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

We aimed to compare 1 year the hemodynamic in-vivo performance of three biological aortic prostheses (Carpentier Perimount Magna Ease^TM, Crown PRT^TM, and Trifecta^TM).

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.

154 patients were included. Carpentier Perimount Magna Ease^TM (n = 48, 31.2%), Crown PRT^TM (n = 51, 32.1%) and Trifecta^TM (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 Ease^TM, 21.4 (IQR 14.5-26.7) and 237.8 (IQR 195.9-261.9) for Crown PRT^TM, and 13 (IQR 9.6-17.8) and 209.7 (IQR 176.5-241.4) for Trifecta^TM, respectively. Pairwise comparisons demonstrated improved mean gradients and maximum velocity of Trifecta^TM as compared to Crown PRT^TM. Among patients with nominal prosthesis sizes ≤ 21, the mean and peak aortic gradient was higher for Crown PRT^TM compared with Trifecta^TM, and in patients with an aortic annulus measured with metric Hegar dilators less than or equal to 22 mm.

One year after surgery, the three prostheses presented a different hemodynamic performance, being Trifecta^TM superior to Crown PRT^TM.