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 EaseTM, Crown PRTTM, and TrifectaTM). 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
Materias:	cardiac surgery aortic valve replacement bioprostheses heart valve Medicine R
Acceso en línea:	https://doaj.org/article/f0938fc3cd294964986ba53fd8554ded
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spelling	oai:doaj.org-article:f0938fc3cd294964986ba53fd8554ded2021-11-25T18:01:54ZOne-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial10.3390/jcm102253402077-0383https://doaj.org/article/f0938fc3cd294964986ba53fd8554ded2021-11-01T00:00:00Zhttps://www.mdpi.com/2077-0383/10/22/5340https://doaj.org/toc/2077-0383Background: 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>.Lourdes Montero-CrucesManuel Carnero-AlcázarFernando José Reguillo-LacruzFrancisco Javier Cobiella-CarnicerDaniel Pérez-CamargoPaula Campelos-FernándezLuis Carlos Maroto-CastellanosMDPI AGarticlecardiac surgeryaortic valve replacementbioprosthesesheart valveMedicineRENJournal of Clinical Medicine, Vol 10, Iss 5340, p 5340 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	cardiac surgery aortic valve replacement bioprostheses heart valve Medicine R
spellingShingle	cardiac surgery aortic valve replacement bioprostheses heart valve Medicine R Lourdes Montero-Cruces Manuel Carnero-Alcázar Fernando José Reguillo-Lacruz Francisco Javier Cobiella-Carnicer Daniel Pérez-Camargo Paula Campelos-Fernández Luis Carlos Maroto-Castellanos One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial
description	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>.
format	article
author	Lourdes Montero-Cruces Manuel Carnero-Alcázar Fernando José Reguillo-Lacruz Francisco Javier Cobiella-Carnicer Daniel Pérez-Camargo Paula Campelos-Fernández Luis Carlos Maroto-Castellanos
author_facet	Lourdes Montero-Cruces Manuel Carnero-Alcázar Fernando José Reguillo-Lacruz Francisco Javier Cobiella-Carnicer Daniel Pérez-Camargo Paula Campelos-Fernández Luis Carlos Maroto-Castellanos
author_sort	Lourdes Montero-Cruces
title	One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial
title_short	One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial
title_full	One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial
title_fullStr	One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial
title_full_unstemmed	One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial
title_sort	one-year hemodynamic performance of three cardiac aortic bioprostheses: a randomized comparative clinical trial
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/f0938fc3cd294964986ba53fd8554ded
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One-Year Hemodynamic Performance of Three Cardiac Aortic Bioprostheses: A Randomized Comparative Clinical Trial

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