Background: The Conformable GORE TAG thoracic endoprosthesis (CTAG) device (W.L. Gore and Associates, Flagstaff, AZ) seeks to optimize thoracic endovascular repair of blunt aortic injuries by better apposition to the aortic arch. The Evaluation of the GORE Conformable TAG Thoracic Endoprosthesis for Treatment of Traumatic Transection (TAG 08-02) study assessed the safety and effectiveness of the CTAG device in the 5 years after treatment.
Methods: This prospective, single-arm study was conducted at 30 US sites with follow-up through 5 years. Patients were evaluated for all-cause mortality and device events through follow-up. An independent core laboratory reviewed pretreatment and posttreatment images.
Results: A total of 51 initial cohort patients and 50 continued access patients were enrolled and underwent placement of a total of 111 CTAG devices (mean, 1.1/subject; range, 1.0 to 3.0) during initial treatment. On average, patients were 42.7 ± 19.5 years old, with a mean Injury Severity Score of 31.5 ± 14.5, and most presented with polytraumatic injuries. The median time between injury and treatment was 21.0 hours (range, 3.2 to 334.4 hours). A total of 60 patients had partial or complete left subclavian artery coverage, but only 1 patient had a stroke that was unable to be attributed to the device or procedure. The freedom from all-cause mortality was 95% and 89% at 1 month and 5 years after the procedure, respectively. There were 2 minor endoleaks. No aortic ruptures, wire frame fractures, erosions, lumen obstructions, device compressions, or thrombus-related events were reported.
Conclusions: The 5-year outcomes verify that the CTAG device is a safe, effective, and durable option for patients with blunt aortic injuries who are undergoing thoracic endovascular aortic repair.
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