Sex-based differences in outcomes between male and female patients with bicuspid aortic stenosis following transcatheter aortic valve replacement: A meta-analysis

Abstract

Bicuspid aortic valve (BAV) is a common congenital anomaly leading to early aortic stenosis. Although transcatheter aortic valve replacement (TAVR) offers a less invasive treatment for BAV stenosis, sex-specific outcome data are scarce. This study evaluates clinical outcomes after TAVR by sex in BAV patients. A systematic literature search was performed across PubMed, ClinicalTrials.gov, and Cochrane CENTRAL to identify relevant English-language randomized controlled trials and observational studies. Risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using fixed- or random-effects models based on heterogeneity. Statistical significance was set at p < .05, and heterogeneity was assessed using the I² statistic. Analyses were performed with Review Manager Version 5.3. Four observational studies comprising 7585 patients met inclusion criteria. Males had a higher incidence of acute kidney injury (AKI) (RR = 1.33; 95% CI: 1.13–1.57; p = .0008) and acute myocardial infarction (MI) (RR = 2.18; 95% CI: 1.54–3.07; p = .00001), but a lower risk of in-hospital mortality (RR = 0.71; 95% CI: 0.51–0.99; p = .04), stroke (RR = 0.70; 95% CI: 0.50–0.95; p = .02), and bleeding (RR = 0.79; 95% CI: 0.63–0.98; p = .03) compared to females. No statistically significant differences were observed in one-year mortality (RR = 1.08; 95% CI: 0.58–2.03; p = .81), 30-day mortality (RR = 1.18; 95% CI: 0.51–2.75; p = .69), or arrhythmia (RR = 0.83; 95% CI: 0.52–1.33; p = .45). Males had increased risks of AKI and MI, while females experienced higher in-hospital mortality, stroke, and bleeding. These findings, derived from a limited number of retrospective observational studies, are hypothesis-generating and highlight the need for sex-specific risk stratification and further prospective research to confirm these patterns and guide clinical practice.

Keywords

bicuspid aortic valve disease / cardiovascular outcomes / mortality / sex-based differences / TAVR

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2026 The Author(s). Precision Medical Sciences published by John Wiley & Sons Australia, Ltd on behalf of Nanjing Medical University Affiliated Cancer Hospital & Jiangsu Cancer Hospital.