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.