Long-Term Outcomes After Melody Transcatheter Pulmonary Valve Replacement in the US Investigational Device Exemption Trial

Jones TK, McElhinney DB, Vincent JA, Hellenbrand WE, Cheatham JP, Berman DP, Zahn EM, Khan DM, Rhodes JF Jr, Weng S, Bergersen LJ. Circ Cardiovasc Interv. 2022 Jan;15(1):e010852. doi: 10.1161/CIRCINTERVENTIONS.121.010852. Epub 2021 Dec 21. PMID: 34930015 


Take Home Points:

  1. Fifty-eight of 149 patients enrolled in the Melody valve US IDE study made it to 10 years follow up
  2. Freedom from mortality at 10 years was 90%
  3. Freedom from valve reintervention at 10 years was 53%
  4. Higher risk of reintervention in younger patients, in patients with primary indication of stenosis, in patients with higher residual post valve gradient, and in patient who had more prior open-heart surgeries
  5. Freedom from TPV endocarditis was 81% and from all site endocarditis was 76% at 10 years
  6. Most common cause of death was endocarditis (5/11)

Commentary from Dr. Thomas Zellers (Dallas, USA), section editor of Congenital Heart Disease Interventions and ACHD Journal Watch:

Summary: This is an important study because it provides 10-year follow up on a subset of patients implanted with the Melody valve during the US IDE study. A total of 171 patients were enrolled in the trial and 149 of the patients were followed for a mean of 8.4 years (5.4-10.1 years). Fifty-eight (58) of the 149 patients had 10-year assessment information.


Estimated freedom from mortality at 10 years was 90%. Eleven patients died, 5 of those from endocarditis. At 10 years, freedom from any reintervention was 55%, freedom from any TPV intervention was 60% and freedom from reoperation was 79%. Freedom from reintervention declined in a shorter period of time in patients implanted younger than age 21. There was a higher risk of reintervention in unprotected (non-stented) conduits, when the primary indication for TPV was stenosis, in those patients with a higher peak to peak gradient post transcatheter valve implant and in those patients who had more open-heart surgeries prior to TPV implantation.


Peak to peak gradients after TPV implant were low throughout the study period. In addition, at 10 years follow up, most patients had none or trivial pulmonary regurgitation; only 26% had mild and 3% had moderate pulmonary regurgitation. The majority of patients (78%) were characterized as NYHA class I.


Endocarditis is a significant complication and occurred in 28 of 149 patients (19%) with an annualized incidence on the TPV of 2% per year.


Limitations: There was a smaller number of patients who made it to 10-year follow up, but this is not unexpected as the extended follow up past 5 years was voluntary. In addition, there was no CORE lab involved in evaluating the imaging results. Finally, the implant procedure changed during the study (for example, pre-stenting of conduits).




Echocardiographic evaluation of valve gradients (above) and valve insufficiency (below). Gradients change little over time and most
patients have mild or less regurgitation out to 10 years.



Freedom from intervention by age group



Freedom from endocarditis Kaplan Meier curves