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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
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QUAND PROPOSER UN TRAITEMENT ELECTRIQUE ? Prof L DE ROY Université de Louvain CLINIQUES UNIVERSITAIRES UCL DE MONT-GODINNE Belgique
Recommendations for ICD Therapy LVEF≤35% Class I (A) MADIT I P=0.009 Moss AJ, N Engl J Med 1996;335:1933-40 Buxton AE,, N Engl J Med1999 MUSTT Class II a (B) 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
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
Stage C Therapy:Reduced LVEF with Symptoms Cardiac Resynchronization (CRTP / CRTD) 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 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
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
Time to mode of death by treatment arm for NYHA class IV in COMPANION trial N=217 CRTD CRT 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
NNT 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
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 Primary time to all-cause death or hospitalization Secondary time to all-cause death N=217 Lindenfeld JA, Circulation. 2007;115:204-212 Time to all-cause death or HF 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 CARE-HF • 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 • Rythme sinusal COMPANION • NYHA III-IV • CHF isch ou non • Hospit dans l’année écoulée • FE<35% • Φ LVED > 60 mm • QRS >120ms • PR >150ms • Rythme sinusal • MIRACLE • NYHA III-IV • FE< 35% • QRS > 130 ms • Φ LVED > 55mm • Rythme sinusal Devices CRT CRT - D CRT - P Bénéfices • Amélioration NYHA, périmètre de marche, QoL. • Réduit les hospitalisations pour IC et toutes causes • Réd. Mortalité tt causes - 36% • Réd. Hospitalisations - 52% • Amélioration des symptômes • Amélioration des capacités d’effort • Réduction de la mortalité -36% • Réduc. Hospitalisations -37%
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% CARE-HF • Critères d’inclusion : • - NYHA III-IV, • QRS > 120ms, • LVEDD > 30 mm • FE < 35%. • Objectifs primaires : • - mortalité - hospitalisation pour cause cardiovasculaire - 36% 813 patients (82 centres en Europe) p = 0.002 TMO [404 patients] TMO + CRT-P [409 patients] 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
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 - COMPANION • Critères d’inclusion : • NYHA III-IV, • QRS > 120 ms, • PR interval > 150ms, • LVEDD > 60mm • EF < 35%. • Objectifs primaires : mortalité ou hospitalisation 1.520 patients (128 centres au Etats-Unis) - 36% TMO [308 patients] TMO + CRT-P [617 patients] TMO + CRT-D [595 patients] p = 0.003 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
Remboursements Critères d’inclusion ESC Remboursements 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 Mort subite TV soutenue Pt survivants de FV FV avec syncope FV avec FE < 40% + sympt DAI AVID Pt NYHA I-III FE <35% Post infar asympt Tachy vent MADIT I Pt CHF FE<35% NYHA II-III DAI SCD- HeFT Pt NYHA I-III FE <30% Post infar asympt LVD MADIT II Symptômes Syncope Périodes de vertige Bradycardie Prophylaxie HF Dysfonction cérébrale Ethiologie Fibrose tissu de conduct. Post MI Congénital Chirurgical /complic. chir. Ablation Syndrome sinus carotid. Cardiomyop – Myocardite Maladie valvulaire ECG AV Block Block Faisceau de Hiss Block de branche Syndrome sinusal Tachy atriale Tachy ventriculaire Pt NYHA III-IV FE <35 DTDS >30 mm/m QRS > 150 CARE HF CRT NYHA III-IV CHF isch ou non Hospit dans l’année écoulée FE<35% Φ LVED > 60 mm QRS >120ms PR >150ms COMPANION CRT-D
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