Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry
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.
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Date
2024-01-14
Type
Article
Subject
Congenital heart disease, Percutaneous pulmonary valve implantation, Pulmonary valve, SAPIEN 3, SAPIEN 3 Ultra, Transcatheter pulmonary valve replacement
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Citation
Hascoët, S., Bentham, J. R., Giugno, L., Betrián-Blasco, P., Kempny, A., Houeijeh, A., Baho, H., Sharma, S. R., Jones, M. I., Biernacka, E. K., Combes, N., Georgiev, S., Bouvaist, H., Martins, J. D., Kantzis, M., Turner, M., Schubert, S., Jalal, Z., Butera, G., Malekzadeh-Milani, S., … EUROPULMS3 investigators (2024). Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry. European heart journal, 45(3), 198–210. https://doi.org/10.1093/eurheartj/ehad663