When William Castle DeVries implanted the first Jarvik-7 artificial heart in a patient with end-stage heart disease, the expensive and high-risk procedure sparked debate within the medical community.
In early December of 1982, Barney Clark was diagnosed by his cardiac specialist, William Castle DeVries, as having only hours left to live. The decision was made to implant the recently developed Jarvik-7 heart in Clark. The U.S. Food and Drug Administration (FDA), which has authority over the use of medical devices, had already given DeVries and his associates permission to perform a total of seven Jarvik heart implants for permanent use. The operation was performed on Clark and was initially considered successful. Widespread news coverage heralded this first triumph of the scientific community to support or replace a severely dysfunctioning heart with a total artificial heart. The media considered this achievement a major event in the history of cardiac care: It seemed DeVries had proved that an artificial heart had been developed that was almost as good as a human heart.
The Jarvik-7 heart, designed and produced by researchers at the University of Utah in Salt Lake City and named for chief developer Robert Jarvik, is one of the most well-known advances in so-called spare-parts medicine. Essentially an air-driven pump made of plastic and titanium, the expensive bionic device is the size of a human heart. It consists of two hollow chambers of polyurethane and aluminum, each containing a flexible plastic diaphragm. Two plastic hoses, routed through incisions in the abdomen, carry compressed air to the heart to pump blood through the pulmonary artery to the lungs and the aorta to the body. A disadvantage of the Jarvik-7 is that patients had to be tethered by 2-meter hoses to a large, cumbersome air compressor, which then had to be wheeled from room to room along with the patient.
Shortly after Clark’s surgery, DeVries went on to implant the device in several other patients with end-stage heart disease. For the time being, all patients survived the operation. As a result, DeVries was soon offered a position at Humana Hospital in Louisville, Kentucky. Humana offered to pay for his first one hundred implant operations. Unfortunately, in the three years following DeVries’ earliest operations with the Jarvik-7, doubts and criticism plagued the earliest version of the artificial heart. Of the people who, by then, had received the plastic and metal device as a permanent replacement for their own diseased hearts, three had died and four suffered disabling strokes. The FDA asked Humana Hospital and Symbion, Inc., the manufacturer of the medical device, for detailed histories of the artificial-heart recipients.
William Castle DeVries.
Infections were diagnosed as the cause of each patient’s condition. Life-threatening infection, or “foreign body” response, is a major limitation in the extended use of any artificial organ. The Jarvik heart, with its metal valves, plastic body, and Velcro attachments, provided a receptive area for particularly virulent strains of bacteria resistant to even the most potent antibiotics. Also, the intensive support required to sustain the artificial heart recipients through surgical complications compromised their immune systems and predisposed them to infections that eventually affected the device itself.
By 1988, researchers concluded that severe infection was virtually an inevitable occurrence and that it was a function of how long each patient had to rely on the artificial heart for circulatory support. Consequently, experts recommended the use of the device be limited to thirty days. Long before this research had been completed, however, heart specialists and medical ethicists had questioned whether the artificial heart experiment was worth continuing. They suggested that it was time to go back to the research phase and to experiment on animals.
When the artificial heart program was first started, the question was simply if it would support life. Soon, however, it was not known if the research should continue. In fact, a heated controversial debate grew around the use of the Jarvik-7. Some ethicists argued that the fact that people were going to die anyway did not justify any human experimentation. Extension of life was considered an ambiguous benefit when it allows a patient to live somewhat longer, but burdened by pain, distress, or incapacity. At times, DeVries claimed it was worth the price for patients to reach another birthday; at other times, he admitted that if he thought a patient was going to spend the remainder of his life in a hospital, he would think twice about performing the implant.
Also, there was an ethical debate that centered on the question of “informed consent” that is, the patient’s understanding that going ahead with a procedure not only has a high risk of failure but also may leave the patient miserable even if it succeeds.
Another question was that of cost. It had to be decided if high-cost, high-technology solutions such as the Jarvik heart should be financed or if more should be allocated to preventive measures. Although it was estimated once that a total artificial heart implant could be performed for about $150,000, actual estimates for DeVries’ patients totaled up to $1 million each.
The medical community was criticized for involving a private corporation in basic research. They called this“for-profit medicine.” Humana, a multibillion-dollar corporation, offered to pay for the first 100 heart implants. Critics saw this not only as a priceless public relations ploy but also as a get-rich scheme, since the corporation could land a potential windfall starting with the 101st patient. Although the surgical techniques involved could not be patented, the expertise Humana would develop could give it a virtual monopoly on a market worth an estimated $5 billion.
Some observers also questioned DeVries’ motives and interests: Should the surgeon who performs the implantation own twenty-seven thousand shares of the company that makes the device? Controversies raged on all aspects of the Jarvik-7 experiment. Finally, in December of 1985, an advisory panel of experts recommended that the FDA permit the experiment to continue but only with close monitoring on a case-by-case basis. Not long after, when experts recommended use of the device be limited to thirty days, the Jarvik heart began to be thought of as a “bridge” transplant, while patients awaited living donor hearts.
In the next few years, pneumatically powered mechanical hearts similar to the Jarvik-7 were employed as a temporary method of circulatory support (or bridge) to buy time while a suitable donor heart was identified and cardiac transplantation was performed. Meanwhile, research on the results of these implantations demonstrated that the less time the prosthesis remained in place, the better the results. Unfortunately, infection continued to be a serious and, at times, lethal accompaniment of staged heart replacement.
Concurrent with the efforts to develop these mechanical devices, cardiac transplantation became a reality. By the end of 1985, an international registry reported that 2,577 patients had received cardiac transplants and that four-year survival among those heart recipients was 76 percent. The successes of cardiac transplantation led to a waning of interest in the Jarvik-7 and other artificial hearts as a long-term support device and to a demand for donor hearts that rapidly exceeded the supply. Subsequently, the unavailability of donor hearts for patients in desperate need of immediate transplantation gave rise to the use of the Jarvik-7 as a temporary bridge to transplantation.
Years after the first artificial heart implant took place, major improvements were made on the partial and total artificial hearts being developed. First, these were powered by implantable compact electric motors rather than by external consoles, which did away with the need for the clumsy pneumatic power line. With these devices, electrical energy was transmitted across the intact skin using inductive coupling. This markedly reduced the risk of infection. Moreover, the bulky external power unit required for the pneumatic hearts was replaced with a portable battery of house-current energy supply to enhance the comfort and mobility of patients.
Experience with the Jarvik-7 made the world keenly aware of how far the medical community is from the dream of the implantable permanent mechanical heart. Patients as well as physicians soon realized it was not the panacea it was once thought to be. Nevertheless, it was a bionic breakthrough in the field of spare-parts medicine, which pushed back the boundaries of conventional medicine. For centuries, the problem of duplicating nature’s handiwork with human technology has challenged scientists. The Jarvik-7, however clinically successful it was or was not, represented an advance in the relatively new field of artificial body parts. Other human-made components include heart valves and synthetic blood vessels, and artificial inner ears that enable profoundly deaf patients to improve their understanding of speech. The permanent artificial heart experiment is not concluded. A second generation of devices overcame some of the limitations of the Jarvik-7 by using electric rather than pneumatic drives and taking advantage of new miniaturization and pump technologies. These newer hearts showed some technical promise, but the larger social and ethical questions remain.
The Jarvik-7 raised many difficult ethical questions about the consent process, for-profit medicine, and the like. Indeed, it demonstrated the confusion of American medical experimentation. One might ask if it is acceptable for such patients to volunteer for experiments that could hasten their deaths. Barney Clark’s widow testified that her husband wanted to make a contribution to the artificial heart program.
Even by the beginning of the twenty-first century, society as a whole had yet to come to terms with many such issues brought to light by the first implantation of an artificial heart. Although this medical experiment had its sobering limitations, DeVries demonstrated the artificial heart’s usefulness as an emergency stopgap measure for patients with end-stage heart disease when used as a bridge to a human-heart transplant. The bridge procedure’s success rate, however, has lagged significantly behind that for normal transplants. Moreover, there is another ethical concern: Patients with mechanical hearts may be given priority over others waiting for donor hearts, which are in desperately short supply.
In the long run, some type of permanent artificial implant may be necessary if the growing demand for replacement hearts is to be met. In 2001, doctors at the University of Louisville implanted a completely self-sustaining artificial heart in a patient who survived for a record seventeen months, renewing hopes for the development of a more permanent artificial heart. These hopes had largely faded owing to the fact that few artificial heart recipients lived longer than six months, a fact that had led to the banning of artificial heart transplants except as a temporary bridge to a human heart transplant. The early efforts of DeVries with the Jarvik-7 and other work with bridge implants have served as a step toward the realization of the artificial heart dream.
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Adler, Jerry. “I Have Him Back Again: The Controversial Operation Behind Him, the World’s Second Artificial Heart Recipient Faces a New Life.” Newsweek, December 10, 1984, 74. Excellent summary of the Jarvik-7 controversy. Includes a diagram explaining how the Jarvik-7 works and a sidebar on for-profit medicine titled “Operating for Profit.” -
Cowart, Virginia S. “Artificial Heart Can Be Reassuring Backup for Surgeons, Says Pioneer.” Journal of the American Medical Association 259 (February 12, 1988): 785. Interview with DeVries highlights the benefits of the Jarvik heart. Details the experience of one patient with a Jarvik-7 followed by a human heart transplant. -
Cutler, David M., ed. The Changing Hospital Industry: Comparing Not-for-Profit and For-Profit Institutions. Chicago: University of Chicago Press, 2000. Examines hospitals’ choice of organizational form, either for-profit or not-for-profit, and how these forms affect patients. -
Lyons, Albert S., and R. Joseph Petrucelli, II. “Cardiology and Cardiac Surgery.” In Medicine: An Illustrated History. New York: Harry N. Abrams, 1978. This massive volume is a highly readable and interesting survey of the history of medicine. Heavily illustrated and includes a selected bibliography. -
Pierce, William S. “Permanent Heart Substitution: Better Solutions Lie Ahead.” Journal of the American Medical Association 259 (February 12, 1988): 891. This article highlights the Jarvik heart’s contribution to ongoing research and its effectiveness as a bridge to cardiac transplantation. Pierce describes the improvements being made on artificial hearts. Includes an excellent bibliography. -
Rice, Louis B., and Adolf W. Karchmer. “Artificial Heart Implantation: What Limitations Are Imposed by Infectious Complications?” Journal of the American Medical Association 259 (February 12, 1988): 894-895. A thorough discussion of the primary limitation of artificial hearts as well as of ventricular assist pumps. Bibliography included.
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