3-Year Outcomes of the Edwards SAPIEN Transcatheter Heart Valve for Conduit Failure in the Pulmonary Position From the COMPASSION Multicenter Clinical Trial.
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.
JACC Cardiovasc Interv
Adolescent; Adult; Cardiac Catheterization; Child; Compassionate Use Trials; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Male; Postoperative Complications; Prospective Studies; Prosthesis Design; Pulmonary Valve; Pulmonary Valve Insufficiency; Recovery of Function; Risk Factors; Time Factors; Treatment Outcome; United States; Ventricular Outflow Obstruction; Young Adult
SAPIEN THV; TPVR; conduit; pulmonary valve replacement; stent; transcatheter
Kenny, D., Rhodes, J. F., Fleming, G. A., Kar, S., Zahn, E. M., Vincent, J., Shirali, G. S., Gorelick, J., Fogel, M. A., Fahey, J. T., Kim, D. W., Babaliaros, V. C., Armstrong, A. K., Hijazi, Z. M. 3-Year Outcomes of the Edwards SAPIEN Transcatheter Heart Valve for Conduit Failure in the Pulmonary Position From the COMPASSION Multicenter Clinical Trial. JACC Cardiovasc Interv 11, 1920-1929 (2018).