Publications

14 janvier 2024
Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry

Eur Heart J. 2024 Jan 14;45(3):198-210. doi: 10.1093/eurheartj/ehad663.
Sebastien Hascoët  1   2   3 , James R Bentham  4 , Luca Giugno  5 , Pedro Betrián-Blasco  6 , Aleksander Kempny  2 , Ali Houeijeh  7 , Haysam Baho  8 , Shiv-Raj Sharma  2 , Matthew I Jones  9 , Elżbieta Katarzyna Biernacka  10 , Nicolas Combes  1   11 , Stanimir Georgiev  12 , Hélène Bouvaist  13 , Jose Diogo Martins  14 , Marinos Kantzis  15 , Mark Turner  16 , Stephan Schubert  17 , Zakaria Jalal  18   19 , Gianfranco Butera  20 , Sophie Malekzadeh-Milani  21 , Estibaliz Valdeolmillos  1   3 , Clement Karsenty  22 , Ender Ödemiş  23 , Philippe Aldebert  24 , Nikolaus A Haas  25 , Ihab Khatib  26   27 , Håkan Wåhlander  28 , Gianpiero Gaio  29 , Alberto Mendoza  30 , Sayqa Arif  31 , Biagio Castaldi  32 , Gaute Dohlen  33 , Ronald G Carere  34 , Maria Jesus Del Cerro-Marin  35 , Erwin Kitzmüller  36 , Antony Hermuzi  37 , Mario Carminati  5 , Patrice Guérin  38 , Anja Tengler  25 , Alain Fraisse  2 ; EUROPULMS3 investigators

PMID: 37874971 DOI: 10.1093/eurheartj/ehad663 

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.

Keywords: Congenital heart disease; Percutaneous pulmonary valve implantation; Pulmonary valve; SAPIEN 3; SAPIEN 3 Ultra; Transcatheter pulmonary valve replacement.

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