Five-Year Outcomes with Conformable GORE® TAG® endoprosthesis used in traumatic aortic transections

Abstract Background The Conformable GORE® TAG® thoracic endoprosthesis (CTAG) device (W.L. Gore and Associates, Flagstaff, AZ) seeks to optimize thoracic endovascular repair (TEVAR) of blunt aortic injuries (BAI) by better apposing to the aortic arch. The TAG 08-02 study evaluated safety and effectiveness of the CTAG device in the 5-years following treatment. Methods This prospective, single-arm study was conducted at 30 U.S. sites with follow-up through 5 years. Patients were evaluated for all-cause mortality and device events through follow-up. An independent core lab reviewed pre- and post-treatment images. Results Fifty-one initial cohort patients and 50 continued access patients were enrolled and received a total of 111 CTAG devices (mean, 1.1/subject; range 1.0 – 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 – 334.4 hours). Sixty patients had partial or complete left subclavian artery coverage, but only one patient developed a stroke that was unable to be attributed to the device or procedure. The freedom of all-cause mortality was 95% and 89% at 1-month and 5-years post-procedure, respectively. There were 2 minor endoleaks. There were no aortic ruptures, wire frame fractures, erosions, lumen obstructions, device compressions, or thrombus related events reported. Conclusions Five-year outcomes verify the CTAG device is a safe, effective, and durable option for BAI patients undergoing TEVAR.