Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms

Abstract

Objective: To determine if a physician-modified endovascular graft (PMEG) is a safe and effective method of treating juxtarenal aortic aneurysms in patients considered to be unsuitable for open surgical repair.

Methods: A retrospective, nonrandomized, single institution evaluation of the safety and efficacy of physician modification of a currently Food and Drug Administration-approved device (Zenith Flex; Cook Inc, Bloomington, Ind) to preserve branch vessels when used in the treatment of patients with elective, symptomatic, or ruptured juxtarenal aortic aneurysms.

Results: Forty-seven consecutive patients underwent fenestrated endovascular repair using PMEG over a 3-year period. Thirty-eight patients (80%) were symptomatic or had rapid aneurysm expansion. Eighty-five percent of patients were American Society of Anesthesiologist category III or IV. Eight-two fenestrations were created for 58 renal arteries, 16 superior mesenteric arteries, three celiac arteries, and the rest accessory vessels. Mean follow-up was 607 days, with a range of 425 to 1460 days. Mean contrast usage and fluoro time were 98 mL and 48 minutes. Technical success rate was 98%, and freedom from aneurysm-related death was 98%. There were six complications (13%). Three (6%) were access related, and three (6%) were procedure related and included one stroke, one case of renal failure, and one branch artery dissection. On follow-up, six patients (13%) had endoleak. There was one type 1 endoleak and five type 2 endoleaks. In-hospital and 30-day mortality was 2%, with one patient expiring due to aspiration on the ward after successful endovascular repair. Two patients died during follow-up; one at 58 days due to cessation of dialysis and one at 485 days due to stent graft migration and occlusion of the superior mesenteric artery. There were two deaths in the first year, one in the second year, and zero in the most recent year of experience. One patient with endoleak (2%) had aneurysm sac expansion at 1 year requiring secondary intervention.

Conclusions: PMEG is a safe and effective alternative for treating patients with juxtarenal aneurysms who have no other alternatives for repair. Longer-term follow-up is needed to assess the durability of repair and potential for device-related complications.