Surgical Versus Transcatheter Aortic Valve Replacement in Patients Aged >60 Years With Bicuspid Valve Stenosis: A Time-to-Event Data Meta-Analysis.

BACKGROUND

The role of transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve stenosis requires further evaluation, particularly as its use has become comparable to surgical aortic valve replacement. We sought to compare midterm outcomes of TAVI and surgical aortic valve replacement in patients with bicuspid aortic valve stenosis.

METHODS

Systematic searches of MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials identified studies reporting TAVI and surgical aortic valve replacement outcomes in patients aged ≥60 years with bicuspid aortic valve stenosis. The primary analysis included only comparative studies with interpretable Kaplan-Meier curves. Individual patient data were reconstructed for time-to-event analysis. Sensitivity analyses incorporated noncomparative single-arm studies. Baseline differences and heterogeneity were addressed using landmark analysis, time-varying hazard ratios (HRs), frailty Cox models, and covariate-adjusted restricted mean survival time. The primary outcome was death with or without unplanned rehospitalization and stroke.

RESULTS

Five comparative, risk-adjusted studies (TAVI, 5901; surgical aortic valve replacement, 12 427) were included. At 48-month follow-up, TAVI was associated with a higher hazard for adverse events (HR, 1.62 [95% CI, 1.46-1.79]; P<0.0001 for the composite end point of death, stroke, or rehospitalization at 48 months); landmark analysis showed an initial benefit with TAVI, followed by a reversal at 6 months that was maintained beyond 12 months (12-48 months; P<0.0001). Time-varying HRs confirmed this trend. Sensitivity analyses, including frailty Cox models on the full cohort and restricted mean survival time analysis, supported the robustness of the findings.

CONCLUSIONS

This meta-analysis found limited midterm benefits (ie, 48 months) of TAVI in bicuspid aortic valve stenosis. These findings should be interpreted considering patient selection, as younger patients with bicuspid aortic valve stenosis are increasingly referred for TAVI.