Transcript 36201

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 physicianassisted 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
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
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.
2.
3.
4.
5.
Primary care physician
Palliative medicine specialist
Electrophysiology (EP) physician
EP nurse or technician
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 lifesustaining 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
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 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 lifesustaining 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.
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 devices
Common ethics arguments
J 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 devices
Common ethics arguments
J 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 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]:712)
• 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
[email protected]