再同步治疗挑战和思考

1、再同步治疗挑战和思考Evidence For Heart Failure在美国，每年因心衰就诊3.4百万，死亡30一年再住院率50%，中重度心衰年死亡率近30%。65岁者患病率610%。QRS120ms患者全因死亡率增加约33%。Evidence For CRTEF35%， QRS120ms ， 经理想药物治疗, NYHA IIIIV : 提高心功能分级，改善生活质量，增加活动耐量。降低死亡率和住院率。提高生存率。 如何让更多患者受益？IMPROVE HF To examine patient and cardiology practice characteristics predictive

2、 of CRT use in eligible patients in an outpatient registry of systolic heart failure patients Fonarow GC, et al. Circ Heart Fail. 2008;1:98106.Percent of Indicated Patients (%)Percent of Indicated PatientsReceiving CRT (CRT-D/CRT-P) at BaselineIMPROVE HF Baseline Performance on CRTAll Practices (Bas

3、eline Review)39.39%Fonarow GC, et al. Circ Heart Fail. 2008;1:98106. IMPROVE HF Registry Less than 40% of CRT-eligible patients received a device at baseline assessment In 1/3 of IMPROVE HF outpatient practices, not a single eligible patient received a CRT deviceat baseline手术成功率在RCTS纳入的4000多例中，CRT（经

4、CS植入LV电极技术）的成功率8892：鞘管难以插入CS冠状静脉狭窄或闭锁难以进入靶血管分支或脱位膈肌刺激115135Amp CS60Straight11560135Amp CSAttain StarFixFirst active fixation left-heart leadMore placement optionsVein sizesVein locationsSoft, polyurethane deployable lobes5 Fr lead body, 5.3 Fr electrode with tip sealFor CRT-D devices, the available

5、LV pace polarities are:LV tip to LV ringLV tip to RV coilLV ring to RV coilFor CRT-P devices, the available LV pace polarities are:LV tip/RV ringUnipolar (LV tip/Can)Bipolar (LV tip/LV ring)Pacing Vector ProgrammabilityLV环至RV线圈LV头端至RV线圈LV头端至LV环Non-responder, true or false ?40 consecutive CRT-D patie

6、nts admitted to Cleveland Clinic HF ICUMet CRT indications at implantImplanted for at least 3 months (mean 19 months)Increased LVEDV from pre-implant baselineAveraged 1.2 HF hospitalizations87.5% with LV lead in lateral or postero-lateral positionBiventricular paced 96% of timeAcute, serial echo and

7、 invasive hemodynamic measurements in CRT ON and CRT OFF modesHidden benefit: when CRT turned off, hemodynamic, ECG & echo parameters worsenedPCWPP 0.001Cardiac OutputP 0.001P 0.001QRS WidthP 0.001LV Filling TimeMullens W, et al. J Am Coll Cardiol 2009;53:600-607启示RCTS并未观察反映CRT疗效的敏感指标。对于某些急性疾病，一种指标就

8、容易反映其疗效。但对于那些慢性疾病则不敏感。窄QRS波心衰心功能3级、4级，左室射血分数减低，窄QRS波心衰患者中，30%UCG提示有收缩失同步。仍而，对于窄QRS波心衰患者是否可以从双室起搏治疗中受益，目前仍无明确的答案。 IIB适应证(中国2006)符合常规心脏起搏适应证并心室起搏依赖的患者，合并器质性心脏病或心功能III级及以上常规心脏起搏并心室起搏依赖者，起搏治疗后出现心脏扩大，心功能III级或以上QRS140ms心室间机械延迟40ms左心室后外侧璧激动延迟Beshai J et al. N Engl J Med 2007;357:2461-2471RethinQ 研究Subgroup

9、 Analysis According to the QRS Interval at 6 MonthsRethinQ 研究 对于QRS0.12S的患者，CRT能增加高峰氧耗量,改善NYHA分级。对于QRS0.12S的患者，CRT并不能增加高峰氧耗量。但是，对于QRS0.12S的患者， CRT可以改善NYHA分级（p=0.04）；有增加六分钟步行距离的趋势（p=0.31）。Echo-CRT研究。% of Patients Hospitalised for HFNumber at Risk CRT OFF 191 187 181 176 119 CRT ON 419 415 411 409 251

10、P=0.03Hazard Ratio=0.47CRT OFFCRT ONMonths Since RandomisationREVERSE: CRT delays time to first HF hospitalisation53%reduction with CRTLinde C, Abraham WT, Gold WR et al for REVERSE Study Group. J Am Coll Cardiol 2008 Dec 2;52(23):1834-43.Ongoing StudiesMADIT CRT Multicenter Automatic Defibrillator

11、Implantation Trial with Cardiac Resynchronization TherapyStudy ObjectiveDetermine if CRT-D will reduce the risk of mortality and heart failure events in mild-to-moderate heart failure patients (NYHA Class I and II) compared to ICD-only therapy.Key Inclusion CriteriaIschemic or nonischemic heart dise

12、ase and NYHA Class I or IIEjection fraction 130ms Sample Size: 1,820MADIT CRTCRT was dramatically effective in this large study population, with a 34% reduction in the risk of all-cause mortality or heart failure. The benefit is dominated by a 41% reduction in heart failure events. This results vali

13、date a new indication for cardiac resynchronisation therapy in the prevention of heart failure in at-risk asymptomatic or mildly symptomatic cardiac patients. DAVID Trial Protocol760 assessed for eligibility250 excluded 149 Did not meet Rx criteria 55 refused 46 Other 510 eligible4 Not randomized 2

14、Required pacing 1 Inadequate defibrillation threshold 1 Decided not to implant506 randomizedVVI-40 (n=256)DDDR-70 (n= 250) 1 had pacing mode set to DDD 1 LTF 10 Discontinued intervention 5 Bradycardia 1 CHF and AF 1 Brady induced Torsade 1 Heart Tx workup 1 AF w rapid V response 1 multiple shocks du

15、e to double counting 3 had pacing mode set to VVI 2 LTF 5 Discontinued intervention 1 Angina 1 CHF and Lead Failure 1 CHF Hospitalization 1 Exacerbation of VT 1 Lead MigrationWilkoff B, et al. JAMA. 2002; 288: 3115-3123.Death or First Hospitalization for New or Worsened CHFHazard ratio (95% CI), 1.6

16、1 (1.06-2.44)061218MonthsCumulative Probability0.40.30.20.1025025615915876902125No. at RiskDDDRVVIWilkoff B, et al. JAMA. 2002; 288: 3115-3123.DDDRVVIDAVID Trial ResultsWilkoff B, et al. JAMA. 2002; 288: 3115-3123.VVI-40DDDR-70P-value6-month EKG:Sinus97.1%42.0%0.001V-paced2.9%55.7%0.001QRSd117 + 29 ms134 + 39 ms0.001Cum % VP:3 months1.5% + 8.0%57.9% + 35.8% 0.0016 months0.6% + 1.7%59.6% + 36.2%0.00112 months3.5% + 14.9%58.9% + 36.0%0.001DAVID Trial ResultsDAVID 试验结论DAVID 试验显示对于没有起搏适应证（AV传导正常）的LVEF40%的ICD治疗患者，双腔起搏过高的心室起搏比例，增加死亡率和心衰住院率。Ongoing StudiesBLOCK HF Bive