Early real-world experience with thoracoabdominal branch endoprosthesis from a physician-initiated multicenter postmarket registry.

Abstract

Recent commercial approval of the thoracoabdominal multibranch endoprosthesis (TAMBE) has enabled wide dissemination of four-vessel multibranched endovascular aortic repairs in the United States. However, the real-world performance benchmarks remain incompletely characterized. This study evaluated 30-day clinical outcomes of patients receiving TAMBE across diverse practice settings. We performed a retrospective study of commercial TAMBE implants across multiple US centers between May 2024 and November 2025. The primary outcomes were 30-day mortality and technical success. Secondary outcomes included overall adverse events (AE) and major adverse events (MAE). Intraoperative metrics and clinical outcomes were compared between centers with previous investigational access to TAMBE (PRE) and those adopting the device after commercial approval (POST). A total of 182 patients from 11 centers were included. The mean age was 73.8 ± 9.01 years. Most patients were the American Society of Anesthesiologists class III (51.6%) or IV (36.3%), with a high prevalence of previous aortic repairs (20.1% open; 40.5% endovascular repair). Aneurysm extent included complex abdominal aneurysms (68.3%) and thoracoabdominal aneurysms (31.7%). Technical success was achieved in 95% of cases. Thirty-day mortality was 3.3%, and 20.3% of patients experienced AE, among which MAE occurred in 13.7%. Technical success, 30-day mortality, and MAE did not differ between the PRE and POST centers. POST centers had longer operative, fluoroscopy times, and higher 30-day AE (33.3% vs 11.8%, P <.001). Thoracoabdominal aortic aneurysms were more frequently repaired in the PRE centers (69% vs 54.5%), whereas pararenal aneurysms were more commonly treated at the POST centers (34.9% vs 27.1%). The overall incidence of spinal cord ischemia (SCI) did not differ significantly between PRE and POST centers (9.1% vs 5.6%; P = .43). At PRE centers, most SCI events resolved with minimal residual deficit (60%), whereas at POST centers, the majority of SCI cases resulted in permanent, severe deficits (75%). Early commercial experience demonstrates that TAMBE can be safely adopted in broader clinical practice, with high technical success and low 30-day mortality across participating centers. Although POST centers demonstrated higher overall 30-day AE rates and longer procedural times, MAE was similar across center types. These findings underscore the importance of comprehensive training, standardized perioperative protocols, and continued monitoring of neurologic outcomes as TAMBE implementation expands.