3 Year Outcomes of Off-the-shelf Gore Thoracoabdominal Multibranch Endoprosthesis and Physician-Modified Endografts for Complex Abdominal and Thoracoabdominal Aortic Aneurysms

Abstract

Fenestrated-branched endovascular aortic repair (FB-EVAR) has shown favorable outcomes for repair of complex aneurysms and thoracoabdominal aortic aneurysms (TAAA). Physician-modified endografting (PMEG) and the Gore Thoracoabdominal Multibranch Endoprosthesis (TAMBE) provide custom and off-the-shelf devices for FB-EVAR, respectively. This study compares the outcomes of TAMBE and PMEG at a single institution. A retrospective review of patients who underwent TAMBE as part of the multicenter pivotal trial or PMEG as part of a prospective physician sponsored investigational device exemption at a single institution between 2020-2022 were completed. Patient demographics, characteristics, perioperative and midterm outcomes were compared. A total of 68 patients were included, with 12 in the TAMBE group and 56 in the PMEG group. Baseline characteristics were comparable between groups. Aneurysm type was most often TAAA in both groups (58% TAMBE and 52% PMEG). TAMBE had a higher rate of upper extremity access (100% vs 63%, P=.013) and longer mean procedure time (247 ± 36 vs 189 ± 49 minutes, P<.001). Other intraoperative metrics were similar between groups. Technical success was 100% in TAMBE and 95% in PMEG (P=0.412). There was no 30-day mortality in either group. No major adverse events occurred with TAMBE, while in PMEG cases, 2% had respiratory failure, 2% required dialysis, and 4% experienced spinal cord ischemia. While overall endoleak rates were similar (50% of TAMBE vs 41% of PMEG, P=0.57), type II accounted for all of the endoleaks in the TAMBE group, while type I or III endoleaks were seen in 11% of PMEG patients. At the median follow-up of 26.7 months for the TAMBE group and 21.2 months for the PMEG group, target vessel instability was seen in 10.4% of TAMBE, and 6.9% of PMEG targeted branches (P=0.401). Reintervention was required in 33% of TAMBE patients and 27% of PMEG patients (P=.646). Estimated freedom from reintervention at 3 years were similar (56% TAMBE vs. 62% PMEG, log-rank P=0.910). Freedom from visceral renal target vessel instability at 3 years was 89% for both groups (log-rank P=0.459). Kaplan Meier 3-year estimated survival was 100% for patients in the TAMBE group and 77% for patients in the PMEG group (log-rank P=.157). At experienced centers, FB-EVAR can be completed with PMEG or TAMBE with comparable, excellent perioperative and midterm outcomes. Reinterventions are frequently needed for both TAMBE and PMEG.