Abstract
BACKGROUND: Medium- and long-term outcomes after transcatheter paravalvular leak (PVL) closure remain poorly documented, with limited prospective data on predictors of morbidity and mortality. AIMS: This study aimed to assess medium-term outcomes and identify key predictive factors of mortality or surgical reintervention at 2 years after transcatheter PVL closure. METHODS: The prospective Fermeture de Fuite ParaProthétique (FFPP) Registry included consecutive symptomatic patients undergoing transcatheter PVL closure across 24 European centres between 2017 and 2019. Predictive factors for mortality and surgical reintervention were analysed over a 2-year follow-up. RESULTS: A total of 213 symptomatic patients underwent 237 procedures. The mean age was 68±11 years, with a median European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of 6 (interquartile range [IQR] 4-10). PVL involved the mitral valve in 64.6% of cases and mechanical prostheses in 53.3%. Heart failure and haemolytic anaemia were present in 89.5% and 49.8% of patients, respectively. The transapical approach was used in 6.8% of cases. Technical success was achieved in 87.3% of procedures, and clinical success at 1 month was achieved in 70.5% of patients. The median follow-up was 24.4 months (IQR 23.2-26.4). The survival rate at 2 years without the need for surgical reintervention was 66.1% (95% confidence interval [CI]: 60.1-72.7). Multivariate analysis identified mitral PVL, mechanical valves, and haemolytic anaemia as independent risk factors for adverse outcomes during follow-up. The absence of clinical success at 1 month was the strongest predictor of adverse outcomes (hazard ratio 5.00, 95% CI: 2.70-9.09; p=0.001). CONCLUSIONS: Transcatheter PVL closure offers a durable therapeutic option for high-risk patients when early clinical success is achieved. Mitral valve involvement, mechanical prostheses, and haemolytic anaemia remain key predictors of poor outcomes over a 2-year follow-up.