title: Clinical and hemodynamic outcomes up to 7 years after transcatheter pulmonary valve replacement in the US melody valve investigational device exemption trial.
abstract: BACKGROUND
  Studies of transcatheter pulmonary valve (TPV) replacement with the Melody valve have demonstrated good short-term outcomes, but there are no published long-term follow-up data.
  
  
  RESULTS
  The US Investigational Device Exemption trial prospectively enrolled 171 pediatric and adult patients (median age, 19 years) with right ventricular outflow tract conduit obstruction or regurgitation. The 148 patients who received and were discharged with a TPV were followed up annually according to a standardized protocol. During a median follow-up of 4.5 years (range, 0.4-7 years), 32 patients underwent right ventricular outflow tract reintervention for obstruction (n=27, with stent fracture in 22), endocarditis (n=3, 2 with stenosis and 1 with pulmonary regurgitation), or right ventricular dysfunction (n=2). Eleven patients had the TPV explanted as an initial or second reintervention. Five-year freedom from reintervention and explantation was 76±4% and 92±3%, respectively. A conduit prestent and lower discharge right ventricular outflow tract gradient were associated with longer freedom from reintervention. In the 113 patients who were alive and reintervention free, the follow-up gradient (median, 4.5 years after implantation) was unchanged from early post-TPV replacement, and all but 1 patient had mild or less pulmonary regurgitation. Almost all patients were in New York Heart Association class I or II. More severely impaired baseline spirometry was associated with a lower likelihood of improvement in exercise function after TPV replacement.
  
  
  CONCLUSIONS
  TPV replacement with the Melody valve provided good hemodynamic and clinical outcomes up to 7 years after implantation. Primary valve failure was rare. The main cause of TPV dysfunction was stenosis related to stent fracture, which was uncommon once prestenting became more widely adopted.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00740870.
authors.affiliation: From Division of Cardiology, Nationwide Children's Hospital, Ohio State University School of Medicine, Columbus (J.P.C., D.P.B.); Division of Pediatric Cardiology, Yale University, New Haven, CT (W.E.H.); Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA (E.M.Z.); Division of Cardiology, Seattle Children's Hospital, University of Washington School of Medicine (T.K.J.); Division of Cardiology, Miami Children's Hospital, FL (D.P.B.); Division of Pediatric Cardiology, Columbia University Medical Center, New York, NY (J.A.V.); and Department of Cardiothoracic Surgery, Stanford University School of Medicine, Palo Alto, CA (D.B.M.). John.Cheatham@NationwideChildrens.org.
authors.forename: John P
authors.initials: JP
authors.lastname: Cheatham
authors.affiliation: From Division of Cardiology, Nationwide Children's Hospital, Ohio State University School of Medicine, Columbus (J.P.C., D.P.B.); Division of Pediatric Cardiology, Yale University, New Haven, CT (W.E.H.); Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA (E.M.Z.); Division of Cardiology, Seattle Children's Hospital, University of Washington School of Medicine (T.K.J.); Division of Cardiology, Miami Children's Hospital, FL (D.P.B.); Division of Pediatric Cardiology, Columbia University Medical Center, New York, NY (J.A.V.); and Department of Cardiothoracic Surgery, Stanford University School of Medicine, Palo Alto, CA (D.B.M.).
authors.forename: William E
authors.initials: WE
authors.lastname: Hellenbrand
authors.affiliation: From Division of Cardiology, Nationwide Children's Hospital, Ohio State University School of Medicine, Columbus (J.P.C., D.P.B.); Division of Pediatric Cardiology, Yale University, New Haven, CT (W.E.H.); Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA (E.M.Z.); Division of Cardiology, Seattle Children's Hospital, University of Washington School of Medicine (T.K.J.); Division of Cardiology, Miami Children's Hospital, FL (D.P.B.); Division of Pediatric Cardiology, Columbia University Medical Center, New York, NY (J.A.V.); and Department of Cardiothoracic Surgery, Stanford University School of Medicine, Palo Alto, CA (D.B.M.).
authors.forename: Evan M
authors.initials: EM
authors.lastname: Zahn
authors.affiliation: From Division of Cardiology, Nationwide Children's Hospital, Ohio State University School of Medicine, Columbus (J.P.C., D.P.B.); Division of Pediatric Cardiology, Yale University, New Haven, CT (W.E.H.); Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA (E.M.Z.); Division of Cardiology, Seattle Children's Hospital, University of Washington School of Medicine (T.K.J.); Division of Cardiology, Miami Children's Hospital, FL (D.P.B.); Division of Pediatric Cardiology, Columbia University Medical Center, New York, NY (J.A.V.); and Department of Cardiothoracic Surgery, Stanford University School of Medicine, Palo Alto, CA (D.B.M.).
authors.forename: Thomas K
authors.initials: TK
authors.lastname: Jones
authors.affiliation: From Division of Cardiology, Nationwide Children's Hospital, Ohio State University School of Medicine, Columbus (J.P.C., D.P.B.); Division of Pediatric Cardiology, Yale University, New Haven, CT (W.E.H.); Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA (E.M.Z.); Division of Cardiology, Seattle Children's Hospital, University of Washington School of Medicine (T.K.J.); Division of Cardiology, Miami Children's Hospital, FL (D.P.B.); Division of Pediatric Cardiology, Columbia University Medical Center, New York, NY (J.A.V.); and Department of Cardiothoracic Surgery, Stanford University School of Medicine, Palo Alto, CA (D.B.M.).
authors.forename: Darren P
authors.initials: DP
authors.lastname: Berman
authors.affiliation: From Division of Cardiology, Nationwide Children's Hospital, Ohio State University School of Medicine, Columbus (J.P.C., D.P.B.); Division of Pediatric Cardiology, Yale University, New Haven, CT (W.E.H.); Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA (E.M.Z.); Division of Cardiology, Seattle Children's Hospital, University of Washington School of Medicine (T.K.J.); Division of Cardiology, Miami Children's Hospital, FL (D.P.B.); Division of Pediatric Cardiology, Columbia University Medical Center, New York, NY (J.A.V.); and Department of Cardiothoracic Surgery, Stanford University School of Medicine, Palo Alto, CA (D.B.M.).
authors.forename: Julie A
authors.initials: JA
authors.lastname: Vincent
authors.affiliation: From Division of Cardiology, Nationwide Children's Hospital, Ohio State University School of Medicine, Columbus (J.P.C., D.P.B.); Division of Pediatric Cardiology, Yale University, New Haven, CT (W.E.H.); Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA (E.M.Z.); Division of Cardiology, Seattle Children's Hospital, University of Washington School of Medicine (T.K.J.); Division of Cardiology, Miami Children's Hospital, FL (D.P.B.); Division of Pediatric Cardiology, Columbia University Medical Center, New York, NY (J.A.V.); and Department of Cardiothoracic Surgery, Stanford University School of Medicine, Palo Alto, CA (D.B.M.).
authors.forename: Doff B
authors.initials: DB
authors.lastname: McElhinney
mesh_terms: D000293:Adolescent; D000328:Adult; D006328:Cardiac Catheterization / Q000639:trends*; D002648:Child; D005260:Female; D005500:Follow-Up Studies; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation / Q000639:trends*; D006439:Hemodynamics / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011665:Pulmonary Valve Insufficiency / Q000175:diagnosis / Q000453:epidemiology / Q000601:surgery*; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014694:Ventricular Outflow Obstruction / Q000175:diagnosis / Q000453:epidemiology / Q000601:surgery*; D055815:Young Adult
keywords: heart diseases; heart valves; pediatrics; pulmonary heart disease; tetralogy of Fallot