Ten Years of Experience with the GORE EXCLUDER® Stent-Graft for the Treatment of Aortic and Iliac Aneurysms: Outcomes from a Single Center Study

Abstract

This study was designed to assess the long-term outcome of selected patients with aortic, aortoiliac, and isolated common iliac aneurysms treated with the GORE EXCLUDER® stent-graft. Between December 1998 and June 2010, 121 nonconsecutive patients underwent insertion of a GORE EXCLUDER® stent-graft to treat an aortic (n=80; 66%), aortoiliac (n=25; 21%), or isolated common iliac (n=16; 13%) aneurysm. Procedural and follow-up data were collected prospectively. Primary endpoints are overall survival, intervention-free survival, and freedom from aneurysm rupture. Secondary endpoints are device- and procedure-related complications, including all types of endoleaks or endotension, and reintervention. The mean follow-up is 4.98 years (standard deviation, 3.18; median follow-up, 4.05 years). The estimated percentage overall survival (with 95% confidence interval) after respectively 5 and 10 years of follow-up is 74.5% (65.8; 81.3) and 57.8% (47.7; 66.7). The estimated intervention-free survival after respectively 5 and 10 years is 90% (84.3; 96.1) and 77.7% (67; 88.4). There was no aneurysm rupture during follow-up. Early postoperative complications occurred in 16 patients (13%); none were fatal. Late reinterventions were performed in 18 patients (15%). Finally, throughout the follow-up period, endoleaks were identified: type I (n=4; 3%); type II (n=39; 32%); type III (n=0; 0%); endotension was seen in 11 patients (9%). Aneurysm exclusion with use of the GORE EXCLUDER® stent-graft is durable through a mean follow-up of nearly 5 years. There was no postprocedural aneurysm rupture. Complications occurred throughout the follow-up period, requiring continued clinical and radiological surveillance.