Author + information
- Received March 22, 2018
- Revision received May 30, 2018
- Accepted June 4, 2018
- Published online October 1, 2018.
- Damien Kenny, MD, MPHa,∗ (, )
- John F. Rhodes, MDb,c,
- Gregory A. Fleming, MDc,
- Saibal Kar, MDd,
- Evan M. Zahn, MDd,
- Julie Vincent, MDe,
- Girish S. Shirali, MBBSf,
- Jeremy Gorelick, PhDg,
- Mark A. Fogel, MDh,
- John T. Fahey, MDi,
- Dennis W. Kim, MD, PhDj,
- Vasilis C. Babaliaros, MDk,
- Aimee K. Armstrong, MDl and
- Ziyad M. Hijazi, MD, MPHm
- aOur Lady’s Children’s Hospital, Dublin, Ireland
- bMiami Children’s Health System, Miami, Florida
- cDuke University School of Medicine, Durham, North Carolina
- dCedars-Sinai Medical Center, Los Angeles, California
- eMorgan Stanley Children’s Hospital, New York, New York
- fChildren’s Mercy, Kansas City, Missouri
- gEdwards Lifesciences, Irvine, California
- hChildren’s Hospital of Philadelphia, Philadelphia, Pennsylvania
- iYale New Haven Hospital, New Haven, Connecticut
- jChildren’s Healthcare of Atlanta, Atlanta, Georgia
- kEmory University School of Medicine, Atlanta, Georgia
- lNationwide Children’s Hospital, Columbus, Ohio
- mSidra Cardiovascular Center of Excellence, Weill Cornell Medical College, Doha, Qatar
- ↵∗Address for correspondence:
Prof. Damien Kenny, Our Lady’s Children’s Hospital, Cooley Road, Crumlin, Dublin 12, Ireland.
Objectives This study provides the 3-year follow-up results of the COMPASSION (Congenital Multicenter Trial of Pulmonic Valve Regurgitation Studying the SAPIEN Transcatheter Heart Valve) trial. Patients with moderate to severe pulmonary regurgitation and/or right ventricular outflow tract conduit obstruction were implanted with the SAPIEN transcatheter heart valve (THV).
Background Early safety and efficacy of the Edwards SAPIEN THV in the pulmonary position have been established through a multicenter clinical trial.
Methods Eligible patients were included if body weight was >35 kg and in situ conduit diameter was ≥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.
Results Fifty-seven of the 63 eligible patients were accounted for at the 3-year follow-up visit 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%) underwent implantation of 26-mm valves, and 47 patients received 23-mm valves. Functional improvement in New York Heart Association functional 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 < 0.001), and mean right ventricular systolic pressure decreased from 59.6 ± 17.7 to 42.9 ± 13.4 mm Hg (p < 0.001). Pulmonary regurgitation was mild or less in 91.1% of patients. Freedom from all-cause mortality at 3 years was 98.4%. Freedom from reintervention was 93.7% and from endocarditis was 97.1% at 3 years. There were no observed stent fractures.
Conclusions Transcatheter pulmonary valve replacement using the Edwards SAPIEN THV demonstrates excellent valve function and clinical outcomes at 3-year follow-up.
The trial was sponsored and funded by Edwards Lifesciences. Drs. Hijazi, Zahn, and Babaliaros are consultants to Edwards Lifesciences.
Dr. Shirali is a consultant to, recipient of research grants from, and member of the advisory board of Philips Medical Systems; and has received research grants from Edwards Lifesciences. Dr. Fogel has received grants from Edwards Lifesciences for the COMPASSION study. Dr. Gorelick was an employee of Edwards Lifesciences during the trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 22, 2018.
- Revision received May 30, 2018.
- Accepted June 4, 2018.
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.