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The Melody transcatheter pulmonary valve has a Humanitarian Device Exemption for use in the U.S. and is increasingly being deployed in patients with right ventricular outflow tract conduit dysfunction. In this report, investigators examined data on 15 patients at eight institutions who received the device for tricuspid stenosis, regurgitation, or both in either a right-atrium-to-right-ventricle conduit (5 patients) or an orthotopically positioned bioprosthetic tricuspid valve (10 patients). Patients ranged in age from 8 to 64 years (mean, 33), and all were symptomatic. The valves were inserted via the femoral or internal jugular vein and deployed by balloon dilation.
In 5 patients with stenosis as the primary indication, the median valve gra…