Five-year results of endovascular abdominal aortic aneurysm repair with the Ovation abdominal stent graft

Abstract

Objective: Endovascular abdominal aortic aneurysm repair (EVAR) has been rigorously compared with open repair for the treatment of abdominal aortic aneurysms in randomized trials and observational studies, but a comparison of individual devices is lacking, and single-device registries and trials are limited by small sample size. Here we report a descriptive analysis of the Effectiveness of Custom Seal with Ovation: Review of the Evidence (ENCORE) database, pooled results of multiple studies evaluating the midterm results of EVAR with the Ovation Abdominal Stent Graft Platform.

Methods: This is a retrospective analysis of the ENCORE database, a cohort of patients undergoing EVAR with the Ovation platform composed of pooled, prospectively collected data from 1296 patients from five clinical trials and the prospectively maintained European Union Post-Market Registry. The primary outcomes were 5-year rates of type IA and type I or III endoleak. Secondary outcomes included were 30-day mortality, 30-day major adverse event, technical success (successful deployment of the aortic body and iliac limbs), as well as 5-year survival, and freedom from aneurysm-related mortality, type II endoleak, device-related intervention, aneurysm rupture, sac expansion, and conversion to open repair.

Results: A total of 1296 patients were included in the analysis. The average age was 73 ± 8 years and 81% of patients were male. Fifty percent of patients had complex aortic anatomy, (neck length <10 mm, neck diameter >28 mm, neck angle >60°, reverse neck taper >10%, distal common iliac artery diameter <10 mm, or external iliac artery diameter <6 mm). Technical success was 99.7%. Thirty-day mortality was 0.3%, 30-day rate of major adverse event was 1.6%, and polymer leak rate was 0.2%. Freedom from type IA endoleak at 1, 3, and 5 years was 97.6%, 97.1%, and 95.8%, respectively; type I or III endoleak at 1, 3, and 5 years was 96.9%, 95.7%, and 94.0%, respectively. Freedom from device-related reintervention at 1, 3, and 5 years was 96.2%, 94.4%, and 92.4% and primary freedom from sac expansion was 97.0% at 1 year, 90.3% at 3 years, and 84.9% at 5 years. Freedom from all-cause mortality and aneurysm-related mortality at 5 years were 78.9% and 99.3%, respectively.

Conclusions: This analysis of the ENCORE database demonstrates that EVAR with the Ovation platform has favorable midterm durability evidenced by successful aneurysm exclusion and 5-year freedom from aneurysm-related mortality.

Keywords: Abdominal aortic aneurysms; EVAR; Endoleak.