Medium-term outcomes and prognostic factors after transcatheter paravalvular leak closure: an international prospective multicentre registry
Year: 2026
Type: article
Study design: Observational Study
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.
Source: EuroIntervention
Authors: Grégoire Albenque, Grzegorz Smolka, David Blanchard, Martin Kloëckner, Eric Brochet, Frederic Bouisset, Guillaume Leurent, Jean-Benoît Thambo, Nicolas Combes, Nicolas Dumonteil, Fabrice Bauer, Mohammed Nejjari, Rémy Pillière, Claire Dauphin, Guillaume Bonnet, Vlad Ciobotaru, Régis Kételers, Romain Gallet, Nadjib Hammoudi, Lionel Mangin, Hélène Bouvaist, Christian Spaulding, Adel Aminian, Teoman Kilic, Batric Popovic, Sébastien Armero, Didier Champagnac, Benoît Gérardin, Sebastien Hascoet
Institutions: Inserm, Université Paris-Saclay, Hôpital Marie Lannelongue, Medical University of Silesia, Assistance Publique – Hôpitaux de Paris, Hôpital Bichat-Claude-Bernard, Hôpital Rangueil, Centre d'Epidémiologie et de Recherche en santé des POPulations de Toulouse, Laboratoire Traitement du Signal et de l'Image, Centre Hospitalier Universitaire de Rennes, Université de Rennes, Hôpital Cardiologique du Haut-Lévêque, Clinique Pasteur, Hôpital Charles-Nicolle, Centre Cardiologique du Nord, Clinique Ambroise Paré, Centre Hospitalier Universitaire de Clermont-Ferrand, Assistance Publique Hôpitaux de Marseille, Hôpital de la Timone, Centre Hospitalier Universitaire Henri-Mondor, Hôpitaux Universitaires Henri-Mondor, Sorbonne Université, Pitié-Salpêtrière Hospital, Centre Hospitalier Universitaire de Grenoble, Hôpital Européen Georges-Pompidou, Kocaeli Üniversitesi, Centre Hospitalier Régional et Universitaire de Nancy, Université de Lorraine, Hôpital Européen
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7122529848