Medtronic announced the one-year results of the Melody transcatheter pulmonary valve US post-approval study, which found that real-world use of the Melody transcatheter pulmonary valve was associated with high procedural success, excellent valve function and few repeat procedures at the primary endpoint of six months. These results were sustained out to one year.
Presented as a late-breaking clinical trial at the American College of Cardiology (ACC) 63rd Annual Scientific Session, the study results demonstrated a procedural success rate of 98% and showed that nearly all patients were free from major stent fracture (99%), transcatheter pulmonary valve dysfunction (98%) and reintervention (100%) at six months.
Following FDA approval in 2010 of the Melody transcatheter pulmonary valve under a Humanitarian Device Exemption, the post-approval study prospectively enrolled 120 patients at 10 US sites not included in the US Melody transcatheter pulmonary valve Investigational Device Exemption (IDE) clinical trial. The patients had a mean age of 20 years (ranging from ages five to 45). The post-approval study results confirm the positive findings of the original Melody transcatheter pulmonary valve US IDE clinical trial, reinforcing the device’s ability to safely prolong the time between open-heart surgeries for patients with a dysfunctional right ventricular outflow tract caused by coronary heart disease.
“The positive results garnered in this real-world setting mirror those seen in other studies of the Melody valve,” says Aimee K Armstrong, associate director, University of Michigan CS Mott Children’s Hospital Cardiac Catheterization Laboratories. “The one-year results show strong performance of the valve, which is intended to delay the time until open-heart surgery is needed. Decreasing the number of open-heart surgeries that our patients need has a significant impact on their lives and quality of life.”
Adverse events seen in the post-approval study ranged from fever to arrhythmia; and endocarditis (n=3) to confined conduit tear (n=6), the latter of which were all resolved with the use of a covered stent.