title: Melody ® transcatheter pulmonary valve implantation: results from a French registry.
abstract: BACKGROUND
  Percutaneous implantation of pulmonary valves has recently been introduced into clinical practice.
  
  
  OBJECTIVE
  To analyse data of patients treated in France between April 2008 and December 2010.
  
  
  METHODS
  Prospective, observational, multi-centric survey by means of a database registry of the Filiale de cardiologie pédiatrique et congénitale.
  
  
  RESULTS
  Sixty-four patients were included, with a median (range) age of 21.4 (10.5-77.3) years. The majority (60.9%) of the patients were New York Heart Association (NYHA) class II. The most common congenital heart disease was tetralogy of Fallot with or without pulmonary atresia (50%). Indication for valve implantation was stenosis in 21.9%, regurgitation in 10.9% and association of stenosis and regurgitation in 67.2%. Implantation was successful in all patients. Pre-stenting was performed in 96.9% of cases. Median (range) procedure time was 92.5 (25-250) minutes. No significant regurgitation was recorded after the procedure, and the trans-pulmonary gradient was significantly reduced. Early minor complications occurred in five cases (7.8%). Three patients died during a median follow-up of 4.6 (0.2-5.2) years, two from infectious endocarditis and one from end-stage cardiac failure. Surgical reintervention was required in three patients. Follow-up with magnetic resonance imaging demonstrated significant improvements in right ventricular volumes and pulmonary regurgitation in mixed and regurgitant lesions.
  
  
  CONCLUSIONS
  Transcatheter pulmonary valve implantation is highly feasible and mid-term follow-up demonstrates sustained improvement of right ventricular function. Late endocarditis is of concern, therefore longer follow-up in more patients is urgently needed to better assess long-term outcome.
  
  
  BACKGROUND
  NCT01250327.
authors.affiliation: Cardiologie Pédiatrique, hôpital de la Timone-Enfants, 13385 Marseille, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Fraisse
authors.affiliation: Cardiologie Pédiatrique, hôpital de la Timone-Enfants, 13385 Marseille, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Aldebert
authors.affiliation: Pediatric Cardiology, unité médico-chirurgicale de cardiologie congénitale et pédiatrique, centre de référence malformations cardiaques congénitales complexes-M3C, Necker Hospital for Sick Children, Assistance publique des Hôpitaux de Paris, 149, rue de Sèvres, 75015 Paris cedex, France; Unit for adults with congenital heart defects, centre de référence malformations cardiaques congénitales complexes-M3C, George-Pompidou European Hospital, Assistance publique des Hôpitaux de Paris, 75015 Paris, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Malekzadeh-Milani
authors.affiliation: Unit for children and adults with congenital heart defects, hospital Bordeaux, 33604 Bordeaux, France.
authors.forename: Jean-Benoit
authors.initials: JB
authors.lastname: Thambo
authors.affiliation: Institut hospitalier Jacques-Cartier, 91300 Massy, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Piéchaud
authors.affiliation: Unit of Clinical Research (URC), George-Pompidou European Hospital, Assistance publique des Hôpitaux de Paris, 75015 Paris, France.
authors.forename: Pascaline
authors.initials: P
authors.lastname: Aucoururier
authors.affiliation: Unit of Clinical Research (URC), George-Pompidou European Hospital, Assistance publique des Hôpitaux de Paris, 75015 Paris, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Chatelier
authors.affiliation: Pediatric Cardiology, unité médico-chirurgicale de cardiologie congénitale et pédiatrique, centre de référence malformations cardiaques congénitales complexes-M3C, Necker Hospital for Sick Children, Assistance publique des Hôpitaux de Paris, 149, rue de Sèvres, 75015 Paris cedex, France; Université Paris-Descartes, Sorbonne Paris-Cité, 75008 Paris, France.
authors.forename: Damien
authors.initials: D
authors.lastname: Bonnet
authors.affiliation: Unit for adults with congenital heart defects, centre de référence malformations cardiaques congénitales complexes-M3C, George-Pompidou European Hospital, Assistance publique des Hôpitaux de Paris, 75015 Paris, France.
authors.forename: Laurence
authors.initials: L
authors.lastname: Iserin
authors.affiliation: Cardiologie Pédiatrique, hôpital de la Timone-Enfants, 13385 Marseille, France.
authors.forename: Béatrice
authors.initials: B
authors.lastname: Bonello
authors.affiliation: Cardiologie Pédiatrique, hôpital de la Timone-Enfants, 13385 Marseille, France.
authors.forename: Anass
authors.initials: A
authors.lastname: Assaidi
authors.affiliation: Cardiologie Pédiatrique, hôpital de la Timone-Enfants, 13385 Marseille, France.
authors.forename: Issam
authors.initials: I
authors.lastname: Kammache
authors.affiliation: Pediatric Cardiology, unité médico-chirurgicale de cardiologie congénitale et pédiatrique, centre de référence malformations cardiaques congénitales complexes-M3C, Necker Hospital for Sick Children, Assistance publique des Hôpitaux de Paris, 149, rue de Sèvres, 75015 Paris cedex, France; Unit for adults with congenital heart defects, centre de référence malformations cardiaques congénitales complexes-M3C, George-Pompidou European Hospital, Assistance publique des Hôpitaux de Paris, 75015 Paris, France; Université Paris-Descartes, Sorbonne Paris-Cité, 75008 Paris, France. Electronic address: younes.boudjemline@nck.aphp.fr.
authors.forename: Younes
authors.initials: Y
authors.lastname: Boudjemline
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D002648:Child; D005260:Female; D005602:France; D019538:Health Care Surveys; D006330:Heart Defects, Congenital / Q000401:mortality / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D011664:Pulmonary Valve / Q000503:physiopathology / Q000601:surgery*; D011665:Pulmonary Valve Insufficiency / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011666:Pulmonary Valve Stenosis / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D020127:Recovery of Function; D012042:Registries; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D016278:Ventricular Function, Right; D055815:Young Adult
keywords: Cardiac catheterization; Cathétérisme interventionnel; Implantation de valve pulmonaire; Pulmonary valve implantation; Trans-cathéter; Transcatheter