- The Washington Times - Friday, April 20, 2001

An adult near death from heart disease will soon receive the first self-contained artificial heart in experimental surgery designed to double life expectancy and greatly improve quality of life.
If all goes well, the patient — one of five slated to receive the new mechanical heart in clinical trials at five U.S. hospitals — will go from a state of immobility to one in which he is able to walk, shower, dress and perform other basic functions, said the hearts developers.
To be eligible for the trial, a patient must have chronic progressive heart disease that is expected to cause death within 30 days.
With the artificial heart — known as the AbioCor — the patient could hope to live for another two months. "And we hope to demonstrate that patients can return to a more normal lifestyle," said Robert T.V. Kung, the top scientist at Abiomed of Danvers, Mass., which manufactures the artificial heart.
Mr. Kung estimates that approximately 100,000 Americans with heart failure could prolong their lives with the device, which has been under development for 30 years.
"But once the AbioCor system gets established beyond clinical trials, we see a much broader patient population it could help," Mr. Kung said.
"In fact," he said, "we hope to so improve our system that well get to a point where it can last five years."
Artificial hearts are nothing new. But the AbioCor is the first implanted complete artificial heart that is not attached to large electrical or pumping power consoles outside the chest.
"Those consoles, which are attached to the patient, are about the size of a washing machine," Mr. Kung said.
The AbioCor, which replaces a natural defective heart, is an electrically powered pump that fits inside the chest, with no wires or tubes sticking through the skin.
Mr. Kung said only about 10 artificial hearts are in use in this country today, and all are in patients awaiting heart transplants. The AbioCor is the only one for use by patients who are not candidates for transplants.
The AbioCor is a pump made of titanium and plastic with four protruding tubes that are connected to the bodys cardiac vessels. There are internal mechanical valves that mimic the action of the natural hearts pump system.
Power comes from a battery pack worn outside the body. A coil sends power through the skin to an implanted coil that then carries the power to an implanted control package and a backup, short-term battery.
The external battery pack must be recharged every four hours, but the patient can wear a spare package. The internal battery is kept charged and can operate the heart for about 30 minutes without the external battery.
The pump, implanted in the chest, and its support devices, implanted in the abdominal cavity, weigh a total of 3 pounds. The external battery pack and monitor, worn on a belt, weigh about 4 pounds.
Company officials said the AbioCor will cost about $75,000, and procedural expenses will add another $175,000.
Mr. Kung said the performance of the mechanical heart can be monitored constantly at a remote center. A low-frequency radio signal is sent from the external monitor worn by the patient, picked up by a transmitter and relayed to a central computer that reads the pumping rate, temperature and general condition of the artificial heart.
The lead scientist said he is "very optimistic about the trials."
"We have good clinical teams working with us, and we have a device that can pump blood and pump it well," he said. "But that doesnt mean we wont encounter problems."
Mr. Kung said many of the same professionals involved in developing AbioCor took part in the development of another cardiac device, known as the intra-aortic balloon, four decades ago. That device, which helps the heart pump, is a staple of cardiac therapy today. But Mr. Kung said the first 13 patients who used it in clinical trials died.
The five hospitals that have received FDA approval to implant the AbioCor are Brigham & Womens and Massachusetts General in Boston; Hahnemann University Hospital in Philadelphia; the Texas Heart Institute in Houston; the Jewish Hospital in Louisville, Ky.; and the UCLA Medical Center in Los Angeles.
Abiomed officials said they will wait at least 30 days after the first artificial heart is installed before announcing the results.
After the five trials are completed, Mr. Kung said, the FDA will review the findings. "They will then come up with an evaluation as to whether we can expand our trials to 15 patients," he said.

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