Data From Study Evaluating Real-World Use of Medtronic's Endurant AAA System Published

July 8, 2015—Konstantinos P. Donas, MD, et al conducted a prospective evaluation of early and late 7-year experience with the Endurant bifurcated stent graft system (Medtronic plc) in 712 consecutive patients with abdominal aortic aneurysms (AAAs) who were treated independently of their morphologic suitability for endovascular aneurysm repair based on instructions for use. The study is available online ahead of print in the Journal of Vascular Surgery (JVS).

The investigators concluded that the performance of the Endurant stent graft during a period of 7 years under real-life conditions was good, with a low incidence of reinterventions and endoleaks.

As summarized in JVS, 712 consecutive high-risk patients with AAAs underwent elective or urgent placement of an Endurant bifurcated endograft between November 14, 2007 and December 2013 at St. Franziskus Hospital Münster in Münster, Germany. The consecutive, all-comers patients were 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 investigators reported that the median follow-up was 19.2 months. Overall, 517 patients (72.6%) were treated on the basis of instructions-for-use conditions, while 195 patients (27.4%) had morphologic data that fell outside the recommendations for use of the Endurant system.

The 30-day mortality rate 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). The overall survival rate was 92.3% at 1 year, 86.4% at 2 years, and 65% at 5 years. The overall freedom from reintervention rate was 93.3% at 1 year, 86.4% at 2 years, and 65% at 5 years.

Five patients (0.7%) underwent a surgical conversion and explantation of the Endurant device. The reasons were endograft infection (n = 1), type Ia endoleak (n = 1), type II endoleak (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), stated the investigators in JVS.