Jones TK, et al. Circ Cardiovasc Interv. 2021;doi:10.1161/CIRCINTERVENTIONS.121.010852.
Jones TK, et al. Circ Cardiovasc Interv. 2021;doi:10.1161/CIRCINTERVENTIONS.121.010852.
At 10 years, transcatheter pulmonary valve replacement provided sustained symptomatic and hemodynamic improvement in most patients with complex congenital heart disease, data from the Melody investigational device exemption trial indicated.
According to the study background, the Melody transcatheter pulmonary valve (TPV; Medtronic) was designed to prolong the useful life of previously implanted right ventricular outflow tract (RVOT) conduits or bioprosthetic pulmonary valves (BPVs) while preserving RV function and reducing the lifetime burden of surgery for patients with complex congenital heart disease.
Trial enrollment occurred from January 2007 to January 2010 at five centers, with extended follow-up completed in 2020.
Thomas K. Jones, MD, director of the cardiac catheterization laboratories and professor of pediatrics at Seattle Children’s Hospital, and colleagues defined the primary outcome as freedom from TPV dysfunction, which included freedom from reoperation, reintervention, moderate or severe pulmonary regurgitation, and/or mean RVOT gradient greater than 40 mm Hg. Stent fracture, catheter reintervention, surgical conduit replacement and death served as secondary endpoints.
The study featured 171 patients (median age, 19 years) with RVOT conduit or BPV dysfunction. Patients had a median discharge mean RVOT Doppler gradient of 17 mm Hg.
Overall, 150 patients received the TPV, of whom 149 were followed for a median of 8.4 years.
At 10 years, researchers estimated the following rates: 90% freedom from mortality, 79% freedom from reoperation and 60% freedom from any reintervention. In addition, freedom from TPV dysfunction at 10 years was 53% and was significantly shorter in patients younger than 22 years at implant. Researchers also estimated that freedom from TPV-related endocarditis was 81% at 10 years (95% CI, 69-89), with an annualized rate of 2% per patient-year.
“The 10-year Post-Approval Study of the Investigational Device Exemption Cohort ... represents a landmark achievement in affirming the important contribution of TPV replacement to the lifetime care of patients with repaired complex congenital heart disease and a dysfunctional RVOT conduit or BPV,” Jones and colleagues wrote. They added that the TPV “fulfills its original design intent to prolong the useful life of existing RVOT conduits or BPV while providing relief of pulmonary valve dysfunction in the majority of subjects. Awareness of the risk factors for earlier TPV dysfunction and reintervention identified in this study should inform physicians caring for these patients about optimal goals for valve implantation and how best to maintain vigilance in long-term care.”
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