Objective: The objective of this study was to report 30-day results from a prospective, nonrandomized, multicenter trial that evaluated the safety and effectiveness of the Zenith Alpha thoracic endovascular graft (Cook Medical, Bloomington, Ind) for treatment of blunt thoracic aortic injuries (BTAIs).
Methods: Eligible patients with BTAIs (grade II to grade IV) in the descending thoracic aorta were treated with the Zenith Alpha device, which is available in smaller graft diameters (starting at 18 mm) and lower profile delivery systems (starting at 16F) than currently available thoracic endografts. The device (nitinol stents and polyester graft material) accommodates a tighter aortic curvature (radius of 20 mm) than the predicate Zenith TX2 Pro-Form. Follow-up clinical and imaging evaluations were performed at 30 days, at 6 and 12 months, and annually thereafter through 5 years. The primary end point was 30-day mortality.
Results: Between January 2013 and May 2014, 50 patients (44 men; mean age, 43 ± 19 years; range, 18-89 years) were treated with the Zenith Alpha device at 17 U.S. sites. The mean Injury Severity Score was 31 ± 14 (range, 3-66). Technical success was achieved in 100% of patients, with 0% intraoperative mortality. Device access was entirely percutaneous in 22 patients (44%). Smaller size grafts (18-24 mm) were used in 15 patients (30%). The mean procedure time was 85 ± 44 minutes (range, 34-278 minutes), and mean blood loss was 103 ± 145 mL (range, 0-1000 mL). The 30-day mortality rate was 2%; one patient died 24 days after the procedure of respiratory failure related to associated injuries and not to the device or procedure as adjudicated by an independent Clinical Events Committee (CEC). One patient experienced a stroke 7 days after the procedure (cause undetermined by the CEC), and one patient underwent reintervention for a site-reported proximal type I endoleak (core laboratory reported unknown endoleak type) at 30 days after the procedure. There have been no conversions to open surgical repair, paraplegia, or aortic rupture within 30 days.
Conclusions: Short-term results indicate that the Zenith Alpha thoracic endovascular graft appears safe and effective for the treatment of BTAIs. This low-profile device enables complete percutaneous repair in a large percentage of patients and can achieve high rates of technical success and very low rates of aortic injury-related mortality within 30 days.
Trial registration: ClinicalTrials.gov NCT01688050.
Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.