title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Rush University Medical Center, 1653 West Congress Parkway, Chicago, IL 60612, USA.
authors.forename: Damien
authors.initials: D
authors.lastname: Kenny
authors.forename: Ziyad M
authors.initials: ZM
authors.lastname: Hijazi
authors.forename: Saibal
authors.initials: S
authors.lastname: Kar
authors.forename: John
authors.initials: J
authors.lastname: Rhodes
authors.forename: Michael
authors.initials: M
authors.lastname: Mullen
authors.forename: Raj
authors.initials: R
authors.lastname: Makkar
authors.forename: Girish
authors.initials: G
authors.lastname: Shirali
authors.forename: Mark
authors.initials: M
authors.lastname: Fogel
authors.forename: John
authors.initials: J
authors.lastname: Fahey
authors.forename: Mary G
authors.initials: MG
authors.lastname: Heitschmidt
authors.forename: Christopher
authors.initials: C
authors.lastname: Cain
mesh_terms: D000328:Adult; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000379:methods*; D015150:Echocardiography, Doppler; D005260:Female; D005500:Follow-Up Studies; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D011664:Pulmonary Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D011665:Pulmonary Valve Insufficiency / Q000000981:diagnostic imaging / Q000601:surgery*; D012086:Reoperation; D017211:Treatment Failure; D014694:Ventricular Outflow Obstruction / Q000000981:diagnostic imaging / Q000209:etiology / Q000601:surgery*