Ethical aspects of deactivating implanted cardiac devices

Paul S. Mueller, MD, MPH, FACP

Associate Professor of Medicine

Disclosures

• I am a member of the Boston Scientific Patient Safety Advisory Board

• I am an associate editor for Journal Watch

• No off-label use of drugs or devices will be discussed

Objectives

• Describe the permissibility of withholding and withdrawing life-sustaining treatments (W/W LSTs)

• Differentiate W/W LSTs from physician-assisted suicide and euthanasia

• Describe the results of research related to the ethical aspects of withholding device therapy and deactivating implanted cardiac devices

Cases and questions to ponder

Case 1Refusal

• 72-year-old man presents with syncope; he is found to have intermittent complete heart block

• Pacemaker (PM) therapy is recommended

• He declines

• He understands the risks and benefits of, and the alternatives to, his decision

• How do you respond?

Case 11. Refer the patient to a psychiatrist since

his decision is irrational

2. Have your institutional ethics committee review and approve his decision

3. Ensure that his decision is informed and if so, respect it

4. Ask one of his loved ones to convince him that his decision is wrong

5. Force him to undergo PM implantation

Case 2Request for withdrawal

• 72-year-old man with CHF and ventricular dysrhythmias undergoes ICD implantation

• Despite medication adjustments, he is shocked 3 times the week after device implantation

• He now demands ICD deactivation• He understands the implications of his

request• How do you respond to his request?

Case 21. Refer the patient to a psychiatrist since his

request is irrational

2. Obtain an ethics consultation

3. Ensure that his request is informed and if so, deactivate the ICD

4. Ask a chaplain to convince him that his request is wrong

5. Refuse to comply as his request is akin to euthanasia

Case 3Request for withdrawal

• 72-year-old man dying of lung cancer

• He has a PM for complete heart block with unstable escape

• Fearing the PM will prolong the dying process, he requests PM deactivation

• He understands the implications of PM deactivation

• How do you respond to his request?

Case 31. Refer the patient to a psychiatrist since his

request is irrational

2. Comply if the hospital attorney agrees

3. Ensure that his request is informed and if so, deactivate the PM

4. Ask his family to convince him that his request is wrong

5. Refuse to comply as granting his request is akin to euthanasia

Case 4Request for withdrawal

• 72-year-old man with CHF has an ICD for ventricular dysrhythmias

• Now hospitalized with cancer and sepsis, he is delirious and dying

• There is no advance directive

• Fearing shocks during the dying process and citing the patient’s values and goals, his family requests ICD deactivation

• They understand the implications of ICD deactivation

• How do you respond?

Question 4

1. Refuse to comply since there is no advance directive

2. Obtain an ethics consultation

3. Call the hospital attorney for advice

4. Deactivate the ICD

5. Refuse to comply as granting the request is akin to euthanasia

QuestionCause of death

If a patient dies of a cardiac dysrhythmia after refusing device implantation, which of the following best describes the cause of death?

1. The patient’s refusal of device therapy

2. The cardiac rhythm disturbance

3. I’m not sure

QuestionCause of death

If a patient dies of a cardiac dysrhythmia after withdrawal of device therapy (deactivation), which of the following best describes the cause of death?

1. Withdrawal of device therapy

2. The cardiac rhythm disturbance

3. I’m not sure

Question

If a decision is made to deactivate a device, who should carry out the deactivation?

1. Primary care physician

2. Palliative medicine specialist

3. Electrophysiology (EP) physician

4. EP nurse or technician

5. Device industry representative

Clinical ethicsBeauchamp and Childress. Principles of Biomedical Ethics, 5th ed.

• Definition: the identification, analysis, and resolution of moral (“should”) problems that arise in patient care

• Prima facie ethical principles:– Beneficence– Non-maleficence– Respect for patient autonomy– Justice These principles often are

at odds with each other.

Is it ethical and legal to withhold or withdraw life-sustaining treatments?

Withholding and withdrawing life-sustaining treatments• Many types: hemodialysis, ventilators, etc.

– Most clinicians regard implanted cardiac devices as life-sustaining

• Ethics principle: respect for autonomy– Rights to refuse, or request the withdrawal of,

unwanted interventions even if doing so results in death; should not impose treatments

– No ethical or legal differences between withholding and withdrawing

– Clinician’s duty: informed refusal

Karen Quinlan70 N.J. 10 (1976), Supreme Court of New Jersey

• Found unresponsive; PVS• The family wanted to withhold

LST; the institution did not• Court decision:

– Patients have the right to refuse treatment

– Surrogates may exercise the patient’s right

– Such decisions are best made by families, not courts

– The state’s interest in preserving life can be overridden by the patient’s right to refuse treatment

Elizabeth Bouvia179 Cal App 3d 1127, 225 Cal Rptr 297, 1986

• Born with cerebral palsy

• Quadriplegic and in constant pain

• At 28, she announced her intent to no longer eat

• She was competent and understood risks

• Received a feeding tube against her will

• Court ordered tube removed; barred replacement without consent

• The right to refuse treatment is not limited to terminally-ill patients

Elizabeth Bouvia179 Cal App 3d 1127, 225 Cal Rptr 297, 1986

“Elizabeth Bouvia’s decision to forego medical treatment or life support through a mechanical means belongs to her. It is not a decision for her physician to make. Neither is it a legal question whose soundness is to be resolved by lawyers or judges. It is not a conditional right subject to approval by ethics committees or courts of law. It is a moral and philosophical question that, being a competent adult, is hers alone.”

Nancy Cruzan

• 1983: in a motor vehicle accident; never regained consciousness (PVS)

• 1988: parents sought removal of feeding tube

• Hospital refused without court order

• Trial court ordered removal of tube

Nancy CruzanMissouri Supreme Court

• Must have clear and convincing evidence of a patient’s wishes (eg, an advance directive) before removing a feeding tube

• The state’s interests in preserving life outweigh the patient’s interests

• Artificially administered hydration and nutrition are not medical treatments

Nancy CruzanUS Supreme Court, 1990

• The Constitution does not prohibit states from adopting a “clear and convincing” standard– Each state may establish their own standard– Upheld Missouri’s requirement

Nancy CruzanUS Supreme Court, 1990

• Competent adults have a constitutional right to refuse unwanted treatments– 14th Amendment “liberty interest”

• This right extends to incompetent persons through their surrogates

• Artificially administered hydration and nutrition are medical treatments

Nancy Cruzan

• Cruzan died in 1990• Her death occurred

12 days after a state court allowed withdrawal of her feeding tube (the decision was based on new evidence of her wishes)

W/W LSTsLegal permissibility

WD=withdrawal, WH=withhold

Precedence of landmark casesNot a right to die, but a right to be left alone

• A competent patient has the right to refuse or request the withdrawal of LSTs

• The incompetent patient has the same right (exercised through a surrogate)

• Hierarchy of surrogate decision-making• The court is not the place to make these decisions• No case must go to court• No difference between withholding and withdrawing

LSTs• Artificial fluid and nutrition are medical treatments• No physician liability for granting such requests

Answers

• It is ethical and legal to withhold or withdraw life-sustaining treatments from patients who do not want them.

• Through surrogates, patients without decision-making capacity have the same ethical and legal rights as those with capacity.

Are withholding and withdrawing life-sustaining treatments akin to euthanasia?

End-of-life decisions

“The distinction comports with fundamental legal principles of causation and intent. First, when a patient refuses life-sustaining medical treatment, he dies from an underlying fatal disease or pathology; but if a patient ingests lethal medication prescribed by a physician, he is killed by that medication...[In Cruzan] our assumption of a right to refuse treatment was grounded not…on the proposition that patients have a…right to hasten death, but on well established, traditional rights to bodily integrity and freedom from unwanted touching.”

Vacco v. QuillU.S. Supreme Court, 1997

Answer

• Withholding and withdrawing life-sustaining treatments are not akin to physician-assisted suicide and euthanasia.

Conscientious objection

• You cannot compel a clinician to perform a medical procedure he or she views as morally unacceptable

• What to do if this is the case

How does this discussion apply to implanted cardiac devices?• Introduction: PM in

1958 and ICD in 1980• PM and ICD therapies

prolong life• The indications for

device therapies are increasing

• Increased prevalence of patients with devices

How does this discussion apply to implanted cardiac devices?• Nearly 3 million

patients with implanted cardiac devices in the U.S.

• More dying patients have devices, increasing the likelihood of device deactivation requests

Deactivating implanted cardiac devicesConcerns raised

• Ethical? Legal?

• Same as physician-assisted suicide or euthanasia?

• Do guidelines exists?

• Who should carry out deactivations?

• What documentation should exist?

• How can we prevent ethical dilemmas?

Device requestsRefusals (withhold) to deactivation (withdraw)

• Patient refuses device implantation

• Patient refuses device exchange at end of battery life

• Patient with device refuses re-implantation after device failure

• Non-dying patient requests device deactivation

• Terminally-ill patient requests deactivation

Deactivating implanted devicesCommon ethics argumentsJ Gen Intern Med 2007;23(Suppl 1):69-72.

• Withholding vs. withdrawing treatment– No ethical or legal

differences– Devices raise no new

moral issues

• Duration of treatment– Not a morally decisive

factor

• Continuous vs. intermittent treatment– May be a reason for

different perceptions regarding deactivating ICDs vs. PMs

– However, we accept WD of both continuous and intermittent LSTs (e.g., ventilation vs. HD)

Deactivating implanted devicesCommon ethics argumentsJ Gen Intern Med 2007;23(Suppl 1):69-72.

• Regulative vs. constitutive treatment– Constitutive treatment

takes over a function the body can no longer provide

– However, we accept WD of constitutive treatments (e.g., ventilation, HD, feeding tube)

• Internal vs. external treatment– Often cited; but,

definitions of killing vs. allowing to die make no reference to internal vs. external

– Internal vs. external doesn’t “seem to mark the moral difference between killing and allowing to die”

Deactivating implanted devicesCommon ethics argumentsJ Gen Intern Med 2007;23(Suppl 1):69-72.

• Replacement vs. substitutive treatment– Substitutive treatment:

more acceptable to WD

– Replacement treatment: “part of the patient” and less acceptable to WD

• Replaces that which is pathologically lost

Features of replacement treatments:

− respond to changes in the host and environment

− self-growth and repair− independent from external

energy sources− controlled by an expert− immunologic compatibility− bodily integration

Example: AVR vs. ICD

Ethics consultations prompted by device deactivation requests Mayo Clin Proc 2003;78:959-963

Deactivating implanted devicesAnalysis prompted by ethics consultationsMayo Clin Proc 2003;78:959-963

• Ethical and legal if consistent with the patient’s values and goals

• Not the same as physician-assisted suicide or euthanasia– Cause of death the underlying heart disease

• Employ a dedicated team of clinicians

• Address conscientious objection

• Call for research

Deactivating ICDs*Literature review

Many patients with ICDs:• Have anxiety about receiving shocks (J Gen

Intern Med 2007;23[Suppl 1]:7-12; Psychiatr Clin N Am 2007;30:677-688)

• Experience shocks while dying (Am J Med 2006;119:892-896; Ann Intern Med 2004;141:835-838)

*The literature on pacemakers is sparse and anecdotal

Deactivating ICDsLiterature review

Few patients with ICDs:• Have ever discussed device deactivation

with their physicians (J Gen Intern Med 2007;23[Suppl 1]:7-12)

• Know that device deactivation is an option (J Gen Intern Med 2007;23[Suppl 1]:7-12)

Deactivating ICDsLiterature review

Advance care planning:

• Articulating goals and preferences for care at the end-of-life

• Regarding devices:– Rarely happens (J Clin Ethics 2006;17:72-78)

• Patients with all devices (PM, ICD, LVAD, etc)• Similar at Mayo

– For patients with ICDs, results in fewer shocks at the end-of-life (Am J Med 2006;119:892-896)

Device deactivation in the dyingSurvey of practices and attitudesPACE 2008;31:560-568

• Web-based survey

• HRS members and field personnel of 2 device manufacturers

• ICDs and pacemakers

• 787 respondents, almost all of whom had patient contact– 63% male, 63% worked for industry, and 23%

were physicians

Survey resultsPACE 2008;31:560-568

All differences are statistically significant

Survey resultsPACE 2008;31:560-568

Survey resultsPACE 2008;31:560-568

*Similar results were found for psychiatric consultation

All differences are statistically significant

Survey resultsPACE 2008;31:560-568

*Anecdotal experience indicates that many device industry representatives do not appreciate this task.

*

Survey conclusionsPACE 2008;31:560-568

• Device deactivation requests are common• A majority of caregivers have cared for

patients who have made these requests and have personally deactivated devices

• In dying patients, a distinction is seen between deactivating an ICD and a PM

• Device manufacturer field representatives are cited as those who deactivate devices most of the time

Deactivating implanted cardiac devices: unanswered questions

Unanswered questionsAdditional research is needed

• Events leading up to device implantation– The treatment imperative: “the almost

inexorable momentum towards intervention that is experienced by physicians, patients, and family members alike” (PLoS Med 2008; 5[3]:e7)

– Paradigm example of how ethical dilemmas arise when new technologies are introduced into clinical practice (note LVADs)

• Living and dying with a device

Unanswered questionsAdditional research is needed

• Who should carry out deactivations?– Further explore the involvement of device

industry representatives– Develop guidelines and policies (See Heart Rhythm

2008;5:e8-10)

• What protocols should be followed?

• How can we improve advance care planning regarding implanted devices?

Thank youmueller.pauls@mayo.edu