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

OBJECTIVES: To demonstrate the safety and effectiveness of a low-profile thoracic endograft (19-23 French) in subjects with blunt traumatic aortic injury.

METHODS: A 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.

RESULTS: Cohort 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.

CONCLUSIONS: RelayPro was safe and effective and may provide an early survival benefit in the treatment of blunt traumatic aortic injury.