Transcript Increasing survival in SCA: The Role of ICD and CRT

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.
2.
3.
4.
5.
6.
7.
8.
CVD Epidemiology and SCA Facts
SCA Risk Factors
ICD and CRT-D Therapies
Secondary Prevention of SCA
Primary Prevention of SCA
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 Department of Health and Human Services. Centers for Disease Control and
Statistics of the U.S., Data Warehouse, National Center for Health Statistics.
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.
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.
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)
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 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:
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.
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 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%
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:
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
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:
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
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.
Severity of Heart Failure
Modes of Death
NYHA II
NYHA III
CHF
12%
CHF
Other
26%
59%
Sudden
Death
24%
64%
Other
15%
n = 103
Sudden
Death
n = 103
NYHA IV
CHF
Other
33%
56%
11%
Sudden
Death
n = 27
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.
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
Myerburg RJ. Heart Disease, A Textbook of Cardiovascular Medicine. 5th 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:
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
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
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.
Secondary Prevention of
Sudden 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?
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 #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.
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)
Relation of Time from MI to ICD Benefit
in the MADIT-II Trial
% Mortality for Each
Time Period
16
Conv
ICD
14
14
11.6
12
10
8
7.8
8.4
8.2
7.2
6
9
4.9
4
2
0
1-17 mo
18 - 59 mo
60 - 119 mo
> 120 mo
Time from MI
(n = 300)
Hazard Ratio
.98
(p = 0.92)
Wilber, D. Circulation. 2004;109:1082-1084.
(n = 283)
0.52
(p = 0.07)
(n = 284)
0.50
(p = 0.02)
(n = 292)
0.62
(p = 0.09)
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 #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 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.
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
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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;
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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
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