Prevention de la Mort Subite Treatment of Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death

1
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
2
Cause of Death
Total Mortality Contribution from Sudden Cardiac
Death

Zheng et al., Circulation 2001
3
Sudden Cardiac Death
Holter recordings from 157 cases with fatal
arrhythmias
Brady- arrhythmias
17
Primary VF
9
62
VT? VF
13
Torsade de Pointes
Bayes de Luna et al. Am Heart J 1989
4
Sudden Cardiac Death
Huikuri et al. NEJM 2001
5
Implantable Defibrillator
6
Sudden Cardiac Death
Incidence
Events per Year
Adult population
CAD
History of a coronary event
Heart failure
Resuscitation
Resuscitation with previous MI
30
20
10
5
2
1
0
300
200
100
0
(x 1000)
( per year)
Myerburg et al., Circulation 1992
7
Sudden Cardiac Death

• Secondary Prevention

• Primary Prevention

8
ICD Trials - Secondary prophylaxis
Dutch trial
CASH
VF, cardiac arrest
CIDS
AVID
sustained VT
10 20 30 40 60 LV-EF ()
9
Summary of 20 Prevention Trials
Hazard ratio
Other features
Trial Name, Pub Year
?
Aborted cardiac arrest
N 1016
AVID
0.62
1997
?
N 191
Aborted cardiac arrest
CASH
2000
0.83
?
Aborted cardiac arrest or syncope
N 659
CIDS
2000
0.82
p 0.0023
?
Meta
HR0.73 (0.59,0.89)
1.8
0.8
1.0
1.2
1.4
1.6
0.4
0.6
ICD better
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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)

11
ICD Trials - Primary prophylaxis
MADIT I
MUSTT
ns VT
DEFINITE
SCD-HeFT
DINAMIT
CAT
High risk no VA
MADIT II
CABG-Patch
5 10 20 30 40
LV-EF ()
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ICD 10 Prevention Trial Results
Hazard Ratio
CABG-Patch
MUSTT
CAD, MI
MADIT I
MADIT II
DINAMIT
CAD, NICM
SCD-HeFT
DEFINITE
AMIOVIRT
NICM
CAT
0
0.5
1
1.5
2
2.5
ICD better
No ICD better
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Risk stratification for sudden death in ICD
trials
? Ejection fraction (EF lt30, lt35, lt40
...) ? Etiology of depressed EF (CAD vs DCM) ?
EP study (inducible VT, VF) ? Timing of remote
myocardial infarction (lt 40 days, gt 40 days / 1
month) ? HRV ? NYHA class ? QRS duration
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Major ICD Secondary Prevention Trials
Study MADIT II DEFINITE SCD HeFT
Sponsor Guidant St Jude MIH/Wyeth/Medtronic
Reported in NEJM Mar 2002 May 2004 Jan 2005
No of patients 1232 458 2521
Disease MI CM/CHF CHF
NYHA 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 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
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LV-function as predictor of SCD
MUSST, MADIT, MADIT-2, SCD-HeFT DINAMIT,
COMPANION,
risk

• 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 ()
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Major ICD 10 Prevention Trials and LVEF
148
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Principle of Guidelines

• EF difficult to measure

• Multiple trials with EF lt 30
• No trials of EF 30-35 or 35-40

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Examples of Guideline Recommendations
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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 Isch
aemic 506 Non-ischaemic 397
SCD HeFT COMPANION (ACM only)
ICD better
ICD not better
0.2
0.4
0.6
0.8
1
1.2
1.4
20
ICD
40 days post MI
Recommendation
21
SCD-HeFT
NYHA II
NYHA III
Bardy G. et al., N Eng J Med 2005 352 225-37
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NYHA Functional Class
NYHA class, MADIT II DEFINITE SCD HeFT
I 37 21.6 -
II 34.5 57.4 70
III 24 21 30
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Recommendations for 10 Prevention
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NYHA Functional Class 1 and LVD
MADIT II DEFINITE
NYHA n I 461 ? I 771 I 99 II 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
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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)

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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

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ICD Indications
Comparison between Guidelines
Group of patients ACC/AHA HF ESC HF ACC/AHA STEMI ACC/AHA/ NASPE for PM and ICD ACC/A/H/A/ESC Ventricular 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 I LOE 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 NYHA II-III Class I LOE 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 30-40 NYHA II-III Class I LOE A
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-III Class I LOE B
NICM, EF 30-35, NYHA II, III Class IIa, LOE B Class I, LOE A N/A N/A LVEF 30-35 NYHA II-III Class I LOE B
NICM, EF ? 30, NYHA I Class IIb, LOE C N/A N/A N/A EF 30-35 Class IIb LOE B
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ICD Indications
Comparison between Guidelines
Group of patients ACC/AHA HF ESC HF ACC/AHA STEMI ACC/AHA/ NASPE for PM and ICD ACC/A/H/A/ESC Ventricular 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 I LOE 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 NYHA II-III Class I LOE 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 30-40 NYHA II-III Class I LOE A
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-III Class I LOE B
NICM, EF 30-35, NYHA II, III Class IIa, LOE B Class I, LOE A N/A N/A LVEF 30-35 NYHA II-III Class I LOE B
NICM, EF ? 30, NYHA I Class IIb, LOE C N/A N/A N/A EF 30-35 Class IIb LOE B
29
ICD Indications
Comparison between Guidelines
Group of patients ACC/AHA HF ESC HF ACC/AHA STEMI ACC/AHA/ NASPE for PM and ICD ACC/A/H/A/ESC Ventricular 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 I LOE 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 NYHA II-III Class I LOE 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 30-40 NYHA II-III Class I LOE A
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-III Class I LOE B
NICM, EF 30-35, NYHA II, III Class IIa, LOE B Class I, LOE A N/A N/A LVEF 30-35 NYHA II-III Class I LOE B
NICM, EF ? 30, NYHA I Class IIb, LOE C N/A N/A N/A EF 30-35 Class IIb LOE B
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Summary and Conclusions

• VASCD 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

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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."
•  

Abraham Lincoln