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Catheter-Delivered Valve May Help People With Heart Defects Avoid Multiple Surgeries
Date:10/26/2009

ital 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."

"Currently, when patients have conduits that become dysfunctional, we are faced with the choice of tolerating that dysfunction or sending them back to surgery," McElhinney exp
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SOURCE Children's Hospital Boston
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