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Increasing Survival in Sudden Cardiac Arrest (SCA): The Role of ICD and CRT-D Therapies 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. 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 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? Agenda 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. CVD Epidemiology and SCA Facts SCA Risk Factors ICD and CRT-D Therapies Secondary Prevention of SCA Primary Prevention of SCA CMS Coverage for ICD and CRT-D Therapies Therapy Economics Implications in Real-World Practice Device Treatment Algorithms Summary CVD Epidemiology and SCA Facts Prevalence of Cardiovascular Diseases in Adults Age 20 and Older by Age and Sex NHANES: 1999-2004 Deaths from Cardiovascular Disease United States: 1900-2004 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. Underlying Arrhythmias of SCA Polymorphic VT 13% Bradycardia 17% Monomorphic VT 62% Bayés de Luna A, et al. Am Heart J. 1989;117:151-159. Primary VF 8% Magnitude of Deaths from SCA in the United States * Range: 166,200 to 310,000 1 Vital 4 2 Chugh 5 Avert Statistics of the U.S., Data Warehouse, National Center for Health Statistics. SS, et al. J Am Coll Cardiol. 2004;44:1268-1275. 3 Nichol G, et al. JAMA. 2008;300:1423-1431. Department of Health and Human Services. Centers for Disease Control and Prevention. Organization: www.avert.org 6 2008 Heart and Stroke Statistics Update. American Heart Association. Per 100,000 Standard US Population SCD Rates for Gender and Ethnicity White Black American Indian/Alaska Native Asian/Pacific Islander 600 502.7 500 407.1 400 336.1 300 270.5 258.8 212.6 200 130.0 100 153.4 0 Males Zheng ZJ, et al. Circulation. 2001;104(18):2158-2163. Females Incidence of SCD by Age and Gender SCD Rate Per 100,000 4500 4000 3500 Men Women 3000 2500 2000 1500 1000 500 0 35 - 54 55 - 64 65 - 74 Age Group Zheng ZJ, et al. Circulation. 2001;104:2158-2163. 75 - 84 > 84 SCA Resuscitation Success versus Time* 100 Chance of success reduced 7-10% each minute 90 80 70 60 % Success 50 40 *Non-linear 30 20 10 0 1 2 3 4 5 6 Time (minutes) Cummins RO. Annals Emerg Med. 1989;18:1269-1275. 7 8 9 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 witnessed1,2 • 85% SCAs occur at home/non-public1 • 4.6% to 8% estimated SCA out-of-hospital survival1,2 1 2 Nichol G, et al. JAMA. 2008;300:1423-1431. Chugh SS, et al. J Am Coll Cardiol. 2004;44:1268-1275. Implantable Cardioverter Defibrillator (ICD) • 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 Cardiac Resynchronization Therapy-Defibrillator (CRT-D) • 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 Secondary Prevention of Sudden Cardiac Arrest 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 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? Arrhythmic Death in VT/VF Patients % Arrhythmic Death AVID Results in Non-ICD Arm 20 18 16 14 12 10 8 6 4 2 0 18% 11% 8% 1 Year Pratt CM. Circulation. 1998;98(suppl I):1494-1495. 2 Years 3 Years AVID Registry Study Survival by Arrhythmia Type Unexplained syncope Non-syncopal VT w/symptoms 1.00 Cumulative Survival (%) VF Transient correctable VT/VF Asymptomatic VT .90 VT w/syncope .80 .70 P = 0.007 .65 0 1 2 Years Anderson JL, et al. Circulation. 1999;99:1692-1699. 3 Randomized Clinical Trials ICD Therapy for the Secondary Prevention of SCA Mortality (%) Trial N Mean Age (yrs) Mean LVEF (%) Follow-up (mos) Control Therapy Control ICD P AVID1 1016 65 ± 10 35 18 ± 12 Amiodarone or sotalol 24.0 15.8 .02 CIDS2 659 64 ± 9 34 36 Amiodarone 29.6 25.3 .14 CASH3 288 58 ± 11 45 57 ± 34 Amiodarone or metoprolol 44.4 36.4 .08 1 The AVID Investigators. N Engl J Med. 1997;337:1576-1583. Kuck KH, et al. Circulation. 2000;102:748-754. 3 Connolly SJ, et al. Circulation. 2000;101:1297-1302. 2 Secondary Prevention Trials: Reduction in Mortality with ICD Therapy % Mortality Reduction w/ ICD Rx 80 60 58% 56% Overall Death Arrhythmic Death 40 33% 31% 23%* 20 20%* 0 AVID1 •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. CASH 2 CIDS 3 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. Primary Prevention of Sudden Cardiac Arrest 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 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? SCA Relationship to HF and Reduced LVEF • Reduced left ventricular ejection fraction (LVEF) remains the single most important risk factor for overall mortality and SCD1 • As HF progresses, pump failure (rather than SCA) becomes relatively more likely as the cause of death2 • 25% overall death in 2.5 years in HF patients and 50% die of SCA3 1 Prior SG, et al. Eur Heart J. 2001;22:1374-1450. Study Group. Lancet. 1999;353:2001-2007. 3Sweeney MO, PACE. 2001;24:871-888. 2 MERIT-HF SCD Risks in HF Patients with LV Dysfunction 50 42 Control Group Mortality % Total Mortality Sudden Cardiac Death 44 41 39.7 40 30 20 20 19 11 9 10 0 17 15 CHF-STAT 45 months 7 GESICA SOLVD V-HeFT I 13 months 41.4 months 27 months MERIT-HF 12 months 6 CIBIS-II 16 months 8 4 CARVEDILOL-US 6 months Total Mortality ~15 to 40%; SCD accounts for ~50% of Total Deaths % Sudden Cardiac Deaths Relation of LVEF to Risk of SCA 8 Note: 56.5% of all SCA victims had an LVEF > 30% 7.5% 7 6 5.1% 5 4 2.8% 3 2 1.4% 1 0 0-30% 31-40% 41-50% LVEF deVreede-Swagemakers JJ, et al. J Am Coll Cardiol. 1997;30:1500-1505. > 50% Severity of Heart Failure Modes of Death NYHA II 12% 64% 24% CHF NYHA III CHF Other Sudden Death 59% 26% Other 15% Sudden Death (N = 103) (N = 103) NYHA IV CHF 33% 11% 56% SCA Pump Failure Other NYHA Class II 64% 12% Sudden Death NYHA Class III 59% 26% NYHA Class IV 33% 56% (N = 27) MERIT-HF Study Group. Lancet.1999;353:2001-2007. 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. Time Dependence of Mortality Risk Post-MI Prediction of Sudden Cardiac Death After Myocardial Infarction in the Beta-Blocking Era1 • 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. Total Mortality 18 15 15 Cardiac Mortality 12 9 6 3 Cumulative Events (%) 18 12 9 Non-SCD 6 SCD Arrhythmia events did not concentrate early after the index event; most occurred > 18 months post-MI. 3 20 40 60 Follow-Up (months) 1 Huikuri HV, et al. J Am Coll Cardiol. 2003;42:652-658. 20 40 60 Follow-Up (months) SCD Rates in Post-MI Patients with LV Dysfunction Control Group Mortality % at 2 years 32 30 Total Mortality 28 28 Arrhythmic Mortality 21 20 20 18 16 14 16 12 10 10 19.8 9.4 7 0 TRACE CAPRICORN EMIAT MADIT MUSTT Inducible MUSTT Registry Total Mortality ~20 to 30%; SCD accounts for ~50% of Total Deaths MADIT II Randomized Clinical Trials Supporting Device Therapy ICD and CRT-D for the Primary Prevention of SCA Mortality (%) Trial N Mean Age (yrs) Mean LVEF (%) Mean Follow-up (mos) Control Therapy Control ICD P 2,521 60.1 25 45.5 Optimal Medical Therapy 36.1 28.9 .007 1,520 67 21 12 -16 months Optimal Medical Therapy 19 12 (CRT-D) .000 3 MUSTT 4 704 67 30 39 No EP-guided Therapy 48 24 .06 MADIT II 5 1,232 64 23 20 Optimal Medical Therapy 19.8 14.2 .007 SCD-HeFT 1,2 COMPANION 1Bardy 3 GH, et al. N Engl J Med. 2005;352:225-237. 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. 2 Packer Primary Prevention Post-MI and HF Trials Reduction in Mortality with ICD or CRT-D Therapy % Mortality Reduction w/ ICD Rx 80 73 Overall Death Arrhythmic Death 64 62 56 60 55 36 40 31 23 20 0 SCD-HeFT 1Bardy 1,2 COMPANION GH, et al. N Engl J Med. 2005;352:225-237. 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. 2 Packer 3 MUSTT 4 MADIT-II 5 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 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? 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 < 35%; a QRS duration > 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. 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 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 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 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. 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) Incremental Cost-Effectiveness Cardiovascular Interventions Incremental Cost per Life-Year Saved $1,000,000 $200,000 $180,000 $160,000 Economically Unattractive $150,000 $135,000 $140,000 $120,000 $120,000 $100,000 Expensive $80,000 $67,000 $60,000 $40,000 $20,000 Borderline Cost-Effective $40,750 Cost-Effective $17,701 $8,461 Highly Cost-Effective $0 PTCA Hypertension CABG (chronic CAD, Therapy (chronic severe angina (diastolic CAD 1 VD) 95 - 104 mild angina, mmHg) 3 VD) End Stage Renal Disease Treatment 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. Exercise SPECT (atypical angina who can walk on treadmill) Lovastatin (chol. = 290 mg/dL, 50 yrs old, male, no risk factors) Carotid Disease Screening (65 yrs old, male, no symptoms) Routine Coronary Angiography (35 - 84 yrs old, low risk MI, has CHF) Cost-Effectiveness and Use of Selected Interventions in the Medicare Population Cost-Effectiveness (Cost/QALY) Implementation Influenza vaccine Cost saving 40-70% Pneumococcal vaccine Cost saving 55-65% < $10,000 85% Mammographic screening $10,000-$25,000 50-70% Colon cancer screening $10,000-$25,000 20-40% Osteoporosis screening $10,000-$25,000 35% Hypertension medication (DBP >105 mmHg) $10,000-$60,000 35% Cholesterol management, as secondary prevention $10,000-$50,000 30% Implantable cardioverter defibrillator $30,000-$85,000 35%* Dialysis in end-stage renal disease $50,000-$100,000 90% Lung-volume – reduction surgery $100,000-$300,000 10,000-20,000 cases per year $500,000-$1.4 million 5,000-100,000 cases per year Intervention Beta blockers after myocardial infarction Left ventricular assist devices Neumann PJ, et al. N Engl J Med. 2005; 353:1516-1522. *Hernandez AF, et al. JAMA. 2007;298(13):1525-1532. Incremental ICD and CRT-D Cost-Effectiveness Results Time Duration for Analysis Δ Cost Δ Survival (yrs) C-E Ratio 3 years $14,101 0.21 $66,677 MADIT-II Type Patients 2 ICD Life Time $90,829 1.8 $50,500 COMPANION 3 CRT 7 years $13,800 .49 $28,100 COMPANION 3 CRT-D 7 years $36,200 .78 $46,700 Life Time $62,420 1.63 $38,389 Study AVID 1 ICD SCD-HEFT 4 ICD 1 Larsen G, et al. Circulation. 2002;105:2049-2057. 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. 2 Al-Khatib Incremental Cost per Life-Year Saved Incremental Cost-Effectiveness ICD, CRT, and CRT-D Therapies $200,000 $180,000 Economically Unattractive $160,000 $140,000 $120,000 $100,000 Expensive $80,000 $67,000 $60,000 $40,000 $46,700 $28,000 Borderline Cost-Effective $50,500 $38,400 Cost-Effective $20,000 Highly Cost-Effective $0 COMPANION CRT3 SCD-HeFT ICD 4 COMPANION CRT-D 3 Heart Failure 1 Larsen G, et al. Circulation. 2002;105:2049-2057. 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. 2 Al-Khatib MADIT-II Type Patients ICD 2 AVID ICD1 Post-MI VT/VF Number Needed to Treat To Save a Life NNTx years = 100 / (% Mortality in Control Group – % Mortality in Treatment Group) 50 Drug Therapies 45 37 40 CRT-D 35 CRT 30 26 ICD 25 20 14 15 9 11 14 Amiodarone Simvastatin 20 10 28 Metoprolol 10 Captopril 5 0 AVID (3 Yr) MADIT II (3 Yr) SCD-HeFT (4 Yr) COMPANION CARE-HF (1 Yr) (1 Yr) (2.5 Yr) SAVE (3.5 Yr) Merit-HF (1 Yr) 4S (6 Yr) Amiodarone Meta-Analysis (2 Yr) References in speaker notes. Implications for Real-World Practice 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. % Eligible Patients Receive ICD Percent of Eligible Patients Receiving ICD Therapy 70 60 50 40 43.6% 35.4% 30 28.2% 29.8% Black Women White Women 33.4% 20 10 All Patients Hernandez AF, et al. JAMA. 2007;298(13):1525-1532. Black Men White Men 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 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? ICD and CRT-D Treatment Algorithms EF Clinic Program Patient Screening Pathway (The Ohio Heart & Vascular Center) PATIENT Does patient have history of cardiac arrest, VF, or symptomatic VT? YES Consult EP for possible ICD Note: Pathway only begins after optimal medical therapy & coronary evaluation / intervention as appropriate NYHA Class II or III CHF NYHA Class I CHF 40 days post MI with EF ≤ 30% Is patient on optimal medical therapy? NO Optimize therapies or consult HF specialist Consult EP for possible ICD YES Determine EF EF ≤ 35% EF > 35% 1. Consider referral to HF Specialist or HF Program. 2. Repeat diagnostics with change of symptoms. Ischemic Non-Ischemic Class III or IV CHF and QRS > 120 ms 40 days post MI OR 3 months post revascularization 3 months post diagnosis Consult EP for possible CRT-D Consult EP for possible ICD Consult EP for possible ICD 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. Summary Summary 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. 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. Appendix Detailed 2008 ACC/AHA/HRS Guidelines 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. 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. 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. 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. 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. 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. CRT/CRT-D Guidelines 1. Patients with LVEF < 35%, a QRS duration > 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 < 35%, a QRS duration > 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. 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. 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 www.medtronic.com