Nicholas J Swerdlow1, Sean P Lyden2, Hence J M Verhagen3, Marc L Schermerhorn4. 1. Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, Mass. 2. Department of Vascular Surgery, Cleveland Clinic, Cleveland, Ohio. 3. Department of Vascular Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands. 4. Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, Mass. Electronic address: mscherm@bidmc.harvard.edu.
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.
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.