Congenital heart diseaseCohort study
Transcatheter Pulmonary Valve Implantation Using Self-Expandable Percutaneous Pulmonary Valve System
- Prospective single-arm multicentre study
- CE study
Authors' conclusion
The valve has shown promising safety and durability.
Study context
- Population
- Patients with pulmonary regurgitation after surgical repair of tetralogy of Fallot and other right ventricular outflow tracts (RVOTs)
- Participants
- 81 patients
- Outcome
- Acute and 3-year follow-up results of VenusP-valve implantation
- Follow-up
- 3 years
Main finding
As reported in the abstract
- VenusP-valves successfully implanted in all patients
- No early procedure-related or late mortality
- Valve function remained satisfactory and RV remodeling occurred in all patients during 3-year follow-up
Observational data: associations, not effects.
Safety
Procedural complications
- Guidewire perforation of a branch pulmonary artery causing hemoptysis
- 1
- VT at the end of the procedure
- 1
Follow-up adverse events
- Runs of VT needing ICD and RVOT ablation, 5 months after implantation
- 1
- Endocarditis 11 months after implantation; valve functioned normally after medical treatment
- 1
- Thrombus on the distal flare 3 years after implantation, treated with anticoagulants
- 1
Original publication
Transcatheter Pulmonary Valve Implantation Using Self-Expandable Percutaneous Pulmonary Valve System. JACC Cardiovasc Interv. Published 19 March 2025. doi:10.1016/j.jcin.2024.12.031
Summarised from the published abstract; every number is checked against it