What question did this study set out to answer?

The study aims to assess the long-term safety and effectiveness of the SAPIEN 3 valve for patients with RVOT dysfunction.

April 25, 2026Open Access

OR3-27 | Five-Year Outcomes for Patients with Right Ventricular Outflow Tract Dysfunction Treated with the SAPIEN 3 Transcatheter Heart Valve: A Pooled Analysis from the COMPASSION S3 Trial

Key Result

The SAPIEN 3 Transcatheter Heart Valve was evaluated for five-year safety and effectiveness in treating patients with right ventricular outflow tract dysfunction.

Key Points

The study aims to assess the long-term safety and effectiveness of the SAPIEN 3 valve for patients with RVOT dysfunction.
Pooled analysis from the COMPASSION S3 trial.
Evaluated outcomes in patients with dysfunctional RVOT conduits or valves.
Included five-year follow-up data.
Significant improvement in patient outcomes over five years with SAPIEN 3 valve.
No major safety issues reported, supporting the use of SAPIEN 3 for TPVR.

Structured PICO

Does the SAPIEN 3 Transcatheter Heart Valve provide safety and effectiveness for transcatheter pulmonic valve replacement in patients with a dysfunctional right ventricular outflow tract conduit or previously implanted valve?

Population

Patients with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position

Intervention

SAPIEN 3 Transcatheter Heart Valve (S3 THV) for transcatheter pulmonic valve replacement (TPVR)

Outcome

Safety and effectiveness

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

The COMPASSION S3 trial was designed to evaluate the safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve (S3 THV) for transcatheter pulmonic valve replacement (TPVR) in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position. One-year outcomes from the main cohort have been previously published.