Evaluation of the Melody transcatheter pulmonary valve and Ensemble delivery system for the treatment of dysfunctional right ventricle to pulmonary artery conduits

Abstract

Synthetic conduits and bioprosthetic valves are used in the treatment of patients with congenital heart disease involving the right ventricular outflow tract and pulmonary valve. In-situ time-dependent degradation uniformly results in conduit and valve dysfunction. The abnormal hemodynamics imposed by valve and conduit dysfunction have been linked to exercise intolerance, arrhythmia, right heart failure, and sudden death. Starting in childhood, affected patients are subjected to repeated open-heart surgeries to restore valve function and potentially reduce morbidity and mortality. Percutaneous transcatheter pulmonary valve replacement with the Melody® Transcatheter Pulmonary Valve (Medtronic, Inc., Minneapolis, MN) has been performed in ≈8000 patients worldwide. The valve and implant procedure provide a far less invasive means of restoring valve and conduit function and allow patients to forego multiple operations. Recent clinical trials have shown excellent and durable results in terms of valve function, relief of obstruction, and improvement in functional class up to 7 years from implant.