Do All Patients With An ICD Indication Need A BiV Pacing Device?

Transcription

1 Do All Patients With An ICD Indication Need A BiV Pacing Device? Muhammad A. Hammouda, MD Electrophysiology Laboratory Department of Critical Care Medicine Cairo University

2 Etiology and Pathophysiology of Sudden Death from Cardiac Causes (Huikuri et al., NEJM, 2001)

3 Clinical Trials in Ventricular Arrhythmias or Sudden Death VT/VF Post-MI Heart Failure AA drugs vs. placebo CAST, EMIAT, CAMIAT, SWORD GESICA, CHF- STAT, SCD-HeFT Conventional AA drugs vs. amiodarone or sotalol ICD vs. AA drugs ESVEM CASCADE CIDS, CASH, AVID, MUSTT MADIT MADITT II SCD-HeFT SCD-HeFT ICD vs. placebo CABG Patch SCD-HeFT

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6 Comparison of AA Drug Trials Study CAST EMIAT ESVEM CHF-STAT GESICA Patients Post MI LVEF < 40% VE >6 /H Post MI LVEF < 40% Spont.V. Ectopy VT, arr., syncope Holter >10 PVC/H EPS: Induced VT CHF: II-->IV LVEF <40% > 10 PVC/H CHF LVEF < 35% > 10 PVC/H Drugs Flecainide Encainide Amiodarone Imipramine, Pirmenol Procain, Quinidine Mexiletine, Propaf Sotalol Amodarone vs. Placebo Amodarone vs. Placebo + antifailure Rx Prophylactic Fl., or En.--->triple mortality in post MI V. ectopy -37% reduction in arrhytmic mortality -No reduction in nonarrhy., non-cardiac mort -AA Rx choice equal with Holter or EPS -Sotalol is best Amio VTs, LVF but did not improve survival Results Amio mortality without arrhythmias

7 Effect of Prophylactic Antiarrhythmic Drug Therapy in Acute Myocardial Infarction Mortality Risk Class IA Class IB Class IC Total Reduced Increased 1.79 P =.05 Class II: -Blockers P = Class III: Amiodarone P =.05 Class IV: Calcium Blockers P = NS Adapted from Teo K. JAMA 1993;270(13): Odds Ratio

8 Clinical Trials in Ventricular Arrhythmias or Sudden Death VT/VF Post-MI Heart Failure AA drugs vs. placebo CAST, EMIAT, CAMIAT, SWORD GESICA, CHF- STAT, SCD-HeFT Conventional AA drugs vs. amiodarone or sotalol ICD vs. AA drugs ESVEM CASCADE CIDS, CASH, AVID, MUSTT MADIT MADITT II SCD-HeFT SCD-HeFT ICD vs. placebo CABG Patch SCD-HeFT

9 Comparison of ICD Therapy Studies Factor MADIT AVID CABG Patch Protocol ICD vs. conventional therapy (mainly amiodarone) ICD vs. amiodarone or sotalol (mainly amiodarone) ICD vs. no ICD Patient characteristics EF <35%; NSVT; inducible VT not suppressed by procainamide Survivors of VF; VT with syncope; VT with EF < 40% CAD; LVEF <36%; abnormal SAECG; elective CABG; no Hx of VT/VF Study population mean EF 26% 32% 27% 24-month mortality in drug or control group 32% 24% 18% Improvement in survival with ICD at 2 yrs F/U 54% 27% 0

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13 Comparison of ICD Therapy Studies Factor MADIT AVID CABG Patch Protocol ICD vs. conventional therapy (mainly amiodarone) ICD vs. amiodarone or sotalol (mainly amiodarone) ICD vs. no ICD Patient characteristics EF <35%; NSVT; inducible VT not suppressed by procainamide Survivors of VF; VT with syncope; VT with EF < 40% CAD; LVEF <36%; abnormal SAECG; elective CABG; no Hx of VT/VF Study population mean EF 26% 32% 27% 24-month mortality in drug or control group 32% 24% 18% Improvement in survival with ICD at 2 yrs F/U 54% 27% 0

14 All-cause mortality (%) ICD reduces total mortality:30-50% ICD reduces SD by 65%

15 Probability of Survival Cardiac Mortality in Patients with and without ICD,* Stratified by Ejection Fraction ICD, LVEF > 40% (n = 55) No ICD, LVEF > 40% (n = 111) ICD, LVEF < 40% (n = 95) 0.40 No ICD, LVEF < 40% (n = 70) Time (months) *Majority are epicardial Adapted from Powell AC. Circulation 1993;88(3):

16 NEJM, 2004, 351:2481

17 DINAMIT: NEJM, 2004, 351:2481

18 DINAMIT: NEJM, 2004, 351:2481

19 DINAMIT: NEJM, 2004, 351:2481

20 DEFINITE NEJM, 2004:350:2151

21 DEFINITE: NEJM, 2004:350:2151

22 DEFINITE: NEJM, 2004:350:2151

23 NEJM, 2004:350:2151

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25 Kaplan-Meier estimates of the probability of (A) all-cause mortality, (B) all-cause mortality or first hospitalization for HF, and (C) first hospitalization for HF with censoring on death MADIT II Circulation. 2006;113:

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28 Causes of increased risk of HF: 1-ICD decreases arrhythmic death and prolongs life to get HF 2-RV apical pacing Dyssynchrony worsens systolic function (thus shock only-vvi ICD lead less to deveolpment of HF) 2-Repeated shocks Myocardial damage (esp with vulnerable pts)

29 Severity of Heart Failure and Mode of Death LANCET, 1999

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31 CRT Pacing in Heart Failure BiV-Pacing Trials in DCM and CHF 1-CRT improves NYHA (III, IV), QOL, 6-min walk 2-CRT ICD safe to use

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33 CRT BiV-Pacing Benefit of CRT in CARE-HF In the CARE-HF trial, 813 patients with New York Heart Association class III or IV heart failure were randomly assigned to cardiac resynchronization therapy (CRT) with biventricular pacing and medical therapy or medical therapy alone. CRT was associated with a significant reduction in the primary end point of death from any cause or unplanned hospitalization for a major cardiovascular event (39 versus 55 percent at a mean of 29 months, hazard ratio [HR] 0.63, 95% CI ). ( Cleland, JG et al., NEJM 2005; 352:1539).

34 CRT BiV-Pacing Mortality benefit from CRT in CARE-HF In the CARE-HF trial, 813 patients with New York Heart Association class III or IV heart failure were randomly assigned to cardiac resynchronization therapy (CRT) with biventricular pacing and medical therapy or medical therapy alone. CRT was associated with a significant reduction in the secondary end point of death from any cause (20 versus 30 percent at a mean of 29 months, hazard ratio [HR] 0.64, 95% CI ). (Cleland, JG, et al., NEJM 2005; 352:1539).

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38 Do All Patients With An ICD Indication Need A BiV Pacing Device? Guidelines Change

39 CRT BiV Pacing in Heart Failure ACC & AHA Guidelines In 2005, the ACC & AHA based on BivP trials, issued an update to their 2001 joint HF treatment guidelines assigning a class I indication (level of evidence A) to CRT (with or without defibrillation) in patients who meat the following criteria: Ischemic or non ischemic dilated CM EF < 35% Sinus rhythm NYHA functional class III and IV Cardiac dyssyncrhrony defined as QRS > 120 Optimal pharmacologic therapy for HF

40 ICD Indications: Indications Primary prevention Coronary disease, LV dysfunction, inducible VT Chronic coronary disease, LVEF </= 30% Secondary prevention Cardiac arrest due to VT or VF Sustained VT, especially with structural heart disease ICD therapy plus biventricular pacing Above indications + QRS >/= 130 msec, LV dilatation, LVEF </= 35%, and advanced heart failure

41 Do All Patients With An ICD Indication Need A BiV Pacing Device? Summary & Conclusion *Cardiac death is due to electric causes (arrhythmias) or mechanical causes (heart failure). *The ICD is indicated for patients with a known risk of arrhythmic SCD *All Trials have shown that ICDs decrease arrhythmic death

42 Do All Patients With An ICD Indication Need A BiV Pacing Device? Summary & Conclusion *ICDs do not affect the systolic function *By decreasing incidence of arrhythmic death, cardiac patients may: - have prolonged life to show up systolic dysfunction, -especially with the deleterious effect of RV apical pacing

43 Do All Patients With An ICD Indication Need A BiV Pacing Device? Summary & Conclusion *In All Patients requiring an ICD, the question of Implanting an ICD + CRT (CRTD) has to be raised. *The decision to implant the CRTD is made on the basis of: -Myocardial contractility (EF), -Associated heart disease, -Absence of definitive Rx, and -Evidence of AV and VV dyssynchrony

44 Do All Patients With An ICD Indication Need A BiV Pacing Device? Conclusion *In All Patients requiring a dual-chamber ICD, implanting CRTD has to be considered in patients with: Myocardial disease, Low EF, Unlikely future improvement in systolic function

45 Do All Patients With An ICD Indication Need A BiV Pacing Device? Probably Yes If HF is Expected to Develop

46 Do All Patients With An ICD Indication Need A BiV Pacing Device? THANK YOU