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

Increasing Survival in
Sudden Cardiac Arrest (SCA):
The Role of ICD and CRT-D Therapies
Objectives
Upon completion of this activity, participants will be able to:
1. Describe current trends in cardiac vascular disease (CVD) and SCA.
2. Assess the risk of SCA in heart failure (HF) and post-myocardial
infarction (MI) patients.
3. Describe 2008 ACC/AHA/HRS Class I guidelines for the use of
implantable cardiac defibrillator (ICD) and cardiac resynchronization
therapy with defibrillation (CRT-D) therapies in patients at risk of
SCA, and the evidence supporting these guidelines.
4. Describe current CMS coverage for use of ICDs and CRT-Ds in
patients at risk of SCA. Compare the economics of these devices
to other medical interventions.
5. Describe current utilization of device therapy and assess current
use of these devices in your practice.
Patient Case #1
History
• 76 y.o. white male
• Type II DM, low-grade renal dysfunction; both
well-controlled
• 3 years post-MI, successfully revascularized
• NYHA Class II; stable
• LVEF is 32% (echo)
• Compliant with meds: antiplatelet, beta blocker,
ACE-I, statin, DM regimen
Patient Case #1
Clinical Decisions
• Should this patient be referred for an ICD
evaluation?
• What factors enter into your decision?
• Is there anything else you’d want to know before
making the decision?
Agenda
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
CVD Epidemiology and SCA Facts
SCA Risk Factors
ICD and CRT-D Therapies
Secondary Prevention of SCA
Primary Prevention of SCA
CMS Coverage for ICD and CRT-D Therapies
Therapy Economics
Implications in Real-World Practice
Device Treatment Algorithms
Summary
CVD Epidemiology
and SCA Facts
Prevalence of Cardiovascular Diseases in Adults
Age 20 and Older by Age and Sex
NHANES: 1999-2004
Deaths from Cardiovascular Disease
United States: 1900-2004
Percentage Breakdown of Deaths from
Cardiovascular Diseases
United States: 2004 (Final)
• About 50% of CHD deaths are due to SCA. This is the
largest cause of CV death.
Underlying Arrhythmias of SCA
Polymorphic VT 13%
Bradycardia
17%
Monomorphic
VT
62%
Bayés de Luna A, et al. Am Heart J. 1989;117:151-159.
Primary VF
8%
Magnitude of Deaths from SCA in the United States
* Range: 166,200 to 310,000
1 Vital
4
2 Chugh
5 Avert
Statistics of the U.S., Data Warehouse, National Center for Health Statistics.
SS, et al. J Am Coll Cardiol. 2004;44:1268-1275.
3 Nichol G, et al. JAMA. 2008;300:1423-1431.
Department of Health and Human Services. Centers for Disease Control and Prevention.
Organization: www.avert.org
6 2008 Heart and Stroke Statistics Update. American Heart Association.
Per 100,000 Standard US Population
SCD Rates for Gender and Ethnicity
White
Black
American Indian/Alaska Native
Asian/Pacific Islander
600
502.7
500
407.1
400
336.1
300
270.5
258.8
212.6
200
130.0
100
153.4
0
Males
Zheng ZJ, et al. Circulation. 2001;104(18):2158-2163.
Females
Incidence of SCD by Age and Gender
SCD Rate Per 100,000
4500
4000
3500
Men
Women
3000
2500
2000
1500
1000
500
0
35 - 54
55 - 64
65 - 74
Age Group
Zheng ZJ, et al. Circulation. 2001;104:2158-2163.
75 - 84
> 84
SCA Resuscitation
Success versus Time*
100
Chance of success reduced
7-10% each minute
90
80
70
60
%
Success
50
40
*Non-linear
30
20
10
0
1
2
3
4
5
6
Time (minutes)
Cummins RO. Annals Emerg Med. 1989;18:1269-1275.
7
8
9
SCA Chain of Survival Statistics
Even in the best EMS/early defibrillation programs,
it is difficult to achieve high survival times due to
any SCA events not being witnessed and the
difficulty of reaching victims within 6-8 minutes.
• 48% to 58% SCAs not witnessed1,2
• 85% SCAs occur at home/non-public1
• 4.6% to 8% estimated SCA out-of-hospital survival1,2
1
2
Nichol G, et al. JAMA. 2008;300:1423-1431.
Chugh SS, et al. J Am Coll Cardiol. 2004;44:1268-1275.
Implantable Cardioverter Defibrillator
(ICD)
• Defibrillation therapy for SCA
• Painless termination of most
arrhythmias with antitachycardia
pacing (ATP)
• Reduced unnecessary right
ventricular pacing
• Comprehensive diagnostic
information for more insightful
patient assessment
• Automatic intrathoracic impedance
(fluid) monitoring
Cardiac Resynchronization Therapy-Defibrillator
(CRT-D)
• Biventricular pacing therapy for
heart failure
• Defibrillation therapy for SCA
• Automatic intrathoracic impedance
(fluid) monitoring
• Painless termination of most
arrhythmias with antitachycardia
pacing (ATP)
• Comprehensive diagnostic
information for more insightful
patient assessment
Secondary Prevention of
Sudden Cardiac Arrest
Patient Case #2
History
• 54 y.o. African-American female
• Ischemic cardiomyopathy
• NYHA Class I
• LVEF 45% per echo at your institution
• Long-time heavy smoker; has COPD
• Compliant and stable on optimal medical therapy
• Syncopal episodes; with documented episodes
of VT
Patient Case #2
Clinical Decisions
• Should this patient be referred for an ICD
evaluation?
• What factors enter into your decision?
• Is there anything else you’d want to know before
making the decision?
Arrhythmic Death in VT/VF Patients
% Arrhythmic Death
AVID Results in Non-ICD Arm
20
18
16
14
12
10
8
6
4
2
0
18%
11%
8%
1 Year
Pratt CM. Circulation. 1998;98(suppl I):1494-1495.
2 Years
3 Years
AVID Registry Study
Survival by Arrhythmia Type
Unexplained syncope
Non-syncopal VT w/symptoms
1.00
Cumulative Survival (%)
VF
Transient correctable VT/VF
Asymptomatic VT
.90
VT w/syncope
.80
.70
P = 0.007
.65
0
1
2
Years
Anderson JL, et al. Circulation. 1999;99:1692-1699.
3
Randomized Clinical Trials
ICD Therapy for the Secondary Prevention of SCA
Mortality
(%)
Trial
N
Mean Age
(yrs)
Mean
LVEF (%)
Follow-up
(mos)
Control
Therapy
Control
ICD
P
AVID1
1016
65 ± 10
35
18 ± 12
Amiodarone
or sotalol
24.0
15.8
.02
CIDS2
659
64 ± 9
34
36
Amiodarone
29.6
25.3
.14
CASH3
288
58 ± 11
45
57 ± 34
Amiodarone
or metoprolol
44.4
36.4
.08
1 The
AVID Investigators. N Engl J Med. 1997;337:1576-1583.
Kuck KH, et al. Circulation. 2000;102:748-754.
3 Connolly SJ, et al. Circulation. 2000;101:1297-1302.
2
Secondary Prevention Trials:
Reduction in Mortality with ICD Therapy
% Mortality Reduction w/ ICD Rx
80
60
58%
56%
Overall Death
Arrhythmic Death
40
33%
31%
23%*
20
20%*
0
AVID1
•Non-significant results.
1 The AVID Investigators. N Engl J Med. 1997;337:1576-1583.
2 Kuck Kh, et al. Circulation. 2000;102:748-754.
3 Connolly SJ, et al. Circulation. 2000;101:1297-1302.
CASH 2
CIDS 3
2008 ACC/AHA/HRS Class I ICD
Secondary Prevention Guidelines for the
Management of Ventricular Arrhythmias
1. History of SCA, VF, hemodynamically unstable sustained VT
(exclude reversible causes)
2. Structural heart disease and spontaneous sustained VT,
whether hemodynamically stable or unstable
3. Syncope of undetermined origin with clinically relevant,
hemodynamically significant sustained VT or VF induced at
EP study
4. Non-sustained VT due to prior MI, LVEF < 40% and inducible
VT at EP study
Epstein AE, et al. Circulation 2008;117:e350-408.
Primary Prevention of
Sudden Cardiac Arrest
Patient Case #3
History
• 52 y.o. woman
• Moderate alcohol consumption, has stopped
since MI
• Lives alone in rural community
• NYHA Class III
• PMHX: MI one year ago, echo on discharge
was 35%
• Medications: BB, ACE-I, lipid-lowering agent,
clopidorgrel, omega-3
Patient Case #3
Clinical Decisions
• Should this patient be referred for an ICD
evaluation?
• What factors enter into your decision?
• Is there anything else you’d want to know before
making the decision?
SCA Relationship to HF and
Reduced LVEF
• Reduced left ventricular ejection fraction (LVEF)
remains the single most important risk factor for
overall mortality and SCD1
• As HF progresses, pump failure (rather than
SCA) becomes relatively more likely as the
cause of death2
• 25% overall death in 2.5 years in HF patients and
50% die of SCA3
1 Prior
SG, et al. Eur Heart J. 2001;22:1374-1450.
Study Group. Lancet. 1999;353:2001-2007.
3Sweeney MO, PACE. 2001;24:871-888.
2 MERIT-HF
SCD Risks in HF Patients
with LV Dysfunction
50
42
Control Group Mortality %
Total Mortality
Sudden Cardiac Death
44
41
39.7
40
30
20
20
19
11
9
10
0
17
15
CHF-STAT
45 months
7
GESICA
SOLVD
V-HeFT I
13 months
41.4 months
27 months
MERIT-HF
12 months
6
CIBIS-II
16 months
8
4
CARVEDILOL-US
6 months
Total Mortality ~15 to 40%; SCD accounts for ~50% of Total Deaths
% Sudden Cardiac Deaths
Relation of LVEF to Risk of SCA
8
Note: 56.5% of all SCA
victims had an LVEF > 30%
7.5%
7
6
5.1%
5
4
2.8%
3
2
1.4%
1
0
0-30%
31-40%
41-50%
LVEF
deVreede-Swagemakers JJ, et al. J Am Coll Cardiol. 1997;30:1500-1505.
> 50%
Severity of Heart Failure
Modes of Death
NYHA II
12%
64%
24%
CHF
NYHA III
CHF
Other
Sudden
Death
59%
26%
Other
15%
Sudden
Death
(N = 103)
(N = 103)
NYHA IV
CHF
33%
11%
56%
SCA
Pump Failure
Other
NYHA Class II
64%
12%
Sudden
Death
NYHA Class III
59%
26%
NYHA Class IV
33%
56%
(N = 27)
MERIT-HF Study Group. Lancet.1999;353:2001-2007.
SCA Relationship to MI
In people who’ve had an MI and have HF,
SCD occurs at 4 times the rate of the
general population.
Adabag AS, et al. JAMA. 2008;300:2022-2029.
Time Dependence of Mortality Risk Post-MI
Prediction of Sudden Cardiac Death After Myocardial Infarction
in the Beta-Blocking Era1
• 700 post-MI patients;
~ 95% on beta
blockers 2 years after
discharge.
• The epidemiologic
pattern of SCD was
different from that
reported in previous
studies.
Total
Mortality
18
15
15
Cardiac
Mortality
12
9
6
3
Cumulative Events (%)
18
12
9
Non-SCD
6
SCD
Arrhythmia events did not
concentrate early after the
index event; most occurred
> 18 months post-MI.
3
20
40
60
Follow-Up (months)
1 Huikuri
HV, et al. J Am Coll Cardiol. 2003;42:652-658.
20
40
60
Follow-Up (months)
SCD Rates in Post-MI Patients
with LV Dysfunction
Control Group Mortality % at 2 years
32
30
Total Mortality
28
28
Arrhythmic Mortality
21
20
20
18
16
14
16
12
10
10
19.8
9.4
7
0
TRACE
CAPRICORN
EMIAT
MADIT
MUSTT
Inducible
MUSTT
Registry
Total Mortality ~20 to 30%; SCD accounts for ~50% of Total Deaths
MADIT II
Randomized Clinical Trials
Supporting Device Therapy
ICD and CRT-D for the Primary Prevention of SCA
Mortality (%)
Trial
N
Mean
Age
(yrs)
Mean
LVEF
(%)
Mean
Follow-up
(mos)
Control
Therapy
Control
ICD
P
2,521
60.1
25
45.5
Optimal Medical
Therapy
36.1
28.9
.007
1,520
67
21
12 -16
months
Optimal Medical
Therapy
19
12
(CRT-D)
.000
3
MUSTT 4
704
67
30
39
No EP-guided
Therapy
48
24
.06
MADIT II 5
1,232
64
23
20
Optimal Medical
Therapy
19.8
14.2
.007
SCD-HeFT 1,2
COMPANION
1Bardy
3
GH, et al. N Engl J Med. 2005;352:225-237.
DL. Heart Rhythm. 2005;2:S38-S39
3 Bristow MR, et al. N Engl J Med. 2004;350:2140-2150.
4 Buxton AE, et al. N Engl J Med. 1999;341:1882-1890.
5 Moss AJ, et al. N Engl J Med. 2002;346:877-883.
2 Packer
Primary Prevention Post-MI and HF Trials
Reduction in Mortality with ICD or CRT-D Therapy
% Mortality Reduction w/ ICD Rx
80
73
Overall Death
Arrhythmic Death
64
62
56
60
55
36
40
31
23
20
0
SCD-HeFT
1Bardy
1,2
COMPANION
GH, et al. N Engl J Med. 2005;352:225-237.
DL. Heart Rhythm. 2005;2:S38-S39
3 Bristow MR, et al. N Engl J Med. 2004;350:2140-2150.
4 Buxton AE, et al. N Engl J Med. 1999;341:1882-1890.
5 Moss AJ, et al. N Engl J Med. 2002;346:877-883.
2 Packer
3
MUSTT
4
MADIT-II
5
Patient Case #4
History
• 68 y.o. male
• NYHA Class III
• LVEF measured in 2006 was 37%
• QRS 130 ms
• PMHX: MI 12 years ago
• Medications: BB, ACE-I, lipid-lowering agent
• Just completed last round of chemotherapy for
Pancreatic CA
Patient Case #4
Clinical Decisions
• Should this patient be referred for a
CRT-D evaluation?
• What factors enter into your decision?
• Is there anything else you’d want to know before
making the decision?
2008 ACC/AHA/HRS Class I Primary Prevention
Guidelines for Management of Ventricular Arrhythmias:
ICD and CRT-D
ICD Class I Guidelines
• LVEF < 35% due to prior MI; who are at least 40 days post-MI; and
are in NHYA Class II or III
• Nonischemic DCM who have an LVEF < 35% and who are in
NYHA Class II or III
• LV dysfunction due to prior MI how are at least 40 days post-MI;
have an LVEF < 30%; and are in NHYA Class I
CRT-D Class I Guideline
• LVEF < 35%; a QRS duration > 0.12 seconds; and sinus rhythm; and
NHYA Class III or ambulatory IV and on optimal medical therapy
Epstein AE, et al. Circulation 2008;117:e350-e408.
CMS ICD Coverage
Secondary Prevention Indications
1. Documented episode of cardiac arrest due to VF not due
to a transient or reversible cause;
2. Documented sustained VT, either spontaneous or
induced by an EP study, not associated with an acute MI
and not due to a transient or reversible cause
www.cms.hhs.gov
CMS ICD Coverage
Primary Prevention Indications
1. Documented familial or inherited conditions with a high
risk of life-threatening VT, such as Long QT syndrome or
hypertrophic cardiomyopathy;
2. CAD with a documented prior MI, a measured LVEF
≤ 0.35, and inducible, sustained VT or VF at EP study.
(MI must have occurred more than 40 days prior to
defibrillator insertion. EP test must be performed > 4
weeks after the qualifying MI.);
3. Documented prior MI and a measured LV EF ≤ 0.30;
www.cms.hhs.gov
CMS ICD/CRT-D Coverage
Primary Prevention Indications
4. Ischemic dilated cardiomyopathy (IDCM), documented
prior MI, NYHA Class II and III HF, and measured
LV EF ≤ 35%;
5. Nonischemic dilated cardiomyopathy (NIDCM) > 3
months, NYHA Class II and III HF, and measured
LV EF ≤ 35% (if registered into ICD Registry); and
6. Meet all current CMS coverage requirements for a cardiac
resynchronization therapy (CRT) device and have NYHA
Class IV HF
www.cms.hhs.gov
Discussion: ICD Contraindications
• Patient Class III contraindications for ICD or CRT-D:
– Not expected to survive with an acceptable functional status for
at least one year
– Incessant VT or VF
– Significant psychiatric illness that may be aggravated by device
transplant or preclude systematic follow-up
– NYHA Class IV with drug-refractory HF, who are not candidates for
cardiac transplantation or CRT-D
– Syncope of undetermined cause without inducible VT and without
structural heart disease
– VT or VF that is amenable to surgical or catheter ablation
– Patients whose VTs due to a completely reversible cause in the
absence of structural heart disease
• Questions
Are there patients who are indicated but who should not get an ICD?
Who makes the decision on whether or not an ICD is offered?
Epstein AE, et al. Circulation. 2008;117:e350-e408.
The Economics of Therapy
Therapy A versus Therapy B
Total Cost A – Total Cost B
Life Expectancy A – Life Expectancy B
= Incremental Cost Per Life Year Saved ($/LYS)
Incremental Cost-Effectiveness
Cardiovascular Interventions
Incremental Cost per Life-Year Saved
$1,000,000
$200,000
$180,000
$160,000
Economically
Unattractive
$150,000
$135,000
$140,000
$120,000
$120,000
$100,000
Expensive
$80,000
$67,000
$60,000
$40,000
$20,000
Borderline
Cost-Effective
$40,750
Cost-Effective
$17,701
$8,461
Highly
Cost-Effective
$0
PTCA
Hypertension
CABG
(chronic CAD,
Therapy
(chronic
severe angina
(diastolic
CAD
1 VD)
95 - 104
mild angina,
mmHg)
3 VD)
End Stage
Renal
Disease
Treatment
Moss AJ. Satellite Symposium, 2003.
Kupersmith J, et al. Prog Cardiovasc Dis. 1995;37:307-346.
Stanton MS, et al. Circulation. 2000;101:1067-1074.
Exercise
SPECT
(atypical
angina who
can walk
on treadmill)
Lovastatin
(chol. =
290 mg/dL,
50 yrs old,
male,
no risk
factors)
Carotid
Disease
Screening
(65 yrs old,
male,
no
symptoms)
Routine
Coronary
Angiography
(35 - 84 yrs
old,
low risk MI,
has CHF)
Cost-Effectiveness and Use of Selected
Interventions in the Medicare Population
Cost-Effectiveness
(Cost/QALY)
Implementation
Influenza vaccine
Cost saving
40-70%
Pneumococcal vaccine
Cost saving
55-65%
< $10,000
85%
Mammographic screening
$10,000-$25,000
50-70%
Colon cancer screening
$10,000-$25,000
20-40%
Osteoporosis screening
$10,000-$25,000
35%
Hypertension medication (DBP >105 mmHg)
$10,000-$60,000
35%
Cholesterol management, as secondary prevention
$10,000-$50,000
30%
Implantable cardioverter defibrillator
$30,000-$85,000
35%*
Dialysis in end-stage renal disease
$50,000-$100,000
90%
Lung-volume – reduction surgery
$100,000-$300,000
10,000-20,000 cases per year
$500,000-$1.4 million
5,000-100,000 cases per year
Intervention
Beta blockers after myocardial infarction
Left ventricular assist devices
Neumann PJ, et al. N Engl J Med. 2005; 353:1516-1522. *Hernandez AF, et al. JAMA. 2007;298(13):1525-1532.
Incremental ICD and CRT-D
Cost-Effectiveness Results
Time Duration
for Analysis
Δ Cost
Δ Survival
(yrs)
C-E Ratio
3 years
$14,101
0.21
$66,677
MADIT-II
Type Patients 2
ICD
Life Time
$90,829
1.8
$50,500
COMPANION 3
CRT
7 years
$13,800
.49
$28,100
COMPANION 3
CRT-D
7 years
$36,200
.78
$46,700
Life Time
$62,420
1.63
$38,389
Study
AVID 1
ICD
SCD-HEFT 4
ICD
1
Larsen G, et al. Circulation. 2002;105:2049-2057.
SM, et al. Ann Intern Med. 2005;142:593-600.
3 Feldman AM, et al. J Am Coll Cardiol. 2005;46:2311-2321.
4 Mark DB, et al. Circulation. 2006;114:135-142.
2 Al-Khatib
Incremental Cost per Life-Year Saved
Incremental Cost-Effectiveness
ICD, CRT, and CRT-D Therapies
$200,000
$180,000
Economically
Unattractive
$160,000
$140,000
$120,000
$100,000
Expensive
$80,000
$67,000
$60,000
$40,000
$46,700
$28,000
Borderline
Cost-Effective
$50,500
$38,400
Cost-Effective
$20,000
Highly
Cost-Effective
$0
COMPANION
CRT3
SCD-HeFT
ICD 4
COMPANION
CRT-D 3
Heart Failure
1 Larsen
G, et al. Circulation. 2002;105:2049-2057.
SM, et al. Ann Intern Med. 2005;142:593-600.
3 Feldman AM, et al. J Am Coll Cardiol. 2005;46:2311-2321.
4 Mark DB, et al. Circulation. 2006;114:135-142.
2 Al-Khatib
MADIT-II
Type
Patients
ICD 2
AVID
ICD1
Post-MI
VT/VF
Number Needed to Treat To Save a Life
NNTx years = 100 / (% Mortality in Control Group – % Mortality in Treatment Group)
50
Drug Therapies
45
37
40
CRT-D
35
CRT
30
26
ICD
25
20
14
15
9
11
14
Amiodarone
Simvastatin
20
10
28
Metoprolol
10
Captopril
5
0
AVID
(3 Yr)
MADIT II
(3 Yr)
SCD-HeFT
(4 Yr)
COMPANION CARE-HF
(1 Yr)
(1 Yr)
(2.5 Yr)
SAVE
(3.5 Yr)
Merit-HF
(1 Yr)
4S
(6 Yr)
Amiodarone
Meta-Analysis
(2 Yr)
References in speaker notes.
Implications for
Real-World Practice
Underserved Patient Populations
ICD use among hospitalized HF patients varied by
gender and race in a large study sponsored by the
American Heart Association (AHA):
• 59,965 HF patients discharged alive from 217 United
States hospitals
• 13,034 HF patients (21.7%) were considered eligible for
ICD therapy and had an LVEF < 30%
• Hospitals were part of AHA’s “Get With the Guidelines –
Heart Failure Quality Improvement Program”
Hernandez AF, et al. JAMA. 2007;298(13):1525-1532.
% Eligible Patients Receive ICD
Percent of Eligible Patients
Receiving ICD Therapy
70
60
50
40
43.6%
35.4%
30
28.2%
29.8%
Black
Women
White
Women
33.4%
20
10
All Patients
Hernandez AF, et al. JAMA. 2007;298(13):1525-1532.
Black Men White Men
Patient Case #5
History
• 78 y.o. man
• Wheelchair bound due to automobile accident
• Plays bridge competitively
• Lives in assisted-living
• PMHX: NIDCM, NYHA Class II, sinus node dysfunction
treated with a pacemaker
• LVEF measured in 2000 was 30%
• Medications: ACE-I, BB, diuretic
Patient Case #5
Clinical Decisions
• Should this patient be referred for an ICD evaluation?
• What factors enter into your decision?
• Is there anything else you’d want to know before making
the decision?
ICD and CRT-D
Treatment Algorithms
EF Clinic Program Patient Screening Pathway
(The Ohio Heart & Vascular Center)
PATIENT
Does patient have
history of cardiac
arrest, VF, or
symptomatic VT?
YES
Consult EP for
possible ICD
Note: Pathway only begins
after optimal medical
therapy & coronary
evaluation / intervention as
appropriate
NYHA Class
II or III CHF
NYHA Class I CHF
40 days post MI
with EF ≤ 30%
Is patient on
optimal medical
therapy?
NO
Optimize therapies or
consult HF specialist
Consult EP for
possible ICD
YES
Determine EF
EF ≤ 35%
EF > 35%
1. Consider referral to
HF Specialist or HF Program.
2. Repeat diagnostics
with change of symptoms.
Ischemic
Non-Ischemic
Class III or IV CHF
and QRS > 120 ms
40 days post MI
OR
3 months post
revascularization
3 months
post diagnosis
Consult EP for
possible CRT-D
Consult EP for
possible ICD
Consult EP for
possible ICD
This is a general protocol to assist
in the management of patients.
This protocol is not designed to
replace clinical judgment or
individual patient needs.
Summary
Summary
1. SCA is a leading cause of death in the United States.
2. Defibrillation is the only effective treatment for SCA.
3. Few SCA victims are treated quickly enough to survive.
4. Patients at risk of SCA need to be identified PRIOR to
an SCA event to increase survival rates.
Summary
5. High risk SCA patients can be identified: low LVEF, HF,
prior MI and prior SCA or VT/VF event.
6. ICD and CRT-D therapies can prevent SCA.
7. ICD and CRT-D therapies are cost-effective and are
reimbursed by most insurance firms.
8. Most eligible patients are not receiving device therapy.
Appendix
Detailed 2008 ACC/AHA/HRS
Guidelines
ICD Guidelines Focused on
Secondary Prevention of SCA
1. Survivors of cardiac arrest due to VF or hemodynamically unstable
sustained VT after evaluation to define the cause of the event and to
exclude any completely reversible causes. Class I, Evidence A
2. Patients with structural heart disease and spontaneous sustained
VT, whether hemodynamically stable or unstable.
Class I, Evidence B
3. Patients with syncope of undetermined origin with clinically relevant,
hemodynamically significant sustained VT or VF induced at EP
study. Class I, Evidence B
Epstein AE, et al. Circulation. 2008;117:e350-408.
ICD Guidelines Focused on
Secondary Prevention of SCA
4. Patients with nonsustained VT due to prior MI; LVEF < 40%; and
inducible VF or sustained VT at EP study. Class I, Evidence B
5. Patients with sustained VT and normal or near-normal ventricular
function. Class IIa, Evidence C
6. Patients with catecholaminergic polymorphic VT who have
syncope and/or documented sustained VT while receiving beta
blockers. Class IIa, Evidence C
Epstein AE, et al. Circulation. 2008;117:e350-408.
ICD Guidelines Focused on the
Primary Prevention of SCA
1. Patients with LVEF < 35% due to prior MI who are at least 40 days
post-MI and are in NYHA Class II or III. Class I, Evidence A
2. Patients with nonischemic DCM who have an LVEF < 35% and
who are in NYHA Class II or III. Class I, Evidence B
3. Patients with LV dysfunction due to prior MI who are at least 40
days post-MI, have an LVEF < 30%, and are in NYHA Class I.
Class I, Evidence B
4. Patients with unexplained syncope, significant LV dysfunction, and
nonischemic DCM. Class IIa, Evidence C
Epstein AE, et al. Circulation. 2008;117:e350-e408.
ICD Guidelines Focused on
Primary Prevention of SCA
5. Non-hospitalized patients awaiting transplantation.
Class IIa, Evidence C
6. Patients with nonischemic heart disease who have an LVEF < 35%
and who are in NYHA Class I. Class IIb, Evidence C
7. Patients with syncope and advanced structural heart disease in
whom thorough invasive and noninvasive investigations have failed
to define a cause. Class IIb, Evidence C
8. Patients with LV non-compaction. Class IIb, Evidence C
Epstein AE, et al. Circulation. 2008;117:e350-408.
ICD Guidelines for
Hereditary Diseases
1. Patients with Long QT syndrome who are experiencing syncope
and/or VT while receiving beta blockers. Class IIa, Evidence B
2. Patients with HCM who have one or more major risk factors
for SCD. Class IIa, Evidence C
3. Patients with arrhythmogenic right ventricular dysplasia/
cardiomyopathy (ARVD/C) who have one or more risk factors
for SCD. Class IIa, Evidence C
Epstein AE, et al. Circulation. 2008;117:e350-e408.
ICD Guidelines for
Hereditary and Other Conditions
4. Patients with Brugada syndrome who have had syncope.
Class IIa, Evidence C
5. Patients with Brugada syndrome who have documented VT that has
not resulted in cardiac arrest. Class IIa, Evidence C
6. Patients with cardiac sarcoidosis, giant cell myocarditis, or Chagas’
disease. Class IIa, Evidence C
7. ICD therapy may be considered for patients with Long QT syndrome
and risk factors for SCD. Class IIb, Evidence C
8. ICD therapy may be considered in patients with a familial
cardiomyopathy associated with sudden death.
Class IIb, Evidence C
Epstein AE, et al. Circulation. 2008;117:e350-408.
CRT/CRT-D Guidelines
1. Patients with LVEF < 35%, a QRS duration > 0.12 seconds, and
sinus rhythm, cardiac resynchronization therapy (CRT) with or
without an ICD is indicated for the treatment of NYHA Class III or
ambulatory Class IV heart failure symptoms on optimal
recommended medical therapy. Class I, Evidence A
2. Patients with LVEF < 35%, a QRS duration > 0.12 seconds, and AF,
CRT with or without an ICD is reasonable for the treatment of NYHA
Class III or ambulatory Class IV heart failure symptoms on optimal
recommended medical therapy. Class IIa, Evidence B
3. Patients with LVEF < 35% with NYHA Class III or ambulatory Class
IV symptoms who are receiving optimal recommended medical
therapy and who have frequent dependence on ventricular pacing,
CRT is reasonable. Class IIa, Evidence C
Epstein AE, et al. Circulation. 2008;117:e350-408.
Brief Statement: Medtronic ICDs and CRT-ICDs
Indications
Medtronic implantable cardioverter defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and
ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Medtronic cardiac resynchronization therapy (CRT) ICDs are indicated for ventricular antitachycardia pacing and
ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and for the reduction of the
symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain
symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction less than or equal to
35% and a prolonged QRS duration.
Contraindications
Medtronic ICDs and CRT-ICDs are contraindicated in patients whose ventricular tachyarrhythmias may have transient
or reversible causes, patients with incessant VT or VF, patients who have a unipolar pacemaker.
Warnings and Precautions
Changes in a patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters.
Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection,
inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or
device damage. Do not place transthoracic defibrillation paddles directly over the device. Additionally, for CRT-ICDs,
certain programming and device operations may not provide cardiac resynchronization.
Potential Complications
Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve
stimulation, oversensing, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of ventricular
tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis.
See the device manual for detailed information regarding the implant procedure, indications, contraindications,
warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at
1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
World Headquarters
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-4879
USA
Tel: (763) 514-4000
Fax: (763) 514-4879
Medtronic USA, Inc.
Toll-free: 1 (800) 328-2518
(24-hour technical support for
physicians and medical professionals)
UC200800351a EN. © Medtronic, Inc. 2008. Minneapolis, MN. All Rights Reserved. 12/2008
www.medtronic.com