The patient has been identified only as a man in his 50s, a man who met all the FDA's qualifications for the procedure: He was at least 18 years old and of large enough build for his chest to accommodate the grapefruit-size titanium-and-plastic device. Both his original heart's pumping chambers had failed, as had all standard heart therapies. He had been rejected for a heart transplant because he also had diabetes, kidney failure and he was drowning internally from pulmonary edema, a buildup of fluid in the lungs that occurs in heart failure. He had an 80 percent chance of dying within 30 days.
"He had no other option," one of the surgeons, Dr. Laman A. Gray, said. "He was in as dire shape as you can ever have anybody in."
So he had what it took to make medical history. And by the end of the seven-hour implantation surgery, performed at Jewish Hospital in Louisville by Dr. Gray and Dr. Robert D. Dowling of the University of Louisville, he was very newsworthy indeed.
The Associated Press learned about the operation Monday from an unnamed source; Tuesday, Dr. Gray and Dr. Dowling were in front of the microphones telling reporters that their patient was resting comfortably, awake and responsive. Then they started talking about the day not far away when a man with a machine in his chest could go back home, go back to work, take out the trash if it wasn't too heavy.
Thursday, Dr. Gray was on "Good Morning America," telling Diane Sawyer and Charles Gibson that he and his patient had a pact: "He's going to take me fishing and teach me how to bass fish."
The patient's new heart is the AbioCor, made by Abiomed of Danvers, Mass. It is the second type of totally artificial heart to be tested in people the Jarvik-7, you may recall, was implanted in patient Dr. Barney Clark at the University of Utah in December 1982 but it is a great leap forward. The Jarvik-7 was air-driven, which meant that tubes had to connect huge compressors to the device. Mobility was impossible; infection and complications were inevitable.
The AbioCor runs on a tiny internal pump that spins about 10,000 times a minute, moving hydraulic fluid through a valve that alternately allows blood to be pumped to the lungs or the body. There is a small battery inside the device powering its control unit; that battery is in turn powered by an external battery pack (worn on the belt or suspenders) that transfers energy across the skin, without any connections. Without wires. Without tubes.
The patient will be the first artificial-heart recipient in history to take a shower.
For now, he is an experiment. Dr. David M. Lederman, Abiomed's president and chief executive, said the initial goal in testing the device would be to "double the life of the patient and to give the patient a reasonable quality of life, which is 60 days." Dr. Lederman said he hoped patients would live longer.
Complications are inevitable with a heart this new and a man this sick, but as the week went on the AbioCor, whirring away at a steady 120 beats a minute (later, it will be adjusted to respond to the patient's level of activity) was outperforming expectations. By Tuesday morning even after a second, two-hour operation to repair a loose stitch it had already cleared the patient's lungs of fluid.
Wednesday, Gray and Dowling were expressing optimism that their patient would be able to return to daily activities. Thursday, he went back on a ventilator, but only to rest and speed his recovery, the doctors said.
Asked Wednesday when he considered the implant a success, Dr. Gray said that as a clinician it was "when we have made him better."
"Success is when we have helped somebody," he added. "We may not achieve everything the first few times, but we are trying to."
If the patient is still alive in a week, news coverage will drop off to nothing clearly a good sign. If the patient is still alive in a month, Dr. Gray may consider himself to have helped. If the patient is still alive in two months, walking around and changing his battery every two hours, he will have met Dr. Lederman's standard and by then will probably have taught his doctors how to bass fish by then.
And then maybe they'll tell us the patient's name.