Performance of the Endurant stent graft in patients with abdominal aortic aneurysms independent of their morphologic suitability for endovascular aneurysm repair based on instructions for use

Abstract

The aim of this study was to prospectively evaluate the early and late 7-year experience with the Endurant bifurcated stent graft system (Medtronic, Santa Rosa, Calif) in patients with abdominal aortic aneurysms. Between November 14, 2007, and December 2013, 712 consecutive high-risk patients with abdominal aortic aneurysms underwent elective or urgent placement of an Endurant bifurcated endograft in our institution. The included patients were consecutive (all comers) and treated independently from their morphologic eligibility for use of the Endurant device based on the instructions for use. The primary study outcome was freedom from all-cause reintervention. The median follow-up was 19.2 months (interquartile range, 6.3-35.9 months). Overall, 517 patients (72.6%) were treated on the basis of instructions for use conditions. On the other hand, 195 patients (27.4%) had morphologic data not consistent with the recommendations for the use of the Endurant system. The 30-day mortality was 1.4% (10 of 712). Nine patients (1.2%) were lost to follow-up because of relocation abroad. The overall mortality rate was 14.74% (101 of 703). Overall survival rate was 92.3% at 1 year, 86.4% at 2 years, and 65% at 5 years. Overall freedom from reintervention rate was 93.3%, 86.4%, and 65% at 1 year, 2 years, and 5 years, respectively. Five patients (0.7%) underwent a surgical conversion and explantation of the Endurant device. The reasons were endograft infection (n = 1), endoleak type Ia (n = 1), endoleak type II (n = 1), endograft and limb thrombotic occlusion (n = 1), and endotension (n = 1). The overall iliac limb occlusion rate was 2.1% (15 of 712). The performance of the Endurant stent graft during a period of 7 years under real-life conditions was good, with low incidence of reinterventions and endoleaks.