Sunday, November 07, 1999
Surgeon's invention could help thousands
Tests begin on device to treat heart disease
BY TIM BONFIELD
The Cincinnati Enquirer
A Tristate surgeon-inventor has developed a simple-looking device that might add years of healthy living to thousands of people dying from congestive heart failure.
Dr. David Melvin calls it the CardioClasp.
At first blush, the idea of wrapping a low-tech metal band around an ailing heart seems too simple a solution to one of America's leading causes of death. But a venture capital group out of Minnesota sees enough promise in the concept to risk a million dollars in seed money.
“This device ... would present an entirely new therapeutic intervention for congestive heart failure for many people and provide a minimally invasive alternative to heart transplants, arti ficial hearts and heart-assist pumps,” Dr. Melvin said.
Animal testing has begun at three research centers: Columbia University, Temple University and Massachusetts General Hospital. If that work goes well, human testing could start within a year.
Heart failure is the steadily declining ability of the heart muscle to pump blood, either from sudden damage caused by heart attacks or deterioration of muscle function from viral infections, valve malfunctions, years of high blood pressure and other problems.
An estimated 5 million Americans are living with heart failure. More than 400,000 new cases are diagnosed a year, according to the American Heart Association. About 50 percent of all sufferers die within five years.
The only cure for heart failure has been an organ transplant. Only about 2,000 people a year nationwide get heart transplants.
So, medical science has been searching for alternatives. Over the years, researchers have designed various types of artificial hearts and pump-assist devices. Several medicines and surgical techniques also help control heart failure symptoms.
To Dr. Melvin however, improving life for heart failure victims is a matter of pure physics.
In heart failure, healthy football-shaped hearts swell into puffy basketball-shaped organs. The tissue is weak, and the change in shape alters the heart's pumping efficiency.
About a decade ago in Brazil, Dr. Randos Batista discovered that removing part of a diseased heart, then stitching the organ back into its proper football shape, can help patients with heart failure.
In 1996 and 1997, several U.S. medical centers started performing Dr. Batista's procedures, including Yale, the Cleveland Clinic, Buffalo General Hospital and the Jewish Hospital in Louisville.
But the Batista surgery failed for as many as one-third of patients, said Dr. Patrick McCarthy, surgical director of the Kaufman Center for Heart Failure at the Cleveland Clinic.
While the surgery often improved the way the heart muscle squeezes, in some patients it also hampered the organ's ability to relax between squeezes. In addition, there was concern that the surgery removes potentially useful heart muscle.
Now, the Cleveland Clinic performs a modified version of the Batista procedure, called the Dor procedure, which reshapes the heart by removing scar tissue caused by past heart attacks.
Dr. Melvin says his CardioClasp can achieve the same results with less risky, less costly surgery.
The CardioClasp consists of two curved pieces of polymer-coated titanium joined with sliding cables to make an adjustable, flexible oval.
The device is wrapped around a bulging, diseased heart to apply just enough pressure to change the shape.
Mathematical models show that changing the internal radius of the heart's pumping chamber as little as a half-inch can significantly ease stress on the heart tissue. In theory, the clamp can improve pumping efficiency 25 to 30 percent, Dr. Melvin said.
The CardioClasp is one of at least three devices at various experimental levels that follow this shape-changing approach, said Dr. McCarthy.
They include a sock-like device used in at least 25 patients in Europe, and a clamp-like device made by
MyoCor Corp. in Minneapolis, that has begun human trials.
The potential advantage of the CardioClasp device is that it requires minimally invasive surgery techniques to install.
Early human tests of CardioClasp will involve a chest incision, but will not require stopping the heart and using a heart-lung machine.
The clasp can be disassembled, its parts inserted through a small hole between the ribs, then reassembled around the heart from the inside as the surgeon watches his work on a video screen.
However, many questions remain. Is the device the right shape to achieve its goal? Once installed on a beating animal heart, will the clamp stay in place? Does it damage heart tissue? Would it interfere with blood vessels leading in and out of the heart, or with coronary bypass grafts?
Dr. Melvin, 56, launched the heart transplant program at University Hospital in 1985. But after helping the hospital win accreditation for the program, he decided to pursue his interest in medical devices.
He spent a year on sabbatical in Vienna. Then he went back to college to pursue a Ph.D in biomedical engineering, which he said is nearly complete. And he started inventing.
In 1996, he started a fledgling company called Cardioenergetics to pursue a handful of ideas related to treating heart disease.
Now, instead of an operating room, Dr. Melvin splits his time between labs at the University of Cincinnati College of Medicine and a used wooden desk in a one-room office at Bio/Start, Cincinnati's biotech business incubator.
If animal testing is successful, CardioClasp could be offered for human testing within a year.
If that is successful, the product would require approval from the U.S. Food and Drug Administration for general marketing — a process that could take about two and a half years, Dr. Melvin said.
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