Transcript ACC-AHA-ESC Guidelines for Management of Patients with

Prevention de la Mort Subite
Treatment of Ventricular Arrhythmias and the Prevention of
Sudden Cardiac Death
S. Nasr, M.D.
Clinical Cardiac Electrophysiologist
Association Franco-Libanaise de Cardiologie
11 Mai 2007 - Beirut, Liban
Cause of Death
Total Mortality: Contribution from Sudden Cardiac Death
%
64
62
60
58
56
54
52
1989 1990 1991 1992 1993 1994 1995 1996 1997 1998
Zheng et al., Circulation 2001
Sudden Cardiac Death
Holter recordings
from 157 cases with
fatal arrhythmias
Bradyarrhythmias
Primary VF
Torsade
de Pointes
17%
9%
13%
Bayes de Luna et al. Am Heart J 1989
62%
VT VF
Sudden Cardiac Death
Huikuri et al. NEJM 2001
Implantable Defibrillator
Sudden Cardiac Death
Incidence
Events per Year
Adult population
CAD
History of a
coronary event
Heart failure
Resuscitation
Resuscitation
with previous MI
0
1
2
5
10
(% per year)
Myerburg et al., Circulation 1992
20
30
0
100
200
(x 1000)
300
Sudden Cardiac Death
• Secondary Prevention
• Primary Prevention
ICD Trials - Secondary prophylaxis
Dutch trial
VF, cardiac arrest
CASH
AVID
CIDS
sustained VT
10
20
30
LV-EF (%)
40
60
Summary of 20 Prevention Trials
Hazard ratio
Other features
Trial Name, Pub Year
●
AVID
N = 1016
Aborted cardiac arrest
0.62
1997
N = 191
CASH
2000
N = 659
CIDS
●
0.83
Aborted cardiac arrest
●
Aborted cardiac arrest or
syncope
0.82
2000
p = 0.0023
Meta
0.4
●
0.6
ICD better
HR:0.73 (0.59,0.89)
0.8
1.0
1.2
1.4
1.6
1.8
Recommendations for 20 Prevention
•
Class I Recommendations
The ICD is effective therapy to reduce mortality by a reduction in SCD in
patients with LVD due to prior MI who present with hemodynamically
unstable sustained VT, who are receiving chronic optimal medical therapy,
and who have reasonable expectation of survival with a good functional
status for more than 1 year (Level of Evidence: A)
An ICD should be implanted in patients with non-ischemic DCM and
significant LVD who have sustained VT or VF, who are receiving chronic
optimal medical therapy, and who have reasonable expectation of survival
with a good functional status for more than 1 year (Level of Evidence: A)
ICD Trials - Primary prophylaxis
MADIT I
MUSTT
ns VT
DEFINITE
SCD-HeFT
DINAMIT
CAT
High risk
no VA
MADIT II
CABG-Patch
LV-EF (%)
5
10
20
30
40
ICD 10 Prevention Trial Results
Hazard Ratio
CABG-Patch
MUSTT
CAD, MI
MADIT I
MADIT II
DINAMIT
CAD,
NICM
SCD-HeFT
DEFINITE
NICM
AMIOVIRT
CAT
0
0.5
1
1.5
ICD better No ICD better
2
2.5
Risk stratification for sudden death
in ICD trials
 Ejection fraction
(EF <30%, <35%, <40% + ...)
 Etiology of depressed EF
(CAD vs DCM)
 EP study
(inducible VT, VF)
 Timing of remote myocardial infarction
(< 40 days, > 40 days / 1 month)
 [HRV]
 NYHA class
 QRS duration
Major ICD Secondary Prevention Trials
Study
MADIT II
DEFINITE
SCD HeFT
Sponsor
Guidant
Mar 2002
1232
MI
37/34.5/24/4.5
St Jude
May 2004
458
CM/CHF
21.6/57.4/21.0/…
MIH/Wyeth/Medtronic
 30 (23)
 35 (21)
 35 (25)
100/…
…/100
52/48
Device
ICD
ICD
ICD
1o end-point
ACM
ACM
ACM
Study duration
Jul 1997 – Nov 2001
July 1998 – June 2002
Sep 1997 – Jul 2001
Follow-up, months
20
29
45.5
Reported in NEJM
No of patients
Disease
NYHA I/II/III/IV
LVEF, %
IHD/NIHD, %
Jan 2005
2521
CHF
…/70/30/…
LV-function as predictor of SCD
risk
MUSST, MADIT, MADIT-2, SCD-HeFT
DINAMIT, COMPANION, ………
LV-EF is considered as the best
parameter for risk stratification after
MI
exponential increase of risk of SCD
below EF 35-40%
LV-EF (%)
Major ICD 10 Prevention Trials and LVEF
SCDHeFT
40
40
 35
35
23
< 25
30
> 30
401
40
 35
35
285
≤ 30
≥ 25
DEFINITE
LVEF
LVEF
LVEF
MADIT II
35
 20
30
30
1675
25 1232
25
25
≤ 30
20
831
20
310
458
25
1390
21
20
148
< 20
15
15
0.2 0.4 0.6 0.8 1.0 1.2 1.4
Defibrillator
Better
Conventional
Better
0.2 0.4 0.6 0.8 1.0 1.2 1.4
15
0.2 0.4 0.6 0.8 1.0 1.2 1.4
Principle of Guidelines
LVEF
LVEF
40
40
Class: IIb; LOE: B
35
35
Class: IIa; LOE: B
30
30
25
A
B
C
Class: 1
LOE: A
• Multiple trials with EF < 30%
• No trials of EF 30-35% or 35-40%
25
Class: 1
LOE: A
• EF difficult to
measure
Examples of Guideline Recommendations
LVEF
CHD
NICM
40
35
≤ 30-40%
≤ 30-35%
30
25
Class: 1
LOE: A
Class: 1
LOE: B
Etiology of Heart Failure
Study
MADIT II
DEFINITE
SCD HeFT
Total
Ischaemic
All (1232)
N/A
52% (884)
2116
Non-ischaemic
N/A
All (458)
48% (792)
1250
Aetiology
n
Ischaemic
884
Non-ischaemic
792
COMPANION
Ischaemic
506
(ACM only)
Non-ischaemic
397
SCD HeFT
ICD better
0.2
0.4
ICD not better
0.6
0.8
1
1.2
1.4
Recommendation:
1.0
LY gained
per device
Probability of Survival
ICD
Defibrillator
0.9
0.8
0.7
Conventional
0,6
0,5
0,4
0,3
0,2
0,1
0
1 year
2 years
3 years
MUSTT MADIT MADIT II
0.6
0.0
0
1
2
3
Year
Annual mortality rate, %
15
ICD
Salukhe TV et al, 2004
4
MADIT II Moss AJ, 2002
Mortality / 100py
≥40 days post MI
Life expectancy >1 y
OPT
10
5
8
6
4
< 18 MO
18-59 MO
60-119 MO
MADIT II Wilber DJ et al, 2004
> 120 MO
6.0
2
0
0
Non-arrhythmic
Arrhythmic
10
1.5
ICD
3.4
3.5
OPT
DINAMIT Hohnloser SH et al, 2004
SCD-HeFT
NYHA II
NYHA III
Bardy G. et al., N Eng J Med 2005; 352: 225-37
NYHA Functional Class
NYHA class, %
MADIT II
DEFINITE
SCD HeFT
MADIT II
DEFINITE
SCD HeFT
I
37
21.6
-
II
34.5
57.4
70
III
24
21
30
NYHA
I
I
I
II
III
II
III
n
461
771
99
263
96
1160
516
ICD not better
ICD better
0
0.4
0.8
1.2
1.6
2
2.4
Recommendations for 10 Prevention
Class 1 Recommendation:
ICD therapy is recommended for primary
prevention to reduce total mortality by a
reduction in SCD in patients with LVD
due to prior MI who are at least 40 days
post-MI, have an LVEF ≤ 30% to 40%, are
New York Heart Association (NYHA)
functional class II or III, are receiving
chronic optimal medical therapy, and
who have reasonable expectation of
survival with a good functional status for
more than 1 year
(Level of Evidence: A)
Class 1 Recommendation:
ICD therapy is recommended for
primary prevention to reduce total
mortality by a reduction in SCD in
patients with non-ischemic DCM who
have an LVEF ≤ 30% to 35%, are NYHA
functional class II or III receiving
chronic optimal medical therapy, and
who have reasonable expectation of
survival with a good functional status for
more than 1 year
(Level of Evidence: B)
NYHA Functional Class 1 and LVD
MADIT II
DEFINITE
NYHA
I
I
I
II
n
461
771
99
263
ICD not better
ICD better
0
0.4
0.8
1.2
1.6
2
2.4
“The writing committee struggled with this issue since guidelines are meant to summarize current
science and not take into account economic issues or the societal impact of making
recommendations. However the committee recognizes that the economic impact and societal issues
will clearly modulate how these recommendations are implemented”
NYHA Class I Recommendations
Class IIa
Class IIb
Implantation of an ICD is reasonable
in patients with LVD due to prior MI
who are at least 40 days post-MI, have
an LVEF of ≤ 30% to 35%, are NYHA
functional class I on chronic optimal
medical therapy, and who have
reasonable expectation of survival
with a good functional status for more
than 1 year
Placement of an ICD might be
considered in patients who have
non-ischemic DCM, LVEF ≤ 30%
to 35%, are NYHA functional
class I receiving chronic optimal
medical therapy, and who have
reasonable expectation of survival
with a good functional status for
more than 1 year
(Level of Evidence: B)
(Level of Evidence: C)
Guidelines for the management of patients
at risk of sudden death
 ACC/AHA 2005 Guideline Update for the
Diagnosis and Management of Chronic Heart
Failure in the Adult
 ESC 2005 Guideline Update for the Diagnosis
and Treatment of Chronic Heart Failure
 ACC / AHA 2004 Guidelines for the management
of Patients with ST-Elevation Myocardial
Infarction
 ACC / AHA / NASPE 2002 Guidelines Update for
Implantation of Cardiac Pacemakers and
Antiarrhythmia Devices
ICD Indications
Comparison between
Guidelines
ACC/AHA/
NASPE for PM
and ICD
ACC/A/H/A/ESC
Ventricular Arrhythmias and
Sudden Cardiac Death
2006
ACC/AHA HF
ESC HF
ACC/AHA
STEMI
2005 update
2005
2004
2002
Class I,
LOE B
Class IIb,
LOE B
Class IIa,
LOE B
Class IIa,
LOE B
s/p MI, EF 30-35%,
NYHA II, III
Class IIa,
LOE B
Class I,
LOE A
Class IIa,
LOE B
N/A
s/p MI, EF 30-40%,
NSVT, positive EPS
N/A
N/A
Class I,
LOE B
Class IIb,
LOE B
s/p MI, EF  30%,
NYHA I
Class IIa,
LOE B
N/A
N/A
N/A
NICM, EF  30%,
NYHA II, III
Class I,
LOE B
Class I,
LOE A
N/A
N/A
NICM, EF 30-35%,
NYHA II, III
Class IIa,
LOE B
Class I,
LOE A
N/A
N/A
NICM, EF  30%,
NYHA I
Class IIb,
LOE C
N/A
N/A
N/A
Group of patients
s/p MI, EF  30%,
NYHA II, III
s/p MI
EF ≤ 30-40%
NYHA II-III
Class I
LOE A
s/p MI, EF ≤ 30-35% NYHA I
Class IIa; LOE B
LVEF ≤ 30-35%
NYHA II-III
Class I
LOE B
EF ≤ 30-35%
Class IIb; LOE B
ICD Indications
Comparison between
Guidelines
ACC/AHA/
NASPE for PM
and ICD
ACC/A/H/A/ESC
Ventricular Arrhythmias and
Sudden Cardiac Death
2006
ACC/AHA HF
ESC HF
ACC/AHA
STEMI
2005 update
2005
2004
2002
Class I,
LOE B
Class IIb,
LOE B
Class IIa,
LOE B
Class IIa,
LOE B
s/p MI, EF 30-35%,
NYHA II, III
Class IIa,
LOE B
Class I,
LOE A
Class IIa,
LOE B
N/A
s/p MI, EF 30-40%,
NSVT, positive EPS
N/A
N/A
Class I,
LOE B
Class IIb,
LOE B
s/p MI, EF  30%,
NYHA I
Class IIa,
LOE B
N/A
N/A
N/A
NICM, EF  30%,
NYHA II, III
Class I,
LOE B
Class I,
LOE A
N/A
N/A
NICM, EF 30-35%,
NYHA II, III
Class IIa,
LOE B
Class I,
LOE A
N/A
N/A
NICM, EF  30%,
NYHA I
Class IIb,
LOE C
N/A
N/A
N/A
Group of patients
s/p MI, EF  30%,
NYHA II, III
s/p MI
EF ≤ 30-40%
NYHA II-III
Class I
LOE A
s/p MI, EF ≤ 30-35% NYHA I
Class IIa; LOE B
LVEF ≤ 30-35%
NYHA II-III
Class I
LOE B
EF ≤ 30-35%
Class IIb; LOE B
ICD Indications
Comparison between
Guidelines
ACC/AHA/
NASPE for PM
and ICD
ACC/A/H/A/ESC
Ventricular Arrhythmias and
Sudden Cardiac Death
2006
ACC/AHA HF
ESC HF
ACC/AHA
STEMI
2005 update
2005
2004
2002
Class I,
LOE B
Class IIb,
LOE B
Class IIa,
LOE B
Class IIa,
LOE B
s/p MI, EF 30-35%,
NYHA II, III
Class IIa,
LOE B
Class I,
LOE A
Class IIa,
LOE B
N/A
s/p MI, EF 30-40%,
NSVT, positive EPS
N/A
N/A
Class I,
LOE B
Class IIb,
LOE B
s/p MI, EF  30%,
NYHA I
Class IIa,
LOE B
N/A
N/A
N/A
NICM, EF  30%,
NYHA II, III
Class I,
LOE B
Class I,
LOE A
N/A
N/A
NICM, EF 30-35%,
NYHA II, III
Class IIa,
LOE B
Class I,
LOE A
N/A
N/A
NICM, EF  30%,
NYHA I
Class IIb,
LOE C
N/A
N/A
N/A
Group of patients
s/p MI, EF  30%,
NYHA II, III
s/p MI
EF ≤ 30-40%
NYHA II-III
Class I
LOE A
s/p MI, EF ≤ 30-35% NYHA I
Class IIa; LOE B
LVEF ≤ 30-35%
NYHA II-III
Class I
LOE B
EF ≤ 30-35%
Class IIb; LOE B
Summary and Conclusions
VA&SCD Guidelines focus on management of actual and
threatened ventricular tachyarrhythmias, and
•
•
•
•
Build on others that have preceded them - some
recommendations have not changed.
Introduce many new and some potentially controversial
recommendations
Favour the ICD and extend its indications: Class I CHF / little or no
LV dysfunction / wider range of ejection fraction / non-ischemic
cardiomyopathy
Acknowledge that not all those who might benefit from ICD
therapy can accept or can receive such treatment - alternative
treatment is recommended for those who do not receive an ICD
Guidelines and Controversy
You can please all
people some of
time, and some of
people all the time,
you cannot please
the people all
time."
the
the
the
but
all
the
Abraham Lincoln