Artificial Hearts for "Investors"

Home Health Columnist / Guide · Jul 10, 2001

Learning Lessons by

Heart Patient Still Stable

From Associated Press at 6:04 PM

The first patient to receive a self-contained artificial heart remained in stable condition Sunday, six days after the transplant.

Doctors and staff at Jewish Hospital, where the surgery was performed last Monday, were able to rest over the weekend during what spokeswoman Linda McGinity Jackson called a "quiet period."

In a National Public Radio interview broadcast Saturday, Dr. Robert Dowling said the man, who is alert and writing notes to family members, is on a blood thinner to prevent clots and might be put on medication for hypertension.

"We couldn't be happier with how he's doing," Dowling said.

--------------------------------------------------------------------

Learning Lessons by Heart

By Guy Gugliotta

Washington Post Staff Writer

Sunday, July 8, 2001; Page A01

http://www.washingtonpost.com/wp-dyn/health/A30161-2001Jul7.html

He lies in a Louisville hospital bed, a middle-aged man about whom almost nothing personal is known except the most intimate details of his health. He was - and perhaps still is - about to die.

Last Monday, surgeons at Jewish Hospital removed his diseased heart and replaced it with a man-made pump constructed of hard plastic and titanium. It was the first fully implantable artificial heart ever put inside a human being.

"He has shown improvement every day," surgeon Robert Dowling said Friday. "He's interacting with doctors and nurses through his gestures, and the device is functioning flawlessly."

Although the man's long-term prospects remain far from clear, his doctors have been surprised by his early progress, said his condition was unchanged yesterday and have even speculated that he may eventually be able to leave the hospital and return to some semblance of a normal life.

In the meantime, however, medicine's latest effort to tackle one of the most difficult technological challenges ever attempted is remarkable for yet another reason - its absence of controversy.

Experimental treatments involving the desperately ill often pose many complex ethical questions, particularly when the object of the treatment is to cheat death in spectacular fashion.

The first artificial heart implants in the 1980s proved so controversial and fraught with ethical pitfalls that the field was all but abandoned for 15 years. Many observers speculated that those problems - coupled with advances in treating heart disease, improvements in the outcomes of transplants, and the development of highly effective partial heart pumps - might preclude any future attempts to develop a full artificial heart.

While some of those questions and potential ethical traps remain, even some of the harshest critics of earlier efforts acknowledge that so far, Abiomed Inc., the Danvers, Mass., company that developed the AbioCor device, appears to have learned well from the mistakes of the past.

"One of the ethical issues that I would have flagged would have been hubris, and they are not guilty," said University of Pennsylvania medical sociologist Renee Fox, an expert on the ethics of organ replacement and transplantation. "They are not only prudent, but very candid."

Abiomed waited until new technology enabled its AbioCor heart to be fully enclosed inside the patient's chest, lessening the chance of infection and eliminating the need for the device to be tethered to a power source through an open wound.

The company wrote a 13-page consent agreement, spelling out 14 separate potentially fatal risks associated with the implant, everything from liver failure to tissue damage caused by an overheated device.

It set up an Independent Patient Advocacy Council to provide each patient with a knowledgeable mentor and funded the council with an irrevocable blind trust, leaving the four initial members to add advocates as they saw fit.

No council member, surgeon or anyone else connected with the clinical aspects of the experiment is allowed to hold stock in Abiomed. No one from Abiomed is allowed to meddle with the council. No one in the media was allowed to know the name of any council member except chairman Elizabeth Haavik Morreim of the University of Tennessee's College of Medicine.

Abiomed briefed reporters on the company and the device in April and discussed the Louisville surgery at a July 4 news conference. But it refused to divulge the patient's name or discuss his background except as it related to his medical condition.

And to further dampen publicity, it has cautioned repeatedly that no matter how well the patient's recovery has appeared to be going, the man was so sick - with diabetes, kidney failure, hypertension and overall weakness - that he could die at any time.

Abiomed Vice President Ed Berger said the company extensively studied the 1980s cases of Barney Clark and William Schroeder, who received Jarvik 7 artificial hearts powered through wires and tubes inserted through incisions in the skin and connected to a noisy, bedside console the size of a refrigerator.

The public's initial euphoria gave way to distress as the two patients contracted infections and illness before dying. Many wondered whether the implants had simply prolonged the men's suffering.

"The extension of life without improving the quality of life is an empty goal," Berger said. "Abiomed took a very, very long time to wait for big technological developments and then apply them to the device."

Electronics miniaturization shrunk the console to the size of a telephone beeper. The transcutaneous energy transmission system, or TETS, enabled electricity to flow from an external battery pack to electrodes mounted inside a patient's abdomen.

Neither advance improved the heart's function, but that wasn't the idea. "They learned that you should not implant an artificial heart that is not totally implantable and totally forgettable," said ethics specialist George Annas of the Boston University School of Public Health. The Jarvik 7 console "was extremely loud, and you could never get away from it. You could never live a normal life."

But Abiomed, like Jarvik, had the additional problem that regardless of how quiet the machine was, its early patients by definition would be so ill that they would never be able to live a "normal" life.

This, Fox said, "is what a colleague calls the 'black years' of developing new medical technologies - when the device is completely new, when the patients are terminally ill and it is likely that unhappy events will occur."

Robert Jarvik said the missteps with Clark and Schroeder were almost inevitable, in part because of the "black years" phenomenon. He noted that a variant of the Jarvik 7 is routinely used today for brief periods without mishap by patients awaiting heart transplants.

"It's not pleasant for so many years to be trashed like that," Jarvik said. "Abiomed faces that risk too, and unfairly if they have bad results. It takes time to work out the details."

Abiomed's formula for success was modest. Patients would be chosen only if they had been rejected for transplantation and were judged to have an 80 percent chance of dying within 30 days. With AbioCor, the company hoped to double the lifespan.

"Can a person in such a situation give an adequately free and informed consent?" asked medical ethicist Robert M. Veatch of Georgetown University's Kennedy Institute of Ethics. "I call this a 'coercively attractive offer' - you die in 30 days, or you take this offer and get 60 days. The offer may be irresistible, but that doesn't necessarily make it immoral. I am not troubled as long as patients know the trade-offs."

The consent agreement made sure of that. Besides the risks associated with the operation, the agreement detailed six activities that patients should avoid, including traveling long distances and swimming, which could cause the device's pressure settings to malfunction. "This could lead to serious injury or death," the agreement said.

Abiomed recruited the University of Tennessee's Morreim to set up the Advocacy Council in mid-1999. The council has two at-large members, including herself, and six on-site members serving as patient advocates at the five hospitals authorized by the Food and Drug Administration to perform the implantations.

Morreim said the on-site advocate in Louisville consulted extensively with the Jewish Hospital patient and his family and was present when the consent agreement was signed. And while in Louisville, Morreim was asked to identify the advocate but she refused.

"At first we were worried about them being misquoted, but then I thought further," Morreim said. "If the [advocate's] face becomes known and he was seen in the hospital, people would know an implant was coming. Would that be a good idea? I don't think so."