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Ethical and Legal Implications of Pacemaker Withdrawal Toward the End of Life
Modern medicine is very complex, and there has been a surge in medication therapy, diagnostic tools, and technological intervention advancements that have improved the survival probability of what would have only recently been considered fatal conditions. An example of the latter is the gradual development of the cardiac pacemaker, which resulted in the first use of transvenous pacing combined with an implanted pacemaker in the United States, Sweden, and France in 1962 and 1963 after years of experimentation, failures involving previous models, and step-by-step improvements.1 Insertion procedure combined with transvenous pacing became the standard method by the mid-1960s. Although there have been many pacemaker technology improvements since then, especially in terms of battery life and the ability to monitor function through external means, the fact remains that the previously almost universally fatal condition of heart block could now be treated with a relatively minor surgical procedure, the effects of which could last for years, if not decades.2
The concepts of ethics law and the inclusion of the ethical principle of autonomy in decision-making altered the previously well-established principle of beneficence, with the physician being the primary determinant of whether that principle was being respected.3 It was established in most Western countries, with the United States acting as the initial impetus, that a patient could decide to remove or refuse medical treatments as long as he or she was deemed to be competent to make such a decision. This type of decision could be made even if it went against physician advice and had the potential to result in death.
Thus began the occasional—and then eventually, the more frequent— request by patients whose lives had, in essence, been saved by the insertion of a cardiac pacemaker to have their function discontinued with or without the device itself being removed. In their wide-ranging 2003 study, Mueller and associates4 described six terminally ill patients who requested (or whose families requested) the removal or discontinuation of their pacemakers or implantable cardioverter-defibrillators. The patients included in the study were neither in long-term care nor in palliative care facilities. The article describes these individuals in detail and provides information on some principles that should be adhered to in order to assure the best outcomes possible for such patients.
This article presents two case vignettes that illustrate the complexity surrounding the decision of refusing medical treatments. A discussion of the psychology behind such decisions, the ethical principles and legal parameters by which such decisions are acted upon by healthcare providers, and how the decisions can be approached in the most humane and supportive manner possible follows. The case vignettes that we present are unique compared with those in Mueller’s study in that our patients were either transferred or admitted directly to a palliative care unit as part of an organized and agreed-upon plan to discontinue their artificial cardiac pacemakers. This process involved many deliberations involving the healthcare team, patients, and families that included discussions on the potential psychological effects that the decision would have on the patients. This unit had been offering palliative care for nearly two decades, and the treating staff and families were an important part of the dynamic that occurred, which was unique for this unit.
End-of-Life Decision Making
Preparing for end-of-life decisions is never easy, whether this is accomplished far in advance of the actual time of the patient’s expected death or in the immediate period before its anticipated occurrence. The instructions included in advance directives, which help proxies (substitute decision makers) fulfill the patient’s previously expressed care wishes, are not necessarily followed if the patient is capable of making his or her own decisions at the time that a decision must be made, as was the situation in the cases we presented.
The usual process for all healthcare decisions is based on the balance between the medical ethical principles characterized generally in the United States as autonomy, beneficence, non-maleficence, and justice. Whenever the principles appear to collide and compete against each other, it is important to determine the wishes of the patient and attempt to weigh the different options before making care decisions. Healthcare decisions must always be made within the context of the legal system, which has established how such decisions best reflect the above-mentioned ethical principles.3
Autonomy is considered a seminal component of healthcare decision making. Clearly, however, the provision of what is deemed the most beneficial care and the avoidance of unnecessary harms cannot be ignored even as autonomy is allowed to guide legally acceptable and condoned medical decisions. The usual translation of autonomy in the United States is manifested by the concept of consent to treatment and the ability to refuse treatment or have it withdrawn or discontinued. Such decisions occur frequently in US hospitals, especially in intensive care units (ICUs). Most jurisdictions have regulations, laws, and protocols regarding how to discontinue life-maintaining treatments once the decision has been made, and the law and professional regulating authorities do not consider such decisions in any way akin to the illegal, unethical, or unprofessional taking of a life. Even in the jurisdictions where physician-assisted suicide (PAS; when a patient is provided with the means [eg, medications] to end his or her life under supervision) is legal (ie, Oregon, Washington, Vermont) and where patients have a right to obtain help in the dying process but the rulings are being appealed or the legislation is being considered (ie, New Mexico, Montana), the discontinuation of life-maintaining treatment is not considered akin to PAS.
Most experts in the fields of ethics and law are relatively clear on the differences between the illegal “ending of one’s life” (whether called euthanasia or some other provocative term) and the decision to discontinue or to refuse life-sustaining treatment. Many, however, often misconstrue the latter situation as PAS, euthanasia, or even suicide due to confusion surrounding what the ethical principles are that form the basis of the decision and what the legal or regulatory implications are of allowing the withdrawal or refusal decisions to be made. The concept of intent is very important in law when making medical decisions that may, by the nature of the medical condition and the medical intervention, determine whether PAS is occurring or whether the illness is following its natural trajectory because of the discontinuation of previously consented-to medical interventions.5 When a patient is unable to participate, proxies often make such decisions based on the usually acceptable criteria or “previously expressed wishes” written in an advance directive or expressed verbally.
Although a patient’s decision to discontinue life-sustaining treatment by disabling a pacemaker that was inserted with the goal of compensating for a previously established, significant bradyarrhythmia, for instance, does not seem to be an extraordinary decision, there is a belief or at least a sense of moral disquiet among many clinicians that by participating in such a decision, they are somehow culpable of some clearly legal, quasi-legal, or ethical infraction. As noted in the 2010 study by Morrison and associates, “Doctors and nurses surveyed overwhelmingly agreed it is appropriate to disable these devices in a terminally ill patient who does not wish to be resuscitated or prolong life. However, respondents emphasized a less defined burden for pacemakers.”6 Healthcare professionals treating patients on dialysis have long accepted their decisions to discontinue dialysis for certain patients with the full knowledge of impending death. That same decision-making process seems more complicated when applied to the pacemaker situation. As concluded in the Mueller et al.4 study, “Granting terminally ill patients’ requests to withdraw unwanted medical support is legal and ethical. Death after withdrawal of support is attributable to the patient’s underlying pathology and is not the same as physician-assisted suicide or euthanasia. Clinician familiarity with these concepts may lead to more expeditious withdrawal of unwanted medical support from terminally ill patients.”4
Unpredictability of Decisions
The consequences of discontinuing pacemakers when they are inserted for a symptomatic bradycardia are unpredictable in terms of likely or certain terminal outcomes. Unlike the withdrawal of dialysis when the underlying condition is such that progression to a fatal outcome is, in essence, a certainty, the discontinuation of a pacemaker may be less predictable. In many ways, the decision-making process and its ethical and legal evolution can draw many lessons from the renowned case of Karen Ann Quinlan, who became unconscious and then lapsed into a coma followed by a persistent vegetative state. Her parents requested that her respirator be disconnected, and they filed suit after this request was denied by the patient’s physicians. Their case went to the New Jersey Supreme Court, which ruled in 1976 that the patient’s ventilator support could be discontinued. Contrary to all predictions and implications of the possibility of the “unethical” and “illegal” charge of euthanasia, the patient survived until 1985 without the ventilator support, thereby defining a very critical principle in such decision making. If she had died, the cause of her death would have to be deemed her underlying illness.7 The intent of the discontinuation of the respirator support was not to kill her but to discontinue a treatment that was deemed to be no longer useful in terms of treatment goals. The fact that she did not die reflects the common uncertainty of the results of medical prognosis, and is an important reminder that physicians must be very careful and circumspect about our predictions regarding the course of complex clinical outcomes.
This case also raised controversial questions about an individual’s right to die. As noted in a 1996 New York Times article, “Karen Ann Quinlan’s legacy is evident in two decades of court cases involving the withdrawal of life-sustaining treatment. She still provides a touchstone for the families whose own dilemmas about dying have plucked them from obscurity and landed them in the public spotlight.”8 The impact and repercussions of the Quinlan decision have affected many families facing similar poignant decisions. Further, hospitals, nursing homes, and hospices began developing formal ethics committees as a result of her case.9
Implications for Cardiologists and Palliative Care, Hospice, and Long-Term Care Physicians
There are important lessons to be learned from the cases presented above. There is a significant range of medical literature, attitudes, and belief systems relating to the relationship between technologically life-maintaining interventions and an individual’s ability to manifest his or her autonomy through medical decisions that result in the discontinuation of potentially life-maintaining treatments. In most North American jurisdictions, the law allows for such decisions. The often emotionally charged leap from the law to professional practice and attitudes can be great and can sometimes acts as an emotionally charged barrier to carrying out the steps required to fulfill the important foundational ethical principle of autonomy. The practitioners who must guide patients along the path of necessary decision making must be clear on the legal and ethical implications of these decisions and they must be correct in the messages that they communicate. As stated in the article by Meisel and associates, “Legal myths about end-of-life care can undermine good care and ethical medical practice. In addition, at times ethics, clinical judgment, and the law conflict. Patients (or families) and physicians can find themselves considering clinical actions that are ethically appropriate, but raise legal concerns.”10 Rather than focusing on whether the decision is “right” or “wrong”, medical practitioners should shift their concern to how best to support the person who has had the courage and self-determination to make such a difficult decision. This is especially important when, as demonstrated in the precedent-setting Quinlan case and the previously described case vignettes, the expected outcome and the prediction of rapid demise do not occur and the person or his or her proxies have to contend with a continued life and the accompanying emotional and physical challenges that were not necessarily anticipated.
An important factor that is often overlooked in this quest and, at times, leads to moral conflict over the ethical and legal implications of such decisions is the very human associations and personal manifestations of such decisions. In the case of ST, the decision led to a very important and meaningful strengthening of the relationship between the patient and her daughter, which might never have occurred if the healthcare professional players had not been as supportive as they were in the decision that was made. In the second case vignette, RL’s prolonged period of life after the withdrawal of his pacemaker allowed him to refocus his efforts on the life that he had left to live, something that can be very important in those at the “end of life.” The staff involved in the care of these patients learned a great deal about their own values and the reasons why they chose to work in the palliative care field, and especially with older adults, as the human complexity and therefore intrinsic persona and professional satisfaction is the result of the humanity encompassed in difficult end-of-life decisions.
Conclusion
End-of-life decisions are never easy. With the proliferation of modern technological interventions, such as the permanent implanted pacemaker for a previously demonstrated serious bradycardia that can promote cardiovascular or respiratory function, the apparent ability to extend or defer the final outcome may become a barrier to a gentle and quality death. It is such a death devoid of modern technology that reverts the focus to comfort and care, the hallmarks of quality palliation, which should be considered as important goals of end-of-life care. Reynolds and associates stated the following in their 2005 article:11
Families and patients should never feel abandoned during this process and attention should be devoted to communicating that care is not being withdrawn. The family needs to be prepared for what the dying process may look like. Assure them that all energy is now being directed toward the comfort of the patient including sedation as required if signs of suffering are observed. Easing death, like easing birth, can be one of the most fulfilling contributions one can make to reduce the suffering and enrich the lives of patients and their families.
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6. Morrison LJ, Calvin AO, Nora H, Porter Storey C Jr. Managing cardiac devices near the end of life: a survey of hospice and palliative care providers. Am J Hosp Palliat Care. 2010;27(8):545-551.
7. Kennedy IM. The Karen Quinlan case: problems and proposals. J Med Ethics. 1976;2(1):3-7.
8. Stryker J. Right to Die; Life After Quinlan. The New York Times. www.nytimes.com/1996/03/31/weekinreview/right-to-die-life-after-quinlan.html. Published March 31, 1996; accessed September 17, 2015.
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11. Reynolds S, Cooper AB, McKneally M. Withdrawing life-sustaining treatment: ethical considerations. Thorac Surg Clin. 2005;15(4):469-480.
