Key result
SAPIEN 3 TPVI achieves ~99% procedural success in CHD patients with RVOT dysfunction.
Why the study?
Does transcatheter pulmonary valve implantation with the SAPIEN 3 valve provide safe and effective outcomes in patients with congenital heart disease and RVOT dysfunction?
Cohort (n=840)
Yes
Does transcatheter pulmonary valve implantation with the SAPIEN 3 valve provide safe and effective outcomes in patients with congenital heart disease and RVOT dysfunction?
Transcatheter pulmonary valve implantation with the SAPIEN 3 valve demonstrates high procedural success and favorable mid-term outcomes in patients with congenital heart disease and RVOT dysfunction.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Patients with congenital heart conditions often undergo multiple invasive surgical procedures, significantly impacting their quality of life. The addition of the innovative Alterra adaptive prestent to the SAPIEN 3 pulmonic platform means that we can now offer minimally invasive therapy to a wider range of pulmonic patients, and delay their potential need for future open-heart surgeries.”
Supports SAPIEN 3 TPVI feasibility in native/patched RVOTs; leaves open need for randomized data on durability and endocarditis risk.
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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Hascoët et al. (2023) conducted a cohort in Right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD) (n=840). SAPIEN 3 transcatheter pulmonary valve implantation was evaluated on Valve implantation success (95% CI 97.4-99.2). Transcatheter pulmonary valve implantation with the SAPIEN 3 valve was successful in 98.5% (95% CI 97.4-99.2) of patients with congenital heart disease and RVOT dysfunction.
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