輕度心衰患者的crt應(yīng)用梁兆光課件

1、輕度心衰患者的輕度心衰患者的CRT應(yīng)用應(yīng)用2011年7月 29日 2004之前的臨床研究證實(shí)之前的臨床研究證實(shí)CRT 改善NYHA III/非臥床 IV 級，LV功能不全和寬QRS患者的心衰癥狀 改善生活質(zhì)量 增加活動能力 逆轉(zhuǎn)LV重構(gòu) - LV size, LVEF 減少二尖瓣返流Cardiac Resynchronization Therapy (CRT) Reduces Hospitalizations, and CRT with Implantable Defibrillator (CRT-D) Reduces Mortality in Chronic Heart Failure: T

2、he COMPANION Trial Bristow MR,(Co-Ch) Feldman AM,(Co-Ch) Saxon LA, DeMarco T, Kass D, Boehmer J, Mann D, Singh S, Carson P, Krueger S, McGrew F, Botteron G, Wagoner L, for the COMPANION InvestigatorsBristow MR , et al. N Engl J Med. 2004 May 20;350(21):2140-50 .COMPANION 研究設(shè)計(jì) 一級終點(diǎn):全因死亡或全因住院的復(fù)合終點(diǎn)主要入選

3、標(biāo)準(zhǔn)NYHA Class:NYHA III/IVLVEF: 35%QRS Duration: 120 msec研究中心:122 US centers基礎(chǔ)評估隨機(jī)1:2:2CRT-P(N = 617)CRT-D(N = 595)平均隨訪平均隨訪12個月個月Bristow MR , et al. N Engl J Med. 2004 May 20;350(21):2140-50 .OPT(N = 308)COMPANION顯示在NYHA III/IV 的患者中CRT-P和CRT-D分別降低19%和20% 的 全因死亡和全因住院的復(fù)合終點(diǎn)COMPANION顯示在NYHA III/IV 的患者中CRT

4、-P和CRT-D分別降低24%和36% 的 全因死亡率The CARE-HF StudyCArdiac REsynchronisation in Heart FailureJohn GF Cleland - Kingston-upon-Hull. UKJean-Claude Daubert Rennes. FranceErland Erdmann Cologne. GermanyNick Freemantle Birmingham. UKDaniel Gras Nantes. FranceLukas Kappenberger Lausanne. SwitzerlandWerner Klein

5、Graz. AustriaLuigi Tavazzi Pavia. Italyon behalf of the CARE-HF Study Investigators Cleland JGF N Eng J Med 2005; 352: 1539 - 49 CARE-HF 研究設(shè)計(jì) 一級終點(diǎn):全因死亡率或主要心血管事件計(jì)劃外住院率主要入選標(biāo)準(zhǔn)NYHA Class:NYHA III/IVLVEF: 35%QRS Duration: 120 msec研究中心:82 European centers基礎(chǔ)評估隨機(jī)1:1CRT-P(N = 409)平均隨訪29個月OPT(N = 404) Cleland

6、 JGF N Eng J Med 2005; 352: 1539 - 49 348118232292404Medical Therapy768166273323409CRTNumber at risk0500100015000.000.250.500.751.00HR 0.63 (95% CI 0.51 to 0.77)Event-free SurvivalDaysP .0001CRT藥物治療CARE- HF顯示在NYHA III/IV 的患者中CRT-P降低37% 的 全因死亡和心血管病因住院的復(fù)合終點(diǎn)CARE-HF 研究顯示在NYHA III/IV 患者中 CRT-P降低40%的全因死亡率

7、Cleland JGF. Eur Heart J. 2006 Aug;27(16):1928-324093833583382098540437233129817863CRTMedical therapyNumber at risk 96Time (days)MedicalTherapyMean Follow-up 36.4 months (range 26.1 to 52.6)CRT Deaths = 101 (24.7%)Medical Therapy Deaths = 154 (38.1%)CRT040016000.000.250.508001200Hazard Ratio 0.60 (9

8、5% CI 0.47 to 0.77; P120 ms?YesNo EF 1 年年?所有患者都為藥物優(yōu)化CRT治療輕度心衰的臨床研究REsynchronization reVErses Remodeling inSystolic left vEntricular dysfunction:Results of the REVERSE TrialCecilia Linde, Stockholm, SwedenWilliam T. Abraham, Columbus, U.S Michael R. Gold, Charleston, U.S.Jean-Claude Daubert, Rennes,

9、France On Behalf of the REVERSEInvestigators and CoordinatorsREVERSE 研究設(shè)計(jì) 一級終點(diǎn):心衰的臨床綜合反應(yīng)惡化% 主要的二級終點(diǎn):左室容量指數(shù) (LVESVi)主要入選標(biāo)準(zhǔn)NYHA Class:NYHA II 或先前有癥狀的 NYHA ILVEF: 40%QRS Duration: 120 msec研究中心:73 centres: US (37); Canada (1); Europe (35)資助:Medtronic基線評估隨機(jī)1:2雙盲CRT Off(n = 191)CRT On(N = 419)Linde C, et

10、al. J Am Coll Cardiol. 2008;52:1834-43.Daubert C, et al. J Am Coll Cardiol 2009;54(20):1837-46.CRT Off(n = 82)CRT On(N = 180)12 Months24 Months (Europe)REVERSE 一級終點(diǎn): 臨床綜合反應(yīng) (惡化%) 1 Linde C, et al. J Am Coll Cardiol. 2008;52:1834-43. 2 Daubert C, et al. J Am Coll Cardiol 2009;54(20):1837-46.24 Months

11、2P=0.01P=0.0006P=0.1012 Months1P=0.004REVERSE 主要二級終點(diǎn): LVESVi平均變化12 Months1P 0.000124 Months2P 0.0001 1 Linde C, et al. J Am Coll Cardiol. 2008;52:1834-43. 2 Daubert C, et al. J Am Coll Cardiol 2009;54(20):1837-46.Number at Risk CRT OFF 82 79 76 70 39 CRT ON 180 176 173 168 7762%reduction with CRTREV

12、ERSE 24-months: 第一個臨床研究顯示在NYHA II患者中降低第一次HF住院或死亡62% MADIT CRT 研究設(shè)計(jì) 一級終點(diǎn)一級終點(diǎn):全因死亡, 或非致命的心衰事件主要入選標(biāo)準(zhǔn)主要入選標(biāo)準(zhǔn)NYHA Class:任何病因的NYHA II; 心梗后NYHA ILVEF: 30%QRS Duration: 130 msec研究中心研究中心:110 centres: US (88); Europe (20); Canada (2)資助資助t:Boston Scientific基線評估隨機(jī)2:3非盲ICD Only(N = 731)CRT-D(N = 1089)平均隨訪29個月Moss

13、 AJ, et al. N Engl J Med. 2009;361(14):1329-38.MADIT-CRT顯示在NYAN I/II患者中CRT-D減少34%的全因死亡或心衰事件風(fēng)險34%reduction with CRTMADIT CRT 證實(shí)了REVERSE: CRT減少死亡或心衰事件MADIT CRT 超聲LV容積和EF一年的平均變化P0.001P0.001P0.001Moss AJ, et al. N Engl J Med. 2009;361(14):1329-38.ResynchronizationDefibrillation for Ambulatory Heart Fail

14、ure TrialRAFTAnthony S.L. Tang, M.D., George A. Wells, Ph.D., Mario Talajic, M.D.,Malcolm O. Arnold, M.D., Robert Sheldon, M.D., Stuart Connolly, M.D.,Stefan H. Hohnloser, M.D., Graham Nichol, M.D., David H. Birnie, M.D.,John L. Sapp, M.D., Raymond Yee, M.D., Jeffrey S. Healey, M.D.,and Jean L. Roul

15、eau, M.D.,Tang AS, Wells GA, Talajic M, et al.Cardiac-resynchronization therapy for mild-to-moderate heart failure. Engl J Med. 2010 Dec 16;363(25):2385-95RAFT 研究設(shè)計(jì) 一級終點(diǎn)一級終點(diǎn):全因死亡, 或 心衰住院主要入選標(biāo)準(zhǔn)主要入選標(biāo)準(zhǔn)NYHA Class:NYHA II/IIILVEF: 30%QRS Duration: 120 msec; 或 起搏 200 msec研究中心研究中心:34 centres: Canada(24); E

16、urope (8); Australia (2)資助資助:Canadian Institutes of Health Research, Medtronic基線評估隨機(jī)1:1雙盲ICD Only(N = 904)CRT-D(N = 894)平均隨訪平均隨訪40個月個月RAFT顯示在NYHA II/III患者中CRT-D降低25%全因死亡或心衰住院復(fù)合終點(diǎn)25%reduction with CRT25%reduction with CRTRAFT顯示在NYHA II/III患者中CRT-D降低25%全因死亡率主要入選標(biāo)準(zhǔn)主要入選標(biāo)準(zhǔn) & 研究設(shè)計(jì)研究設(shè)計(jì): REVERSEMADIT CR

17、TRAFTNYHA 心功能分級I, III (post-MI only), IIII, IIILVEF 40% 30% 30%QRS duration 120 ms 130 ms 120 msAFNoNoPermitted患者數(shù)610 (503 Cl. II)1820 (1555 Cl. II)1798 (1438 Cl. II)一級終點(diǎn)臨床復(fù)合反應(yīng)惡化%全因死亡或HF事件全因死亡或HF住院結(jié)果臨床復(fù)合反應(yīng)12 months, 21% CRT OFF 惡化 vs. 16% CRT ON, p=0.10. 24 months (Europe only), 34% CRT OFF 惡化 vs. 1

18、9% CRT ON, P=0.007.無報告無報告 (死亡率和HF事件*復(fù)合終點(diǎn)降低95% confidence interval) 12 months: 沒有報告24 months:62%, p=0.003所有患者:34% (16%, 48%) NYHA Class II:沒有報告所有患者: 25% (13%, 36%)NYHA Class II:27% (12%, 39%) CRT/D降低 HF事件* (95% CI) 12 months: 53%, p=0.0324 months:61%, p=0.01所有患者:41% (26%, 53%) NYHA Class II:無報告所有患者:

19、32% (17%, 44%)NYHA Class II:30% (11%, 45%)CRT/D降低全因死亡率 (95% CI) 12 months: 無差異, P=0.6324 months: 無差異, p=0.09所有患者: 無差異, P=0.99All patients: 25% (9%, 38%), p=0.003NYHA Class II:29% (9%, 44%), p=0.006CRT-D/P, ICD productMedtronicBoston ScientificMedtronic0%5%10%15%20%25%30%06121824Months Since Randomis

20、ationPercentage Hospitalised for HFor DiedCRT ONCRT OFF24.0%11.7%Hazard Ratio: 0.38 95%CI: 0.20-0.73P=0.003Number at Risk CRT OFF 82 79 76 70 39 CRT ON 180 176 173 168 7762%reduction with CRTREVERSE (24-m)顯顯示示:在在NYHA II患者中降低第一次患者中降低第一次HF住院或死亡住院或死亡62%Daubert et al. J Am Coll Cardiol 2009;Vol 54, No 2

21、0CRT在NYHA II 中的臨床效果與NYHA III-IV 一樣的MADIT CRT 證實(shí)證實(shí)REVERSE：CRT降低心衰事件或死亡降低心衰事件或死亡RAFT進(jìn)一步證實(shí)：進(jìn)一步證實(shí)：CRT降級心衰死亡或住院降級心衰死亡或住院25%reduction with CRTCARE-HF: CRT 降低死亡或心血管事件住院率降低死亡或心血管事件住院率CRT在NYHA II 中的臨床效果與NYHA III-IV 一樣的有關(guān)心臟重構(gòu)的作用LVESV0 ml-27 mlp0.001Change from baseline in mlLVEFChange from baseline in % units

22、p120 ms?YesNo EF 150 ms?YesNo EF 120 ms?YesNo EF 35%?YesNo2010 ESC2009 中國中國I Level AIIA輕度心衰患者QRS波越寬獲益越大 在REVERSE, MADIT CRT和RAFT三個臨床中，發(fā)現(xiàn)QRS波越寬的患者，特別是150ms，從CRT中獲益越多，這意味QRS波的寬度對于選擇對CRT有反應(yīng)的患者是一個非常重要的指標(biāo)REVERSE (12m)RAFTMADIT CRT三個臨床研究共同證實(shí) CRT降低NYHA II級患者的死亡率或心衰事件，尤其是CRT-D 缺血和非缺血心衰患者同樣受益 患者QRS波越寬獲益越大Med

23、tronic引領(lǐng)心衰臨床研究10075502500 1 2 3 4 5 6YearsDevice longevity per centp0.0001IntermedicBoston ScientificMedtronicSt Jude1007550250 0 24 48 72 96 MonthsMedtronicPer cent of devices event-freep0.0001BiotronikELABoston ScientificSt JudeKnopf et al 2009. PACE 32:12761285Scherer et al 2009. Heart Rhythm in press. DOI: 10.1016/j.hrthm.2009.09.013Scherer et al 2009: 單中心注冊 n=644 植入始于