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<p>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.</p> Graphical abstract <p></p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月15日

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  • Kazuki Suruga,
  • Vivek Patel,
  • Yuchao Guo,
  • Hidemasa Shitan,
  • Daniel Ng,
  • Takashi Nagasaka,
  • Jaideep Menda,
  • Adishwar Singh,
  • Mitch Gheorghiu,
  • Dhairya Patel,
  • Aakriti Gupta,
  • Tarun Chakravarty,
  • Wen Cheng,
  • Yuito Okada,
  • Hasan Jilaihawi,
  • Mamoo Nakamura,
  • Raj R. Makkar

摘要

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.

Graphical abstract