A Fix For Failing Hearts
A FIX FOR FAILING HEARTS:
ANN ARBOR, MI -University of Michigan athletes really know how to handle footballs and basketballs. But can they turn a basketball into a football?
Probably not — but U-M heart surgeons can. They're fixing sick, basketball-shaped hearts and restoring them to a more normal, football-like shape, using a new device invented at the U-M Cardiovascular Center. The result is new hope, and a new treatment option, for people with heart failure.
More than 5 million Americans have heart failure, which is a catch-all term for hearts that can't pump enough blood to the body. Whether it's caused by a heart attack, an infection, high blood pressure or a birth defect, heart failure changes the shape of the heart, making it round and enlarged like a basketball. The heart muscle has to work much harder than when it was a normal football shape, and patients feel weak and out of breath all the time. Their organs suffer from lack of blood, and they soon die.
But the new device — a tiny titanium and silicone rubber ring — attacks this problem like never before. It fixes a leak within the heart, and at the same time adjusts the size and shape of the heart's main pumping chamber.
That makes it possible to restore some of the heart's normal pumping ability, which helps many patients live better and longer, says U-M heart surgeon Steven Bolling, M.D.
Bolling has been operating on heart failure patients for over 10 years, fixing the structure called the mitral valve that regulates blood flow from the lungs to the heart. In people with heart failure, as the heart gets bigger, the mitral valve doesn't close all the way, and blood leaks backwards toward the lungs. This means the heart has to work even harder all the time and can't keep up — a “vicious cycle,” Bolling calls it.
Fixing the mitral valve alone helps patients, but it would be even better if the pumping chamber, called the left ventricle, could get smaller and more efficient. That idea led Bolling to work on the new ring, which has a special shape that allows it to alter the left ventricle shape and size while also letting the mitral valve close properly.
Now, the ring will be available to other heart surgeons, under the name GeoForm. It will be marketed by a medical device company, Edwards Lifesciences Corp., which licensed the device for development and commercialization, and received clearance from the U.S. Food and Drug Administration for use in mitral valve repair.
“We have been very pleased with the results with this ring,” says Bolling, who has treated 25 patients with the ring so far and says 75 other patients have received the ring at other hospitals. “It does not make patients' hearts normal, and in fact their hearts may never be normal, but we believe that we're affecting not only the quantity of life that they have left, but clearly the quality as well.”
Bolling, who heads the U-M Cardiovascular Center's Mitral Valve Clinic and is a professor of surgery at the U-M Medical School, serves as a consultant for Edwards Lifesciences, which has also funded his research study on the ring's use. He is a co-inventor of this technology, with Italian cardiac surgeon Ottavio Alfieri of the St. Raffaele Hospital in Milan, Both the co-inventors and U-M stand to benefit financially from the sale of this technology.
Not every heart failure patient is a candidate to have their mitral valve repaired and their heart remodeled with the GeoForm ring or more conventional mitral valve rings, Bolling points out.
Each year, nearly 600,000 Americans learn that they've been diagnosed with heart failure. About half of them will develop a leaky mitral valve as their heart changes shape. Many of these patients can get relief from combinations of medicines to make the heart pump faster or stronger, and a few patients will go on to receive a heart transplant or an implanted mechanical pumping device. The U-M Cardiovascular Center offers all of these forms of treatment through its nationally recognized heart failure program.
But about half of patients with heart failure and leaky mitral valves can't be helped by drugs alone. And the number of people diagnosed with heart failure is increasing every year.
“This is a very bad, even disastrous situation for these patients because they now have a very poor heart, and it's not only forced to push blood forwards but also backwards through the mitral valve,” Bolling explains. “The heart is being asked to do twice as much work. It's almost as if you broke your leg and the therapy was to run a marathon.”
Without help, these patients will eventually begin to suffer from kidney failure, liver failure or other problems because their bodies and organs aren't getting enough blood. And once that process begins, death is not far behind. More than 266,000 Americans die each year from heart failure; half of the patients will die within five years of being diagnosed. Many others spend weeks in the hospital as their condition worsens. In fact, caring for heart failure patients cost $25.8 billion last year in the United States alone.
The GeoForm ring, or surgery with another kind of ring, may give many heart failure patients with mitral valve problems their only hope for living longer and better. “The ring itself is made of titanium, so it's very rigid and will hold its shape even against the strength of these very large ventricles and hearts,” says Bolling. “It's wrapped in silicone and then with a nylon cloth that is well liked by the inside lining of the heart and can actually be incorporated into the heart.”
The shape of the ring, he explains, brings the parts of the mitral valve, called leaflets, together. “But it also elevates, or lifts up, the whole ventricle by pulling it up by the whole mitral valve, changing the size and shape of the heart,” he adds. “It's been very clear on the echocardiograms and other tests we've performed on patients that we have changed the shape of the left ventricle, and changed the geometry of the heart with this device.”
The GeoForm ring will be widely available next year, but in the meantime Bolling says he will continue to operate on selected patients who are good candidates to receive it. He's also collecting data on how well these patients do in the hospital and once they go home, and hopes to compile it into a research paper. In April of this year, he presented data from about 25 patients at the annual meeting of the American Association for Thoracic Surgery, and told top heart surgeons from around the country about the GeoForm.
As a member of the U-M heart failure treatment team, Bolling emphasizes that surgery alone isn't enough to make life better for patients. Careful attention to medicines, diet, exercise and stopping smoking are crucial to keeping as healthy as possible and holding on to life's many activities.
But with many more Americans facing the prospect of heart failure as their hearts start to give up, he hopes that mitral valve repair and the GeoForm ring will become important treatment options for patients.
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