RESUMEN
BACKGROUND: Previous studies on the impact of sex differences after transcatheter aortic valve replacement (TAVR) have shown conflicting results. The aim was to analyze the risk of long-term mortality, heart failure hospitalization, myocardial infarction, stroke, bleeding and aortic valve reintervention in females versus males after TAVR. METHODS: This nationwide, population-based cohort study included all patients who underwent TAVR in Sweden between 2008 and 2022 from the SWEDEHEART register. Additional baseline and outcome data were gathered from other national health data registers. Regression standardization was used to adjust for differences between the sexes. RESULTS: Of 10,475 patients, 4,886 (47%) were female and 5,589 (53%) were male. The mean age was 81 years. The cumulative incidence of mortality at 1, 5, and 10 years was 8% vs. 10%, 38% vs. 45%, and 75% vs. 82% for females and males, respectively. After regression standardization, the risk of all-cause mortality was lower for females (absolute difference at 10 years of 6.4%, 95% confidence interval [CI] 4.4%-8.4%). The mean follow up was 3.1 years (maximum 14.1 years). Females also had a lower risk of major bleeding than males (absolute survival difference at 10 years of 4.0%, 95% CI 1.9%-6.2%), but there was no difference in the risk of heart failure, myocardial infarction, stroke, or reintervention between the sexes. CONCLUSIONS: Females had a higher survival rate and a lower bleeding risk than males after TAVR. Sex-specific factors are important to consider in the management of patients after TAVR.
Asunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Femenino , Masculino , Suecia/epidemiología , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/mortalidad , Factores Sexuales , Anciano , Complicaciones Posoperatorias/epidemiología , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Sistema de Registros , Infarto del Miocardio/epidemiología , Factores de Riesgo , Insuficiencia Cardíaca/epidemiología , Incidencia , Factores de Tiempo , Tasa de Supervivencia/tendencias , Estudios de Seguimiento , Reoperación/estadística & datos numéricosRESUMEN
Importance: Aggregated data and long-term follow-up in national health data registers offer the opportunity to compare the performance of mechanical aortic prostheses within the same population. Objective: To investigate the clinical performance of mechanical aortic valve prostheses. Design, Setting, and Participants: This nationwide cohort study included all 5224 patients who underwent primary mechanical aortic valve replacement in Sweden between January 1, 2003, and December 31, 2018. Statistical analysis was performed between May and September 2023. Exposures: Surgical aortic valve replacement with the On-X, Carbomedics, Bicarbon, Standard, Regent, Open Pivot, Masters, or Advantage valve models. Main Outcomes and Measures: The primary outcome was all-cause mortality, and secondary outcomes were reintervention, heart failure, major bleeding, stroke, and embolic events. Regression standardization was used to account for baseline differences. Results: Overall, 5224 patients (mean [SD] age, 56.8 [11.7] years; 3908 men [74.8%]) were included. Total follow-up time was 43â¯982 person-years (mean [SD], 8.4 [4.6] years; maximum, 17.2 years). After regression standardization, there was a significant difference in 10-year mortality between the Carbomedics model group (17%; 95% CI, 15%-18%), Regent model group (17%; 95% CI, 13%-20%), and Standard model group (17%; 95% CI, 14%-19%) compared with the Bicarbon model group (27%; 95% CI, 21%-34%). Conclusions and Relevance: In this cohort study of mechanical valve surgical aortic replacement outcomes in Sweden, the rate of all-cause mortality was higher in the Bicarbon group than in the Carbomedics, Regent, and Standard model groups. These findings warrant further research on the long-term clinical performance of the Bicarbon valve.