Download INTERNAL DEFIBRILLATOR DEVICES

INTERNAL
DEFIBRILLATOR
DEVICES
Ethical dilemmas involving
use and deactivation
Elizabeth L. Maher, MD
Hospice Homecare Physician
Objectives
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Review indications for use of ICD
Recognize the complexity and common
complications of newest devices
Identify considerations and risk assessment
tools prior to ICD insertion
Evaluate the ongoing management of
patients with ICDs
Apply treatment guidelines for the
deactivation of ICDs at the end of life
ETHICS and ICDs
“Implanted cardioverter defibrillators represent another
new life-extending technology for which examination
of its ethical implications lags behind its use.”
“Generally, medical organizations are more attentive to
developing indications for use of new technologies
than to assessing appropriate treatment withdrawal.”
Berger, J Ann Intern Med 2005;142:631-634
Ethical Questions related to
ICD
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Who should be offered the technology particularly
when used for primary prevention?
How involved should primary care physicians be in
helping patients make this decision vs. the
interventional cardiologist?
How/when to readdress continued use of device?
Specifically, what happens when CHF progresses to
NYHA Class IV or new illnesses develop?
Is an ICD contraindicated with a DNR?
Can an ICD be considered palliative care?
Primary Indication for use
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Minimize risk of sudden cardiac arrest
SCD most common cause of death
Josephson, M. Circulation 2004; 109:2685-2691
A Hospice MD’s bias:
When faced with the alternatives,
sudden cardiac death isn’t such a bad
way to go.
ICD: Increased usage
Josephson, M. Circulation 2004; 109:2685-2691
Indications for AICD:
SECONDARY PREVENTION
After an episode of resuscitated VT/VF which
includes patients with a variety of heart
diseases
OR
 In pts with episode of sustained VT in the
presence of structural heart disease
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Indications for AICD:
PRIMARY PREVENTION
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Ischemic or non-ischemic cardiomyopathy
with EF <35% and NYHA Class II/III Ezekowitz J Ann
Intern Med 2007;147:251-262
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Hx of MI and impaired left ventricular function
EF<30% Moss A NEJM 2002;346:877-883
Hx unexplained syncope or structural heart
disease and inducible VT/VF on EPS
Selected pts with hypertrophic
cardiomyopathy or long QT syndrome
Cases to consider
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58 yo WM following an episode of sudden cardiac
arrest in O’Hare Airport
59 yo WM completely asymptomatic with medical
management 7yrs after anterior MI with stent
placement, complicated by CHF with EF of 25%
which is unchanged Zimetbaum P JAMA 2007;297:1909-1917
39 yo WF with known hypertrophic cardiomyopathy
and a prior hx of unexplained syncope Maron B JAMA
2007;298:405-412
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18 yo BM with HCM, hx of non-sustained VT on
Holter monitoring and mother who died SCD age 50
82 yo WF with EF 20% and run of nonsustained VT
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What information are pts given
prior to decision to insert ICD?
Agard A J Med Ethics 2007;33: 514-518
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Group of patients in Sweden with moderate CHF
and hx of malignant arrhythmia
None received information about alternative
treatment with antiarrhythmic meds
No information was received about estimated risk of
fatal arrhythmia or expected time of survival from
heart failure itself
Despite this, pts did not complain about the lack of
information or lack of participation in decisionmaking
When told that they needed it, patients accepted it
What info should pts be given
BEFORE initiating therapy?
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Thorough and earnest discussion of the
accuracy of current risk assessment tools
*Seattle Heart Failure Model*
Risks and benefits of ICD therapy
Review pt’s viewpoints on procedures,
devices and death…goals of care/patient
values
Discuss of eventual deactivation option
http://depts.washington.edu/shfm/
Understanding the device
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Earliest ones designed to defibrillate only and
were “committed” which meant once device
started to charge, energy would be delivered
even if rhythm had changed
Newer devices are sophisticated but
complicated and prone to recalls.
Newer ICDs perform multiple
functions
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antibradycardic pacing –traditional
pacemaker
antitachycardic pacing-overdrive pacing*
low energy cardioversion of VT*
high energy defibrillation
electrogram storage
*Best part of these newer devices because it
can prevent the need for high energy shock
WHAT IS THE SHOCK LIKE?
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ICD is programmed to deliver a shock 10 joules
greater than the defib threshold which is ~15 joules,
therefore usual shock is 25 joules.
From AVID study, most described the shocks as
severe: “a swift kick to the chest”, “blow to the body”
or “spasm causing the body to jump”
23% dreaded the shocks and 5% would prefer not to
have it.
Most pts tolerated the shocks because they were
lifesaving.
Adjunctive therapy with ICD
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Antiarrhythmic drugs (amiodarone or sotalol) are
used to
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Decrease frequency of shocks delivered
Suppress other arrhythmias that lead of inappropriate
shocks i.e. sinus tachycardia, AF
Drugs change the defib threshold, therefore the
device needs to be checked whenever meds are
added or when events occur that alter the
pharmokinetics of the drug used
AVID study:18% of pt with ICD for secondary
prevention required addition of drugs Klein R J Cardiovasc
Electrophysiol 2003;14
How often do arrhythmic events
occur after ICD insertion?
AVID trial of secondary prevention
Frequency of arrhythmic events (death,
sustained ventricular arrhythmia, shock or
antitachycardic pacing)
• 35% at 3 months post insertion
• 53% at one year
• 68% at 2 years
First shocks or antitachycardic pacing was rare
after 2nd year.
Quality of Life and ICDs
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No question about the survival benefit for prevention
of SCD
Increased anxiety and depression which increases
with the frequency of shocks, device recalls and
limitation on lifestyle (such as driving restrictions or
return to work) Sears S Pacing Clin Electro 2000:23;939, Groeneveld P Am J Cardio
2006;198:1409-1415
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Some patients develop severe psychiatric problems
after receiving APPROPRIATE shocks Bourke J Heart 1997;78:581
Anxiety and depression can be mitigated by support
groups and relaxation therapies Kohn C Pacing Clin Electrophysiol
2000;23:450, Tscho P Int J Psychiatry Med 1989;19:393
Driving and ICDs
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ICD does NOT decrease the need for a
driving restriction
Even with rapid treatment of rhythm
disturbance, syncope occurs in 15% of pts
ICDs decrease but do not eliminate the risk of
SCD which still continues at 1-2% per year
Inappropriate shocks/SVT
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Pts with ventricular tacchyarrhythmias often also
have supraventricular tachyarrhythmias
IF ICD interpretes SVT (could be sinus tachycardia
or AF) as VT, pt is given an inappropriate shock and
usually more than one in a series of shocks
THIS OCCURS IN 20-25% OF PATIENTS Wood J Am Coll
Cardiology 1994;24:1692 , Klein J Cardiovasc Electrophysiol 2003;14:940, Rosenqvist M Circulation 1998
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Newer dual chamber ICDs are designed to
discriminate atrial from ventricular tachycardias and
prevent this most common cause of inappropriate
shock
Inappropriate ICD
shocks/other causes
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Electrical noise
ICD malfunction such as lead fracture or
inappropriate sensing
Complicated devices
Once ICD is implanted, how
are changes monitored?
Only one study looked at how often physicians
discussed management of ICD with patients at EOL
Goldstein N Ann Intern Med 2004;141:835-838
Postmortem interviews with next of kin of 100
patients who had received ICDs
Deaths were classified into one of 4 groups:
• Sudden cardiac 9%
• Nonsudden cardiac 51%
• Sudden noncardiac 4%
• Nonsudden noncardiac 36%
How often physicians discuss
ICD at EOL
Goldstein, N Ann Intern Med 2004;141:835-838
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Discussion of deactivation of the device occurred in
only 27% of the patients and most of these
conversations occurred in last few days of life *
Discussion was more likely if the pt had a DNR
27% of the patients received a shock in the last
month of life, 8% received a shock in the minutes
before death
Potential for complicated grief for family members
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“Every 20 min, he would get a shock and get jolted awake.”
“His defibrillator kept going off…it went off 12 times in one
night.”
“Conversations about deactivation
occurred not as decisions
planned well in advance of death
but as reactions to distress in the
days, hours and minutes before
the patient died.”
ICDs and Elderly
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Elderly patients (>75) were excluded from many of
the major ICD trials
Specific disqualifying comorbidities for ICDs have
not been defined
MADIT-II trial (primary prevention post MI) found no
mortality benefit if patients had an estimated GFR of
<35ml/min
Center for Medicare Services (CMS) requires that
expected survival of at least one year to qualify for
ICD therapy.
Pts are surviving longer and becoming “elderly”
while the devices are in place
ICDs and Elderly
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Improves long term survival in patients
cardiac disease, can result in pts living long
enough for HF to develop or progress
No information available about how to
manage pts that progress from NYHA class
III to IV, or who develop new comorbidities
such as PVD, CVA, renal failure, dementia or
cancer
http://depts.washington.edu/shfm/
Cause of death in CHF
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Sudden death is common in early CHF:
>50% risk NYHA Class II vs. 10-30% risk in
Class IV heart disease
Advanced CHF associated with pump failure
with bradycardia common-traditional
pacemaker usage is felt to mitigate some of
the symptoms of end stage CHF
Pulseless electrical activity is a common final
pathway
Indications for deactivation of
ICD
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Continued use is inconsistent with patient
goals
Avoiding sudden death is no longer the goal
Withdrawal of anti-arrhythmic medications
Imminent death
Deactivation is NOT a requirement for
Hospice admission
Deactivation is NOT a requirement prior to
HIU transfer unless admission is for EOL
ICD and EOL: Guidelines for a
Patient's request for withdrawal
Mueller, P Mayo Clin Proc 2003;78:959-963
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Pt needs decision-making capacity and
attempts should be made to reverse any
processes that could impair capacity
If no capacity, is there a HCP who will make
decisions based on pt’s previously
expressed goals/values or act in pt’s best
interest?
Pt (or HCP) needs to be informed about
nature of illness and its treatment and the
alternatives to withdrawal
ICD and EOL: Guidelines for
PATIENT request for withdrawal
Mueller, P Mayo Clin Proc 2003
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Before withdrawal explicit plans for palliative
care should be made
If clinician conscientiously objects to the
request, he/she should tell the patient and
make arrangements for transfer of care.
If any ambiguity exists, consider having
case reviewed by a colleague or a ethics
consult.
Is ICD and DNR incompatible?
“Striving to define ICD function as resuscitation or
arrhythmia management is less important than
efforts to clarify each patient’s goal of care and
objectively assess whether the ICD serves that
purpose.”
Some pts are OK with their present QOL but would not
want CPR due to concerns about potential loss of
cognitive/functional status due to resuscitation, but if
resuscitation had high likelihood of success (ie rapid
internal cardioversion) that would be acceptable.
Berger J Ann Intern Med 2005
When should physicians suggest
deactivation of ICD?
Lewis W Am J Med 2006;119:892-896
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Interdisciplinary strategy to address withdrawal of shock
treatment in terminally ill patients
Applied during EVERY routine device F/U visit until time
of death
Review of interim hx and if any new significant illness,
discussion of prognosis occurred with pt and PMD
If new illness was irreversible, then option of withdrawal
was discussed
RESULTS: Only 1/3rd of patients were identified as
“terminal”. Remaining 2/3rd had rapid decline which
prevented discussion of withdrawal and therefore got
shocked closer to end of life.
Treatment
Guidelines for ICD
Discussion of about ICD should occur whenever
goals of care are discussed. Ask what is patient’s
understanding of his/her present condition?
Goals of care should be readdressed after each
subsequent hospital admission, CHF exacerbation
or shock received
Monitor for “milestones” of end-stage
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Becoming bedbound
Significantly decreased intake of food and fluid
Sleeping more hours of the day
Treatment
Guidelines for ICD
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If antiarrhythmic drugs are discontinued, ICD deactivation
needs to be discussed due to increased likelihood of increased
# shocks
Educate patient and family about:
ability to deactivate defib while maintaining pacer function
non-invasive procedure done at home with a magnet
disabling defib function will not CAUSE or HASTEN death-it will
prevent shock if specific arrhythmia noted
Disabling the defib will allow for touch/holding as death
approaches
If decision is made to deactivate unit, obtain order from
cardiologist or primary MD and notify device manufacturer who
will make home visit within 24hrs.
New Frontier/Challenges
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Left ventricular assist devices (LVADs) as
“destination therapy” for people ineligible for
heart transplant Rogers J J Am Coll Cardiology 2007;50:741-747
Use of CRT (cardiac resynchronization
therapy) in pts with NYHA Class IV CHF
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Report by ACC/AHA CHF Guidelines for Diagnosis and
Management of Chronic Heart Failure in the Adult: “strong
evidence to support use of CRT to improve symptoms, exercise
capacity, quality of life, LVEF and survival and to decrease
hospitalizations in patients with persistently symptomatic heart
failure undergoing optimal medical management and who have
cardiac dyssynchrony.
CHF Challenges
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CHF has high mortality rate and symptom
burden
New interventions are being developed daily
Prognostic difficulties in CHF should not lead
to “prognostic paralysis”
Preparation for crisis and discussion of GOC
and treatment limitations in light of functional
declines is imperative
Selman L Heart 2007;93:963-967
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