Sudden Cardiac Arrest: Increasing Survival Cynthia M. Tracy, M.D. George Washington University Medical Center Speaker has no relationships with any proprietary.

Sudden Cardiac Arrest:Increasing Survival

Cynthia M. Tracy, M.D.George Washington University Medical Center

Speaker has no relationships with any proprietary entity producing health care goods or services consumed by or used on patients

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 utilization of device therapy and assess current use of these devices in your practice.

Agenda

1. CVD Epidemiology and SCA Facts2. SCA Risk Factors3. ICD and CRT-D Therapies4. Secondary Prevention of SCA5. Primary Prevention of SCA6. Implications in Real-World Practice7. Device Treatment Algorithms8. Summary

CVD Epidemiology and SCA Facts

Prevalence of Cardiovascular Diseases in AdultsAge 20 and Older by Age and Sex

NHANES: 1999-2004

Deaths from Cardiovascular DiseaseUnited States: 1900-2004

Percentage Breakdown of Deaths fromCardiovascular DiseasesUnited States: 2004 (Final)

• About 50% of CHD deaths are due to SCA. This is the largest cause of CV death.

Underlying Arrhythmias of SCA

Bradycardia17%

Monomorphic VT

62% Primary VF8%

Polymorphic VT 13%

Bayés de Luna A, et al. Am Heart J. 1989;117:151-159.

* Range: 166,200 to 310,0001 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.org3 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

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

Sta

nd

ard

US

Po

pu

lati

on

258.8212.6

153.4

130.0

0

100

200

300

400

500

600

Males Females

WhiteBlackAmerican Indian/Alaska NativeAsian/Pacific Islander

Incidence of SCD by Age and Gender

Zheng ZJ, et al. Circulation. 2001;104:2158-2163.

Age Group

SC

D R

ate

Per

100

,000

0

500

1000

1500

2000

2500

3000

3500

4000

4500

35 - 54 55 - 64 65 - 74 75 - 84 > 84

Men

Women

Cummins RO. Annals Emerg Med. 1989;18:1269-1275.

SCA Resuscitation Success versus Time*

10

20

30

40

50

60

70

80

90

100

0 1 2 3 4 5 6 7 8 9

% Success

*Non-linear

Time (minutes)

Chance of success reduced 7-10% each minute

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 Nichol G, et al. JAMA. 2008;300:1423-1431.2 Chugh SS, et al. J Am Coll Cardiol. 2004;44:1268-1275.

Time Dependent Risk

• Risk of SCD after a clinical event is not linear

• Risk of SCD and total cardiac death highest within 6-18 months after index event

• Survival curves show similar characteristics after:

– Survival of CA

– Diagnosis of heart failure

– Unstable angina

– Recent MI

• Mortality is highest in the 1st month post MI in patients with <30% EF

Substrates for Sudden Cardiac Arrest

• 3/4 pts with SCD have CHD

• Hypertrophic cardiomyopathy (HCM)

• Dilated cardiomyopathy (DCM)

• RV cardiomyopathy

• Long QT Syndrome/short QT Syndrome/Brugada, etc...

• Other (AS, MVP, WPW)

Myerburg RJ. Heart Disease, 5th ed, Vol 1. Philadelphia: WB Saunders Co;1997:ch 24. Fogoros RN. Practical Cardiac Diagnosis: EP Testing, 2nd ed. Blackwell Science, pp 172.The AVID Investigators. N Engl J Med. 1997;337:1576-1583.Myerburg RJ. Ann Intern Med.. 1993;119:1187-1197. Demirovic J. Progr Cardiovasc Dis. 1994;37:39-48. Friedlander Y. Circulation. 1998;97:155-160.

Substrates for Sudden Cardiac Arrest:Sudden Cardiac Arrest Survivors

• Highest risk factor for Sudden Cardiac Arrest is prior SCA event

• 30 to 50% of SCA survivors will experience another SCA event within one year

• First-degree relatives of SCA patients have a 50% higher risk of MI or primary cardiac arrest

Myerburg RJ. Heart Disease, 5th ed, Vol 1. Philadelphia: WB Saunders Co;1997:ch 24. Fogoros RN. Practical Cardiac Diagnosis: EP, 2nd ed. Blackwell Science, pp 172.The AVID Investigators. N Engl J Med. 1997;337:1576-1583.

Substrates for Sudden Cardiac Arrest:Prior Episode of VT

• VT in combination with syncope or a low ejection fraction (LVEF < 40%) leads to an increased risk of Sudden Cardiac Arrest

– One-year risk of SCA - 20 to 50%

Myerburg RJ. Heart Disease, 5th ed,Vol 1. Philadelphia: WB Saunders Co;1997:ch 24.De Vreede-Swagemakers JJ. J Am Coll Cardiol. 1997;30:1500-1505. Kannel WB. Circulation. 1975;51:606-613.Shen WK. Mayo Clin Proc. 1991;66:950-962. Bigger JT. Circulation. 1984;69:250-258. Ruberman W. Circulation. 1981;64:297-305.Buxton AE. N Engl J Med. 1999;341:1882-1890.

Substrates for Sudden Cardiac Arrest:

Prior MI • Prior MI identified in as many as 75% of SCA patients

• Prior MI raises the one-year risk of SCA by 5% as a single risk factor

• Five-year risk of SCA is 32% for patients with all 3 risk factors:

– Prior MI

– Non-sustained, inducible, nonsuppressible VT

– LVEF < 40%

Futterman LG. Am J Crit Care. 1997;6:472-482.Demirovic J. Progr Cardiovasc Dis. 1994;37:39-48.Moss AJ. N Engl J Med. 1996;335:1933-1940.Friedlander Y. Circulation. 1998;97:155-160.

Substrates for Sudden Cardiac Arrest:Coronary Artery Disease

• Extensive CAD is seen in approx 75% SCA patients

– 3-4 vessel disease

– Autopsies have shown acute changes e.g. thrombus, plaque disruption in >50%

• Over 50% of SCA victims had no manifestations of CAD prior to the sudden death episode

• SCA is the first sign of heart disease in 20-50% of cases

Myerburg RJ. Heart Disease. 5th ed, Vol 1. Philadelphia: WB Saunders Co; 1997:ch 24.Middlekauf HR. J Am Coll Cardiol. 1993;21:110-116. Stevenson WE. Circulation. 1993;88:2953-2961.

Substrates for Sudden Cardiac Arrest:

Heart Failure • About one-half of all deaths in heart failure

patients are characterized as sudden due to arrhythmias

• The risk of SCA increases as left ventricular function deteriorates (low LVEF)

• Unexplained syncope has predicted SCA in patients in functional NYHA Class II - IV

Severity of Heart FailureModes of Death

MERIT-HF Study Group. Effect of Metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL randomized intervention trial in congestive heart failure (MERIT-HF). LANCET. 1999;353:2001-07.

12%

24%

64%

CHF

Other

SuddenDeath

n = 103

NYHA II

26%

15%

59%

CHF

Other

SuddenDeathn = 103

NYHA III

56%

11%

33%

CHF

Other

SuddenDeath

n = 27

NYHA IV

Myerburg RJ. Heart Disease, A Textbook of Cardiovascular Medicine. 5 th ed, Vol 1. Philadelphia: WB Saunders Co; 1997:ch 24.Maron BJ. New Engl J Med. 2000;342:365-373.

Substrates for Sudden Cardiac Arrest: Hypertrophic Cardiomyopathy

• Sudden cardiac death is the most common cause of death in patients with HCM

• Prevalence of HCM is about 0.2% of the general population and about 10% of HCM patients are considered to be at high risk of SCA

• Recent study showed that over a ten year period > 50% of high-risk patients would experience SCA

• HCM is the most common cause of SCA in athletes under 35 years of age

• EP testing of limited utility

Substrates for Sudden Cardiac Arrest: Arrhythmogenic Right Ventricular Cardiomyopathy

• ARVC suspected in young pts (usually men) with RV arrhythmias

• Syncope, presyncope, less frequently biventricular failure seen

• VA typically LBBB morphology and ranges from NSVT, VT to VF

• ECG typically shows precordial T wave inversion- v1-v3 and QRS >110 ms

• Low voltage potentials (epsilon waves) following QRS are characteristic but rare

• >50% have abnormal SAECG

Substrates for Sudden Cardiac Arrest: Arrhythmogenic Right Ventricular Cardiomyopathy

• SCD is frequently the first manifestation 0.08% to 9%

• SCD occurs relatively frequently during exercise or stress

• SCD more common in those with gross RV abnormalities but can occur in those with only microscopic abnormalities

• Certain genetic types may be associated with increased risk

– Current state of knowledge- genetic testing does not contribute to risk stratification

– May be increased risk if > 1 family member with SCD

• EP testing of limited utility

Schwartz PJ. Curr Probl Cardiol. 1997;22:297-351. Smith WM. Ann Intern Med. 1980;93:578-584. Garson A Jr. Circulation. 1993;87:1866-1872.

Substrates for Sudden Cardiac Arrest: Long QT Syndrome

• Idiopathic LQTS is a congenital disorder that may lead to unexplained syncope, seizures, and SCA

• Patients either remain asymptomatic or are prone to symptomatic and potentially lethal arrhythmias

• A positive family history of LQTS or SCA is present in 60% of LQTS patients

• Due to the hereditary linkage, it is necessary to identify other family members at risk

Secondary Prevention ofSudden Cardiac Arrest

Patient Case #1

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 #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?

024

68

101214

161820

1 Year 2 Years 3 Years

Arrhythmic Death in VT/VF PatientsAVID Results in Non-ICD Arm

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

% A

rrh

yth

mic

Dea

th

8%

11%

18%

AVID Registry Study Survival by Arrhythmia Type

Anderson JL, et al. Circulation. 1999;99:1692-1699.

1.00

.90

.80

.70

.65

0 1 2 3

Years

Cu

mu

lati

ve S

urv

ival

(%

)

Unexplained syncope

Non-syncopal VT w/symptoms

VF

Transient correctable VT/VF

Asymptomatic VT

VT w/syncope

P = 0.007

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;337:1576-1583.2 Kuck KH, et al. Circulation. 2000;102:748-754.3 Connolly SJ, et al. Circulation. 2000;101:1297-1302.

•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

0

20

40

60

80

AVID CASH CIDS

Overall Death

Arrhythmic Death

1 2 3

31%

56%

23%*

58%

20%*

33%

% M

ort

alit

y R

edu

cti

on

w/

ICD

Rx

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 #2

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 #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?

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;22:1374-1450.2 MERIT-HF Study Group. Lancet. 1999;353:2001-2007.3Sweeney MO, PACE. 2001;24:871-888.

SCD Risks in HF Patients with LV Dysfunction

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

12 months 16 months41.4 months 27 months 13 months45 months 6 months

Co

ntr

ol G

rou

p M

ort

alit

y %

17

8

20

15

9

19

7 64

42 41 39.7

44

11

0

10

20

30

40

50

CHF-STAT GESICA SOLVD V-HeFT I MERIT-HF CIBIS-II CARVEDILOL-US

Total Mortality

Sudden Cardiac Death

Relation of LVEF to Risk of SCA

deVreede-Swagemakers JJ, et al. J Am Coll Cardiol. 1997;30:1500-1505.

LVEF

% S

ud

den

Car

dia

c D

eath

s

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%

Severity of Heart FailureModes of Death

MERIT-HF Study Group. Lancet.1999;353:2001-2007.

12%

24%64%

CHF

Other

SuddenDeath(N = 103)

NYHA II

26%

15%59%

CHF

Other

SuddenDeath(N = 103)

NYHA III

56%

11%

33%

CHF

Other

SuddenDeath(N = 27)

NYHA IVSCA Pump Failure

NYHA Class II 64% 12%

NYHA Class III 59% 26%

NYHA Class IV 33% 56%

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-MIPrediction of Sudden Cardiac Death After Myocardial Infarction

in the Beta-Blocking Era1

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.

TotalMortality

CardiacMortality

Non-SCD

SCDCu

mu

lati

ve

Ev

en

ts (

%)

18

15

12

9

6

3

18

15

12

9

6

3

20 40 60 20 40 60

Follow-Up (months) Follow-Up (months)

14

11.6

8.47.898.2

4.9

7.2

0

2

4

6

8

10

12

14

16

1-17 mo 18 - 59 mo 60 - 119 mo > 120 mo

Conv

ICD

(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 Benefitin the MADIT-II Trial

Time from MI

% M

ort

alit

y fo

r E

ach

T

ime

Per

iod

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 16

129.4

28

1820

28

0

10

20

30

TRACE CAPRICORN EMIAT MADIT MUSTTInducible

MUSTTRegistry

MADIT II

Co

ntr

ol G

rou

p M

ort

alit

y %

at

2 ye

ars

Total Mortality

Arrhythmic Mortality

Randomized Clinical Trials Supporting Device Therapy

ICD and CRT-D for the Primary Prevention of SCA

Mortality (%)

Trial N MeanAge

(yrs)

Mean LVEF (%)

Mean

Follow-up (mos)

Control Therapy

Control ICD P

SCD-HeFT 1,2 2,521 60.1 25 45.5 Optimal Medical Therapy

36.1 28.9 .007

COMPANION 3 1,520 67 21 12 -16 months

Optimal Medical Therapy

19 12

(CRT-D)

.0003

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

1Bardy GH, et al. N Engl J Med. 2005;352:225-237.2 Packer DL. Heart Rhythm. 2005;2:S38-S393 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

1,2 3 5

% M

ort

alit

y R

edu

cti

on

w/

ICD

Rx

4

23

36

55

31

64

56

73

62

0

20

40

60

80

SCD-HeFT COMPANION MUSTT MADIT-II

Overall Death

Arrhythmic Death

1Bardy GH, et al. N Engl J Med. 2005;352:225-237.2 Packer DL. Heart Rhythm. 2005;2:S38-S393 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.

Patient Case #3

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 #3

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.

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.

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.Many 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 onPrimary 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.

CMS ICD Coverage Secondary Prevention Indications

• Documented episode of cardiac arrest due to VF not due to a transient or reversible cause;

• 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

• Documented familial or inherited conditions with a high risk of life-threatening VT, such as Long QT syndrome or hypertrophic cardiomyopathy;

• 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.);

• Documented prior MI and a measured LV EF ≤ 0.30;

www.cms.hhs.gov

CMS ICD/CRT-D Coverage Primary Prevention Indications

• Ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA Class II and III HF, and measured LV EF ≤ 35%;

• Nonischemic dilated cardiomyopathy (NIDCM) > 3 months, NYHA Class II and III HF, and measured LV EF ≤ 35% (if registered into ICD Registry); and

• Meet all current CMS coverage requirements for a cardiac resynchronization therapy (CRT) device and have NYHA Class IV HF

www.cms.hhs.gov