One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial

Background: We aimed to compare 1 year the hemodynamic in-vivo performance of three biological aortic prostheses (Carpentier Perimount Magna Ease<sup>TM</sup>, Crown PRT<sup>TM</sup>, and Trifecta<sup>TM</sup>). Methods: The sample used in this study comes from th...

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Autores principales: Lourdes Montero-Cruces, Manuel Carnero-Alcázar, Fernando José Reguillo-Lacruz, Francisco Javier Cobiella-Carnicer, Daniel Pérez-Camargo, Paula Campelos-Fernández, Luis Carlos Maroto-Castellanos
Formato: article
Lenguaje:EN
Publicado: MDPI AG 2021
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Acceso en línea:https://doaj.org/article/f0938fc3cd294964986ba53fd8554ded
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Sumario:Background: We aimed to compare 1 year the hemodynamic in-vivo performance of three biological aortic prostheses (Carpentier Perimount Magna Ease<sup>TM</sup>, Crown PRT<sup>TM</sup>, and Trifecta<sup>TM</sup>). Methods: The sample used in this study comes from the “BEST-VALVE” clinical trial, which is a phase IV single-blinded randomized clinical trial with the three above-mentioned prostheses. Results: 154 patients were included. Carpentier Perimount Magna Ease<sup>TM</sup> (<i>n</i> = 48, 31.2%), Crown PRT<sup>TM</sup> (<i>n</i> = 51, 32.1%) and Trifecta<sup>TM</sup> (<i>n</i> = 55, 35.7%). One year after the surgery, the mean aortic gradient and the peak aortic velocity was 17.5 (IQR 11.3–26) and 227.1 (IQR 202.0–268.8) for Carpentier Perimount Magna Ease<sup>TM</sup>, 21.4 (IQR 14.5–26.7) and 237.8 (IQR 195.9–261.9) for Crown PRT<sup>TM</sup>, and 13 (IQR 9.6–17.8) and 209.7 (IQR 176.5–241.4) for Trifecta<sup>TM</sup>, respectively. Pairwise comparisons demonstrated improved mean gradients and maximum velocity of Trifecta<sup>TM</sup> as compared to Crown PRT<sup>TM</sup>. Among patients with nominal prosthesis sizes ≤ 21, the mean and peak aortic gradient was higher for Crown PRT<sup>TM</sup> compared with Trifecta<sup>TM</sup>, and in patients with an aortic annulus measured with metric Hegar dilators less than or equal to 22 mm. Conclusions: One year after surgery, the three prostheses presented a different hemodynamic performance, being Trifecta<sup>TM</sup> superior to Crown PRT<sup>TM</sup>.