Final 5-Year Results of the United States Zenith Fenestrated Prospective Multicenter Study for Juxtarenal Abdominal Aortic Aneurysms

Abstract Purpose To report 5-year results of the prospective, multicenter study designed to evaluate the Zenith Fenestrated AAA Endovascular Graft (William A. Cook Australia, Brisbane) for juxtarenal abdominal aortic aneurysms (AAAs). Methods Sixty-seven patients (54 male, mean age 74±8 years) were prospectively enrolled at 14 United States centers from 2005 to 2012. Fenestrated stent-grafts were used in patients with infrarenal aortic neck lengths of 4-14 mm to target 178 renal-mesenteric arteries with a mean of 2.7 vessels per patient. At five years, 42 of the 67 patients completed the final study follow up, with clinical examination obtained in 41 and CT imaging in 39. Outcomes adjudicated by clinical events committee included all-cause and aneurysm-related mortality, major adverse events, renal stent occlusion/stenosis, renal function changes and renal infarcts, aneurysm sac enlargement (>5mm), device migration (≥10mm), type I/III endoleak and secondary interventions. Results Median follow-up was 59.8 months (range, 0.1 - 67.5 months). There were seven deaths, including one (1.5%) within 30 days (procedure-related), and six beyond 30 days (not procedure-related in five, indeterminate in one). At 5 years, freedom from all-cause mortality was 88.8±4.2%, and freedom from aneurysm-related mortality was 96.8±2.3%. There were no aneurysm ruptures or conversions to open surgery. Of the 129 renal arteries targeted by fenestrations, 5 (4%) occluded and 14 (11%) developed in-stent stenosis. Treatment included redo stenting/angioplasty in 13 vessels, renal artery bypass in two vessels, and failed thrombectomy in one vessel. Primary and secondary renal target patency was 82.7±4.1% and 95.7±2.1% at 5 years, respectively. Dialysis was required in one patient who had pre-existing chronic kidney disease. During the 5 years, there was one type IA endoleak (1.5%), one type IB endoleak (1.5%), two device migrations (3%), and four aneurysm sac enlargements (6%). Overall, 81% of patients had sac shrinkage at 5 years. Of twenty patients who underwent secondary interventions, 12 were for renal in-stent stenosis or occlusion, 7 were for endoleak, and one for both indications. Freedom from secondary intervention was 63.5±7.2% at 5 years. Conclusion These 5-year results confirm the safety and effectiveness of the Zenith Fenestrated AAA stent-graft with no late graft- or aneurysm-related deaths. In-stent stenosis of bare metal renal stents was the most frequent indication for secondary intervention. The low rate of type IA endoleak, sac enlargement, and device migration support its use in patients with juxtarenal AAAs.