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Nearly two million Americans suffer from severe heart failure, and for them even the most mundane tasks can be extremely difficult.
Because the blood circulation is impeded throughout the body, patients may be out of breath by simply walking in a room or climbing stairs. Some have to sit down to avoid looking for air.
Medications can help control symptoms, but the disease takes ceaseless action and most people with severe heart failure do not have long to live. Until now, few doctors can do it.
But on Sunday, the researchers reported that a tiny staple inserted into the heart significantly reduced death rates in patients with severe heart failure.
In a large clinical trial, physicians found that these patients also avoided additional hospitalizations and described a significantly improved quality of life with fewer symptoms.
The findings, reported at a medical meeting in San Diego and published simultaneously in the New England Journal of Medicine, were much more encouraging than what heart specialists expected.
"This is a huge breakthrough," said Dr. Howard Herrmann, director of interventional cardiology at the University of Pennsylvania, who recruited a few patients. "This shows that we can treat and improve the results of an illness in a way that we never thought we could do."
If the device is approved by the Food and Drug Administration for the treatment of severe heart failure, as expected, insurers, including Medicare, will likely cover it.
In case of heart failure, the organ itself is damaged and flaccid, often as a result of a heart attack. The muscle pumps inefficiently and, in an attempt to compensate, the heart enlarges and becomes misshapen.
The enlarged organ pulls on the mitral valve, which controls blood flow from the left atrium into the left ventricle. Deformed valve malfunctions, flaps sway. The blood that is supposed to be pumped into the body goes back into the heart and lungs.
A vicious circle follows: the heart enlarges, so that the mitral valve leaks. The leaking mitral valve makes the heart even bigger by trying to compensate and the heart failure worsens.
In the new study, a device called MitraClip was used to repair the mitral valve by clipping its two paws in the middle. (The clip is produced by Abbott, who funded the study, and external experts reviewed the trial data.)
The result was to convert a valve that barely worked into a valve that could regulate blood flow to and from the heart.
Until today, researchers were unsure that mitral valve repair would help these patients a lot. A small study in France with similar patients did not manage to find an advantage for the MitraClip.
But this research included many patients with less severe valve problems, the intervention was not as effective 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 randomized to receive a MitraClip at the same time as a standard medical treatment or to continue with standard treatment alone.
Of those who received only medical treatment, 151 were hospitalized for heart failure over the next two years. Sixty-one are dead.
In contrast, only 92 people who received the device were hospitalized for heart failure during the period and 28 died.
The results left the leading researchers unexpectedly optimistic. The lawsuit sends "a very, very powerful message," said Dr. Gilbert Tang, a cardiac surgeon at Mount Sinai Medical Center, who recruited a patient into the trial.
"This is a game changer. It's huge," said Dr. Mathew Williams, director of the NYU Langone Heart Valve Program. Health, who had a few patients in the study.
Dr. Williams estimates that the number of heart failure patients in the United States is comparable to the number of trials. But, he adds, the number of people likely to be treated will be less than the number of people who can be treated.
The device itself costs around $ 30,000, not counting hospital and physician fees: a surgeon, an interventional cardiologist and an echocardiologist, among others, all in the operating room.
The cardiologists said that the study had been executed flawlessly.
The doctors who introduced the device first had to demonstrate their expertise. An independent panel of experts found that the medical care provided to patients was optimal; Too often, patients with heart failure do not receive an ideal treatment.
Patients with severe heart failure are often seriously ill, too sick to undergo open heart surgery and have mitral valves replaced. "It's not worth the risk," said Dr. Gregg Stone of Columbia University Medical Center, lead researcher of the study.
(Mr. Stone did not report any relevant conflict, but stated that Columbia University is getting royalties from the sale of MitraClip.)
But the new procedure is much less invasive than open heart surgery.
A cardiologist passes the device to the heart through a blood vessel in the groin. Once reached the heart, the MitraClip is guided towards the valve and the device is used to staple both flaps.
Not all cardiologists are equipped to insert the clip. "These are difficult procedures that require training and dedication," said Dr. Herrmann.
During the procedure, for example, a small echocardiogram camera is placed in the patient's esophagus behind the heart to show where the catheter is going with the clip.
Physicians must look at a radiographic screen and an echocardiogram when they guide the clip toward the mitral valve. When the clip arrives, "you have to see where you grab to get a good result," said Dr. Tang.
The device is already approved by F.D.A. for patients too fragile for surgery, but whose heart is fine, with the exception of a mitral valve that does not work properly.
Cardiologists have predicted the F.D.A. would also quickly approve the device for patients with severe heart failure. It is already used in Europe for these patients, but no rigorous study has shown its effectiveness.
The new trial promises to alter the outlook of many people with severe heart failure and having relatively few options. "This will change the way we treat these patients," said Dr. Williams.
It is possible, he added, that the valve repair procedure is even more effective if they were not so fragile when they were obtained.
"We may have to intervene sooner," he said.
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