Five-Year Outcomes for Patients With RVOT Dysfunction Treated With the SAPIEN 3 Transcatheter Heart Valve: A Pooled Analysis From the COMPASSION S3 Trial.

BACKGROUND

The COMPASSION S3 trial (Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional Transcatheter Heart Valve) was designed to evaluate the safety and effectiveness of the SAPIEN 3 transcatheter heart valve (THV) for transcatheter pulmonic valve replacement in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position. Here, 5-year clinical and hemodynamic outcomes for patients in the main cohort and the continued access protocol are reported.

METHODS

The COMPASSION S3 trial was a single-arm, multicenter study enrolling patients with either moderate-to-severe pulmonic regurgitation, a mean RVOT gradient ≥35 mm Hg, or both. The primary end point was THV dysfunction at 1 year, a nonhierarchical composite of RVOT reintervention, ≥moderate total pulmonic regurgitation, and mean RVOT gradient >40 mm Hg. Clinical and echocardiographic outcomes were assessed at baseline, discharge, 30 days, 6 months, 1 year, and then annually to 5 years.

RESULTS

Between 2016 and 2020, 69 patients were enrolled and successfully implanted with the SAPIEN 3 THV. The mean patient age was 32.1 years, and most patients (70.8%) had a conduit as the most recent prior intervention. At 5 years, the rate of THV dysfunction was 12.0%: 3 patients required reintervention, 2 patients had ≥moderate pulmonic regurgitation, and 1 patient had a mean gradient >40 mm Hg. There were 3 cases of device-related endocarditis (4.4%). One death occurred on postoperative day 560 due to cardiogenic shock. No cases of tricuspid valve injury, stent fractures, or valve malposition were reported. Post-transcatheter pulmonic valve replacement, mean gradients were low and stable through 5-year follow-up. Through 5 years, >95% of patients had ≤mild total pulmonic regurgitation, and 97.9% of patients had none/trace paravalvular regurgitation.

CONCLUSIONS

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.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02744677.