(CNN) – A tiny new device is offering hope of a better life for people with severe heart failure, reducing hospitalization rates and improving mortality risk within two years of treatment, a new study finds.
Heart failure affects an estimated 5.7 million Americans and more than 26 million people globally, causing shortness of breath and tiredness among those affected as their heart struggles to pump blood around the body.
One cause of severe heart failure that currently has a poor prognosis is a leaky valve, particularly the leakage of the mitral valve, which control’s blood flow in the left part of the heart. When leakage is severe, the heart can enlarge.
Estimated to affect more than two million people in the US, failure of the mitral valve causes blood to flow backwards when pumped out, meaning it can’t reach the rest of the body efficiently.
But a new device — called a MitraClip — clips the faulty valve back together, helping it work properly and pump blood out of the heart. It has now shown promising results in the study published Sunday.
Drugs are available to ease symptoms of a leaky mitral valve, but the long-term effects are unknown, the authors write. Surgery is also an option, and can be curative, but brings significant risk of complications, as patients are often older and more frail.
Implanting the MitraClip is minimally invasive, with the device transferred up through a small incision in the groin, and has now been shown to reduce recovery time and hospitalization, according to the study.
To measure the effectiveness of the device, Dr. Greg Stone, professor of medicine at Columbia University College of Physicians, and his team enrolled 614 patients from the US and Canada with heart failure and moderate to severe secondary mitral valve regurgitation — a leaky mitral valve — who continued to have symptoms despite being on drug treatment for their condition. The secondary form of the condition is when a person’s left ventricle is damaged, prohibiting the valve from functioning properly.
Of the participants, 302 were given the new device and 312 acted as controls. Among those who received the MitraClip, there were 32.1% fewer hospitalizations per year within to years of follow-up.
“The annualized rate of all hospitalizations for heart failure within 24 months was 35.8% per patient-year in the device group as compared with 67.9% per patient-year in the control group,” the authors wrote.
Overall mortality from any cause within those two years was also 17% lower among patients who were implanted with the device compared with the control group, at 29.1% and 46.1%, respectively.
“It’s shocking how positive it is as a new therapy for patients whose hearts are very weak,” said Dr. Michael Acker, the chief of the Division of Cardiovascular Surgery at Penn Medicine. Acker, who is not connected to the research, noted the study findings were far more encouraging than the results of a similar trial reported last month. “On face value, it is very exciting,” he said, but he indicated that further study was necessary to understand the differences in the population groups of each study.
The MitraClip technique was first pioneered 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’s use to treat the secondary form of the condition is currently under investigation and has not yet been approved by the FDA.
The new study was part of the COAPT trial for secondary mitral regurgitation and funded by American health care company Abbott, which produces the device.
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