Valvular & structural heart diseaseCohort study
Transcatheter Pulmonary Valve Implantation With the Alterra Adaptive Prestent and SAPIEN 3 Transcatheter Heart Valve: 3-Year Pooled Outcomes of the ALTERRA Trials
- multicenter, prospective trial
- pooled analysis of the ALTERRA pivotal trial, Continued Access Protocol, and Pulmonic Delivery System Registry
Authors' conclusion
This analysis reports the longest follow-up in the largest cohort of patients from the ALTERRA trials. The Alterra Adaptive Prestent with the SAPIEN 3 THV system has shown excellent procedural outcomes and is effective in reducing PR at 3-year follow-up.
Study context
- Population
- Patients with moderate or greater pulmonary regurgitation (PR) and right ventricular outflow tract (RVOT)/pulmonary valve anatomy suitable for implantationpatients implanted with the Alterra/SAPIEN 3 transcatheter heart valve (THV) system at 14 sites
- Participants
- 118 patients
Main finding
As reported in the abstract
THV dysfunction (nonhierarchical composite:
- RVOT/pulmonary valve reintervention
- Moderate or greater PR
- Mean RVOT/pulmonary valve gradient ≥35 mm Hg)
Alterra/SAPIEN 3 THV
3.5%
4/113 of 118
Observational data: associations, not effects.
Further findings
| Outcome | Values |
|---|---|
| Freedom from reintervention · 3 years · valve implant population | Alterra/SAPIEN 3 THV 97.3% |
| Mean RVOT/pulmonary valve gradients <35 mm Hg · 3 years | Alterra/SAPIEN 3 THV 100% |
| Mild or lesser total PR · 3 years | Alterra/SAPIEN 3 THV 93.3% |
Safety
| Outcome | Values |
|---|---|
| All-cause mortality (Kaplan-Meier estimate) · 3 years | Alterra/SAPIEN 3 THV Kaplan-Meier estimate 3.5% |
Coronary artery compression, hemopericardium, or endocarditis
- There were no cases of coronary artery compression, hemopericardium, or endocarditis
Original publication
Transcatheter Pulmonary Valve Implantation With the Alterra Adaptive Prestent and SAPIEN 3 Transcatheter Heart Valve: 3-Year Pooled Outcomes of the ALTERRA Trials. Circ Cardiovasc Interv. Published 9 February 2026. doi:10.1161/circinterventions.125.015873
Summarised from the published abstract; every number is checked against it