FDA-approved heart valve aims to prevent recurring open-heart surgeries

A heart valve recently approved by the Food and Drug Administration can help restore normal life to people born with a congenital heart defect without invasive surgery — and it can prevent open-heart surgeries later in life.

It’s called the Harmony heart valve.

Congenital heart disease is the No. 1 birth defect in the U.S. and world, and about 20% of the cases involve the right side of the heart. Early surgical repairs on infants and young children often leave the pulmonary valve damaged so badly that it leaks.

By the time those patients enter teenage years, become young adults or adults, their symptoms — which include easy fatigue and heart rhythm problems — progressively worsen as the valve becomes less functional.

“Their only option up until this recent approval was to go back for open-heart surgery again to have a surgically placed pulmonary valve on a cardiopulmonary bypass,” said Dr. John P. Cheatham, professor emeritus in the Department of Pediatrics and Cardiology at The Ohio State University College of Medicine.

“The new Harmony transcatheter pulmonary valve, however, can be placed, minimally invasive, with a small catheter through the leg vein or neck vein … the valve immediately starts functioning as soon as we implant it,” he said.

“Patients are usually in the hospital less than 24 hours and resuming normal activity.”

Cheatham is past co-director of The Heart Center and director of cardiac catheterization at Nationwide Children’s Hospital.

“We’re talking about babies and children with congenital heart disease … and trying to provide a lifestyle in that group of patients that will have a normal life expectancy and normal life activities. But the only way to do that is to make sure we have the heart function the way it’s supposed to function,” Cheatham said.

People who get the Harmony valve experience significant symptoms before the therapy, he said, but their quality-of-life improvement is almost immediate.

“The heart that was enlarged reshapes, remodels and starts to function normally, and that can happen in a matter of months,” Cheatham said.

Most valves used in congenital heart disease are tissue valves, because mechanical valves require the use of blood-thinning medicines that are not good for children. Tissue valves are temporary fixes and don’t last the lifetime of a patient. The Harmony valve is made of the outer lining of pig hearts.

“When this valve gives out and doesn’t work as well, which is somewhere down the future, we can place another valve through the same kind of minimally invasive [procedure] inside of this valve,” Cheatham said. “So again, the patient will avoid open-heart surgery.”

The first prototype device of such a valve was implanted in 2009; clinical trials began in 2012.

“So it’s been a very long process,” he said. “It took a company that was dedicated to seeing this through, and so we’re all very excited that we do finally have FDA approval, and the device has worked very, very nicely.”

You can see a demonstration of how it works on the Medtronic website.

Kristi King

Kristi King is a veteran reporter who has been working in the WTOP newsroom since 1990. She covers everything from breaking news to consumer concerns and the latest medical developments.

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