Melody ® transcatheter pulmonary valve implantation: results from a French registry

Arch Cardiovasc Dis. 2014 Nov;107(11):607-14. doi: 10.1016/j.acvd.2014.10.001. Epub 2014 Nov 6.


Background: Percutaneous implantation of pulmonary valves has recently been introduced into clinical practice.

Aim: 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.

Clinical trial registration: NCT01250327.

Keywords: Cardiac catheterization; Cathétérisme interventionnel; Implantation de valve pulmonaire; Pulmonary valve implantation; Trans-cathéter; Transcatheter.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Cardiac Catheterization / methods
  • Cardiac Catheterization / mortality
  • Child
  • Female
  • France
  • Health Care Surveys
  • Heart Defects, Congenital / mortality
  • Heart Defects, Congenital / surgery*
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis Implantation / methods
  • Heart Valve Prosthesis Implantation / mortality
  • Heart Valve Prosthesis*
  • Humans
  • Kaplan-Meier Estimate
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Predictive Value of Tests
  • Prospective Studies
  • Prosthesis Design
  • Prosthesis Failure
  • Pulmonary Valve / physiopathology
  • Pulmonary Valve / surgery*
  • Pulmonary Valve Insufficiency / diagnosis
  • Pulmonary Valve Insufficiency / etiology
  • Pulmonary Valve Insufficiency / mortality
  • Pulmonary Valve Insufficiency / physiopathology
  • Pulmonary Valve Insufficiency / therapy*
  • Pulmonary Valve Stenosis / diagnosis
  • Pulmonary Valve Stenosis / etiology
  • Pulmonary Valve Stenosis / mortality
  • Pulmonary Valve Stenosis / physiopathology
  • Pulmonary Valve Stenosis / therapy*
  • Recovery of Function
  • Registries
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Ventricular Function, Right
  • Young Adult

Associated data