Three-Year COMPASSION Data Evaluate Edwards' Sapien THV to Treat Pulmonary Valve Regurgitation
October 9, 2018—Three-year follow-up results from the COMPASSION study, which evaluated the Sapien transcatheter heart valve (THV; Edwards Lifesciences) in patients with pulmonary regurgitation and/or right ventricular outflow tract conduit obstruction, were published by Damien Kenny, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2018;11:1920–1929).
The study investigators concluded that patients with moderate to severe pulmonary regurgitation and/or right ventricular outflow tract conduit obstruction who underwent transcatheter pulmonary valve replacement with the Sapien THV demonstrated excellent valve function and clinical outcomes at 3-year follow-up.
As summarized in JACC: Cardiovascular Interventions, the study was composed of eligible patients with a body weight > 35 kg and in situ conduit diameter ≥ 16 and ≤ 24 mm. Adverse events were adjudicated by an independent clinical events committee. Three-year clinical and echocardiographic outcomes were evaluated in these patients.
At the 3-year follow-up visit, 57 of the 63 eligible patients were accounted for from a total of 69 implantations in 81 enrolled patients. THV implantation was indicated for pulmonary stenosis (7.6%), regurgitation (12.7%), or both (79.7%). Twenty-two patients (27.8%) received 26-mm valves, and 47 patients received 23-mm valves.
The 3-year findings included:
- Functional improvement in New York Heart Association class was observed in 93.5% of patients
- Mean peak conduit gradient decreased from 37.5 ± 25.4 to 17.8 ± 12.4 mm Hg (P < .001)
- Mean right ventricular systolic pressure decreased from 59.6 ± 17.7 to 42.9 ± 13.4 mm Hg (P < .001)
- Pulmonary regurgitation was mild or less in 91.1% of patients
- Freedom from all-cause mortality was 98.4%
- Freedom from reintervention was 93.7%
- Freedom from endocarditis was 97.1%
There were no observed stent fractures, reported the COMPASSION investigators in JACC: Cardiovascular Interventions.