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

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 Facts2. SCA Risk Factors3. ICD and CRT-D Therapies4. Secondary Prevention of SCA5. Primary Prevention of SCA6. CMS Coverage for ICD and CRT-D Therapies7. Therapy Economics 8. Implications in Real-World Practice9. Device Treatment Algorithms10. 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.

• 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)

• 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)

Secondary Prevention ofSudden 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




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 #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




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)

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 #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-EffectivenessCardiovascular Interventions

HypertensionTherapy(diastolic95 - 104mmHg)

Expensive

BorderlineCost-Effective

Cost-Effective

HighlyCost-Effective

Incr

emen

tal

Co

st p

er L

ife-

Yea

r S

aved

EconomicallyUnattractive

Lovastatin(chol. =

290 mg/dL,50 yrs old,

male, no riskfactors)

PTCA(chronic CAD,severe angina

1 VD)

CABG(chronic

CADmild angina,

3 VD)

End Stage Renal

Disease Treatment

Exercise SPECT (atypical

angina who can walk

on treadmill)

RoutineCoronary

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

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

InterventionCost-Effectiveness

(Cost/QALY)Implementation

Influenza vaccine Cost saving 40-70%

Pneumococcal vaccine Cost saving 55-65%

Beta blockers after myocardial infarction < $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

Left ventricular assist devices $500,000-$1.4 million 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

StudyTime Duration for Analysis

Δ CostΔ Survival

(yrs)C-E Ratio

AVID 1

ICD3 years $14,101 0.21 $66,677

MADIT-IIType Patients 2

ICDLife Time $90,829 1.8 $50,500

COMPANION 3

CRT7 years $13,800 .49 $28,100

COMPANION 3 CRT-D

7 years $36,200 .78 $46,700

SCD-HEFT 4

ICDLife Time $62,420 1.63 $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.

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

COMPANIONCRT-D 3

Incr

emen

tal

Co

st p

er L

ife-

Yea

r S

aved

COMPANIONCRT3

MADIT-IIType

Patients ICD 2

AVIDICD1

$28,000

$67,000

Expensive

BorderlineCost-Effective

Cost-Effective

HighlyCost-Effective

EconomicallyUnattractive

SCD-HeFTICD 4

$38,400$46,700

Heart Failure

Post-MI VT/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

Number Needed to Treat To Save a Life

NNTx years = 100 / (% Mortality in Control Group – % Mortality in Treatment Group)

ICD

Drug Therapies

COMPANION(3 Yr) (4 Yr) (1 Yr) (1 Yr) (2.5 Yr)

(3.5 Yr)

(1 Yr) (6 Yr)

(2 Yr)

CRT-DCRT

(3 Yr)

References in speaker notes.

37

2826

20

10

141411

9

0

5

10

15

20

25

30

35

40

45

50

AVID MADIT II SCD-HeFT CARE-HF SAVE Merit-HF 4S AmiodaroneMeta-Analysis

Simvastatin

Captopril

Metoprolol

Amiodarone

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 %

Eli

gib

le P

atie

nts

Re

ceiv

e IC

D

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 Patients BlackWomen

WhiteWomen

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?



ICD and CRT-D Treatment Algorithms

EF Clinic Program Patient Screening Pathway(The Ohio Heart & Vascular Center)

Does patient havehistory of cardiac

arrest, VF, orsymptomatic 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 CHFand QRS > 120 ms



Is patient on optimal medical

therapy?YES

YES

NO

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


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

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


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


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


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


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


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


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.

ContraindicationsMedtronic 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 PrecautionsChanges 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 ComplicationsPotential 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 HeadquartersMedtronic, Inc.710 Medtronic Parkway Minneapolis, MN 55432-4879USATel: (763) 514-4000Fax: (763) 514-4879

Medtronic USA, Inc.Toll-free: 1 (800) 328-2518(24-hour technical support for physicians and medical professionals)

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

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