1. Increasing Survival in Sudden Cardiac Arrest (SCA): The Role of ICD and CRT-D Therapies

2. Objectives Upon completion of this activity, participants will be able to: 1.Describe current trends in cardiac vascular disease (CVD) and SCA. 2.Assess the risk of SCA in heart failure (HF) and post-myocardial infarction (MI) patients. 3.Describe 2008 ACC/AHA/HRS Class I guidelines for the use of implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy with defibrillation (CRT-D) therapies in patients at risk of SCA, and the evidence supporting these guidelines. 4.Describe current CMS coverage for use of ICDs and CRT-Ds in patients at risk of SCA. Compare the economics of these devices to other medical interventions. 5.Describe current utilization of device therapy and assess current use of these devices in your practice.

3. Patient Case #1 History 76 y.o. white male Type II DM, low-grade renal dysfunction; both well-controlled 3 years post-MI, successfully revascularized NYHA Class II; stable LVEF is 32% (echo) Compliant with meds: antiplatelet, beta blocker, ACE-I, statin, DM regimen

4. Patient Case #1 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 1.CVD Epidemiology and SCA Facts 2.SCA Risk Factors 3.ICD and CRT-D Therapies 4.Secondary Prevention of SCA 5.Primary Prevention of SCA 6.CMS Coverage for ICD and CRT-D Therapies 7.Therapy Economics 8.Implications in Real-World Practice 9.Device Treatment Algorithms 10.Summary

6. CVD Epidemiology and SCA Facts

7. Prevalence of Cardiovascular Diseases in Adults Age 20 and Older by Age and Sex NHANES: 1999-2004

8. Deaths from Cardiovascular Disease United States: 1900-2004

9. Percentage Breakdown of Deaths from Cardiovascular Diseases United States: 2004 (Final) About 50% of CHD deaths are due to SCA. This is the largest cause of CV death.

10. Underlying Arrhythmias of SCA Bradycardia 17% Monomorphic VT 62% Primary VF 8% Polymorphic VT 13% Bayés de Luna A, et al. Am Heart J. 1989;117:151-159.

11. * Range: 166,200 to 310,000 1 Vital Statistics of the U.S., Data Warehouse, National Center for Health Statistics. 4 Department of Health and Human Services. Centers for Disease Control and Prevention. 2 Chugh SS, et al. J Am Coll Cardiol. 2004;44:1268-1275. 5 Avert Organization: www.avert.org 3 Nichol G, et al. JAMA. 2008;300:1423-1431. 6 2008 Heart and Stroke Statistics Update. American Heart Association. Magnitude of Deaths from SCA in the United States

12. SCD Rates for Gender and Ethnicity Zheng ZJ, et al. Circulation. 2001;104(18):2158-2163. 407.1 502.7 270.5 336.1 Per 100,000 Standard US Population 258.8 212.6 153.4 130.0 0 100 200 300 400 500 600 MalesFemales White Black American Indian/Alaska Native Asian/Pacific Islander

13. Incidence of SCD by Age and Gender Zheng ZJ, et al. Circulation. 2001;104:2158-2163. Age Group SCD Rate Per 100,000 0 500 1000 1500 2000 2500 3000 3500 4000 4500 35 - 5455 - 6465 - 7475 - 84> 84 Men Women

14. Cummins RO. Annals Emerg Med. 1989;18:1269-1275. SCA Resuscitation Success versus Time * 10 20 30 40 50 60 70 80 90 100 0123456789 % Success *Non-linear Time (minutes) Chance of success reduced 7-10% each minute

15. SCA Chain of Survival Statistics Even in the best EMS/early defibrillation programs, it is difficult to achieve high survival times due to any SCA events not being witnessed and the difficulty of reaching victims within 6-8 minutes. 48% to 58% SCAs not witnessed 1,2 85% SCAs occur at home/non-public 1 4.6% to 8% estimated SCA out-of-hospital survival 1,2 1 Nichol G, et al. JAMA. 2008;300:1423-1431. 2 Chugh SS, et al. J Am Coll Cardiol. 2004;44:1268-1275.

16. Defibrillation therapy for SCA Painless termination of most arrhythmias with antitachycardia pacing (ATP) Reduced unnecessary right ventricular pacing Comprehensive diagnostic information for more insightful patient assessment Automatic intrathoracic impedance (fluid) monitoring Implantable Cardioverter Defibrillator (ICD)

17. Biventricular pacing therapy for heart failure Defibrillation therapy for SCA Automatic intrathoracic impedance (fluid) monitoring Painless termination of most arrhythmias with antitachycardia pacing (ATP) Comprehensive diagnostic information for more insightful patient assessment Cardiac Resynchronization Therapy-Defibrillator (CRT-D)

18. Secondary Prevention of Sudden Cardiac Arrest

19. Patient Case #2 History 54 y.o. African-American female Ischemic cardiomyopathy NYHA Class I LVEF 45% per echo at your institution Long-time heavy smoker; has COPD Compliant and stable on optimal medical therapy Syncopal episodes; with documented episodes of VT

20. Patient Case #2 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?

21. 0 2 4 6 8 10 12 14 16 18 20 1 Year2 Years3 Years Arrhythmic Death in VT/VF Patients AVID Results in Non-ICD Arm Pratt CM. Circulation. 1998;98(suppl I):1494-1495. % Arrhythmic Death 8% 11% 18%

22. AVID Registry Study Survival by Arrhythmia Type Anderson JL, et al. Circulation. 1999;99:1692-1699. 1.00.90.80.70.65 0123 Years Cumulative Survival (%) Unexplained syncope Non-syncopalVT w/symptoms VF Transient correctable VT/VF Asymptomatic VT VT w/syncope P = 0.007

23. Randomized Clinical Trials ICD Therapy for the Secondary Prevention of SCA Mortality (%) TrialNMean Age (yrs) Mean LVEF (%) Follow-up (mos) Control Therapy ControlICDP AVID 1 101665 ± 103518 ± 12Amiodarone or sotalol 24.015.8.02 CIDS 2 65964 ± 93436Amiodarone29.625.3.14 CASH 3 28858 ± 114557 ± 34Amiodarone or metoprolol 44.436.4.08 1 The AVID Investigators. N Engl J Med. 1997;337:1576-1583. 2 Kuck KH, et al. Circulation. 2000;102:748-754. 3 Connolly SJ, et al. Circulation. 2000;101:1297-1302.

24. Non-significant results. 1 The AVID Investigators. N Engl J Med. 1997;337:1576-1583. 2 Kuck Kh, et al. Circulation. 2000;102:748-754. 3 Connolly SJ, et al. Circulation. 2000;101:1297-1302. Secondary Prevention Trials: Reduction in Mortality with ICD Therapy 123 31% 56% 23%* 58% 20%* 33% % Mortality Reduction w/ ICD Rx

25. 2008 ACC/AHA/HRS Class I ICD Secondary Prevention Guidelines for the Management of Ventricular Arrhythmias 1.History of SCA, VF, hemodynamically unstable sustained VT (exclude reversible causes) 2.Structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable 3.Syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or VF induced at EP study 4.Non-sustained VT due to prior MI, LVEF < 40% and inducible VT at EP study Epstein AE, et al. Circulation 2008;117:e350-408.

26. Primary Prevention of Sudden Cardiac Arrest

27. Patient Case #3 History 52 y.o. woman Moderate alcohol consumption, has stopped since MI Lives alone in rural community NYHA Class III PMHX: MI one year ago, echo on discharge was 35% Medications: BB, ACE-I, lipid-lowering agent, clopidorgrel, omega-3

28. Patient Case #3 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?

29. SCA Relationship to HF and Reduced LVEF Reduced left ventricular ejection fraction (LVEF) remains the single most important risk factor for overall mortality and SCD 1 As HF progresses, pump failure (rather than SCA) becomes relatively more likely as the cause of death 2 25% overall death in 2.5 years in HF patients and 50% die of SCA 3 1 Prior SG, et al. Eur Heart J. 2001;22:1374-1450. 2 MERIT-HF Study Group. Lancet. 1999;353:2001-2007. 3 Sweeney MO, PACE. 2001;24:871-888.

30. SCD Risks in HF Patients with LV Dysfunction Total Mortality ~15 to 40%; SCD accounts for ~50% of Total Deaths 12 months16 months41.4 months27 months 13 months45 months6 months Control Group Mortality % 17 8 20 15 9 19 7 6 4 42 41 39.7 44 11 0 10 20 30 40 50 CHF-STATGESICASOLVDV-HeFT IMERIT-HFCIBIS-IICARVEDILOL-US Total Mortality Sudden Cardiac Death

31. Relation of LVEF to Risk of SCA deVreede-Swagemakers JJ, et al. J Am Coll Cardiol. 1997;30:1500-1505. LVEF % Sudden Cardiac Deaths 7.5% 5.1% 2.8% 1.4% Note: 56.5% of all SCA victims had an LVEF > 30% 0 1 2 3 4 5 6 7 8 0-30%31-40%41-50%> 50%

32. 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 SCAPump Failure NYHA Class II64%12% NYHA Class III59%26% NYHA Class IV33%56%

33. SCA Relationship to MI In people who’ve had an MI and have HF, SCD occurs at 4 times the rate of the general population. Adabag AS, et al. JAMA. 2008;300:2022-2029.

34. Time Dependence of Mortality Risk Post-MI Prediction of Sudden Cardiac Death After Myocardial Infarction in the Beta-Blocking Era 1 1 Huikuri HV, et al. J Am Coll Cardiol. 2003;42:652-658. 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. Total Mortality Cardiac Mortality Non-SCD SCD Cumulative Events (%) 18 15 12 9 6 3 18 15 12 9 6 3 204060204060 Follow-Up (months)

35. SCD Rates in Post-MI Patients with LV Dysfunction Total Mortality ~20 to 30%; SCD accounts for ~50% of Total Deaths 32 21 19.8 14 10 7 16 12 9.4 28 18 20 28 0 10 20 30 TRACECAPRICORNEMIATMADITMUSTT Inducible MUSTT Registry MADIT II Control Group Mortality % at 2 years Total Mortality Arrhythmic Mortality

36. Randomized Clinical Trials Supporting Device Therapy ICD and CRT-D for the Primary Prevention of SCA Mortality (%) TrialNMean Age (yrs) Mean LVEF (%) Mean Follow-up (mos) Control Therapy ControlICDP SCD-HeFT 1,2 2,52160.12545.5Optimal Medical Therapy 36.128.9.007 COMPANION 3 1,520672112 -16 months Optimal Medical Therapy 1912 (CRT-D).000 3 MUSTT 4 704673039No EP-guided Therapy 4824.06 MADIT II 5 1,232642320Optimal Medical Therapy 19.814.2.007 1 Bardy GH, et al. N Engl J Med. 2005;352:225-237. 2 Packer DL. Heart Rhythm. 2005;2:S38-S39 3 Bristow MR, et al. N Engl J Med. 2004;350:2140-2150. 4 Buxton AE, et al. N Engl J Med. 1999;341:1882-1890. 5 Moss AJ, et al. N Engl J Med. 2002;346:877-883.

37. Primary Prevention Post-MI and HF Trials Reduction in Mortality with ICD or CRT-D Therapy 1,235 % Mortality Reduction w/ ICD Rx 4 23 36 55 31 64 56 73 62 0 20 40 60 80 SCD-HeFTCOMPANIONMUSTTMADIT-II Overall Death Arrhythmic Death 1 Bardy GH, et al. N Engl J Med. 2005;352:225-237. 2 Packer DL. Heart Rhythm. 2005;2:S38-S39 3 Bristow MR, et al. N Engl J Med. 2004;350:2140-2150. 4 Buxton AE, et al. N Engl J Med. 1999;341:1882-1890. 5 Moss AJ, et al. N Engl J Med. 2002;346:877-883.

38. Patient Case #4 History 68 y.o. male NYHA Class III LVEF measured in 2006 was 37% QRS 130 ms PMHX: MI 12 years ago Medications: BB, ACE-I, lipid-lowering agent Just completed last round of chemotherapy for Pancreatic CA

39. Patient Case #4 Clinical Decisions Should this patient be referred for a CRT-D evaluation? What factors enter into your decision? Is there anything else you’d want to know before making the decision?

40. 2008 ACC/AHA/HRS Class I Primary Prevention Guidelines for Management of Ventricular Arrhythmias: ICD and CRT-D ICD Class I Guidelines LVEF < 35% due to prior MI; who are at least 40 days post-MI; and are in NHYA Class II or III Nonischemic DCM who have an LVEF < 35% and who are in NYHA Class II or III LV dysfunction due to prior MI how are at least 40 days post-MI; have an LVEF < 30%; and are in NHYA Class I CRT-D Class I Guideline LVEF 0.12 seconds; and sinus rhythm; and NHYA Class III or ambulatory IV and on optimal medical therapy Epstein AE, et al. Circulation 2008;117:e350-e408.

41. CMS ICD Coverage Secondary Prevention Indications 1.Documented episode of cardiac arrest due to VF not due to a transient or reversible cause; 2.Documented sustained VT, either spontaneous or induced by an EP study, not associated with an acute MI and not due to a transient or reversible cause www.cms.hhs.gov

42. CMS ICD Coverage Primary Prevention Indications 1.Documented familial or inherited conditions with a high risk of life-threatening VT, such as Long QT syndrome or hypertrophic cardiomyopathy; 2.CAD with a documented prior MI, a measured LVEF ≤ 0.35, and inducible, sustained VT or VF at EP study. (MI must have occurred more than 40 days prior to defibrillator insertion. EP test must be performed > 4 weeks after the qualifying MI.); 3.Documented prior MI and a measured LV EF ≤ 0.30; www.cms.hhs.gov

43. CMS ICD/CRT-D Coverage Primary Prevention Indications 4.Ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA Class II and III HF, and measured LV EF ≤ 35%; 5.Nonischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II and III HF, and measured LV EF ≤ 35% (if registered into ICD Registry); and 6.Meet all current CMS coverage requirements for a cardiac resynchronization therapy (CRT) device and have NYHA Class IV HF www.cms.hhs.gov

44. Discussion: ICD Contraindications Patient Class III contraindications for ICD or CRT-D: –Not expected to survive with an acceptable functional status for at least one year –Incessant VT or VF –Significant psychiatric illness that may be aggravated by device transplant or preclude systematic follow-up –NYHA Class IV with drug-refractory HF, who are not candidates for cardiac transplantation or CRT-D –Syncope of undetermined cause without inducible VT and without structural heart disease –VT or VF that is amenable to surgical or catheter ablation –Patients whose VTs due to a completely reversible cause in the absence of structural heart disease 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? Epstein AE, et al. Circulation. 2008;117:e350-e408.

45. The Economics of Therapy Therapy A versus Therapy B Total Cost A – Total Cost B Life Expectancy A – Life Expectancy B = Incremental Cost Per Life Year Saved ($/LYS )

46. Incremental Cost-Effectiveness Cardiovascular Interventions Hypertension Therapy (diastolic 95 - 104 mmHg) Expensive Borderline 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, et al. Prog Cardiovasc Dis. 1995;37:307-346. Stanton MS, et al. Circulation. 2000;101:1067-1074. $0 $20,000 $40,000 $60,000 $80,000 $100,000 $120,000 $140,000 $160,000 $180,000 $200,000

47. Cost-Effectiveness and Use of Selected Interventions in the Medicare Population Intervention Cost-Effectiveness (Cost/QALY) Implementation Influenza vaccineCost saving40-70% Pneumococcal vaccineCost saving55-65% Beta blockers after myocardial infarction< $10,00085% Mammographic screening$10,000-$25,00050-70% Colon cancer screening$10,000-$25,00020-40% Osteoporosis screening$10,000-$25,00035% Hypertension medication (DBP >105 mmHg)$10,000-$60,00035% Cholesterol management, as secondary prevention$10,000-$50,00030% Implantable cardioverter defibrillator$30,000-$85,00035%* Dialysis in end-stage renal disease$50,000-$100,00090% Lung-volume – reduction surgery$100,000-$300,00010,000-20,000 cases per year Left ventricular assist devices$500,000-$1.4 million5,000-100,000 cases per year Neumann PJ, et al. N Engl J Med. 2005; 353:1516-1522. *Hernandez AF, et al. JAMA. 2007;298(13):1525-1532.

48. Incremental ICD and CRT-D Cost-Effectiveness Results Study Time Duration for Analysis Δ Cost Δ Survival (yrs) C-E Ratio AVID 1 ICD 3 years$14,1010.21$66,677 MADIT-II Type Patients 2 ICD Life Time$90,8291.8$50,500 COMPANION 3 CRT 7 years$13,800.49$28,100 COMPANION 3 CRT-D 7 years$36,200.78$46,700 SCD-HEFT 4 ICD Life Time$62,4201.63$38,389 1 Larsen G, et al. Circulation. 2002;105:2049-2057. 2 Al-Khatib SM, et al. Ann Intern Med. 2005;142:593-600. 3 Feldman AM, et al. J Am Coll Cardiol. 2005;46:2311-2321. 4 Mark DB, et al. Circulation. 2006;114:135-142.

49. Incremental Cost-Effectiveness ICD, CRT, and CRT-D Therapies COMPANION CRT-D 3 Incremental Cost per Life-Year Saved COMPANION CRT 3 MADIT-II Type Patients ICD 2 AVID ICD 1 $28,000 $67,000 Expensive Borderline Cost-Effective Highly Cost-Effective Economically Unattractive SCD-HeFT ICD 4 $38,400 $46,700 Heart Failure Post-MIVT/VF $50,500 1 Larsen G, et al. Circulation. 2002;105:2049-2057. 2 Al-Khatib SM, et al. Ann Intern Med. 2005;142:593-600. 3 Feldman AM, et al. J Am Coll Cardiol. 2005;46:2311-2321. 4 Mark DB, et al. Circulation. 2006;114:135-142. $0 $20,000 $40,000 $60,000 $80,000 $100,000 $120,000 $140,000 $160,000 $180,000 $200,000

50. Number Needed to Treat To Save a Life NNT x years = 100 / (% Mortality in Control Group – % Mortality in Treatment Group) ICD Drug Therapies COMPANION (3 Yr)(4 Yr)(1 Yr) (2.5 Yr)(3.5 Yr)(1 Yr)(6 Yr) (2 Yr) CRT-D CRT (3 Yr) References in speaker notes. 37 28 26 20 10 14 11 9 0 5 10 15 20 25 30 35 40 45 50 AVIDMADIT IISCD-HeFTCARE-HFSAVEMerit-HF4SAmiodarone Meta-Analysis Simvastatin Captopril Metoprolol Amiodarone

51. Implications for Real-World Practice

52. Underserved Patient Populations ICD use among hospitalized HF patients varied by gender and race in a large study sponsored by the American Heart Association (AHA): 59,965 HF patients discharged alive from 217 United States hospitals 13,034 HF patients (21.7%) were considered eligible for ICD therapy and had an LVEF < 30% Hospitals were part of AHA’s “Get With the Guidelines – Heart Failure Quality Improvement Program ” Hernandez AF, et al. JAMA. 2007;298(13):1525-1532.

53. Percent of Eligible Patients Receiving ICD Therapy % Eligible Patients Receive ICD Hernandez AF, et al. JAMA. 2007;298(13):1525-1532. 35.4% 28.2% 29.8% 33.4% 43.6% 10 20 30 40 50 60 70 All PatientsBlack Women White Women Black MenWhite Men

54. Patient Case #5 History 78 y.o. man Wheelchair bound due to automobile accident Plays bridge competitively Lives in assisted-living PMHX: NIDCM, NYHA Class II, sinus node dysfunction treated with a pacemaker LVEF measured in 2000 was 30% Medications: ACE-I, BB, diuretic

55. Patient Case #5 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?

56. ICD and CRT-D Treatment Algorithms

57. EF Clinic Program Patient Screening Pathway (The Ohio Heart & Vascular Center) 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 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 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. PATIENT Determine EF

59. Summary

60. 1.SCA is a leading cause of death in the United States. 2.Defibrillation is the only effective treatment for SCA. 3.Few SCA victims are treated quickly enough to survive. 4.Patients at risk of SCA need to be identified PRIOR to an SCA event to increase survival rates.

61. Summary 5.High risk SCA patients can be identified: low LVEF, HF, prior MI and prior SCA or VT/VF event. 6.ICD and CRT-D therapies can prevent SCA. 7.ICD and CRT-D therapies are cost-effective and are reimbursed by most insurance firms. 8.Most eligible patients are not receiving device therapy.

62. Appendix Detailed 2008 ACC/AHA/HRS Guidelines

63. ICD Guidelines Focused on Secondary Prevention of SCA 1.Survivors of cardiac arrest due to VF or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes. Class I, Evidence A 2.Patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable. Class I, Evidence B 3.Patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or VF induced at EP study. Class I, Evidence B Epstein AE, et al. Circulation. 2008;117:e350-408.

64. ICD Guidelines Focused on Secondary Prevention of SCA 4.Patients with nonsustained VT due to prior MI; LVEF < 40%; and inducible VF or sustained VT at EP study. Class I, Evidence B 5.Patients with sustained VT and normal or near-normal ventricular function. Class IIa, Evidence C 6.Patients with catecholaminergic polymorphic VT who have syncope and/or documented sustained VT while receiving beta blockers. Class IIa, Evidence C Epstein AE, et al. Circulation. 2008;117:e350-408.

65. ICD Guidelines Focused on the Primary Prevention of SCA 1.Patients with LVEF < 35% due to prior MI who are at least 40 days post-MI and are in NYHA Class II or III. Class I, Evidence A 2.Patients with nonischemic DCM who have an LVEF < 35% and who are in NYHA Class II or III. Class I, Evidence B 3.Patients with LV dysfunction due to prior MI who are at least 40 days post-MI, have an LVEF < 30%, and are in NYHA Class I. Class I, Evidence B 4.Patients with unexplained syncope, significant LV dysfunction, and nonischemic DCM. Class IIa, Evidence C Epstein AE, et al. Circulation. 2008;117:e350-e408.

66. ICD Guidelines Focused on Primary Prevention of SCA 5.Non-hospitalized patients awaiting transplantation. Class IIa, Evidence C 6.Patients with nonischemic heart disease who have an LVEF < 35% and who are in NYHA Class I. Class IIb, Evidence C 7.Patients with syncope and advanced structural heart disease in whom thorough invasive and noninvasive investigations have failed to define a cause. Class IIb, Evidence C 8.Patients with LV non-compaction. Class IIb, Evidence C Epstein AE, et al. Circulation. 2008;117:e350-408.

67. ICD Guidelines for Hereditary Diseases 1.Patients with Long QT syndrome who are experiencing syncope and/or VT while receiving beta blockers. Class IIa, Evidence B 2.Patients with HCM who have one or more major risk factors for SCD. Class IIa, Evidence C 3.Patients with arrhythmogenic right ventricular dysplasia/ cardiomyopathy (ARVD/C) who have one or more risk factors for SCD. Class IIa, Evidence C Epstein AE, et al. Circulation. 2008;117:e350-e408.

68. ICD Guidelines for Hereditary and Other Conditions 4.Patients with Brugada syndrome who have had syncope. Class IIa, Evidence C 5.Patients with Brugada syndrome who have documented VT that has not resulted in cardiac arrest. Class IIa, Evidence C 6.Patients with cardiac sarcoidosis, giant cell myocarditis, or Chagas’ disease. Class IIa, Evidence C 7.ICD therapy may be considered for patients with Long QT syndrome and risk factors for SCD. Class IIb, Evidence C 8.ICD therapy may be considered in patients with a familial cardiomyopathy associated with sudden death. Class IIb, Evidence C Epstein AE, et al. Circulation. 2008;117:e350-408.

69. CRT/CRT-D Guidelines 1.Patients with LVEF 0.12 seconds, and sinus rhythm, cardiac resynchronization therapy (CRT) with or without an ICD is indicated for the treatment of NYHA Class III or ambulatory Class IV heart failure symptoms on optimal recommended medical therapy. Class I, Evidence A 2.Patients with LVEF 0.12 seconds, and AF, CRT with or without an ICD is reasonable for the treatment of NYHA Class III or ambulatory Class IV heart failure symptoms on optimal recommended medical therapy. Class IIa, Evidence B 3.Patients with LVEF < 35% with NYHA Class III or ambulatory Class IV symptoms who are receiving optimal recommended medical therapy and who have frequent dependence on ventricular pacing, CRT is reasonable. Class IIa, Evidence C Epstein AE, et al. Circulation. 2008;117:e350-408.

70. Brief Statement: Medtronic ICDs and CRT-ICDs Indications Medtronic implantable cardioverter defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Medtronic cardiac resynchronization therapy (CRT) ICDs are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration. Contraindications Medtronic ICDs and CRT-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. Warnings and Precautions Changes in a patient’s disease and/or medications may alter the efficacy of the device’s 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. Additionally, for CRT-ICDs, certain programming and device operations may not provide cardiac resynchronization. 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 Medtronic’s website at www.medtronic.com. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

71. www.medtronic.com World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-4879 USA Tel: (763) 514-4000 Fax: (763) 514-4879 Medtronic USA, Inc. Toll-free: 1 (800) 328-2518 (24-hour technical support for physicians and medical professionals) UC200800351a EN. © Medtronic, Inc. 2008. Minneapolis, MN. All Rights Reserved. 12/2008