Long-term outcomes following transcatheter pulmonary valve implantation with the sapien 3 valve: an international multicentre registry

Abstract Background Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract dysfunction related to congenital heart disease. Long-term outcomes following TPVI with the new-generation SAPIEN 3 valve are not well documented. Purpose We investigated mid-term outcomes in a large cohort of patients who underwent TPVI using the SAPIEN 3 valve. Methods We retrospectively analysed data from a multicentre observational registry of patients who underwent TPVI with SAPIEN 3 in 30 centres in 12 countries from Europe, the Middle East, and Canada. Patient-related, procedural, and mid-term-outcome data were assessed. Results We obtained data for 713 patients treated in 2014–2021. Number of procedures performed among centres varied from 1 to 190 with a median of 15. Median age was 29.4-year-old [19.0–42.8]. The most common underlying diagnosis was cono-truncal defect (68.9%), with a native or patched right-ventricular outflow tract, a bioprosthetic valve, a homograft and a conduit, in 50.8%, 19.6%, 16.5% and 13.2% patients, respectively. Pre-stenting was performed in 74.8% patients. The 20-mm, 23-mm, 26-mm, and 29-mm valves were used in 0.4%, 28.2%, 31.2%, and 40.2% of patients, respectively. Valve implantation was successful in 98.6% patients. Life-threatening peri-procedural adverse events occurred in 3.7% patients, including 0.6% peri-procedural death. Median follow-up was 1.4 years (maximum, 5.9 years; 1160 patient-years), At last follow-up, pulmonary regurgitation grade 2, 3 and 4 was noted in 6.9%, 0.9% and 0.0% patients, respectively. Median maximal gradient at last follow-up was 18 mmHg. Six patients experienced infective endocarditis (0.5 per 100 patient-years) of whom 1 died and 2 required pulmonary valve replacement. Nine patients (0.8 per 100 patient-years) had secondary pulmonary valve replacement (including 2 by valve-in-valve TPVI; 7 patients had 23-mm and 2 had 26-mm valves). Four patients experienced pulmonary valve thrombosis (0.6 per 100 patient-year) of whom one died and 3 resolved under anticoagulation therapy. Cumulative incidences of infective endocarditis, secondary pulmonary valve replacement and valve thrombosis were 0.7%, 1.3% and 1.3%; 0.4%, 1.3% and 4.6%; 0.5%, 0.5% and 0.8% at 1, 3 and 5 years after TPVI respectively. Conclusion TPVI with the SAPIEN 3 valve was feasible and safe in a wide range of patients with congenital heart defects, most of whom had large native right-ventricular outflow tracts. Mid-term outcomes were favourable. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): The study is promoted and financially supported by a Research grant of the Groupe Hospitalier Paris Saint Joseph