Multicenter trial of the PowerLink bifurcated system for endovascular aortic aneurysm repair.

PURPOSE The purpose of this study was to assess the results of abdominal aortic aneurysm repair with the PowerLink bifurcated endovascular graft (Endologix, Inc, Irvine, Calif). METHOD Twelve centers used the PowerLink bifurcated system for elective endovascular aneurysm repair in 118 patients recruited during a 16-month interval and followed for a 25-month interval (mean follow-up, 16 months) as part of a pivotal US Food and Drug Administration trial. Stent grafts were oversized by 10% to 20% relative to computed tomographic scan-based diameter measurements. All repairs were performed in the operating room through one surgically exposed femoral artery and a contralateral 9F sheath percutaneously placed. Results were assessed with contrast-enhanced computed tomography and plain abdominal radiography at 1, 6, and 12 months after surgery. RESULTS Three failed insertions and one late conversion for endoleak remediation occurred, resulting in four conversions (3.3%) to open surgery. Of the failed insertions, two were from a faulty delivery system design, which was corrected. No failures occurred after the modification. One perioperative death (0.8%) occurred that was not device related. Eight late deaths were from unrelated causes, and one was from complications after reoperation for treatment of an endoleak. Endoleaks were noted in 19 patients (16%) at the time of the endograft procedure: 12 resolved spontaneously, four resolved with secondary interventions (three type I, one type II), and three underwent observation, yielding a 30-day endoleak rate of 5.9%. Two graft limb thromboses (0.8%) were seen. One graft migration (0.8%) was of no clinical significance. No ruptures or wire fractures were found. The mean aneurysm diameter was reduced from 51 mm (preoperative) to 45 mm (12 months; P <.0001). CONCLUSION The PowerLink system appears to be safe and effectively protects patients from abdominal aortic aneurysm rupture over the short to medium term. The low endoleak rate is superior to that reported for other devices. The graft and stent materials have thus far been free from failure and fatigue. The sutureless stent and endoskeleton design confer a number of unique advantages and challenges. Careful follow-up over the longer term is necessary to assure the durability of these results.