Researchers behind a seven-year retrospective analysis of a physician-developed unitary stent graft system for endovascular debranched aortic repair of various thoracoabdominal aortopathies reported a 30-day mortality rate of 3.6%, with an all-cause mortality rate of 23% and an aneurysm-related mortality rate of 3.6% at median follow-up (360 days).
The data were reported by Naiem Nassiri, MD, a vascular surgeon at the Yale University School of Medicine, Yale New Haven Hospital, in New Haven, Connecticut, during SCVS 2024.
The study included 139 consecutive patients at prohibitive risk for open surgery who underwent endovascular debranched aortic repair for the treatment of dissecting and non-dissecting thoracoabdominal aortic aneurysms (TAAAs). It took place at three sites in the U.S., two under the auspices of investigational device exemptions (IDEs) and one pre-submission IDE.
The patient population contained 34% who were smokers, had high rates of congestive heart failure, and a number with chronic kidney disease. Nassiri said that about 18% had prior repairs, and the types of aneurysms included shortneck infrarenal aneurysms (1.4%), type I Crawford TAAA (1.4%), type II (6.5%), type III (4.3%), type IV (71.2%), type V (2.2%), and chronic dissections (12.9%).
“We had 100% technical success on 539 target vessels,” Nassiri told the audience. “Primary and secondary patency rates were 94.4% and 99%.”
The 30-day mortality rate saw five deaths, with major adverse events including respiratory failure, myocardial infarction, renal failure, bowel ischemia, stroke and paraplegia.
“The unitary stent graft is based on the Medtronic Endurant platform, and it was designed to divide aortic flow into a visceral limb and an infrarenal limb,” Nassiri explained.
“Given it’s not a modular-based design, the unitary stent graft system offers safe and effective, reproducible and, importantly, an off-the-shelf option for endovascular debranch aortic repair for various thoracoabdominal aortopathies,” he said. “This includes failed prior repairs of all sorts. It has been our experience that it has been applicable anatomically in 100% of patients.”
