6 Practice : CRT-D vs. CRT-P CRT-D (%) USA Europe Korea 73% of all CRT in % of all CRT in 2006 (expected) 50-60% of all CRT in % (25/102) (54% (7/13) in AMC) Saxon LA et al. European HJ 2006;27:1891
7 Decision Summary (2005) CMS determined ICD is reasonable and necessary for the followings : 1. Patients with ischemic CMP, prior MI, NYHA class II-III heart failure and measured LVEF 30% 2. Patients with non-ischemic dilated CMP > 9 months, NYHA class II-III heart failure and measured LVEF 30%
9 COMPANION study N=1520 Advanced heart failure(nyha class III or IV) Ischemic or non-ischemic QRS interval 120msec 1) OPT (Optimal pharmacologic therapy) 2) CRT-P (CRT-Pacemaker) 3) CRT-D (CRT-Defibrillator)
10 Bristow MR. N Eng J Med 2004;350:
11 Bristow MR. N Eng J Med 2004;350:
12 The CARE-HF Study CArdiac REsynchronisation in Heart Failure : Inclusion Criteria Currently in NYHA class III/IV LV systolic dysfunction and dilation EF 35%; EDD 30mm/height in metres - NEJM 352(15), , QRS 120 ms Dyssynchrony confirmed by echo if QRS ms Aortic pre-ejection delay >140 ms Interventricular mechanical delay >40 ms Delayed activation of postero-lateral LV wall Patients with AF or requiring pacing or ICD excluded
13 CARE-HF : All-Cause Mortality 1.00 HR 0.64 (95% CI 0.48 to 0.85) Event-free Survival CRT Medical Therapy P = Number at risk Days CRT Medical Therapy
14 Issues-- SCD prevention by CRT? Is it enough? Risk predictors of sudden death in CRT patients? NYHA Functional class III or IV?
16 Mortality and mode of death 29 Europace 2006;8:499 50% reduction of SD risk by CRT-D compared to CRT-P in these study Strongly Over suggest 1/3 of added deaths value in of CRT-P ICD for arm CRT were recipients. sudden
17 CARE-HF trial extension phase CARE-HF F/U SCD in SCD in European HJ 2006;27:1928 med. Tx CRT 29m 38/404 vs. 29/409 CARE-HF exten. 37m 54/404 vs. 32/409 HF death Ability of CRT-P to reduce SCD is delayed and potentially dependent on beneficial ventricular remodeling Sudden death
18 Effect of CRT alone vs. control on SCD European HJ 2006;27:2682
19 Risk stratification of SCD in CRT patients Predictors of ICD therapy in CRT-D patients Ventak CHF / Contak CD study, n=501 Retrospective analysis during 6 months post-implant. 14% (73/501) appropriate ICD therapy Two independent predictors Hx of spontaneous, sustained ventricular arrhythmia NYHA class IV CHF Desai AD et al. J Cardiovasc Electrophysiol 2006;17:486
20 COMPANION subgroup : Class IV - Lindenfeld J et al. Circulation 2007;115:204 - SCD
21 NYHA class III vs. IV? Much greater mortality from SCD in NYHA class III vs. class IV HF : ~60% vs. ~20-33% (Lehmann MH et al. J Cardiovasc Electrophysiol 2006;17:491) Individuals with severe LV dysfunction and worsening HF may be more prone to die from disease complication other than ventricular tachyarrhythmias, not reversed by defibrillators (Ermis C et al. Europace 2006;8:499) Still no reasonable risk predictor for CRT-D
22 Benefit of CRT-D in HF with and N=191 without ventricular arrhythmias : advanced HF, EF<35% and QRSd>120 msec 71 with Hx of VA (secondary prevention) 120 without VA (primary prevention) During 18±4 months F/U, ICD therapy in 21% of primary prevention patients 35% of secondary prevention patients (p<0.05) No predictors of ICD therapy in primary prevention patients Ypenburg C et al. JACC 2006;48:464
23 No direct comparison study? : CRT-P vs CRT-D Study require 1300 patients per group and follow-up period equivalent to CARE-HF (mean F/U 29m) Who will undertake such a study?
24 Conclusions Currently, there is no strong scientific evidence indicating that CRT-D must be offered to all CRT candidates (at least, CRT-D for secondary prevention or younger patients without major comorbidities) Because CRT improves functional class, it is likely that the relative risk for sudden death remains high and provide a rationale for ICD as an excellent complement to CRT therapy.