People who have heart failure and an associated valve disease called mitral regurgitation typically have symptoms such as extreme fatigue and shortness of breath that affect their quality of life, and medications may not be enough to improve the condition. There now is a new treatment option that may restore these patients to fuller lives. In March, the Food and Drug Administration (FDA) approved use of a valve repair device, called MitraClip, for patients with moderate or severe mitral regurgitation and symptoms of heart failure.
MitraClip has been on the market since 2013 for patients with abnormalities in the mitral valve (the valve between the left atrium and the left ventricle) who cannot tolerate surgery. That condition is known as primary or degenerative mitral regurgitation.
The FDA is now permitting MitraClip for patients with a normal mitral valve who develop heart failure along with moderate to severe mitral regurgitation because the left heart chamber is no longer functioning properly — a condition known as functional regurgitation.
“The MitraClip was developed as an alternative to surgery if the valve is leaky because regurgitation is from a degenerative problem,” says Marcella Calfon Press, MD, an interventional cardiologist. “The exciting development is there is this whole other group of people with functional regurgitation who now can be helped by use of the MitraClip device.”
Mitral regurgitation occurs when blood leaks backward through the mitral valve into the heart’s left atrium. In patients with functional mitral regurgitation, the valve is not damaged, but the left heart chamber does not function properly, interfering with blood flow through the valve and worsening the symptoms of heart failure.
Cardiologists typically try various medications to treat the condition or may use cardiac synchronization, which involves implanting a pacemaker in the heart to improve heart rhythm. But those options may not be enough. “There are so many patients who have heart failure and are on medication who remain symptomatic,” Dr. Press says. “We can now offer them another therapy that could make a big difference in their quality of life.”
The MitraClip treatment is a minimally invasive procedure performed by an interventional cardiologist. The physician threads a thin catheter through the femoral vein in the groin and guides it to the heart’s left atrium through a small puncture. The MitraClip is guided toward the mitral valve using ultrasound. The device is deployed and attaches to the two leaflets of the valve to clip them together and reduce the backflow of blood. Dr. Press says that Mitraclip implantation is a safe treatment option with low rates of procedural-related complications.
A study of 614 patients with functional mitral regurgitation published late last year in the New England Journal of Medicine showed that the risk of being rehospitalized for heart failure symptoms was reduced by about 47 percent in people who received the MitraClip compared to those who continued medication therapy. The risk of death within two years was reduced by about 37 percent. “We’ve seen how much better patients feel after this,” Dr. Press says. “One of the most gratifying things is how the quality of life of our patients improves. They are able to walk longer, and they feel better and come to the hospital less often. For some patients, it is life changing.”