Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry.
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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, EUROPULMS3 investigators
Аннотация
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.