(CNN) – A small novel device gives hope for a better life to people with severe heart failure, because it reduces the number of hospitalizations and increases the risk of death after two years of treatment, according to a new study.
Heart failure affects about 5.7 million Americans and over 26 million people around the world. People affected by the disease report dyspnoea and fatigue, because their heart is trying to pump blood into the body.
One of the reasons is currently the failure of valves, especially the mitral valve, which controls the blood flow on the left side of the heart. When the failure is severe, the heart may grow larger.
It is estimated that this disease affects over two million people in the United States. This failure causes blood to flow back during pumping, which means that it does not reach the rest of the body effectively.
However, a new device, called MitraClip, keeps the faulty valve together and helps it function properly and pumps blood from the heart. Promising results in the study turned out.
According to the authors, there are medications that reduce the symptoms of mitral regurgitation, but their long-term effects are unknown. Surgery is also an option and may be a drug, but it can have serious complications because patients are usually older and weaker.
MitraClip implementation is minimally invasive: the device is transmitted through a small incision in the groin and has been shown to reduce recovery time and hospitalization, according to the study.
To measure the effectiveness of this device, Greg Stone, a professor of medicine at Columbia University Medical School (USA), recruited 614 people with heart failure and secondary mitral regurgitation in the United States and Canada (when the mitral valve does not seal well) of severity from moderate to severe due to which symptoms are still present despite pharmacological treatment. The secondary form of this condition is the damage to the left ventricle of the patient, which prevents proper operation of the valve.
Of the participants, the new device was implanted 302, and 312 the control group. Among those who received MitraClip, there were 32,1% fewer hospitalizations per year in the next two years.
"The annual hospitalization rate for heart failure over 24 months was 35.8% per patient per year in the group in which the device was implanted, as opposed to 67.9% per patient per year in the control group," the authors wrote.
The total mortality from any cause during these two years was also 17% lower among the patients in whom the device was implanted (29.1%), in contrast to the control group (46.1%).
"It's amazing how positive this new therapy is for patients with very weak heart," said Michael Acker, head of the Department of Heart and Vascular Surgery at the Pennsylvania State University School of Medicine. Acker, who is not related to the study, said the study results were much more encouraging than the results of a similar study published in August.
"First of all, it is very exciting," but he added that more research is needed to understand the differences between population groups in each investigation.
The MitraClip technique was first tested in 2003, and in October 2013. It obtained the approval of the American Food and Drug Administration (FDA) for the treatment of primary (or degenerative) mitral regurgitation. , according to scientists from the University of Washington. Its use in the treatment of the secondary version of this disorder is still being investigated and has not been approved by the FDA.
This new study was part of the COAPT trial for secondary mitral regurgitation and received funding from Abbott, an American medical company that manufactures the device.