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

Abstract

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 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 EaseTM (n = 48, 31.2%), Crown PRTTM (n = 51, 32.1%) and TrifectaTM (n = 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 EaseTM, 21.4 (IQR 14.5–26.7) and 237.8 (IQR 195.9–261.9) for Crown PRTTM, and 13 (IQR 9.6–17.8) and 209.7 (IQR 176.5–241.4) for TrifectaTM, respectively. Pairwise comparisons demonstrated improved mean gradients and maximum velocity of TrifectaTM as compared to Crown PRTTM. Among patients with nominal prosthesis sizes ≤ 21, the mean and peak aortic gradient was higher for Crown PRTTM compared with TrifectaTM, 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 TrifectaTM superior to Crown PRTTM.