The AneuRx stent graft: four-year results and worldwide experience 2000.

OBJECTIVE The objective was to review the current results of endovascular abdominal aortic aneurysm repair with the AneuRx stent graft and to determine the effectiveness of the device in achieving the primary objective of preventing aneurysm rupture. METHODS The outcome of all patients treated during the past 4 years in the U.S. AneuRx clinical trial was determined, and the worldwide clinical experience was reviewed. RESULTS A total of 1192 patients were treated with the AneuRx stent graft during all phases of the U.S. Clinical Trial from June 1996 to November 1999, with follow-up extending to June 2000. Ten (0.8%) patients have had aneurysm rupture, with most ruptures (n = 6) occurring in 174 (3.4%) patients treated with an early stiff bifurcation stent graft design used in phase I and in the initial stages of phase II. Since the current, flexible, segmented bifurcation stent graft design was introduced, four (0.4%) ruptures have occurred among 1018 patients treated. Of these, one was during implantation, two were placed too far below the renal arteries, and one patient refused treatment of a type I endoleak. Kaplan-Meier analysis of all 1192 patients treated with the AneuRx stent graft including both stent graft designs revealed the patient survival rate to be 93% at 1 year, 88% at 2 years, and 86% at 3 years, freedom from conversion to open repair to be 98% at 1 year, 97% at 2 years, and 93% at 3 years, and freedom from secondary procedure to be 94% at 1 year, 92% at 2 years, and 88% at 3 years. Freedom from aneurysm rupture with the commercially available segmented bifurcation stent graft was 99.7% at 1 year, 99.5% at 2 years, and 99.5% at 3 years. The presence or absence of endoleak on contrast computed tomography scanning after stent graft placement was not found to be a significant predictor of long-term outcome measures. Worldwide experience with the AneuRx device now approaches 10,000 patients. CONCLUSIONS Endovascular management of abdominal aortic aneurysms with the AneuRx stent graft has markedly reduced the risk of aneurysm rupture while eliminating the need for open aneurysm surgery in 98% of patients at 1 year and 93% of patients at 3 years. The device was effective in preventing aneurysm rupture in 99.5% of patients over a 3-year period. The overall patient survival rate was 93% at 1 year and 86% at 3 years.