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LOUISVILLE, Ky. (AP) — A patient on the brink of death has received the world’s first self-contained artificial heart — a battery-powered device the size of a softball that runs without the need for wires, tubes or hoses sticking out of the chest.

Two surgeons from the University of Louisville implanted the titanium and plastic pump during a seven-hour operation at Jewish Hospital on Monday. The hospital said the patient was “awake and responsive” Tuesday and resting comfortably. It refused to release personal details.

The patient had been expected to die within a month without the operation, and doctors said they expect the artificial heart to extend the person’s life by only about a month.

But the device is considered a major step toward improving patients’ quality of life.

The new pump, called the AbioCor, is also a technological leap from the mechanical hearts used in the 1980s, which were attached by wires and tubes to bulky machinery outside the body. The most famous of those, the Jarvik-7, used air as a pumping device and was attached to an apparatus the size of a washing machine.

“I think it’s potentially a major step forward in the artificial heart development,” said Dr. David Faxon, president of the American Heart Association.

However, he said the dream of an implantable, permanent artificial heart is not yet a reality: “This is obviously an experimental device whose long-term success has to be demonstrated.”

Only about half of the 4,200 Americans on a waiting list for donor hearts received them last year; most of the rest died.

Some doctors, including Robert Higgins, chairman of cardiology at the Medical College of Virginia in Richmond, said artificial hearts are unlikely to replace donor hearts.

“A donor heart in a good transplant can last 15 to 30 years,” he said. “It’s going to be hard to replace that with a machine.”

The experimental heart, made by Abiomed Inc. of Danvers, Mass., was implanted by Drs. Laman Gray and Robert Dowling, one of five surgical teams across the country trained to use the device in human experiments.

The AbioCor has a two-pound pumping unit, and electronic controls that adjust the pumping speed based on the body’s needs. It is powered by a small battery pack worn outside the body that transmits current through the skin.

The heart also has a rechargeable internal battery, about the size of a pager, that can work on its own for about 30 minutes — long enough for a patient to remove the battery pack and take a shower, for example.

The hope is that such mechanisms will one day allow recipients to lead a relatively normal life, said John Watson of the National Heart Lung and Blood Institute, which has given $20 million toward research into self-contained artificial hearts.

“They are able to do just about anything they like to do up through, what I call, moderate exercise,” Watson said.

David M. Lederman, Abiomed president and chief executive, said in April that the company had received federal approval to perform at least five human trials with the artificial heart. The patient in Louisville is the first to receive the device.

Patients selected for the trial must be suffering from a chronic, progressive heart disease expected to result in death within 30 days. They have to be ineligible for a human heart transplant. Most of the patients are so ill that they cannot walk or perform the daily routine of life.

The

goal of the experiments with the artificial heart is to double the life span of these patients to 60 days, Lederman said earlier this year.

“Every patient will probably die on the AbioCor,” he said. “We need to understand that with this new technology, we may have failures.”

The first recipient of an artificial heart, Barney Clark, a Seattle-area dentist, lived 112 days after receiving a Jarvik-7 in 1982. William Schroeder of Jasper, Ind., lived longest with a complete artificial heart — 620 days before he died in 1986.

Artificial heart patients of the 1980s all had a variety of complications, and the use of the devices as permanent replacements for diseased hearts was largely suspended in the United States.

The inventor of the Jarvik-7, Dr. Robert K. Jarvik, said he favors devices that help the heart heal and said the new AbioCor is not needed.

“Many years of experience have taught us that cutting out the heart is unnecessary,” said Jarvik, president of a company that makes heart assist pumps.

Copyright 2001 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

After surgeons implant artificial heart, debate rages on its usefulness

By MIKE CHAMBERS Associated Press Writer

LOUISVILLE, Ky. (AP) — As the world’s first self-contained artificial heart throbbed inside the chest of its recipient, reaction from the medical community to the experimental operation ranged from guarded excitement to sharp criticism.

The procedure — the first major advance in the development of an artificial replacement heart in nearly two decades — received a cool reception from one of the field’s best-known pioneers, Dr. Robert K. Jarvik.

“Many years of experience have taught us that cutting out the heart is unnecessary,” said Jarvik, who helped develop artificial heart technology. Medical science should instead focus on devices that assist the heart in healing, he said.

The softball-sized titanium and plastic pump was implanted into a dying patient Monday by surgeons from the University of Louisville during a seven-hour operation at Jewish Hospital.

The hospital said the patient was resting comfortably and had been responsive to family members Tuesday night but did not speak. Officials refused to release any personal details.

Jarvik said the latest artificial heart is too large to fit almost all women and would affect only about 1 percent of the potential heart transplant candidates.

The heart implanted Monday has electronic controls that adjust the pumping speed based on the body’s needs. It is powered by a small battery pack worn outside the body that transmits current through the skin.

Called AbioCor, the heart also has a rechargeable internal battery, about the size of a pager, that can work on its own for about 30 minutes — long enough for a patient to remove the battery pack and take a shower, for example.

The patient given the AbioCor had been expected to die within a month without the operation, and doctors said they expect the artificial heart to extend the person’s life by only about a month.

“I think it’s potentially a major step forward in the artificial heart development,” said Dr. David Faxon, president of the American Heart Association.

However, he said the dream of an implantable, permanent artificial heart is not yet a reality: “This is obviously an experimental device whose long-term success has to be demonstrated.”

Abiomed Inc., the Danvers, Mass.-based maker of the device, sees it as a potential tool to not only save lives but to allow patients to maintain a quality of life after heart failure.

Over 700,000 Americans die each year from heart failure and this new technology could benefit more than 100,000 people in the United States, the company said. Only about half of the 4,200 Americans on a waiting list for donor hearts received them last year; most of the rest died.

The AbioCor is considered a technological leap from the mechanical hearts used in the 1980s. Those devices were attached by wires and tubes to bulky machinery outside the body.

The most famous of those, the Jarvik-7, used air as a pumping device and was attached to an apparatus the size of a washing machine. Five people would get the device in the early 1980s.

The first recipient, Barney Clark, a Seattle-area dentist, lived 112 days after receiving a Jarvik-7 in 1982. His widow was pleased Tuesday upon hearing there had been a completely contained, mechanical heart implanted in Kentucky.

“I’m really thrilled,” said UnaLoy Clark-Farrer from her home in St. George, Utah., recalling her late husband’s decision to volunteer his life for medical science.

Some doctors, including Robert Higgins, chairman of cardiology at the Medical College of Virginia in Richmond, said artificial hearts are unlikely to replace donor hearts.

“A donor heart in a good transplant can last 15 to 30 years,” he said. “It’s going to be hard to replace that with a machine.”

The latest experimental heart was implanted by Drs. Laman Gray and Robert Dowling, one of a handful of surgical teams across the country trained to use the device in human experiments.

The hope is that such mechanisms will one day allow recipients to lead a relatively normal life, said John Watson of the National Heart Lung and Blood Institute, which has given $20 million toward research into self-contained artificial hearts.

Copyright 2001 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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