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1、轻中度心衰患者的植入器械治疗,上海交通大学医学院附属瑞金医院 吴立群,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 Failu
2、re 2008,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,Heart Failure: NYHA Classification,NYHA 分级I-II者约为2/3,Gras D: HRS 2008,轻
3、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RCTs CRT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 Resynch
4、ronization 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 an
5、alysis,All Geographies: 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 rhythm QRS 120 ms LVEF 40%, LVEDD 55 mm Without bradycar
6、dia With or without ICD indication On 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
7、 Asymptomatic Patients With Left Ventricular 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 A
8、l, JACC 2008; 52: 1834-1843,12 Month Change 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),
9、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: 9.5% 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
10、%,34%,81% 54%/27%,66% 29%/37%,19%,CRT ON,Entire distribution analysis 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
11、-values compare 24-month changes.,LVEDVi (ml/m2),LVEF (%),Daubert C et 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
12、C et al. JACC 2009;54:1837-46,REVERSE 24-months analysis: Reductions in risk 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 200
13、9; 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; 36
14、1:1329-38,MADIT CRT: 一级终点,Hazard Ratio (CRT-D:ICD) = 0.66 34% reduction in risk of death or HF 41% reduction in risk of HF events,N = 1820 P0.001,N=1820 P0.001,Hazard Ratio (CRT-D:ICD)=0.66 34% reduction in risk of death or HF 41% reduction in risk of HF events,Mean Changes in Echo LV Volumes and EF
15、 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. 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; 全因死亡率或心衰; EF30%; QRS120; NYHA II; n=1800,CRT 10年: 治疗目标的进展,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,谢谢,