Comparing Outcomes From the Melody Transcatheter Pulmonary Valve IDE and Post-Approval Trials

June 11, 2021

The Melody® transcatheter pulmonary valve was approved by the U.S. Food and Drug Administration (FDA) in 2010 after completion of the initial investigational device exemption (IDE) trial that enrolled 171 patients. Results from the initial IDE showed highly favorable results and excellent outcomes in the study cohort. The FDA required the device manufacturer (Medtronic) to conduct a five-year post-approval study on a second patient cohort at centers not included in the initial study.  

The recently completed five-year post-approval study (PAS) was published in April in the journal Catheterization & Cardiovascular Interventions and included a longitudinal comparison between  the two studies (IDE and PAS). 

Jacqueline Kreutzer, MD, FAAC, FSCAI, co-director of the Heart Institute at UPMC Children’s Hospital of Pittsburgh and chief of the Division of Pediatric Cardiology, was the principal investigator of the post-approval study and lead author of the recently published study results.

“This an important study that prospectively assessed the long-term outcomes of the Melody transcatheter pulmonary valve in two independent cohorts of congenital heart disease patients,  showing comparable and favorable outcomes longitudinally for both cohorts. Given the lack of significant differences, the study also provokes further considerations on the need to perform expensive mandatory post-approval studies for such medical devices,” says Dr. Kreutzer.

Summary of Key Findings

The 10 year results of the initial IDE trial cohort, and the five-year outcomes for the PAS  demonstrate excellent long-term outcomes and comparable performance at follow-up. 

Both hemodynamic status and reintervention rates were similar in both trials and also in line with the previously published one-year PAS outcomes, demonstrating the effectiveness of the Melody transcatheter pulmonary valve.

"Patients from both trials have experienced excellent outcomes longitudinally, while the incidence and risk of adverse events was and remains low in both groups," says Dr. Kreutzer. "While we did see minor variations between the two cohorts for things like stent fracture, reintervention, device removal, and cases of endocarditis, these may have been due to the variations in trial protocols and the longer experience with the devices relative to the second cohort.”

Reference

Kreutzer J, Armstrong AK, Rome JJ, et al. Comparison of the Investigational Device Exemption and Post-Approval Trials of the Melody Transcatheter Pulmonary Valve. Catheter Cardiovasc Inter. 2021; 1-13.

Further Reading

Armstrong AK, Balzer DT, Cabalka AK, Gray RG, Javois AJ, Moore JW, Rome JJ, Turner DR, Zellers TM, Kreutzer K. One-Year Follow-Up of the Melody Transcatheter Pulmonary Valve Multicenter Post-Approval Study. JACC Cardiovasc Interv. 2014; 7(11): 1254-1262.

Zahn EM, Hellenbrand WE, Lock JE, McElhinney DB. Implantation of the Melody Transcatheter Pulmonary Valve in Patients With a Dysfunctional Right Ventricular Outflow Tract Conduit: Early Results From the U.S. Clinical Trial. J Am Coll Cardiol. 2009; 54: 1722- 1729.