Faculty Collaboration Database

Early survival benefit of a low-profile endograft in blunt traumatic aortic injury. J Vasc Surg 2024 Sep;80(3):678-684.e1

Date

04/28/2024

Pubmed ID

38677660

DOI

10.1016/j.jvs.2024.04.051

Scopus ID

2-s2.0-85197064974 (requires institutional sign-in at Scopus site)

Abstract

OBJECTIVE: The aim of this study was 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 centers in the United States between 2017 and 2021. The primary endpoint was 30-day all-cause mortality.

RESULTS: The cohort was mostly male (74%), with a mean age of 42.4 ± 17.2 years, and treated for traumatic injuries (4% Grade 1, 8% Grade 2, 76% Grade 3, and 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 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% confidence interval [CI] of 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 4 years (95% CI, 86.6%-99.7%). Kaplan-Meier estimated freedom from major adverse events, all-cause mortality, paralysis, and stroke, was 98.0% at 30 days and 95.8% from 6 months to 4 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.

Author List

Starnes BW, Rajani RR, Rossi P, Singh N, Benarroch-Gampel J, Cho JS, Nassiri N, Smeds MR, Kalapatapu V, Stern JR, Kabutey NK, Corvera J, RelayPro Investigators

Author

Peter J. Rossi MD Chief, Professor in the Surgery department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Aged
Aorta, Thoracic
Blood Vessel Prosthesis
Blood Vessel Prosthesis Implantation
Endovascular Procedures
Female
Humans
Male
Middle Aged
Postoperative Complications
Prospective Studies
Prosthesis Design
Risk Assessment
Risk Factors
Stents
Time Factors
Treatment Outcome
United States
Vascular System Injuries
Wounds, Nonpenetrating
Young Adult