Elizabeth Cohen: Ethics of the artificial heart

CNN Correspondent Elizabeth Cohen

CNN Medical Correspondent Elizabeth Cohen discusses the ethics behind giving a patient an experimental artificial heart, the first artificial heart fully contained inside a human body. She talks about the patient, his progress and what doctors are hoping.

Q: This man had been given an 80 percent chance of dying within 30 days. What will be considered a success with this artificial heart?

COHEN: One measure of success that has been used for experiments on patients with this kind of life span is can you double the life span. Can the doctors get him to 60 days, instead of just 30 days?

If they can, then they will ask the FDA for permission to put this heart in 15 patients, instead of just the five they are planning to do now.

The doctors are hoping for at least six months, however. They say, 'Yes, two months would be a success.' But they're really hoping for six months to a year.

A bigger question is what kind of quality of life will the patient have. After all, the Jarvik heart worked on Barney Clark for 120 days and worked on William Schroeder for nearly two years. But their quality of life, according to many, was pretty terrible.

The doctors here say they are very committed to a quality of life that is much better than what the Jarvik patients had.

Q: What are the major ethical questions within the medical community about whether these hearts should be used on a more regular basis?

COHEN: The major ethical questions for the doctors at this stage are: Are they using this man for more than just a guinea pig? In other words, can he expect something more than just a life lying in bed? Are they offering him some hope of having a better life?

Ethicists say we shouldn't just use patients as guinea pigs, that we have to offer them something.

The other ethical question is: Has the company that makes the heart, AbioMed, fully informed the patient and his family about what he's getting into? The company says it has. It has not handed over a copy of the consent form he signed. But company officials say they told him he may not even make it through the operation.

Q: Do the doctors expect the patient to be mobile or bed-ridden once he has recovered from the surgery?

COHEN: They say he is not going to be running marathons, but he will be able to get out, go shopping, walk around and do household chores and other activities. That's what they're hoping for.

But I emphasize the word, hope, because they really don't know what will happen. This man was at death's door. This is a heart that's never been put in a human being before. He might not last the next two months. They just don't know.

Before the surgery, he was able to do almost nothing. He was given less than a 20 percent chance of living through the next month. He was in a wheelchair. He could walk only a few feet. He had renal failure. He had diabetes. He had trouble eating.

Q: How do the doctors feel at this point?

COHEN: The doctors are very, very excited, but then in almost the same breath they say, 'We don't know what's going to happen to this man.' They say he is doing better than expected. He is able to nod and squeeze people's hands in response to questions. Still, they are very cautious.

Q: What's the main difference between this heart and the Jarvik-7 artificial heart of the 1980s?

COHEN: The Jarvik-7 hearts had to be tethered to a power source the size of a dishwasher. This heart is completely implanted inside the body. A person can last about a half-hour without any kind of external battery, but most of the time the patient will have a battery pack around his waist. The external battery powers an internal battery. The external battery can last about four hours. If the patient is going to be out doing things for longer than that, he needs to bring extra batteries.

Q: How much does such a heart cost and does insurance cover it?

COHEN: Like any other experiment, it's the maker of the device that's paying for it.

This procedure is so experimental. It's the first time it's ever been done in a human being. The whole question of insurance is way, way, way down the line. The doctors estimate it would cost about $70,000 per patient. But again they don't even really know if this works well in humans.

Q: Has this heart been used in animals?

COHEN: The doctors tried this heart in calves, and they say the calves did fabulously. However, calves grow fast, and they outgrew the heart after about three months. So they don't know if they were going to last more than three months, but it was proof of the principle that the heart works in a living, breathing animal with blood running through it.