Ethical aspects of deactivating implanted cardiac devices by suchenfz

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									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 1
Refusal
• 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 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
Case 2
Request 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 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
Case 3
Request 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 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
Case 4
Request for withdrawal
• 72-year-old man with     • Fearing shocks during
  CHF has an ICD for         the dying process and
  ventricular                citing the patient’s
  dysrhythmias               values and goals, his
• Now hospitalized with      family requests ICD
  cancer and sepsis, he      deactivation
  is delirious and dying   • They understand the
• There is no advance        implications of ICD
  directive                  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
Question
Cause 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
Question
Cause 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 ethics
Beauchamp 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 Quinlan
70 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 Bouvia
179 Cal App 3d 1127, 225 Cal Rptr 297, 1986

• Born with cerebral               • Received a feeding
  palsy                              tube against her will
• Quadriplegic and in              • Court ordered tube
  constant pain                      removed; barred
• At 28, she announced               replacement without
  her intent to no longer            consent
  eat                              • The right to refuse
• She was competent                  treatment is not
  and understood risks               limited to terminally-ill
                                     patients
Elizabeth Bouvia
179 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 Cruzan
Missouri 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 Cruzan
US 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 Cruzan
US 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 LSTs
Legal permissibility




WD=withdrawal, WH=withhold
Precedence of landmark cases
Not 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
Vacco v. Quill
U.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 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.”
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
devices
Concerns 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 requests
Refusals (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 devices
Common ethics arguments
J Gen Intern Med 2007;23(Suppl 1):69-72.

• Withholding vs.                  • Continuous vs.
  withdrawing treatment              intermittent treatment
   – No ethical or legal              – May be a reason for
     differences                        different perceptions
   – Devices raise no new               regarding deactivating
     moral issues                       ICDs vs. PMs
• Duration of treatment               – However, we accept
                                        WD of both continuous
   – Not a morally decisive             and intermittent LSTs
     factor                             (e.g., ventilation vs.
                                        HD)
Deactivating implanted devices
Common ethics arguments
J Gen Intern Med 2007;23(Suppl 1):69-72.

• Regulative vs.                   • Internal vs. external
  constitutive treatment             treatment
   – Constitutive treatment           – Often cited; but,
     takes over a function              definitions of killing vs.
     the body can no longer             allowing to die make
     provide                            no reference to
   – However, we accept                 internal vs. external
     WD of constitutive               – Internal vs. external
     treatments (e.g.,                  doesn’t “seem to mark
     ventilation, HD,                   the moral difference
     feeding tube)                      between killing and
                                        allowing to die”
Deactivating implanted devices
Common ethics arguments
J Gen Intern Med 2007;23(Suppl 1):69-72.

• Replacement vs.                  Features of replacement
  substitutive treatment             treatments:
   – Substitutive treatment:       − respond to changes in the
     more acceptable to              host and environment
     WD                            − self-growth and repair
   – Replacement                   − independent from
     treatment: “part of the         external energy sources
     patient” and less             − controlled by an expert
     acceptable to WD              − immunologic compatibility
       • Replaces that which is
         pathologically lost
                                   − bodily integration
                                   Example: AVR vs. ICD
Ethics consultations prompted
by device deactivation requests
Mayo Clin Proc 2003;78:959-963
Deactivating implanted devices
Analysis prompted by ethics consultations
Mayo 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 ICDs
Literature 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 ICDs
Literature 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 dying
Survey of practices and attitudes
PACE 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 results
PACE 2008;31:560-568




All differences are statistically significant
Survey results
PACE 2008;31:560-568
Survey results
PACE 2008;31:560-568




*Similar results were found for psychiatric consultation
All differences are statistically significant
Survey results
PACE 2008;31:560-568




                                       *




*Anecdotal experience indicates that many device industry
representatives do not appreciate this task.
Survey conclusions
PACE 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 questions
Additional 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 questions
Additional 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 you
mueller.pauls@mayo.edu

								
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