Long-Term Outcomes of the Ovation Stent Graft System: Single-Center Experience

TL;DR

This study evaluates the long-term effectiveness of the Ovation stent graft for treating abdominal aortic aneurysms, showing good outcomes but some device-related issues.

Contribution

The study provides mid- to long-term clinical data on the Ovation stent graft system in a single-center cohort, highlighting its performance in complex cases.

Findings

The Ovation stent graft achieved durable aneurysm exclusion with no aneurysm-related deaths over a mean follow-up of 82.7 months.

The actuarial freedom from reintervention remained high at 80.1% at 120 months.

Two graft-related adverse events were observed, prompting structural improvements in newer device versions.

Abstract

Background/Objective: To report mid-term to long-term outcome data for endovascular aortic repair using the Ovation stent graft system (Endologix, Santa Rosa, CA) for the correction of abdominal aortic aneurysms (AAAs) in a single center. Methods: All patients treated with the Ovation stent graft between December 2011 and February 2018 were included. Patient demographics, anatomical and operative details, as well as follow- up data including complications, the need for further interventions, and mortality were recorded prospectively in an electronic dataset and analyzed. Results: A total of 99 patients (86.10% males; mean age 73.6 ± 7.26 years) were treated with the Ovation stent graft. The mean maximal aortic diameter was 53.7 ± 8.8 mm mm. The main indications for Ovation use were small iliac accesses and thrombus/calcification at the proximal neck level. The technical success rate was 93.06%. No perioperative reintervention or limb occlusion was reported. Two graft-related perioperative adverse events were recorded. At a mean follow up of 82.70 ± 40 months, cumulative late survival was 97.90%, 92.60%, 81.00%, 73.40%, 48.70%, and 45.10%, respectively, at 12, 24, 48, 60, 108, and 120 months. No AAA-related death was recorded. Actuarial freedom from reintervention rate was 97.90%, 95.70%, 92.10%, and 80.10%, respectively, at 12, 24, 60, 108, and 120 months; estimated freedom from conversion was 98.90%, 97.70%, and 95.20% at 24, 60, 108, and 120 months. Conclusions: The Ovation stent graft demonstrated durable AAA exclusion even in complex anatomies evidenced by successful aneurysm exclusion and mid- to long-term freedom from aneurysm-related mortality. However, in this series, the not insignificant graft-related adverse event rate suggested the need for structural improvements, which were implemented in the next-generation devices.

Figures