Ethical aspects of deactivating implanted cardiac devices

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Ethical aspects of deactivating implanted cardiac
devices

• Paul S. Mueller, MD, MPH, FACP
• Associate Professor of Medicine

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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

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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

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Cases and questions to ponder
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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?

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Case 1

1. 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

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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?

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Case 2

1. 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

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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?

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Case 3

1. 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

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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 patients values and goals, his family
  requests ICD deactivation
• They understand the implications of ICD
  deactivation
• How do you respond?

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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

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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?
• The patients refusal of device therapy
• The cardiac rhythm disturbance
• Im not sure

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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?
• Withdrawal of device therapy
• The cardiac rhythm disturbance
• Im not sure

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Question

• If a decision is made to deactivate a device, who
  should carry out the deactivation?
• Primary care physician
• Palliative medicine specialist
• Electrophysiology (EP) physician
• EP nurse or technician
• Device industry representative

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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.
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Is it ethical and legal to withhold or withdraw
life-sustaining treatments?
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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
• Clinicians duty informed refusal

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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 patients right
• Such decisions are best made by families, not
  courts
• The states interest in preserving life can be
  overridden by the patients right to refuse
  treatment

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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

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

Elizabeth Bouvias 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.
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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

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Nancy CruzanMissouri Supreme Court

• Must have clear and convincing evidence of a
  patients wishes (eg, an advance directive)
  before removing a feeding tube
• The states interests in preserving life outweigh
  the patients interests
• Artificially administered hydration and nutrition
  are not medical treatments

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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 Missouris requirement

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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

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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)

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W/W LSTsLegal permissibility
WDwithdrawal, WHwithhold
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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

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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.

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Are withholding and withdrawing life-sustaining
treatments akin to euthanasia?
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End-of-life decisions
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Vacco v. QuillU.S. Supreme Court, 1997
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 noton the proposition that patients
have aright to hasten death, but on well
established, traditional rights to bodily
integrity and freedom from unwanted touching.

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Answer

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

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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

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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

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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

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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?

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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

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Deactivating implanted devicesCommon ethics
argumentsJ Gen Intern Med 200723(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)

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Deactivating implanted devicesCommon ethics
argumentsJ Gen Intern Med 200723(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 doesnt seem to mark the
  moral difference between killing and allowing to
  die

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Deactivating implanted devicesCommon ethics
argumentsJ Gen Intern Med 200723(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

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Ethics consultations prompted by device
deactivation requests Mayo Clin Proc
200378959-963
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Deactivating implanted devicesAnalysis prompted
by ethics consultationsMayo Clin Proc
200378959-963

• Ethical and legal if consistent with the
  patients 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

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Deactivating ICDsLiterature review

• Many patients with ICDs
• Have anxiety about receiving shocks (J Gen Intern
  Med 200723Suppl 17-12 Psychiatr Clin N Am
  200730677-688)
• Experience shocks while dying (Am J Med
  2006119892-896 Ann Intern Med 2004141835-838)

The literature on pacemakers is sparse and
anecdotal
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Deactivating ICDsLiterature review

• Few patients with ICDs
• Have ever discussed device deactivation with
  their physicians (J Gen Intern Med 200723Suppl
  17-12)
• Know that device deactivation is an option (J Gen
  Intern Med 200723Suppl 17-12)

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Deactivating ICDsLiterature review

• Advance care planning
• Articulating goals and preferences for care at
  the end-of-life
• Regarding devices
• Rarely happens (J Clin Ethics 20061772-78)
• 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 2006119892-896)

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Device deactivation in the dyingSurvey of
practices and attitudesPACE 200831560-568

• 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

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Survey resultsPACE 200831560-568
All differences are statistically significant
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Survey resultsPACE 200831560-568
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Survey resultsPACE 200831560-568
Similar results were found for psychiatric
consultation All differences are statistically
significant
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Survey resultsPACE 200831560-568

Anecdotal experience indicates that many device
industry representatives do not appreciate this
task.
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Survey conclusionsPACE 200831560-568

• 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

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Deactivating implanted cardiac devices
unanswered questions
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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 53e7)
• Paradigm example of how ethical dilemmas arise
  when new technologies are introduced into
  clinical practice (note LVADs)
• Living and dying with a device

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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
  20085e8-10)
• What protocols should be followed?
• How can we improve advance care planning
  regarding implanted devices?

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Thank youmueller.pauls_at_mayo.edu