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1、轻中度心衰患者的心脏再同步治疗,上海交通大学医学院附属瑞金医院吴立群,心脏再同步治疗随机临床试验进展累计图,2005ACC公布，据此ESC指南将CRT列为I类适应症,对4500余例以上NYHA III/IV的CHF、EF130ms的患者的临床试验表明:,CRT可以增强功能状况:CRT可以限制疾病进展:CRT可以减少心衰住院:CRT可以降低死亡率(泵衰竭所致),生活质量(QOL)NYHA分级运动耐量,逆转重构改善心脏功能,ACC/AHA/HRS 2008指南,LVEF35%QRS波间期0.12s窦律NYHA分级III或动态IV经优化的药物治疗,CRT或CRT-D的适应证:I类A级,心力衰竭:NY
2、HA 分级,NYHA 分级I-II者约为2/3,Gras D:HRS 2008,心衰分期与NYHA分级的关系:(ACCF/AHA Heart Failure Guidelines JACC 2009;53:e1-90),A期:有危险因素,无症状和器质性心脏病B期:有器质性心脏病,无症状或体征C期:有器质性心脏病伴既往或现在的HF症状D期:需特殊治疗的终末期心衰患者,慢性心衰按NYHA分级治疗的目的:,Adapted from ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure 200
3、8,轻中度心衰患者CRT的RCTs:,迄今为止,约有包含5000例症状轻微患者的RCTsCRT限制了这类患者心衰的进展,随访(月),Contak CD,MIRACLE ICD II,CARE-HF,REVERSE,REVERSE(Europe),MADIT CRT,RAFT:Tang AS,et al.Curr Opin Cardiol 2009;24(1):1-8,目的:检验CRTICD在12月是否能:对象:,减缓疾病的进展逆转左室重构,NYHA分级I,II(ACC/AHA C期)EF40%QRS120ms,Randomized Trial of Cardiac Resynchronizat
4、ion in Mildly Symptomizatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure symptoms(Linde C et al.JACC 2008;52:1834-43),Randomised 1:2(US;Europe;Canada),REVERSE:Study Design,Europe:all patients CRT ON,12 Months=Main analysis,All Geogr
5、aphies:Follow-up 5 years,CRT OFF(OMT ICD),CRT ON(OMT ICD),All patients receive CRT or CRTD,24 Months=European Health Economics analysis,U.S.,Canada:all patients CRT ON,NYHA Class II or I(previously symptomatic)In sinus rhythmQRS 120 msLVEF 40%,LVEDD 55 mmWithout bradycardia With or without ICD indic
6、ationOn optimal medical therapy,Linde et al.Am Heart J 2006;151:288-94.,延长期,610例,191例,419例,262例,一级终点:心衰临床复合反应:比较CRT OFF 对CRT ON 患者心衰恶化的比率=治疗的临床益处二级终点:左室收缩末期容量指数=重构逆转,Randomized Trial of Cardiac Resynchronization in Mildly Symptomizatic Heart Failure Patients and in Asymptomatic Patients With Left Ve
7、ntricular Dysfunction and Previous Heart Failure symptoms(Linde C et al.JACC 2008;52:1834-43),40%,54%,39%,30%,16%,21%,0%,CRT OFF,CRT ON,Pre-Specified Analysis Proportion Worsened,Worsened,Unchanged,Improved,P=0.10,REVERSE主试验:12月,40%,60%,100%,80%,20%,C Linde et Al,JACC 2008;52:1834-1843,12 Month Chan
8、ge in LVESVi,P0.0001,P=0.004,Randomized Trial of Cardiac Resynchronization in Mildly Symptomizatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure symptoms(Linde C et al.JACC 2008;52:1834-43),心衰住院,53%,REVERSE:安全性,植入成功率:97%左室导线相关的并发症:9.
9、5%左室导线移位、膈神经刺激、锁骨下静脉血栓等,C Linde et Al,JACC 2008;52:1834-1843,REVERSE:结论,REVERSE是第一个显示CRT可使无或症状轻微心衰患者获益的大型、随机和双盲的临床试验(在优化药物治疗的情况下):逆转左室重构延迟因心衰住院的时间改善临床结果(通过临床复合反应评估)CRT在这类患者中安全可行,C Linde et Al,JACC 2008;52:1834-1843,REVERSE延长期的一级终点:临床复合反应,66%,34%,81%54%/27%,66%29%/37%,19%,CRT ON,Entire distribution a
10、nalysis of worsened,unchanged and improved:P=0.0006,CRT OFF,Daubert C et al.JACC 2009;54:1837-46,Powered Secondary End Point:LVESVi,P-value compares 24-month changes.,Daubert C et al.JACC 2009;54:1837-46,Other Remodeling Parameters,P-values compare 24-month changes.,LVEDVi(ml/m2),LVEF(%),Daubert C e
11、t al.JACC 2009;54:1837-46,Other Secondary Endpoints,P-values compares 24-month changes.,P-value compares 24-month NYHA.,Daubert C et al.JACC 2009;54:1837-46,Number at Risk CRT OFF 82 79 76 70 39 CRT ON 180 176 173 168 77,Daubert C et al.JACC 2009;54:1837-46,REVERSE 24-months analysis:Reductions in r
12、isk of first HF hospitalisation or death,62%reduction with CRT,REVERSE研究的结论:,REVERSE研究24月(欧洲群组)的结果显示在优化药物治疗的基础上,CRT可使无或症状轻微的心衰患者:临床结果改善心室结构和功能改善疾病的进展受到限制,Daubert C et al.JACC 2009;54:1837-46,Moss AJ et al.N Eng J Med 2009;361:1329-38,MADIT CRT,1820例伴ICD一级预防指征的患者3:2随机CRT-D（1089例）：ICD（731例）平均随访:29月缺血性
13、心肌病:NYHA I级和II级非缺血性心肌病:NYHA II级LVEF30%QRS130ms,Moss AJ et al.N Eng J Med 2009;361:1329-38,MADIT CRT:一级终点,复合终点:全因死亡率或心衰事件的联合发生率,门诊患者因心衰加重应用静脉支持药物或心衰静脉支持药物升级或住院期间心衰口服药物升级加量,Moss AJ et al.N Eng J Med 2009;361:1329-38,MADIT CRT:一级终点,Hazard Ratio(CRT-D:ICD)=0.6634%reduction in risk of death or HF41%reduc
14、tion in risk of HF events,N=1820P0.001,N=1820P0.001,Hazard Ratio(CRT-D:ICD)=0.6634%reduction in risk of death or HF41%reduction in risk of HF events,Mean Changes in Echo LV Volumes and EF from Baseline to 1-year by Treatment Group,=-37ml=-39ml=+0.08,CRT-D 与心腔缩小和心功能改善显著相关,基线QRS是一项重要的参数,Moss AJ et al.
15、N Eng J Med 2009;361:1329-38,MADIT-CRT研究的结论:,MADIT-CRT提供了极其强有力的循证医学证据表明:CRT-D可降低无或症状轻微心脏病患者发生心衰的危险性,Moss AJ et al.2009 ESC meeting,在进行中的相关临床研究,RAFT:CRT-D对ICD(1:1);全因死亡率或心衰;EF30%;QRS120;NYHA II;n=1800,心脏再同步治疗建议(2009修订版)(中华医学会心电生理和起搏分会心脏再同步治疗专家工作组),窦律缺血或非缺血心肌病优化药物治疗,NYHA I-II级EF30%QRS120ms可考虑CRT-P或CRT-D(IIa类),2001-2005年:对严重心衰的辅助治疗NYHA分级:III-IV;MUSTICCARE-HF,2008-2010年:防止疾病进展NYHA分级:I-II;REVERSEMADIT-CRT,2010年不同步的一级预防:BIOPACE,BLOCK-HF有或无HF/LVSD的患者起搏诱发HF,CRT疗效的预测-我们仍然需要努力,谢谢,
