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The artificial heart juggernaut.

The Artificial Heart Juggernaut

In May 1985 a panel of experts urged the National Institutes of Health to resume funding to develop a totally implantable permanent artificial heart:

Fully implantable ventricular assist systems, in which an auxiliary pump takes over the function of the diseased ventricle, may be beneficial for some patients; for other patients, bilateral functional replacement or a total artificial heart will be necessary. Therefore, the mission of the NHLBI (National Heart, Lung and Blood Institute) program should include the fully implantable total artificial heart.1

Based on that recommendation, in January 1988 the government awarded grants worth more than $22 million to four research groups. Then in May, the NIH abruptly announced that it would suspend the program as of September 30. But two months later there was yet another shift in policy; bowing to congressional pressure, NIH restored the funding. To understand the ebbs and flows in government policy regarding the artificial heart, it is necessary to review recent medical developments and changing assessments of the device.

Failed Promises

The 1985 report was issued in the flush of excitement and publicity surrounding the implantation of Jarvik-7 pneumatic artificial hearts on a permanent basis in four patients--William Schroeder, Murray Haydon, and Jack Burcham in Louisville, KY, and Leif Stenberg in Stockholm--since November 1984. Three were still alive. (The first permanent recipient, Barney Clark, lived 112 days after his December 1981 operation.) Schroeder had suffered a stroke but was living with his wife in a specifically equipped apartment across the street from the hospital after six months on the Jarvik-7. Haydon was experiencing respiratory problems but was stroke-free after three months on the device, and Stenberg appeared to be recovering well a month after his implant. Only the case of Burcham, who died ten days after his April 1985 operation, was a clear failure. His surgeon, William C. DeVries, acknowledged that the device may have shortened Burcham's life.

Four years later, however, reports in the lay press and medical journals have contributed to a widespread perception that the Jarvik heart and artificial hearts in general are unacceptable as permanent devices. The misgivings about the Jarvik-7 are evident in the difficulty DeVries, who performed four of the five permanent implants, has had in finding volunteers for another such operation. None has been done since April 1985. While the increasing age limit for heart transplants has had much to do with this, DeVries himself has said that negative news reports about the artificial heart have led to reduced patient referrals. In the afterglow of Schroeder's implant, DeVries received 100 inquiries a week. By early 1988 they were down to one every other week.(2)

The negative news accounts concerned the difficult lives of Schroeder, Haydon, Burcham and Stenberg. Schroeder lived 620 days on the Jarvik heart, but in that time he suffered four strokes and chronic infections that sapped his strength and left him severely impaired, both mentally and physically. Near the end, believing their husband and father had been through enough, Schroeder's family asked that no more heroic measures be taken to extend his life (The Courier-Journal, (Louisville, KY), 8 August 1988, 1A). Haydon lived more than a year, but spent most of that time in the intensive care unit attached to a respirator that assisted his breathing. He also suffered a minor stroke and infections. Stenberg probably gained the highest quality of life of all the permanent recipients. In the months after his implant, he was able to live outside the hospital during the day, dine out at restaurants and walk the streets of Stockholm. But that all came to an end when he suffered a massive stroke after four months on the artificial heart. The stroke convinced Stenberg's surgeon, Dr. Bjarne Semb, that the Jarvik-7 should not be used as a permanent device until it is modified (The Courier-Journal, 26 October 1985, 1B).

The extent of the problems--and the difficulty of finding solutions--was revealed in February 1988 by DeVries and colleagues in a series of unusually frank articles in the Journal of the American Medical Association. DeVries attempted to put the results in the most favorable light. "It is extremely rare--if ever--that clinical research has been so dramtically successful for the initial subjects," he wrote, noting that because of the artificial heart, the patients "enjoyed their families, births of grandchildren, marriages of their children, fishing excursions, and even participated in parades."(3) The device, he noted, proved reliable, except for a single valve failure with Barney Clark, and was capable of supporting life for almost two years.

But the reports also said severe infections were virtually inevitable after thirty days on the Jarvik-7. The synthetic device acted like a magnet or culture medium for bacteria, which thrived in and around it. Significantly, the drive lines that had carried compressed air from the external power source to the hearts in Schroeder's and Haydon's chests were found to be relatively free of bacteria. The implication was clear: The infection problem, which had been thought of largely as a complication associated with devices tethered to external pumps, would not be defeated simply by implanting the entire device, thereby eliminating cross-skin connections. "It is evident from our observations that further developments in the field of biomaterial compatibility are needed to improve the prospect for prolonged survival of patients with artificial hearts," wrote DeVries and his colleagues.(4) More-over, the device's propensity to throw off clots, the cause of strokes, appears related to the infection problem, DeVries reported, noting that strokes coincided with blood infections.

Nonetheless, DeVries contends that it is too early to draw conclusions about the Jarvik-7 after only five permanent implants. He is fond of recalling that the first sixteen kidney dialysis patients died. "I can say I can give the patients a long life, and I think I can give them a better quality of life than they had," DeVries said the week before the JAMA articles appeared. "I intend to go on with the project."(5) (In June, however, DeVries resigned from the Humana Heart Institute International, which funded his artificial-heart work. It was the final act in a long-running feud with the institute's director, but also indicated DeVries's desire to devote more time to his private practice and less to development of a machine to replace the human heart.) In editorials accompanying DeVries's JAMA reports, two of his peers said DeVries's work had helped pave the way for bridges to transplant and had illuminated how the body responds to implantation of a mechanical pump. But Dr. William S. Pierce, developer of the Penn State artificial heart and the Pierce-Donachy ventricular assist device, and Dr. Gerald M. Lawrie of Baylor College of Medicine, said little would be gained from further permanent implants of the Jarvik-7. "Unfortunately, given the present state of the art and science," Pierce wrote, the problems of strokes and infections "will not be readily solved."(6)

While DeVries's work with permanent implants was idled, Symbion, manufacturer of the Jarvik-7 (now the J-7), found a new market for its heart. Between August 1985 and December 31, 1988, 138 Jarvik hearts were implanted as bridges to transplant in patients whose natural hearts failed before a donor heart became available. Just over half--seventy-four patients--received subsequent transplants and lived at least thirty days. Pierce has used his pneumatic Penn State Heart on three patients, with no post-transplant survivors.

The ventricular assist device (VAD), another type of pump intended to help rather than replace a failing human heart, also is being used as a bridge to transplant. As of December 1988, eighty-four bridge patients had been connected to the Pierce-Donachy pneumatic VAD, manufactured by Thoratec, and forty-seven were discharged alive after getting transplants. As of February 1988, four patients had been bridged with a Thermedics pneumatic assist device, with one long-term survivor after transplant, and six of eighteen patients were longterm post-transplant survivors after being bridged with an electric VAD made by Novacor. All together, artificial hearts and heart-assist devices have been implanted as bridges in more than 200 patients worldwide. Since 1986, more than 100 Americans have received heart transplants after being kept alive with a bridge device. That represents about 3 percent of the estimated 4,000 heart transplants performed during that period.

Ventricular assist devices have performed at least as well as the Jarvik-7 in holding patients over for transplants. At a February 1988 conference on circulatory support devices sponsored by the Society of Thoracic Surgeons, a number of surgeons said that so far, it seemed patients bridged with assist devices were suffering fewer infections and other problems than those bridged with artificial hearts. This made sense, they said, because the natural heart, which can help fight infections, remains inside the chest with assist devices. Even Dr. Bartley Griffith, who has used the Jarvik-7 as a bridge more than anyone else in the United States, said, "There's something about taking the heart away that makes a difference in infection." But he added that it was too early to tell whether the Jarvik-7 or ventricular assist devices were better bridges to transplant.

The assist devices are not problem-free. The same week DeVries's articles appeared in JAMA, a study in the New England Journal of Medicine reported that six of twenty-nine patients suffered infections while supported by the Pierce-Donachy VAD, and seven of twenty-one who got transplants had post-transplant infections. Infections caused death in two patients. Two recipients suffered minor strokes, probably due to device-related blood clots. And excessive bleeding was a major problem, as it is for artificial hearts. Moreover, the authors cautioned that putting the hardware inside the body could make the device subject to the problem plaguing the artificial heart--the synthetic materials are prone to infection.(7)

Nevertheless, at least two companies appear close to trying totally implantable electric VADs in humans. Dr. Peer Portner, president of Novacor, predicted recently that his company's totally implantable VAD will receive government approval for human trials by the end of 1989. Novacor is already testing an electric assist device in humans, but its power source remains outside the body, requiring a wire to cross the skin. Only one-third of the patients bridged with this device are alive, but one of the survivors was on the pump ninety days. The fully implantable version is undergoing durability tests in the laboratory. A dozen such systems have operated continuously for eighteen months without failure, Portner said (The Courier-Journal, 13 May 1988, 1B). Another company, Thermedics, expects to begin human trials with its fully implantable electric VAD by February 1990. The device recently kept a calf alive for five months (Newsweek, 22 February 1988, 74-75).

The Public Policy Pendulum

The federal government's involvement with artificial hearts began in 1964, when Congress appropriated $581,000 to establish an artificial heart program in the National Institutes of Health. The program quickly became a top priority, with annual funding of about $10 million and an ambitious goal of starting human testing of a totally implantable artificial heart by 1970. But progress in both government and private laboratories was slow, and efforts to devise a reliable and implantable pump foundered, particularly when an NIH panel concluded in 1973 that the then-favored plutonium-powered heart posed an unacceptable risk to the public. By the late 1960, the NIH director had given top priority to the development of implantable left ventricular assist devices, and in 1973 these devices became the sole focus of the artificial heart program. Because assist devices were simpler than artificial hearts, NIH believed they would pose fewer engineering challenges. The government research agency also felt that assist devices would benefit a majority of heart patients because heart disease often primarily affects one ventricle. Finally, government researchers believed that as problems with ventricular assist devices were overcome, the solutions would be applicable to artificial hearts.(8) While the government continued to spend about $10 million a year on heart assist devices, the task of developing a device to replace irreversibly diseased hearts fell to the private sector.

NIH's approach changed somewhat with the 1985 report of the Working Group on Mechanical Circulatory Support of the National Heart, Lung and Blood Institute. The panel endorsed--albeit with some ambivalence--continued government support of development of circulatory support devices and urged NIH to include fully implantable artificial hearts in its program. In his charge to the panel in 1983 NHLBI director Claude Lenfant asked the Working Group to assess whether "technical advances, clinical advances, or perceptions of clinical needs...made a cardiac replacement device (artificial heart) an appropriate current targeted goal" (p. 40). The panel answered "yes," but other than stating that some patients will need mechanical support for both sides of the heart, the report does not detail why they advocated this change in course. In an October interview Lenfant said that VAD components had been developed to the point that a fully implantable artificial heart appeared feasible. It seems reasonable that clinical advances, namely the Jarvik-7 implants in Utah and Kentucky, also helped to persuade the panel that artificial hearts showed promise and should receive federal support. Federal involvement also would serve as a check on private developers seeking to rush the devices into widespread use. Besides, said panelist Albert R. Jonsen, it would have been futile to seek to stop development of the artificial heart at that point, before it had been adequately tested. "It seems necessary that a new device or procedure show itself to be unacceptable before the society will reject it," he wrote.(9) By May 1985 the artificial heart had not shown itself to be unacceptable.

But three years later Lenfant found it to be just that. "While the device itself seemed to work well, the biology didn't work," he said. "The human body just couldn't seem to tolerate it...We were left wondering whether the idea of a permanent replacement will ever work" (The Atlanta Constitution, 12 May 1988, 1A). Lenfant said he was influenced by DeVries's JAMA articles and reports of complications suffered by bridge patients who remained on the Jarvik-7 longer than a few weeks.

Despite all his misgivings about the artificial heart, Lenfant might have continued its funding had the money not been needed elsewhere. In October Lenfant said the decisive factor in his decision to suspend funding was that the implantable left ventricular assist devices are about ready for human testing. Lenfant said the nearness of human trials became evident only in 1988. The NHLBI does not have enough money, he said, to fund both human testing of ventricular assist devices and continued development of the artificial heart (The New York Times, 20 May 1988, 12A). Besides, he said, it makes sense to first see if the simpler ventricular assist devices work, and to fix their problems, before spending more on artificial hearts (The Atlanta Constitution, 12 May 1988, 1A).

Lenfant's decision can be viewed as the outcome of an ethical debate. Since Clark's implant in 1981, critics have questioned many aspects of the artificial heart experiment: the consent process, the independence of institutional review boards, the involvement of for-profit Humana Inc., the allocation of huge sums for an end-stage treatment instead of for prevention of heart disease, and the patients' quality of life. Because of such questions, an advisory panel of the Food and Drug Administration held a hearing in late 1985 to review the agency's oversight of DeVries's experiment. It decided to require DeVries to submit detailed reports of each case before he be permitted to implant another heart. In addition, it recommended that "outside collaborators" be added to DeVries's team of researchers to ensure that scientific data were put together in a more orderly fashion and were submitted to the FDA and professional medical journals (The Courier-Journal, 21 December 1985, 1A). These steps probably accounted in part for the extraordinarily thorough articles DeVries prepared for JAMA. DeVries said the news media also deserved credit for the explicit articles. "I had to report my negative results," DeVries said recently--something that is not often done--because of extensive press coverage of his patients' difficulties.(10) Armed with the JAMA articles and other negative reports, Lenfant decided that no more money should be spent on artificial hearts, at least temporarily. It should be noted, however, that Lenfant was not suggesting, as many critics have urged, a reallocation of health care dollars to prevention programs. No, the money was steered to another expensive mechanical treatment for endstage heart disease, and Lenfant left open the possibility of later resuming support for artificial heart development if heart assist devices prove successful (The New York Times, 17 May 1988, 1C).

Ultimately, politics overrode ethics. Lenfant's May announcement of the funding suspension threw artificial heart manufacturers and other backers into an uproar. Their sentiment, as later stated by Jarvik-7 developer Dr. Robert Jarvik, was that Lenfant "should expand the program markedly, rather than attempt to cripple it" (The New York Times, 8 August 1988, 16A). Without added government support to speed the development of a new generation of miniature hearts--such as an egg-sized pump Jarvik is developing to fit inside the ventricles--the Japanese or scientists and engineers from some other nation would realize the dream first.

The spurned contractors enlisted the support of two powerful senators, Edward M. Kennedy and Orrin G. Hatch, who not incidentally represented the home states of two contractors. Hatch wrote a bill that would have barred NIH from starting any new programs before funding the artificial heart contracts, and Kennedy, chairman of the committee that approves NIH's budget, also applied pressure. In defense of their actions, the senators noted that an NHBLI advisory panel, while ratifying Lenfant's decision, had appealed for more funding to continue the artificial heart program (The New York Times, 8 August 1988, 16A). Not surprisingly, Lenfant's superiors bowed to the senators' wishes and ordered him to continue the funding. Lenfant meanwhile asserted that "nobody was much interested in my original reasons" for cancelling the contracts. "It troubles me that the issue became me against the four contractors instead of one scientific viewpoint against another" (The New York Times, 8 July 1988, B7).

Bridge over Troubled Waters

This was not the first time, nor will it be the last, that entrepreneurs have been allowed to push ahead despite questions, all the while being rooted on by a public yearning to cheat death. The recent experience with bridges to transplant provides several examples of ethical concerns--about inadequate reporting of data, uninformed consent, "wasting" of donor hearts and inequitable access to transplants--being mostly ignored. George Annas has argued convincingly that bridges to transplant do not save lives--they merely shuffle the recipients of donor hearts;(11) but surgeons, perhaps out of a sense of obligation to do everything possible for individual patients, have been unable to resist using the growing palette of devices. "Everyone laughed at this a few years ago, and now they're trying to jump on the bandwagon and get it themselves," said Dr. Donald Hill, who in 1984 did the first bridge with a ventricular assist device.(12) Surgeons have gladly cooperated with the for-profit device manufacturers--some even own stock in the companies--which are eager to enlist more doctors and hospitals. The manufacturers sell the still-experimental devices to hospitals and even charge money to train hospital staffs in their use. Some doctors complain in private that the companies are slow to make needed, but costly, improvements in their devices, but the doctors continue to use them. And the for-profit Humana hospital chain is not alone in seeing the publicity benefits from using artificial hearts and assist devices. In a television commercial Humana ran in 1988 for its Medicare supplement insurance plan, actor Burt Lancaster described Humana as "the people associated with the artificial heart..." Not to be outdone, the president of nonprofit Jewish Hospital in Louisville, seated among reporters at an April press conference to announce the transplantation of a patient who had been bridged with a Pierce-Donachy pump, stood without identifying himself to ask the transplant surgeon whether the Jarvik-7 artificial heart was "becoming passe." The Jarvik heart, of course, just happens to be used as a bridge device at Humana Hospital-Audubon, Jewish's main local competitor in heart surgery.

In this climate, it is hardly surprising that some medical centers without government approval to use artificial hearts or ventricular assist devices have devised their own bridges devices by using the blood pumps from heart-lung bypass machines--something any hospital that does heart surgery has. Because the pumps have already been approved by the FDA for use in heart-lung machines, no further authorization is required for doctors to use them as bridges to transplant. And their use in this fashion need not be reported to the FDA, manufacturers, or anyone else. Consequently, there are no reliable numbers available on how frequently these so-called centrifugal pumps have been used as bridges. At the February 1988 conference of thoracic surgeons, however, it was reported that a heart-transplant registry had received voluntary reports of twentyfive centrifugal pumps being used as bridges, with ten patients being discharged from the hospital after transplants. At the meeting, the largest to date devoted to circulatory support devices, a number of surgical teams, including some who practice in community hospitals, presented mostly positive results of their use of centrifugal pumps either as bridges or to allow the heart to recover after openheart surgery. The presentations no doubt encouraged some of the hundreds of heart surgeons in attendance to go home and try it themselves. But if they did, their decision was based on selective and probably overly optimistic results. Without the FDA compelling complete reporting, surgeons often do not report their patients' deaths at conferences or in journals.

for example, DeVries said in a February 1988 interview that he has used the centrifugal pump on four patients whose hearts did not resume pumping after open-heart surgery, and his colleagues at Humana-Audubon have used the devices on four or five other patients since 1984. All died, and none of the cases has been reported, he said. With such incomplete or nonexistent reporting, it becomes impossible to compare the results of using centrifugal pumps with those of the other bridge devices--known as pulsatile pumps because they pulse blood like the natural heart. As a result, DeVries noted, he cannot fulfill the requirements of the informed consent process; he cannot assure his patients that a better device than the one he uses is not available. DeVries is particularly bitter that the FDA required him to report his results with permanent implants of the Jarvik-7 after each operation, while centrifugal pumps go unregulated. This inconsistency is not only unfair, it skews surgeons' decisions about which devices to use. DeVries said he used the centrifugal pump on several occasions, even though he had the Jarvik heart on the shelf, because the FDA had not yet given him approval to use the artificial heart as a temporary device. In addition, he said, patients must sign a consent form before receiving a device as part of an FDA clinical trial. Obtaining a patient's consent can be impossible, however, if the patient cannot be weaned from a heart-lung machine or goes into acute rejection following a transplant. In those cases, doctors turn to the centrifugal pump because patients need not consent to its use, DeVries said.

Dr. Laman A. Gray, Jr., a University of Louisville transplant surgeon who has used centrifugal pumps about ten times in the last two years, said the low cost of the pumps, in the absence of data showing them inferior to other devices, influences his decision to use them. While he is reluctant to use the $9,000 Pierce-Donachy assist device on patients who are not transplant candidates and whom he deems to have a poor chance of survival after heart surgery, he is more likely to try the $1,000 centrifugal pump as a last resort, he said.(13)

Finally, the incomplete reporting of the centrifugal pump data prevents its proponents from making the argument that the device's use as a bridge to transplant is ethically justifiable because of the knowledge that may be gained about the human heart or a device that can be used permanently. If the device does not save lives, as Annas argues, and it does not contribute to knowledge, then its use as a bridge cannot be defended on ethical grounds. To some extent this criticism can also be leveled at FDA-regulated bridge devices. In a speech at the thoracic surgeons meeting, Abhijit Acharya, director of cardiovascular devices for the agency, complained that the view that bridge devices are therapy and not experimentation has created obstacles to orderly data gathering. Some manufacturers and surgeons have moved slowly to use uniform protocols, and some have been reluctant to share data, he said.

In the past two years, the waiting list for heart transplants has grown from 300 to 1,000 patients, and many will die before organs become available. With transplant candidates far outnumbering the available donor hearts, the use of artificial hearts and assist devices as bridges to transplant becomes increasingly attractive, but as Annas wrote in 1985, "leaves us with a significant number of patients on artificial hearts that were believed to be temporary, but have become permanent" (p. 28).

Annas was prescient. Simple mathematics makes it clear why this is happening. Circulatory support devices become more prone to infections and stroke-causing clots the longer they are implanted, and recent studies suggest they become especially vulnerable after three weeks. Infections and most strokes are contraindications to heart transplants. Yet the median wait for a heart transplant in the United States now surpasses sixty days.(14) In Kentucky the wait is even longer: 77.7 days in 1987 compared to 5.5 days in 1984. This gap has proven fatal for a number of patients. Twice in 1987 and once in 1988, patients on the Pierce-Donachy assist device waited weeks for heart transplants but then developed complications that forced them to be removed from the transplant waiting list. They later died.(15) A number of recipients of the Novacor assist device also have developed complications and died after waits of as long as a month for a donor heart.(16) In a sense, these patients were fortunate; they died soon after being doomed to a permanent existence on the devices. Others lived longer. Robert Cresswell lived 376 days with a Penn State artificial heart pumping inside his chest--longer than three of the five "permanent" artificial heart recipients--following acute rejection of a heart transplant. He suffered kidney failure and a stroke, and the search for a suitable donor organ was complicated because he had circulating antibodies that necessitated a careful match. Bernadette Cheyrez lived 244 days with a Jarvik-7 at the University of Arizona, during which she suffered kidney failure and a series of infections. She also had circulating antibodies. She died of acute rejection during a last-ditch transplant operation.

Ethical problems arise in these cases of temporary-turned-permanent bridges because it is evident that patients do not know what is in store for them. For example, the Penn State consent form Cresswell would have signed did not mention that complications could occur that would prevent a patient from getting a transplant and would keep him indefinitely tethered to the pump. Most consent forms contain such cautions in one form or another, but even then the information often does not sink in. that is hardly surprising, given the urgent, life-and-death circumstances under which consent is sought. "In my experience, most families don't read them before signing," Penn State's Pierce said at the thoracic surgeons' meeting. He was complaining to FDA officials that the length of consent forms is unfair to families and patients. Whether or not Thomas J. Reynolds read a consent form before signing, he said in May 1988, after fifty-two days on a Jarvik-7, that depending on the pump is "the worst life God could have designed for me." The fifty-nine-year-old patient at Methodist Hospital in Indianapolis said he had asked himself if the experience had been worth it, "and there are times when I get the wrong answer back. That's probably the most difficult thing. You want to quit" (Indianapolis Star, 19 May 1988, 1). (Reynolds died of a stroke August 12, 1988, after 137 days on the device.)

Walton Jones, Jr., signed the consent form for a Jarvik-7 implant last December at Humana Hospital-Audubon in Louisville even though he had expressed his desire to his cardiologist and friends that he never wanted to be permanently tied to the machine. An outdoorsman, he had hunted deer the day before. "Sonny said he would never sign it to be permanent," said a relative. "He said, 'I do not want to be tethered to that machine....I want to live, and if that's what it takes... I will sign it to be put on the artificial pump until I can get a new heart.' He had no intentions to be put on it until the end" (The Courier-Journal, 7 December 1987, 1A). Yet Jones signed the form even though he could not be guaranteed it would be temporary. (Jones underwent a transplant after two weeks on the Jarvik-7, but bled profusely during surgery. He died a month later.)

The spectre of patients permanently tethered to mechanical pumps, when they have expressly said they don't want to be, terrifies surgeons, and many feel compelled to go to great lengths to get the patients donor hearts. This attitude has led surgeons to use hearts when they knew the chances of success were slim, or certainly less than for other patients on the waiting list. In a study of twenty-nine patients bridged with the Pierce-Donachy VAD published in the New England Journal of Medicine, the authors concluded that the patients' survival after transplantation was comparable to that after conventional heart transplantation. They added, "Since each patient had to requalify for cardiac transplantation after device implantation, donor hearts were not 'wasted' on patients who would not survive transplantation."(17) Yet after sixty-five days on two Pierce-Donachy pumps, Bishop Harris was given a transplant last April in Louisville's Jewish Hospital despite having suffered a stroke and infection. Dr. Laman A. Gray, Jr., said Harris's chances of survival were less than for an ordinary transplant recipient, but added, "I would not have transplanted him unless I thought he had a reasonable chance" (The Courier-Journal, 28 April 1988, 1B). (Harris was released from the hospital six weeks later but died in July.) Two other Pierce-Donachy patients died under similar circumstances. Both had been on the device more than three weeks and were given transplants despite widespread active infection (The Courier-Journal, 24 April 1988, 1A). Bernadette Cheyrez was given a transplant after 244 days on the Jarvik-7 even though she had an infection in her chest. She never got out of the operating room.(18) And in Indianapolis, doctors offered to transplant a poorly matched heart into Thomas Reynolds after seven weeks on the Jarvik-7 even though they said it probably would be rejected and a better matched candidate was in the hospital's intensive care unit. Reynolds declined and the other patient received the heart.

This approach of transplanting bridge patients at any cost is not universal. For example, Dr. Christian Cabrol of La Pitie Hospital in Paris had transplanted only twelve of the thirty patients he had bridged with the Jarvik-7 as of February 1988 because he believes that these patients should be transplanted only when they have no infections, no bleeding problems and a good donor heart is available.(19) But in the United States, when surgeons put in a bridge device, "We feel obligated to go on to transplantation," Dr. George J. Magovern, of Allegheny General Hospital in Pittsburgh, said in response to Cabrol.(20)

This sense of obligation also has taken the form of surgeons manipulating the organ distribution system. On February 23, 1988, the day after Bishop Harris was connected to two assist devices as a bridge to transplant, his surgeon listed him on the national organ procurement network as a "UNOS Stat"--meaning Harris was expected to live less than twelve hours. Network officials telephoned all organ procurement agencies within reach of Louisville to alert them of Harris's urgent need. No heart was turned up, but neither did Harris die. He lasted sixtyfive days on the pumps before undergoing a transplant.

This example points up a problem of bridge devices: They have been used to put patients at the top of the transplant waiting list, even though they may have been more stable than candidates not connected to mechanical pumps. Under the system for allocating hearts in effect until this year, patients on mechanical assist devices (artificial hearts, VADs, intra-aortic balloon pumps and ventilators) were automatically categorized as status six, giving them top priority among all candidates in their area. In addition, a surgeon could make the subjective decision to declare a patient as a "UNOS Stat," thereby improving the chances of getting a heart. Defenders of this system argued that while mechanical devices help to stabilize patients, they also leave them prone to complications such as infections and strokes, which could kill them at any time. But giving favorable treatment to patients on mechanical devices penalizes those in hospitals without access to assist devices, and threatens to create a situation where transplants go to the sickest patients--the ones least likely to survive.

These concerns are beginning to be addressed. The United Network of Organ Sharing, the agency that runs the organ procurement system, has revised its categories, folding the former six tiers into two. Under the new system, patients on mechanical assist devices will have to share the top priority with patients in the intensive care unit who require inotropic drugs to maintain their heart function. All others will be classified as status two. The new system appears to remove the incentive of putting a patient on an assist device to improve his or her chances of getting a transplant. UNOS also has done away with the easily abused "UNOS Stat" listing.

Unfortunately, the move toward a fairer system for distributing donor hearts does not seem to portend a new era of self-regulation and restraint in the industry of high technology medicine. The changes in the UNOS protocol may have more to do with transplant surgeons' desire for autonomy and flexibility than with issues of equity. The chances of government intervention also appear slim, given the lessons of congressional "oversight" learned last summer. In fact, the success of congressional pressure to restore artificial heart funding has emboldened an increasing number of spurned grant applicants to "turn to their senators and congressmen to try to influence the system," Lenfant said in October. So far no others have succeeded, but Lenfant worries that the trend "may cause real problems in the long run... We do what the legislative branch says. They say jump. We jump." Certainly the FDA, which has demonstrated no inclination to stop even the use of unapproved experimental hearts, will not step in to protect patients from the abusive use of mechanical hearts. The artificial heart's momentum will be stopped only when results sour--as happened with DeVries's project--and profit-seeking manufacturers, publicity-seeking hospitals and surgeons seeking to stall death at any cost no longer derive benefit from its use. Patients' and the public's benefit will remain secondary.

References (1)Working Group on Mechanical Circulatory Support, National Heart, Lung and Blood Institute, Artificial Heart and Assist Devices: Directions, Needs, Costs, Societal and Ethical Issues (Bethesda, MD: National Institutes of Health, 1985). (2)William C. DeVries, interview with author, February 1988. (3)William C. DeVries, "The Permanent Artificial Heart: Four Case Reports," Journal of the American Medical Association. 259:6 (1988), 849-59. (4)Joanne J. Dobbins, et al., "Postmortem Microbiological Findings of Two Total Artificial Heart Recipients," Journal of the American Medical Assosication 259:6 (1988), 865-9. (5)William C. DeVries, "Experience with Permanent Artificial Hearts" (paper presented at the Society of Thoracic Surgeons Topical Meeting on Circulatory Support Devices, St. Louis, MO, February 1988). (6)William S. Pierce, "Permanent Heart Substitution: Better Solutions Lie Ahead," Journal of the American Medical Association 259:6 (1988), 891. (7)David J. Farrar, et al., "Heterotopic Prosthetic Ventricles as a Bridge to Cardiac Transplantation," New England Journal of Medicine 318:6 (1988), 333-40. (8)Working Group on Mechanical Circulatory Support, Artificial Heart and Assist Devices, 13. (9)Albert R. Jonsen, "The Artificial Heart's Threat to Others," Hastings Center Report 16:1 (1986), 9-11. (10)DeVries, interview with author. (11)George J. Annas, "No Cheers for Temporary Artificial Hearts," Hastings Center Report 15:5 (1985), 27-28. (12)Ellen Hale, Gannett News Service, 23 December 1986. (13)Laman A. Gray, Jr., interview with author, April 1988. (14)Division of Organ Transplantation, Public Health Service, Scientific and Clinical Status of Organ Transplantation: Report for 1987 (Washington, DC: US Department of Health and Human Services, 1988). (15)John Lawson, director of professional services, Thoratec; interview with author, June 1988. (16)Peer M. Portner, interview with author, May 1988. (17)Farrar, et al., "Heterotopic Prosthetic Ventricles," 339. (18)Calvin M. Kunin, et al., "Infectious Complications in Four Long-term Recipients of the Jarvik-7 Artificial Heart," Journal of the American Medical Association 259:6 (1988), 860-64. (19)Christian Cabrol, "Weaning and Bridging" (paper presented at the Society of Thoracic Surgeons Topical Meeting on Circulatory Support Devices, St. Louis, MO, February 1988). (20)George J. Magovern, interview with author, February 1988.
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Author:Gil, Gideon
Publication:The Hastings Center Report
Date:Mar 1, 1989
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