Implantable Defibrillators in the Terminally Ill

1
Implantable Defibrillators in the Terminally Ill

• Aaron Trammell, MS4
• UNC School of Medicine

11/13/2007
2
Case

• A 79-year-old man with a long history of ischemic
  heart disease, complicated by Class III heart
  failure, received an ICD and dual-chamber
  pacemaker.
• Approximately 18 months after implantation, he
  was admitted to a rural hospital following a
  stroke. It soon became evident that the stroke
  had caused massive and irreversible neurological
  damage resulting in coma. The family requested
  that the ICD be deactivated and prolonged
  suffering be avoided. The ICD had recorded 5
  significant tachyarrhythmias within the previous
  month. After appropriate discussion with the
  family, the ICD was deactivated and the pacemaker
  rate was reduced to 40 per minute. The patient
  expired within 24 hours from complications of his
  stroke.

Braun TC, Hagen NA, Hatfield RE, Wyse DG. Cardiac
pacemakers and implantable defibrillators in
terminal care. J Pain Symptom Manage. Aug
199918(2)126-131.
3
Scope of the Problem

• First ICD was placed in 1980.
• 29,000 were placed in 1997.
• gt3 Million people in North America are now
  eligible for an ICD.
• Most pacemakers and ICDs are placed in elderly
  patients.
• As the number of elderly grows, as do the
  indications for devices, we will see more ICDs
  in end-of-life care.

Mueller PS, Hook CC, Hayes DL. Ethical analysis
of withdrawal of pacemaker or implantable
cardioverter-defibrillator support at the end of
life. Mayo Clin Proc. Aug 200378(8)959-963. Lewi
s WR, Luebke DL, Johnson NJ, Harrington MD,
Costantini O, Aulisio MP. Withdrawing implantable
defibrillator shock therapy in terminally ill
patients. Am J Med. Oct 2006119(10)892-896.
4
So Many ICDs for a Reason
Josephson M, Wellens HJ. Implantable
defibrillators and sudden cardiac death.
Circulation. Jun 8 2004109(22)2685-2691.
5
Ethical Dilemma

• ICDs prevent sudden death and last many years.
• Terminal illnesses may develop after
  implantation.
• With terminal illness, goals of treatment change.
• Dying patients develop hypoxia, sepsis, and
  electrolyte disturbances, predisposing them to
  shocks.
• Shocks cause psychological and physical pain.
• CPR and external defibrillation are rarely
  effective in the terminally ill.
• No evidence, but implanted defibrillation may be
  no different.
• Pacing and automatic defibrillation can lengthen
  life, death, and suffering.
• Arrhythmic death may be avoided in light of a
  less desirable death.

6
Disabling an ICD or Pacemaker

• Should be viewed as withdrawal of treatment,
  which is legal and ethical in the setting of
  informed consent.
• No different than withdrawal of other
  life-sustaining interventions.
• Noninvasive, can be done in the patients home.
• In one study, disabling an ICD was only discussed
  in 27 of those who died with one.
• 3/4 of those happened in the last few days before
  death.
• 22 in the last hours before death.

Goldstein NE, Lampert R, Bradley E, Lynn J,
Krumholz HM. Management of implantable
cardioverter defibrillators in end-of-life care.
Ann Intern Med. Dec 7 2004141(11)835-838.
7
Literature Review

• What does the literature tell us?
• Lots about who needs an ICD
• Case reports about withdrawal
• Many articles discussing legal and ethical
  aspects
• Very few withdrawal studies

8
Secondary Prevention AVID

• ICD vs. AAD (amiodarone or sotalol)
• Mortality endpoint with 18.2mo mean follow-up
• Demographics and exclusion
• Mean age 65
• Class IV HF and life expectancy lt1yr excluded
• Results
• ICD 15.8 mortality
• AAD 24 mortality
• Sicker patients (lower EF) received more benefit
• Average additional life with ICD was 2.7mo at
  3yrs
• How many got shocked?
• 35 at 3mo, 53 at 1yr, 68 at 2yr
• Described shocks as severe a swift kick to the
  chest, blow to the body, or spasm causing the
  body to jump.

A comparison of antiarrhythmic-drug therapy with
implantable defibrillators in patients
resuscitated from near-fatal ventricular
arrhythmias. The Antiarrhythmics versus
Implantable Defibrillators (AVID) Investigators.
N Engl J Med. Nov 27 1997337(22)1576-1583.
9
AVID
10
Primary Prevention MADIT-II

• MI and LVEF lt30
• ICD vs. conventional medical therapy
• Mortality endpoint with 20mo mean follow-up
• Demographics and exclusion
• Mean age 65
• Class IV HF, non-cardiac high likelihood of
  death excluded
• Results
• Conventional therapy 19.8 mortality
• ICD 14.2 mortality
• No difference in benefit of Class I vs. II or III
  HF

Moss AJ, Zareba W, Hall WJ, et al. Prophylactic
implantation of a defibrillator in patients with
myocardial infarction and reduced ejection
fraction. N Engl J Med. Mar 21 2002346(12)877-88
3.
11
MADIT-II
12
Primary Prevention SCD-HeFT

• ICD vs. placebo vs. amiodarone in Class II-III HF
  with LVEF 35
• Mortality endpoint with 45.5mo mean follow-up
• Demographics and exclusion
• Mean age 60
• Exclusion criteria not published
• Results
• Placebo 29 mortality
• Amiodarone 28 mortality
• ICD 22 mortality (absolute 7 decrease in
  mortality over 5yrs)
• Mortality reduction restricted to class II HF
  group
• 31 of ICD group received shocks

Bardy GH, Lee KL, Mark DB, et al. Amiodarone or
an implantable cardioverter-defibrillator for
congestive heart failure. N Engl J Med. Jan 20
2005352(3)225-237.
13
SCD-HeFT
14
Indications for ICD Placement

• Prior VT or VF cardiac arrest
• Sustained VT
• LVEF 30 with history of MI
• Class II-III HF with low EF
• Class III (no benefit, possible harm)
• Terminal illnesses with life expectancy lt 6
  months
• NYHA Class IV HF

Gregoratos G AJ, Epstein AE, Freedman RA, Hayes
DL, Hlatky MA, Kerber RE, Naccarelli GV,
Schoenfeld MH, Silka MJ, Winters SL.
ACC/AHA/NASPE 2002 guideline update for
implantation of cardiac pacemakers and
antiarrhythmia devices a report of the American
College of Cardiology/American Heart Association
Task Force on Practice Guidelines (ACC/AHA/NASPE
Committee on Pacemaker Implantation). 2002.
15
Study on Withdrawal of ICD

• Lewis, et al.
• All patients in a device clinic enrolled
• ICD withdrawal discussed with end-of-life
  decisions
• Advance directives, DNR
• ICD withdrawal tied into comfort care
• ICD turned off within 24 hours of comfort care
  decision
• Charts review of all deceased in device clinic

Lewis WR, Luebke DL, Johnson NJ, Harrington MD,
Costantini O, Aulisio MP. Withdrawing implantable
defibrillator shock therapy in terminally ill
patients. Am J Med. Oct 2006119(10)892-896.
16
Study on Withdrawal of ICD

• Group 1 (20)
• Terminal illness identified, ICD disabled
• Chronic illness, more predictable death
• 15 received a shock within 30 days of death
• 20 received a shock within 90 days of death
• ICD disabled 49 89 days before death
• Group 2 (43)
• No terminal illness identified, ICD active
• More likely to have acute death
• 21 received a shock within 30 days of death
• 28 received a shock within 90 days of death
• Time to death was not significantly different
  between those with pacemakers and those without

Lewis WR, Luebke DL, Johnson NJ, Harrington MD,
Costantini O, Aulisio MP. Withdrawing implantable
defibrillator shock therapy in terminally ill
patients. Am J Med. Oct 2006119(10)892-896.
17
Recommended Steps for Requests

• Ensure patient capacity.
• If not, is there an advance directive or
  surrogate decision maker?
• Fully inform regarding illness, treatments and
  alternatives, as well as withdrawal of treatment.
• Patients request should be consistent with
  previously expressed values and goals.
• Before withdrawal, care team, and patient should
  make plans for palliative care.
• If the physician objects, another provider should
  be sought.
• If the situation is ambiguous, an ethics
  committee may be helpful.

Mueller PS, Hook CC, Hayes DL. Ethical analysis
of withdrawal of pacemaker or implantable
cardioverter-defibrillator support at the end of
life. Mayo Clin Proc. Aug 200378(8)959-963.
18
Case

• A 79-year-old man with a long history of ischemic
  heart disease, complicated by Class III heart
  failure, received an ICD and dual-chamber
  pacemaker.
• Approximately 18 months after implantation, he
  was admitted to a rural hospital following a
  stroke. It soon became evident that the stroke
  had caused massive and irreversible neurological
  damage resulting in coma. The family requested
  that the ICD be deactivated and prolonged
  suffering be avoided. The ICD had recorded 5
  significant tachyarrhythmias within the previous
  month. After appropriate discussion with the
  family, the ICD was deactivated and the pacemaker
  rate was reduced to 40 per minute. The patient
  expired within 24 hours from complications of his
  stroke.

Braun TC, Hagen NA, Hatfield RE, Wyse DG. Cardiac
pacemakers and implantable defibrillators in
terminal care. J Pain Symptom Manage. Aug
199918(2)126-131.
19
Conclusions

• Goals of therapy should be defined.
• ICD therapy should be reevaluated in the context
  of the patients current state of health.
• If an ICD is likely to prolong or increase
  suffering, it should be disabled.
• Frequent, undesired shocks
• Less-desirable, foreseeable cause of death

20
Other Thoughts

• Devices must be removed before cremation.
• Funeral homes then discard them.
• Shocks can be transmitted to anyone touching the
  patient when the ICD discharges.
• Movement can be felt as the ICD fires.

21
Pacemakers in the Terminally Ill

• A bit different than ICDs.
• Deactivating a pacemaker could result in a worse
  death.
• Symptomatic bradycardia resulting in slow,
  irreversible multisystem organ failure
• Failure of pacing ? worsened HF ? dyspnea
• In the Lewis study, time to death was not
  different between those with and those without
  pacemakers.

22
References

• A comparison of antiarrhythmic-drug therapy with
  implantable defibrillators in patients
  resuscitated from near-fatal ventricular
  arrhythmias. The Antiarrhythmics versus
  Implantable Defibrillators (AVID) Investigators.
  N Engl J Med. Nov 27 1997337(22)1576-1583.
• Bardy GH, Lee KL, Mark DB, et al. Amiodarone or
  an implantable cardioverter-defibrillator for
  congestive heart failure. N Engl J Med. Jan 20
  2005352(3)225-237.
• Braun TC, Hagen NA, Hatfield RE, Wyse DG. Cardiac
  pacemakers and implantable defibrillators in
  terminal care. J Pain Symptom Manage. Aug
  199918(2)126-131.
• Goldstein NE, Lampert R, Bradley E, Lynn J,
  Krumholz HM. Management of implantable
  cardioverter defibrillators in end-of-life care.
  Ann Intern Med. Dec 7 2004141(11)835-838.
• Gregoratos G AJ, Epstein AE, Freedman RA, Hayes
  DL, Hlatky MA, Kerber RE, Naccarelli GV,
  Schoenfeld MH, Silka MJ, Winters SL.
  ACC/AHA/NASPE 2002 guideline update for
  implantation of cardiac pacemakers and
  antiarrhythmia devices a report of the American
  College of Cardiology/American Heart Association
  Task Force on Practice Guidelines (ACC/AHA/NASPE
  Committee on Pacemaker Implantation). 2002.
• Lewis WR, Luebke DL, Johnson NJ, Harrington MD,
  Costantini O, Aulisio MP. Withdrawing implantable
  defibrillator shock therapy in terminally ill
  patients. Am J Med. Oct 2006119(10)892-896.
• Moss AJ, Zareba W, Hall WJ, et al. Prophylactic
  implantation of a defibrillator in patients with
  myocardial infarction and reduced ejection
  fraction. N Engl J Med. Mar 21 2002346(12)877-88
  3.
• Mueller PS, Hook CC, Hayes DL. Ethical analysis
  of withdrawal of pacemaker or implantable
  cardioverter-defibrillator support at the end of
  life. Mayo Clin Proc. Aug 200378(8)959-963.
• Josephson M, Wellens HJ. Implantable
  defibrillators and sudden cardiac death.
  Circulation. Jun 8 2004109(22)2685-2691.