title: Incidence and predictors of Melody® valve endocarditis: a prospective study.
abstract: BACKGROUND
  Percutaneous pulmonary valve replacement (PPVR) has achieved standard of care for the management of dysfunctional right ventricular outflow tract.
  
  
  OBJECTIVE
  Because of increasing reports of Melody(®) valve (Medtronic, Inc., Minneapolis, MN, USA) infective endocarditis (IE), we aimed to evaluate its incidence and predictors of occurrence.
  
  
  METHODS
  We collected data on all patients who received a Melody valve in the pulmonary position from 2009 to 2012.
  
  
  RESULTS
  A total of 86 consecutive patients underwent PPVR from 2009 to 2012; of these, five developed IE (5.8%). Freedom from IE was 91% at 50 months. Baseline demographics, type of conduit, PPVR procedural success, residual gradients and in situ duration of Melody valve were similar in IE and non-IE patients. A significant number of IE patients had additional unprotected invasive procedures during follow-up and abruptly discontinued antiplatelet therapy (P=0.0139 and P=0.002, respectively). The cumulative probability of survival without cardiovascular events for IE patients was 20% at 20 months, compared with 98.1% for non-IE patients (P<0.0001). Death was statistically associated with IE.
  
  
  CONCLUSIONS
  Early- and late-onset IE of the Melody valve is emerging as a catastrophic complication of PPVR. Abrupt aspirin discontinuation and additional unprotected invasive procedures during follow-up are significant predictors of Melody valve IE. Owing to its rapidly progressive nature, aggressive invasive management should not be delayed.
authors.affiliation: Centre de Référence Malformations Cardiaques Congénitales Complexes (M3C), Necker Hospital for Sick Children-HEGP, AP-HP, Paris, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Malekzadeh-Milani
authors.affiliation: Centre de Référence Malformations Cardiaques Congénitales Complexes (M3C), Necker Hospital for Sick Children-HEGP, AP-HP, Paris, France.
authors.forename: Magalie
authors.initials: M
authors.lastname: Ladouceur
authors.affiliation: Centre de Référence Malformations Cardiaques Congénitales Complexes (M3C), Necker Hospital for Sick Children-HEGP, AP-HP, Paris, France.
authors.forename: Mehul
authors.initials: M
authors.lastname: Patel
authors.affiliation: Centre de Référence Malformations Cardiaques Congénitales Complexes (M3C), Necker Hospital for Sick Children-HEGP, AP-HP, Paris, France.
authors.forename: Fazia-Marie
authors.initials: FM
authors.lastname: Boughenou
authors.affiliation: Centre de Référence Malformations Cardiaques Congénitales Complexes (M3C), Necker Hospital for Sick Children-HEGP, AP-HP, Paris, France.
authors.forename: Laurence
authors.initials: L
authors.lastname: Iserin
authors.affiliation: Centre de Référence Malformations Cardiaques Congénitales Complexes (M3C), Necker Hospital for Sick Children-HEGP, AP-HP, Paris, France; Université Paris Descartes, Sorbonne Paris Cité, 75006 Paris, France.
authors.forename: Damien
authors.initials: D
authors.lastname: Bonnet
authors.affiliation: Centre de Référence Malformations Cardiaques Congénitales Complexes (M3C), Necker Hospital for Sick Children-HEGP, AP-HP, Paris, France; Université Paris Descartes, Sorbonne Paris Cité, 75006 Paris, France. Electronic address: younes.boudjemline@nck.aphp.fr.
authors.forename: Younes
authors.initials: Y
authors.lastname: Boudjemline
mesh_terms: D000293:Adolescent; D000328:Adult; D004696:Endocarditis / Q000453:epidemiology* / Q000503:physiopathology; D005260:Female; D006330:Heart Defects, Congenital / Q000453:epidemiology; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D016459:Prosthesis-Related Infections / Q000453:epidemiology*; D011664:Pulmonary Valve; D055815:Young Adult
keywords: Cardiopathies congénitales; Complications; Congenital heart diseases; Endocardite; Endocarditis; Melody valve; Remplacement valvulaire percutané; Transcatheter pulmonary valve; Valve Melody