title: One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study.
abstract: OBJECTIVE
  This study sought to confirm that the short-term hemodynamic effectiveness of the Melody transcatheter pulmonary valve (TPV) (Medtronic, Inc., Minneapolis, Minnesota) achieved by real-world providers is equivalent to the historical results established in the initial 5-center Investigational Device Exemption trial.
  
  
  BACKGROUND
  TPV replacement has been used to treat right ventricular outflow tract (RVOT) conduit dysfunction for >10 years. The Melody TPV received U.S. Food and Drug Administration approval in 2010 as a Humanitarian Use Device.
  
  
  METHODS
  Patients with dysfunctional RVOT conduits were entered in this prospective, nonrandomized study at 10 centers. The primary endpoint was acceptable hemodynamic function at 6 months post-implantation, defined as a composite of RVOT echocardiographic mean gradient ≤30 mm Hg, pulmonary regurgitation less than moderate as measured by echocardiography, and freedom from conduit reintervention and reoperation.
  
  
  RESULTS
  Cardiac catheterization was performed in 120 patients for potential implantation of the Melody TPV; of these, 100 patients were implanted, with a 98.0% procedural success rate. There were no procedure-related deaths. Acceptable hemodynamic function at 6 months was achieved in 96.7% of patients with evaluable data (87.9% of the entire implanted cohort), with results maintained through 1 year. No patient had moderate or severe pulmonary regurgitation after implantation. No patient required catheter reintervention in the first year after implantation, and 2 patients required reoperation for conduit replacement. The rate of freedom from TPV dysfunction was 96.9% at 1 year.
  
  
  CONCLUSIONS
  This first prospective, real-world experience with the Melody TPV in the United States demonstrates continued high procedural success, excellent short-term TPV function, and low reintervention and reoperation rates at 1 year. (Melody Transcatheter Pulmonary Valve Post-Approval Study; NCT01186692).
authors.affiliation: Department of Pediatrics and Communicable Diseases, Division of Pediatric Cardiology, University of Michigan, Ann Arbor, Michigan. Electronic address: aimeearm@med.umich.edu.
authors.forename: Aimee K
authors.initials: AK
authors.lastname: Armstrong
authors.affiliation: Department of Pediatrics, Division of Pediatric Cardiology, St. Louis Children's Hospital, St. Louis, Missouri.
authors.forename: David T
authors.initials: DT
authors.lastname: Balzer
authors.affiliation: Division of Pediatric Cardiology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Allison K
authors.initials: AK
authors.lastname: Cabalka
authors.affiliation: Department of Pediatric Cardiology, University of Utah, Salt Lake City, Utah.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Gray
authors.affiliation: Department of Pediatrics, Division of Pediatric Cardiology, Hope Children's Hospital, Oak Lawn, Illinois.
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: Javois
authors.affiliation: Division of Cardiology, Department of Pediatrics, Rady Children's Hospital, San Diego, California.
authors.forename: John W
authors.initials: JW
authors.lastname: Moore
authors.affiliation: Division of Cardiology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
authors.forename: Jonathan J
authors.initials: JJ
authors.lastname: Rome
authors.affiliation: Division of Cardiology, Carman and Ann Adams Department of Pediatrics, Children's Hospital of Michigan, Detroit, Michigan.
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Turner
authors.affiliation: Division of Cardiology, Department of Pediatrics, Children's Medical Center, Dallas, Texas.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Zellers
authors.affiliation: Division of Pediatric Cardiology, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Kreutzer
mesh_terms: D000293:Adolescent; D000328:Adult; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D002648:Child; D005260:Female; D006330:Heart Defects, Congenital / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006439:Hemodynamics; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D011664:Pulmonary Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D011665:Pulmonary Valve Insufficiency / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011666:Pulmonary Valve Stenosis / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography; D014481:United States; D055815:Young Adult
keywords: congenital heart disease; pulmonary regurgitation; right ventricular outflow tract conduit; transcatheter heart valve