Long-term outcomes of transcatheter paravalvular leak closure: an international prospective multicenter study

Data on long-term outcomes following transcatheter paravalvular leak (PVL) closure are limited. Few prospective cohort studies have explored the predictive factors for morbidity and mortality in this procedure. This study aims to report the long-term outcomes of transcatheter PVL closure and identify factors associated with mortality or the need for surgical reintervention. This prospective registry (Fermeture de Fuite ParaProthétique, FFPP) included consecutive patients referred to 24 European centers for transcatheter PVL closure between 2017 and 2019. Predictive factors for mortality and surgical reintervention were analyzed over a two-year follow-up period. A total of 213 symptomatic patients who underwent 237 procedures were included. Mean age was 68 years (±11), with a median EUROSCORE II of 6 [4–10]. Targeted PVL was mitral in 64.6% of cases, with mechanical valves in 50.6%. Heart failure was present in 89.5%, and/or hemolytic anemia in 49.8%. Transapical access was used in 6.8% of cases. Technical success was achieved in 87.3% of procedures, with clinical success at 1 month in 70.5% of patients. At 2 years, survival without surgical reintervention was 66%, 95%CI [60.07- 72.69]. Multivariate analysis identified mitral PVL involvement (OR 1.92 [1.03–3.70]; p=0.041), mechanical prostheses (OR 1.88 [1.12–3.22]; p=0.017), hemolytic anemia (OR 1.96 [1.17–3.29]; p=0.010) and transapical (OR 1.91 [0.98–3.75]; p=0.059) as risk markers. Transcatheter PVL closure is an effective and safe procedure for symptomatic patients with an intermediate/high EUROSCORE II risk. However, at 2 years post-procedure, mortality and the need for surgical reintervention remain significant challenges, with mitral valve involvement, mechanical prosthesis, hemolytic anemia and apical access identified as key predictive factors