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. 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

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% Primary VF 8% Bayés de Luna A, et al.

Am Heart J.

1989;117:151-159.

Magnitude of Deaths from SCA in the United States

* 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 .

SCD Rates for Gender and Ethnicity

600 500 400 300 200 100 407.1

502.7

258.8

212.6

0 Males

Zheng ZJ, et al.

Circulation.

2001;104(18):2158-2163.

White Black American Indian/Alaska Native Asian/Pacific Islander 270.5

336.1

153.4

130.0

Females

Incidence of SCD by Age and Gender

4500 4000 3500 3000 2500 2000 1500 1000 500 0 Men Women 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

*

% Success

*Non-linear

100 90 80 70 60 50 40 30 20 10 Chance of success reduced 7-10% each minute 0 1 2

Cummins RO.

Annals Emerg Med.

1989;18:1269-1275.

3 4 5 Time (minutes) 6 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 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.

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 AVID Results in Non-ICD Arm

20 18 16 14 12 10 8 6 4 2 0 8% 11% 18% 1 Year 2 Years 3 Years

Pratt CM.

Circulation.

1998;98(suppl I):1494-1495.

1.00

.90

AVID Registry Study Survival by Arrhythmia Type

Unexplained syncope Non-syncopal VT w/symptoms VF Transient correctable VT/VF Asymptomatic VT VT w/syncope .80

.70

.65

0 P = 0.007

1

Anderson JL, et al.

Circulation.

1999;99:1692-1699.

Years 2 3

Randomized Clinical Trials

ICD Therapy for the Secondary Prevention of SCA Trial AVID 1 CIDS 2 N 1016 659 Mean Age (yrs) 65 ± 10 Mean LVEF (%) 35 Follow-up (mos) 18 ± 12 Control Therapy Amiodarone or sotalol 64 ± 9 34 36 Amiodarone Mortality (%) Control ICD 24.0

29.6

15.8

25.3

P .02

.14

CASH 3 288 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.

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

80 Overall Death Arrhythmic Death 58% 60 56% 40 20 31% 23%* 20%* 33% 0 AVID

1 •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 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.

SCD Risks in HF Patients with LV Dysfunction

50 40 42 41 39.7

44 Total Mortality Sudden Cardiac Death 30 20 19 20 17 15 10 9 11 7 6 8 4 0 CHF-STAT

45 months

GESICA

13 months

SOLVD

41.4 months

V-HeFT I

27 months

MERIT-HF

12 months

CIBIS-II

16 months

CARVEDILOL-US

6 months

Total Mortality ~15 to 40%; SCD accounts for ~50% of Total Deaths

Relation of LVEF to Risk of SCA

8 7 2 1 0 6 5 4 3 7.5% 5.1% Note: 56.5% of all SCA victims had an LVEF > 30% 2.8% 0-30% 31-40% LVEF 41-50%

deVreede-Swagemakers JJ, et al.

J Am Coll Cardiol

. 1997;30:1500-1505.

1.4% > 50%

Severity of Heart Failure Modes of Death

NYHA II 64% 12% 24% CHF Other Sudden Death

(N = 103)

NYHA III 59% 26% 15% CHF Other Sudden Death

(N = 103)

NYHA IV 33% 56% 11% CHF Other Sudden Death

(N = 27)

NYHA Class II NYHA Class III NYHA Class IV SCA

64% 59% 33%

Pump Failure

12% 26% 56% 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 Era 1

18 15 12 9 6 3 Total Mortality Cardiac Mortality 18 15 12 9 6 3 20 40 60 Follow-Up (months)

1 Huikuri HV, et al.

J Am Coll Cardiol.

2003;42:652-658.

Non-SCD

• 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.

SCD Arrhythmia events did not concentrate early after the index event; most occurred > 18 months post-MI.

20 40 60 Follow-Up (months)

30

SCD Rates in Post-MI Patients with LV Dysfunction

32 28 Total Mortality Arrhythmic Mortality 28 21 20 19.8

20 18 16 16 14 12 10 10 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 Trial SCD-HeFT 1,2 COMPANION 3 1,520 MUSTT 4 MADIT II 5 N 2,521 704 1,232 Mean Age (yrs) 60.1

67 67 64 Mean LVEF (%) 25 Mean Follow-up (mos) 45.5

Control Therapy Optimal Medical Therapy Mortality (%) Control ICD 36.1

28.9

21 30 23 12 -16 months 39 20 Optimal Medical Therapy No EP-guided Therapy Optimal Medical Therapy 19 48 19.8

12 (CRT-D) 24 14.2

P .007

.000

3 .06

.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.

Primary Prevention Post-MI and HF Trials

Reduction in Mortality with ICD or CRT-D Therapy

80 64 73 Overall Death Arrhythmic Death 62 56 60 55 36 40 31 23 20 0 SCD-HeFT

1,2

COMPANION

3 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.

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

$1,000,000 $200,000 $180,000 $160,000 $140,000 $120,000 $100,000 $80,000 $60,000 $40,000 $20,000 $0 $8,461 $17,701 $40,750 PTCA (chronic CAD, severe angina 1 VD) CABG (chronic CAD mild angina, 3 VD) Hypertension Therapy (diastolic 95 - 104 mmHg) $67,000 $120,000 End Stage Renal Disease Treatment Exercise SPECT (atypical angina who can walk on treadmill) $135,000 Lovastatin (chol. = 290 mg/dL, 50 yrs old, male, no risk factors ) $150,000 Carotid Disease Screening (65 yrs old, male, no symptoms) Routine Coronary Angiography (35 - 84 yrs old, low risk MI, has CHF)

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.

Economically Unattractive Expensive Borderline Cost-Effective Cost-Effective Highly Cost-Effective

Cost-Effectiveness and Use of Selected Interventions in the Medicare Population

Intervention

Influenza vaccine Pneumococcal vaccine Beta blockers after myocardial infarction Mammographic screening Colon cancer screening Osteoporosis screening Hypertension medication (DBP >105 mmHg) Cholesterol management, as secondary prevention

Implantable cardioverter defibrillator

Dialysis in end-stage renal disease Lung-volume – reduction surgery Left ventricular assist devices

Cost-Effectiveness (Cost/QALY)

Cost saving Cost saving < $10,000 $10,000-$25,000 $10,000-$25,000 $10,000-$25,000 $10,000-$60,000 $10,000-$50,000

$30,000-$85,000

$50,000-$100,000 $100,000-$300,000 $500,000-$1.4 million

Implementation

40-70% 55-65% 85% 50-70% 20-40% 35% 35% 30%

35%*

90% 10,000-20,000 cases per year 5,000-100,000 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.

Incremental ICD and CRT-D Cost-Effectiveness Results

Study Time Duration for Analysis AVID 1

ICD 3 years

MADIT-II Type Patients 2

ICD

COMPANION 3

CRT

COMPANION 3

CRT-D Life Time 7 years 7 years

SCD-HEFT 4

ICD Life Time 1 3 Larsen G, et al.

Circulation.

2002;105:2049-2057.

2 Al-Khatib SM, et al.

Ann Intern Med.

Feldman AM, et al. 2005;142:593-600.

J Am Coll Cardiol.

2005;46:2311-2321.

4 Mark DB, et al.

Circulation.

2006;114:135-142.

Δ Cost

$14,101 $90,829 $13,800 $36,200 $62,420

Δ Survival (yrs) C-E Ratio

0.21

$66,677 1.8 .49

.78

1.63

$50,500 $28,100 $46,700 $38,389

Incremental Cost-Effectiveness ICD, CRT, and CRT-D Therapies

$200,000 $180,000 $160,000 $140,000 $120,000 $100,000 $80,000 $60,000 $40,000 $20,000 $0 $28,000 $38,400 $46,700 COMPANION CRT 3 SCD-HeFT ICD 4 Heart Failure COMPANION CRT-D 3 $50,500 MADIT-II Type Patients ICD 2 Post-MI $67,000 AVID ICD 1 VT/VF

1 Larsen G, et al.

Circulation.

2002;105:2049-2057.

2 Al-Khatib SM, et al.

Ann Intern Med.

3 Feldman AM, et al. 2005;142:593-600.

J Am Coll Cardiol.

2005;46:2311-2321.

4 Mark DB, et al.

Circulation.

2006;114:135-142.

Economically Unattractive Expensive Borderline Cost-Effective Cost-Effective Highly Cost-Effective

Number Needed to Treat To Save a Life

NNT x years = 100 / (% Mortality in Control Group – % Mortality in Treatment Group) 50 45 40 35 30 25 20 15 10 5 0 9 ICD 11 14 CRT-D 14 CRT 10 20 Captopril 26 Drug Therapies 28 Simvastatin Metoprolol AVID (3 Yr) MADIT II SCD-HeFT (3 Yr) (4 Yr) COMPANION (1 Yr) CARE-HF SAVE Merit-HF (1 Yr) (2.5 Yr) (3.5 Yr) (1 Yr) 4S 37 Amiodarone Amiodarone (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.

Percent of Eligible Patients Receiving ICD Therapy

70 60 50 40 30 20 10 35.4% 28.2%

All Patients Black Women

29.8% 33.4% 43.6%

White Women Black Men White Men Hernandez AF, et al.

JAMA.

2007;298(13):1525-1532.

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) Does patient have history of cardiac arrest, VF, or symptomatic VT?

YES Consult EP for possible ICD PATIENT

NYHA Class I CHF 40 days post MI with EF ≤ 30%

Consult EP for possible ICD

EF > 35%

1. Consider referral to HF Specialist or HF Program.

2. Repeat diagnostics with change of symptoms.

NYHA Class II or III CHF

Note: Pathway only begins after optimal medical therapy & coronary evaluation / intervention as appropriate

Is patient on optimal medical therapy?

NO Optimize therapies or consult HF specialist YES Determine EF

EF ≤ 35% Ischemic 40 days post MI OR 3 months post revascularization

Consult EP for possible ICD

Non-Ischemic 3 months post diagnosis

Consult EP for possible ICD

Class III or IV CHF and QRS > 120 ms

Consult EP for possible CRT-D

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.

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)