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Background <p>Sex-specific differences in outcomes after transcatheter aortic valve replacement (TAVR) are well established, with females more often presenting with advanced disease and experiencing higher peri-procedural risk, yet consistently exhibiting superior long-term survival. However, data on the sex-related impact on bioprosthetic valve durability and very long-term clinical outcomes remain scarce. This study aimed to assess 10-year survival, prognosis, and valve performance in males and females undergoing TAVR with self-expanding bio-prostheses (CoreValve/Evolut R).</p> Methods <p>Consecutive patients with severe symptomatic aortic stenosis treated with TAVR between 2007 and 2014 at ten Italian centers were prospectively included in the Medtronic One Hospital Clinical Service (OHCS) database and included in the present analysis. The overall population was classified according to sex. The primary endpoint was a composite of all-cause mortality, heart failure rehospitalization, or stroke at 10&#xa0;years. Secondary endpoints included the single components of the primary endpoint, cardiovascular death, and valve performance.</p> Results <p>Among 1944 patients included in the analysis, 54.9% (<i>n</i> = 1068) were female. Compared to males, females were older and exhibited a higher baseline risk profile, characterized by more advanced renal disease and higher transvalvular gradients, yet they more frequently had preserved left ventricular ejection fraction and a lower prevalence of prior cardiovascular events. At 10&#xa0;years, the primary endpoint occurred significantly more often in male patients, a finding that persisted after adjustment for relevant confounders (adjusted HR 1.15;&#xa0;<i>p</i> = 0.028) and was primarily driven by all-cause mortality. Structural valve deterioration, bioprosthetic valve failure, and valve performance were comparable between sexes at the 10-year follow-up.</p> Conclusions <p>Despite older age and increased procedural risk, female patients demonstrated more favorable long-term survival and similar valve durability compared to males over 10&#xa0;years following TAVR with first-generation CoreValve/Evolut R prostheses. These findings underscore the long-term reliability of self-expanding valves and highlight the need for individualized, sex-specific strategies in TAVR patient selection and management.</p> Graphical Abstract <p>Sex-specific characteristics and 10-year outcomes in 1944 patients with severe aortic stenosis treated with self-expanding valves (CoreValve/Evolut R) at 10 Italian centers. Female patients, despite older age and a higher baseline risk profile, exhibited lower all-cause mortality and composite event rates but higher stroke incidence. In contrast, males had more reinterventions and a higher rate of bioprosthetic valve deterioration. Structural valve deterioration and bioprosthetic valve failure were comparable, underscoring durable valve performance across sexes.</p> <p></p>

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Sex-based differences in 10-year outcomes and bioprosthetic durability after TAVR with self-expanding valve bio-prosthesis: insights from a multicenter cohort

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月4日

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  • Francesca Maria Di Muro,
  • Barbara Bellini,
  • Giuseppe Bruschi,
  • Giuliano Chizzola,
  • Ottavia Cozzi,
  • Giulia Costa,
  • Marco De Carlo,
  • Marco Di Maio,
  • Mario Ferraioli,
  • Erica Ferrara,
  • Cristina Giannini,
  • Riccardo Gorla,
  • Antongiulio Maione,
  • Mauro Massussi,
  • Bruno Merlanti,
  • Matteo Montorfano,
  • Marco Stefano Nazzaro,
  • Edoardo Pancaldi,
  • Adele Pierri,
  • Arnaldo Poli,
  • Luca Testa,
  • Francesco Vigorito,
  • Francesco Saia,
  • Gennaro Galasso,
  • Carmine Vecchione,
  • Tiziana Attisano

摘要

Background

Sex-specific differences in outcomes after transcatheter aortic valve replacement (TAVR) are well established, with females more often presenting with advanced disease and experiencing higher peri-procedural risk, yet consistently exhibiting superior long-term survival. However, data on the sex-related impact on bioprosthetic valve durability and very long-term clinical outcomes remain scarce. This study aimed to assess 10-year survival, prognosis, and valve performance in males and females undergoing TAVR with self-expanding bio-prostheses (CoreValve/Evolut R).

Methods

Consecutive patients with severe symptomatic aortic stenosis treated with TAVR between 2007 and 2014 at ten Italian centers were prospectively included in the Medtronic One Hospital Clinical Service (OHCS) database and included in the present analysis. The overall population was classified according to sex. The primary endpoint was a composite of all-cause mortality, heart failure rehospitalization, or stroke at 10 years. Secondary endpoints included the single components of the primary endpoint, cardiovascular death, and valve performance.

Results

Among 1944 patients included in the analysis, 54.9% (n = 1068) were female. Compared to males, females were older and exhibited a higher baseline risk profile, characterized by more advanced renal disease and higher transvalvular gradients, yet they more frequently had preserved left ventricular ejection fraction and a lower prevalence of prior cardiovascular events. At 10 years, the primary endpoint occurred significantly more often in male patients, a finding that persisted after adjustment for relevant confounders (adjusted HR 1.15; p = 0.028) and was primarily driven by all-cause mortality. Structural valve deterioration, bioprosthetic valve failure, and valve performance were comparable between sexes at the 10-year follow-up.

Conclusions

Despite older age and increased procedural risk, female patients demonstrated more favorable long-term survival and similar valve durability compared to males over 10 years following TAVR with first-generation CoreValve/Evolut R prostheses. These findings underscore the long-term reliability of self-expanding valves and highlight the need for individualized, sex-specific strategies in TAVR patient selection and management.

Graphical Abstract

Sex-specific characteristics and 10-year outcomes in 1944 patients with severe aortic stenosis treated with self-expanding valves (CoreValve/Evolut R) at 10 Italian centers. Female patients, despite older age and a higher baseline risk profile, exhibited lower all-cause mortality and composite event rates but higher stroke incidence. In contrast, males had more reinterventions and a higher rate of bioprosthetic valve deterioration. Structural valve deterioration and bioprosthetic valve failure were comparable, underscoring durable valve performance across sexes.