Percutaneous Implantation of the Edwards SAPIEN Transcatheter Heart Valve for Conduit Failure in the Pulmonary Position Early Phase 1 Results From an International Multicenter Clinical Trial

Objectives The purpose of this study was to evaluate the safety and effectiveness of the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences LLC, Irvine, California) in the pulmonary position in patients with moderate to severe pulmonary regurgitation with or without stenosis. Background Transcatheter pulmonary valve replacement is evolving, but to date, experience has been limited to the Melody valve (Medtronic Inc., Minneapolis, Minnesota). Methods Eligible patients with dysfunctional right ventricle-to-pulmonary artery conduits were screened if body weight was >= 35 kg and the in situ conduit diameter was >= 16 mm and >= 24 mm. Standardized implantation and follow-up protocols were used. Results Thirty-six patients from 4 centers were recruited between April 2008 and May 2010. Mean body weight was 73.4 +/- 22.9 kg. Successful valve deployment was achieved in 33 of 34 attempts (97.1%). Valve migration occurred in 3 patients, with 2 requiring surgical retrieval; however, 1 patient underwent successful perventricular valve implantation. Further intraprocedure complications included pulmonary hemorrhage (n = 2), ventricular fibrillation (n = 1), and stent migration (n = 1). Pullback gradient across the conduit decreased from 26.8 +/- 18.4 mm Hg to 11.7 +/- 8.0 mm Hg (p < 0.001). The right ventricular/aortic pressure ratio decreased from 0.6 +/- 0.2 to 0.4 +/- 0.1 (p < 0.001). Peak Doppler gradient across the right ventricular outflow tract decreased from 41.9 +/- 27.9 mm Hg to 19.1 +/- 13.3 mm Hg (p < 0.001). At 6-month follow-up, all patients were alive. The number of patients with New York Heart Association functional class I increased from 5 at baseline to 27 at follow-up. Pulmonary regurgitation was <= 2+ in 97% of patients. Freedom from reintervention was 97% with 1 patient undergoing elective placement of a second valve due to conduit-induced distortion of the initial implant. Conclusions Transcatheter pulmonary valve replacement using the Edwards SAPIEN transcatheter heart valve is safe and effective in patients with dysfunctional right ventricle-to-pulmonary artery conduits. (J Am Coll Cardiol 2011;58:2248-56) (C) 2011 by the American College of Cardiology Foundation