Five-Year Mortality of Surgical and Transcatheter Aortic Valve Replacement in the Real-World Scenario: A Systematic Review and Meta-Analysis of Propensity Score Matching Studies.

Introduction: Randomized controlled trials (RCTs) provide evidence of efficacy, while real-world data (RWD) demonstrate effectiveness in real-world practice. We designed a systematic review and meta-analysis of reconstructed time-to-event (RTE) data from propensity score matching studies comparing transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) to compare their effectiveness and evaluate the generalizability of TAVI indications.

Methods: Systematic review of literature between 2007 and 2023 including propensity score matching studies comparing TAVI or SAVR that reported at least one-year Kaplan-Meier curves of endpoints.

Results: Twenty-one studies were included (39538 participants). TAVI shows a higher all-cause mortality (hazard ratio [HR] 1.41; 95% confidence interval [CI] 1.34-1.47, P-value < 0.001), with a significant heterogeneity. The analysis of HR trend over time shows that TAVI superiority is limited to the first month with a steep reversal afterwards, when SAVR becomes clearly superior. All-cause mortality is significantly higher in TAVI in low-risk (HR 1.35; 95% CI 1.08-1.69, P-value < 0.001) as well as in intermediate (HR 1.73; 95% CI 1.35-2.22, P-value < 0.001) and high-risk (HR 1.61; 95% CI 1.38-1.88, P-value < 0.001) patients. The HR trend in the subgroups of risk confirms the data from the whole mixed population.

Conclusion: In a real-word setting, TAVI is associated with higher incidence of all-cause death and maintains a survival benefit only in the first month after implantation. These results show that TAVI effectiveness may not reflect the efficacy demonstrated by RCTs and pose a threat to their external validity.