PERSPECTIVE

Cardiac transplants and the artificial heart: ethicalconsiderationsJOHN C. FLETCHER, PH.D.

THE ETHICAL CONSIDERATIONS relevant to car-

diac transplantation and the artificial heart haveevolved with intensity since the first human tissuetransplant nearly 40 years ago. Ethical issues raisedhave led to an ongoing debate that permeates our entire

society. Recent implantation of an artificial heart in a

human being has made these issues even more cogent.A brief historical perspective and some definitions

may be useful. The ethical framework in which medi-cal decisions relevant to cardiac transplantation and theartificial heart are made is evolving constantly. Typi-cally, ethics help us make such decisions i.e., deci-sions occasioned by changing technology. Should we

choose A (the old way), B (the new way), C (seek yetanother way), or D (elect not to decide)? Ethics pro-

vide protection against special threats to moral life,such as partiality and tendentious consideration of one-self or one's group as being exempt from moral rules.

Ethical issues develop generally in four stages:

threshold, conflict, debate, and adaptation. In the firststage, conditions for moral conflict are present. Isolat-ed individuals may anticipate problems that later be-come more widely recognized. In the conflict stage, a

number of significant or notorious cases arise, con-

firming predicted inconsistencies and leading to emo-

tional polarization. In the third stage, social debatebecomes widespread. Ethical principles are applied,solutions are tested, and evidence is gathered to sup-

port various alternatives. In the fourth stage, moraladaptations and the development and implementationof public policies with administrative and legislativeformulations occur in this climate of socioethicaldebate.

With respect to human organ transplantation, the

From the Warren G. Magnuson Clinical Center, National Institutes ofHealth, Bethesda.

Address for correspondence: John C. Fletcher, Ph.D., Building 10,Room lC-150, National Institutes of Health, Bethesda, MD 20205.

Received April 6, 1983; revision accepted Aug. 11, 1983.Dr. Fletcher is assistant for bioethics in a 500-bed research hospital

that is the clinical arm of the National Institutes of Health. His specialinterests are in the ethics of clinical research and also in ethical problemsin applied human genetics.

Vol. 68, No. 6, December 1983

threshold stage (1944 to 1964) began with Cunning-ham and Medawar, who recognized the future implica-tions of tissue transplants. Cunningham's dissertation'on the morality of transplantation, prepared for theCatholic University in 1944, was a pioneering andseminal work. Writing at a time when skin was thehuman tissue being transplanted, Cunningham main-tained that even visceral organ donation was an accept-able practice under Roman Catholic ethics. He chal-lenged inconsistencies in the old tradition of"physicalism" that stressed the biological aspect ofsurgery as opposed to any social, psychological, orspiritual benefits that it might confer. At the sametime, Medawar's research2 on graft rejection foreshad-owed many of the problems of transplantation thatwould later come to the fore.

Shortly after World War II, the transplantation ofhuman organs began in earnest. In accordance with theform and content of medical ethics at that time, peerreview was the sole basis for decisions concerningtransplantation. After colleagues in relevant medicaldisciplines had been consulted, decisions were made.The earliest heterotopic transplant of a cadaver kid-

ney occurred in 1947. The patient was pregnant and insevere shock, had been anuric for 10 days, and was in adeep coma. Because of administrative opposition, thesurgery had to be performed under adverse conditionsin a secluded area of the hospital. The transplantedkidney produced urine and was removed 2 days later.The patient recovered.3

In the early years of renal transplants and dialysis(1954 to 1964) physicians identified ethical' issues stillrelevant to cardiac transplantation and the artificialheart. Transplant surgeons developed guidelines forfour basic problems: patient selection, donor selection,informed consent, and definition of death. Early gui-dance was provided by a code for transplant ethicspublished by the American Medical Association.4However, discussion of the issues involved was limit-ed primarily to members of the medical community.

Several less tractable issues also arose during theearliest experience with dialysis - namely, high

1339

by guest on June 16, 2018http://circ.ahajournals.org/

Dow

nloaded from

FLETCHER

costs, prolongation of life by artificial means affectingthe quality of life, requests of patients to be allowed todie, and macroallocation issues. Because of the em-phasis in American medical ethics on the individualpatient rather than society as a whole, contributionsfrom other disciplines were needed to help structurethe social and ethical considerations involved.

Pressing legal questions required resolution. Hencelawyers were among the first of other disciplines torespond.- The forms and decision-making proceduresof medical ethics were about to undergo significantchange.

The conflict stage (1964 to 1972) began when ex-perimental transplants from primates to humans led tosignificant ethical challenges to then-current proce-dures. In 1964, a surgeon (supported partly by NIHfunds) transplanted a chimpanzee kidney to a man wholived for 2 months.6 Soon another surgeon, who wasalso supported by NIH funds,7 performed a cardiacheterotransplant. The second patient died shortly aftersurgery.

Dr. James Shannon, Director of the NIH from 1955to 1968, learned of the cardiac heterotransplantthrough the media. He was deeply concerned that thesurgeon had gone ahead with the procedure "on hisown without prior consultation with anybody in hisown institution and with little prospect of therapeuticbenefit or scientific information."8 Several doctorssubsequently published ethical criticisms of the experi-ment. This controversial case, coupled with risingpublic concern over practices in clinical research,9prompted an intensive review of ethics in research. In1966 the Surgeon General of the Public Health Servicemandated prior group consideration of research.Amid growing public awareness of transplantation

and hemodialysis, an international conference was or-ganized in 1965 to examine the implications of the newprocedures. Although a separate legal analysis ad-dressed some of the ethical questions, no independentsocioethical discussions appeared in the conferencereport. 0

In that same year, I had an encounter that illustratedhow little progress had been made toward appreciationof the deeper ethical issues involved in transplantation.As a graduate student, I served as chaplain for the staffand students of the New York Hospital-Cornell Medi-cal Center. While visiting a patient with end-stagerenal disease, I learned that heterotransplantation wasbeing considered. Dialysis had become impossible fortechnical reasons, and no cadaver kidney or livingdonor could be found for the man. The surgeon askedthe patient to consider transplantation of a chimpanzee

1340

kidney, which might allow him to survive until a ca-daver kidney were available. I asked that I be allowedto observe the consent process and to follow the patientbefore surgery. The surgeon agreed, and we reviewedall available options with the patient. A realistic expla-nation was given by the surgeon.

Since no human kidney was available, the patientpreferred the heterograft to a lingering death. Somedata existed documenting short-term survival in simi-lar cases, and I found no reason to object when thepatient asked me for guidance. I told him that I couldsupport any decision he made. He died shortly after theoperation.On the following weekend, I met the surgeon by

chance in the medical library. When he avoided me, Iapproached him and asked what was wrong. He repliedthat although he believed he had handled the treatmentof his patient properly, he still "felt bad" about thepatient's death. I stated that he had been honest withthe patient and had done nothing of which to beashamed. In retrospect, however, it is sobering to thinkof the great risk the patient chose to undertake, espe-cially when no prior review of the plan had been com-pleted.

In the public arena, the early discussions of cardiactransplantation were also marked by emotional polar-ization. Political leaders, such as Senators Mondaleand Ribicoff, responded to the growing public interestin the issue. Senator Mondale introduced a resolutionto establish the National Commission on Health Sci-ence and Society, a legislative precursor of the Nation-al Commission for the Protection of Human Subjectsauthorized by Congress in 1973. Mondale held hear-ings on the proposed commission in 1968. One ex-change between Senator Ribicoff and Dr. Barnard isparticularly worth recalling.

Senator Ribicoff: Do you think this matter is so open andshut, doctor, that the doctors only should decide between themultiplicity of patients, or do you think there is a matter of greatsocial and ethical policy that society has to do a lot of soulsearching to determine how their decision ultimately will bemade?

Dr. Barnard: Sir, I do not think the matter is open and shut. Ithink it is difficult we have difficult problems, but I wouldlike to point out to you these problems the doctors have hadto handle for many years. These are not new problems. Youcannot tell me one single new problem in our heart transplanta-tion that we have not had for many years.

Senator Ribicoff: Except the usual situation of a limited num-ber of hearts available for transplanting ''

What was new, however, was not only the prospect oflimited donor organs, but the entire occasion: politicalleaders and physicians squaring off across an issue-board. The public, through their elected officials, ex-

CIRCULATION

by guest on June 16, 2018http://circ.ahajournals.org/

Dow

nloaded from

PERSPECTIVE

pected reasonable answers. This -led to new responsi-bilities for physicians: they had to learn tocommunicate their ideas to people outside the medicalprofession. Some physicians were ready for this chal-lenge. Shumway, for one, supported the idea of aCommission

. .not because of the regulatory aspects. I do not believe thatsuch a Commission would stricture or regulate physicians. Butwhat such a Commission would do is educate - not just Con-gress, not just lay people in general, but also physicians. Andthis is a very important thing.'a

-The beginning of the adaptation stage (1972 to1980) was marked by widespread social debate,changes on the clinical level, and early public-policydecisions. The National Heart and Lung Institute con-vened the first panel charged with assessing the artifi-cial heart (1972 to 1973). Although the panel's workindicated that an attempt at assessment would be pre-mature, their report served as a point of departure formore widespread debate. The National Commissionfor the Protection of Human Subjects (1973 to 1978)provided an important forum for the discussion of awide range of issues in research ethics. The remainderof the 1970s was punctuated by authoritative views-from those in the fields of philosophy, religion, andpublic-policy sciences - on ethical issues in healthcare.

Clinically, physicians developed decision-makingprocedures that were more in line with evolving ethicalstandards. The secrecy that had surrounded the firstdecisions to perform cardiac transplantation (1967 to1969) and to implant an artificial heart (1969) came tobe viewed as not conforming to the ethical ideals ofscientific investigation. New decision-making proce-dures involved higher standards for prior research re-view and opened the process to a wider range of com-munity members. The rigorous prior review of theUtah artificial heart implant12 and the current cardiactransplant patient selection criteria'3 exemplify thesechanges.

Three key public-policy initiatives influenced thedevelopment of cardiac transplantation and the artifi-cial heart in this period. The Uniform Anatomical GiftAct (UAGA) - first proposed in 1968 and subse-quently adopted in all the states made a potentialorgan donor's wishes binding after death and allowedfamily members to consent to the removal of organs.Twenty-five states passed laws that recognized braindeath as a legitimate reason to declare that death hadoccurred. In 1972 Congress approved a measure toextend Medicare coverage to persons with renal dis-ease requiring dialysis or transplantation.Vol. 68, No. 6, December 1983

Current social and ethical priorities

Recent advances in transplantation have led to im-pressive results: longer graft survival, lower cost, andlonger patient life expectancy. The benefits of trans-plantation, coupled with the results of the recent artifi-cial heart experiment in Utah, have elicited fresh con-cern and debate over the issues of organ procurement,resource allocation, and therapeutic research with hu-man subjects. A search for new ethical guidance isnow underway.

In cardiac transplantation, the lack of donor organsposes a critical problem. Even as its efficacy is beingproven, dying patients are denied the procedure forreasons that do not conform to basic ethical principles.

Practices used in securing donor organs in the Unit-ed States and 28 other countries have been discussedby Stuart et al.,"' who delineated two underlying prob-lems that lead to a shortage of donor organs in theUnited States: the tendency to deny the possibility ofone's own death, and the reluctance of physicians tobroach the subject with the families of potentialdonors.The first of these problems was clearly illustrated

when the state of Maryland first made the reverse sideof drivers' licenses available as donor cards; only 1.5%of eligible persons signed the cards. Another revealingstatistic is the fact that only 20% of all persons who dieleave wills. '5 Clearly, the psychological constraintsagainst imagining one's own death and choosing to fillout a donor card are considerable.The second problem, reticence on the part of attend-

ing physicians, involves the irrational but real guiltexperienced by physicians whose patients have died.The surgeon I encountered in 1965 who "felt bad"when his patient died is a vivid example. Despite stud-ies that show how families who give consent for dona-tion benefit emotionally from the decision,'6 physi-cians generally do not initiate the subject with agrieving family. Furthermore, since transplant sur-geons do not attend patients who are the most likelyorgan donors, additional problems of communicationand coordination arise.The moral argument for organ donation is straight-

forward. The moral rule to be kind to kin, companions,and other members of society clearly supports acts thatprevent death and disease. The decision to donate or-gans before death is a choice that costs its maker onlythe safety of a complex illusion that death befalls oth-ers but not self. Centuries of wisdom advise us tosurrender this illusion. No violation of moral princi-ples occurs if one chooses to open oneself to the reality

1341

by guest on June 16, 2018http://circ.ahajournals.org/

Dow

nloaded from

FLETCHER

of death and pass on the gift of life to others. On thecontrary, any rational person would praise this choice.

In the interest of saving lives, several steps could betaken to mitigate problems of organ procurement.First, all states could, at registration and reregistration,assertively offer drivers the opportunity to indicatetheir donor choice (yes or no) on the reverse side oftheir drivers' licenses. This policy is already in effectin Colorado, where 900,000 out of 1.3 million licenseddrivers have registered as organ donors. Another ap-proach would be for states to require that the donorchoice section of drivers' licenses be completed. Amore assertive step would be a policy of presumedconsent, whereby all persons would be presumed tohave consented to donate organs unless they had regis-tered an objection.

I know of no moral justification for interia in theopportunity to save lives. Therefore, if less assertivepolicies fail, I can see no weighty ethical objections tothe presumed-consent approach. Under such a policy,individuajs would be free to stipulate that they not bedonors, thereby qualifying as legitimate exceptions toa general social policy.

Additional steps could be taken to improve procure-ment procedures in hospitals. Recent efforts in Atlantaarea hospitals'7 indicate that the education of physi-cians and the presence of transplant coordinators whocan help to relieve attending physicians of some of thepsychological burdens can increase organ donations ina short interval.

The clergy can contribute by intensifying theirteaching about the moral issues involved in donation.Since the decision to donate can help those who other-wise feel helpless, clergy should consider suggestingdonation to families in danger of losing a member todeath. Family members can be encouraged to showforgiveness toward physicians who are not able to savethe life of one of their relatives. Such acts of foregive-ness have a real effect on physicians and, in the longrun, may encourage even attending physicians to sug-gest organ donation.

Another burning issue is the question of resourceallocation: how much should be spent on these expen-sive technologies? In the absence of more fairness inthe distribution of the mundane aspects of health care,large expenditures on procedures like cardiac trans-plantation and the artificial heart widen the prospectsfor moral cynicism and despair. Moreover, presentinequities in the distribution of health care affect thelife chances of many persons, while relatively fewindividuals can be helped by cardiac transplantation orthe artificial heart. In addition to the 20 million Amen-

cans who lack medical insurance because of povertyand chronic unemployment, an additional II millionworkers and dependents have recently lost coverage

under employers' insurance plans due to unemploy-ment. II

In 1980 Secretary of the Department of Health andHuman Services (DHHS) Patricia Harris announcedthe general exclusion of cardiac transplantation fromMedicare coverage. She also stated that it and othernew health technologies should undergo careful re-

view before any decisions are made to support theirwide distribution. Along these lines, the then-extantNational Center for Health Care Technology was toundertake a National Heart Transplantation Study. Al-though now being run under private auspices,'9 thisstudy is about to begin at six centers at which thetechnology is used. The findings of the study willlikely determine the course of Medicare reimburse-ment policy for years to come.

In the wake of the recent trial with the artificial heartin Utah, another important study is being set up by theNational Heart, Lung and Blood Institute. It will beconducted on a smaller scale, appropriate to the more

limited (at present) availability of the artificial heart.A third important study, recently completed by a

President's ethics commission,20 deals with the ethicalimplications of differences in availability of healthservices. The commission argues that society has a

moral obligation to ensure access to an adequate levelof health care for all without imposing excessive bur-dens on any group. Given the diverse membership ofthe commission and their virtual unanimity on the re-

port's central argument., this study may well be a freshchapter in society's quest for equity in health care.

I do not believe that the larger issue of fair access

must be resolved before decisions on reimbursementfor cardiac transplantation or the artificial heart. Iwould argue, however, that decisions about reim-bursement must be made as rationing decisions in thelight of a larger commitment to fairness. To pretendthat we do not or will not ration health resources ismerely to engage in one more form of denial.On the whole, I take an evolutionary perspective on

the ethical considerations involved with cardiac trans-plantation and the artificial heart. Our current ethicalguidelines have evolved from the less complex medi-cal ethics of the past. A richer, broader, and less partialarray of ethical guidance now exists an array thathas evolved in the context of our larger socioethicalsystem.The direction we should take in the future is, as I see

it, an open question. We must, however, preserve the

1342 CIRCULATION

by guest on June 16, 2018http://circ.ahajournals.org/

Dow

nloaded from

PERSPECTIVE

freedom to innovate in order to save lives, even whilewe strive to resolve the larger issue of fairness.

Society and its leaders cannot evade the "tragicchoices'"21 involved in allocation decisions. If ours isto remain an open society, we must expect that nosingle moral view or approach will prevail for long. Infact, we must depend on moral conflict to help deter-mine morality. In a totalitarian society there is conflict,but no conflict of values. In our society, conflict andgradual harmony between a variety of moral traditionsand approaches will be required for focus and formula-tion of new directions in cardiac transplantation andthe use of the artificial heart.

I am grateful to Harry R. Keiser, M.D., and Peter L. From-mer, M.D., of the National Heart, Lung and Blood Institute forconsultation on this article and suggestions on an earlierversion.

References1. Cunningham J: The morality of organic transplantation. Studies

in sacred theology No. 86. Washington, D.C., 1944, CatholicUniversity Press

2. Medawar PB: The behavior and fate of skin autografts and skinhomografts in rabbits. J Anat 78: 176, 1944

3. Moore FD: Give and take. The development of tissue transplanta-tion. Philadelphia, 1964, W. B. Saunders Company, pp 14-15

4. American Medical Association: Current opinions of the judicialcouncil. Section 2.09, Organ transplantation guidelines, 1981

5. Sadler AM, Sadler BL: Transplantation and the law: the need fororganized sensitivity. Georgetown Law J 57: 27, 1968

6. Reemtsma K, McCracken BH, Schlegel JU, Pearl MA, DewittCW, Creech 0: Reverse of early graft rejection after renal hetero-transplantation in man. JAMA 187: 691, 1964

7. Hardy JD, Chavez CM, Kurrus FD, Neeley WA, Eraslan S,Turner MD, Fabian LW, Labecki JD: Heart transplantation inman: developmental studies and report of a case. JAMA 188:1132, 1964

8. Frankel MS: Public policymaking for biomedical research: thecase of human experimentation, dissertation. George WashingtonUniversity, 1976, p 153

9. Lear J: Do we need new rules for experiments on people? Sat RevLit, Feb. 5, 1966, p 65

10. Wolstenholm GEW, O'Connor M, editors: Ciba FoundationSymposium. Ethics in medical progress: with special reference totransplantation. London, 1966, J and A Churchill

11. Hearings before the Subcommittee on Government Research ofthe Committee on Government Operations, U. S. Senate: NationalCommission on Health Science and Society. Washington D.C.,1968, U.S. Government Printing Office, p 81

1la. Hearings before the Subcommittee on Government Research ofthe Committee on Government Operations, U.S. Senate: NationalCommission on Health Science and Society. Washington D.C.,1968, U.S. Government Printing Office, p 147

12. Eichwald EJ, Woolley FR, Cole B, Beamer V: Insertion of thetotal artificial heart. IRB 3: 4, 1981

13. Christopherson LK: Heart transplants. Hastings Cent Rep 12: 18,1982

14. Stuart FP, Veith FJ, Cranford RE: Brain death laws and patternsof consent to remove organs for transplantation from cadavers inthe United States and 28 other countries. Transplantation 31: 238,1981

15. Dukeminier J: Supplying organs for transplantation. Mich LawRev 68: 811, 1970

16. Simmons RC, Klein SD, Simmons RL: Gift of life. New York,1977, John Wiley and Sons. p 365

17. Bart KJ, Macon EJ, Humphries LA, Baldwin RJ, Fitch T, PopeRS, Rich MJ, Langford D, Teutsch SM, Blount JH: Increasingthe supply of cadaveric kidneys for transplantation. Transplanta-tion 31: 383, 1981

18. Rivlin AM: Health insurance and the unemployed. Statementbefore the Subcommittee on Health and the Environment, Com-mittee on Energy and Commerce, U.S. House of Representatives,Jan. 24, 1983

19. Evans RW: National heart transplantation study (update no 1).Health and Population Study Center. Seattle, 1982, Battelle Hu-man Affairs Research Centers

20. President's Commission for the Study of Ethical Problems inMedicine and Biomedical and Behavioral Research: Securing Ac-cess to Health Care. Washington, D.C., 1983, U.S. GovernmentPrinting Office

21. Calabresi G, Bobbitt P: Tragic choices. New York, 1978, Nortonand Company, p 198

Vol. 68, No. 6, December 1983 1 343

by guest on June 16, 2018http://circ.ahajournals.org/

Dow

nloaded from

J C FletcherCardiac transplants and the artificial heart: ethical considerations.

Print ISSN: 0009-7322. Online ISSN: 1524-4539 Copyright © 1983 American Heart Association, Inc. All rights reserved.

is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231Circulation doi: 10.1161/01.CIR.68.6.1339

1983;68:1339-1343Circulation. 

http://circ.ahajournals.org/content/68/6/1339.citationthe World Wide Web at:

The online version of this article, along with updated information and services, is located on

  http://circ.ahajournals.org//subscriptions/

is online at: Circulation Information about subscribing to Subscriptions: 

http://www.lww.com/reprints Information about reprints can be found online at: Reprints:

  document. Permissions and Rights Question and Answer information about this process is available in the

located, click Request Permissions in the middle column of the Web page under Services. FurtherEditorial Office. Once the online version of the published article for which permission is being requested is

can be obtained via RightsLink, a service of the Copyright Clearance Center, not theCirculationpublished in Requests for permissions to reproduce figures, tables, or portions of articles originallyPermissions:

by guest on June 16, 2018http://circ.ahajournals.org/

Dow

nloaded from