Prevention de la Mort Subite Prevention de la Mort Subite Treatment of Ventricular Arrhythmias and the Prevention of Treatment of Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death Sudden Cardiac Death S. Nasr, M.D. Clinical Cardiac Electrophysiologist Association Franco-Libanaise de Cardiologie 11 Mai 2007 - Beirut, Liban
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Prevention de la Mort Subite Treatment of Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death S. Nasr, M.D. Clinical Cardiac Electrophysiologist.
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Prevention de la Mort SubitePrevention de la Mort Subite Treatment of Ventricular Arrhythmias and the Prevention of Treatment of Ventricular Arrhythmias and the Prevention of
Sudden Cardiac DeathSudden Cardiac Death
S. Nasr, M.D.
Clinical Cardiac Electrophysiologist
Association Franco-Libanaise de Cardiologie 11 Mai 2007 - Beirut, Liban
Cause of Death
52
54
56
58
60
62
64
1989 1990 1991 1992 1993 1994 1995 1996 1997 1998
%
Total Mortality: Contribution from Sudden Cardiac Death
Zheng et al., Circulation 2001
Holter recordingsfrom 157 cases with
fatal arrhythmiasBrady-arrhythmias
62%
17%
Bayes de Luna et al. Am Heart J 1989
VT VFPrimary VF 9%
13%Torsadede Pointes
Sudden Cardiac Death
Sudden Cardiac Death
Huikuri et al. NEJM 2001
Implantable Defibrillator
Myerburg et al., Circulation 1992
3020105210 3002001000
(% per year)(x 1000)
Incidence Events per Year
Adult population
CAD
History of acoronary event
Heart failure
Resuscitation
Resuscitationwith previous MI
Sudden Cardiac Death
Sudden Cardiac Death
• Secondary Prevention
• Primary Prevention
10 20 30 40 60
LV-EF (%)LV-EF (%)
CIDSCIDS
CASHCASH
Dutch trialDutch trial
AVIDAVID
VF, cardiac arrestVF, cardiac arrest
sustained VTsustained VT
ICD Trials - Secondary prophylaxis
Summary of 20 Prevention Trials
0.6 0.8 1.0 1.2 1.4
AVID
1.6 0.4
1997
N = 1016
0.62
Hazard ratio
ICD better
1.8
Other features
CASH2000
N = 191 Aborted cardiac arrest
CIDS2000
N = 659
0.82
Aborted cardiac arrest or syncope
Trial Name, Pub Year
0.83
Aborted cardiac arrest
HR:0.73 (0.59,0.89)
p = 0.0023Meta
●●
●
●
Recommendations for 20 Prevention
• Class I RecommendationsThe 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)
5 10 20 30 40
CATCAT
CABG-PatchCABG-Patch
MUSTTMUSTTMADIT IMADIT I
ns VT ns VT
High riskHigh riskno VAno VA MADIT IIMADIT II
DINAMITDINAMIT
SCD-HeFTSCD-HeFT
DEFINITEDEFINITE
LV-EF (%)LV-EF (%)
ICD Trials - Primary prophylaxis
ICD 10 Prevention Trial Results
CABG-Patch
MUSTT
MADIT I
MADIT II
DINAMIT
SCD-HeFT
DEFINITE
AMIOVIRT
CAT
0 0.5 1 1.5 2 2.5
CAD, MI
NICM
CAD, NICM
Hazard Ratio
ICD better No ICD better
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
Study MADIT II DEFINITE SCD HeFT
Sponsor Guidant St Jude MIH/Wyeth/Medtronic
Reported in NEJM Mar 2002 May 2004 Jan 2005No of patients 1232 458 2521Disease MI CM/CHF CHFNYHA I/II/III/IV 37/34.5/24/4.5 21.6/57.4/21.0/… …/70/30/…LVEF, % 30 (23) 35 (21) 35 (25)IHD/NIHD, % 100/… …/100 52/48
Device ICD ICD ICD1o end-point ACM ACM ACMStudy duration Jul 1997 – Nov 2001 July 1998 – June 2002 Sep 1997 – Jul 2001
Follow-up, months 20 29 45.5
Major ICD Secondary Prevention Trials
LV-EF is considered as the best parameter for risk stratification after MI
exponential increase of risk of SCD below EF 35-40%
• Multiple trials with EF < 30%• No trials of EF 30-35% or 35-40%
• EF difficult to measure
Examples of Guideline Recommendations
40
35
30
25Class: 1LOE: A
LVEF
Class: 1LOE: B
CHD NICM
≤ 30-40% ≤ 30-35%
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
AetiologyAetiology nn
IschaemicIschaemic 884884
Non-ischaemicNon-ischaemic 792792
IschaemicIschaemic 506506
Non-ischaemicNon-ischaemic 397 397
0.2 0.4 0.6 0.8 1 1.2 1.4
SCD HeFTSCD HeFT
COMPANIONCOMPANION(ACM only)(ACM only)
ICD better ICD not better
ICD Recommendation:≥40 days post MI
0
2
4
6
8
10
ICD OPT
Non-arrhythmic Arrhythmic
6.0
1.5
3.4
3.5Ann
ual m
orta
lity
rate
, %
0
5
10
15
< 18 MO 18-59 MO 60-119 MO > 120 MO
ICD OPT
Pro
bab
ilit
y o
f S
urv
ival 1.0
0.9
0.8
0.7
0.6
0.0
Defibrillator
Conventional
0 1 2 3 4Year
DINAMIT Hohnloser SH et al, 2004MADIT II Wilber DJ et al, 2004
MADIT II Moss AJ, 2002
Salukhe TV et al, 2004
00,10,20,30,40,50,6
MUSTT MADIT MADIT II
1 year 2 years 3 years
LY g
aine
d p
er d
evic
e
Mo
rtal
ity
/ 100
py
Life expectancy >1 y
Bardy G. et al., N Eng J Med 2005; 352: 225-37Bardy G. et al., N Eng J Med 2005; 352: 225-37
SCD-HeFT
NYHA II NYHA III
NYHA Functional ClassNYHA class, % MADIT II DEFINITE SCD HeFT
I 37 21.6 -
II 34.5 57.4 70
III 24 21 30
NYHANYHA nn
II 461461 I I 771771II 9999IIII 263263IIIIII 9696IIII 11601160IIIIII 516516 ICD better ICD not better
MADIT IIMADIT II
DEFINITEDEFINITE
SCD HeFTSCD HeFT
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 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)
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)
NYHA Functional Class 1 and LVD
“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”
NYHANYHA nn
II 461461 I I 771771II 9999IIII 263263
ICD better ICD not better
MADIT IIMADIT II
DEFINITEDEFINITE
0 0.4 0.8 1.2 1.6 2 2.4
NYHA Class I Recommendations
Class IIa
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
(Level of Evidence: B)
Class IIb
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: 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
Group of patients ACC/AHA HF ESC HF ACC/AHA STEMI
ACC/AHA/NASPE for PM
and ICD
ACC/A/H/A/ESCVentricular Arrhythmias and
Sudden Cardiac Death
2005 update 2005 2004 2002 2006
s/p MI, EF 30%, NYHA II, III
Class I, LOE B
Class IIb, LOE B
Class IIa, LOE B
Class IIa,LOE B s/p MI
EF ≤ 30-40%NYHA II-III
Class ILOE A
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 BClass IIb,
LOE B
s/p MI, EF 30%, NYHA I
Class IIa, LOE B N/A N/A N/A s/p MI, EF ≤ 30-35% NYHA I
Class IIa; LOE B
NICM, EF 30%, NYHA II, III
Class I, LOE B
Class I, LOE A N/A N/A LVEF ≤ 30-35%
NYHA II-IIIClass ILOE B
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 EF ≤ 30-35%
Class IIb; LOE B
Comparison between Guidelines
ICD Indications
Group of patients ACC/AHA HF ESC HF ACC/AHA STEMI
ACC/AHA/NASPE for PM
and ICD
ACC/A/H/A/ESCVentricular Arrhythmias and
Sudden Cardiac Death
2005 update 2005 2004 2002 2006
s/p MI, EF 30%, NYHA II, III
Class I, LOE B
Class IIb, LOE B
Class IIa, LOE B
Class IIa,LOE B s/p MI
EF ≤ 30-40%NYHA II-III
Class ILOE A
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 BClass IIb,
LOE B
s/p MI, EF 30%, NYHA I
Class IIa, LOE B N/A N/A N/A s/p MI, EF ≤ 30-35% NYHA I
Class IIa; LOE B
NICM, EF 30%, NYHA II, III
Class I, LOE B
Class I, LOE A N/A N/A LVEF ≤ 30-35%
NYHA II-IIIClass ILOE B
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 EF ≤ 30-35%
Class IIb; LOE B
Comparison between Guidelines
ICD Indications
Group of patients ACC/AHA HF ESC HF ACC/AHA STEMI
ACC/AHA/NASPE for PM
and ICD
ACC/A/H/A/ESCVentricular Arrhythmias and
Sudden Cardiac Death
2005 update 2005 2004 2002 2006
s/p MI, EF 30%, NYHA II, III
Class I, LOE B
Class IIb, LOE B
Class IIa, LOE B
Class IIa,LOE B s/p MI
EF ≤ 30-40%NYHA II-III
Class ILOE A
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 BClass IIb,
LOE B
s/p MI, EF 30%, NYHA I
Class IIa, LOE B N/A N/A N/A s/p MI, EF ≤ 30-35% NYHA I
Class IIa; LOE B
NICM, EF 30%, NYHA II, III
Class I, LOE B
Class I, LOE A N/A N/A LVEF ≤ 30-35%
NYHA II-IIIClass ILOE B
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 EF ≤ 30-35%
Class IIb; LOE B
Comparison between Guidelines
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 the people some of the time, and some of the people all the time, but you cannot please all the people all the time."