Clip on valve seen as help in treatment of heart failure
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, direccardiology 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.
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 clip is made by Abbott, which funded the study; outside experts reviewed the trial data.)
The result was to convert a valve that barely to regulate blood flow in and out of the heart.
Until today, researchers were not sure that fixing the mitral valve would do much to help these patients. A smaller study in France with similar patients failed to find a benefit for the MitraClip.
But that research included many patients with less severe valve problems, the procedure was not performed as adeptly, and the patients’ medications were not as well optimized as in the new study.
In the new trial, 614 patients with severe heart failure in the United States and Canada were randomly assigned to receive a MitraClip along with standard medical treatment or to continue with standard care alone.
Among those who received only medical treatment, 151 were hospitalized for heart failure in the ensuing two years. Sixty-one died.
In contrast, just 92 who got the device were hospitalized for heart failure during the period, and 28 died.
The results have left leading researchers unexpectedly optimistic. The trial sends "a very, very powerful message," said Dr. Gilbert Tang, a heart surgeon at Mount Sinai Medical Center, which enrolled a patient in the trial.