Early survival benefit of a low-profile endograft in blunt traumatic aortic injury

Abstract

ObjectivesTo demonstrate the safety and effectiveness of a low-profile thoracic endograft (19-23 French) in subjects with blunt traumatic aortic injury. MethodsA prospective, multicenter study assessed the RelayPro thoracic endograft for the treatment of traumatic aortic injury. Fifty patients were enrolled at 16 US centers between 2017-2021. The primary endpoint was 30-day all-cause mortality. ResultsCohort was mostly male (74%) with a mean age of 42.4 ± 17.2 years treated for traumatic injuries (4% Grade 1, 8% Grade 2, 76% Grade 3; 12% Grade 4) due to motor vehicle collision (80%). The proximal landing zone was proximal to the left subclavian artery in 42% and access was primarily percutaneous (80%). Most (71%) were treated with a non-bare stent (NBS) endograft. Technical success was 98% (one early Type Ia endoleak). All-cause 30-day mortality was 2% (compared with an expected rate of 8%), with an exact two-sided 95% CI, 0.1%, 10.6% below the performance goal upper limit of 25%. Kaplan-Meier analysis estimated freedom from all-cause mortality to be 98% at 30 days through four years (95% CI, 86.6—99.7%). Kaplan-Meier estimated freedom from major adverse events, all-cause mortality, paralysis, and stroke, of 98.0% at 30 days and 95.8% from six months to four years (95% CI, 84.3—98.9%). There were no strokes and one case of paraplegia (2%) during follow-up. ConclusionsRelayPro was safe and effective and may provide an early survival benefit in the treatment of blunt traumatic aortic injury.