One-year outcomes of the RESILIA balloon-expandable transcatheter valve: survival, hemodynamics, and hypoattenuated leaflet thickening

TL;DR

A new heart valve (S3UR) shows better survival and performance than older models after one year, with less leaflet thickening.

Contribution

The study provides first-year clinical and hemodynamic outcomes of the RESILIA valve compared to prior models in TAVR patients.

Findings

The S3UR valve was associated with lower all-cause mortality at one year compared to S3/S3U valves.

S3UR demonstrated better hemodynamic performance, including lower gradients and reduced prosthesis-patient mismatch.

The S3UR group had a significantly lower incidence of hypoattenuated leaflet thickening at 30 days.

Abstract

Performance evaluation of the latest fifth-generation SAPIEN 3 Ultra RESILIA (S3UR) valve in patients who underwent transcatheter aortic valve replacement (TAVR) is limited. The aim of this study was to compare the 1-year clinical outcomes, including valve performance, in patients undergoing TAVR with the S3UR compared to the SAPIEN 3 or SAPIEN 3 Ultra (S3/S3U). Patients with severe native aortic stenosis who underwent TAVR with either the S3UR or the S3/S3U valve were matched using propensity scores. Predictors of 1-year outcomes were identified. A subgroup analysis of patients who underwent post-TAVR CT was conducted. Among 4,908 patients, 312 matched pairs were assessed. At 1-year, compared to the S3/S3U group, the S3UR group exhibited lower all-cause mortality (HR: 0.42; 95% CI: 0.18–0.96; p = 0.041). The S3UR group demonstrated superior hemodynamic performance, including lower transvalvular gradients, larger effective orifice areas, and decreased incidence of severe prosthesis-patient mismatch and paravalvular leak. In patients who underwent post-TAVR CT (n = 280), prevalence of hypoattenuated leaflet thickening (HALT) at 30-day was lower in the S3UR group compared to S3/S3U (5.7% vs 16.2%; p = 0.006). In multivariate analysis, the S3UR group was independently associated with lower 1-year mortality and reduced HALT. In this propensity score-matched cohort, compared with the S3/S3U group, the S3UR group demonstrated favorable clinical outcomes and superior hemodynamic performance. In subgroup analysis, S3UR was also associated with a lower HALT incidence.

The online version contains supplementary material available at 10.1007/s12928-025-01227-1.

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