1. Early survival benefit of a low-profile endograft in blunt traumatic aortic injury.
- Author
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Starnes BW, Rajani RR, Rossi P, Singh N, Benarroch-Gampel J, Cho JS, Nassiri N, Smeds MR, Kalapatapu V, Stern JR, Kabutey NK, and Corvera J
- Subjects
- Humans, Male, Female, Adult, Middle Aged, Prospective Studies, Time Factors, Treatment Outcome, United States, Aorta, Thoracic surgery, Aorta, Thoracic injuries, Aorta, Thoracic diagnostic imaging, Stents, Risk Factors, Aged, Young Adult, Risk Assessment, Postoperative Complications mortality, Postoperative Complications etiology, Wounds, Nonpenetrating surgery, Wounds, Nonpenetrating mortality, Wounds, Nonpenetrating diagnostic imaging, Blood Vessel Prosthesis, Endovascular Procedures instrumentation, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Blood Vessel Prosthesis Implantation instrumentation, Blood Vessel Prosthesis Implantation mortality, Blood Vessel Prosthesis Implantation adverse effects, Vascular System Injuries surgery, Vascular System Injuries mortality, Vascular System Injuries diagnostic imaging, Prosthesis Design
- 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., Competing Interests: Disclosures All authors were principal investigators in the study and as such received research grants to conduct the study. B.S. has been paid a consulting fee by Terumo Corporation for an unrelated project., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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