Mortality in patients with mild and moderate paravalvular leakage after transcatheter aortic valve implantation

Background Transcatheter aortic valve implantation (TAVI) has become the most common aortic valve replacement method for aortic stenosis. A known complication after valve replacement is paravalvular leakage (PVL). Severe PVL has been shown to increase mortality, but the significance of minor PVL remains uncertain. The aim of this retrospective observational cohort study was to investigate the clinical significance of mild and moderate PVL on mortality. Methods This study was based on data from the Swedish transcatheter cardiac intervention registry (SWENTRY) and included 14 296 patients undergoing TAVI during the years 2008–2025. SWENTRY was combined with the Swedish population registry to obtain survival data. Multivariate cox proportional hazards regression was used to analyse survival, where patients with mild and moderate PVL after TAVI were compared to patients with no PVL after TAVI. Landmark analyses from 30 days, 1 year and 5 years were performed to verify the effect of PVL on survival across varying post-surgical time-periods. Results Moderate PVL was associated with a significant higher hazard of mortality (HR 1.21, 95% CI [1.07–1.38], p=0.003). The results were consistent in the 30-day-landmark analysis (HR 1.16, 95% CI [1.02–1.32], p=0.027), but not in the other landmark analyses. Mild PVL was not associated with a statistically significantly higher hazard of mortality in any of the analyses (HR 1.05, 95% CI [0.99–1.11], p=0.107). Conclusions The results indicate that mild PVL does not have a statistically significant adverse effect on mortality. However, moderate PVL seems to have a more pronounced negative impact on survival, which should not be disregarded. This adverse effect seems to occur mainly during the first years after TAVI. These results indicate that mild PVL is presumably not associated with increased mortality, as well as highlight the clinical relevance of moderate PVL and imply that further attention to its management might be needed.