Abstract
Objective
The purpose of this study was to report the updated results of a prospective, multicenter,
nonrandomized, single-arm investigational device exemption study conducted at 17 sites
in the United States to assess safety and effectiveness of the Zenith Alpha thoracic
endovascular graft (Cook Medical, Bloomington, Ind) for treatment of blunt thoracic
aortic injury (BTAI).
Methods
The primary safety end point was 30-day all-cause mortality and aortic injury-related
mortality. The primary effectiveness end point was 30-day device success. Additional
outcomes evaluated included major adverse events and imaging findings including aortic
injury healing, graft patency, and device integrity as analyzed by the core laboratory
on follow-up computed tomography imaging through 5 years.
Results
A total of 50 patients with BTAI were enrolled in the TRANSFIX study between January
2013 and May 2014. Mean follow-up was 21 months (range, 0.6-35 months). The 30-day
mortality was 2% (n = 1), and it was unrelated to the aortic repair or study device.
Five deaths occurred after 30 days, and one was considered procedure related. Freedom
from all-cause and BTAI-related mortality was 89.3% and 97.6%, respectively, at 2 years.
Aortic injury healing was noted in 96% at 2 years. An incidental finding of thrombus
formation within the stent graft, most commonly at the distal aspect of the study
device, occurred in 15 patients (30%; 12 by core laboratory, 3 by site) and was confirmed
in 13 patients (26%). None of these patients were noted to have clinical sequelae
on most recent follow-up.
Conclusions
The updated results from the TRANSFIX study continue to show low rates of aortic injury-related
mortality and major adverse events during follow-up. However, findings of in-graft
thrombus have resulted in the manufacturer's voluntary removal of the BTAI indication
for this device. Caution should be exercised in appropriate and accurate device sizing
and planning (eg, limiting graft oversizing) as well as in regular, lifelong follow-up
evaluation.
Keywords
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Article Info
Publication History
Published online: January 31, 2020
Accepted:
May 3,
2019
Received:
October 27,
2018
From the Western Vascular SocietyFootnotes
The TRANSFIX study was sponsored by Cook Medical .
ClinicalTrials.gov identifier: NCT01688050.
Author conflict of interest: B.W.S. has received funding for research support from Cook,Inc ; he is not a consultant or a paid speaker for Cook. C.Y. is a full-time employee of Cook Research Incorporated, a Cook Group Company.
The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.
Identification
Copyright
© 2019 by the Society for Vascular Surgery. Published by Elsevier Inc.
