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INTERNAL DEFIBRILLATOR DEVICES

INTERNAL DEFIBRILLATOR DEVICES. Ethical dilemmas involving use and deactivation Elizabeth L. Maher, MD Hospice Homecare Physician. Objectives. Review indications for use of ICD Recognize the complexity and common complications of newest devices

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INTERNAL DEFIBRILLATOR DEVICES

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  1. INTERNAL DEFIBRILLATOR DEVICES Ethical dilemmas involving use and deactivation Elizabeth L. Maher, MD Hospice Homecare Physician

  2. Objectives • 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

  3. 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

  4. Ethical Questions related to ICD • 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?

  5. Primary Indication for use • Minimize risk of sudden cardiac arrest • SCD most common cause of death Josephson, M. Circulation 2004; 109:2685-2691

  6. A Hospice MD’s bias: When faced with the alternatives, sudden cardiac death isn’t such a bad way to go.

  7. ICD: Increased usage Josephson, M. Circulation 2004; 109:2685-2691

  8. 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

  9. Indications for AICD:PRIMARY PREVENTION • Ischemic or non-ischemic cardiomyopathy with EF <35% and NYHA Class II/III Ezekowitz J Ann Intern Med 2007;147:251-262 • 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

  10. Cases to consider • 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 • 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 ?????????????????????????????????????????

  11. What information are pts given prior to decision to insert ICD? Agard A J Med Ethics 2007;33: 514-518 • 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 decision-making • When told that they needed it, patients accepted it

  12. What info should pts be given BEFORE initiating therapy? • 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

  13. http://depts.washington.edu/shfm/

  14. Understanding the device • 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.

  15. Newer ICDs perform multiple functions • 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

  16. WHAT IS THE SHOCK LIKE? • 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.

  17. Adjunctive therapy with ICD • Antiarrhythmic drugs (amiodarone or sotalol) are used to • 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

  18. 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.

  19. Quality of Life and ICDs • 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 • 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

  20. Driving and ICDs • 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

  21. Inappropriate shocks/SVT • 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 • Newer dual chamber ICDs are designed to discriminate atrial from ventricular tachycardias and prevent this most common cause of inappropriate shock

  22. Inappropriate ICD shocks/other causes • Electrical noise • ICD malfunction such as lead fracture or inappropriate sensing • Complicated devices

  23. 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%

  24. How often physicians discuss ICD at EOL Goldstein, N Ann Intern Med 2004;141:835-838 • 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 • “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.”

  25. “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.”

  26. ICDs and Elderly • 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

  27. ICDs and Elderly • 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

  28. http://depts.washington.edu/shfm/

  29. Cause of death in CHF • 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

  30. Indications for deactivation of ICD • 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

  31. ICD and EOL: Guidelines for a Patient's request for withdrawalMueller, P Mayo Clin Proc 2003;78:959-963 • 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

  32. ICD and EOL: Guidelines for PATIENT request for withdrawalMueller, P Mayo Clin Proc 2003 • 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.

  33. 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.” Berger J Ann Intern Med 2005 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.

  34. When should physicians suggest deactivation of ICD?Lewis W Am J Med 2006;119:892-896 • 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.

  35. 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 • Becoming bedbound • Significantly decreased intake of food and fluid • Sleeping more hours of the day

  36. Treatment Guidelines for ICD • 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.

  37. New Frontier/Challenges • 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 • 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.

  38. CHF Challenges • CHF has high mortality rate and symptom burden • New interventions are being developed daily • Prognostic difficulties in CHF should not lead to “prognostic paralysis” Selman L Heart 2007;93:963-967 • Preparation for crisis and discussion of GOC and treatment limitations in light of functional declines is imperative

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