Benjamin W Starnes1, Amit Dwivedi2, Joseph Giglia3, Karen Woo4, Chyon Yeh5. 1. Division of Vascular Surgery, Department of Surgery, University of Washington, Seattle, Wash. Electronic address: starnes@uw.edu. 2. Division of Vascular Surgery and Endovascular Therapeutics, Department of Surgery, University of Louisville, Louisville, Ky. 3. Division of Vascular Surgery, Department of Surgery, University of Cincinnati, Cincinnati, Ohio. 4. Division of Vascular Surgery, Department of Surgery, University of California Los Angeles, Los Angeles, Calif. 5. Cook Research Incorporated, West Lafayette, Ind.
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.
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.