New treatment could help fix heart's forgotten valve

For the first time, patients with damaged tricuspid valves in their hearts might have a safe treatment that actually helps.

More than 1 million mostly older Americans have seriously leaking tricuspids, a valve on the right side of the heart that lets deoxygenated blood flow between the right atrium and the right ventricle. When the valve leaks, blood flows backward. As a result, fluid accumulates in vital organs while legs and feet get swollen. The eventual outcome is heart failure.

Patients' symptoms often are severe — fatigue, abdominal distention, swollen legs and general feelings of malaise. Even their eyes can get swollen, said Dr. Gregg Stone, an interventional cardiologist at Icahn School of Medicine at Mount Sinai.

“Imagine a beach ball filled with fluid in your stomach all the time,” said Dr. Joseph Cleveland Jr., a cardiothoracic surgeon at the University of Colorado School of Medicine.

Medicine to mitigate the injury causes perilous side effects, and surgical repair of the valve usually has been too dangerous to attempt.

Now medical device company Abbott is reporting results from a clinical trial of a treatment that involves clipping the floppy tricuspid valve to make it smaller and better able to function. The clipping device used is similar to a successful one used to treat patients with damage to another part of the heart, the mitral valve.

The results were published Saturday in The New England Journal of Medicine to coincide with a presentation at the annual meeting of the American College of Cardiology. And patients soon may have a different option for treatment when another company, Edwards Lifesciences, completes a clinical trial of a different approach that is underway.

For the study financed by Abbott,

researchers report that the clip stopped much of the leakage and allowed many patients who had been debilitated by symptoms to get their lives back. “It's really nice to see quality-of-life improvement,” said Cleveland, who was not involved in the Abbott trial. “This gives an option which is great.”

The treatment was also safe, with a less than 1% mortality risk in these very sick patients and, on average, a one-day hospital stay. The price of the procedure is not yet known.

Patients in the Abbott study now have been followed for at least one year. The clip did not extend life but, said Dr. David Adams, cardiac surgeon in chief at Mount Sinai Health System and co-principal investigator for the study, “We would never see a mortality difference — one year was not enough time.”

The clinical trial by Edwards is testing a different method. It replaces the tricuspid valve by threading a new valve into the heart, pushing aside the old in a manner similar to a method called transcatheter aortic valve replacement. The aorta controls blood flow from the heart, and the TAVR method has been used to replace the valves of hundreds of thousands of patients.

The developments come after years of inattention to the tricuspid problem. The valve long was known as the forgotten valve. Cardiologists had assumed that if they fixed problems on the left side of the heart — like a leaky mitral or aortic valve — the tricuspid valve would fix itself.

Their assumption was wrong. Patients and cardiologists have long sought an effective treatment for tricuspid leakage. The only medical treatment today is with drugs called loop diuretics. They flush excess fluid out of patients' body, but only temporarily. As the diuretic treatment is repeated, patients' fluid retention gets worse and worse until the kidneys fail and eventually even the tricuspid valve itself gets engorged with fluids.