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Implantable Cardioverter Defibrillators in Heart Failure 2005 11 02

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Implantable Defibrillators in the Terminally Ill Aaron Trammell, MS4 UNC School of Medicine 11/13/2007

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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 1999;18(2):126-131.

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Scope of the Problem First ICD was placed in 1980. 29,000 were placed in 1997. >3 Million people in North America are now eligible for an ICD. Most pacemakers and ICD’s are placed in elderly patients. As the number of elderly grows, as do the indications for devices, we will see more ICD’s 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 2003;78(8):959-963. 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 2006;119(10):892-896.

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So Many ICDs for a Reason Josephson M, Wellens HJ. Implantable defibrillators and sudden cardiac death. Circulation. Jun 8 2004;109(22):2685-2691.

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Ethical Dilemma ICD’s 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.

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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 patient’s 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 2004;141(11):835-838.

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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

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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 <1yr 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 1997;337(22):1576-1583.

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AVID

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Primary Prevention – MADIT-II MI and LVEF <30% 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 2002;346(12):877-883.

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MADIT-II

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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 2005;352(3):225-237.

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SCD-HeFT

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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 < 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.

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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 2006;119(10):892-896.

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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 2006;119(10):892-896.

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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. Patient’s 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 2003;78(8):959-963.

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Conclusions Goals of therapy should be defined. ICD therapy should be reevaluated in the context of the patient’s 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

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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.

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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.

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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 1997;337(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 2005;352(3):225-237. Braun TC, Hagen NA, Hatfield RE, Wyse DG. Cardiac pacemakers and implantable defibrillators in terminal care. J Pain Symptom Manage. Aug 1999;18(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 2004;141(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 2006;119(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 2002;346(12):877-883. 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 2003;78(8):959-963. Josephson M, Wellens HJ. Implantable defibrillators and sudden cardiac death. Circulation. Jun 8 2004;109(22):2685-2691.

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