Tiny Device Is a ‘Huge Advance’ for Treatment of Severe Heart Failure


In the new study, a device called the MitraClip was used to repair the mitral valve by clipping its two flaps together in the middle. The result was to convert a valve that barely functioned into one able to regulate blood flow in and out of the heart.

Almost 2 million Americans have severe heart failure, and for them even mundane tasks can be extraordinarily difficult.

With blood flow impeded throughout their bodies, patients may become breathless simply walking across a room or up stairs. Some must sleep sitting up to avoid gasping for air.

Drugs may help to control the symptoms, but the disease takes a relentless course, and most people with severe heart failure do not have long to live. Until now, there has been little doctors can do.

But on Sunday, researchers reported that a tiny clip inserted into the heart sharply reduced death rates in patients with severe heart failure.

In a large clinical trial, doctors found that these patients also avoided additional hospitalizations and described a drastically improved quality of life with fewer symptoms.

The results, reported at a medical meeting in San Diego and published simultaneously in the New England Journal of Medicine, were far more encouraging than heart specialists had expected.

“It’s a huge advance,” said Dr. Howard Herrmann, director of interventional cardiology at the University of Pennsylvania, which enrolled a few patients in the study. “It shows we can treat and improve the outcomes of a disease in a way we never thought we could.”

If the device is approved by the Food and Drug Administration for treatment of severe heart failure, as expected, then insurers, including Medicare, likely will cover it.

In heart failure, the organ itself is damaged and flaccid, often as a consequence of a heart attack. The muscle pumps inefficiently, and in an attempt to compensate, the heart enlarges and becomes misshapen.

The enlarged organ tugs apart the mitral valve, which controls blood flow from the left atrium into the left ventricle. The distorted valve functions poorly, its flaps swinging apart. Blood that is supposed to be pumped into the body backs up into the heart and lungs.

A vicious cycle ensues: The heart enlarges, so the mitral valve leaks. The leaky mitral valve makes the heart enlarge even more, as it tries to compensate, and heart failure worsens.

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