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QUAND PROPOSER UN
TRAITEMENT ELECTRIQUE ?
Prof L DE ROY
Université de Louvain
CLINIQUES
UNIVERSITAIRES UCL DE
MONT-GODINNE
Belgique
J Am Coll Cardiol 2002;40:1703–19
Recommendations for ICD Therapy
LVEF≤35%
Class I (A)
MADIT I
P=0.009
Moss AJ, N Engl J Med 1996;335:1933-40
Class II a (B)
Buxton AE,, N Engl J Med 1999
MUSTT
LVEF≤30%
MADIT II
P=0.007
Moss AJ, N Engl J Med 2002;346:877-83
J Am Coll Cardiol 2002;40:1703–19
Pacing Recommendations for Dilated Cardiomiopathy
P<0.001
MUSTIC
P<0.001
J Am Coll Cardiol 2002;40:1703–19
MUSTIC
MIRACLE
N Engl J Med 2001;344:873-80
P=0.03
N Engl J Med 2002;346:1845-53
Swedberg et al., EHJ 2005;26:1115-1140
CRT Pacemakers
Swedberg et al., EHJ 2005;26:1115-1140
CRTP -CRTD
N Engl J Med 2004;350:2140-50
CRTP
Class I B
Cleland JG, N Engl J Med 2005;352:1539-1549
CARE-HF trial : extension phase
Worsening heart failure
All cause mortality
Sudden cardiac death
Cleland et al Eur Heart J 2006;27:1928-32
ICD – ICD +CRT
ICD +CRT
Class II a (B)
(COMPANION)
Class I (A)
(AVID)
ICD
Class I (A)
(MADIT II/SCD HeFT)
Swedberg et al., EHJ 2005;26:1115-1140
Class II a (B)
Hunt SA,Circulation 2005;20: e154-e685
Stage C Therapy:Reduced LVEF with Symptoms
Cardiac Resynchronization (CRTP / CRTD)
I IIa IIb III
Hunt SA,Circulation 2005;20: e154-e685
CARE-HF
The use of an ICD in combination with CRT should be based on the indications for
ICD therapy.
Stage D Therapy
Inform on option to
inactivate defibrillation
I IIa IIb III
Patients with refractory end-stage HF and
implantable defibrillators should receive
information about the option to inactivate
defibrillation.
Characteristics of patients enrolled and QRS eligibility
criteria of the major RCTs on CRT
Boriani G., J Interv Card Electrophysiol 2007
Results of cardiac resynchronization in CHF from CRT*
*with estimated extent of effect
Boriani G., J Interv Card Electrophysiol 2007, feb 24
Indication to CRT according to
recent ACC/AHA guidelines
CL I (A)
Boriani G., J Interv Card Electrophysiol 2007
Qu’en est-il de l’asynchronisme et QRS fins
Magnitude of Improvement in Clinical and
Echocardiographic Parameters After CRT*
n =33
n =33
Bleeker GB, J Am Coll Cardiol 2006;48:2243–50
Changes in LVESV, LVEDV, and EF in HF pts with narrow QRS
complexes with/without significant systolic asynchrony according to
asynchrony index
Left ventricular end-systolic vol.
Left ventricular end-diastolic vol.
N=102
Left ventricular ejection fraction
Yu CM.,J Am Coll Cardiol 2006;48:2251–7
Qu’en est-il de la classe IV
Time to mode of death by treatment arm for NYHA class
IV in COMPANION trial
CRTD
CRT
N=217
A. Time to sudden death
B. Time to HF death
Lindenfeld JA, Circulation. 2007;115:204-212
FAUT-IL ADJOINDRE SYSTEMATIQUEMENT
UN DAI A LA CRT ?
Residual risk of sudden cardiac death in
heart failure beta-blocker trials
Field M, J Interv Card Electrophysiol, 2007
Survival for biventricular ICD and biventricular PM
Ermis C, J Cardiovasc Electrophysiol 2004(15):862-866
CRTD VS CRT
META-ANALYSIS OF COMPANION +
ERMIS:
ALL CAUSE MORTALITY:
OR = 0.69 (0.53,0.91) P= 0.008
ABDULLA 2006
Estimated annualized sudden cardiac death rates in patients
with nonischemic dilated cardiomyopathy receiving medical therapy
Field M, J Interv Card Electrophysiol, 2007
7.5
RE-HF
NNT Resynchronisation
NNT HF studies
NNT HF studies
30
25
NNT
20
15
26
10
5
11
14
17
14
11
17
20
20
14
7.5
0
MADIT
COMPANION
II
MADIT
CARE-HF
II
1 an
3 ans
CRT-D
CRT-P
COPERNICUS
MADIT II
1 an
Carvedilol
MADIT
SAVE
II
COPERNICUS
MERIT-HF SAVE
3.5 ans
Captopril
1 an
Succinate de
metoprolol
Aurrichio et al, Circulation 2004, 109; 300 - 307
Number of patients with NYHA class IV heart failure
enrolled in primary prevention ICD trials
Field M, J Interv Card Electrophysiol, 2007
Percentage of patients after 2 years survival with
sustained LV remodeling or an increase in absolute
LVEF of 5% after CRT
N=89
sustained LV remodeling means LV end systolic volume (LVESV) reduction of 10%
Delnoy PP., J Cardiovasc Electrophysiol, 2007(18):298-302
NYHA class IV endpoints by treatment arm in COMPANION trial
Secondary time to all-cause death
N=217
Time to all-cause death or HF hospitalization
Lindenfeld JA, Circulation. 2007;115:204-212
Primary time to all-cause death or hospitalization
Death among patients with AF randomized
to CRT vs RV pacing
CRT: 49% reduction in the relative risk of all-cause mortality
p=0.547
MUSTIC–AF: Multisite Stimulation in Cardiomyopathy Study–Atrial Fibrillation
PAVE: Post AV Nodal Ablation Evaluation
OPSITE: Optimal Pacing SITE Study
Bradley DJ.,Heart Rhythm 2007;4:224 –232
Results of cardiac resynchronization in CHF from CRT*
*with estimated extent of effect
Boriani G., J Interv Card Electrophysiol, 2007
Effect of CRT on all-cause mortality
Abdulla J.,Cardiology 2006;106:249–255
Identification des patients: les études en
resynchronisation
Patients






MIRACLE
NYHA III-IV
FE< 35%
QRS > 130 ms
Φ LVED > 55mm
Rythme sinusal
CARE-HF





COMPANION
NYHA III-IV (+ de 6 sem)
Ischémique ou non
DTDS > 30 mm/m²
FE <35%
QRS > 120 ms




Si 120 <QRS>149 ms
2 des critères suivants sont requis:
•
Retard pré-éjection Ao > 140 ms
•
Délai inter-vent mécan.> 40 ms
•
Retard activation postéro-lat.
paroi vent. gauche





NYHA III-IV
CHF isch ou non
Hospit dans l’année écoulée
FE<35%
Φ LVED > 60 mm
QRS >120ms
PR >150ms
Rythme sinusal
Rythme sinusal
Devices
CRT
CRT - P
CRT - D
Bénéfices
1.
Amélioration NYHA, périmètre de
marche, QoL.
2.
Réduit les hospitalisations pour IC
et toutes causes
1.
Réd. Mortalité tt causes
- 36%
1.
Réduction de la mortalité
-36%
2.
Réd. Hospitalisations
- 52%
2.
Réduc. Hospitalisations
-37%
3.
Amélioration des symptômes
4.
Amélioration des capacités d’effort
CARE-HF
Critères d’inclusion :
- NYHA III-IV,
-QRS > 120ms,
- LVEDD > 30 mm
-FE < 35%.
Objectifs primaires :
- mortalité
hospitalisation pour cause cardiovasculaire
Pourcentage de mortalité
-
40.0%
813 patients
- 36%
30.0%
p = 0.002
30.0%
(82 centres en Europe)
TMO
TMO + CRT-P
[404 patients]
[409 patients]
Etiologie HF
Fraction d’éjection
NYHA 1-2-3-4 [%]
Durée du suivi
Arythmies auriculaires
Historique de diabète
Durée du QRS
QRS > 120 ms
Test de marche 6 min
38% ischémique
26%
0 – 0 – 94 – 6
29.4 mois
21%
21%
165 ms
100%
-
ACE I
Bétabloquant
Diurétique
Spironolactone
Statine
80%
72%
99%
56%
39%
20.0%
20.0%
10.0%
0.0%
Contrôle
Thérapie CRT-P
http://www.care-hf.com
La réduction du risque absolu (RA) est de 9.4% (p = 0.002) après
29.4 mois. Elle (RA) grimpe à 13.4% (p<0.0001) après 36.4 mois
(Care HF extension)
Cleland JN Engl J Med. April 14, 2005;352:1539-1549
COMPANION
Critères d’inclusion :
-NYHA III-IV,
-QRS > 120 ms,
- PR interval > 150ms,
-LVEDD > 60mm
- EF < 35%.
Objectifs primaires : mortalité ou hospitalisation
Pourcentage de mortalité
40.0%
1.520 patients
(128 centres au Etats-Unis)
30.0%
- 36%
TMO
TMO + CRT-D
TMO + CRT-P
[308 patients]
[595 patients]
[617 patients]
20.0%
19.0%
p = 0.003
12.0%
Etiologie HF
Fraction d’éjection
NYHA 1-2-3-4 [%]
Durée du suivi
Arythmies auriculaires
Historique de diabète
Durée du QRS
QRS > 120 ms
Test de marche 6 min
59% ischémique
22%
0 – 0 – 86 – 14
12 mois
41%
160 ms
100%
258 m
ACE I
Bétabloquant
Diurétique
Spironolactone
Statine
69%
68%
97%
55%
-
10.0%
0.0%
Contrôle
Thérapie CRT-D
Le défibrillateur associé à la resynchronisation diminue la
mortalité de 36% (p = 0.003) par rapport au groupe contrôle.
Bardy GH. N Engl J Med. January 20, 2005;352:225-237
Critères d’inclusion
Remboursements
AVID
MADIT I
Pt survivants de FV
FV avec syncope
FV avec FE < 40% + sympt
ESC
DAI
Remboursements
Mort subite
Mort subite
TV soutenue
TV soutenue
Pt NYHA I-III
FE <35%
Post infar asympt
Tachy vent
Patient IC symptomat.
SCD- HeFT
MADIT II
CARE HF
COMPANION
Pt CHF
FE<35%
NYHA II-III
DAI
FE Basse < 30 – 35%
Post MI > 40 j
Pt NYHA I-III
FE <30%
Post infar asympt
LVD
Symptômes
Syncope
Périodes de vertige
Bradycardie
Prophylaxie
HF
Dysfonction cérébrale
Pt NYHA III-IV
FE <35
DTDS >30 mm/m
QRS > 150
NYHA III-IV
CHF isch ou non
Hospit dans l’année écoulée
FE<35%
Φ LVED > 60 mm
QRS >120ms
PR >150ms
Ethiologie
Fibrose tissu de conduct.
Post MI
Congénital
Chirurgical /complic. chir.
Ablation
Syndrome sinus carotid.
Cardiomyop – Myocardite
Maladie valvulaire
NYHA III-IV
CRT
QRS Long > 120 ms
FE altérée
ECG
CRT-D
NYHA III IV
FE Basse < 35%
QRS Long > 120 ms
AV Block
Block Faisceau de Hiss
Block de branche
Syndrome sinusal
Tachy atriale
Tachy ventriculaire
Life-Years Gained per Device Implanted
Saluke TV,Circulation, 2004;109:1848-1853
Meta-analysis of trials comparing ICD with control
on mortality in patients with heart failure and/or left ventricular
systolic dysfunction
Cleland JGF,The European Journal of Heart Failure 6 (2004) 501–508
All-cause mortality among patients with NICM
randomised to ICD vs medical therapy in secondary
prevention
NICM=nonischemic cardiomyopathy
Desai AS, JAMA 2004;292/2874-2879
Total annual costs of New York Heart Association
class III–IV heart failure patients
Field M, J Interv Card Electrophysiol, 2007
LV ejection fraction after CRT at 2 years survival
P<0.001
Delnoy PP., J Cardiovasc Electrophysiol, 2007(18):298-302
Number of patients with NYHA class IV heart failure
enrolled in primary prevention ICD trials
Field M, J Interv Card Electrophysiol, 2007
Effect of ICD on cardiac death in randomized controlled trials
Abdulla J.,Cardiology 2006;106:249–255
Patients With Cardiac Structural Abnormalities or
Remodeling Who Have Not Developed HF Symptoms
Class I
1. All Class I recommendations for Stage A should apply to patients with cardiac
structural abnormalities who have not developed HF. (Levels of Evidence: A, B,
and C as appropriate)
2. Beta-blockers and ACEIs should be used in all patients with a recent or remote
history of MI regardless of EF or presence of HF. (Level of Evidence: A)
3. Beta-blockers are indicated in all patients without a history of MI who have a
reduced LVEF with no HF symptoms (see Table 3 and text). (Level of Evidence:
C)
4. Angiotensin converting enzyme inhibitors should be used in patients with a
reduced EF and no symptoms of HF, even if they have not experienced MI.
(Level of Evidence: A)
Hunt SA,Circulation 2005;20: e154-e685
Patients With Cardiac Structural Abnormalities or
Remodeling Who Have Not Developed HF Symptoms
Class I
5. An ARB should be administered to post-MI patients without HF
who are intolerant of ACEIs and have a low LVEF. (Level of
Evidence: B)
6. Patients who have not developed HF symptoms should be treated
according to contemporary guidelines after an acute MI. (Level of
Evidence: C)
7. Coronary revascularization should be recommended in
appropriate patients without symptoms of HF in accordance with
contemporary guidelines (Level of Evidence: A)
8. Valve replacement or repair should be recommended for patients
with hemodynamically significant valvular stenosis or regurgitation
and no symptoms of HF in accordance with contemporary
guidelines. (Level ofEvidence: B)
Hunt SA,Circulation 2005;20: e154-e685
Patients With Cardiac Structural Abnormalities or
Remodeling Who Have Not Developed HF Symptoms
Class IIa
Placement of an ICD is reasonable in patients with ischemic
cardiomyopathy who are at least 40 days post-MI, have an LVEF
of 30% or less, are NYHA functional class I on chronic optimal
medical therapy, and 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 without HF
who have nonischemic cardiomyopathy and an LVEF less than or
equal to 30% who are in NYHA functional class I with chronic
optimal medical therapy and have a reasonable expectation of
survival with good functional status for more than 1 year.
(Level of Evidence: C)
Hunt SA,Circulation 2005;20: e154-e685
Applying Classification of Recommendations and level of evidence
Hunt SA,Circulation 2005;20: e154-e685
Major implantable ICD trials
Zipes DP,Europace 2006(8):746-837
Swedberg et al., EHJ 2005;26:1115-1140
N Engl J Med 2004;350:2140-50
Zipes DP, Europace 2006(8):746-837
Ventricular arrhythmia and sudden cardiac death related to specific pathology
Left ventricular dysfunction due to prior myocardial infarction
Recommendations for ICD implantation
Class I
Zipes DP, Europace 2006(8):746-837
Placement of an ICD is reasonable in patients with ischemic cardiomyopathy who are at least 40
days post-MI, have an LVEF of 30% or less, are NYHA functional class I on chronic optimal
medical therapy, and have reasonable expectation of survival with a good functional status for
more than 1 year.
Hunt SA,Circulation 2005;20: e154-e685
I IIa IIb III
SCD-HeFT
Bardy GH, N Engl J Med 2005;352:225-37
Patients With Current or Prior Symptoms of HF,
With Reduced LVEF
I IIa IIb III
Hunt SA,Circulation 2005;20: e154-e685
SCD-HeFT
Bardy GH, N Engl J Med 2005;352:225-37
Stage D Therapy
Recommended Therapies Include:
•Control of fluid retention
•Referral to a HF program for appropriate pts
•Discussion of options for end-of-life care
•Informing re: option to inactivate defibrillator
•Device use in appropriate patients
•Surgical therapy –
•Cardiac transplantation
•Mitral valve repair or replacement
•Other
•Drug Therapy –
•Positive inotrope infusion as palliation
in appropriate patients
(MADIT II
(MADIT II
Swedberg et al., EHJ 2005;26:1115-1140
P<0.02
AVID
N Engl J Med 1997;337:1576-83
LES RECOMMENDATIONS
Stage B Therapy:Asymptomatic LV dysfunction
ICD
I IIa IIb III
I IIa IIb III
Placement of an ICD is reasonable in patients with
ischemic cardiomyopathy who are at least 40 days
post-MI, have an LVEF of 30% or less, are NYHA
functional class I on chronic optimal medical therapy,
and have reasonable expectation of survival with a
good functional status for more than 1 year. (MADIT II)
Placement of an ICD might be considered in patients
without HF who have nonischemic cardiomyopathy
and an LVEF less than or equal to 30% who are in
NYHA functional class I with chronic optimal medical
therapy and have a reasonable expectation of survival
with good functional status for more than 1 year. (DEFINITE,
SCD-HeFT)
Hunt SA,Circulation 2005;20: e154-e685
All-cause mortality among patients with NICM
randomised to ICD or CRT-D vs medical therapy in
primary prevention
P=0.02
NICM=nonischemic cardiomyopathy
Desai AS, JAMA 2004;292/2874-2879
Placement of an ICD might be considered in patients without HF who have nonischemic
cardiomyopathy and an LVEF less than or equal to 30% who are in NYHA functional
class I with chronic optimal medical therapy and have a reasonable expectation of
survival with good functional status for more than 1 year.
Hunt SA,Circulation 2005;20: e154-e685
SCD-HeFT
I IIa IIb III
Bardy GH, N Engl J Med 2005;352:225-37
Stages of Heart Failure
At Risk for Heart Failure:
STAGE A High risk for developing HF
STAGE B Asymptomatic LV dysfunction
Heart Failure:
STAGE C Past or current symptoms of HF
STAGE D End-stage HF
Stage C Therapy:Reduced LVEF with Symptoms
Recommended Therapies:
•General measures as advised for Stages A and B
•Drug therapy for all patients
•Diuretics for fluid retention
•ACEI
•Beta-blockers
•Drug therapy for selected patients
•Aldosterone Antagonists
•ARBs
•Digitalis
•Hydralazine/nitrates
•ICDs in appropriate patients
•Cardiac resynchronization in appropriate patients
•Exercise Testing and Training
Stage C Therapy:Reduced LVEF with Symptoms
ICD
I IIa IIb III
I IIa IIb III
An ICD is recommended as secondary prevention to
prolong survival in patients with current or prior
symptoms of HF and reduced LVEF who have a history of
cardiac arrest, ventricular fibrillation, or hemodynamically
destabilizing ventricular tachycardia. (AVID)
ICD therapy is recommended for primary prevention to
reduce total mortality by a reduction in sudden cardiac
death in patients with ischemic heart disease who are at
least 40 days post-MI, have an LVEF less than or equal to
30%, with NYHA functional class II or III symptoms while
undergoing chronic optimal medical therapy, and have
reasonable expectation of survival with a good functional
status for more than 1 year. (MADIT II)
Hunt SA,Circulation 2005;20: e154-e685
Patients With Current or Prior Symptoms of HF,
With Reduced LVEF
I IIa IIb III
Hunt SA,Circulation 2005;20: e154-e685
P<0.02
N Engl J Med 1997;337:1576-83
Stage C Therapy:Reduced LVEF with Symptoms
ICD
I IIa IIb III
ICD therapy is recommended for primary prevention to
reduce total mortality by a reduction in sudden cardiac
death in patients with nonischemic cardiomyopathy who
have an LVEF less than or equal to 30%, with NYHA
functional class II or III symptoms while undergoing
chronic optimal medical therapy, and who have
reasonable expectation of survival with a good functional
status for more than 1 year. (DEFINITE; SCD-HeFT)
I IIa IIb III
Placement of an ICD is reasonable in patients with LVEF
of 30% to 35% of any origin with NYHA functional class II
or III symptoms who are taking chronic optimal medical
therapy and who have reasonable expectation of survival
with good functional status of more than 1 year.
Hunt SA,Circulation 2005;20: e154-e685
Patients With Current or Prior Symptoms of HF,
With Reduced LVEF
I IIa IIb III
Hunt SA,Circulation 2005;20: e154-e685
SCD-HeFT
Bardy GH, N Engl J Med 2005;352:225-37
Patients With Current or Prior Symptoms of HF,
With Reduced LVEF
I IIa IIb III
Hunt SA,Circulation 2005;20: e154-e685
MADIT II
SCD-HeFT
Bardy GH, N Engl J Med 2005;352:225-37
Moss AJ, N Engl J Med 2002;346:877-883
SCD-HeFT
Trials overview
Mortalité groupe
Etudes
# patients
Age
Coronariens
FE
Suivi (mois)
MADIT
196
63
100
≤ 35
27
17
54
MUSTT
704
66
100
≤ 40
39
14
51
MADIT II
1232
64
100
≤ 30
20
19
31
COMPANION
1520
67
59
≤ 35
15
19
36
DEFINITE
458
58
0
≤ 35
29
7
35
SCD-HeFT
2521
60
52
≤ 35
46
7
23
DINAMIT
674
62
100
≤ 35
30
8
neg
Arch maladies du coeur et des vaisseaux 99, 2 141-154
contrôle
RRR
NNT Défibrillateurs
NNT HF studies
NNT
0
30
30
5
25
25
0
20
20
5
15
15
0
5
0
26
10
10
14
14
5
7.5
5
0
COMPANION
SCD-HeFT CARE-HF
3.3 ans
DAI
17
11
20
14
MADIT II
MADIT II
COPERNICUS
1 ans
2 ans
1 an
3.5 ans
DAI
DAI
Carvedilol
Captopril
Aurrichio et al, Circulation 2004, 109; 300 - 307
SAVE
MERIT-HF
1 an
Succinate
de
metoprolol
Le NNT des def. diminue avec le
temps
133
133
140
123
120
100
1 an
80
2 ans
60
3 ans
40
24
21
20
11
3.3 1.7
8 4.6
11
17
8
11
15
5.6
4.7 2.5
0
MADIT
AVID
CIDS
MADIT II
CASH
MUSTT
Lifeyears gained from ICD implantation
Saluke TV,Circulation, 2004;109:1848-1853
Brugada syndrome
Recommendations for ICD implantation
Class I
Class IIa
Class IIa
Zipes DP, Europace 2006(8):746-837
Long QT syndrome
Recommendations for ICD implantation
Class I
Class IIa
Class IIb
Zipes DP, Europace 2006(8):746-837
The CRT trials
Behan MW,Int J Clin Pract, 2006, 60, 9, 1107–1114
Indications majeures de Défibrillateurs
Classe
Arrêt cardiaque

•
•
•
I
A
I
B
I
B
I
B
IIa
B
I
B
I
B
IIa
B
IIa
B
sur cardiopathie symptomatique
TV soutenue spontanée II

•
•
•
mal tolérée
TR ou ablation ayant échoué
sans anomalie cardiaque
Syncope

•
•
•
sans cause connue
avec TV soutenue ou FV déclenchable
avec anomalie cardiaque
Patient avec maladie génétique

•
•
à haut risque de mort subite par FV
sans TRx connu
Coronariens I

•
•
•
1 mois après IM et 3 mois après
revascularisation
FE ≤ 35%
arythmie ventriculaire déclenchable
Coronariens II

•
Cardiopathies
VF ou TV
sans causes aiguë ou réversible
TV soutenue spontanée I

Trouble du
rythme
ventriculaire
documenté
Preuve Remboursement
•
•
1 mois post IM et 3 mois après
revascularisation
FE≤30%
NYHA II ou III
Insuffisance cardiaque
•
•
•
•
NYHA III ou IV
FE ≤ 35%
QRS ≥ 120 ms
TMO
Cardiomyopathie dilatée

•
FE ≤ 35%
Class III
J Am Coll Cardiol 2002;40:1703–19
HOSPITALISATION
Symptoms
Class I A
Class I A
J Am Coll Cardiol 2002;40:111– 8
MIRACLE
Class I A
N Engl J Med 2002;346:1845-53
MADIT II
P=0.007
Moss AJ, N Engl J Med 2002;346:877-883
Class I (A)
MADIT II
Swedberg et al., EHJ 2005;26:1115-1140
DEFINITE
Moss AJ, N Engl J Med 2002;346:877-883
SCD-HeFT
Kadish A, N Engl J Med 2004;350:2151-2158
Bardy GH, N Engl J Med 2005;352:225-237
SCD-HeFT trial
DEFINITE
DEFINITE
P=0.006
Kadish A, N Engl J Med 2004;350:2151-2158
Bardy GH, N Engl J Med 2005;352:225-37