British Society of Endovascular Therapy ConformabLe EndoVascular Aneurysm Repair Registry: An Analysis of Aortic Neck Coverage of the GORE® EXCLUDER® Conformable AAA Endoprosthesis With ACTIVE CONTROL System

Objective: Primarily to evaluate the area of neck coverage and secondarily, technical and clinical outcomes of the GORE ® EXCLUDER ® Conformable AAA Endoprosthesis (EXCC), designed to treat patients with significant angulation of the aortic neck, in routine clinical treatment of patients with abdominal aortic aneurysm (AAA).

Design: A prospective, multicentre, observational cohort study.

Materials and Methods: Patients aged >55 years with a nonruptured infrarenal AAA requiring treatment, were enrolled into the registry from June 2019 to December 2021. Baseline clinical, procedural, and follow-up data were collected pre-, peri-, and postoperatively at 3 and 12-months. CT images were assessed using a strict protocol at a core laboratory. The primary outcome was the estimated percentage of the total aortic neck that remained uncovered by the graft assessed on the first follow-up CT scan.

Results: One hundred five patients with AAA underwent endovascular aneurysm repair (EVAR) with the EXCC device in 13 UK study centers (mean age 77.5 years, 14/105 female, 7/105 symptomatic). One hundred two participants with available CT scans were placed into group A-beta angulation <60° and aortic neck >10 mm (51/102); group B-beta angulation <90° and >60° and aortic neck >15 mm (37/102); and group C-those outside of instructions for use (14/102). The primary outcome of median percentage of neck that remained uncovered after EVAR was 5.1% [IQR 1.9-12.4]; 4.8% in group A, 6.0% in group B, and 3.8% in group C. Overall technical success was 96% (97.9%, 100%, and 84.6% in group A, B, and C, respectively). One-year overall and aneurysm related mortality was 9.1% and 0%. Four patients required re-intervention for proximal neck complications (including 2/14 patients in group C).

Conclusion: The EXCC device can be accurately placed even in patients with significant angulation of the aortic neck. Clinical outcomes are acceptable to 1 year; however, physicians should exercise caution when treating patients where the graft is placed outside the instructions for use.Clinical ImpactThis prospective registry assessed the performance of a novel device with greater conformability, and angulation control of the delivery system to treat abdominal aortic aneurysm (AAA) with up to 90° neck angulation within instructions for use (IFU). In 105 patients, the primary outcome of estimated median percentage of uncovered aortic neck was 5.1% [IQR 1.9-12.4]. In patients with anatomy conforming to IFU, there was no difference in the percentage of neck that was uncovered in angulated (>60°) versus nonangulated patients (0-60°) and no early type 1a endoleak. This suggests excellent apposition of the graft to the aortic wall despite significant angulation of the aortic neck. Clinical outcomes were acceptable to 1 year.