輕中度心衰患者的植入器械治療.ppt

輕中度心衰患者的植入器械治療,上海交通大學(xué)醫(yī)學(xué)院附屬瑞金醫(yī)院 吳立群,心衰分期與NYHA分級(jí)的關(guān)系: ( ACCF/AHA Heart Failure Guidelines JACC 2009;53:e1-90),A期: 有危險(xiǎn)因素, 無癥狀和器質(zhì)性心臟病 B期: 有器質(zhì)性心臟病, 無癥狀或體征 C期: 有器質(zhì)性心臟病伴既往或現(xiàn)在的HF癥狀 D期: 需特殊治療的終末期心衰患者,慢性心衰按NYHA分級(jí)治療的目的:,Adapted from ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008,對(duì)4500余例以上NYHA III/IV的CHF、EF130ms的患者的臨床試驗(yàn)表明:,CRT可以增強(qiáng)功能狀況: CRT可以限制疾病進(jìn)展: CRT可以減少心衰住院: CRT可以降低死亡率(泵衰竭所致),生活質(zhì)量(QOL) NYHA分級(jí) 運(yùn)動(dòng)耐量,逆轉(zhuǎn)重構(gòu) 改善心臟功能,ACC/AHA/HRS 2008指南,LVEF35% QRS波間期0.12s 竇律 NYHA分級(jí)III或動(dòng)態(tài)IV 經(jīng)優(yōu)化的藥物治療,CRT或CRT-D的適應(yīng)證: I類A級(jí),Heart Failure: NYHA Classification,NYHA 分級(jí)I-II者約為2/3,Gras D: HRS 2008,輕中度心衰患者CRT的RCTs:,迄今為止, 約有包含5000例癥狀輕微患者的RCTs CRT限制了這類患者心衰的進(jìn)展,隨訪(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: 檢驗(yàn)CRTICD在12月是否能: 對(duì)象:,減緩疾病的進(jìn)展 逆轉(zhuǎn)左室重構(gòu),NYHA分級(jí)I,II(ACC/AHA C期) EF40% QRS120ms,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),Randomised 1:2 (US; Europe; Canada),REVERSE: Study Design,Europe: all patients CRT ON,12 Months = Main analysis,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 bradycardia With or without ICD indication On optimal medical therapy,Linde et al. Am Heart J 2006;151:288-94.,延長(zhǎng)期,610例,191例,419例,262例,一級(jí)終點(diǎn): 心衰臨床復(fù)合反應(yīng): 比較CRT OFF 對(duì)CRT ON 患者心衰惡化的比率=治療的臨床益處 二級(jí)終點(diǎn): 左室收縮末期容量指數(shù)=重構(gòu)逆轉(zhuǎn),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),40%,54%,39%,30%,16%,21%,0%,CRT OFF,CRT ON,Pre-Specified Analysis Proportion Worsened,Worsened,Unchanged,Improved,P=0.10,REVERSE主試驗(yàn): 12月,40%,60%,100%,80%,20%,C Linde et Al, 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),心衰住院,53%,REVERSE: 安全性,植入成功率: 97% 左室導(dǎo)線相關(guān)的并發(fā)癥: 9.5% 左室導(dǎo)線移位、膈神經(jīng)刺激、鎖骨下靜脈血栓等,C Linde et Al, JACC 2008; 52: 1834-1843,REVERSE: 結(jié)論,REVERSE是第一個(gè)顯示CRT可使無或癥狀輕微心衰患者獲益的大型、隨機(jī)和雙盲的臨床試驗(yàn)(在優(yōu)化藥物治療的情況下): 逆轉(zhuǎn)左室重構(gòu) 延遲因心衰住院的時(shí)間 改善臨床結(jié)果(通過臨床復(fù)合反應(yīng)評(píng)估) CRT在這類患者中安全可行,C Linde et Al, JACC 2008; 52: 1834-1843,REVERSE延長(zhǎng)期的一級(jí)終點(diǎn): 臨床復(fù)合反應(yīng),66%,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-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 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研究的結(jié)論:,REVERSE研究24月(歐洲群組)的結(jié)果顯示在優(yōu)化藥物治療的基礎(chǔ)上, CRT可使無或癥狀輕微的心衰患者: 臨床結(jié)果改善 心室結(jié)構(gòu)和功能改善 疾病的進(jìn)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一級(jí)預(yù)防指征的患者3:2隨機(jī)CRT-D（1089例）：ICD（731例） 平均隨訪: 29月 缺血性心肌病: NYHA I級(jí)和II級(jí) 非缺血性心肌病: NYHA II級(jí) LVEF30% QRS130ms,Moss AJ et al. N Eng J Med 2009; 361:1329-38,MADIT CRT: 一級(jí)終點(diǎn),復(fù)合終點(diǎn): 全因死亡率或心衰事件的聯(lián)合發(fā)生率,門診患者因心衰加重應(yīng)用靜脈支持藥物或 心衰靜脈支持藥物升級(jí)或住院期間心衰口服藥物升級(jí)加量,Moss AJ et al. N Eng J Med 2009; 361:1329-38,MADIT CRT: 一級(jí)終點(diǎn),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 from Baseline to 1-year by Treatment Group, = -37ml = -39ml = +0.08,CRT-D 與心腔縮小和心功能改善顯著相關(guān),基線QRS是一項(xiàng)重要的參數(shù),Moss AJ et al. N Eng J Med 2009; 361:1329-38,MADIT-CRT研究的結(jié)論:,MADIT-CRT提供了極其強(qiáng)有力的循證醫(yī)學(xué)證據(jù)表明: CRT-D可降低無或癥狀輕微心臟病患者發(fā)生心衰的危險(xiǎn)性,Moss AJ et al. 2009 ESC meeting,在進(jìn)行中的相關(guān)臨床研究