輕中度心衰患者的心臟再同步治療課件

1、輕中度心衰患者的心臟再同步治療課件輕中度心衰患者的心臟再同步治療課件心臟再同步治療隨機(jī)臨床試驗進(jìn)展累計圖2005ACC公布，據(jù)此ESC指南將CRT列為I類適應(yīng)癥心臟再同步治療隨機(jī)臨床試驗進(jìn)展累計圖2005ACC公布，據(jù)此對4500余例以上NYHA III/IV的CHF、EF130ms的患者的臨床試驗表明: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分級運(yùn)動耐量逆轉(zhuǎn)重構(gòu)改善心臟功能對4500余例以上NYHA III/IV的CHF、EF35ACC/AHA/HRS 2008指南LVEF35%QRS波間期0.12s

2、竇律NYHA分級III或動態(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ACC/AHA/HRS 2008指南LVEF35%CRT或心力衰竭: NYHA 分級NYHA 分級I-II者約為2/3Gras D: HRS 2008心力衰竭: NYHA 分級NYHA 分級I-II者約為2/3心衰分期與NYHA分級的關(guān)系:( ACCF/AHA Heart Failure Guidelines JACC 2009;53:e1-90)A期: 有危險因素, 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分期B

3、CDNYHA分級IIIIIIIV癥狀體力活動不受限體力活動輕度受限體力活動明顯受限不能進(jìn)行任何體力活動心衰分期與NYHA分級的關(guān)系:( ACCF/AHA Hea慢性心衰按NYHA分級治療的目的:NYHA 分級IIIIIIIV預(yù)后降低死亡率病殘率 減輕癥狀和體征 改善生活質(zhì)量 減輕水腫和體液潴留 增加運(yùn)動耐量 減輕疲勞和氣急 降低住院率 臨終關(guān)懷預(yù)防 心肌損傷的進(jìn)展 心肌重構(gòu) 癥狀或體液潴留重現(xiàn) 住院Adapted from ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008

4、 慢性心衰按NYHA分級治療的目的:NYHA 分級IIIIII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RCTsCRT限制了這類患者心衰的進(jìn)展隨訪(月)Contak CD*MIRACLEICD IIREVERSEMADIT CRTRAFT0304050607080910ActualForecastedCARE-HF*Contak CDMIRACLE ICD IICARE-HFREVERSEREVERSE(Europe)MADIT CRTRAFT: Tang AS, et al. Curr Opin Cardiol 2009;24(1):1-8輕中度心衰患者CR

5、T的RCTs:迄今為止, 約有包含5000目的: 檢驗CRTICD在12月是否能:對象:減緩疾病的進(jìn)展逆轉(zhuǎn)左室重構(gòu)NYHA分級I,II(ACC/AHA C期)EF40%QRS120msRandomized 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.

6、JACC 2008;52:1834-43)目的: 檢驗CRTICD在12月是否能:減緩疾病的進(jìn)展NYRandomised 1:2(US; Europe; Canada)REVERSE: Study DesignEurope: all patients CRT ON12 Months = Main analysis All Geographies: Follow-up 5 yearsCRT OFF (OMT ICD)CRT ON (OMT ICD)All patients receive CRT or CRTD24 Months = European Health Economics analy

7、sisU.S., Canada: all patients CRT ONNYHA Class II or I (previously symptomatic)In sinus rhythmQRS 120 msLVEF 40%,LVEDD 55 mmWithout bradycardia With or without ICD indicationOn optimal medical therapy Linde et al. Am Heart J 2006;151:288-94.延長期610例191例419例262例Randomised 1:2REVERSE: Study D一級終點:心衰臨床復(fù)

8、合反應(yīng): 比較CRT OFF 對CRT ON 患者心衰惡化的比率=治療的臨床益處二級終點: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)一級終點:Random

9、ized Trial of Cardi40%54%39%30%16%21%0% CRT OFFCRT ON Pre-Specified Analysis Proportion Worsened WorsenedUnchangedImprovedP=0.10 REVERSE主試驗: 12月 40% 60% 100%80%20%C Linde et Al, JACC 2008; 52: 1834-1843 2) D D 2) D 707580859095100105110115Baseline12 MonthsLVESVi (ml/m2)CRT OFF D = -1.3CRT ON D = -18

10、.412 Month Change in LVESViP0.0001P=0.00440%54%39%30%16%21%0% CRT ORandomized 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

11、53%Randomized Trial of Cardiac ReREVERSE: 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: 1834-1843REVERSE: 安全性植入成功率: 97%C Linde REVERSE: 結(jié)論REVERSE是第一個顯示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(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間改善臨床結(jié)果(通過臨床復(fù)合反應(yīng)評估)CRT在這類患者中安全可行C Linde et Al, JACC 200

12、8; 52: 1834-1843REVERSE: 結(jié)論REVERSE是第一個顯示CRT可使無REVERSE延長期的一級終點: 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=0.0006CRT OFFDaubert C et al. JACC 2009;54:1837-46REVERSE延長期的一級終點: 臨床復(fù)合反應(yīng)66% 34Powered Secondary End Point: LVESViP-value co

13、mpares 24-month changes.Daubert C et al. JACC 2009;54:1837-46Powered Secondary End Point: LOther Remodeling ParametersP-values compare 24-month changes.LVEDVi (ml/m2)LVEF (%)Daubert C et al. JACC 2009;54:1837-46Other Remodeling ParametersP-vOther Secondary EndpointsP-values compares 24-month changes

14、.P-value compares 24-month NYHA.Daubert C et al. JACC 2009;54:1837-46Other Secondary EndpointsP-valNumber at Risk CRT OFF 82 79 76 70 39 CRT ON 180 176 173 168 77Daubert C et al. JACC 2009;54:1837-46REVERSE 24-months analysis:Reductions in risk of first HF hospitalisation or death0%5%10%15%20%25%30%

15、06121824Months Since RandomisationPercentage Hospitalised for HFor DiedCRT ONCRT OFF24.0%11.7%Hazard Ratio: 0.38 95%CI: 0.20-0.73P=0.00362% reduction with CRT Number at Risk DaubREVERSE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;54:18

16、37-46REVERSE研究的結(jié)論:REVERSE研究24月(歐洲群組Moss AJ et al. N Eng J Med 2009; 361:1329-38Moss AJ et al. N Eng J Med 200MADIT CRT1820例伴ICD一級預(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級和II級非缺血性心肌病: NYHA II級LVEF30%QRS130msMoss AJ et al. N Eng J Med 2009; 361:1329-38MADIT CRT1820例伴ICD一級預(yù)防指征的患者3:2MAD

17、IT CRT: 一級終點復(fù)合終點: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或住院期間心衰口服藥物升級加量Moss AJ et al. N Eng J Med 2009; 361:1329-38MADIT CRT: 一級終點復(fù)合終點:門診患者因心衰加重應(yīng)MADIT CRT: 一級終點Hazard Ratio (CRT-D:ICD) = 0.6634% reduction in risk of death or HF41% reduction in risk of HF eventsN = 1820P0.001N=1820P0.001Hazard R

18、atio (CRT-D:ICD)=0.6634% reduction in risk of death or HF41% reduction in risk of HF eventsMADIT CRT: 一級終點Hazard Ratio (CMean Changes in Echo LV Volumes and EF from Baseline to 1-year by Treatment Group = -37ml = -39ml = +0.08CRT-D 與心腔縮小和心功能改善顯著相關(guān)Mean Changes in Echo LV Volume基線QRS是一項重要的參數(shù)Moss AJ et al. N Eng J Med 2009; 361:1329-38基線QRS是一項重要的參數(shù)Moss AJ e