New Treatment Option for Failing Pulmonary Valve Conduits

It is comprised of a bovine jugular vein (BJV) valve that is sutured within a platinum iridium frame, which provides natural venous valve leaflets that open and close under minimal pressure, resulting in optimal hemodynamics. The deep coaptation of the leaflets also provides valve competency across a range of conduit sizes and geometries.

Melody TPV placement is via a transcatheter procedure using the Medtronic Ensemble delivery system under fluoroscopic guidance, using balloon-in-balloon (BIB) technology for controlled deployment of the valve, which includes a radiopaque stent for visualization ease during the procedure. In addition to the initial indication for the Melody TPV to prolong the time between open-heart surgeries for patients with a pulmonary conduit caused by CHD, it can now be also used to replace a failed surgical bioprosthetic pulmonary heart valve as an interim solution to further surgery.

“Unlike other transcatheter valves currently on the market, Melody TPV is uniquely designed for use in the pulmonic position, and is thus well suited for implantation in failed surgical pulmonary heart valves,” said Rhonda Robb, vice president and general manager of the heart valve therapies business unit at Medtronic. “This approval further demonstrates our commitment to improving treatment options for congenital heart disease and we look forward to bringing this proven non-surgical option to congenital patients.”

“The Melody TPV brought a breakthrough non-surgical option to treat failing pulmonary valve conduits; thousands of congenital patients globally have benefited from this therapy in the past decade,” said Jeremy Asnes, MD, associate director of the congenital cardiac catheterization laboratory at Yale School of Medicine (New Haven, CT, USA). “With this expanded indication, we can further reduce the need for obtrusive open-heart surgery, and allow even more patients to benefit from this minimally invasive treatment option.”

Surgical correction of CHD defects such as Tetralogy of Fallot and pulmonary atresia has increased dramatically over the last several decades. But despite excellent long-term survival, they typically require multiple operative procedures until adulthood, as the homograft pulmonary artery conduits or BJV grafts have no ability to grow and remodel with the somatic growth of the child. Additionally, an intense inflammatory reaction to these materials commonly occurs, resulting in early calcification and failure, leading typically to the need for 5-7 operative procedures during the patient’s lifetime.