Clinical Outcomes of Mild Paravalvular Leak Following Transcatheter Aortic Valve Replacement

Background: Paravalvular leak (PVL) following transcatheter aortic valve replacement (TAVR) is common, and while moderate-to-severe PVL is consistently associated with adverse outcomes, the long-term clinical impact of mild PVL remains uncertain. Question: Is there an association between mild PVL and mortality or heart failure hospitalizations in TAVR patients? Methods: We performed a systematic review and meta-analysis of studies comparing outcomes in patients with mild versus no PVL following TAVR. A comprehensive search of PubMed/MEDLINE, Embase, and Cochrane was conducted from inception through March 2026. Two independent reviewers screened studies and conducted full-text reviews using predefined inclusion and exclusion criteria. Random-effects models were used to pool hazard ratios (HRs) with 95% confidence intervals (CIs). Prespecified subgroup analyses were performed according to follow-up duration (1-2 years, 2-5 years, ≥5 years) and heart failure rehospitalization. Results: 33 studies met inclusion criteria; due to variability in reporting and time-to-event data, 20 studies contributed to the primary all-cause mortality analysis. Overall, across all follow-up periods (median follow-up 2.25 years), mild PVL was associated with increased mortality (HR 1.29, 95% CI 1.18-1.41; p < 0.0001; I 2 = 55.7%). Although there was no significant difference in mortality at 1-2 years (HR 1.09, 95% CI 0.94-1.25; p = 0.25; I 2 = 0%), the difference emerged at 2-5 years (HR 1.44, 95% CI 1.26-1.64; p < 0.0001; I 2 = 48.2%) and persisted at ≥5 years (HR 1.21, 95% CI 1.09-1.35; p = 0.0006; I 2 = 58.5%) (Figure 1). These associations persisted in both the VARC-2 and VARC-3 eras. Mild PVL was also associated with increased hospitalizations for heart failure (HR 1.25, 95% CI 1.05-1.49; p = 0.011; I 2 = 0%), though this was mostly driven by a single 2-year follow-up study. Conclusions: Our analysis demonstrated that patients with mild PVL experienced a higher risk of all-cause mortality and may be at higher risk of heart failure hospitalization, though confounding from the burden of calcification, bicuspid anatomy, or post-dilatation cannot be excluded. Mild PVL should not be considered benign; efforts should be taken to minimize PVL at implantation, and close longitudinal follow-up is essential.