2. DAI BIVENTRICULAIRE La solution à tous les problèmes ? Julien Laborderie CHU Haut Lévèque Service Pr Clémenty

3. Mortalité dans l‘insuffisance cardiaque all-cause mortality: 81.5% CV death non CV death 18.5% Publications reporting all-cause mortality, CV death, SCD, death by progression of HF (N= 20728 pts, control groups, 16 studies) Consensus, Solvd T, Solvd P, Save, Aire, Trace, Rales, Ephesus, Cibis, S Carvedilol, Merit HF, Cibis II, Best, Capricorn, Copernicus, Comet

4. Sudden Cardiac Death 42% HF Progression 36% Other CV death Publications reporting all-cause mortality, CV death, SCD, death by progression of HF (N= 20‘728 pts, control groups, 16 studies) Consensus, Solvd T, Solvd P, Save, Aire, Trace, Rales, Ephesus, Cibis, US Carvedilol, Merit HF, Cibis II, Best, Capricorn, Copernicus, Comet Mortalité dans l‘insuffisance cardiaque

5. Décès en fonction de la classe NYHA MERIT-HF Study Group. Effect of metoprolol CR/XL in chronic heart failure: metoprolol CR/XL randomized intervention trial in congestive heart failure (MERIT-HF). LANCET. 1999;353:2001-07. NYHA II 12% 64% 24% CHF Other Sudden Death Deaths = 103 NYHA IV 56% 11% 33% CHF Other Sudden Death Deaths = 27 NYHA III 26% 15% 59% CHF Other Sudden Death Deaths = 232

6. I.E.C b-BLOQUANTS ALDACTONE (EPLERENONE?) NITRÉS +/- Digoxine si FA RESYNCHRO+/- DEF ASSISTANCE CIRCULATOIRE - TRANSPLANTATION Asymptomatique symptomatique sévère réfractaire Optimisation du traitement médicamenteux RÈGLES HYGIÉNO-DIÉTÉTIQUES - ÉDUCATION THÉRAPEUTIQUE DIURETIQUE DE L’ANSE L’insuffisance cardiaque

7. Défibrillateur Bi-ventriculaire Concept Assurer à l ’aide d ’une seule prothèse implantable les fonctions: d ’un stimulateur multisite d ’un défibrillateur automatique Avec pour objectifs d ’améliorer la qualité de vie (hémodynamique), et de réduire la mortalité (hémodynamique, événements arythmiques ventriculaires)

8. Prévalence et valeur pronostique de la désynchronisation ventriculaire 41% Schoeller 53% Aaronson 27% Aaronson 46% Lamp 31% Shamim 0 50 100 150 200 <120 ms >120 ms Nombre de patients 60% 70% 80% 90% 100% 060120180240300360 Days in Trial Cumulative Survival QRS Duration (msec) <90 90-120 -170 -220 >220 Adapted from Gottipaty et al. 60% 70% 80% 90% 100% 060120180240300360 Days in Trial Cumulative Survival QRS Duration ( msec ) <90 90-120 -170 -220 >220 Adapted from Gottipaty et al. 200 250 300 350 (ms) PR 50 100 150 040201030 QRS Xiao: International Journal of Cardiology 1996; 53, 163-70

9. RV pacing LV pacing BBB PROXIMAL OU DISTAL CONDUCTION ALTEREE ANOMALIE DE CONTRACTION AMELIORATION DE LA CONTRACTION SINUSAL BIV CONCEPT Cazeau S Cazeau S (PACE 94;17(Pt. II):1974-79) RSYNCHRONISATION Concept de la resynchronisation

11. CRT dans l’insuffisance cardiaque Qualité de vie Diminution de la mortalité

12. Study (n) NYHAQRSSinusICD?StatusResults MIRACLE (453) III, IV  130 NormalNoPublished+ MUSTIC SR (58) III  150 NormalNoPublished+ MUSTIC AF (43) III  200* AFNoPublished+ PATH CHF (41) III, IV  120 NormalNoPublished+ MIRACLE ICD (369) III-IV  130 NormalYesPublished+ CONTAK CD (227) II-IV  120 NormalYesPublished+ MIRACLE ICD II (186) II  130 NormalYesPublished+ PATH CHF II (89) III, IV  120 NormalY/NoPublished+ COMPANION (1520) III, IV  120 NormalNoPublished+ CARE HF (813) III, IV  120 † NormalNoPublished+ * RV paced QRS † Echo-based criteria for QRS < 150 msec LVEF  35% for all trials 3800 patients included !!! CRT Improves: NYHA Class, Quality of life score (MLWHF), Exercise Capacity: 6 MW, Peak VO2 LV function: EF, MR Reverse remodeling: LVEDV Hospitalization, Mortality 30% of non responder patients !! La resynchronisation cardiaque

13. Cardiac Resynchronisation in Heart Failure CARE-HF Baseline Evaluation Randomization (1:1) OMT CRT (CRT+OMT) Minimum 18 Months Follow-up 813 patients, 82 centers,12 countries, FU: 29.4 M NYHA class III/IV, EF  35% QRS  150 ms or Echo if QRS 120-149 ms

14. CRT Medical Therapy 01600 0.00 0.25 0.50 0.75 1.00 Survival Time (days) 4008001200 CRT = 38 HF deaths (9.3%) Medical Therapy = 64 HF deaths (15.8%) Hazard Ratio 0.55 (95% CI 0.37 to 0.82; P=0.003) Cardiac Resynchronisation in Heart Failure CARE-HF Diminution de la mortalité globale

15. CRT Medical Therapy 01600 0.00 0.25 0.50 0.75 1.00 Survival Time (days) 4008001200 CRT = 32 sudden deaths (7.8%) Medical Therapy = 54 sudden deaths (13.4%) Hazard Ratio 0.54 (95% CI 0.35 to 0.84; P=0.006) Cardiac Resynchronisation in Heart Failure CARE-HF

17. DAI: prévention secondaire VT/VF Patients ICD Therapy vs. AA Drugs AVID CIDS CASH

18. * Non-significant results. 1 The AVID Investigators. N Engl J Med. 1997;337:1576-1583. 2 Kuck K. Circulation. 2000;102:748-754. 3 Connolly S. Circulation. 2000;101:1297-1302. DAI: prévention secondaire 12 3 31% 56% 23% 58% 20%* 33% % Mortality Reduction w/ ICD Rx 3 Years4.75 Years 3 Years

19. Prévention primaire Post-infarctus tardif MADIT Multicenter Automatic Defibrillator Implantation Trial Moss AJ. N Engl J Med 1996:335:1933-40. MUSTT Multicenter Unsustained Tachycardia Trial Buxton AE. N Engl J Med. 1999;341:1882-90. MADIT-II Multicenter Automatic Defibrillator Implantation Trial-II Moss AJ. N Engl J Med. 2002;346:877-83.

20. 1232 pts: 742 ICD Rx 490 Conv.Rx 31% reduction in mortality with ICD Rx (20 months mean follow-up) 55-60% reduction in mortality with ICD Rx (39 months mean follow- up) 54% reduction in mortality with ICD Rx (27 months mean follow- up) 704 randomized pts: 353 no EP guided 352 EP guided: 190 AA drugs 161 ICDs 196 pts: 101 Conv. Rx 95 ICD Rx MI, EF < 30%CAD, EF < 40%, NSVT, inducible VT at EPS (95% MI Hx) MI, EF < 35%, NSVT, inducible VT at EPS, nonsuppressible with AA drug MADIT-II 3 MUSTT 2 MADIT 1 1 Moss AJ. N Engl J Med. 1996;335:1933-40. 2 Buxton AE. N Engl J Med. 1999;341:1882-90. 3 Moss AJ. N Engl J Med. 2002; 346:877

21. Moss AJ. N Engl J Med. 2002;346:877-83. Defibrillator Conventional P = 0.007 1.0 0.9 0.8 0.7 0.6 0.0 Probability of Survival 01234 Year No. At Risk Defibrillator742502 (0.91)274 (0.94)110 (0.78)9 Conventional490329 (0.90)170 (0.78) 65 (0.69)3 MADIT-II ICM + LVEF < 30% Prévention primaire Post-infarctus tardif

22. Prévention primaire Myocardiopathie primitive N Engl J Med 2004;350:2151-2158 A Death from Any Cause Probability of Survival Survival (yr) 1.0 6543210 0.9 0.8 0.7 0.0 ICD P=0.08 Standard therapy Prophylactic ICD in Non-ischemic DCM (LVEF<36%),n=454, 79% NYHA I-II DEFINITE Trial

23. SCD-HeFT: The Sudden Cardiac Death in Heart Failure Trial Bardy, N Engl J Med. 2005;342:225-37 Prévention primaire Myocardiopathie primitive + ischémique

24. N = 440 N = 880 Primary end point: all cause hospitalisation or all cause mortality COMPANION Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure Trial Prévention primaire DAI ± CRT

27. CRT and ICD thérapies Contak CD study 2002

28. 27 MADIT II March 2002 Previous ACC/AHA Guidelines for ICDs September 2002 COMPANION May 2004 SCD-HeFT January 2005 The Road to the New Guidelines ESC updated guidelines May 2005 ACC/AHA updated guidelines August 2005 CARE-HF April 2005 Updated guidelines as result of evidence-based medicine Recommandations SFC february 2006

30. Classe I: recommandations françaises

31. Classe II: recommandations françaises

32. New ESC guidelines 2005 for HF CRT ”in patients with EF 120 msec) and who remain symptomatic (NYHA III-IV) despite OMT to improve symptoms and reduce hospitalizations (class I, level of evidence A) and mortality (class I, level of evidence B)” ICD is reasonable “in selected symptomatic patients with LVEF < 30- 35%, not within 40 days of MI,on OMT..” (Class 1 recommendation, level of evidence A) (Class 1 recommendation, level of evidence A) CRT-D “in patients who remain symptomatic with HF NYHA Class III- IV, LVEF 120 ms… to improve morbidity and mortality…” (Class 2a recommendation, level of evidence B) (Class 2a recommendation, level of evidence B) CRT should be considered as part of routine therapy for pts with moderate to severe HF due to LVSD with evidence of cardiac dyssynchrony

33. Limites et Perspectives CRT -Diminution des non répondeurs: - meilleure sélection des patients - optimisation de la position des sondes - optimisation de la programmation (PEA, délai VV) -Extension des indications: - QRS fins - QRS fins - classe II (REVERSE,MADIT CRT) - classe II (REVERSE,MADIT CRT) - FE > 35% - FE > 35%

34. Limites et Perspectives DAI -Age des patients, stade IV NYHA, chocs inappropriés, rupture de sonde……. -Doit on implanter systématiquement un DAI? (CMD primitive en prévention primaire) DAI triple chambre 16500 € PM triple chambre 4600 € Coût

35. Conclusion Progrès indéniable OUI! Solution à tous les problèmes NON!