Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry
Sébastien Hascoët, James R. Bentham, Luca Giugno, Pedro Betrián-Blasco, Aleksander Kempny, Ali Houeijeh, Haysam Baho, Shiv-Raj Sharma, Matthew I Jones, Elżbieta Katarzyna Biernacka, Nicolas Combes, Stanimir Georgiev, Hélène Bouvaist, José Diogo Martins, Marinos Kantzis, Mark Turner, Stephan Schubert, Zakaria Jalal, Gianfranco Butera, Sophie Malekzadeh‐Milani, Estíbaliz Valdeolmillos, Clément Karsenty, Ender Ödemiş, Philippe Aldebert, Nikolaus Haas, Ihab Khatib, Håkan Wåhlander, Gianpiero Gaio, Alberto Mendoza, Sayqa Arif, Biagio Castaldi, Gaute Døhlen, Ronald G. Carere, María Jesús del Cerro Marín, Erwin Kitzmüller, Antony Hermuzi, Mário Carminati, Patrice Guérin, Anja Tengler, Alain Fraisse, the EUROPULMS3 investigators, Lars Aaberge, Mariama Akodad, María Álvarez-Fuente, Clément Batteux, Carles Bautista-Rodríguez, Radwa Bedair, Lisa Bianco, Damien Bonnet, Gilles Bosser, Massimo Chessa, Marcin Demkow, Andreas Eicken, Peter Ewert, Michael Α. Gatzoulis, Mario Giordano, François Godart, Jochen Grohmann, Janus Freyr Guðnason, Raymond N. Haddad, Mete Han Kızılkaya, Abdelmonem Helal, Anthony Hermuzi, Dolores Herrera, Wan Kim, Robin Le Ruz, Wei Li, Petra Loureiro, Ketil Lunde, Reaksmei Ly, Gerard Martí‐Aguasca, Anders Nygren, Maria Victoria Ordoñez, Jérôme Petit, Julien Plessis, Enrico Piccinelli, Mara Pilati, Shakeel A. Qureshi, Miarisoa Ratsimandresy, Micol Rebonato, Éric Rosenthal, M. Riahi, Witold Rużyłło, Fernando Sarnago, Lídia de Sousa, Jean‐Benoît Thambo, Maria Toledano-Navarro, Daniel Velasco, Martin Bogale Ystgaard
Abstract
BACKGROUND AND AIMS: Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). Outcomes of TPVI with the SAPIEN 3 valve that are insufficiently documented were investigated in the EUROPULMS3 registry of SAPIEN 3-TPVI. METHODS: Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries. RESULTS: Data for 840 consecutive patients treated in 2014-2021 at a median age of 29.2 (19.0-41.6) years were obtained. The most common diagnosis was conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%-99.2%] of patients. Median follow-up was 20.3 (7.1-38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P = .009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%-1.0%), 0.9% (0.2%-1.6%), and 3.8% (0.0%-8.4%); pulmonary valve replacement, 0.4% (0.0%-0.8%), 1.3% (0.2%-2.4%), and 8.0% (1.2%-14.8%); and pulmonary valve thrombosis, 0.4% (0.0%-0.9%), 0.7% (0.0%-1.3%), and 0.7% (0.0%-1.3%), respectively. CONCLUSIONS: Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs.