0Ethical Challenges With Deactivation of Durable Mechanical Circulatory Support at the End of Life: Left Ventricular Assist Devices and Total Artificial Hearts
Mohamed Y. Rady, BChir, MB (Cantab), MA, MD (Cantab), FRCS (Edin.), FRCS (Eng.), FRCP (UK), FCCM1, and Joseph L. Verheijde, PhD, MBA, PT2,3
Journal of Intensive Care Medicine 2014, Vol 29(1) 3-12 © The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0885066611432415 jic.sagepub.com
Abstract
Left ventricular assist devices (LVADs) and total artificial hearts (TAHs) are surgically implanted as permanent treatment of unrecoverable heart failure. Both LVADs and TAHs are durable mechanical circulatory support (MCS) devices that can prolong patient survival but also alter end-of-life trajectory. The permissibility of discontinuing assisted circulation is controversial because device deactivation is a life-ending intervention. Durable MCS is intended to successfully replace native physiological functions in heart disease. We posit that the presence of new lethal pathophysiology (ie, a self-perpetuating cascade of abnormal physiological processes causing death) is a central element in evaluating the permissibility of deactivating an LVAD or a TAH. Consensual discontinuation of durable MCS is equivalent with allowing natural death when there is an onset of new lethal pathophysiology that is unrelated to the physiological functions replaced by an LVAD or a TAH. Examples of such lethal conditions include irreversible coma, circulatory shock, overwhelming infections, multiple organ failure, refractory hypoxia, or catastrophic device failure. In all other situations, deactivating the LVAD/TAH is itself the lethal pathophysiology and the proximate cause of death. We postulate that the onset of new lethal pathophysiology is the determinant factor in judging the permissibility of the life-ending discontinuation of a durable MCS.
Keywords
autonomy, cardiac devices, constitutive treatment, destination therapy, durable mechanical circulatory support, euthanasia, physician-assisted death, left-ventricular assist device, total artificial heart
Received April 18, 2011, and in revised form August 10, 2011. Accepted for publication September 19, 2011.
Introduction
Durable mechanical circulatory support (MCS) is currently feasible with the use of left ventricular assist devices (LVADs) and total artificial hearts (TAHs) as permanent treatment of unrecoverable heart failure. These devices are surgically implanted to replace mechanical cardiac function when spontaneous function is irreversibly lost. We have previously described the essential requirements of informed consent and palliative care counseling before surgical implantation of LVADs in destination therapy to ensure optimal end-of-life care.1 However, deactivating such devices remains one of the ethical challenges because it can influence a patient's end-of-life trajectory (Figure 1). Bio-technological advances in medical devices not only have made it possible to replace permanently vital physiological functions, but they also added complexity to the appraisal of lethal pathophysiology and causation of death whenever physicians are asked to discontinue these devices.
In this article, we offer an alternative assessment of the discontinuation of durable MCS devices such as LVADs or TAHs with a primary emphasis on the lethal pathophysiology as the central element in the evaluation of the permissibility (ie, intention, causation, and responsibility of death) of this life-ending intervention (Figure 2).2-4 The appraisal of the lethal pathophy-siology or mode of death is useful in identifying situations of assisted death.5'6 Since the US Supreme Court set constitutional
1 Department of Critical Care Medicine, Mayo Clinic Hospital, Phoenix, AZ, USA
2 Center for Biology and Society, College of Liberal Arts and Sciences, Arizona State University, Tempe, AZ, USA
3 Department of Physical Medicine and Rehabilitation, Phoenix, AZ, USA
Corresponding Author:
Mohamed Y. Rady, Department of Critical Care Medicine, Mayo Clinic Hos-
pital, Mayo Clinic, 5777 East Mayo Boulevard, Phoenix, Arizona, USA, 85054. Email: rady.mohamed@mayo.edu
Figure 1. End-of-life trajectory and deactivating left ventricular assist device (LVAD) in destination therapy (DT). The use of an LVAD as a destination therapy can influence end-of-life trajectory (dotted lines) compared to medically treated patients (solid line) with end-stage heart failure. In trajectory B, the patient dies from lethal complications after surgery for device implantation. In trajectories A or C, the patient survives with the LVAD and request to electively deactivate the LVAD to end his (her) life because of unacceptable quality of life (subjective futility). Deactivating an LVAD causes a rapid death within minutes to hours at the final phase of end-of-life trajectory A or C (adapted with permission1).
parameters for life-terminating acts in Washington v Glucks-berg7 and Vacco v Quill,8 commentators necessarily have directed attention to the standard elements (intention, causation, and responsibility) to differentiate situations in which a patient is allowed to die from those in which a patient is assisted to die.9-13 Sulmasy highlighted the critical importance of intention, causation, and responsibility in analyzing the permissibility of life-ending interventions (Table 1).3 We have discussed, elsewhere, the distinction between a physician's act of commission and act of omission in the causation of death in other end-of-life situations.1415 Deactivating a cardiac device is viewed medically and legally as an act of commission rather than an act of omission.16-18 Therefore, in different situations, deactivating durable MCS devices can have different legal and ethical consequences.19 Patients and/or surrogates may ask physicians to electively turn off an LVAD or TAH to end life.20 We posit that the onset of new lethal pathophysiology can distinguish situations when deactivating an LVAD or TAH is considered allowing the natural death of a patient rather than physician-assisted death (PAD). Differentiating between allowing natural death and assisted death is relevant in medical practice for moral, legal, cultural, and religious reasons. The ethical considerations of deactivating durable MCS devices such as LVADs/TAHs are similar to those arising from discontinuing other biotech-nological devices such as implantable electronic cardiac devices, mechanical ventilators, and hemodialysis machines. The ability to identify situations in which deactivating a medical device is permissible provides essential information for patients and surrogates to assist with advance end-of-life planning.
Figure 2. Lethal pathophysiology and the permissibility of life-ending interventions. A lethal pathophysiology is a self-perpetuating cascade of abnormal physiological processes that will inevitably culminate in irreversible cessation of 3 primary physiological functions (ie, consciousness, respiration, and circulation). The lethal pathophysiology of death is clinically relevant when discontinuing a treatment at the end of life.2 The lethal pathophysiology is a central element in evaluating the permissibility of end-of-life interventions that is, intention, causation, and responsibility of death.2-4 In assisted death, the left ventricular assist device (or total artificial heart) is effective in maintaining circulation and patient's life but the device must be discontinued to introduce a new nontherapeutic lethal pathophysiology for a preplanned or hastened death. In natural death, the lethal pathophysiology is already set in motion from an acute life-threatening illness and/or a treatment-refractory disease. Examples include circulatory shock from massive hemorrhage, overwhelming infections, multiple organ failures, refractory hypoxia, or catastrophic device failure. In these clinical situations, a normally operating device is ineffective in maintaining circulation and life in that patient and death ensues.
Life-Ending Interventions in Medical Practice
The term "euthanasia" has several descriptive adjectives (ie, active, passive, voluntary, involuntary, or nonvoluntary) which can obscure a critical analysis of the physician's role (allowing vs assisting death) in end-of-life care.21 Kuiper et al advocated using terms that describe the actions that are taking place to better differentiate between natural and assisted death.21 Quill used PAD to describe life-ending interventions that intentionally hasten the dying process or facilitate a preplanned death.22 Physician-assisted death refers to both physician-assisted suicide and euthanasia.23-25 Physicians perform the life-terminating act in euthanasia and patients perform the life-terminating act in assisted suicide by taking medication provided by a physician. However, physicians' perceptions of life-ending interventions in similar cases as either PAD or natural death are not uniform.26 The inconsistency of labeling similar life-ending interventions as PAD prevents societal regulation in countries where PAD is legal.26 The type of life-ending intervention, whether discontinuing a biotechnological device and/or administering medication,
Table 1. Analysis of Standard Elements in Natural Death Versus Assisted Death.a
Analysis
Standard Elements Natural Death Assisted Death
Pathophysiology
Introducing a new nontherapeutic lethal pathophysiology No Yes
Authorization
Consent for an elective preplanned (assisted) death No Yes
Intention
Physician is intending death No Yes
Causation
Physician's active intervention is necessary (act of commission) No Yes
Moral judgment/responsibility
Physician's active intervention is responsible for death No Yes
a The permissibility of life-ending interventions is determined by the lethal pathophysiology as a central element to evaluate intention, causation, and responsibility of death. These standard elements can differentiate allowing natural death from assisted death following a life-ending intervention. Data adapted from sources.2-4,8
and the time to death may not accurately distinguish PAD from natural death.27
The inconsistency of labeling similar life-ending interventions as either natural death or PAD is illustrated in several surveys on the deactivation of implantable cardiac devices. In one survey, 11% of health care providers responded that pacemaker deactivation is euthanasia.28 In another survey, 9% of physicians viewed deactivating pacemakers as euthanasia and 19% viewed this as physician-assisted suicide.16 In a multiprofession opinion survey, 32% of medical professionals, 12% of legal professionals, and 24% of patients considered deactivating pacemakers as physician-assisted suicide or euthanasia.17 Generally, patients viewed deactivating implantable cardiac devices as morally different from other life-support treatment in the intensive care unit and some viewed this as euthanasia or physician-assisted suicide.18 Strachan et al surveyed 24 patients who consented to a permanent implantable cardiover-ter defibrillator for the primary prevention of sudden cardiac death.29 Most patients refused deactivating the device at the end of life as the mode of death and preferred to die from other natural causes or illnesses.28
Life-support treatment means artificial maintenance of ventilation and/or circulation as well as artificial hydration, nutrition, and hemodialysis. The medical, ethical, and legal issues regarding discontinuing permanent life-support treatment upon
13 19 30 31
a patient's request to end life remain unsettled.13'19'30'31 For the past decade, the moral debate on acts of commission or omission and causing or allowing death has been primarily grounded in theoretical and philosophical considerations.32-36 These philosophical reflections have been, to a large extent, unhelpful and somewhat detached from the reality of clinical practice and bedside medicine. In order to illustrate the importance of including a clinical perspective in differentiating between natural death and PAD, we analyze a hypothetical scenario of deactivating an LVAD in a device-dependent patient. Hypothetical end-of-life scenarios are useful to highlight situational differences between PAD and natural death.26 37
Hypothetical Scenario
Consider the following hypothetical patient: Albert is 71 years old with an LVAD that was implanted as destination therapy for intractable left heart failure 3 years earlier. He lives at home with his spouse as his primary caregiver. Albert asks his physician to administer sedatives and deactivate the LVAD to end his life. We evaluate whether the action specifically related to deactivating the LVAD is PAD or allowing Albert to die naturally. The role of sedatives to induce deep sedation in relation to Albert's death will not be discussed. We have previously addressed the administration of sedatives to induce continuous deep sedation until death and its relation to PAD.4'15
We examine the general application of pathophysiological differentiation of causation of death to evaluate the permissibility of deactivating durable MCS devices. Sulmasy has proposed that the pathophysiology causing death may be a useful criterion to distinguish PAD from natural death when discontinuing biotechnological devices.2 From a clinical perspective, assisted death is defined as "an act in which an agent performs an action that creates a new, nontherapeutic, lethal pathophysiological state in a human being with the intention of thereby causing that human being's death.''2 A pathophysiology is an abnormal physiological process. A lethal patho-physiology is a self-perpetuating cascade that will inevitably culminate in irreversible cessation of the 3 primary physiological functions (ie, consciousness, respiration, and circulation; Figure 2). Death can occur without prior deactivation of the durable MCS device because of the onset of irreversible loss of vascular vasomotor tone. An acute life-threatening illness is the trigger of a lethal pathophysiology. Once the lethal patho-physiology is set in motion in imminently dying patients, death is inevitable despite continued life-support treatment and without the need to withdraw treatment (ie, physiological futility). In this situation, the withholding/withdrawal of treatment is still congruent with allowing natural death because the treatment is no longer effective in supporting patient's physiology and maintaining vital functions of life. Withdrawing life-support
treatment with consent is medically, ethically, and legally appropriate in situations of physiological futility because of the presence of acute life-threatening illnesses.38'39
Durable MCS Devices as Alternative to Heart Transplantation Destination Therapy
There are 2 types of medical treatment: (1) a treatment that reverses a pathological process (eg, administering antibiotics for infections or chemotherapy for malignant tumors) and (2) a treatment that replaces a specific body function and maintains normal physiology (eg, organ replacement in end-stage organ failure). A treatment with a biotechnological device is intended to support a specific body function and maintain normal phy-siology.2 If the body function recovers, the treatment is discontinued with no harm to the patient. If the body function is unrecoverable, the treatment is permanent and its continuation is essential for patient's normal physiology and life. Durable MCS devices such as LVADs and TAHs are examples of bio-technological devices that permanently replace mechanical function of the ventricles, when native ventricular function is unrecoverable. Patients with extensive myocardial fibrosis of the left ventricle are permanently dependent on LVADs for normal systemic circulation.40 Left and right ventricles are surgically removed to implant a TAH; the patient has no native ventricular activity. A TAH replaces mechanical function of both the left and right ventricles. Rapid cessation of circulation and death will occur if normal operation of the LVAD/TAH is interrupted in a device-dependent patient. The cardiac device is part of the normal physiology of the patient.
Ethical Controversies in the Deactivation of Durable MCS Devices
Elective withdrawal of a permanent treatment to end a patient's life can be viewed as either allowing natural death or assisting death. To uphold the ethical appropriateness of treatment withdrawal, Sulmasy categorized a permanent life-support treatment as either regulative or constitutive treatment.2 A regulative treatment restores the body homeostatic equilibrium such as hemodialysis in unrecoverable kidney disease.2 A constitutive treatment can either replace or substitute a permanently lost native physiological function that is essential to life.2 A replacement treatment meets specific criteria (Table 2).2 A substitute treatment can fulfill some, but not all, of the criteria that are characteristic of a replacement treatment. A transplanted heart is a replacement treatment,2 but a durable MCS device, such as a TAH, is a substitute treatment. Cardiac devices (eg, permanent pacemakers, cardioverter defibrillators, cardiac resynchronization therapy devices, and ventricular assist devices) are considered substitute treatments.2,41 Sulmasy suggested that it is permissible to electively withdraw a regulative treatment (eg, hemodialysis in end-stage kidney disease) or a substitute treatment (eg, cardiac devices) because this is allowing natural death, but, he argues, it is impermissible to withdraw a replacement treatment (eg, transplanted heart) because that
Table 2. Criteria of a Replacement Treatment and Characteristics of Implantable Electronic and Mechanical Cardiac Devices.a
Criteria of a replacement treatment
• Responsiveness to changes in the organism or its environment
• Properties such as growth and self-repair
• Independence from external energy sources or supplies
• Independence from external control by an expert
• Immunologic compatibility
• Physical integration into the patient's body Characteristics of implantable cardiac devices
• Permanent replacement of native physiological functions of the heart
• Normal operation of the device is integral to patient's physiology
• Continuous control of electric and/or mechanical functions of the heart
• Intrinsic responsiveness to changing body demands
• External dependence on energy source and expert supervision
• Immunological compatibility with the body
• Internal implantation of the device within the body
• Cessation of circulation and vital signs on deactivation
aData adapted from sources.2,41
would constitute PAD.2 This arbitrary treatment categorization fails to acknowledge that interrupting either regulative or constitutive (replacement and substitute) treatment can introduce a new nontherapeutic lethal pathophysiology (Table 1) but with different end-of-life trajectories. Therefore, withdrawal of permanent treatment with mechanical ventilators, hemodialysis machines, or cardiac devices can be the proximate causation of death depending on the situation.
The permissibility of deactivating an LVAD (and TAH) based upon whether it replaces or substitutes a specific physiological function can complicate end-of-life decisions for several reasons.
First, the criteria that categorize a treatment as either a replacement or a substitute are clinically inconsistent. An LVAD or TAH is categorized as a substitute treatment and therefore, it is always permissible to discontinue treatment at any time to end life.42 A transplanted heart is categorized as a replacement treatment; it cannot be discontinued to end life.242 However, a transplanted heart is immunologically incompatible and the recipient is dependent on regular intake of immunosuppressive medication and expert supervision to prevent biological rejection, making it less likely that the criteria of a replacement treatment have been met (Table 2). If a transplant recipient decides to end his life, he can discontinue taking immunosuppressive medication resulting in rejection of the transplanted heart and death. In contrast, an implanted LVAD/TAH is immunologically compatible, physically integrated in the body, capable of intrinsically responding to changing body demands, and categorized as a substitute treatment. If a patient with an LVAD/TAH decides to end his life, then the device power supply can be turned off. Therefore, the LVAD/TAH might be better categorized as a replacement treatment similar to a transplanted heart. A transplanted heart is considered a replacement because its surgical removal will
result in the patient's death, and surgical explantation of a TAH or an LVAD in a device-dependent patients will also result in death.2 42
Second, there is neither an accepted standard nor an agreement in clinical practice on designating a biotechnological device as either a replacement or a substitute of native physiological functions. This is substantiated by the lack of consensus among physicians on the deactivation of cardiac devices at the end of life. Some physicians view deactivating cardiac devices as no different from withdrawing life-support treatment in critically ill or imminently dying patients in intensive care units.41-43 Categorizing implantable cardiac devices as substitute life-support treatment can be construed as a defense of the permissibility of deactivating these devices in patients who are requesting to end their lives.41 However, cardiac devices have different characteristics from common life-support treatments used in the intensive care unit (Table 2). Deactivating an LVAD/TAH in a device-dependent patient is not unlike deactivating a permanent pacemaker in a pacemaker-dependent patient. Circulation ceases within minutes to hours after deactivating the TAH or LVAD, respectively. In one study, all patients became unconscious after LVAD deactivation and died in <20 minutes.44 Brush et al reported that of the 20 patients who participated in end-of-life decisions, 17 elected to turn off the device, whereas 3 elected to allow ''natural'' end of life to occur without actively turning off the pump until after they became unconscious.44 Deactivating an LVAD or TAH introduces a nontherapeutic lethal pathophysiology related to device type and implantation surgical procedure.42 Surgical implantation of durable MCS devices permanently alters native structural and functional configuration of the heart, so that spontaneous effective systemic circulation can no longer be maintained if the device is interrupted.45-47 Prolonged LVAD support is also associated with irreversible disruption of normal heart valves (eg, aortic valve)45 and introduces new lethal pathophysiology upon device deactivation in some patients. We challenge the claim that a patient's death following LVAD/TAH deactivation is a ''natural'' death secondary to preexisting heart disease.42 The lethal pathophysiology in a patient who is dying naturally from heart disease and without an implanted device is different from a patient who dies after deactivating an LVAD or TAH.5
Third, analysis of the lethal pathophysiology restricts the ethical permissibility of deactivating an LAVD in certain situations, as in Albert's situation, irrespective of classifying the device as replacement or substitute treatment. It is important to differentiate discontinuing an LVAD in the hypothetical scenario from a situation in which Albert would be imminently dying from a life-threatening illness or a catastrophic device failure. Examples of acute life-threatening illnesses may include a hemorrhagic or ischemic brain infarction leading to central apnea and vasomotor collapse, circulatory shock from massive hemorrhage or overwhelming infections, multiple organ failure, refractory hypoxia of lung disease, or catastrophic device failure. In these clinical situations, Albert will die because of the onset of lethal pathophysiology from a new
illness without the LVAD being deactivated. Normal operation of a durable MCS device does not prevent death in these clinical situations. Therefore, the situation in which an LVAD is deactivated determines the ethical and legal permissibility of this life-ending intervention.
Deactivating Durable MCS Devices and the Lethal Pathophysiology
We distinguish 2 situations regarding the permissibility of treatment withdrawal: (1) temporary treatment as encountered in critically ill patients in the intensive care units and (2) permanent treatment initiated as a lifelong treatment because of an unrecoverable body function. A temporary treatment may be initiated to reverse a specific pathological process such as administering antibiotics to treat infections. A permanent treatment may be initiated as replacement of an unrecoverable body function essential for life. We focus our discussion on the second situation in which, we argue, the permissibility of treatment withdrawal should be based on the onset of new lethal pathophysiology. The patient perceives the implanted LVAD/ TAH as part of his self-image. His own physical, emotional, and psychological well-being is closely connected with the normal operation of the device.48-51 Kraemer has argued that deactivating a durable MCS device is indeed active euthanasia if the patient perceives the implanted device to be an integral part of his or her body.52 The normal operation of an LVAD or TAH is necessary to maintain a patient's circulation. From a patient's perspective, the LVAD/TAH: (1) maintains systemic circulation, (2) constitutes the vital sign of a patient's circulation, and (3) treats successfully and therefore, these devices are perceived as a cure for heart disease. Device discontinuation not only terminates an effective treatment but also introduces new nontherapeutic lethal pathophysiology. Deactivating an LVAD or TAH predictably results in a rapid cessation of circulatory function. We posit that from a clinical perspective, the lethal pathophysiology is a key criterion in assessing the permissibility of life-ending interventions in medical practice and in differentiating natural death from assisted death (Figure 2). We apply this proposed model in Albert's scenario of deactivating an LVAD to end his life.
Ethical Analysis of Discontinuing Durable MCS
Albert refuses to continue treatment with an LVAD. Respect for autonomy is widely believed to entail the right to refuse treatment at any time. Refusing durable MCS with an LVAD might be considered consistent with the right to self-determination. It is often argued that withdrawing and withholding life-support treatment at the end of life are morally and legally equivalent.38 The question is whether this argument can apply in situations in which biotechnological devices have successfully replaced native physiological functions. If the answer is yes, can this argument uphold the notion that deactivating an LVAD is synonymous with allowing natural death rather than
assisting death? In our hypothetical situation, treatment is being withdrawn because Albert considers his quality of life as unacceptable (subjective futility) although the treatment remains physiologically effective in supporting his life. Albert's life cannot (clinically) be terminated without stopping that treatment. A durable MCS device can maintain life in a patient without spontaneous cardiac function and deactivating the device is necessary if the patient wishes to end his or her life. An LVAD can support Albert's life for an unknown time provided that he does not develop an acute life-threatening illness or lethal complications from the device. Deactivating the LVAD triggers the lethal pathophysiology and becomes the proximate causation of death. Albert's death is caused by deactivating the LVAD and not by heart disease because the latter was effectively treated with the device.
Albert can disconnect himself from the LVAD to intentionally cause his own death, but he may have a distressful death. When a person disconnects his or her LVAD it is regarded sui-cide.53 However, Albert asks his physician to help him die peacefully and painlessly by inducing deep sedation before deactivating his LVAD. The physician who administers sedatives and deactivates Albert's LVAD, then, is participating in PAD. An act of commission is the proximate causation of Albert's death. However, this life-terminating act may be perceived as allowing Albert to die based on his autonomous decision to reject further treatment and the broadly appreciated ethical equivalency of withdrawing and withholding treatment. We think that this perceived equivalency is unfounded in clinical scenarios mirroring our hypothetical case because of the unequivocal and predictable fatal outcome of deactivating the LVAD. The fatal outcome of this act is not just foreseen but intended. When deactivating Albert's LVAD, the physician is intending to introduce a lethal pathophysiology, thus hastening the dying process and bringing about a preplanned death. An act intended to expedite death is ethically and legally the same as causing death.10,39,54,55 Imminently dying patients die regardless of whether an LVAD is continued or discontinued because of the onset of lethal pathophysiology triggered by a life-threatening illness. In the latter situations, the normal operation of an LVAD is no longer effective in supporting the patient's circulation and life (ie, physiological futility). Therefore, deactivating the device is not necessary for death to occur.
The President's Commission Report from 1983 permits the withdrawal of life-support treatment legally and ethically if patients have expressed these wishes through health care directives or authorized health care proxy.38 Withdrawal of lifesupport treatment is common in end-of-life decisions made in intensive care units. However, when withdrawing life-support treatment at the end of life, Sprung et al drew attention to gray areas between palliation and intending to hasten death.54 It can be difficult to distinguish palliating symptoms from hastening death, because physicians' true intentions in end-of-life care are private.56 Quill pointed to the difficulty of ascertaining physicians' true intentions in life-ending situations "multilayered intentions are present in most, if not all, end-of-life decisions ... we would do well to look beneath the idealized, sanitized
intentions espoused by many medical ethicists to the actual experience of doctors and patients.''57
Deactivating the LVAD is a prerequisite to end Albert's life and fulfill his wish of a preplanned (ie, time, place, and manner) death. Albert finds the quality of his life unacceptable which constitutes subjective futility. Subjective futility is related to whether patients perceive their quality of life as acceptable or unacceptable. Psychosocial, financial, and physical burden are common reasons for patients requesting PAD.58 It can be concluded from the analysis of intention and causation that deactivating Albert's LVAD would be appropriately defined as PAD. Furthermore, a patient's consent for this act does not abrogate a physician's moral responsibility of causing death10,13 by LVAD deactivation.
The Principle of Autonomy and Life-Terminating Medical Decisions
The principle of autonomy is pivotal in evaluating treatment refusal and the permissibility of life-ending interventions. The right to accept or reject treatment is a common law right based on bodily integrity and self-determination and also a constitutional right based on privacy and liberty.4142 The legal inferences of the right to refuse medical treatment are often generalized to include (1) treatment reversing pathological processes (eg, chemotherapy for cancer) and (2) treatment replacing permanently unrecoverable physiological functions (eg, biotech-nological devices). It is argued that this right also extends to a patient's right to refuse an ongoing effective treatment with a cardiac device.4142 The Patient Self-Determination Act of 1991 consolidated a patient's (prima facie) right to refuse treatment.59 The act was introduced after the US Supreme Court decision in Cruzan v Director, Missouri Dept. of Health6 Based on this act, deactivating an LVAD to intentionally end life can be construed as a patient's right, although the patient may neither be terminally ill nor imminently dying.41 Physicians do not have to agree with the reasons why patients are refusing treatment in order to respect their right. However, a patient's right of treatment refusal does not imply a right to assisted death (eg, deactivating an LVAD). Seale has reported that the willingness of physicians to engage in assisted death or perform life-terminating acts varied by the medical specialty and religious affiliations.6162 Could the patient's right of self-determination legitimize assisted death in US medical practice (Table 3)? The US Supreme Court commented in Vacco v Quill that ''No matter how noble a physician's motives may be, he may not deliberately cause, hasten, or aid a patient's death.''8 The court also opined in Washington v Glucksberg that the right to assisted suicide [assisted death] is not a fundamental liberty interest protected by the US Constitution.7 Commentators have misinterpreted the decision in Cruzan as an affirmation of a constitutional right to die.63 The opinion of the court in Washington v Glucksberg addressed this misinterpretation of Cruzan:
Although Cruzan is often described as a right to die case, Cruzan
recognized the more specific interest in making decisions about
Table 3. The US Supreme Court Opinions on the Constitutional Right of Refusing Medical Treatment and the Constitutional Right to Die.a Cruzan v Director Missouri Dept. of Health (I990)60:
I. • The right to refuse treatment is based on the common law right to informed consent and a constitutional privacy right
• Competent persons are able to exercise the right to refuse unwanted medical treatment under the Due Process Clause of the Fourteenth Amendment
• Clear and convincing evidence standard is required for withdrawal of life-sustaining treatment in an incompetent person
• Refusal of unwanted medical treatment applies to withdrawing and withholding of medical treatment
• Other inferences made from the case:
• Applicability to withdrawing all types of medical treatment:
■ Temporary vs. permanent
■ Biotechnology devices vs. medications
■ Replacement of physiological functions vs. reversal of pathological processes.
• Permissibility of withdrawal of medical treatment for the purpose of aiding, hastening or assisting death. Vacco v Quill8 and Washington v Glucksberg7
• The constitutional right to die [or assisted death] is not protected by the Fourteenth Amendment's Equal Protection Clause
• The constitutional right to die [or assisted death] is not protected by the Fourteenth Amendment's Due Process Clause
• The elements of causation and intent distinguish between treatment refusal and assisted death
• No matter how noble a physician's motives may be, he may not deliberately cause, hasten, or aid a patient's death.
• State prohibition on assisted death is grounded in society's interest to preserve human life
• State prohibition on assisted death is grounded in historical and national traditions and practices
'Adapted from multiple sources.7,8,60 The Supreme Court ruling in Nancy Cruzan case is inferred to generally mean a constitutional right to die and that elective termination of life by treatment withdrawal is permissible. The legal boundaries of physicians' roles in assisting, aiding or hastening death by either euthanasia or assisted suicide were outlined in the Supreme Court opinions in Vacco v Quill and Washington v Glucksberg.
how to confront an imminent death.7(p722) In Cruzan, we acknowledged that competent, dying persons have the right to direct the removal of life-sustaining medical treatment and thus hasten death. The right [of withdrawal of hydration and nutrition] assumed in Cruzan, however, was not simply deduced from abstract concepts of personal autonomy. Given the common-law rule that forced medication was a battery, and the long legal tradition protecting the decision to refuse unwanted medical treatment, our assumption was entirely consistent with this Nation's history and constitutional traditions.7^725 [W]e certainly gave no intimation that the right to refuse unwanted medical treatment could be some how transmuted into a right to assistance in committing suicide.7(p726) We have recognized, however, that this common-law right to refuse treatment is neither absolute nor always sufficiently weighty to overcome valid countervailing state interests.7(p742) These interests include prohibiting intentional killing and preserving human life; preventing the serious public-health problem of suicide, especially among the young, the elderly, and those suffering from untreated pain or from depression or other mental disorders; protecting the medical profession's integrity and ethics and maintaining physicians' role as their patients' healers; protecting the poor, the elderly, disabled persons, the terminally ill, and persons in other vulnerable groups from indifference, prejudice, and psychological and financial pressure to end their lives; and avoiding a possible slide toward voluntary and perhaps even involuntary euthanasia.7(p703) [S]ome individuals who no longer have the option of deciding whether to live or to die because they are already on the threshold of death have a constitutionally protected interest that may outweigh the State's interest in preserving life at all costs.7(p745)
We think that the onset of new lethal pathophysiology can objectively define the threshold of death and imminently dying patients and the permissibility of treatment withdrawal
and allowing natural death. Our analysis has additional implications for clinical practice. Withdrawing constitutive lifesupport treatment at the end of life can harm patients as this may introduce additional distressing symptoms and suffering which will require large doses of sedatives and opioids for the effective control of these symptoms.42,64-66 We have argued elsewhere that inflicting an additional burden of distressful symptoms to dying patients through withdrawing constitutive life-support treatment to end life or hasten death is PAD (euthanasia).15,67 However, the onset of new lethal pathophy-siology will result in death without the need for withdrawing constitutive life-support treatment or causing additional distress in dying patients, that is natural death. Justice Breyer in Washington v Glucksberg (concurring in judgments) reminded the medical profession that the primary goal of medicine in these patients should be the provision of optimal "palliative care, including the administration of drugs as needed to avoid pain at the end of life.''7 The goal of medicine should not be intervening to hasten death as the means to relieve suffering.67
Allowing natural death by an act of omission (eg, withholding a treatment) is morally different from assisting death by an act of commission for example, deactivating pacemakers and implantable cardioverter defibrillators.68 Deactivating an LVAD or TAH at the end of life has the same moral significance. When a rapidly progressing fatal illness is already present in a LVAD/TAH patient, deactivating a cardiac device may not be morally challenging. For example, if Albert was to develop a life-threatening infection or uncontrolled internal hemorrhage resulting in circulatory collapse, then Albert will die despite normal operation of the LVAD. Likewise, the lethal pathophysiology can be triggered if Albert were to suffer
widespread brain infarction and herniation leading to central apnea and vasomotor collapse.
The Hippocratic tradition of medicine is that physicians must not intentionally harm or cause death. Patients, surrogates, and physicians must acknowledge the ethical challenges about deactivating durable MCS devices. An open and transparent debate is necessary to determine the situations when this life-ending intervention can be legally and ethically permissible. Physicians may deny that they are responsible for causing death (ie, claiming to allow natural death and not to assist death) if they continue to perceive that discontinuing durable MCS devices is no different from the withdrawal oflife support in imminently dying patients in intensive care units. Upholding this perception can also deceive patients and families who object to PAD because of cultural, ethnic, or religious beliefs. Kramer et al emphasized the importance of respecting patients' religious values and beliefs about assisted death when deactivating implanted cardiac devices at the end of life.18 Abraha-mic religions (Judaism, Christianity, and Islam) condemn acts of commission intended to end life or hasten death.5
Recognizing that deactivating LVADs/TAHs, in certain situations, is PAD might have unintended negative consequences. Physicians may avoid discussing device deactivation with patients and surrogates as part of advance planning for end-of-life care. Physicians may object to discontinuing these devices in clinical situations when death is imminent after the onset of new lethal pathophysiology. The utilization of LVAD/ TAH technology in heart failure might also decline. Patients and families may be reluctant to consider durable MCS devices as a treatment option if they appreciate the ethical dilemma about deactivating these devices at the end of life. The reluctance toward utilization of these devices could adversely affect both the research and development and the clinical application of future technology in medicine.
Expansion of life-prolonging biotechnology without addressing the ethical consequences can transgress the Hippocratic tradition of medicine of not harming or killing patients. Some countries legally prohibit withdrawal of life-support technol-ogy,69,70 and cardiac devices41 (eg, deactivating pacemakers) as life-ending intervention. A Death with Dignity Act has been enacted in a few states in the United State to ease the tension between Hippocratic tradition of medicine and physicians' involvement in life-ending interventions.4 However, legalizing PAD in society does not resolve the ethical conflicts facing medical professionals. Finally, legalization of PAD can expand to nonconsensual life-ending interventions in vulnerable and incompetent patients. Nonconsensual ending of life of patients with diseases that have unpredictable end-of-life trajectories and who are not dependent on life-support treatment is reported in countries where PAD is legal.25
Conclusions
Durable MCS devices such as LVADs and TAHs permanently replace native ventricular functions in unrecoverable heart failure. It is necessary to distinguish natural death from assisted
death when deactivating durable MCS devices in patients who are not imminently dying. Discontinuing durable MCS is allowing natural death, if a new lethal pathophysiology is present that is unrelated to functions already supported by the LVAD/TAH. In all other situations, deactivating the device is the lethal pathophysiology and can constitute PAD. The onset of new lethal pathophysiology is a central element in evaluating permissibility of discontinuing durable MCS.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
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