Endovascular placement of a nitinol-ePTFE stent-graft for abdominal aortic aneurysms: Initial and midterm results

PURPOSE: Because first-generation stent-grafts did not meet initial expectations, a recently designed nitinol-expanded polytetrafluoroethylene (ePTFE) stent-graft was tested for treatment of abdominal aortic aneurysms (AAAs) in a prospective clinical study. The primary study endpoints; were technical success and safety. MATERIALS AND METHODS: A nitinol-ePTFE self-expandable stent-graft (Excluder) was used to treat 72 patients with AAAs. The median follow-up period was 21.5 months +/- 13 (range, 1-46 mo). RESULTS: Primary technical success in accurate placement of the device was achieved in 70 of 72 patients (97%). Complete exclusion of the aneurysm from arterial flow was achieved in 57 of 72 patients (79.2%). Three type I leaks were observed during implantation and were immediately corrected with a proximal cuff prosthesis in two patients. Fourteen of 72 patients (19.4%) had a type 11 leak. Major complications were observed in three patients (4.1%), including one death in the early postinterventional period (one of 72, 1.4%). At 3 months, aneurysms were excluded in 70 of 71 patients (98.6%), and at 12 months, aneurysms were occluded in 29 of 30 patients (96.7%). The maximum diameter of the aneurysm decreased from 55 mm +/- 11 (median +/- SD) before intervention to 53 mm +/- 13 at 6 and 12 months. None of the patients showed aneurysm growth. CONCLUSION: This newly designed stent-graft proved to be effective and safe for treatment of AAAs.