For around two million Americans, heart failure is a prominent, life-threatening issue. Everyday life can be difficult—just sitting up straight or walking a few feet can make people with heart failure run out of breath. Certain medical conditions or traumas, like a heart attack, can cause one’s heart to significantly weaken or stiffen, to the effect of not being able to pump blood efficiently. The heart then swells and works harder to compensate, and it eventually becomes misshapen. This process damages the organ further by causing the mitral valve (which regulates blood flow) to spring a leak; blood that was originally directed to flow into the body begins flowing into the lungs and back into the heart. And although drugs have been able to control the symptoms to some degree, there is no cure. Considering that most people do not have long to live moving forward from a heart failure diagnosis, it is essentially a near-death sentence.
COURTESY OF NORTHWESTERN MEDICINE
But the future is looking up! The NY Times recently reported that a new device is sharply reducing the number of deaths and hospital visits among patients with heart failure. It has even been shown to reduce the intensity of symptoms in a large clinical trial.
The device is made by Abbott Laboratories and is called the “MitraClip”: a small clip is inserted into a patient’s heart and positioned between the two flaps of their damaged/leaking mitral valve in order to keep them closed together. Although Abbott funded the trial, outside experts have reviewed the resultant data. They concluded that the clip functions properly, insofar as its purpose to repair a broken valve in the heart so that it can once again regulate blood flow in and out of the heart as normal.
Some studies of the MitraClip in France have yielded conclusions that it is ultimately unsubstantiated in its claims to cure heart failure patients. However, these participants had less severe heart failure and less optimal medications than the patients in the U.S.-Canada trial. In this trial, there were 212 people who received only medications and no clip, then 120 who received the clip. Of those with no clip, 151 were hospitalized in the following two years and 61 died. Of those with the clip, only 92 were hospitalized and 28 died. Cardiologists—including those from Mount Sinai Hospital in N.Y.—say the study was executed flawlessly and are very optimistic about its development.
The MitraClip alone costs $30,000, not including the expenses of a hospital and a team of doctors, like a surgeon, interventional cardiologist, echocardiologist, etc. Although it is expensive, most medical insurers will cover the device once/if it is approved by the FDA for all patients with heart failure. It is already approved for patients with less severe heart failure who are too frail for most procedural measures, but cardiologists predict it will not take long for the FDA to approve it for more severe cases as well. In fact, Dr. Gregg Stone of Columbia University has stated how the insertion of the MitraClip is much less invasive than the alternative (open-heart surgery), which can be too intense for some patients.