Valvular & structural heart disease
Five-Year Outcomes for Patients With Right Ventricular Outflow Tract (RVOT) Dysfunction Treated With the SAPIEN 3 Transcatheter Heart Valve: A Pooled Analysis From the COMPASSION S3 Trial
Authors' conclusion
Five-year results from the COMPASSION S3 trial demonstrate that the SAPIEN 3 THV provides durable RVOT relief with low rates of reintervention or endocarditis, supporting the device as a safe and versatile option for transcatheter pulmonic valve replacement across diverse anatomies and clinical scenarios.
Study context
- Population
- Patients with a dysfunctional RVOT conduit or previously implanted valve in the pulmonic position, with moderate-to-severe pulmonic regurgitation, a mean RVOT gradient ≥35 mm Hg, or bothenrolled and successfully implanted with the SAPIEN 3 transcatheter heart valve (THV), 2016–2020
- Participants
- 69 patients
- Outcome
- THV dysfunction (nonhierarchical composite of RVOT reintervention, ≥moderate total pulmonic regurgitation, and mean RVOT gradient >40 mm Hg)
- Follow-up
- 1 year
Methodological detailspooled analysis of main cohort and continued access protocol
- Pooled analysis of main cohort and continued access protocol
Further pooled results
| Outcome | Values |
|---|---|
| THV dysfunction · 5 years | SAPIEN 3 THV 12.0% · required reintervention 3 patients · ≥moderate pulmonic regurgitation 2 patients · mean gradient >40 mm Hg 1 patient |
Baseline characteristics
- Mean patient age
- 32.1 years
- Conduit as the most recent prior intervention
- 70.8%
Mean gradients · through 5-year follow-up
- Mean gradients were low and stable
Pulmonic and paravalvular regurgitation · through 5 years
- ≤mild total pulmonic regurgitation
- >95%
- None/trace paravalvular regurgitation
- 97.9%
Safety
| Outcome | Values |
|---|---|
| Device-related endocarditis | SAPIEN 3 THV 4.4% |
| Death · postoperative day 560 · due to cardiogenic shock | SAPIEN 3 THV One events |
Tricuspid valve injury, stent fractures, valve malposition
- No cases reported
Original publication
Five-Year Outcomes for Patients With RVOT Dysfunction Treated With the SAPIEN 3 Transcatheter Heart Valve: A Pooled Analysis From the COMPASSION S3 Trial. Circ Cardiovasc Interv. Published 26 March 2026. doi:10.
Summarised from the published abstract; every number is checked against it