Prof L DE ROY Université de Louvain Université de Louvain CLINIQUES UNIVERSITAIRES UCL DE MONT-GODINNEBelgique QUAND PROPOSER UN TRAITEMENT ELECTRIQUE.

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)

P=0.009

Moss AJ, N Engl J Med 1996;335:1933-40

Buxton AE,, N Engl J Med 1999

MADIT I

MADIT II

P=0.007

LVEF≤35%

LVEF≤30%

MUSTTClass II a (B)

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

MIRACLE

MUSTIC

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

CARE-HF trial : extension phase

Cleland et al Eur Heart J 2006;27:1928-32

All cause mortality

Worsening heart failure

Sudden cardiac death

ICD – ICD +CRT

(COMPANION)

(AVID)

(MADIT II/SCD HeFT)

Class II a (B)

Class I (A)

ICD +CRT

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

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

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

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

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

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

sustained LV remodeling means LV end systolic volume (LVESV) reduction of 10%

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

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)

[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

Contrôle Thérapie CRT-P

http://www.care-hf.com

p = 0.002

COMPANION

1.520 patients

(128 centres au Etats-Unis)

[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

Contrôle Thérapie CRT-D

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

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

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

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)

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)

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)

Applying Classification of Recommendations and level of evidence

Major implantable ICD trials

Zipes DP,Europace 2006(8):746-837

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

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.

SCD-HeFT

Bardy GH, N Engl J Med 2005;352:225-37

Patients With Current or Prior Symptoms of HF, With Reduced LVEF

SCD-HeFT

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

N Engl J Med 1997;337:1576-83

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)

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.

SCD-HeFT

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

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)

N Engl J Med 1997;337:1576-83

P<0.02

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.

Stage C Therapy:Reduced LVEF with SymptomsICD

SCD-HeFT

Hunt SA,Circulation 2005;20: e154-e685MADIT II

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

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

3.3 ans

Le NNT des def. diminue avec le Le NNT des def. diminue avec le tempstemps

123133 133

114.71.7 4.6

11 8 5.6 2.5

MADIT AVID CIDS MADIT II CASH MUSTT

Saluke TV,Circulation, 2004;109:1848-1853

Lifeyears gained from ICD implantation

Brugada syndrome Recommendations for ICD implantation

Class I

Class IIa

Long QT syndromeRecommendations for ICD implantation

Class I

Class IIb

Class IIa

The CRT trialsB

,Int J C

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

Trouble du rythme ventriculaire documenté

Remboursement

Cardiopathies

Class III

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

SCD-HeFT

DEFINITE

MADIT II

Kadish A, N Engl J Med 2004;350:2151-2158

Class I (A)

SCD-HeFT trial DEFINITE

P=0.006

Kadish A, N Engl J Med 2004;350:2151-2158

DEFINITE

Prof L DE ROY Université de Louvain Université de Louvain CLINIQUES UNIVERSITAIRES UCL DE MONT-GODINNEBelgique QUAND PROPOSER UN TRAITEMENT ELECTRIQUE.

j nyha

ms fe altre nyha

ms lved

qrs165 ms qrs

qrs160 ms qrs

amlioration nyha

sem nyha

patients tmo

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