Intermediate results of a United States multicenter trial of fenestrated endograft repair for juxtarenal abdominal aortic aneurysms

Objective: This article reports the intermediate-term (24-month) outcomes of a prospective multicenter trial designed to evaluate the Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, Ind) for treating juxtarenal abdominal aortic aneurysms with short proximal necks. The study goals were to evaluate the safety and preliminary effectiveness of the device and refine patient selection criteria. Methods: Five centers in the United States enrolled 30 patients with juxtarenal aortic aneurysms with >= 50-mm diameter and short proximal necks. Devices were custom-designed for each patient based on measurements from reconstructed computed tomography (CT) data. Follow-up studies included physical examinations, laboratory studies, CT imaging, mesenteric-renal duplex ultrasound imaging, and abdominal flat plate radiographs at hospital discharge, at 1, 6, and 12 months, and yearly thereafter up to 5 years. Results: During a 1-year period, 30 patients (80% men; mean age, 75 years) with a mean aneurysm size of 61.4 mm were enrolled. In these 30 patients, 77 visceral vessels were accommodated by fenestrations located within the sealing segment of the grafts. The most common design accommodated two renal arteries and the superior mesenteric artery (66.7%). All prostheses were implanted successfully. No visceral arteries were lost. Of the 30 patients treated, 27 were available for 12-month follow-up and 23 were available for 24-month follow-up. No aneurysm-related deaths, aneurysm ruptures, or conversions were observed through 24 months of follow-up. No type I or type III endoleaks were observed. Type 11 endoleaks were noted in six (26.1%) at 12 months and four (20.0%) at 24 months. No patients had aneurysm growth >5 mm. Aneurysm size decreased in 16 of 23 (69.6%) and was stable in the remaining patients at 24 months. Eight patients experienced a renal event (4 renal artery stenoses, 2 renal artery occlusions, and 2 renal infarcts). Five underwent secondary interventions. No renal failure developed requiring dialysis. Conclusions: The intermediate-term (24-month) results of the 30 patients in this multicenter study are concordant with previous single-center studies and support the concept that placement of fenestrated endovascular grafts is safe and effective at centers with experience in endovascular repair and renal/mesenteric stent placement. (J Vasc Surg 2009;50:730-7.)