News Room

The device, known as the Melody transcatheter pulmonary valve (Medtronic, Inc), received backing from an FDA advisory panel in July, suggesting FDA approval may come soon for certain patients. (See article). The device is currently approved in Europe and Canada; if approved by the FDA, it could be the first catheter-placed heart valve to be approved in the U.S.

The study, the first prospective, multicenter study of the device, involved 34 children and young adults at Children's Hospital Boston, Miami Children's Hospital and Morgan Stanley Children's Hospital (New York, NY) whose existing right-ventricular outflow conduits were malfunctioning, causing blood to flow backward from the pulmonary artery into the right ventricle (known as pulmonary regurgitation) or obstruction of blood from the right ventricle to the lungs. They had various forms of congenital heart disease, including tetralogy of Fallot, truncus arteriosus, aortic valve disease and transposition of the great arteries.

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. In July, the advisory panel members called for longer-term monitoring of patients, but said the potential benefits outweighed concerns about fractures. Medtronic is now working on an improved version.

"This study shows that the valve can be used safely and effectively in the hands of many different trained cardiologists," says McElhinney. "These are early and short term data, but if the longer-term data are equally encouraging, this technology could have a major impact on the long-term health of our patients and their hearts."

Chronic conduit dysfunction can cause symptoms and eventually lead to dysfunction of the ventricle. Because the transcatheter valve can be implanted without the risks and morbidity of surgery, the threshold for intervening can be lowered, offering patients a chance at an improved quality of life, preserved heart function and fewer surgeries, McElhinney says.

"Of course, we need to learn more before we know whether the promise of this technology is realized," he adds.

The study was supported by Medtronic, Inc., manufacturer of the Melody valve. For more on the study, click here.

A video of device (courtesy Medtronic) can be seen at http://www.visibleheart.com/video/melody_valve.mov.

Contact:
Rob Graham
617-919-3110
rob.graham@childrens.harvard.edu

Founded in 1869 as a 20-bed hospital for children, Children's Hospital Boston today is one of the nation's leading pediatric medical centers, the primary pediatric teaching hospital of Harvard Medical School, and the largest provider of health care to Massachusetts children. In addition to 396 pediatric and adolescent inpatient beds and more than 100 outpatient programs, Children's houses the world's largest research enterprise based at a pediatric medical center, where its discoveries benefit both children and adults. More than 500 scientists, including eight members of the National Academy of Sciences, 11 members of the Institute of Medicine and 13 members of the Howard Hughes Medical Institute comprise Children's research community. For more information about the hospital visit: www.childrenshospital.org/newsroom.