What is the clinical evidence from this study?

Study design: Cohort. Population: severe aortic stenosis (n=513). Intervention: SAPIEN 3 Ultra RESILIA (S3UR) valve vs. SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) valves. Primary outcome: Device success per VARC-3 criteria.

What does this research mean for the field?

The SAPIEN 3 Ultra RESILIA valve demonstrates superior hemodynamic performance and significantly reduces paravalvular leak compared to earlier-generation SAPIEN 3 valves, while maintaining comparable procedural success and safety. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

What question did this study set out to answer?

To evaluate the procedural, hemodynamic, and short-term clinical outcomes of the SAPIEN 3 Ultra RESILIA valve against earlier models.

May 25, 2026Open Access

Improved hemodynamic performance and reduced paravalvular regurgitation with the SAPIEN 3 Ultra RESILIA valve: a propensity-matched single-center TAVR study

MKMeha KrishnareddigariUniversity of California, Los Angeles GJGolsa JoodiYale University RZRadoslav ZinovievUniversity of California, Los Angeles

Key Result

The SAPIEN 3 Ultra RESILIA valve achieved comparable device success (>98%) and significantly lower 30-day mean aortic valve gradients (9.06 vs 12.53 mmHg) compared to earlier-generation valves.

Key Points

To evaluate the procedural, hemodynamic, and short-term clinical outcomes of the SAPIEN 3 Ultra RESILIA valve against earlier models.
Analyzed 513 patients undergoing transfemoral TAVR from 2022 to 2024 at Ronald Reagan UCLA Medical Center.
216 received SAPIEN 3 Ultra RESILIA valve and 297 received earlier SAPIEN models, with propensity-score matching creating 181 balanced pairs.
Primary endpoints were device success per VARC-3 criteria, with secondary endpoints including 30-day safety and echocardiographic performance.
The S3UR group exhibited significantly lower post-procedural mean aortic valve gradients (7.45 mmHg) compared to the S3U/S3 group (9.06 mmHg; p < 0.001).
Moderate paravalvular leak was 0% in the S3UR vs. 8.9-10.1% in S3U/S3 (p < 0.001).
Procedural success was over 98% in both groups, with reduced readmission rates in the S3UR cohort (7.8% vs. 13.9%), though not statistically significant.

Study Design

Type

Cohort (n=513)

Multicenter

Structured PICO

Does the SAPIEN 3 Ultra RESILIA valve improve hemodynamic performance and reduce paravalvular leak compared to earlier-generation SAPIEN 3/SAPIEN 3 Ultra valves in patients undergoing transfemoral TAVR?

Population

513 patients who underwent transfemoral transcatheter aortic valve replacement (TAVR) at Ronald Reagan UCLA Medical Center between 2022 and 2024. Excluded: prior surgical or transcatheter aortic valve prosthesis, valve-in-valve procedures, or non-transfemoral access. Propensity-score matching yielded 181 well-balanced patient pairs. Matched cohort mean age ~81 years, ~62% male.

Intervention

SAPIEN 3 Ultra RESILIA (S3UR) transcatheter heart valve

Comparator

Earlier-generation SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) transcatheter heart valves

Outcome

Device success as defined by the Valve Academic Research Consortium-3 (VARC-3) criteriacomposite

The SAPIEN 3 Ultra RESILIA valve provides superior short-term hemodynamic performance and reduced paravalvular leak compared to earlier generations, without compromising procedural safety.

Main Result

Absolute Event Rate: 98.7% vs 98.1%

Limitations

Single-center retrospective analysis subject to unmeasured confounding
Echocardiographic measurements were site-reported and subject to interobserver variability
Temporal confound due to the S3UR valve being introduced later in the study period
Limited to procedural and 30-day outcomes with no long-term follow-up available

Abstract

Background Transcatheter aortic valve replacement (TAVR) has rapidly evolved into a standardized treatment for severe aortic stenosis, particularly in patients at increased surgical risk. The fifth-generation SAPIEN 3 Ultra RESILIA (S3UR) valve notably incorporates RESILIA-treated tissue as well as an enhanced external skirt in order to reduce structural valve deterioration (SVD) and paravalvular leak (PVL). However, real-world data on its clinical performance remains limited. Objectives To evaluate procedural, hemodynamic, and short-term clinical outcomes of the S3UR valve compared to earlier-generation SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) platforms in Ronald Raegan UCLA medical center. Methods 513 patients who underwent transfemoral TAVR at Ronald Reagan UCLA Medical Center between 2022 and 2024 were analyzed. Of these, 216 received the S3UR valve and 297 received S3U/S3 valves. Propensity-score matching (1:1) yielded 181 well-balanced patient pairs. Primary endpoints included device success per VARC-3 criteria, with secondary endpoints encompassing 30-day safety, echocardiographic performance, and procedural complications. Results The S3UR group demonstrated significantly lower post-procedural and 30-day mean aortic valve gradients (7.45 ± 3.37 mmHg and 9.06 ± 2.94 mmHg, respectively; p 0.001) compared to the S3U/S3 group. Rates of moderate PVL were 0% in the S3UR group vs. 8.9–10.1% in S3U/S3 patients ( p 0.001). Procedural success exceeded 98% in both groups, with no significant differences in stroke, mortality, or new pacemaker implantation. Readmission rates trended lower in the S3UR cohort (7.8% vs. 13.9%), though not statistically significant. Conclusions The SAPIEN 3 Ultra RESILIA valve demonstrated superior hemodynamic performance and significantly reduced PVL compared to earlier-generation balloon-expandable valves, while maintaining comparable safety and procedural success. These findings add institutional-level evidence to the growing body of data supporting the S3UR valve; however, multicenter prospective studies with longer follow-up are needed to confirm these results and assess long-term durability.

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