Microsoft PowerPoint - Benefits of CRT-D in CHF.ppt

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1 Benefits of CRT-D in CHF 울산의대서울아산병원 최기준

2 ICD and CRT : The Perfect Marriage? Michel Mirowski and Morton Mower : Two Baltimore cardiologists

3 If CRT-P alone provide predictable SCD prevention (or anti-arrhythmic benefit), Physician s decision making would be simple.

4 If CRT-D has same cost with CRT-P and/or government (medical insurance) covers all CRT-D cases, Physician s decision making would be simple.

5 In Real World -- Price (Device) Price (Device + leads) 환자부담 (10%) * CRT-P 1010 만원 1300 만원 130 만원 CRT-D 2150 만원 2500 만원 250 만원 ICD (dual chamber) 2030 만원 2300 만원 230 만원 * 6 개월간보험적용입원비중최대 300 만원만본인부담

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%

8 한국에서의 ICD 보험인정기준 1. 일시적이거나가역적인원인이없는심실세동이나심실빈맥에의한심정지 2. 기질적심질환이있는자발적지속성심실빈맥환자 3. 기질적심질환이없는자발적지속성심실빈맥환자에서다른치료방법으로조절되지않는경우 4. 원인을알수없는실신 + 전기생리학검사에서혈역동학적으로의미있는심실빈맥의유발 + 약물치료는효과가없거나복용을못하는경우 5. 이전의심근경색환자, 관상동맥질환환자, 좌심실기능부전환자에서다음세가지조건에해당 30% 이하의 low EF 비지속성심실빈맥 전기생리학검사에서심실세동이나지속성심실빈맥의유발 6. Brugada 증후군환자에서 비후성심근증환자로 Long QT 증후군환자에서 ---

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?

15 SCD prevention by CRT-P? CARE-HF(2005) : mortality benefit (+), SCD (-) CARE-HF extended phase (European Heart J 2006; 27:1928) : SCD prevention (+) Mechanism Reduced ventricular volume Improved cardiac output Reduced wall stretch Diminished catecholamine reduced tachyarrhythmia risk

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.