L O U I S V I L L E, Ky., July 3, 2001 -- Each year 38,000 Americans wait for a heart transplant, but only about 2,000 get their wish. Monday, researchers took a giant step toward a solution, by implanting a patient with the first-ever completely self-contained mechanical heart.
The operation, led by surgeons Laman Gray and Robert Dowling, took place at Jewish Hospital in Louisville. It is the first of five implants authorized by the Food and Drug Administration on terminally ill heart patients.
The seven-hour procedure consisted of removing the patient's weakened heart muscle, leaving just the major blood vessels, then attaching the AbioCor, a pump made of titanium and plastic.
At 2 pounds and 4 inches in diameter, the AbioCor is the first artificial heart to fit entirely inside a patient's chest. There are no protruding wires or tubes, reducing the risk of infection. The pump is recharged by a small battery pack, worn by the patient, that passes energy across the skin without piercing the surface.
"I'm very excited by this," said David Faxon of the American Heart Association. "This is a major breakthrough … One of the advantages of a totally implantable artificial heart is that people can walk around, they can go to the store, and they can go shopping. They can do normal daily activities."
The AbioCor is about an inch larger than an ordinary human heart and can only be fitted into patients with bodies large enough to accommodate the device.
'An Alternative to Transplant'
Nevertheless, it represents a great improvement over earlier attempts at artificial hearts. The most famous model, the Jarvik-7, kept Seattle dentist Barney Clark alive for 112 days in 1982. In addition to requiring constant attachment to a mammoth external source, the Jarvik-7 caused Clark and other patients to suffer from depression and repeated strokes, prompting the FDA to discontinue further research.
During its current trial the AbioCor, which had until now only been tested in calves, will be implanted in patients with about a month left to live and no chance of receiving a human heart transplant. "Initially, we're putting this in the group of people who are the sickest they can be, until we can prove that it works and find out more about this operation," says Gray.
Hospital administrators are providing no details on the recipient of the heart, other than to say the patient is resting comfortably. Abiomed, the company behind the AbioCor, did warn that the first recipients would be so sick that surviving just a couple of months would be considered "success."
In most other patients with failing hearts, researchers say the pump might extend lives by years. "Our goal here is to have a device that will function for five years, maybe longer, to have as an alternative to transplant," said Gray.