Transcript Module_3_ICD_Indications_and_Studies

Module 3: ICD
Indications and
Clinical Studies
ACC/AHA Indications
– Class I – Conditions for which there is evidence
and/or general agreement that a pacemaker is
beneficial
– Class II – Conditions for which there is conflicting
evidence about the benefits of a pacemaker
Class IIa – Weight of evidence/opinion in favor of
benefits
Class IIb – Benefits are less well established by
evidence/opinion
– Class III – Conditions for which there is evidence
and/or general agreement that a pacemaker is not
useful/effective and in some cases may be harmful
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Leading Causes of Death in the US
0%
5%
Source: Sudden Cardiac Arrest Foundation
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10%
15%
20%
25%
Arrhythmic Cause of Sudden Cardiac Arrest
12%
Other Cardiac
Cause
88%
Arrhythmic
Cause
4
.
Albert CM. Circulation. 2003;107:2096-2101
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Underlying Arrhythmias of Sudden Cardiac Arrest
Torsades de Pointes
13%
Bradycardia
17%
VT
62%
5
Bayés de Luna A. Am Heart J. 1989;117:151-159.
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Primary VF
8%
Indications: Secondary vs. Primary
Prevention ICD implant Indications
Secondary prevention
ICD implantation improves survival in patients with a
history of life-threatening ventricular arrhythmia.
Primary Prevention
ICD implantation also improves survival as primary
prophylaxis against Sudden Cardiac Death in patients at
high risk for ventricular tachyarrhythmias.
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Secondary Prevention Indication Rules
 Rule #1
– Survival of SCD episode (not due to
reversible cause)
 Rule #2
– VT or VF induced at EP study when
drugs are ineffective
 Rule #3
– NSVT with CAD/prior MI that is not
suppressible by antiarrhythmic
therapy
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ICD Trials: Secondary Prevention
AVID: Antiarrhythmics Versus Implantable Defibrillators
CASH: The Cardiac Arrest Study Hamburg
CIDS: The Canadian Implantable Defibrillator Study
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AVID
Mortality Reduction ICD vs. Antiarrhythmic Drug
History of VF, VT with syncope or sustained VT
with EF<40%
Mortality reduction with ICD
1 year: 39%
2 years: 27%
3 years: 31%
NEJM 1997; 337:1576-1583
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CASH
24% Mortality Reduction with ICD
Survivors of cardiac arrest secondary to
sustained ventricular arrhythmia
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Circulation. 2000;102:748-754
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CIDS
20% Mortality reduction with ICD
CIDs substantiated the efficacy of ICD
over Amiodarone as seen in AVID
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Circulation 2000 101:1297-1302
Secondary Prevention Summary
% Mortality Reduction
Overall Death
100
90
80
70
60
50
40
30
20
10
0
2
3
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61
56
31
AVID at 3 Years
1
Arrhythmic Death
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CASH at 3 Years
The AVID Investigators. NEJM. 1997;337:1576-1583.
Kuck K. Circ.2000;102:748-754.
Connolly S. Circ. 2000;101:1297-1302.
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CIDS at 2 Years
Primary Prevention ICD Indications
 Rule #1
– Left ventricular ejection fraction
(LVEF) of 35% or less
 Rule #2
– New York Heart Association class II or
III heart failure
OR
– History of myocardial infarction (s/p
40 days)
 Rule #3
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– Medically optimized
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ICD Trials: Primary Prevention
CABG-Patch:
Coronary Artery Bypass Graft Patch
DEFINITE:
Defibrillators in Non-Ischemic
Cardiomyopathy Treatment Evaluation Trial
DINAMIT:
The Defibrillator in Acute Myocardial
Infarction Trial
MADIT I:
Multicenter Automatic Defibrillator
Implantation Trial I
MADIT II:
Multicenter Automatic Defibrillator
Implantation Trial II
SCD-HeFT:
Sudden Cardiac Death in Heart Failure Trial
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CABG-Patch
Prophylactic use of ICD with patient at time
of CABG
NEJM 1997; 337:1569-1575
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DEFINITE
*NIDCM, LVEF <36% and PVC or NSVT
(NIDCM = Non-ischemic dilated cardiac myopathy)
35% Reduction in
All Cause Mortality
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NEJM 2004;350:2151-8
20% Reduction in
SCD from arrhythmia
DINAMIT
6 – 40 days post MI, LVEF ≤ 35%
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NEJM 2004;351,24
MADIT
55% Mortality Reduction
NEJM 1996;335
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MADIT II
30% Mortality Reduction
Post MI and LVD
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NEJM 2002;346
SCD-HeFT
23% mortality reduction
Primary prevention: ICM and NICM
N Engl. J Med. 2005; 352:225-237.
23% Reduction in
All Cause Mortality
For ICD Therapy
(p-value 0.007)
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The Details
 2,521 patients followed for a minimum of 45.5
months
 Randomized for Amiodarone, placebo, or ICD
 Significant reduction in all cause mortality over a
placebo or Amiodarone by 23%.
– Ischemic or nonischemic dilated cardiomyopathy
– New York Heart Association (NYHA) class II and III
heart failure
– Ejection fraction (EF) ≤ 30%
– No history of prior sustained ventricular tachycardia
(VT)/VF
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CMS: Centers for Medicare & Medicaid Services
 Yes! We will pay
for ICDs!!
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% Mortality Reduction
w/ ICD Rx
Primary vs. Secondary Prevention
75
%
80
60
40
54
%
55
%
Arrhythmic Death
61
%
31
%
20
0
MADIT
1
27
months
% Mortality Reduction
w/ ICD Rx
Overall Death
76
%
MUSTT
2
39
months
MADIT-II 3,
20
months
4
80
60
40
56%
31%
59%
28%
20
33%
20%
0
AVID 5
3 Years
23
Overall Death
Arrhythmic Death
CASH 6
3 Years
CIDS 7
3 Years
1 Moss AJ. N Engl J Med. 1996;335:1933-40.
2 Buxton AE. N Engl J Med. 1999;341:1882-90.
3 Moss AJ. N Engl J Med. 2002;346:877-83
4 Moss AJ. Presented before ACC 51st Annual Scientific Sessions, Late
Breaking Clinical Trials, March 19, 2002.
5 The AVID Investigators. N Engl J Med. 1997;337:1576-83.
6 Kuck K. Circ. 2000;102:748-54.
7 Connolly S. Circ. 2000:101:1297-1302.
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ICD mortality
reductions in
primary
prevention
trials
are equal to or
greater
than those in
secondary
prevention
trials.
ACC/AHA classifications based on studies
Indication
Class
Supporting
Studies
Structural heart disease, sustained VT
Class I
AVID,
CASH, CIDS
Syncope of undetermined origin,
inducible VT or VF at EPS
Class I
CIDS
LVEF <35% due to prior MI, at least 40
days post-MI, NYHA Class II or III
Class I
SCD-HeFT
LVEF ≤35%, NYHA Class II or III
Class I
SCD-HeFT
LVEF ≤30% due to prior MI, at least 40
days post-MI
Class I
MADIT II
LVEF <40% due to prior MI, inducible VT
or VF at EPS
Class I
MADIT,
MUSTT
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New Directions
 PAINFREE RX II: Pacing Fast VT Reduces Shock
Therapies
 EMPIRIC: Preventing Shocks After ICD
Implantation by a Strategy of Standardized ICD
Programming
 PREPARE: Primary Prevention Parameters
Evaluation trial of implantable cardioverter
defibrillators to reduce patient morbidity
 MADIT RIT: Strategic programming:
– Standard
– Delayed therapy
– High rate detection
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