Midterm results of the multicenter trial of the powerlink bifurcated system for endovascular aortic aneurysm repair.

PURPOSE: We assessed the results of abdominal aortic aneurysm (AAA) repair with the Powerlink bifurcated endovascular graft compared with open AAA repair.
METHOD: A prospective controlled multicenter trial of the Powerlink system for endovascular aneurysm repair was conducted at 15 sites as part of a pivotal US Food and Drug Administration trial. Between July 2000 and March 2003, 258 patients (192 test patients, 66 control patients) were enrolled. Stent grafts were oversized by 10% to 20% relative to computed tomography scan (CT)-based diameter measurements. All repairs were performed in the operating room through 1 surgically exposed femoral artery and a contralateral 9F sheath percutaneously placed. Results were assessed with contrast material-enhanced CT scans and plain abdominal x-ray studies at 1, 6, and 12 months, and annually postoperatively.
RESULTS: Patients were followed up for a mean of 22 months (median, 24 months). Technical success was achieved in 97.9% of patients, with 4 failed insertions (3 early conversions because of deployment issues, 1 access failure). There were no significant differences in mortality between the Powerlink and control groups, and only 1 death was procedure-related. Blood loss (341 mL vs 1583 mL; P < .0001), operative time (136 minutes vs 222 minutes; P < .0001), intensive care unit stay (0.78 days vs 4.1 days; P < .0001), and hospital length of stay (3.3 days vs 9.5 days; P < .0001) were significantly less in the Powerlink cohort compared with the control group. There were significantly fewer adverse events (myocardial infarction, P = .0131; renal failure, P = .0042; gastrointestinal complications, P = .0125) in the perioperative period in the Powerlink cohort compared with the control group, but in the longer follow-up interval adverse event-free survival was equivalent between groups (P = .456, log-rank test). At the time of the first-month CT scan, endoleaks were noted in 25 patients, yielding a 30-day endoleak rate of 22.7%. Type II endoleaks predominated, and there were no type III or IV endoleaks. Secondary procedures were performed in 19 patients (10%), for treatment of endoleak (n = 10), limb obstruction (n = 7), and other causes (n = 2). There were 3 graft migrations (2.2%), 1 of which resulted in an endoleak. There were no ruptures, graft fabric defects, or wire fractures. Significant reduction in mean AAA diameter and volume was noted at every follow-up interval. Increase in AAA diameter was noted in only 1.5% of patients at 24 months.
CONCLUSION: The Powerlink system appears safe, and effectively protects patients from AAA rupture over the intermediate term. The graft and stent materials have thus far been free from failure and fatigue. Percutaneous contralateral limb access facilitates graft placement in patients with disadvantaged access routes. Endovascular aneurysm repair with the Powerlink system produces significantly fewer early adverse events compared with open AAA repair, but mortality is equivalent with both procedures. Careful follow-up over the longer term is necessary to ensure the durability of these results.

RCT Entities:   Population Interventions Outcomes