Comparative outcomes of balloon-expandable and self-expanding valves in transcatheter aortic valve replacement: A systematic review and meta-analysis

Background Balloon-expandable valves (BEVs) and self-expanding valves (SEVs) are the two primary platforms for transcatheter aortic valve replacement (TAVR), differing in design, deployment, and hemodynamic performance. Comparative evidence on their clinical and procedural outcomes remains limited and inconsistent. Methods A systematic review and meta-analysis were conducted, searching PubMed, Scopus, Web of Science, and Cochrane Library up to July 2025 for studies comparing BEVs and SEVs in adults with severe aortic stenosis undergoing transfemoral TAVR. Outcomes included all-cause mortality, cardiovascular mortality, stroke, permanent pacemaker implantation, hemodynamic parameters, device success, and safety endpoints. Dichotomous and continuous outcomes were pooled as risk ratios (RR) and mean differences (MD) with corresponding 95% confidence intervals (CI) using a random-effects model. Results Fifty-three studies ( n = 157,921) were included (6 randomized controlled trials, 12 prospective, and 35 retrospective cohorts). BEVs showed significant early survival benefits at 1 month (RR = 0.75, 95% CI 0.57–0.97, p = 0.03) and 6 months (RR = 0.33, 95%CI0.18–0.60, p < 0.001), with reduced cardiovascular mortality at 12 months (RR = 0.88, 95% CI 0.79–0.99, p = 0.03). Permanent pacemaker implantation rates were consistently lower with BEVs (e.g. RR = 0.75, 95% CI 0.64–0.88, p < 0.001 at 1 month). SEVs exhibited superior hemodynamics, with lower mean gradients (MD = −3.16 to −7.77 mmHg) and larger aortic valve areas (MD = +0.11 to +0.13 cm2). Long-term mortality and safety outcomes, including major bleeding, vascular complications, and myocardial infarction, were comparable. Conclusion BEVs offer early survival and conduction preservation advantages, while SEVs provide superior hemodynamic performance. These findings highlight the importance of individualized valve selection based on patient-specific factors. Further randomized trials with extended follow-up are needed to evaluate long-term durability and outcomes in diverse patient populations. © 2026 Japanese College of Cardiology.