Patient gets first totally implanted artificial heart
By Rhonda Rowland
(CNN) -- A patient has received the first completely implanted artificial heart that totally replaces the function of the human heart, researchers announced Tuesday. The implantation is part of a clinical trial of the device.
Surgeons from the University of Louisville implanted the heart Monday in a seven-hour procedure at Jewish Hospital in Louisville, Kentucky. The patient is said to be resting comfortably, but has not been identified.
The AbioCor Implantable Replacement Heart, manufactured by Abiomed Inc., fits inside the body and is battery-operated. The patient is one of five who will be included in initial studies of the experimental artificial heart. They'll be followed for two months and if the results are acceptable, doctors with Abiomed say the FDA may allow studies to expand to include 15 patients.
Abiomed says the device will improve patients' quality of life by allowing them to remain active and productive.
"The major obstacles to all artificial devices, and in particular the new technologies, are making sure the patients have adequate quality of life," said Dr. Mehmet Oz, one of the approved investigators who could be implanting the device in another patient.
"The device needs to be forgettable. You need to have it on and live your life and not worry about it. From a purely medical perspective, the main obstacles are infection and stroke," he added. Oz is director of the Cardiovascular Institute of the College of Physicians and Surgeons at Columbia University.
The AbioCor is designed to move blood through the lungs and to the rest of the body, simulating the rhythm of a heartbeat. The device consists of an internal thoracic unit that weighs about two pounds. It includes two artificial ventricles with valves and a motor-driven hydraulic pumping system.
It has an internal controller and electronics that regulate the pumping speed. It runs on an internal battery that is continually recharged by an external battery. Patients wear the external battery around the waist. A transduction device attached to the skin transmits the charge to the internal battery.
The artificial heart is designed for patients with heart failure or coronary heart disease who have failed all existing therapies. More than 700,000 patients die from heart failure each year in the United States. Many of these patients could be helped with heart transplants, but only about 2,000 donor hearts become available each year for transplantation.
How often would an artificial heart actually be used?
"Occasionally we need an artificial heart," said Dr. Patrick McCarthy of the Cleveland Clinic. "Not very commonly ... but every once in awhile we throw up our hands because the existing options aren't quite good enough."
If studies of AbioCor are successful, researchers say 100,000 heart patients could be helped each year. The cost per device is expected to be about $70,000.
"One of the key issues as a population that we have to address is what are we willing to pay for these new technologies," explained Oz. "I think that we should expect to spend about $70,000 per year to keep someone alive. Not twice that, but also not half that. If we have that rational expectation and insist on getting that quality for our money, I think we'll be happy."
In the early days, some cardiologists warned that the new device might unnecessarily raise patient hopes.
"We'd like the public to have rational expectations," said Oz. "Don't treat a failure of the device as a failure of the technology. We never flew across the world in our first endeavor."
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