Prof L DE ROY Prof L DE ROY Université de Université de Louvain Louvain CLINIQUES UNIVERSITAIRES UCL DE MONT-GODINNE Belgique Belgique QUAND PROPOSER UN QUAND PROPOSER UN TRAITEMENT ELECTRIQUE ? TRAITEMENT ELECTRIQUE ?
Apr 03, 2015
Prof L DE ROYProf L DE ROYUniversité de Louvain Université de Louvain
CLINIQUES UNIVERSITAIRES UCL DE
MONT-GODINNE
BelgiqueBelgique
QUAND PROPOSER UN QUAND PROPOSER UN TRAITEMENT ELECTRIQUE ?TRAITEMENT ELECTRIQUE ?
J Am Coll Cardiol 2002;40:1703–19
Recommendations for ICD Therapy
Class I (A)
J Am Coll Cardiol 2002;40:1703–19
P=0.009
Moss AJ, N Engl J Med 1996;335:1933-40
Buxton AE,, N Engl J Med 1999
MADIT I
MADIT II
Moss AJ, N Engl J Med 2002;346:877-83
P=0.007
LVEF≤35%
LVEF≤30%
MUSTTClass II a (B)
J Am Coll Cardiol 2002;40:1703–19
N Engl J Med 2001;344:873-80
N Engl J Med 2002;346:1845-53
Pacing Recommendations for Dilated Cardiomiopathy
P=0.03
P<0.001
P<0.001
MIRACLE
MUSTIC
MUSTIC
Swedberg et al., EHJ 2005;26:1115-1140
Swedberg et al., EHJ 2005;26:1115-1140
CRT Pacemakers
N Engl J Med 2004;350:2140-50CRTP -CRTD
Cleland JG, N Engl J Med 2005;352:1539-1549
Class I B
CRTP
CARE-HF trial : extension phase
Cleland et al Eur Heart J 2006;27:1928-32
All cause mortality
Worsening heart failure
Sudden cardiac death
Swedberg et al., EHJ 2005;26:1115-1140
ICD – ICD +CRT
(COMPANION)
(AVID)
(MADIT II/SCD HeFT)
Class II a (B)
Class I (A)
Class I (A)
ICD +CRT
ICD
Class II a (B)
Hunt SA,Circulation 2005;20: e154-e685
Cardiac Resynchronization (CRTP / CRTD)
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
Stage C Therapy:Reduced LVEF with Symptoms
Hunt SA,Circulation 2005;20: e154-e685
The use of an ICD in combination with CRT should be based on the indications for ICD therapy.
CARE-HF
Stage D Therapy
Patients with refractory end-stage HF and implantable defibrillators should receive information about the option to inactivate defibrillation.
Inform on option to inactivate defibrillation
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
Boriani G., J Interv Card Electrophysiol 2007
Characteristics of patients enrolled and QRS eligibility criteria of the major RCTs on CRT
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 Qu’en est-il de l’asynchronisme et QRS finsfins
Bleeker GB, J Am Coll Cardiol 2006;48:2243–50
Magnitude of Improvement in Clinical and Echocardiographic Parameters After CRT*
n =33 n =33
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.
Left ventricular ejection fraction Yu CM.,J Am Coll Cardiol 2006;48:2251–7
N=102
Qu’en est-il de la classe IV
Time to mode of death by treatment arm for NYHA class IV in COMPANION trial
A. Time to sudden death
Lindenfeld JA, Circulation. 2007;115:204-212
B. Time to HF death
N=217CRTDCRT
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 CRTCRTD VS CRT
META-ANALYSIS OF COMPANION + META-ANALYSIS OF COMPANION + ERMIS:ERMIS:
ALL CAUSE MORTALITY: ALL CAUSE MORTALITY:
OR = 0.69 (0.53,0.91) P= 0.008OR = 0.69 (0.53,0.91) P= 0.008
ABDULLA 2006ABDULLA 2006
Estimated annualized sudden cardiac death rates in patients with nonischemic dilated cardiomyopathy receiving medical therapy
Field M, J Interv Card Electrophysiol, 2007
NNT ResynchronisationNNT Resynchronisation
1 an 3 ans 1 an 3.5 ans 1 an
CRT-D CRT-P Carvedilol Captopril 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
Delnoy PP., J Cardiovasc Electrophysiol, 2007(18):298-302
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%
Lin
den
feld JA
, Circu
lation. 2007;115:204-212
NYHA class IV endpoints by treatment arm in COMPANION trial
Primary time to all-cause death or hospitalization Secondary time to all-cause death
Time to all-cause death or HF hospitalization
N=217
Death among patients with AF randomized to CRT vs RV pacing
Bradley DJ.,Heart Rhythm 2007;4:224 –232
MUSTIC–AF: Multisite Stimulation in Cardiomyopathy Study–Atrial FibrillationPAVE: Post AV Nodal Ablation Evaluation OPSITE: Optimal Pacing SITE Study
CRT: 49% reduction in the relative risk of all-cause mortality p=0.547
Results of cardiac resynchronization in CHF from CRT*
*with estimated extent of effect
Boriani G., J Interv Card Electrophysiol, 2007
Abdulla J.,Cardiology 2006;106:249–255
Effect of CRT on all-cause mortality
Identification des patients: les études en Identification des patients: les études en resynchronisationresynchronisation
MIRACLEMIRACLE NYHA III-IVNYHA III-IV FE< 35%FE< 35% QRS > 130 msQRS > 130 ms ΦΦ LVED > 55mm LVED > 55mm Rythme sinusalRythme sinusal
CARE-HFCARE-HF
NYHA III-IV (+ de 6 sem)NYHA III-IV (+ de 6 sem) Ischémique ou non Ischémique ou non DTDS > 30 mm/m²DTDS > 30 mm/m² FE <35%FE <35% QRS > 120 msQRS > 120 ms
Si 120 <QRS>149 msSi 120 <QRS>149 ms2 des critères suivants sont requis:2 des critères suivants sont requis:• Retard pré-éjection Ao > 140 msRetard pré-éjection Ao > 140 ms• Délai inter-vent mécan.> 40 msDélai inter-vent mécan.> 40 ms• Retard activation postéro-lat. Retard activation postéro-lat.
paroi vent. gauche paroi vent. gauche Rythme sinusalRythme sinusal
CRT - P CRT
COMPANIONCOMPANION
NYHA III-IVNYHA III-IV CHF isch ou nonCHF isch ou non Hospit dans l’année écouléeHospit dans l’année écoulée FE<35%FE<35% ΦΦ LVED > 60 mm LVED > 60 mm QRS >120ms QRS >120ms PR >150msPR >150ms Rythme sinusalRythme sinusal
CRT - D
1. Amélioration NYHA, périmètre de marche, QoL.
2. Réduit les hospitalisations pour IC et toutes causes
1. Réd. Mortalité tt causes - 36%
2. Réd. Hospitalisations - 52%
3. Amélioration des symptômes
4. Amélioration des capacités d’effort
1. Réduction de la mortalité -36%
2. Réduc. Hospitalisations -37%
Bénéfices
Devices
Patients
CARE-HF
813 patients
(82 centres en Europe)
TMO
[404 patients]
TMO + CRT-P
[409 patients]
Critères d’inclusion :- NYHA III-IV, -QRS > 120ms, - LVEDD > 30 mm -FE < 35%.
Objectifs primaires : - mortalité - hospitalisation pour cause cardiovasculaire
Etiologie HF 38% ischémique
Fraction d’éjection 26%
NYHA 1-2-3-4 [%] 0 – 0 – 94 – 6
Durée du suivi 29.4 mois
Arythmies auriculaires 21%
Historique de diabète 21%
Durée du QRS 165 ms
QRS > 120 ms 100%
Test de marche 6 min -
ACE I 80%
Bétabloquant 72%
Diurétique 99%
Spironolactone 56%
Statine 39%
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
Pourcentage de mortalité
30.0%
20.0%
0.0%
10.0%
20.0%
30.0%
40.0%
Contrôle Thérapie CRT-P
http://www.care-hf.com
- 36%
p = 0.002
COMPANION
1.520 patients
(128 centres au Etats-Unis)
TMO
[308 patients]
TMO + CRT-P
[617 patients]
Critères d’inclusion :-NYHA III-IV, -QRS > 120 ms,- PR interval > 150ms, -LVEDD > 60mm - EF < 35%.
Objectifs primaires : mortalité ou hospitalisation
Etiologie HF 59% ischémique
Fraction d’éjection 22%
NYHA 1-2-3-4 [%] 0 – 0 – 86 – 14
Durée du suivi 12 mois
Arythmies auriculaires -
Historique de diabète 41%
Durée du QRS 160 ms
QRS > 120 ms 100%
Test de marche 6 min 258 m
ACE I 69%
Bétabloquant 68%
Diurétique 97%
Spironolactone 55%
Statine -
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
TMO + CRT-D
[595 patients]
Pourcentage de mortalité
19.0%
12.0%
0.0%
10.0%
20.0%
30.0%
40.0%
Contrôle Thérapie CRT-D
- 36%
p = 0.003
Mort subite
TV soutenue
Patient IC symptomat.
FE Basse < 30 – 35%
Post MI > 40 j
NYHA III-IV
QRS Long > 120 ms
FE altérée
NYHA III IV
FE Basse < 35%
QRS Long > 120 ms
Critères d’inclusion ESC Critères d’inclusion ESC RemboursementsRemboursements
MADIT II
CARE HF
COMPANION
Pt NYHA I-IIIFE <30%Post infar asymptLVD
Pt NYHA III-IVFE <35DTDS >30 mm/mQRS > 150
NYHA III-IVCHF isch ou nonHospit dans l’année écouléeFE<35%Φ LVED > 60 mmQRS >120ms PR >150ms
Mort subite
TV soutenue
CRT-D
DAI
DAI
CRT
SymptômesSymptômesSyncope Syncope Périodes de vertigePériodes de vertigeBradycardieBradycardieProphylaxieProphylaxieHFHFDysfonction cérébraleDysfonction cérébrale
EthiologieEthiologieFibrose tissu de conduct.Fibrose tissu de conduct.Post MIPost MICongénitalCongénitalChirurgical /complic. chir.Chirurgical /complic. chir.AblationAblationSyndrome sinus carotid.Syndrome sinus carotid.Cardiomyop – MyocarditeCardiomyop – MyocarditeMaladie valvulaireMaladie valvulaire
ECGECGAV BlockAV BlockBlock Faisceau de HissBlock Faisceau de HissBlock de brancheBlock de brancheSyndrome sinusalSyndrome sinusalTachy atrialeTachy atrialeTachy ventriculaireTachy ventriculaire
AVIDPt survivants de FVFV avec syncopeFV avec FE < 40% + sympt
Pt NYHA I-IIIFE <35%Post infar asymptTachy vent
MADIT I
Pt CHF FE<35%NYHA II-III
SCD- HeFT
Remboursements
Saluke TV,Circulation, 2004;109:1848-1853
Life-Years Gained per Device Implanted
Cleland JGF,The European Journal of Heart Failure 6 (2004) 501–508
Meta-analysis of trials comparing ICD with control on mortality in patients with heart failure and/or left ventricular
systolic dysfunction
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
Delnoy PP., J Cardiovasc Electrophysiol, 2007(18):298-302
P<0.001
Number of patients with NYHA class IV heart failure enrolled in primary prevention ICD trials
Field M, J Interv Card Electrophysiol, 2007
Abdulla J.,Cardiology 2006;106:249–255
Effect of ICD on cardiac death in randomized controlled trials
Patients With Cardiac Structural Abnormalities or Remodeling Who Have Not Developed HF Symptoms
Class I1. 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 I5. 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 IIaPlacement 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 IIbPlacement 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 pathologyLeft 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
SCD-HeFT
Bardy GH, N Engl J Med 2005;352:225-37
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
Patients With Current or Prior Symptoms of HF, With Reduced LVEF
Hunt SA,Circulation 2005;20: e154-e685
SCD-HeFT
Bardy GH, N Engl J Med 2005;352:225-37
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
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
N Engl J Med 1997;337:1576-83
AVID
P<0.02
LES RECOMMENDATIONS
Stage B Therapy:Asymptomatic LV dysfunction
Placement of an ICD is reasonable in patients withischemic cardiomyopathy who are at least 40 dayspost-MI, have an LVEF of 30% or less, are NYHAfunctional 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 patientswithout HF who have nonischemic cardiomyopathyand an LVEF less than or equal to 30% who are inNYHA functional class I with chronic optimal medicaltherapy and have a reasonable expectation of survival
with good functional status for more than 1 year. (DEFINITE, SCD-HeFT)
ICD
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
Hunt SA,Circulation 2005;20: e154-e685
Desai AS, JAMA 2004;292/2874-2879
All-cause mortality among patients with NICM randomised to ICD or CRT-D vs medical therapy in
primary prevention
NICM=nonischemic cardiomyopathy
P=0.02
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
Bardy GH, N Engl J Med 2005;352:225-37
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
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
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
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)
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
Stage C Therapy:Reduced LVEF with Symptoms
Hunt SA,Circulation 2005;20: e154-e685
ICD
Patients With Current or Prior Symptoms of HF, With Reduced LVEF
Hunt SA,Circulation 2005;20: e154-e685
N Engl J Med 1997;337:1576-83
P<0.02
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
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)
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.
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
Stage C Therapy:Reduced LVEF with SymptomsICD
Hunt SA,Circulation 2005;20: e154-e685
Patients With Current or Prior Symptoms of HF, With Reduced LVEF
Hunt SA,Circulation 2005;20: e154-e685
SCD-HeFT
Bardy GH, N Engl J Med 2005;352:225-37
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
Patients With Current or Prior Symptoms of HF, With Reduced LVEF
Hunt SA,Circulation 2005;20: e154-e685MADIT II
Moss AJ, N Engl J Med 2002;346:877-883
Bardy GH, N Engl J Med 2005;352:225-37
SCD-HeFT
SCD-HeFT
Trials overviewTrials overview
EtudesEtudes # patients# patients AgeAge CoronariensCoronariens FEFE Suivi Suivi (mois)(mois)Mortalité Mortalité groupe groupe
contrôlecontrôle RRRRRR
MADITMADIT 196196 6363 100100 ≤≤ 3535 2727 1717 5454
MUSTTMUSTT 704704 6666 100100 ≤≤ 4040 3939 1414 5151
MADIT IIMADIT II 12321232 6464 100100 ≤≤ 3030 2020 1919 3131
COMPANIONCOMPANION 15201520 6767 5959 ≤≤ 3535 1515 1919 3636
DEFINITEDEFINITE 458458 5858 00 ≤≤ 3535 2929 77 3535
SCD-HeFTSCD-HeFT 25212521 6060 5252 ≤≤ 3535 4646 77 2323
DINAMITDINAMIT 674674 6262 100100 ≤≤ 3535 3030 88 negneg
Arch maladies du coeur et des vaisseaux 99, 2 141-154
NNT DéfibrillateursNNT Défibrillateurs
14
0
5
10
15
20
25
30
SCD-HeFT
1 ans 2 ans 1 an 3.5 ans 1 an
DAI DAI Carvedilol Captopril Succinate de
metoprololAurrichio et al, Circulation 2004, 109; 300 - 307
5
10
15
20
25
30
NNT
3.3 ans
DAI
Le NNT des def. diminue avec le Le NNT des def. diminue avec le tempstemps
11
21
123133 133
15
3.38
2417
114.71.7 4.6
11 8 5.6 2.5
0
20
40
60
80
100
120
140
MADIT AVID CIDS MADIT II CASH MUSTT
1 an
2 ans
3 ans
Saluke TV,Circulation, 2004;109:1848-1853
Lifeyears gained from ICD implantation
Brugada syndrome Recommendations for ICD implantation
Class I
Class IIa
Class IIa
Zipes DP, Europace 2006(8):746-837
Long QT syndromeRecommendations for ICD implantation
Zipes DP, Europace 2006(8):746-837
Class I
Class IIb
Class IIa
The CRT trialsB
ehan
MW
,Int J C
lin P
ract, 2006, 60, 9, 1107–1114
Indications majeures de DéfibrillateursIndications majeures de Défibrillateurs Arrêt cardiaqueArrêt cardiaque
• VF ou TV VF ou TV • sans causes aiguë ou réversiblesans causes aiguë ou réversible
TV soutenue spontanée I TV soutenue spontanée I • sur cardiopathie symptomatiquesur cardiopathie symptomatique
TV soutenue spontanée II TV soutenue spontanée II • mal toléréemal tolérée• TR ou ablation ayant échouéTR ou ablation ayant échoué• sans anomalie cardiaquesans anomalie cardiaque
Syncope Syncope • sans cause connuesans cause connue• avec TV soutenue ou FV déclenchable avec TV soutenue ou FV déclenchable • avec anomalie cardiaqueavec anomalie cardiaque
Patient avec maladie génétiquePatient avec maladie génétique• à haut risque de mort subite par FVà haut risque de mort subite par FV• sans TRx connusans TRx connu
Coronariens ICoronariens I• 1 mois après IM et 3 mois après 1 mois après IM et 3 mois après
revascularisationrevascularisation• FE ≤ 35%FE ≤ 35%• arythmie ventriculaire déclenchablearythmie ventriculaire déclenchable
Coronariens IICoronariens II• 1 mois post IM et 3 mois après 1 mois post IM et 3 mois après
revascularisationrevascularisation• FE≤30%FE≤30%• NYHA II ou IIINYHA II ou III
Insuffisance cardiaqueInsuffisance cardiaque• NYHA III ou IVNYHA III ou IV• FE ≤ 35%FE ≤ 35%• QRS ≥ 120 msQRS ≥ 120 ms• TMOTMO
Cardiomyopathie dilatéeCardiomyopathie dilatée• FE ≤ 35%FE ≤ 35%• NYHA II ou IIINYHA II ou III
Classe Preuve
I A
I B
I B
I B
IIa B
I B
I B
IIa B
IIa B
Trouble du rythme ventriculaire documenté
Remboursement
Cardiopathies
Class III
J Am Coll Cardiol 2002;40:1703–19
J Am Coll Cardiol 2002;40:111– 8
Symptoms
HOSPITALISATION
Class I A Class I A
N Engl J Med 2002;346:1845-53
MIRACLE
Class I A
P=0.007
MADIT II
Moss AJ, N Engl J Med 2002;346:877-883
Swedberg et al., EHJ 2005;26:1115-1140
SCD-HeFT
DEFINITE
MADIT II
Bardy GH, N Engl J Med 2005;352:225-237
Kadish A, N Engl J Med 2004;350:2151-2158
Moss AJ, N Engl J Med 2002;346:877-883
Class I (A)
Bardy GH, N Engl J Med 2005;352:225-37
SCD-HeFT trial DEFINITE
P=0.006
Kadish A, N Engl J Med 2004;350:2151-2158
DEFINITE