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.


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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.