Salt Lake City Utah, Dr. William DeVries operated on Barney Clark, a dentist from Seattle, to replace his failing heart with a mechanical one. Clark suffered multiple complications, both involving his own body and the functionality of the Jarvik-7 mechanical heart, and after 112 days of extraordinary efforts to keep Clark alive, his heart was turned off on March 23, 1983, and he died. When he died, the Jarvik-7 heart had beaten 12,912,499 times (Pence, DATE).
This medical event raised a number of medical, legal and ethical issues involving The ability of Clark to continue to make his own medical decisions, the NIH decision to allow DeVries to use the heart on a human, whether the state of Clark's health following his surgeries justified the extreme measures taken to try to extend his life, and possible conflicts of interest regarding Dr. DeVries.
Shortly after World War II, two members of congress who had special interests in medical issues generally and heart disease in particular pushed for the government to fund research on the causes and treatments of heart disease (Pence, DATE).
This research led to a variety of developments in the treatment of life-threatening heart disease. Michael DeBakey developed a "left ventricle assist device" (LVAD) in the 1960's (Pence, DATE). Research on that approach continues to this day. LVAD's, by supporting the function of the ventricles, can keep a heart going until a transplant is available.
The National Institutes of Health (NIH) funded the development of artificial hearts from 1964 to 1982 as well as LVAD's. During that time they provided $200 million in funds for that research (Pence, DATE). DeVries, working with Robert Jarvik, who had previously invented the first devices for hemodialysis to support patients with kidney failure, worked on an artificial heart that would attach to the atria, replace the ventricles, and be pumped from external equipment. The patient would have to be connected by tubes to the external machinery, which weighed 375 lb. And was contained on a rolling cart fo the patient could have some mobility (Pence, DATE).
Barney Clark was not the first patient caught up in ethical discussions regarding an artificial heart, however. In 1969, a colleague of DeBakey secretly hired some of DeBakey's staff in an attempt to develop his own artificial heart. The patient, Haskell Karp, was supposed to receive an artificial, in itself a very new and controversial procedure then. Instead, Cooley implanted his LVAD, without permission from the United States Public Health Services committee that reviews medical experiments (Pence, DATE). Karp survived, comatose, for three days. It turned out later that Cooley had tried his device in several calves, all of whom died. Cooley repeated the operation on a human two years later with similar results. By comparison, DeVries was working on his artificial heart working within rules established within the medical profession (Pence, DATE).
There were serious medical issues involved in the decision to implant the first Jarvik-7 heart into Barney Clark. Clark had not only severe heart disease but severe emphysema as well. He might have been a candidate for a heart-lung transplant, except for his age, 61. The heart-lung transplant program had a cutoff age of 50 (Pence, DATE). Medically it was a difficult decision because of the very real possibility that the surgery itself could kill Clark (Pence, DATE).
The Jarvik-7 was designed to replace the lower two chambers of the heart, the left and right atria, the parts that do the pumping. It was constructed primarily of plastic, polyurethene and aluminum, and attached to the ventricles with Velcro, with one strip of the two-piece system attached to the bottoms of the ventricles. It ran on compressed air provided by the external unit and connected to the mechanical heart with tubes (Pence, DATE).
The surgery itself was not uneventful. DeVries could not get the implanted heart to function properly, and after trying to force it to work three times, doing something that introduced real risk of a stroke for the patient each time, he had to replace a defective part from another Jarvik-7. They also had great difficulty stitching the Velcro strip to Clark's ventricles because the walls were very thin.
Clark suffered many medical problems after the surgery. Repeated infections because of the necessity of hoses entering his body led to complications from all the antibiotics. He deteriorated in significant ways psychologically, and finally died from multiple organ failure, never achieving anything resembling what most would consider an acceptable quality of life (Pence, DATE).
DeVries had permission from the NIH to proceed under some guidelines. In addition the hospital had put strict guidelines in place, requiring among other things that the patient be near death (Pence, DATE). DeVries technically met the multiple restraints placed on whom should receive the first Jarvik-7.
One of the grounds for criticizing DeVries' determination that the operation was a success was that other prominent heart surgeons seemed to set a higher mark. Michael DeBakey, for instance, argued that a good outcome should be that the patient returned to "normal life" (Pence, DATE). DeVries argued that Clark's surgery amounted to being experimental. While Clark acknowledged that the surgery was experimental, clearly he also hoped that it would be therapeutic and thereby extend his life (p. 286). DeVries argued that it was up to the patient and his family to judge whether the quality of life was adequate. Clark was willing to take a gamble on life, but critics argue that he may not have fully realized just how severe the complications after the surgery might be, and in particular they argue that he might not have agreed had he known that his ability to think clearly would end up compromised (Pence, DATE). These considerations suggest that DeVries rationalized the success of the surgery. Interviews with Clark were heavily edited so that most people did not hear the negative things he had to say about his medical experience with the Jarvik-7. Others compared Clark's experience to the case of Karen Quinlan, who remained on life support for years before dying (Pence, DATE). Critics suggest that DeVries put so much time and energy into developing an artificial heart that he had lost objectivity regarding its usefulness and potential risks.
This seems borne out by what DeVries had to say at the time. He described Clark as better off: "up and around. He was putting golf at one point..." (Academy of Achievement, DATE). DeVries did not mention the mental deterioration or what it took to be "up and around" but tethered to a rolling 375 lb. machine, unable to leave the hospital.
Another ethical consideration deals with the organ the Jarvik-7 replaced. If the mechanical heart fails, the patient will die within minutes. This is not true with dialysis; the patient can simply be hooked up to another machine, or wait a day for dialysis. While unpleasant, it would not cause immediate death. The mechanics of an artificial heart need to be very dependable, and in the case of the Jarvik-7 they were not. Valves broke and the interior surfaces made it easy for clots to form (Pence, DATE). It's also questionable whether Clark could make medical decisions for himself after the first surgery because of his deteriorated mental health (Pence, DATE).
But one of the most serious issues is DeVries' conflict of interest. In addition to his years of research on artificial hearts, which may have clouded his objectivity, DeVries had significant financial interest in the company that sold the Jarvik-7. Several companies had invested in this company and one had, in 1982, pledged a significant purchase -- if a successful Jarvik-7 surgery was performed. That was the same year Clark was operated on.
The newer artificial hearts weigh about 2 pounds and are completely contained within the human body, eliminating tubes and the ongoing risk of infection they represent (Simmons, 2001). The interior surfaces are extremely smooth so the surfaces will not facilitate clot formation (Simmons, 2001).
However, research with animals has its limitations. Often calves have been used to test new artificial hearts, but the circulatory system of the cow includes small blood vessels at the base of the skull that prevent blood clots from entering the brain. Thus that biological model cannot test one of the greatest risks to human recovery (Simmons, 2001).
Simmons (2001) argues that informed consent must include a more realistic explanation of the many medical risks that will follow such surgery, along with a realistic assessment of just how unpleasant those complications can be. He notes that researchers will continue to work on artificial hearts, making ethical questions timely and important.
Critics argue that "prolonging death is no triumph" (Ehrenman, 2003). This may depend on the nature of the prolonged death. A cancer patient who lives for three more years, 33 months of which is spent able to be with his family, walk his daughter down the aisle to get married or see a grandchild born, might say the price was worth the…