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.
Observational (n=1,550)
Yes
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?
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.
Effect estimate: HR 0.79 (95% CI 0.602–1.036)
Absolute Event Rate: 10.3% vs 13.4%
p-value: p=0.089
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.
Iwata et al. (2026) conducted an 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.
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