Implantable Implantable Defibrillators in Defibrillators in

the Terminally Illthe Terminally IllAaron Trammell, MS4Aaron Trammell, MS4

UNC School of MedicineUNC School of Medicine

11/13/2007

CaseCase

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 Braun TC, Hagen NA, Hatfield RE, Wyse DG. Cardiac pacemakers and implantable defibrillators in terminal care. defibrillators in terminal care. J Pain Symptom Manage. J Pain Symptom Manage. Aug 1999;18(2):126-131.Aug 1999;18(2):126-131.

Scope of the ProblemScope of the Problem

First ICD was placed in 1980.First ICD was placed in 1980. 29,000 were placed in 1997.29,000 were placed in 1997. >3 Million people in North America are >3 Million people in North America are

now eligible for an ICD.now eligible for an ICD. Most pacemakers and ICD’s are placed in Most pacemakers and ICD’s are placed in

elderly patients.elderly patients. As the number of elderly grows, as do the As the number of elderly grows, as do the

indications for devices, we will see more indications for devices, we will see more ICD’s in end-of-life care.ICD’s in end-of-life care.

Mueller PS, Hook CC, Hayes DL. Ethical analysis of withdrawal of pacemaker or Mueller PS, Hook CC, Hayes DL. Ethical analysis of withdrawal of pacemaker or implantable cardioverter-defibrillator support at the end of life. implantable cardioverter-defibrillator support at the end of life. Mayo Clin Proc. Mayo Clin Proc. Aug Aug 2003;78(8):959-963.2003;78(8):959-963.Lewis WR, Luebke DL, Johnson NJ, Harrington MD, Costantini O, Aulisio MP. Lewis WR, Luebke DL, Johnson NJ, Harrington MD, Costantini O, Aulisio MP. Withdrawing implantable defibrillator shock therapy in terminally ill patients. Withdrawing implantable defibrillator shock therapy in terminally ill patients. Am J Med. Am J Med. Oct 2006;119(10):892-896.Oct 2006;119(10):892-896.

So Many ICDs for a So Many ICDs for a ReasonReason

Josephson M, Wellens HJ. Implantable defibrillators and sudden cardiac death. Josephson M, Wellens HJ. Implantable defibrillators and sudden cardiac death. CirculationCirculation. Jun 8 . Jun 8 2004;109(22):2685-2691.2004;109(22):2685-2691.

Ethical DilemmaEthical Dilemma ICD’s prevent sudden death and last many years.ICD’s prevent sudden death and last many years. Terminal illnesses may develop after implantation.Terminal illnesses may develop after implantation. With terminal illness, goals of treatment change.With terminal illness, goals of treatment change. Dying patients develop hypoxia, sepsis, and Dying patients develop hypoxia, sepsis, and

electrolyte disturbances, predisposing them to electrolyte disturbances, predisposing them to shocks.shocks. Shocks cause psychological and physical pain.Shocks cause psychological and physical pain.

CPR and external defibrillation are rarely effective in CPR and external defibrillation are rarely effective in the terminally ill.the terminally ill. No evidence, but implanted defibrillation may be no No evidence, but implanted defibrillation may be no

different.different. Pacing and automatic defibrillation can lengthen life, Pacing and automatic defibrillation can lengthen life,

death, and suffering.death, and suffering. Arrhythmic death may be avoided in light of a less Arrhythmic death may be avoided in light of a less

desirable death.desirable death.

Disabling an ICD or Disabling an ICD or PacemakerPacemaker

Should be viewed as withdrawal of treatment, Should be viewed as withdrawal of treatment, which is legal and ethical in the setting of which is legal and ethical in the setting of informed consent.informed consent.

No different than withdrawal of other life-No different than withdrawal of other life-sustaining interventions.sustaining interventions.

Noninvasive, can be done in the patient’s home.Noninvasive, can be done in the patient’s home. In one study, disabling an ICD was only In one study, disabling an ICD was only

discussed in 27% of those who died with one.discussed in 27% of those who died with one. 3/4 of those happened in the last few days before 3/4 of those happened in the last few days before

death.death. 22% in the last hours before death.22% in the last hours before death.

Goldstein NE, Lampert R, Bradley E, Lynn J, Krumholz HM. Management of implantable Goldstein NE, Lampert R, Bradley E, Lynn J, Krumholz HM. Management of implantable cardioverter defibrillators in end-of-life care. cardioverter defibrillators in end-of-life care. Ann Intern Med. Ann Intern Med. Dec 7 2004;141(11):835-Dec 7 2004;141(11):835-838.838.

Literature ReviewLiterature Review

What does the literature tell us?What does the literature tell us? Lots about who needs an ICDLots about who needs an ICD Case reports about withdrawalCase reports about withdrawal Many articles discussing legal and Many articles discussing legal and

ethical aspectsethical aspects Very few withdrawal studiesVery few withdrawal studies

Secondary Prevention – Secondary Prevention – AVIDAVID

ICD vs. AAD (amiodarone or sotalol)ICD vs. AAD (amiodarone or sotalol) Mortality endpoint with 18.2mo mean follow-up*Mortality endpoint with 18.2mo mean follow-up* Demographics and exclusionDemographics and exclusion

Mean age 65Mean age 65 Class IV HF and life expectancy <1yr excludedClass IV HF and life expectancy <1yr excluded

ResultsResults ICD: 15.8% mortalityICD: 15.8% mortality AAD: 24% mortalityAAD: 24% mortality Sicker patients (lower EF) received more benefitSicker patients (lower EF) received more benefit Average additional life with ICD was 2.7mo at 3yrsAverage additional life with ICD was 2.7mo at 3yrs How many got shocked?How many got shocked?

35% at 3mo, 53% at 1yr, 68% at 2yr35% at 3mo, 53% at 1yr, 68% at 2yr Described shocks as severe: “a swift kick to the chest,” Described shocks as severe: “a swift kick to the chest,”

“blow to the body,” or “spasm causing the body to “blow to the body,” or “spasm causing the body to jump.”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 1997;337(22):1576-1583.

AVIDAVID

Primary Prevention – Primary Prevention – MADIT-IIMADIT-II

MI and LVEF <30%MI and LVEF <30% ICD vs. “conventional medical therapy”ICD vs. “conventional medical therapy” Mortality endpoint with 20mo mean follow-upMortality endpoint with 20mo mean follow-up Demographics and exclusionDemographics and exclusion

Mean age 65Mean age 65 Class IV HF, “non-cardiac high likelihood of death” Class IV HF, “non-cardiac high likelihood of death”

excludedexcluded ResultsResults

Conventional therapy: 19.8% mortalityConventional therapy: 19.8% mortality ICD: 14.2% mortalityICD: 14.2% mortality No difference in benefit of Class I vs. II or III HFNo 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 2002;346(12):877-883.

MADIT-IIMADIT-II

Primary Prevention – Primary Prevention – SCD-HeFTSCD-HeFT

ICD vs. placebo vs. amiodarone in Class II-III HF ICD vs. placebo vs. amiodarone in Class II-III HF with LVEF ≤35%with LVEF ≤35%

Mortality endpoint with 45.5mo mean follow-upMortality endpoint with 45.5mo mean follow-up Demographics and exclusionDemographics and exclusion

Mean age 60Mean age 60 Exclusion criteria not publishedExclusion criteria not published

ResultsResults Placebo: 29% mortalityPlacebo: 29% mortality Amiodarone: 28% mortalityAmiodarone: 28% mortality ICD: 22% mortality (absolute 7% decrease in mortality ICD: 22% mortality (absolute 7% decrease in mortality

over 5yrs)over 5yrs) Mortality reduction restricted to class II HF groupMortality reduction restricted to class II HF group 31% of ICD group received shocks31% 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 2005;352(3):225-237.

SCD-HeFTSCD-HeFT

Indications for ICD Indications for ICD PlacementPlacement

Prior VT or VF cardiac arrestPrior VT or VF cardiac arrest Sustained VTSustained VT LVEF ≤ 30% with history of MILVEF ≤ 30% with history of MI Class II-III HF with low EFClass II-III HF with low EF Class III (no benefit, possible harm)Class III (no benefit, possible harm)

Terminal illnesses with life expectancy Terminal illnesses with life expectancy < 6 months< 6 months

NYHA Class IV HFNYHA Class IV HFGregoratos G AJ, Epstein AE, Freedman RA, Hayes DL, Hlatky MA, Kerber RE, 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 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 update for implantation of cardiac pacemakers and antiarrhythmia devices: a report of the American College of Cardiology/American Heart Association Task Force on Practice the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee on Pacemaker Implantation). 2002.Guidelines (ACC/AHA/NASPE Committee on Pacemaker Implantation). 2002.

Study on Withdrawal of Study on Withdrawal of ICDICD

Lewis, et al.Lewis, et al. All patients in a device clinic “enrolled”All patients in a device clinic “enrolled” ICD withdrawal ICD withdrawal discusseddiscussed with end-of- with end-of-

life decisionslife decisions Advance directives, DNRAdvance directives, DNR

ICD withdrawal tied into comfort careICD withdrawal tied into comfort care ICD ICD turned offturned off within 24 hours of comfort within 24 hours of comfort

care decisioncare decision Charts review of all deceased in device Charts review of all deceased in device

clinicclinicLewis WR, Luebke DL, Johnson NJ, Harrington MD, Costantini O, Aulisio MP. Lewis WR, Luebke DL, Johnson NJ, Harrington MD, Costantini O, Aulisio MP. Withdrawing implantable defibrillator shock therapy in terminally ill patients. Withdrawing implantable defibrillator shock therapy in terminally ill patients. Am J Med. Am J Med. Oct 2006;119(10):892-896.Oct 2006;119(10):892-896.

Study on Withdrawal of Study on Withdrawal of ICDICD

Group 1 (20)Group 1 (20) Terminal illness identified, ICD disabledTerminal illness identified, ICD disabled Chronic illness, more predictable deathChronic illness, more predictable death 15% received a shock within 30 days of death15% received a shock within 30 days of death 20% received a shock within 90 days of death20% received a shock within 90 days of death ICD disabled 49 ± 89 days before deathICD disabled 49 ± 89 days before death

Group 2 (43)Group 2 (43) No terminal illness identified, ICD activeNo terminal illness identified, ICD active More likely to have acute deathMore likely to have acute death 21% received a shock within 30 days of death21% received a shock within 30 days of death 28% received a shock within 90 days of death28% received a shock within 90 days of death

Time to death was not significantly different Time to death was not significantly different between those with pacemakers and those between those with pacemakers and those withoutwithout

Lewis WR, Luebke DL, Johnson NJ, Harrington MD, Costantini O, Aulisio MP. Lewis WR, Luebke DL, Johnson NJ, Harrington MD, Costantini O, Aulisio MP. Withdrawing implantable defibrillator shock therapy in terminally ill patients. Withdrawing implantable defibrillator shock therapy in terminally ill patients. Am J Med. Am J Med. Oct 2006;119(10):892-896.Oct 2006;119(10):892-896.

Recommended Steps for Recommended Steps for RequestsRequests

Ensure patient capacity.Ensure patient capacity. If not, is there an advance directive or If not, is there an advance directive or

surrogate decision maker?surrogate decision maker? Fully inform regarding illness, treatments and Fully inform regarding illness, treatments and

alternatives, as well as withdrawal of treatment.alternatives, as well as withdrawal of treatment. Patient’s request should be consistent with Patient’s request should be consistent with

previously expressed values and goals.previously expressed values and goals. Before withdrawal, care team, and patient should Before withdrawal, care team, and patient should

make plans for palliative care.make plans for palliative care. If the physician objects, another provider should If the physician objects, another provider should

be sought.be sought. If the situation is ambiguous, an ethics If the situation is ambiguous, an ethics

committee may be helpful.committee may be helpful.Mueller PS, Hook CC, Hayes DL. Ethical analysis of withdrawal of pacemaker or Mueller PS, Hook CC, Hayes DL. Ethical analysis of withdrawal of pacemaker or implantable cardioverter-defibrillator support at the end of life. implantable cardioverter-defibrillator support at the end of life. Mayo Clin Proc. Mayo Clin Proc. Aug Aug 2003;78(8):959-963.2003;78(8):959-963.

CaseCaseA 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 Braun TC, Hagen NA, Hatfield RE, Wyse DG. Cardiac pacemakers and implantable defibrillators in terminal care. defibrillators in terminal care. J Pain Symptom Manage. J Pain Symptom Manage. Aug 1999;18(2):126-131.Aug 1999;18(2):126-131.

ConclusionsConclusions

Goals of therapy should be defined.Goals of therapy should be defined. ICD therapy should be reevaluated in ICD therapy should be reevaluated in

the context of the patient’s current the context of the patient’s current state of health.state of health.

If an ICD is likely to prolong or increase If an ICD is likely to prolong or increase suffering, it should be disabled.suffering, it should be disabled. Frequent, undesired shocksFrequent, undesired shocks Less-desirable, foreseeable cause of deathLess-desirable, foreseeable cause of death

Other ThoughtsOther Thoughts

Devices must be removed before Devices must be removed before cremation.cremation. Funeral homes then discard them.Funeral homes then discard them.

Shocks can be transmitted to anyone Shocks can be transmitted to anyone touching the patient when the ICD touching the patient when the ICD discharges.discharges.

Movement can be felt as the ICD Movement can be felt as the ICD fires.fires.

Pacemakers in the Pacemakers in the Terminally IllTerminally Ill

A bit different than ICDs.A bit different than ICDs. Deactivating a pacemaker could result Deactivating a pacemaker could result

in a worse death.in a worse death. Symptomatic bradycardia resulting in slow, Symptomatic bradycardia resulting in slow,

irreversible multisystem organ failureirreversible multisystem organ failure Failure of pacing Failure of pacing worsened HF worsened HF

dyspneadyspnea In the Lewis study, time to death was In the Lewis study, time to death was

not different between those with and not different between those with and those without pacemakers.those without pacemakers.

ReferencesReferences1.1. A comparison of antiarrhythmic-drug therapy with implantable A comparison of antiarrhythmic-drug therapy with implantable

defibrillators in patients resuscitated from near-fatal ventricular defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. The Antiarrhythmics versus Implantable Defibrillators arrhythmias. The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. (AVID) Investigators. N Engl J Med. N Engl J Med. Nov 27 1997;337(22):1576-1583.Nov 27 1997;337(22):1576-1583.

2.2. Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. cardioverter-defibrillator for congestive heart failure. N Engl J Med. N Engl J Med. Jan Jan 20 2005;352(3):225-237.20 2005;352(3):225-237.

3.3. Braun TC, Hagen NA, Hatfield RE, Wyse DG. Cardiac pacemakers and Braun TC, Hagen NA, Hatfield RE, Wyse DG. Cardiac pacemakers and implantable defibrillators in terminal care. implantable defibrillators in terminal care. J Pain Symptom Manage. J Pain Symptom Manage. Aug 1999;18(2):126-131.Aug 1999;18(2):126-131.

4.4. Goldstein NE, Lampert R, Bradley E, Lynn J, Krumholz HM. Goldstein NE, Lampert R, Bradley E, Lynn J, Krumholz HM. Management of implantable cardioverter defibrillators in end-of-life Management of implantable cardioverter defibrillators in end-of-life care. care. Ann Intern Med. Ann Intern Med. Dec 7 2004;141(11):835-838.Dec 7 2004;141(11):835-838.

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

6.6. Lewis WR, Luebke DL, Johnson NJ, Harrington MD, Costantini O, Lewis WR, Luebke DL, Johnson NJ, Harrington MD, Costantini O, Aulisio MP. Withdrawing implantable defibrillator shock therapy in Aulisio MP. Withdrawing implantable defibrillator shock therapy in terminally ill patients. terminally ill patients. Am J Med. Am J Med. Oct 2006;119(10):892-896.Oct 2006;119(10):892-896.

7.7. Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection defibrillator in patients with myocardial infarction and reduced ejection fraction. fraction. N Engl J Med. N Engl J Med. Mar 21 2002;346(12):877-883.Mar 21 2002;346(12):877-883.

8.8. Mueller PS, Hook CC, Hayes DL. Ethical analysis of withdrawal of Mueller PS, Hook CC, Hayes DL. Ethical analysis of withdrawal of pacemaker or implantable cardioverter-defibrillator support at the end pacemaker or implantable cardioverter-defibrillator support at the end of life. of life. Mayo Clin Proc. Mayo Clin Proc. Aug 2003;78(8):959-963.Aug 2003;78(8):959-963.

9.9. Josephson M, Wellens HJ. Implantable defibrillators and sudden cardiac Josephson M, Wellens HJ. Implantable defibrillators and sudden cardiac death. death. CirculationCirculation. Jun 8 2004;109(22):2685-2691.. Jun 8 2004;109(22):2685-2691.