Transcatheter pulmonary valve replacement (TPVR) with the Melody transcatheter pulmonary valve (TPV) is associated with favorable 10-year outcomes, according to new findings published in Circulation: Cardiovascular Interventions.
The Melody TPV, manufactured by Medtronic, was designed to help restore hemodynamic function in patients with failing right ventricular outflow tract (RVOT) conduits or bioprosthetic pulmonary valves (BPVs) without requiring the patient to undergo open surgery.
For this study, a total of 149 patients underwent TPVR with the Melody TPV from January 2007 to January 2010. All patients presented with a dysfunctional RVOT conduit or a stented BPV, and the median patient age was 19 years old.
This study represents an updated analysis of data from the Melody IDE trial, which first started back in 2007. The original trial was scheduled to end after five years, but strong outcomes led researchers to continue their work for another five years.
Overall, after 10 years, researchers found that the estimated freedom from mortality was 90%. Freedom from another operation, meanwhile, was 79%, and freedom from any reintervention was 60%.
Also, the estimated freedom from TPV dysfunction after 10 years was 53%; that number was 64% among patients younger than 21 years old, but 46% among patients 21 years old and older.
“The Melody valve, therefore, fulfills its original design intent to prolong the useful life of existing RVOT conduits or BPVs while providing relief of pulmonary valve dysfunction in the majority of subjects,” wrote lead author Thomas K. Jones, MD, a specialist with Seattle Children’s Hospital, and colleagues.
Medtronic did sponsor this analysis. Multiple authors, including Jones, reported significant working relationships with Medtronic.
The full analysis is available here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.