What is the clinical evidence from this study?

Study design: Observational. Population: Elderly patients (mean age 83.6 years) with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) with balloon-expandable valves (n=1550). Intervention: SAPIEN 3 Ultra RESILIA (S3UR) balloon-expandable transcatheter aortic valve vs. SAPIEN 3 (S3) balloon-expandable transcatheter aortic valve. Primary outcome: 1-year all-cause mortality (HR 0.79, 95% CI 0.602–1.036, p=0.089).

What does this research mean for the field?

Transcatheter aortic valve implantation using the SAPIEN 3 Ultra RESILIA valve results in significantly lower all-cause mortality, stroke, and heart failure rehospitalization compared to the previous generation SAPIEN 3 valve at one year post-procedure. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

What question did this study set out to answer?

To compare 1-year clinical outcomes of SAPIEN 3 Ultra RESILIA and SAPIEN 3 after transcatheter aortic valve implantation.

March 4, 2026Open Access

Mechanisms underlying superior outcomes of transcatheter aortic valve implantation with the latest balloon expandable valve

JIJuri IwataKeio University MYMasanori YamamotoToyohashi Heart Center RARyo AritaKeio University

Key Result

The SAPIEN 3 Ultra RESILIA valve reduced 1-year all-cause mortality from 13.4% to 10.3% compared to SAPIEN 3 in elderly patients undergoing TAVI, with HR 0.79 (95% CI 0.60–1.04), p=0.089; mortality benefit was significant in patients with smaller valves.

Key Points

To compare 1-year clinical outcomes of SAPIEN 3 Ultra RESILIA and SAPIEN 3 after transcatheter aortic valve implantation.
Conducted a 1:1 propensity score-matched analysis of patients in the OCEAN-TAVI registry.
Compared outcomes between S3UR and S3 for 1 year post-TAVI.
Evaluated all-cause mortality, stroke, and heart failure rehospitalization.
S3UR showed lower all-cause mortality (10.3% vs. 13.4%) and stroke (0.9% vs. 3.4%) than S3.
Heart failure rehospitalization was significantly lower with S3UR (1.4% vs. 2.7%).
S3UR demonstrated a larger effective orifice area and a lower mean pressure gradient at discharge.

Study Design

Type

Observational (n=1,550)

Multicenter

Yes

Structured PICO

Does TAVI with the SAPIEN 3 Ultra RESILIA valve improve 1-year clinical outcomes and hemodynamics compared to the SAPIEN 3 valve in patients with aortic stenosis?

Population

2,369 patients with aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) from the OCEAN-TAVI registry (775 propensity-matched pairs analyzed), mean age 83.6, 41.3% male, based in Japan.

Intervention

Transcatheter aortic valve implantation (TAVI) using the balloon-expandable SAPIEN 3 Ultra RESILIA (S3UR) valve

Comparator

Transcatheter aortic valve implantation (TAVI) using the previous generation SAPIEN 3 (S3) valve (historical cohort)

Outcome

1-year clinical outcomes including all-cause mortality, stroke, and heart failure rehospitalizationhard clinical

The latest-generation SAPIEN 3 Ultra RESILIA valve demonstrated superior 1-year clinical outcomes and echocardiographic hemodynamics compared to the SAPIEN 3 valve, particularly in patients with smaller aortic annuli.

Main Result

Effect estimate: HR 0.79 (95% CI 0.602–1.036)

Absolute Event Rate: 10.3% vs 13.4%

p-value: p=0.089

Limitations

Observational non-randomized design with potential residual confounding despite propensity score matching
No independent core laboratory for echocardiographic assessments
Data on post-TAVI multidetector CT not available to investigate changes in valve effective orifice area and paravalvular leakage in detail
Potential learning curve and temporal bias because S3 was historical cohort and S3UR more recent
Unclear whether benefits derive from RESILIA tissue or skirt design improvements
Generalizability limited to elderly Japanese population with mean age 83.6 years

Abstract

Abstract Transcatheter aortic valve implantation (TAVI) using SAPIEN 3 Ultra RESILIA (S3UR) offers improved hemodynamic performance than its former generation, SAPIEN 3 (S3). This study compared 1-year clinical outcomes after TAVI using S3UR and S3. Among 2,369 patients from the OCEAN-TAVI registry (UMIN000020423), a 1:1 propensity score-matched analysis identified 775 matched pairs. One-year post-TAVI, S3UR showed significantly lower all-cause mortality (10.3% vs. 13.4%, p = 0.026), stroke (0.9% vs. 3.4%, p = 0.001), and heart failure rehospitalization (1.4% vs. 2.7%, p < 0.001) than S3. These differences were pronounced in patients receiving smaller valves (20–23 mm). S3UR demonstrated a larger effective orifice area, lower mean pressure gradient, and lower incidence of paravalvular leakage than S3 at discharge. At 1 year, S3UR showed significantly reduced paravalvular leakage and lower incidences of mean pressure gradient ≥20 mmHg than S3. We concluded that S3UR demonstrated superior hemodynamic performance to S3, exhibiting better prognosis, particularly in patients with smaller valves.

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Cite This Study

Iwata et al. (Mon,) conducted a observational in Elderly patients (mean age 83.6 years) with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) with balloon-expandable valves (n=1,550). SAPIEN 3 Ultra RESILIA (S3UR) balloon-expandable transcatheter aortic valve vs. SAPIEN 3 (S3) balloon-expandable transcatheter aortic valve was evaluated on 1-year all-cause mortality (HR 0.79, 95% CI 0.602–1.036, p=0.089). The SAPIEN 3 Ultra RESILIA valve reduced 1-year all-cause mortality from 13.4% to 10.3% compared to SAPIEN 3 in elderly patients undergoing TAVI, with HR 0.79 (95% CI 0.60–1.04), p=0.089; mortality benefit was significant in patients with smaller valves.

synapsesocial.com/papers/69a7cc8ed48f933b5eed821a https://doi.org/https://doi.org/10.1038/s44325-026-00105-w

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