Heart failure affects nearly two million Americans and millions more worldwide. It can range from mild to severe wherein even the ordinary activities of daily life become difficult.
A new device called the MitraClip (from Abbott) has been shown to benefit patients with secondary mitral regurgitation and reduce death rates among them significantly.
The heart is a relentless worker in the body that pumps out blood to the different parts of the body. As the heart muscles fail due to disease or drugs or other pathologies, the pumping action declines.
A walk up the stairs and sometimes even across the room may lead to severe breathlessness among sufferers.
There are medications that can help control the symptoms related to heart failure, but this is a progressive condition with no known cure.
This week however, researchers have come up with a heart device that can help patients with secondary mitral regurgitation.
The team of researchers used the MitraClip in a large clinical trial and found that patients using it had fewer hospitalizations, fewer debilitating symptoms and also a marked improvement in quality of life.
The results of the study called COAPT, were published in the latest issue of the New England Journal of Medicine and were also presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 meeting in San Diego by lead author Gregg Stone, MD, from Columbia University, New York City.
The mitral valve controls the blood flow between the left atrium and the left ventricle. As the heart fails and the organ becomes weak, the mitral valve gets pulled and fails to function normally.
This leads to stagnation of the blood within the heart that back flows into the lungs causing more severe symptoms. The MitraClip made by Abbott, is used to repair the mitral valve by attaching the two flaps together in the centre.
Some of the patient recruitments took place at the University of Pennsylvania and its Director of interventional cardiology, Dr. Howard Herrmann, called this study a “huge advance”. “It shows we can treat and improve the outcomes of a disease in a way we never thought we could,” he said.
The next step would be seeking approval from the Food and Drug Administration for its use in the treatment of severe secondary mitral regurgitation.
The researchers hope that insurers like Medicare would cover it soon. This study was funded by the makers Abbott and was reviewed by external experts. Earlier a smaller study in France (Mitra-FR) had failed to find the MitraClip effective in heart failure patients. There were several problems with this study though, say experts.
Once the MitraClip was in place, the valve functions were renewed and blood flow out of the heart normalized. In this new trial 614 patients with secondary mitral regurgitation from United States and Canada were recruited. The participants were divided into two groups – those on standard care alone and those on the MitraClip along with standard care.
- Those on medical treatment alone had 151 (68 percent) hospitalizations for secondary mitral regurgitation in the duration of the study (2 years)
- 92 (36 percent) of those on medical treatment and MitraClip were hospitalized for secondary mitral regurgitation
- 70 (23 percent) of those on medical treatment alone died during the first 12 months of the study
- 57 (19 percent) of those on MitraClip and medical treatment died during the first 12 months of the study
- Deaths at 24 months during the study were 29 percent among those with the MitraClip and 46 percent among those without the device
- Only 3.4 percent of those who underwent the MitraClip surgery faced complications
- The device functioned perfectly as planned in 95 percent participants
Mount Sinai Medical Center also enrolled some patients for the study. Dr. Gilbert Tang, a heart surgeon there, said that this trial was a “powerful message”. NYU Langone Health also recruited a few patients and Dr. Mathew Williams, director of the heart valve program there called this a “game changer”.
Expert cardiologists reviewing the study have called it “impeccably executed”. The device alone is estimated to cost around $30,000.