Study Supports Cook's Zenith Fenestrated Endovascular Graft to Treat Juxtarenal AAA

December 1, 2014—The results of a prospective, multicenter trial designed to evaluate the safety and effectiveness of Cook Medical’s Zenith fenestrated endovascular graft for treatment of juxtarenal abdominal aortic aneurysms (AAAs) were published by Gustavo S. Oderich, MD, et al in the Journal of Vascular Surgery (2014;60:1420­–1428). The data were first presented in June at the 2014 Vascular Annual Meeting of the Society for Vascular Surgery in Boston, Massachusetts.

The investigators concluded that this study demonstrated that endovascular repair of juxtarenal AAAs with the Zenith fenestrated AAA stent graft is safe and effective, resulting in low mortality and morbidity in properly selected patients treated in centers with experience in these procedures.

As summarized in the Journal of Vascular Surgery, the investigators prospectively enrolled 67 patients with juxtarenal AAAs at 14 centers in the United States from 2005 to 2012. Custom-made fenestrated stent grafts were designed with one to three fenestrations on the basis of analysis of computed tomography data sets. Renal alignment was performed with balloon-expandable stents.

Follow-up included clinical examination, laboratory studies, mesenteric-renal duplex ultrasound, abdominal radiography, and computed tomography imaging at hospital discharge, 1 month, 6 months, 12 months, and yearly up to 5 years.

The study was composed of 54 male and 13 female patients with a mean age of 74 ± 8 years. 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 nine. Of these, all 118 small fenestrations (100%), eight of the scallops (16%), and one of the large fenestrations (11%) were aligned by stents. The technical success rate was 100%.

The investigators found that there was one postoperative death within 30 days (1.5%). Mean length of hospital stay was 3.3 ± 2.1 days. No aneurysm ruptures or conversions were noted during a mean follow-up of 37 ± 17 months (range, 3–65 months). Two patients (3%) had migration ≥ 10 mm with no endoleak, both due to cranial progression of aortic disease.

Of a total of 129 renal arteries targeted by a fenestration, there were four (3%) renal artery occlusions and 12 (9%) stenoses. Fifteen patients (22%) required secondary interventions: renal artery stenosis/occlusion in 11 patients, type II endoleak in three patients, and type I endoleak in one patient.

At 5 years, patient survival was 91% ± 4%, and freedom from major adverse events was 79% ± 6%; primary and secondary patency of targeted renal arteries was 81% ± 5% and 97% ± 2%, respectively; freedom from renal function deterioration was 91% ± 5%; and freedom from secondary interventions was 63% ± 9%, reported the investigators in the Journal of Vascular Surgery.