Branched Stented Anastomosis Frozen Elephant Trunk Repair: Early Results From a Physician-Sponsored Investigational Device Exemption Study

This study evaluates the early safety of a new technique called branched stented anastomosis frozen elephant trunk repair (B-SAFER) for treating multisegment thoracic aortic disease, which aims to improve outcomes in high-risk patients undergoing total aortic arch replacement. A total of 178 patients were enrolled between May 27, 2021, and December 31, 2022, with varying aortic conditions, including acute syndrome, chronic dissection, degenerative aneurysm, and congenital disorders.  Patients underwent surgery using different configurations of stented anastomoses. The procedure involved median cardiopulmonary bypass time of 188 minutes, and 97 percent of patients underwent antegrade cerebral perfusion for a median of 46 minutes. The study found an operative mortality rate of 5.6 percent, with additional serious complications including disabling stroke (2.9 percent), respiratory failure (11.4 percent), and acute kidney injury (10 percent). Survival rates were 95 percent at 30 days, 88 percent at 90 days, 84 percent at six months, and 79 percent at one year, with variability based on the underlying aortic condition.  Overall, B-SAFER demonstrated early safety and effectiveness, but further follow-up is needed to refine the technique and develop new devices.