Cardiologists from Miami Children’s Hospital, Morgan Stanley Children’s Hospital, New York, and Children’s Hospital Boston just published preliminary results from the study of Medtronic’s Melody® Transcatheter Pulmonary Valve in 34 children and young adults who were implanted with the device for dysfunctional right ventricular outflow tract conduits. The early results are promising and may help the Melody valve get approved in the US as the first transcatheter cardiac valve on the market.
All patients underwent cardiac catheterization with the intention of implanting the artificial valve, and 30 of the 34 underwent actual implantation attempts, of which 29 were successful. Three patients (9 percent) had complications during implantation, but all survived.
At follow-up six months later, no patient had more than mild pulmonary regurgitation. Of 24 patients who had Class II or III heart failure (mild to moderate limitation of physical activity) before the procedure, 19 had improved by at least one functional class at six months, and no patient’s function had declined.
Eight of the 29 devices developed partial fractures during follow-up, and 3 patients required a second Melody valve (inserted inside the first one) for recurrent blockage.
Children’s Hospital Boston press statement: Catheter-delivered Valve May Help People with Heart Defects Avoid Multiple Surgeries; Medtronic statement: Melody® Transcatheter Valve Demonstrates Encouraging Results in Study on Patients with Congenital Heart Disease…
Abstract in Journal of the American College of Cardiology: Implantation of the Melody Transcatheter Pulmonary Valve in Patients With a Dysfunctional Right Ventricular Outflow Tract Conduit …
Product page: Melody® Transcatheter Pulmonary Valve and Ensemble® Transcatheter Delivery System …
Flashbacks: Medtronic’s Melody Transcatheter Pulmonary Valve on Track for Approval ; Melody Transcatheter Pulmonary Valve Still Being Tested in the US …; The Melody Valve Approved in Canada; The Melody Transcatheter Pulmonary Valve
