The Fridley, Minn.-based medtech giant virtually presented its 10-year outcomes at the 2020 Society for Cardiovascular Angiography & Interventions (SCAI) scientific sessions. Melody demonstrated strong long-term hemodynamic and safety outcomes, while the investigational Harmony TPV pivotal trial met safety and efficacy endpoints for hemodynamic function at six months, according to a news release.
Melody TPV demonstrated consistent hemodynamics through 10 years with strong valve efficacy with 97% none/trace/mild pulmonary regurgitation. Annualized incidence of TPV-related endocarditis was 2% per patient-year, while freedom from major stent fracture came in at 84% at 10 years and freedom from reintervention was 61%.
That study included 150 implanted patients between age 7 and age 53, with a median age of 19 and the primary indication for intervention being pulmonary regurgitation.
Medtronic touts the Melody transcatheter valve as the first of its kind to be implanted in a human anywhere in the world and to win FDA approval. In 2017, it won expanded indication for implantation in patients whose surgical bioprosthetic pulmonary heart valves have failed, making it the first TPV to earn that indication.
“Having long-term data is an important milestone especially for this pediatric patient population who are growing and changing so rapidly during a ten-year period,” Seattle Children’s director of cardiac catheterization Dr. Thomas Jones said in the release. “While the study reinforces the longevity, durability, and efficacy of the Melody TPV, it will also serve as a study model for future evaluations of novel pediatric congenital heart disease technologies.”
The Harmony TPV results revealed that 100% of patients experienced freedom from procedure- or device-related mortality at 30 days and acceptable hemodynamic function at six months was observed in 89% of trial participants, surpassing the performance target of 75%.
At six months, 94% of patients had no or mild pulmonary regurgitation and 97% had no or mild paravalvular leak, according to the release.
The trial included 50 patients across 12 sites in the U.S., Canada and Japan. Harmony TPV is designed for patients with right ventricular outflow tract (RVOT) anomalies who develop severe pulmonary regurgitation when a previous repair fails. It is not yet approved for anything other than investigational use in the U.S.
“As demonstrated by these late-breaking studies, we’re consistently building our body of new, short-, and long-term research around innovative, minimally-invasive TPV solutions for CHD patients,” Medtronic structural heart division VP and GM Sandra Lesenfants said in the release. “These Harmony data demonstrate our commitment to generating new therapies and growing our congenital heart disease program to support a lifetime of care that this patient population needs.”