Paravalvular leaks (PVL) are a frequent complication following surgical valve replacement, occurring in 5% to 18% of prosthetic valves. Incidence varies according to valve position, ranging from 2% to 10% in aortic valves and from 7% to 17% in mitral valves. While many PVLs remain asymptomatic and clinically insignificant, others may lead to severe complications such as heart failure and hemolytic anemia, often requiring repeat intervention.
In recent years, transcatheter PVL closure (PVLc) has become established as a minimally invasive alternative, particularly in patients at high or prohibitive surgical risk. Previously reported short-term results have confirmed that PVLc is a safe and effective option. However, data regarding mid- and long-term outcomes remain limited.
The aim of this study was to evaluate mid-term outcomes and identify predictors of mortality or surgical reintervention at 2 years following the procedure.
Resultados a 2 años del cierre transcatéter de leak paravalvular: supervivencia y necesidad de reintervención
A total of 213 symptomatic patients underwent 237 procedures. The mean age was 68 ± 11 years, with a median EuroSCORE II of 6. PVL involved the mitral valve in 64.6% of cases and mechanical prostheses in 53.3%. Heart failure and hemolytic anemia were present in 89.5% and 49.8% of patients, respectively. The transapical approach was used in 6.8% of procedures.
Technical success was achieved in 87.3% of cases, and clinical success at one month was observed in 70.5% of patients. The median follow-up was 24.4 months. Two-year survival free from surgical reintervention was 66.1% (95% confidence interval: 60.1–72.7). Multivariable analysis identified mitral PVL, mechanical valves, and hemolytic anemia as independent risk factors for adverse outcomes during follow-up. Lack of clinical success at one month was the strongest predictor of adverse outcomes (HR: 5.00; 95% CI: 2.70–9.09; p = 0.001).
Conclusion
Transcatheter PVL closure represents a durable therapeutic strategy in high-risk patients, provided early clinical success is achieved. Mitral involvement, the presence of mechanical prostheses, and hemolytic anemia emerge as key adverse predictors in this population.
Original Title: Medium-term outcomes and prognostic factors after transcatheter paravalvular leak closure: an international prospective multicentre registry.
Reference: Grégoire Albenque et al EuroIntervention 2026;22:e113-e122.
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