LB03 - 30-day outcomes of the first 100 patients treated with an off-the-shelf multibranch aortic device during the FDA post-approval study

Objectives: To report the 30-day outcomes of the first 100 patients treated with the TAMBE device from the FDA-required post-approval study.

Methods: This multicenter, nonrandomized, prospective, post-approval study of TAMBE included patients consecutively treated with Extent I-IV TAAA and pararenal AAAs. Demographics, core-lab adjudicated imaging characteristics, perioperative metrics, and 30-day postoperative outcomes are reported.

Results: FDA approval for TAMBE occurred in January 2024 with this prospective study beginning in December 2024. Of the first 100 patients (30% female, 81% white, median age 74), anatomic classifications included 22.4% Extent I-III TAAA, 26.5% Extent IV TAAA, 21.4% pararenal AAA, and 12.2% juxtarenal AAA. 45% of the patients were treated at sites without prior TAMBE experience. 82.7% had degenerative aneurysms, and 11.2% had post dissection pathology. Prior aortic surgery was noted in 48% of patients (21 TEVAR, 18 EVAR, 6 open thoracic, 7 open abdominal). For patients with Extent I-III TAAA, staging of the procedure with initial TEVAR occurred in 31.8%. Median aneurysm diameter was 6.2cm, with planned celiac artery stenting in 97% of patients, SMA 100%, R renal 98%, and L renal 89%. Perioperative metrics included median EBL 250mL, contrast use 150mL, fluoro time 75 minutes, hospital length of stay 4 days with 76% going to ICU postop. 84% of patients were discharged to home. 362 branches were treated with a success rate of 98.9% (average of 1.39 celiac stents, 1.44 SMA stents, 1.62 R renal stents, and 1.59 L renal stents per portal). VBX stents were used in the majority of branches, with self-expanding viabahn stents used in 7% of patients. 15% of patients had planned plug occlusion of one or more portals. At 30-day follow-up, 7 subjects underwent 8 reinterventions, including 5 patients with type I/III endoleak and 2 renal branch occlusions. No patient experienced device migration, rupture, device integrity issues, or conversion to open surgical repair. 8.1% of patients suffered major adverse events, with 1 respiratory failure, 4 renal function decline, 1 bowel ischemia with surgical resection, and 4 with paraplegia (3 permanent). 30-day mortality was 3%.

Conclusions: The post-approval outcomes in this prospective multicenter cohort treated with the TAMBE device demonstrate applicability to more extensive thoracoabdominal pathology with excellent outcomes. Distinct findings for TAMBE 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.