L6. Five-Year Results of the United States Multicenter Prospective Study Evaluating the Zenith® Fenestrated Endovascular Graft for Treatment of Juxtarenal Abdominal Aortic Aneurysms

Abstract

This study reports results of a prospective, multicenter trial designed to evaluate the safety and effectiveness of the Zenith® Fenestrated AAA Endovascular Graft (ZFEN, Cook Medical, Bloomington IN) for treatment of juxtarenal abdominal aortic aneurysms (AAAs). Sixty-seven patients with juxtarenal AAAs were prospectively enrolled in 14 U.S. centers (2005-2012). Custom-made fenestrated stent-grafts were designed with up to three fenestrations based on analysis of computed tomography (CT) datasets. Renal alignment was performed using balloon-expandable stents. Follow up included clinical examination, laboratory studies, duplex ultrasound, abdominal X-rays and CT imaging at hospital discharge, 1, 6, 12 months, and yearly thereafter up to 5 years. here were 54 male and 13 female patients with a mean age of 74±8 years old enrolled. Mean aneurysm diameter was 60 ± 10 mm. A total of 178 visceral arteries required incorporation with small fenestrations in 118, scallops in 51 and large fenestrations in 9. Of these, all 118 small fenestrations (100%), 8 of the scallops (16%), and 1 of the large fenestrations (11%) were aligned by stents. Technical success was 100%. There was one postoperative death within 30 days (1.5%). Mean length of hospital stay was 3 ± 2 days. There were no type I or III endoleaks, aneurysm ruptures or conversions noted during a mean follow up of 37 ± 17 months (3-65 months). Two patients (3%) had migration >5 mm with no endoleak due to cranial progression of aortic disease. Of a total of 129 renal arteries targeted by a fenestration, there were 4 (3%) renal artery occlusions and 10 (8%) stenoses. Fifteen patients (22%) required secondary interventions for renal artery stenosis/occlusion in 11 patients, type II endoleak in three and indeterminate endoleak in one. At 5 years, patient survival was 91% ± 4%, freedom from major adverse events was 79% ± 6%, primary and secondary patency of targeted renal arteries was 81±5% and 97% ± 2%, freedom from renal function deterioration was 91±5%, and freedom from secondary interventions was 63% ± 9%. This prospective study demonstrates that endovascular repair of juxtarenal AAAs using ZFEN is safe, effective and durable. Mortality and morbidity are low in properly selected patients treated in centers with experience in these procedures.