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Total Aortic Arch Replacement Using a Frozen Elephant Trunk Device: Results of a One-Year US Multicenter Trial

Friday, September 9, 2022

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Source Name: The Journal of Thoracic and Cardiovascular Surgery


Joseph S. Coselli, Eric E. Roselli, Ourania Preventza, S. Chris Malaisrie, Allan Stewart, Paul Stelzer, Hiroo Takayama, Edward P. Chen, Anthony L. Estrera, Thomas G. Gleason, Michael P. Fischbein, Leonard N. Girardi, Himanshu J. Patel, Joseph E. Bavaria, Scott A. LeMaire

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.

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