(CNN) – A small new device is giving hope for a better life for people with severe heart failure, as it reduces hospitalization rates and improves the risk of mortality after two years of treatment, according to a new study.
Heart failure occurs in about 5.7 million Americans and more than 26 million people worldwide. Affected people report shortness of breath and fatigue because their heart is struggling to pump blood to the body.
One of the causes currently is the insufficiency of the valves, particularly the mitral valve, which controls the flow of blood on the left side of the heart. When the insufficiency is severe, the heart may increase.
It is estimated that this disease affects more than two million people in the United States. This failure causes the blood to flow backward at the time of pumping, which means that it does not efficiently reach the rest of the body.
However, the new device, called MitraClip, keeps the defective valve together and helps it work properly and pump the blood out of the heart. It showed promising results in the study.
According to the authors, there are medications to relieve the symptoms of mitral valve insufficiency, but their long-term effects are unknown. Surgery is also an option and may be the cure, but it can have serious complications because patients tend to be older and more fragile.
The implementation of MitraClip is minimally invasive: the device is transferred through a small incision in the groin and has been shown to reduce recovery time and hospitalization, according to the study.
To measure the efficacy of the device, Greg Stone, a professor of medicine at Columbia University Medical School (USA), and his team recruited 614 people with heart failure and secondary mitral regurgitation in the United States and Canada (when the mitral valve does not close well ) of moderate to severe who continued to present symptoms despite being on pharmacological treatment. The secondary form of this condition is when the patient's left ventricle is damaged, which prevents the valve from working properly.
Of the participants, the new device was implanted in 302 and 312 were the control group. Among those who received MitraClip, 32.1% fewer hospitalizations were recorded per year for the following two years.
"The annual rate of hospitalizations for heart failure at 24 months was 35.8% per patient per year in the group where the device was implanted, in contrast to 67.9% per patient per year in the control group," wrote the authors .
Overall mortality from any cause in these two years was also 17% lower among patients to whom the device was implanted (29.1%), differently from the control group (46.1%).
"It's amazing how this new therapy is good for patients who have a very weak heart," said Michael Acker, head of the Division of Cardiovascular Surgery at the Pennsylvania State University School of Medicine. Acker, who is unrelated to the survey, said the results of the study were much more encouraging than the results of a similar study published in August.
"First of all, it's very exciting," but added that more studies are needed to understand the differences between the population groups of each investigation.
The MitraClip technique was first tested in 2003 and in October 2013 received the approval of the United States Food and Drug Administration (FDA) for the treatment of primary (or degenerative) mitral regurgitation. , according to researchers at the University of Washington. Its use for the treatment of the secondary version of this disorder is still under investigation and has not received FDA approval.
This new study was part of the COAPT study for secondary mitral regurgitation and was funded by Abbott, the US healthcare company that manufactures the device.