found to have occurred in 55% of patients, aortic sac increased up to 10% in 20% of the patients, and by more than 10% in 25% of the patients. Proximal neck reinforcement with a Palmaz stent serves as an effective endovascular adjunct to treat intraoperative type I endoleaks, and has a very high technical success rate. Most importantly, it has a clinical effect on delayed type I endoleak formation and stent-graft migration.

Arthurs ZM ，Lyden SP ，Rajani RR ，Eagleton MJ ，Clair DG ... -  《-》