Multicenter observational study of the gore excluder conformable endograft for endovascular abdominal aortic repair: Initial results

Abstract

Abstract Objective Endovascular repair (EVAR) has become the standard of care for treatment of abdominal aortic aneurysms. However, a significant number of EVAR remains outside the IFU, especially in cases of severe proximal angulation (>60 degrees), resulting in failure. The new device GORE EXCLUDER Conformable AAA Endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz) has been designed to accommodate neck angulation, due to conformability and angulation control. The aim of this multicenter study is to report the initial results of this device. Methods From March 2019 to January 2021, the data of all consecutive patients with AAA treated with the Gore Excluder Conformable endograft at 4 vascular centers were reviewed. Patients were followed using a standardized protocol, with CT-scan at 1, 6 and 12 months, and then yearly. The primary endpoint was technical success and secondary outcomes were postoperative morbidity, rate of endoleak (EL) and any aneurysm-related re-interventions during follow-up. Results Among the 32 patients included, most were men with a mean age of 77 years old (range 60-92). Half of patients were smokers and 72% had hypertension. The mean diameter of AAA was 62 mm (47-90). The mean length of aortic neck was 26 mm (10-69), the mean diameter 23 mm (16-31) and the median neck angulation was 81 degrees (range 40-110). The mean procedural duration was 102 min (54-153) with a mean time of scopy of 24 min (8-47) and a total volume of contrast of 101 ml (40-165). Thirteen iliac branch device have been used in 7 patients. The technical success was 97% with 1 type Ia EL (3%). In the post-operative period, 4 medical and 3 surgical complications were observed. Two reinterventions were needed with an iliac stenting for a stenosis and a correction of a femoral false aneurysm. During the mean follow-up of 7 months, 2 type Ia ELs were observed. One spontaneously resolved and the other one was followed. One distal limb extension was succesfully implanted at 3 months for a type Ib EL for a total rate of reintervention of 9%. No migration was observed. No death occured. Conclusion The use of the Gore Excluder Conformable endograft seems to be safe and effective in difficult anatomies and especially high angulation. It allows for precise deployment without the need for additional contrast or operation time. Longer follow-up and more patients are required to confirm these excellent initials results.