One-Year Clinical and Hemodynamic Outcomes in Latest Generation Balloon-Expandable and Self-Expandable Transcatheter Heart Valves.

BACKGROUND

One-year clinical and hemodynamic outcomes after transcatheter aortic valve replacement (TAVR) using the latest generation balloon-expandable valve (BEV) and self-expandable valve (SEV) is not well understood. This study is aimed to compare 1-year morality and hemodynamics between the latest generation BEV and SEV after TAVR.

METHODS

We retrospectively analyzed 1393 patients undergoing TAVR using BEV (63.7%) (SAPIEN3 Ultra RESILIA) and SEV (36.3%) (Evolut FX). The incidence of all-cause mortality and bioprosthetic valve dysfunction (BVD) over 1-year were compared between BEV and SEV in both overall and propensity score (PS) matched cohort.

RESULTS

During 1-year follow-up, the incidence of all-cause mortality was comparable between BEV and SEV in the overall (10.8% vs. 8.0%, log-rank p = 0.30) and PS matched cohort (11.0% vs. 8.9%, log-rank p = 0.40). The incidence of BVD through 1-year was also comparable between BEV and SEV in the overall (6.2% vs. 6.9%, p = 0.59) and PS matched cohort (6.7% vs. 8.2%, p = 0.55). Of BVD component, post-procedural mean pressure gradient more than 20mmH was higher in BEV, while para-valvular leakage more than moderate was higher in SEV. There was non-linear relationship between annulus size and BVD, in which TAVR with BEV had higher BVD in a small annulus, while SEV had higher BVD in a large annulus.

CONCLUSIONS

In TAVR using the latest generation valves, incidences of mortality and valve performance during 1-year were comparable between BEV and SEV. Whereas, the impact of annulus size on the difference of valve hemodynamics between BEV and SEV is still observed.