Early outcomes of the Conformable endograft in severe neck angulation from the Triveneto Conformable Registry

Abstract

Objective: The study reports retrospective evaluation of early outcomes from a multicentric experience with the Excluder conformable endograft with active control system (CEXC Device) in the treatment of abdominal aortic aneurysms. Its design allows more flexibility, given by proximal unconnected stent rows and a bending wire within the delivery catheter enables control of proximal angulation. This study specifically focuses on the severe neck angulation (SNA) subgroup (≥60°).

Methods: All patients treated with CEXC Device in nine vascular surgery centers of Triveneto area (Northeast Italy) between January 2019 and July 2022 were enrolled prospectively and analyzed retrospectively. Demographic and aortic anatomical characteristics were evaluated. Endovascular aneurysm repair in SNA were selected for analysis. Major investigated outcomes were technical success, endoleaks, morbidity, mortality, and reinterventions at 30 days and during follow-up. Endograft migration and postoperative aortic neck angulation changes were also analyzed.

Results: A total of 129 patients were enrolled. An infrarenal angle of ≥60° was observed in 56 patients (43%) (SNA group) and their data analyzed. The mean patient age was 78.9 ± 5.9 years and median abdominal aortic aneurysm diameter 59 mm (range, 45-94 mm). Median aortic infrarenal neck length, angulation and diameter were 22 mm (range, 13-58 mm), 77° (range, 60°-150°), and 22.0 ± 3.5 mm respectively. Analysis revealed a technical success rate of 100% and perioperative major complication rate of 1.7%. Intraoperative and perioperative morbidity and mortality rates were 3.5% (one buttock claudication and one inguinal surgical cutdown) and 0%, respectively. No perioperative type I endoleaks were observed. The median follow-up was 13 months (range, 1-40 months). Five patients died during follow-up from aneurysm-unrelated causes. Two reinterventions occurred (3.5%): one conversion for a type IA endoleak and one sac embolization for a type II endoleak. Aneurysm sac shrinkage was observed in 15 patients (26%) and aneurysm stability in 35 patients (62%), respectively. Estimated freedom from reinterventions at 24 months was 92%. Aortic neck median postoperative angulation was 75° (range, 45°-139°).

Conclusions: The Triveneto Conformable Registry shows good early results of the CEXC device in severely angulated aortic infrarenal necks. These data need confirmation on longer follow-up and a wider cohort of patients to further increase endovascular aneurysm repair eligibility in SNA.

Keywords: Abdominal aortic aneurysm; EVAR; Early results; Severe neck angulation; Technical success.