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Total Aortic Arch Replacement Using a Frozen Elephant Trunk Device: Results of a One-Year US Multicenter Trial
The authors of this study reported the safety and one-year clinical outcomes of the Thoraflex Hybrid frozen elephant trunk prosthesis from the US Investigational Device Exemption trial. Follow-up was available in 63 of 65 patients from twelve centers at one-year, when the mortality was 11 percent (7/65), and freedom was 81 percent (51/63) from major adverse events, including permanent stroke (n = 3), permanent paraplegia/paraparesis (n = 3), unanticipated aortic-related reoperation, or all-cause mortality (n = 7); planned extension procedures were performed in twenty-six (41%), including twenty-two endovascular procedures by a median of four months. While one-year results are acceptable, long-term data are needed to assess durability of the repairs.