Feature: The total artificial heart: Is paying for it immoral and stopping it murder?

Winter 2004,  Vol. 11, Issue 1

By Robert M. Veatch, PhD
Professor of Medical Ethics
The Kennedy Institute of Ethics
Georgetown University, Washington, DC

Slowly, but surely, we are developing the ultimate replacement part for the human body. The idea of a totally artificial heart (TAH) has been with us for decades. ¹ A range of devices to totally replace the heart are in clinical trials. Some are envisioned as a bridge to transplant while others are seen as permanent replacements for the human's biological pump. ^{2 - 9} As long as these devices are used as temporary support while a patient awaits transplant, most of the moral issues raised by them will not be too novel or too challenging. The issues of consent, ¹⁰ government approval¹¹ and the use of humans as subjects ^{12, 13} have arisen with the artificial heart from the beginning and will continue.

Murder vs. forgoing treatment

The development of a permanent replacement device, especially the TAH, will, by contrast, create some truly new problems. One of these involves terminal care ethics. Over the past two or three decades a mainstream consensus has emerged that relies on some conceptual distinctions: between actions and omissions, as well as between directly intended killing and death that results as a side effect of actions that are in themselves good. ¹⁴ It is now commonplace to accept the forgoing of life-support even though active interventions to kill are illegal and many consider them unethical. Patients may withhold or withdraw consent, as long as doing so does not intentionally, directly cause their death. The death is thought of as a side effect of forgoing a burdensome or useless intervention.

The TAH may change all of that. How should we think about patients who demand that their TAHs be stopped? When dealing with lifesupporting technologies not directly related to the heart, many concluded that we could forgo a technology that was maintaining life even if the end result was that death could proceed unabated. We accepted, for example, a patient's decision to forgo hemodialysis even though everyone knew that the patient would die without it. The common wisdom was that the purpose of forgoing the treatment was to remove an intervention that failed to offer more benefit than harm. As long as the death of the patient was merely a foreseen, but unintended outcome and it was the consequence rather than part of the patient's action, even traditional Roman Catholics opposed to all euthanasia have found the forgoing of life-supporting technologies morally acceptable.

Now, however, we anticipate the case in which the life-supporting technology does not merely make continued life possible, but whose functioning actually is the basis for saying that life continues. In the old world of 20th century medical ethics, clinicians could choose to believe that, when the patient refused dialysis or a ventilator and the physician removed the technology deemed disproportionately burdensome, the physician didn't cause the patient's death; some intervening disease process did.

Some have always found this distinction between direct and indirect killing problematic. The new TAH technology, however, presents a new twist. If one stops a TAH or removes the machine, one does not merely permit the dying process to continue. The very act of stopping the machine is the event that, by traditional cardiac-based definition of death standards, we call "death." A person dies, according to that definition, when cardiac function ceases irreversibly. Turning off the TAH is the direct and immediate cause of death just as certainly as injecting potassium into the ventricle.

We have some options: One would appeal to "liberals" who never accepted the doctrine of double effect. They have tended to be consequentialists. They have long believed that it makes no difference whether one forgoes life support or actively, intentionally kills a patient. According to them, it is not the action/omission distinction or the direct/indirect distinction that is critical; it is whether the patient is better off dead. For them, even if turning off the TAH is an act of direct killing it may be morally justified.

Another option might appeal more to conservatives. They might insist that stopping the TAH is somehow different from stopping any other technology necessary for life and insist it is both unethical and illegal.

There is a third option, however. The conclusion that stopping the TAH is a direct killing rests on the use of the traditional cardiac definition of death. One dies according to current law when either the heart or the brain function ceases irreversibly. A patient is legally dead when the heart stops permanently (even if, hypothetically, the brain continued to function).

Some of us are now convinced that can't really be correct. If we believe in brain death, it is because we accept the notion that the essence of a living human being has something to do with the functioning of the brain. Imagine the hypothetical case of someone whose cardiac function had irreversibly stopped, but whose brain continued to function - who continued to think, feel, reason and emote. Surely, that person is not dead just because the cardiac function is gone.

If so, then stopping the TAH is no more the immediate cause of death than stopping a ventilator or a dialysis machine. The patient would continue to live for the few seconds or minutes when the heart was not beating, but the brain was still alive and functioning. Stopping the TAH would turn out to be no different from stopping any other lifesupporting treatment.

It could turn out that the TAH will force us to fix our now naive and implausible two-pronged definition of death that permits death to be pronounced when either heart or brain function is lost and replace it with one relying only on brain function loss. We could, of course, continue to use loss of heart function as a sign that the brain function is irreversibly gone just as we always have, but it would now be merely an indicator of brain function. Moreover, the first few minutes of heart function loss would not imply brain death; only loss long enough to conclude that brain cells could not survive would signal death.

The TAH will raise an additional problem. Until now, we have generally assumed that the right to refuse treatment implies the duty of the clinician to stop whatever life-support is currently functioning. The removal of treatment has generally been noninvasive or only minimally so. But removing a TAH would involve significant surgery. It may be we will have to develop an entirely new set of moral standards for the duty of clinicians in such cases. It may be, for example, that the clinician would have a duty to turn the TAH off, but not a duty to remove it. Some clinicians may object to stopping the TAH, which they perceive as direct killing, but they plausibly would nevertheless have such an obligation.

We may also have to contemplate the reverse case: the one in which the clinician sees no point in continuing, but the patient insists that the TAH be maintained. The clinician may come to see the TAH as "futile" in the case of someone whose life cannot otherwise be maintained. Some commentators have claimed that physicians should not be forced to provide support for a TAH once they conclude it is serving no purpose, ¹⁵ but they usually don't address the interesting case of when the patient still sees value in the treatment. One thing seems clear: when the physician and patient disagree about the value of a treatment that could continue to maintain life, there is no reason to assume that the physician's view must prevail. The ultimate resource allocation problem The transplant of human hearts is one of the most expensive medical technologies. It currently comes, however, with a natural constraint. In the United States, fewer than 2,500 human hearts are available in a given year. Because of that limit, the cost of heart transplants in the United States is in the range of $350 - 700 million a year. ¹⁶

If that natural limit were overcome through the use of artificial organs, present heart transplant costs would dwarf in comparison. Estimates are that as many as 100,000 patients a year could be candidates for these devices. For the first implantable heart attempts, the devices alone would cost $75,000. Although they expect costs could be reduced to about a third with mass production, that would amount to $2.5 billion a year - just for the pump. Evans estimates that the total direct annual costs for cardiac assistance and replacement would be in the range of $5-24 billion.¹⁶

When the technical problems are solved, the scarcity of transplantable hearts will be replaced by financial scarcity. Providing them for all Americans would tax the system significantly. The TAH may be the device that pushes the inevitability of rationing into the open. If the TAH arrives before universal health insurance, money will determine which patients are covered for the TAH. Otherwise the society will have to decide which factors justifiably limit access - medical hopelessness, low expected benefit, patient age, or an element of voluntary lifestyle risk that was the cause of the cardiac disease. They would all be better than ability to pay or judging the social usefulness of the recipients.

They would probably all be better than blindly attempting to pay for all artificial organs and leaving other important projects underfunded. When the TAH arrives, we should be ready to figure out whether giving the machine to everyone who could bene- fit will break the bank as well as ready to figure out whether stopping it would be murder or merely forgoing disproportionally burdensome treatment.

Footnotes

¹ Report by Artificial Heart Assessment Panel. The totally implantable artificial heart. National Heart and Lung Institute June 1973.

² Goldstein DJ. Worldwide experience with the MicroMed DeBakey Ventricular Assist Device as a bridge to transplantation. Circulation 2003;108 Suppl 1:II272-7.

³ Dowling RD, Gray LA Jr, Etoch SW, Laks H, Marelli D, Samuels L, et al. The AbioCor implantable replacement heart. Ann Thorac Surg 2003;75(6 Suppl):S93-9.

⁴ Jeevanandam V, Jayakar D, Anderson AS, Martin S, Piccione W Jr, Heroux AL, et al. Circulatory assistance with a permanent implantable IABP: initial human experience. Circulation 2002;106(12 Suppl 1):I183-8.

⁵ Copeland JG, Arabia FA, Smith RG, Sethi GK, Nolan PE, Banchy ME. Arizona experience with CardioWest Total Artificial Heart bridge to transplantation. Ann Thorac Surg 1999;68(2):756-60.

⁶ Catanese KA, Goldstein DJ, Williams DL, Foray AT, Illick CD, Gardocki MT, et al. Outpatient left ventricular assist device support: a destination rather than a bridge. Ann Thorac Surg 96;62(3):646-52.

⁷ Pierce WS, Sapirstein JS, Pae WE Jr. Total artificial heart: from bridge to transplantation to permanent use. Ann Thorac Surg 1996;61(1):342-6.

⁸ Frazier OH, Myers TJ, Westaby S, Gregoric ID. Use of the Jarvik 2000 left ventricular assist system as a bridge to heart transplantation or as destination therapy for patients with chronic heart failure. Ann Surg 2003;237(5):631-6;discussion 636-7.

⁹ Dowling RD, Etoch SW, Stevens KA, Johnson AC, Gray LA Jr. Current status of the AbioCor implantable replacement heart. Ann Thorac Surg 2001;71(3 Suppl):S147-9.

¹⁰ Goldberg D. Artificial heart implant leads to suit over consent process: recipient's widow says she and her husband were misinformed and misled on risks, benefits. Washington Post 2002;Nov 30:A3.

¹¹ Altman LK. Unsanctioned artificial heart implanted in Arizona patient. NY Times 1985:Mar 7: A1, A25.

¹² Eichwald EJ, Woolley FR, Cole B, Beamer V. Insertion of the total artificial heart. IRB 1981;Aug./Sep.; 3(7):4-5.

¹³ Morreim H. AbioCor: an experiment in research. Hastings Cent Rep 2001;31(6):7.

¹⁴ Meisel A. The legal consensus about forgoing life-sustaining treatment: its status and its prospects. Kennedy Inst of Ethics J 1992(4):309-45.

¹⁵ Bramstedt KA. Replying to Veatch's concerns: special moral problems with total artificial heart inactivation. Death Stud 2003;27(4):317-20.

¹⁶Evans RW. Economic impact of mechanical cardiac assistance. Prog Cardiovasc Dis 2000;43(1): 81-94.

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in collaboration with
Dartmouth-Hitchcock Medical Center

The opinions expressed in the journal, Lahey Clinic Medical Ethics,
belong to the individual contributors and do not represent the institutional position
of Lahey Clinic on any subject matters discussed.