Post-approval study preliminary 1-month outcomes of the first 100 patients treated with an off-the-shelf multibranch aortic device

OBJECTIVES: To report the preliminary 1-month outcomes from the post-approval study of the first 100 patients treated with the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE). METHODS: This multicenter, nonrandomized, prospective study of the TAMBE aortic component included endovascular repair of an aortic disease involving the visceral vessels. Demographics, core-lab adjudicated imaging characteristics, perioperative metrics, and postoperative 1-month outcomes are reported. RESULTS: The first 100 patients treated were 30% female, 81% white, and the median was age 74 years. Anatomic classifications included 48 patients (49.0%) with Extent I-IV thoracoabdominal aortic aneurysm (TAAA), 21 (21.4%) with pararenal abdominal aortic aneurysm (AAA), 12 (12.2%) with juxtarenal AAA, and 17 patients with post dissection pathology (n=11) or 'other' (n=6). Enrollment and treatment of 45.0% of the patients were at sites without prior TAMBE device experience. Prior aortic surgery was noted in 48.0% of patients treated. For patients with Extent I-III TAAA (n=22), staging of the TAMBE procedure was planned with initial proximal thoracic endovascular aortic repair in 7 patients (31.8%). Median aneurysm diameter was 6.2 cm. The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis was used in all patients, with additional use of a VIABAHN® self-expanding stent in six patients. Intentional non-use of one or more portals (with planned plug occlusion) was a strategy used in 15 (15.0%) patients. Median procedure time was 280 minutes, and median length of stay was four days with 83 patients (83.8%) discharged to home. Branch target vessel technical success rate was 98.9% (average of 1.39 stents into the celiac, 1.44 superior mesenteric artery, 1.62 right renal, and 1.59 left renal per portal). Three patients (3.0%) died, all were procedure related. Major adverse events in 8 patients (8.1%, 3 had ≥1 event) included 1 (1.0%) respiratory failure, 4 (4.0%) permanent paraplegia, 4 (4.0%) renal function decline, and 1 (1.0%) bowel ischemia. No patient experienced a major stroke, aneurysm rupture, or myocardial infarction. A total of eight Type 1c or Type IIIa/IIIc endoleaks were detected in 6 (6.1%) patients. No conversion to open-surgical repair, rupture, or device migration/integrity issues were reported. CONCLUSIONS: The preliminary analysis of the FDA-mandated post-approval study 1-month outcomes in this prospective multicenter cohort treated with the TAMBE device demonstrates applicability to more extensive thoracoabdominal pathology with similar outcomes to the pivotal trial. Distinct findings for the TAMBE device in the real-world include successful treatment of post-dissection aneurysms, increased staging strategies for spinal cord protection with low paraplegia rates, and rapid adoption by many sites that did not participate in the pivotal trial. CLINICALTRIALS: GOV: NCT06578741.