Congenital heart diseaseCohort study
Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry
- Retrospective cohort study
- international registry
- multicentre (35 centres, 15 countries)
- consecutive patients
Authors' conclusion
Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs.
Study context
- Population
- Patients with congenital heart disease (CHD) and right-ventricular outflow tract (RVOT) dysfunction treated with SAPIEN 3 transcatheter pulmonary valve implantation (TPVI), 2014–2021
- Participants
- 840 consecutive patients
Main finding
As reported in the abstract
Successful valve implantation
98.5% (95% CI 97.4%-99.2%)
Infective endocarditis
8 patients
Pulmonary valve replacement (lower incidence for larger valves, P = .009)
11 patients
Pulmonary valve thrombosis (1 died, 3 recovered with anticoagulation)
4 patients
Observational data: associations, not effects.
Further findings
Cumulative incidence of infective endocarditis · 1, 3 and 6 years after TPVI
- 1 year
- 0.5% (0.0%-1.0%)
- 3 years
- 0.9% (0.2%-1.6%)
- 6 years
- 3.8% (0.0%-8.4%)
- 95% CI
Cumulative incidence of pulmonary valve replacement · 1, 3 and 6 years after TPVI
- 1 year
- 0.4% (0.0%-0.8%)
- 3 years
- 1.3% (0.2%-2.4%)
- 6 years
- 8.0% (1.2%-14.8%)
- 95% CI
Cumulative incidence of pulmonary valve thrombosis · 1, 3 and 6 years after TPVI
- 1 year
- 0.4% (0.0%-0.9%)
- 3 years
- 0.7% (0.0%-1.3%)
- 6 years
- 0.7% (0.0%-1.3%)
- 95% CI
Original publication
Summarised from the published abstract; every number is checked against it