Total aortic arch replacement using a frozen elephant trunk device: Results of a 1-year US multicenter trial.

OBJECTIVE: In this prospective US investigational device exemption trial, we assessed the safety and 1-year clinical outcomes of the Thoraflex Hybrid device (Terumo Aortic) for the frozen elephant trunk technique to repair the ascending aorta, aortic arch, and descending thoracic aorta. METHODS: For the trial, which involved 12 US sites, 65 patients without rupture were recruited into the primary study group, and 9 patients were recruited into the rupture group. All patients underwent open surgical repair of the ascending aorta, aortic arch, and descending thoracic aorta in cases of aneurysm and/or dissection. The primary end point was freedom from major adverse events (MAE), defined as permanent stroke, permanent paraplegia/paraparesis, unanticipated aortic-related reoperation (excluding reoperation for bleeding), or all-cause mortality. RESULTS: In the primary study group, 2 patients were lost to follow-up at 1 year. Freedom from MAE at 1 year was 81% (51/63). Seven patients (11%) died (including 2 before 30 days or discharge), 3 patients (5%) suffered permanent stroke, and 3 (5%) developed permanent paraplegia/paraparesis. Twenty-six patients (41%) underwent planned extension procedures, including 22 endovascular procedures within a median of 122 (interquartile range, 64-156) days. In the aortic rupture group, 2 patients were lost to follow-up at 1 year. Freedom from MAE at 1 year was 71% (5/7). One patient (14%) died, 2 patients (29%) had permanent stroke, and none had permanent paraplegia/paraparesis. No extension procedures were performed in the rupture group. CONCLUSIONS: One-year results with the Thoraflex Hybrid device are acceptable. Long-term data are necessary to assess the durability of these repairs.