Key result
Braile Inovare Proseal TAVR reduces maximum transvalvular gradient ~84% without significant paravalvular leak.
Why the study?
To evaluate the hemodynamic performance and pre- and postoperative multislice computed tomography imaging of the new and experimental Braile Inovare Proseal transcatheter prosthesis.
Does transcatheter aortic valve replacement with the Braile Inovare Proseal device improve hemodynamic gradients and maintain device circularity in high-risk patients with aortic valve disease?
Cohort (n=21)
Does transcatheter aortic valve replacement with the Braile Inovare Proseal device improve hemodynamic gradients and maintain device circularity in high-risk patients with aortic valve disease?
p-value: p=<0.001
The Braile Inovare Proseal device offers excellent hemodynamics, reliable expansion, and very low rates of paravalvular leak for high-risk patients undergoing TAVR.
May support Braile Inovare Proseal TAVR hemodynamics in high-risk patients; hypothesis-generating pending randomized confirmation.
Objective: To evaluate the hemodynamic performance (i.e., gradients and paravalvular leakage [PVL]) of the new and experimental Braile Inovare Proseal. Additionally, we aimed to assess pre and postoperatively the aortic annulus and the transcatheter prosthesis using multislice computed tomography (MSCT).
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Fiori et al. (2020) conducted a cohort in Aortic valve disease (n=21). Braile Inovare Proseal transcatheter aortic valve was evaluated on Maximum transvalvular gradient (p=<0.001). Transcatheter aortic valve replacement with the Braile Inovare Proseal significantly reduced the maximum transvalvular gradient from 74.02 mmHg to 12.14 mmHg without causing paravalvular leakage worse than mild.
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