Endurant Stent Graft Demonstrates Promising Outcomes in Challenging Abdominal Aortic Aneurysm Anatomy.

Abstract Objective We aimed to assess the five-year safety and effectiveness outcomes of patients enrolled in the Endurant Stent Graft Natural Selection Global Post Market Registry (ENGAGE) who were treated outside the approved indications for use (IFU) of the Endurant stent graft. Methods Our primary outcome measure was 12-month treatment success, defined as successful endograft delivery and deployment and the absence of type I or III endoleak, stent migration or limb occlusion, late conversion, and AAA diameter increase or rupture. Secondary outcome measures included 30-day all-cause mortality, major adverse events, secondary procedures, technical observations, aneurysm-related mortality, and all-cause mortality within 12 months. Results Demographic characteristics of ENGAGE patients treated outside (225, 17.8%) and within (1038, 82.2%) the IFUs were similar, except that female patients comprised a much higher percentage of the outside IFU group (19.1% vs. 8.7%, p 99% of all patients. The outside and within IFU groups showed a comparable and low occurrence of uncorrected type I (0.9% vs. 1.2%, p=1.00) and type III endoleak (0.4% vs. 0.3%, p=0.54) immediately after device implantation. The five-year freedom from type Ia endoleaks was 89.4% vs. 96.7% (p Conclusions Differences were not observed in all-cause mortality, aneurysm-related mortality, and secondary procedures between within- and outside-IFU patients through a five-year follow-up in the ENGAGE registry. Proximal necks with angulation or diameters outside the IFUs were the most common reasons for patients identified as being outside-IFU, and the cohort had increased incidence of type Ia endoleaks. Despite the challenges presented from the broad range of aortic and AAA morphologies, the Endurant stent graft showed promising five-year outcomes.