Key result
The Trifecta biological aortic prosthesis demonstrated superior hemodynamic performance at 1 year, with a lower mean aortic gradient (13 vs 21.4) compared to the Crown PRT prosthesis.
Why the study?
The study aimed to compare the 1-year in-vivo hemodynamic performance of three biological aortic prostheses.
Does the Trifecta biological aortic prosthesis improve hemodynamic performance compared to Carpentier Perimount Magna Ease and Crown PRT in patients receiving biological aortic prostheses?
RCT (n=154)
Single-blind
Does the Trifecta biological aortic prosthesis improve hemodynamic performance compared to Carpentier Perimount Magna Ease and Crown PRT in patients receiving biological aortic prostheses?
Absolute Event Rate: 13% vs 21.4%
The Trifecta biological aortic prosthesis provides superior hemodynamic performance at 1 year compared to the Crown PRT prosthesis, particularly in patients with smaller aortic annuli.
Supports Trifecta preference for better hemodynamics in AVR, especially small annuli; extends RCT data on bioprosthesis selection.
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.
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Montero-Cruces et al. (2021) conducted an RCT in Aortic valve disease requiring biological prosthesis (n=154). TrifectaTM biological aortic prosthesis vs. Crown PRTTM and Carpentier Perimount Magna EaseTM was evaluated on Mean aortic gradient at 1 year. The Trifecta biological aortic prosthesis demonstrated superior hemodynamic performance at 1 year, with a lower mean aortic gradient (13 vs 21.4) compared to the Crown PRT prosthesis.
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