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A new study reveals that a very small device offers the hope of a better life for people with severe heart failure, by reducing hospitalization rates and by improving the risk of death within two years of treatment.
NEW YORK – A brand new device offers hope for a better life for people with severe heart failure, reducing hospitalization rates and improving mortality risk within two years following treatment, according to new study.
Heart failure affects about 5.7 million Americans and more than 26 million people worldwide, causing shortness of breath and fatigue in people with heart disease because their hearts are struggling to pump blood into the heart. the body.
One of the causes of severe heart failure that currently has a poor prognosis is a leaking valve, particularly the leakage of the mitral valve, which controls blood flow to the left side of the heart. When the leak is severe, the heart may enlarge.
Estimated to more than two million people in the United States, mitral valve failure causes blood flow backwards when blood is pumped, which means that it can not effectively reach the rest of the body.
But a new device, called MitraClip, makes it possible to reassemble the defective valve, to make it work properly and to pump blood from the heart. He has now shown promising results in the study published on Sunday.
Medications are available to relieve the symptoms of a mitral valve leak, but the authors claim that the long-term effects are unknown. Surgery is also an option and can be curative, but presents a significant risk of complications because patients are often older and more fragile.
According to the study, the implantation of MitraClip is minimally invasive, the device being transferred upwards by a small incision in the groin. It has been shown to reduce recovery time and hospitalization.
To measure the effectiveness of the device, Dr. Gregg Stone, a professor of medicine at Columbia University's College of Physicians, and his team recruited 614 patients from the United States and Canada suffering from heart failure and mitral regurgitation moderate to severe secondary. – who continued to have symptoms despite the drug treatment of their condition. The secondary form of the disease is the case where the left ventricle of a person is damaged, which prevents the proper functioning of the valve.
Of the participants, 302 received the new device and 312 acted as controls. Among those who received MitraClip, there was 32.1% fewer hospitalizations per year over the years of follow-up.
"The annualized rate of all hospitalizations for heart failure in 24 months was 35.8% per patient-year in the device group versus 67.9% per patient-year in the control group," the authors write.
Overall mortality for all causes in both years was also 17% lower in patients implanted with the device compared to the control group, with 29.1% and 46.1% respectively.
"It's shocking to see how positive it is as a new therapy for patients with very weak hearts," said Dr. Michael Acker, chief of the Penn Cardiovascular Surgery Division. Acker, who is not related to the research, noted that the results of the study were much more encouraging than the results of a similar trial reported last month. "At first glance, it's very exciting," he said, but said that further study was needed to understand the differences between population groups in each study.
The MitraClip technique was launched in 2003 and approved by the FDA in October 2013 to treat the primary (or degenerative) form of mitral regurgitation, according to researchers at the University of Washington.
It is currently used to treat the secondary form of the disease and has not yet been approved by the FDA.
The new study was part of the COAPT trial for secondary mitral regurgitation and was funded by the American health care company Abbott, which produces the device.
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