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  • To the Speaker: Note that the talk does not address ICD functionality or implant. Nor does it address the use of drug therapies in the prevention of SCA. This slide is optional, but may be necessary if the talk is being given as a CME offering.
  • To the Speaker: This case (which continues on the next slide) is intended to represent a patient with a Class I indication for ICD therapy, but also with significant issues of co-morbidities and age. If possible, please replace this case with one from your practice that will allow discussion of the same point but allow you to personalize the case study.
  • To the Speaker: This graph is taken from the American Heart Association Power Point presentation entitled: Heart Disease and Stroke – 2006 Update. This slide is included here because of the high Cardiovascular Disease (CVD) mortality. According to the Centers for Disease Control and Prevention (CDC), more than 910,000 Americans die of cardiovascular diseases each year, which is 1 death every 35 seconds. Although these largely preventable conditions are more common among people aged 65 or older, the high CVD related mortality is a matter of great concern from the disability and the economic burden it causes. Sudden cardiac arrest represents a sizable portion of this CVD mortality. Roughly 335,000 individuals in the United Stated die from sudden cardiac arrest each year. References: Heart Disease and Stroke Statistics — 2006 Update. CDC/NCHS. * Preliminary. AHA. Accessed from: www.americanheart.org State-Specific Mortality from Sudden Cardiac Death. United States, 1999: February 15, 2002 / 51(06);123-6. Accessed from: www.cdc.gov/mmwr/preview/mmwrhtml/mm5106a3.htm
  • Additional Discussion Points: Albert CM, et al. (2003) make the following points on gender differences in SCA: Sex differences in sudden death victims and cardiac arrest survivors are poorly understood. Women are at decreased risk at all ages compared to men, constituting only 21% of ventricular fibrillation arrest victims in Seattle, and 32% of sudden death victims in the Framingham study. In women, SCA is often the first manifestation of heart disease. 64% of sudden deaths compared with 50% in men occur in persons without prior clinical evidence of coronary heart disease. Classic coronary risk factors do not appear to predict sudden death to the same degree in women as they do in men. Suggested Reading: Albert CM, et al. Prospective study of sudden cardiac death among women in the United States. Circulation. 2003;107:2096-2101. Albert CM, et al. Sex differences in cardiac arrest survivors. Circulation. 1996;93:1170-1176. Kannel WB, et al. Sudden coronary death in women. Am Heart J. 1998;136:205-202. References: Centers for Disease Control. State-specific mortality from sudden cardiac death: United States, 1999. MMWR Morb Mortal Wkly Rep 2002; 57: 123-126 Goraya TY, Jacobsen SJ, Kottke TE, et al. Coronary heart disease death and sudden cardiac death: a 20-year population-based study. Am J Epidemiol. 2003; 157:763-770.
  • Additional Discussion Points: SCA is one of the leading causes of death in the United States, exceeded only when you include all cancers as a group. References: National Vital Statistics Report. 2001:49(11). State-specific mortality from sudden cardiac death – United States 1999. MMWR. 2002;51:123-126.
  • Additional Discussion Points: SCA is common, highly lethal, and typically occurs out-of-hospital. References: Seidl K, Senges J. Worldwide utilization of implantable cardioverter/defibrillators now and in the future. Card Electrophysiol Rev. 2003;7:5-13. Heart Disease and Stroke Statistics — 2005 Update. AHA. Accessed from: www.americanheart.org/downloadable/heart/1105390918119HDSStats2005Update.pdf Crespo EM, Kim J, Selzman KA. The use of implantable cardioverter defibrillators for the prevention of sudden cardiac death: a review of the evidence and implications. Am J Med Sci. 2005;329:238-246. Zheng ZJ, et al. Sudden cardiac death in the United States, 1989 to 1998. Circulation. 2001;104:2158-2163. Zipes DP, et al. ACC/AHA/ESC 2006 Guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: Circulation. 2006;114;385-484.
  • To the Speaker: Use this case to illustrate the real-world problem of applying a practice algorithm to secondary prevention patients. It would be best if you used this slide as a template and used an actual patient from your practice experience for discussion.
  • To the Speaker: The key idea here is that the ACC/AHA/ESC guidelines rest upon the results of multiple trials. Abbreviations: AVID = Antiarrhythmic Versus Implantable Defibrillator; CABG Patch = Coronary Artery Bypass Graft Patch Trial; CASH = Cardiac Arrest Study Hamburg; CAT = Cardiomyopathy Trial; CIDS = Canadian Implantable Defibrillator Study; DEFINITE = Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation study; EP = electrophysiologic; LVEF = left ventricular ejection fraction; MADIT = Multicenter Automatic Defibrillator Implantation Trial; MUSTT = Multicenter Unsustained Tachycardia; SCD-HeFT = Sudden Cardiac Death-Heart Failure. References: DiMarco JP. Implantable cardioverter-defibrillators. N Engl J Med . 2003;349:1836-1847. Accessed from: www.medscape.com/viewprogram/3120_pnt Young JB. Sudden cardiac death in heart failure: Managing the “wild card" of cardiovascular disease. 2004. Accessed from: www.medscape.com/viewprogram/3120_pnt
  • To the Speaker: The key idea here is that the ACC/AHA/ESC guidelines rest upon the results of multiple trials. Abbreviations: AVID = Antiarrhythmic Versus Implantable Defibrillator; CABG Patch = Coronary Artery Bypass Graft Patch Trial; CASH = Cardiac Arrest Study Hamburg; CAT = Cardiomyopathy Trial; CIDS = Canadian Implantable Defibrillator Study; DEFINITE = Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation study; EP = electrophysiologic; LVEF = left ventricular ejection fraction; MADIT = Multicenter Automatic Defibrillator Implantation Trial; MUSTT = Multicenter Unsustained Tachycardia; SCD-HeFT = Sudden Cardiac Death-Heart Failure. References: DiMarco JP. Implantable cardioverter-defibrillators. N Engl J Med . 2003;349:1836-1847. Accessed from: www.medscape.com/viewprogram/3120_pnt Young JB. Sudden cardiac death in heart failure: Managing the “wild card" of cardiovascular disease. 2004. Accessed from: www.medscape.com/viewprogram/3120_pnt
  • Additional Discussion Points: Population-based risk is getting steadily more well-defined. References: Myerburg RJ, et al. Interpretation of outcomes of antiarrhythmic clinical trials. Circulation . 1998;97:1514-1521.
  • To the Speaker: Use this case to illustrate the real-world problem of applying a practice algorithm to primary prevention patients. It would be best if you used this slide as a template and use an actual patient from your practice experience for discussion.
  • References: Sudden Cardiac Arrest Fast Facts. HRS. Accessed from: www.hrsonline.org/media/facts_sca.asp Risk factors for sudden cardiac death. Accessed from: www.heartinstitute.org.au/Community/scdMain.asp Buxton AE, et al. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med. 1999;341:1882-1890.
  • The authors speculated that this altered temporal distribution of SCD may be because beta-blockers seem to provide an increased protection from an early occurrence of SCD.
  • These results come from the MADIT-II study. Mortality risk in contemporary post- MI pts with EF < 30% tends to increase as a function of time from last MI. Correspondingly, survival benefit from the ICD increases significantly with time, up to 15 years following MI. Mortality risk in contemporary post- MI pts with EF < 30% tends to increase as a function of time from last MI. These results show the mortality results for each time period studied. They are not cumulative mortality rates.
  • To the Speaker: The second bullet, “As HF progresses, pump failure (rather than SCA) becomes relatively more likely as the cause of death,” is amplified on the next slide, and can be explained to the audience. References: Heart Disease and Stroke Statistics — 2005 Update. AHA. Accessed from: www.americanheart.org/downloadable/heart/1105390918119HDSStats2005Update.pdf
  • Additional Discussion Points: Note that SCA is a significant cause of death in all NYHA classes, but especially so in classes II and III. References: MERIT-HF Study Group (No authors listed). Effect of metoprolol in chronic heart failure: Metoprolol CR/XL randomised intervention trial in congestive heart failure (MERIT-HF). Lancet. 1999;353:2001-2007.
  • To the Speaker: The key idea here is that the ACC/AHA/ESC guidelines rest upon the results of multiple trials. Abbreviations: AVID = Antiarrhythmic Versus Implantable Defibrillator; CABG Patch = Coronary Artery Bypass Graft Patch Trial; CASH = Cardiac Arrest Study Hamburg; CAT = Cardiomyopathy Trial; CIDS = Canadian Implantable Defibrillator Study; DEFINITE = Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation study; EP = electrophysiologic; LVEF = left ventricular ejection fraction; MADIT = Multicenter Automatic Defibrillator Implantation Trial; MUSTT = Multicenter Unsustained Tachycardia; SCD-HeFT = Sudden Cardiac Death-Heart Failure. References: DiMarco JP. Implantable cardioverter-defibrillators. N Engl J Med . 2003;349:1836-1847. Accessed from: www.medscape.com/viewprogram/3120_pnt Kadish A, et.al. Prophylactic Defibrillator Implantation in Patients with Nonischemic Dilated Cardiomyopathy. N Engl J Med 2004;350:2151-8. Young JB. Sudden cardiac death in heart failure: Managing the “wild card" of cardiovascular disease. 2004. Accessed from: www.medscape.com/viewprogram/3120_pnt
  • Additional Discussion Points: Population-based risk is getting steadily more well-defined. References: Myerburg RJ, et al. Interpretation of outcomes of antiarrhythmic clinical trials. Circulation . 1998;97:1514-1521.
  • To the Speaker: The key idea here is that the ACC/AHA/ESC guidelines rest upon the results of multiple trials. Abbreviations: AVID = Antiarrhythmic Versus Implantable Defibrillator; CABG Patch = Coronary Artery Bypass Graft Patch Trial; CASH = Cardiac Arrest Study Hamburg; CAT = Cardiomyopathy Trial; CIDS = Canadian Implantable Defibrillator Study; DEFINITE = Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation study; EP = electrophysiologic; LVEF = left ventricular ejection fraction; MADIT = Multicenter Automatic Defibrillator Implantation Trial; MUSTT = Multicenter Unsustained Tachycardia; SCD-HeFT = Sudden Cardiac Death-Heart Failure. References: DiMarco JP. Implantable cardioverter-defibrillators. N Engl J Med . 2003;349:1836-1847. Accessed from: www.medscape.com/viewprogram/3120_pnt Young JB. Sudden cardiac death in heart failure: Managing the “wild card" of cardiovascular disease. 2004. Accessed from: www.medscape.com/viewprogram/3120_pnt
  • To the Speaker: If time allows, please moderate a discussion on participants’ own views on contraindications. The questions on the slide are sample questions to start the discussion.
  • To the Speaker: This is an optional section; only if time permits. You have only one hour for the whole talk. Cover microvolt T-wave alternans depending upon audience interest, and use the next three slides accordingly. This test may have the ability to identify which patients are NOT at risk of SCD even though they may reside in a mild to moderate risk group in terms of population studies.
  • To the Speaker: The 2006 ACC/AHA/ESC guidelines state, "It is reasonable to use T-Wave Alternans for improving the diagnosis and risk stratification of patients with ventricular arrhythmias or who are at risk for developing life-threatening ventricular arrhythmias. (Class IIa. Level of Evidence: A)." The outcome of the test does not change the indication for ICD. The guidelines do not state that an ICD is not recommended if the T-wave test is negative. References: Bloomfield DM, et al. Microvolt T-wave alternans and the risk of death or sustained ventricular arrhythmias in patients with left ventricular dysfunction. J Am Coll Cardiol. 2006;47:456-463. Gehi AK, et al. Microvolt T-wave alternans for the risk stratification of ventricular tachyarrhythmic events: A meta-analysis. J Am Coll Cardiol. 2005;46(1):75-82. Zipes DP. et al. ACC/AHA/ESC 2006 Guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Circulation. 2006;114;385-484. Centers for Medicare & Medicaid Services: Decision Memorandum for Microvolt T-wave Alternans Testing. Accessed from: www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=165
  • Suggested Readings: Bloomfield DM, et al. Microvolt T-wave alternans and the risk of death or sustained ventricular arrhythmias in patients with left ventricular dysfunction. J Am Coll Cardiol. 2006;47:456-463. Hohnloser SH, et al. T–wave alternans negative coronary patients with low ejection and benefit from defibrillator implantation. Lancet. 2003;362:125-126.
  • To the Speaker: The danger here is to spend too much time on discussion of these tests. The key take-away is that there are a number of tests being explored. References: Siddiqui A, Kowey PR. Sudden death secondary to cardiac arrhythmias: mechanisms and treatment strategies. Curr Opin Cardiol. 2006;21:517-25.
  • To the Speaker: This slide sets the stage for the following one, in which figures are given for ICD therapy from several trials. References: Moss AJ. Satellite Symposium : Cost-effectiveness of device therapy in the heart failure population. 2003. Kupersmith J, et al. Cost-effectiveness analysis in heart disease, part III: Ischemia, congestive heart failure, and arrhythmias. Progress in Cardiovascular Diseases. 1995;37:5:307-346. Stanton M. Economic outcomes of implantable cardioverter-defibrillators. Circulation. 2000;101:1067-1074.
  • To the Speaker: There is the possibility of an objection to the definitions of Highly Cost-Effective, Cost-Effective, etc. Try to move the group past this point if the objection occurs. What is of most importance is that ICD therapy is generally regarded as cost-effective in terms of these generally-accepted measures. Suggested Reading: Sanders G.D., Hlatky M.A., Owens D.K.. Cost-effectiveness of implantable cardioverter-defibrillators. N Engl J Med. 2005;353:1471-1480. References: Al-Khatib SM, et al. Clinical and economic implications of the multi-center automatic defibrillator implantation trial-II. Ann Intern Med. 2005;142:593-600. Larsen G. Cost-effectiveness of the implantable cardioverter-defibrillator versus antiarrhythmic drugs in survivors of serious ventricular tacharrhythmias: results of the antiarrhythmics versus impantable defibrillators (AVID) economic analysis substudy. Circulation. 2002;105:2049-2057. Mark DB. Cost-effectiveness of defibrillator therapy or Amiodarone in chronic stable heart failure. Circulation. 2006;114:135-142. Accessed from: http://circ.ahajournals.org/cgi/content/full/114/2/135
  • Additional Discussion Points: NNT is dramatically dependent on the time window over which the benefit is assigned. E.g., for MADIT II: NNT at 1 year = 133 patients NNT at 2 year = 17 patients NNT at 3 year = 8 patients Therefore it is hard to compare studies where NNT estimates are made at different time periods. However, it is generally accepted that for a high initial cost therapy for which the benefit lasts over time, the true cost can only be assessed using an NNT over several years. Abbreviations: NNT= Number Needed to Treat: A Descriptor for Weighing Therapeutic Options Additional Trial Information: SAVE = captopril; Merit-HF = metoprolol succinate; 4S = simvastatin References: Camm J, Klein H, Nisam S. The cost of implantable defibrillators: perceptions and reality. Eur Heart J. doi:10.1093/eurheart/eji166; 2006.
  • To the Speaker: Use this case to illustrate the real-world problem of applying a practice algorithm to difficult patients. It would be best if you used this slide as a template and used an actual patient from your practice experience for discussion.
  • Additional Discussion Points: Population-based risk is getting steadily more well-defined, but how do you apply the studies in the case of your individual patients? References: Myerburg RJ, et al. Interpretation of outcomes of antiarrhythmic clinical trials. Circulation . 1998;97:1514-1521.
  • To the Speaker: Please spend the time you have remaining on a discussion of the practice realities. This discussion should focus on the realities and difficulties encountered in changing practice behavior and implementing a new practice algorithm. You probably will have your own questions and examples that will stimulate the discussion. The questions on the slide are sample questions to get you started. The next 2 slides give examples of decision trees and practice algorithms. Please feel free to use/share examples from your practice. Additional Discussion Points: The evolving challenge in improving patient selection is through judicious risk-stratification. ICDs should go to those who need them most. Fewer ICDs can be implanted in patients who are not destined to suffer SCD. The challenges in primary prevention, its use today in clinical practice, and where this field is headed in the future are discussed in an excellent interview entitled: Primary prevention of sudden cardiac death: Current status and future directions – An expert interview with Grant Simons, MD. The interview can be accessed from: http://www.medscape.com/viewarticle/540409
  • To the Speaker: Used with permission from The Ohio Heart & Vascular Center.
  • To the Speaker Used with permission from the Texas Heart Institute Journal. References: Narayan, SM. Implantable defibrillators with and without resynchronization. Current Issues in Cardiology. 2005:32:3.
  • Transcript

    • 1. Increasing Survival in Sudden Cardiac Arrest (SCA): The Role of ICD Therapy
    • 2. Objectives
      • Upon completion of this activity, participants will be able to:
      • Describe current trends in the epidemiology and etiology of sudden cardiac arrest (SCA).
      • Assess the risk of SCA in ischemic and non-ischemic populations, including post-MI patients and HF patients.
      • Describe the current evidence underlying the most recent ACC/AHA/ESC guidelines (2006) for the use of ICDs in patients at risk of SCA, and apply those guidelines.
      • List risk-assessment tools being used in clinical practice or under investigation, and describe the current evidence for each.
      • Describe the current CMS coverage for use of ICDs in patients at risk of SCA, and compare the economics of such use to other medical interventions.
      • Assess their current use of ICDs in patients at risk for SCA.
    • 3. Patient Case
        • History
        • 76-y.o. white male
        • Type II DM, low-grade renal dysfunction; both well-controlled
        • 3 years post-MI, successfully revascularized
        • NYHA functional class II; stable
        • LVEF is 32% (echo)
        • Compliant with meds: antiplatelet, beta-blocker, ACE-I, statin, DM regimen
    • 4. Patient Case
      • Clinical Decisions
        • Should this patient be referred for an ICD evaluation?
        • What factors enter into your decision?
        • Is there anything else you'd want to know before making the decision?
    • 5. AGENDA
      • Epidemiology and Etiology
      • Secondary Prevention
      • Primary Prevention
      • Beyond EF: Microvolt T-wave Alternans
      • The Economics of ICDs
      • Implications for Real-World Practice
      • ICD Treatment Algorithms
      • Summary
    • 6. Epidemiology and Etiology
    • 7. Cardiovascular Disease Mortality Trends for Males and Females: United States: 1979-2003* Heart Disease and Stroke Statistics — 2006 Update. CDC/NCHS. * Preliminary . AHA. www.americanheart.org State-Specific Mortality from Sudden Cardiac Death. www.cdc.gov 0
    • 8. SCA Mortality Trends Age-adjusted cardiovascular deaths have declined; however mortality due to Sudden Cardiac Death has not. Over 60% of coronary artery deaths are attributable to sudden cardiac arrest Goraya TY, et al. Am J Epidemiol. 2003; 157:763-770. Centers for Disease Control. 1999. MMWR Morb Mortal Wkly Rep 2002; 57: 123-126
    • 9. Leading Causes of Death in the US National Vital Statistics Report. 2001;49;11. MMWR. 2002;51:123-126. Sudden Cardiac Arrest (SCA) 0% 5% 10% 15% 20% 25% Septicemia Nephritis Alzheimer’s Disease Influenza/Pneumonia Diabetes Accidents/Injuries Chronic Lower Respiratory Diseases Cerebrovascular Disease Other Cardiac Causes All Cancers SCA is a leading cause of death in the U.S., second to all cancers combined.
    • 10. SCA Survival & Mortality Data
      • At least 335,000 SCA deaths in the U.S. each year
      • Only 5 to 10% survive first episode of SCA
      • Roughly two-thirds of SCA deaths occur
      • out-of-hospital
      Seidl K, Senges J. Card Electrophysiol Rev . 2003;7:5-13. Heart Disease and Stroke Statistics — 2005 Update. AHA. www.americanheart.org Crespo EM, Kim J, Selzman KA. Am J Med Sci. 2005;329:238-246. Zheng ZJ, et al. Circulation. 2001;104:2158-2163. Zipes, DP, et al. 2006 ACC/AHA/ESC Practice Guidelines 5. Circulation. 2006;114;385-484.
    • 11. Secondary Prevention of Sudden Cardiac Arrest
    • 12. Patient Case
      • History
      • 54-y.o. African-American female
      • Ischemic cardiomyopathy
      • NYHA functional class I
      • LVEF = 28% per echo at your institution
      • Long-time heavy smoker; has COPD
      • Compliant and stable on optimal medical therapy
      • Syncopal episodes
    • 13. Patient Case
      • Clinical Decisions
        • Should this patient be referred for an ICD evaluation?
        • What factors enter into your decision?
        • Is there anything else you'd want to know before making the decision?
    • 14. Key Randomized Clinical Trials Adapted from: DiMarco JP. N Engl J Med . 2003;349:1836-47. www.medscape.com Young JB. Sudden cardiac death in heart failure. www.medscape.com ICD therapy for the secondary prevention of SCA .08 36.4 44.4 Amiodarone or metoprolol 57 ± 34 45 58 ± 11 288 CASH .14 25.3 29.6 Amiodarone 36 34 64 ± 9 659 CIDS .02 15.8 24.0 Amiodarone or sotalol 18 ± 12 35 65 ± 10 1016 AVID P ICD Control Control Therapy Follow-up (mos) Mean LVEF (%) Age (yrs) N Trial Mortality (%)
    • 15. 2006 ACC/AHA/ESC Guidelines for the Management of Ventricular Arrhythmias: Secondary Prevention of SCD
      • ICD Class I Recommendation :
      • Patients with a history of SCA, VF, hemodynamically unstable VT, or unexplained syncope
      Zipes, DP, et al. 2006 ACC/AHA/ESC Practice Guidelines 5. Circulation. 2006;114;385-484
    • 16. Myerburg RJ, et al. Circulation . 1998. 97:1514-1521. Patients with a previous cardiac arrest are at high risk for subsequent SCA events but account for a small percentage of annual sudden deaths MADIT I, MUSTT AVID, CASH, CIDS SCD-HeFT, MADIT II
    • 17. Primary Prevention of Sudden Cardiac Arrest
    • 18. Patient Case
      • History
      • 52 year old woman
      • Moderate alcohol consumption, has stopped since MI
      • Lives alone in rural community; manages on-line content for a large dog food manufacturer
      • PMHX: MI 1 year ago, echo on discharge was 35%
      • Medications: BB, ACE-I, lipid-lowering agent, clopidorgrel, omega-3
    • 19. Patient Case
      • Clinical Decisions
        • Should this patient be referred for an ICD evaluation?
        • What factors enter into your decision?
        • Is there anything else you'd want to know before making the decision?
    • 20. SCA Relationship to MI
      • A previous MI can be identified in as many as 75% of SCA patients.
      • A previous MI as a single risk-factor raises the one-year risk of SCA by 5%.
      • The five-year risk of SCA is 32% for patients with all of these risk-factors:
        • history of MI
        • non-sustained, inducible, non-suppressible VT
        • LVEF ≤ 40%
      Sudden Cardiac Arrest Fast Facts. HRS. www.hrsonline.org Risk factors for sudden cardiac death. www.heartinstitute.org.au/Community/scdMain.asp Buxton AE, et al. N Engl J Med. 1999;341:1882-1890.
    • 21. Time Dependence of Mortality Risk Post-MI Prediction of Sudden Cardiac Death After Myocardial Infarction in the Beta-Blocking Era 1
      • 700 post-MI patients; ~ 95% on beta-blockers 2 years after discharge.
      • The epidemiologic pattern of SCD was different from that reported in previous studies.
        • Arrhythmia events did not concentrate early after the index event; most occurred > 18 months post-MI.
      1 Huikuri HV. J Am Coll Cardiol. 2003;42:652-658. Total Mortality Cardiac Mortality Non-SCD SCD Cumulative Events (%) 18 15 12 9 6 3 18 15 12 9 6 3 20 40 60 20 40 60 Follow-Up (months) Follow-Up (months)
    • 22. (n = 300) (n = 283) (n = 284) (n = 292) Hazard Ratio .98 (p = 0.92) 0.52 (p = 0.07) 0.50 (p = 0.02) 0.62 (p = 0.09) Wilber, D. Circulation . 2004;109:1082-1084. Relation of Time from MI to ICD Benefit in the MADIT-II Trial Time from MI % Mortality for Each Time Period
    • 23. SCA Relationship to HF
      • Patients with HF are overall at 6-9 times higher risk for SCD than general population
      • As HF progresses, pump failure (rather than SCA) becomes relatively more likely as the cause of death
      Heart Disease and Stroke Statistics – 2005 Update. AHA. www. americanheart.org
    • 24. Severity of Heart Failure Modes of Death MERIT-HF Study Group. Lancet. 1999;353:2001-2007. 12% 24% 64% CHF Other Sudden Death (N = 103) NYHA II 26% 15% 59% CHF Other Sudden Death (N = 103) NYHA III 56% 11% 33% CHF Other Sudden Death (N = 27) NYHA IV 56% 33% NYHA Class IV 26% 59% NYHA Class III 12% 64% NYHA Class II Pump Failure SCA
    • 25. SCA Relation to LVEF Gorgels PMA. European Heart Journal . 2003;24:1204-1209. LVEF % SCA Victims 7.5% 5.1% 2.8% 1.4% EF is an Important Risk Stratifier
    • 26. Key Randomized Clinical Trials Adapted from: DiMarco JP. N Engl J Med. 2003;349:1836-47. www.medscape.com Kadish A, et.al. N Engl J Med 2004;350:2151-8. Young JB. Sudden cardiac death in heart failure. www.medscape.com ICD therapy for the primary prevention of SCA .08 7.9 14.1 Optimal Medical Therapy 29.0±14.4 21 58 458 DEFINITE .06 24 48 No EP-guided therapy 39 30 67 ± 12 704 MUSTT .007 14.2 19.8 Optimal Medical Therapy 20 23 64 ± 10 1232 MADIT II .009 15.7 38.6 Conventional 27 26 63 ± 9 196 MADIT .007 28.9 36.1 Optimal Medical Therapy 45.5 25 60.1 2521 SCD-HeFT P ICD Control Control Therapy Follow-up (mos) Mean LVEF (%) Age (yrs) N Trial Mortality (%)
    • 27. Myerburg RJ, et al. Circulation . 1998. 97:1514-1521. Heart Failure and Left Ventricular Dysfunction are indicators of SCA risk MADIT I, MUSTT AVID, CASH, CIDS SCD-HeFT, MADIT II
    • 28. 2006 ACC/AHA/ESC Guidelines for the Management of Ventricular Arrhythmias: Primary Prevention of SCD
      • ICD Class I Recommendations :
      • Patients with ischemic cardiomyopathy who are at least 40 days post-MI with an LVEF ≤ 30 - 40% and NYHA functional class II or III
      • Patients with NYHA Class II-III, LVEF ≤ 30 - 35%, non-ischemic cardiomyopathy
      • Patients who are at high risk of SCA due to genetic disorders such as long QT syndrome, Brugada syndrome, hypertrophic cardiomyopathy and arrhythmogenic right ventricular dysplagia (ARVD).
      • ICD Class II Recommendation:
      • Ischemic and non-ischemic patients with NYHA functional class I, LVEF ≤ 30-35%
      Zipes, DP, et al. 2006 ACC/AHA/ESC Practice Guidelines 5. Circulation. 2006;114;385-484
    • 29. Current CMS ICD Coverage*
      • In brief, this policy expands coverage for:
        • 1) Patients with ischemic dilated cardiomyopathy (IDCM), prior MI, NYHA Class II & III heart failure, LVEF less than or equal to 35%
        • 2) Patients with non-ischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II & III heart failure, LVEF less than or equal to 35%
      Overall, this NCD covers the SCD-HeFT population and all the MADIT II population . * ICD coverage expanded in January 2005 and updated in April 2006.
    • 30. Discussion: ICD Contraindications
      • Standard Contraindications for ICD Therapy
        • Hospitalized patients with advanced age
        • Advanced (NYHA class IV) HF and limited life expectancy
        • Patients whose VT’s may have transient or reversible causes
        • Patients with incessant VT or VF
        • Patients who have a unipolar pacemaker
      • Questions
        • Are there patients who are indicated but who should not get an ICD?
        • Who makes the decision on whether or not an ICD is offered?
    • 31. Beyond EF
    • 32. Microvolt T-Wave Alternans
      • Noninvasive, ECG-based test
      • HR elevation by exercise, atrial pacing, or dobutamine infusion
      • Measures beat-to-beat microvolt variations in the shape, amplitude, or timing of the ECG T-wave
    • 33. Microvolt T-Wave Alternans
      • Sometimes used as a risk-stratification tool
      • Negative result may suggest low risk of SCA
      • High negative-predictive value, low positive-predictive value
      • CMS has approved Medicare coverage when spectral-analytic method used
      • Microvolt T-wave alternans has received a Class IIa recommendation in the 2006 ACC/AHA/ESC Guidelines
          • The guidelines do not state that an ICD is not recommended if the T-wave test is negative.
          • The outcome of the test also does not change the indication for ICD.
      Bloomfield DM, et al. J Am Coll Cardiol. 2006:47:456-463 Gehi AK, et al. J Am Coll Cardiol. 2005:46(1):75-82 Zipes, DP, et al. 2006 ACC/AHA/ESC Practice Guidelines 5. Circulation. 2006;114;385-484 CMS: Decision Memorandum for Microvolt T-wave Alternans Testing. www.cms.hhs.gov
    • 34. Microvolt T-Wave Alternans: Issues
      • Patients must be in sinus rhythm (but up to 30% of patients at risk have AF)
      • A patient must sustain a heart rate of 105 for 10 minutes, which may be difficult for patients on beta-blockers.
      • Can be indeterminate
      • Non-sustained MTWA in up to 10% of normals
      • Value beyond LVEF not fully established, further studies underway
      • Cost-effectiveness being assessed
    • 35. Many methods to further risk stratify patients at risk for SCA have been studied... Siddiqui A, Kowey PR. Curr Opin Cardiol. 2006;21:517-25. Prior SG, et al. Eur Heart J, Vol 22:16:August 2001 But a reduced EF remains the single most important risk factor for overall mortality and sudden cardiac death. Invasive, expensive 65–93 48–73 Induction of VA’s EP Study Cannot be used in AF 37–83 77–93 Identification of repolarization abnormalities Microvolt T-Wave Alternans (MTWA) Not useful in non-ischemic cardiomyopathy 74–81 56-68 Induction of late potentials Signal Averaged ECG (SAECG) Multiple non-standardized methods 75–88 38–62 Assessment of low heart rate variability HR variability 75–80 55–65 Measurement of LVEF Echo Limitations Specificity (%) Sensitivity (%) Objective Test
    • 36. The Economics of Therapy
    • 37. Incremental Cost-Effectiveness Cardiovascular Interventions Hypertension Therapy (diastolic 95 - 104 mmHg) Expensive Borderline Cost-Effective Cost-Effective Highly Cost-Effective Incremental Cost per Life-Year Saved Economically Unattractive Lovastatin (chol. = 290 mg/dL, 50 yrs old, male, no risk factors ) PTCA (chronic CAD, severe angina 1 VD) CABG (chronic CAD mild angina, 3 VD) End Stage Renal Disease Treatment Exercise SPECT (atypical angina who can walk on treadmill) Routine Coronary Angiography (35 - 84 yrs old, low risk MI, has CHF) $8,461 $17,701 $40,750 $67,000 $135,000 $150,000 Carotid Disease Screening (65 yrs old, male, no symptoms) $1,000,000 $120,000 Moss AJ. Satellite Symposium, 2003. Kupersmith J. Progress in Cardiovascular Diseases. 1995;37:5:307-346. Stanton M. Circulation. 2000;101:1067-1074.
    • 38. Incremental Cost-Effectiveness of ICD Therapies Al-Khatib SM, et al. Ann Intern Med. 2005;142:593-600. Larsen G, et al. Circulation. 2002;105:2049-2057. Mark DB. Circulation. 2006;114:135-142. http://circ.ahajournals.org Incremental Cost per Life-Year Saved MADIT-II ICD 2 AVID ICD 3 $50,000 $67,000 Expensive Borderline Cost-Effective Cost-Effective Highly Cost-Effective Economically Unattractive SCD-HeFT ICD 1 $38,000 $0 $20,000 $40,000 $60,000 $80,000 $100,000 $120,000 $140,000 $160,000 $180,000 $200,000
    • 39. Number-Needed-to-Treat (NNT) to Save One Life for ICDs and Various Drugs Camm J, Klein H, Nisam S. European Heart Journal. doi:10.1093/eurheart/eji166; 2006 MADIT II (3 year) Incremental Cost per Life-Year Saved SAVE (3.5 year) MUSTT (5 year) MADIT (2.4 year) AVID (3 year) SCDHeFT (5 year) Merit-HF (1 year) 4S (6 year) 4 11 9 20 26 28 14 0 5 10 15 20 25 30
    • 40. Implications for Real-World Practice
    • 41. Patient Case
      • History
      • 78 year old man
      • Wheelchair bound due to automobile accident
      • Plays bridge competitively
      • Lives in assisted-living
      • PMHX: NIDCM, HF class II, sinus node dysfunction treated with a pacemaker, EF measured in 2000 was 30%
      • Medications: ACE-I, BB, Diuretic
    • 42. Patient Case
      • Clinical Decisions
        • Should this patient be referred for an ICD evaluation?
        • What factors enter into your decision?
        • Is there anything else you'd want to know before making the decision?
    • 43. Myerburg RJ, et al. Circulation . 1998. 97:1514-1521. Sudden Death Risk MADIT I, MUSTT AVID, CASH SCD-HeFT, MADIT II How can a practice effectively identify patients at-risk?
    • 44. Discussion: Practice Realities
      • Questions
        • If you were to implement a new SCA algorithm
        • in your practice, what would happen?
        • What do you see as possible problems in
        • implementing the guidelines?
        • Are there situations that are unique to your
        • practice?
    • 45. ICD Treatment Algorithms
    • 46. EF Clinic Program Patient Screening Pathway (The Ohio Heart & Vascular Center) Determine EF Does patient have history of cardiac arrest, VF, or symptomatic VT? Non-Ischemic Consult EP for possible CRT-D Optimize therapies or consult HF specialist EF ≤ 35% Ischemic PATIENT 40 days post MI with EF ≤ 30% NYHA Class I CHF EF > 35% 40 days post MI OR 3 months post revascularization Consult EP for possible ICD 3 months post diagnosis 1. Consider referral to HF Specialist or HF Program. 2. Repeat diagnostics with change of symptoms. Class III or IV CHF and QRS > 120 ms Consult EP for possible ICD Consult EP for possible ICD Is patient on optimal medical therapy? YES YES NO Note : Pathway only begins after optimal medical therapy & coronary evaluation / intervention as appropriate Consult EP for possible ICD NYHA Class II or III CHF This is a general protocol to assist in the management of patients. This protocol is not designed to replace clinical judgment or individual patient needs.
    • 47. ICD Practical Flowchart ICD LVEF ≤ 35% Optimal Medical Therapy NYHA Class III – IV, Wide QRS? YES NO CRT-D NO Prior MI No Prior MI EF ≤ 30% MADIT II NYHA II/III EPS + MADIT-1 NYHA II/III Syncope OR OR Source: Narayan SM. Current Issues in Cardiology. 2005: 32:3. COMPANION SCD-HeFT
    • 48. Key Points
      • The majority of cases are in patients with:
        • Coronary artery disease, previous MI
        • Low left ventricular ejection fraction
        • Dilated cardiomyopathy and heart failure
      • Defibrillation is the only effective treatment option
      • High-risk patients can be evaluated for known risk factors before they experience a Sudden Cardiac Arrest
        • EF remains a key indicator
    • 49. In Summary…
      • SCA is a leading cause of death
      • There is solid clinical evidence for ICDs as:
        • The only effective means to prevent SCD
        • Superior to optimal medical therapy
      • ICDs are cost-effective
      • There are practical ways to assess SCA risk in ischemic and non-ischemic populations
      Sudden Cardiac Death CAN be Prevented With an ICD
    • 50.
        • Brief Statement
        • Medtronic ICDs
        • Indications
        • Medtronic implantable cardioverter defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation
        • for automated treatment of life-threatening ventricular arrhythmias.
        • Contraindications
        • Medtronic ICDs are contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, patients
        • with incessant VT or VF, patients who have a unipolar pacemaker, and patients whose primary disorder is bradyarrhythmia.
        • Warnings/Precautions
        • Changes in a patient¹s disease and/or medications may alter the efficacy of the device¹s programmed parameters. Patients should
        • avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy
        • delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation
        • paddles directly over the device.
        • Potential Complications
        • Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation,
        • oversensing, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of ventricular tachycardia, and surgical
        • complications such as hematoma, infection, inflammation, and thrombosis.
        • See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions,
        • and potential complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult
        • Medtronic¹s website at www.medtronic.com .
        • Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.