Experimental Procedure Could Lead to More Options for Patients With Failing Hearts
By WebMD Medical News
Reviewed by Gary D. Vogin, MD
July 3, 2001 -- In a milestone experimental procedure, surgeons from the University of Louisville implanted the first self-contained, mechanical heart into a critically ill patient at Jewish Hospital.
In January, the FDA approved the use of the titanium and plastic pump in five patients, who all would be too sick to undergo a transplant with a genuine human heart. The researchers say this device is expected to extend a patient's life for just a month or so, but they are hoping it will help usher in a new era where doctors have more options to offer patients with failing hearts.
Laman Gray, MD, and Robert Dowling, MD, had trained by implanting the grapefruit-sized device in calves and performed the surgery on the patient Monday. The hospital gave no information on the patient, not even saying whether it was a man or a woman. All that was announced was that the patient was "resting comfortably" on Tuesday.
Heart surgery teams at five U.S. hospitals had been trained and poised to remove a diseased natural heart and install in its place an electric-powered pump designed to fit inside the chest with no wires or tubes sticking through the skin.
The device, known as AbioCor, is made by Abiomed Inc. of Danvers, Mass. It is designed to allow recipients to maintain a productive lifestyle while wearing it, which is considered a technological leap from earlier mechanical hearts.
Power is sent from a battery pack worn outside the body through the skin to an implanted coil, control package and backup battery.
David M. Lederman, Abiomed's president and chief executive officer, said earlier this year that if the experiments are successful, more patients could be added to the trial.
The patients selected for the trial must be suffering from a chronic, progressive heart disease expected to result in death within 30 days. They had to be ineligible for receiving a human heart transplant.
The price tag of the artificial heart should range between $70,000 and $100,000, which is less than the cost of a regular heart transplant. But doctors say it is too soon to project how the costs will compare between this experimental procedure and the standard transplant.
So far, the goal of the experimental trials with the artificial heart is to "double the life span of these patients" to 60 days, Lederman said. And they are being realistic about their results.
"Every patient will probably die on the AbioCor," he said. "We need to understand that, with this new technology, we may have failures."
Lederman said a second goal is to evaluate how the mobile mechanical heart affects the quality of life of those patients, most of whom are so ill that they cannot walk or perform the daily routine of life, such as getting dressed.
And, in the long run, the technology may one day allow doctors to help patients who are eligible for standard heart transplantation but are unable to locate a donor organ quickly. AbioMed has said that there are 100,000 patients who need a heart transplant each year, but only 2,000 organs become available.
For decades, that difference between organ supply and the number of patients who could benefit by receiving one has made doctors interested in developing artificial models.
The artificial hearts used experimentally in the 1980s, however, were different from the AbioMed version in that they were attached to machinery outside the body with wires and tubes.
The first recipient, Barney Clark, a Seattle-area dentist, lived 112 days after receiving a Jarvik-7 device on Dec. 2, 1982. The survival record for a total artificial heart is held by William Schroeder of Jasper, Ind., who lived 620 days on one before he died in August 1986.
But artificial heart patients of the 1980s all had a variety of complications, and use of the devices as permanent replacements for diseased hearts was largely suspended.
Still, the scientists building the next generation of devices -- including those that assist rather than replace a diseased heart -- learned too much to consider those early tests mistakes.
The second man to receive a Jarvik-7, Thomas Gaidosh, of Sutersville, Pa., was on the device only a few days before he received a human heart transplant. He lived 11 more years, long enough to be best man at the wedding of inventor Robert Jarvik, MD.