Clinical research in cardiology : official journal of the German Cardiac Society · 2026
Sex-based differences in 10-year outcomes and bioprosthetic durability after TAVR with self-expanding valve bio-prosthesis: insights from a multicenter cohort.
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Di Muro Francesca Maria, Bellini Barbara, Bruschi Giuseppe, Chizzola Giuliano, Cozzi Ottavia, Costa Giulia, De Carlo Marco, Di Maio Marco, Ferraioli Mario, Ferrara Erica, Giannini Cristina, Gorla Riccardo, Maione Antongiulio, Massussi Mauro, Merlanti Bruno, Montorfano Matteo, Nazzaro Marco Stefano, Pancaldi Edoardo, Pierri Adele, Poli Arnaldo, Testa Luca, Vigorito Francesco, Saia Francesco, Galasso Gennaro, Vecchione Carmine, Attisano Tiziana
Аннотация
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.
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.