Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry
Authors: Hascoët Sebastien , Bentham James R , Giugno Luca , Betrián-Blasco Pedro , Kempny Aleksander , Houeijeh Ali , Baho Haysam , Sharma Shiv-Raj , Jones Matthew I , Biernacka Elżbieta Katarzyna , Combes Nicolas , Georgiev Stanimir , Bouvaist Hélène , Martins Jose Diogo , Kantzis Marinos , Turner Mark , Schubert Stephan , Jalal Zakaria , Butera Gianfranco , Malekzadeh-Milani Sophie , Valdeolmillos Estibaliz , Karsenty Clement , Ödemiş Ender , Aldebert Philippe , Haas Nikolaus A , Khatib Ihab , Wåhlander Håkan , Gaio Gianpiero , Mendoza Alberto , Arif Sayqa , Castaldi Biagio , Dohlen Gaute , Carere Ronald G , Del Cerro-Marin Maria Jesus , Kitzmüller Erwin , Hermuzi Antony , Carminati Mario , Guérin Patrice , Tengler Anja , Fraisse Alain ,   the EUROPULMS3 investigators, Aaberge Lars , Akodad Mariama , Alvarez-Fuente Maria , Batteux Clément , Bautista Carles , Bedair Radwa , Bianco Lisa , Bonnet Damien , Bosser Gilles , Chessa Massimo , Demkow Marcin , Eicken Andreas , Ewert Peter , Gatzoulis Michael , Giordano Mario , Godart Francois , Grohmann Jochen , Gudnason Janus Freyr , Haddad Raymond , Kizilkaya Mete Han , Helal Abdelmonem , Hermuzi Anthony , Herrera Dolores , Kim Wan Cheol , Ruz Robin Le , Li Wei , Loureiro Petra , Lunde Ketil , Ly Reaksmei , Marti-Aguasca Gerard , Nygren Anders , Ordonez Maria Victoria , Petit Jerome , Plessis Julien , Piccinelli Enrico , Pilati Mara , Qureshi Shakeel , Ratsimandresy Miarisoa , Rebonato Micol , Rosenthal Eric , Riahi Mounir , Rużyłło Witold , Sarnago Fernando , Sousa Lidia , Thambo Jean-Benoit , Toledano-Navarro Maria , Velasco Daniel , Ystgaard Martin Bogale 
Published: October 2023

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.