Medtronic delivered new data from two clinical trials evaluating the long-term safety and shorter-term performance of its transcatheter pulmonary valve replacement therapies for children with congenital heart disease.
Presented virtually as late-breaking studies during the scientific session of the Society for Cardiovascular Angiography and Interventions, 10-year data showed sustained function and stable hemodynamics with the company’s Melody valve compared to a historical control group using a surgically implanted conduit. Additionally, 97% of patients showed either mild, trace or no pulmonary regurgitation after a decade.
“Having long-term data is an important milestone especially for this pediatric patient population who are growing and changing so rapidly during a 10-year period,” Thomas Jones, director of cardiac catheterization at Seattle Children’s, said in a statement.
According to Medtronic, congenital heart disease is the most common type of birth defect in the U.S., affecting about 40,000 infants annually. About 22% have structural malformations in the portion of the right ventricle that helps connect the heart to the lungs and typically undergo open-heart surgery to help increase blood flow.
Many patients may receive an implanted tube early in life, but once that conduit is no longer functional, the transcatheter Melody valve is designed as a method to help delay additional procedures. In the 10-year study, 61% of implanted patients did not need an additional surgery or catheter-based reintervention.
Meanwhile, a new study of Medtronic’s investigational Harmony valve—designed for patients that have received a transannular patch, with significantly distorted portions of their right ventricle—met its safety and efficacy endpoints at six months.
All 50 treated patients experienced no procedure- or device-related mortality after one month, with acceptable hemodynamic function at six months maintained in 89% of participants. At the same time, 94% of patients had either mild or no pulmonary regurgitation while 97% had either mild or no paravalvular leaks.
"These pivotal data support the rationale for a potential new therapy designed specifically for the right ventricular outflow tract,” said lead principal investigator John Cheatham, professor emeritus in pediatric cardiology at Nationwide Children's Hospital. “If future study data continues to be strong, we’re hopeful that Harmony may potentially impact this critical, hard-to-treat segment of patients, who have limited treatment choices with current transcatheter technologies.”