心衰器械治疗选择CRT-P还是CRT-D

单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,单击此处编辑母版标题样式,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,心衰器械治疗选择CRT-P还是CRT-D,CHF,的患病率和死亡率,World Health Statistics, World Health Organization, 1995,American Heart Association, 2002,患病率：全球,22,00,500,中国,585,0.9%,，,2003,),新发病例：,2,00,50,万,CHF,5,年生存率：,50%,，差于恶性肿瘤,心衰器械治疗的历史,起搏器：,1990,年首次使用双心腔起搏及短,AV,间期改善心功能,CRT,：,1998,年实现左、右心室同步起搏,2002,年,ACC/AHA/NASPE,将心衰列为,CRT,的,a,类适应证,2005,年成为,Ia,类适应症,ICD,：,1998,年：心梗后左室功能低下，,EP,诱发出持续性,VT/VF,I,类,AAD,不抑制,2002,年,IIa,类：左室功能低下，,LVEF1,年,AVID,CIDS,CASH,MADIT-II,SCD-HeFT,SCD-HeFT,DEFINITE,Endpoints (mean 29.4 months):,Time to first event for the composite of hospitalization for,a major cardiovascular event or all-cause mortality,CARE-HF,研究,813 patients with patients with advanced heart failure (LVEF 35%, NYHA class III or IV), and cardiac dyssynchrony,despite standard pharmacological therapy.,Randomized,Control,Continued optimal pharmacological therapy,n=404,CRT,Pharmacological therapy with CRT,n=409,ACC 2005,CARE-HF,入选标准,18,岁,NYHA III/IV,，需要襻利尿剂治疗的心衰至少持续,6,周,已接受标准药物治疗,LVEF=30mm/m,（除以身高参数,),QRS=120ms,如果患者,QRS,在,120-149ms,之间需满足下列,3,条心脏收缩不同步标准中的两条：,主动脉射血前间期延迟,140ms,心室间机械延迟,40ms,左室后外侧壁激动延迟,CARE-HF,的,一级终点,(,所有原因死亡率或心血管住院率联合终点,),1.00,CRT : 159 pts (39%),3,48,118,232,292,404,Medical Therapy,7,68,166,273,323,409,CRT,Number at risk,0,500,1000,1500,0.00,0.25,0.50,0.75,HR 0.63 (95% CI 0.51 to 0.77),Event-free Survival,Days,P ,无事件组,(35.9,14.2 /0.52,6.0ms,，,p =,0.0323),。,QTD,无事件组,(46.4,13.5/5.1,4.1ms,p 0.0001),QTD,增加组,29%,发生,MACE,事件， 不增加组,3%,（,p=0.0017,）,多元回归分析：基线,QTD,改变强烈预示,MACE,的发生，,独立于,QTc,，,QRS,宽度，,LVEF,，,LVEDV(p 0.001),之外,结论：,双室起搏后,MACE,事件与起搏诱导的,QTD,增加有关,安置双室起搏时测定心室复极时间可能有助于识别,CRT,后可能,发生严重致心律失常事件的病人指导临床及时选择,CRTD,治疗,CRT,治疗对心室复极的影响,JOURNAL OF CLINICAL MEDICINE IN PRACTICE,2009 13(19),22,例,CRT,治疗后随访体表心电图,QT,离散度及,Tpeak-,end,间期以及,Tpeak-end,离散度,评价心室复极异质性,CRT,术前、术后,1-12,个月，分别在右室起搏、左室起,搏、双室起搏三种模式下测量心室复极异质性指标,QT,离散度及,Tpeak-end,、,Tpeak-end,离散度在,双室起搏,时最小,，,左室起搏时最大,CRT,治疗后心室复极异质性指标明显改善，并且随着,时间延长，心室复极异质性指标逐渐变小,CRT,可能增加猝死发生率,动物和人类的研究发现：心外膜起搏增加跨室壁的复,极离散（,TDR),，后者是室性心律失常发生的基础,荟萃分析发现：人类,CRT,治疗对致心律失常基质的影,响结果不一致，有研究认为,CRT,增加心律失常的危险（,Becareful,研究），有研究认为,CRT,有抗,SCD,作用（,Care-HF,研究,),但是,CRT,术后,SCD,仍然很高，,COMPANION,研究证实,只有,CRT-D,显著降低总死亡率，尤其是猝死发生率,Buxton AE. N Engl J Med. 1999;341:1882-90.,Time after Enrollment (Years),0,0.1,0.2,0.3,0.4,0.5,0.6,心律失常死亡和心脏骤停发生率,1,2,3,4,5,0,p 0.001,EP-,指导的抗心律失常药物治疗,没有抗心律失常药物治疗,EP-,指导的,ICD,治疗,MUSTT,研究,MI, EF0.40, NSVT,或,EP,诱发,VT,与,EP,指导,AAD,治疗组和无,AAD,治疗组相比,ICD,能够明显降低总死亡率,55%,，心律失常死亡率,73%,MADIT-II,的结果,除颤器组,14.2%,传统组,19.8%,P = 0.007,0.9,0.8,0.7,0.6,0.0,生存率,0,1,2,3,4,Year,No. At Risk,除颤器组,742502 (0.91)274 (0.94)110 (0.78)9,传统组,490329 (0.90)170 (0.78) 65 (0.69)3,Moss AJ. N Engl J Med. 2002;346:877-83.,ICD,与对照组相比，总死亡率减少,30%,平均随访,12,个月,MI,后至少,1,个月，,LVEF0.3,Endpoints (median 45.5 months):,All-cause mortality,SCD-HeFT,2,521 patients with moderately symptomatic CHF (NYHA Class II or III) and LVEF 35%,Randomized, double-blind, multicenter,Conventional CHF Treatment,+,Placebo,Conventional CHF Treatment + ICD,Single lead implantable cardioverter defibrillator programmed for ventricular fibrillation (VF) treatment only,Treatment,Conventional CHF Treatment + Amiodarone,Antiarrhythmic agent,800 mg Week 1, 400 mg Week 2-4,Chronic therapy:,200 mg/day if 200 lbs,N ENG J MED 2005,0.4,0.3,0.2,0.1,0,Mortality,0,6,12,18,24,30,36,42,48,54,60,Months of follow-up,Amiodarone,ICD Therapy,Placebo,HR97.5% ClP-Value,Amiodarone vs. Placebo1.060.86, 1.300.529,ICD Therapy vs. Placebo0.770.62, 0.960.007,SCD-HeFT,结果,对于中度,CHF,，预防性植入,ICD,能降低,23,死亡率，,延长寿命,28. 9%,34. 1%,35. 8%,入选标准,n=458,OMT n=229,OMT+ICD n=229,平均随访,29,个月,Optimize:,B, ACE-I, Diuretics,DEFINITE,方案,21,岁,非缺血性心脏病,有症状,CHF,病史,LVEF,35%,过去,6,个月内有,NSVT,Holter,发现,10,PVCs/h,DEFINITE,试验，,79% NYHA,只有,I-II,级,Hazard Ratio (95% CI) ICD vs. OMT,P-Value,Reduction in Death w/ICD,全因死亡,(All Pts),0.65 (0.40 - 1.06),0.08,35%,全因死亡,(NYHA Class III),0.37 (0.15 - 0.90),0.02,63%,心律失常所致猝死,0.20 (0.06 - 0.71),0.006,80%,有,ICD,作为后备的,CRT,治疗总死亡率下降,20%,Am J Cardiol 2007;99:232238,CRT-P vs CRT-D,疗效研究,N=1298,例,Age: 64+/-9ICM: 43%EF: 24+/-7CRTD: 56%AF: 19%,MILOS,研究,2005,年,ACC/AHA/ESC,心力衰竭指南,ICD/CRT,治疗建议,ICD,CRT,缺血性心肌病,非缺血性心肌病,左室功能不全,(,30-35%),(,120ms,2007,年,ESC,心脏起搏和再同步化治疗指南,心衰患者中,CRT-P,或,CRT-D,应用推荐,I,类,尽管药物优化治疗，仍有症状，,NYHA III-IV,LVEF 35%,LV,扩大,(LVEDD55 mm),窦性节律,宽,QRS,波,( 120 ms),CRT-P,可以降低发病率和死亡率（证据分级：,A,）,CRT-D,对于有良好功能状态，预计生存超过一年的,患者是可接受的选择（证据分级：,B,）,ACC/AHA/HRS 2008,器械治疗指南,LVEF,0.12s,，窦性节律，有或没有,ICD,功能的,CRT,是经药物优化治疗，,NYHA III,级或非卧床,IV,级心衰症状患者治疗适应证,LVEF,0.12s,， 和,AF,，有或没有,ICD,功能的,CRT,对经药物优化治疗，有,NYHA III,级或非卧床,IV,级心衰症状患者是合理的,I,I,I,IIa,IIa,IIa,IIb,IIb,IIb,III,III,III,I,I,I,IIa,IIa,IIa,IIb,IIb,IIb,III,III,III,I,I,I,IIa,IIa,IIa,IIb,IIb,IIb,III,III,III,IIa,IIa,IIa,IIb,IIb,IIb,III,III,III,B,I,I,I,IIa,IIa,IIa,IIb,IIb,IIb,III,III,III,I,I,I,IIa,IIa,IIa,IIb,IIb,IIb,III,III,III,I,I,I,IIa,IIa,IIa,IIb,IIb,IIb,III,III,III,IIa,IIa,IIa,IIb,IIb,IIb,III,III,III,A,*,All primary SCD prevention ICD recommendations apply only to patients who are receiving optimal medical therapy and have reasonable expectation of survival with good functional capacity for more than 1 year.,没有明确那些病人必须,CRTD,2009,年我国,CRT,治疗指南,扩心病或缺血性心肌病经充分抗,CHF,药物治疗后,NHYA,仍为,III,级或不必卧床的,IV,级,窦性心律,LVEF35,LVDD55mm,QRS,120ms,CRT,可使心功能改善，重构逆转，减少恶性室性心律,失常发生，减少,ICD,放电次数,ICD,能有效防止猝死,CRT-D,是最佳治疗方案,CRTP,或,CRTD,对心功能,III,到,IV,级的病人的建议,CRTP,或,CRTD,对心功能,I,到,II,级的病人的建议,心力衰竭病人器械治疗的选择,QRS0.12s,NYHA II-IV,级,QRS0.12s,NYHA IV,级,?,QRS0.12s,NYHA II-III,级,CRTD,是否对所有心力衰竭病人较,CRT,有额外获益不清楚，加之费用，手术复杂性和危险性增加，迫切需要进一步循证医学研究或荟萃分析结果，以及明确的指南或共识提供临床参考,谢谢,谢谢！,