FY15Q3-CRT生理性起搏模式-adaptivCRT算法课件.pptx

1、CRT的生理性起搏模式AdaptivCRTTM 动态优化，随心所跳美敦力市场部 邹鹏 1 Cleland J,et al.N Engl J Med.2005;352:1539-1549.2 Cleland J,et al.Eur Heart J.2006;27:1928-1932.3Bristow M,et al.J Card Fail.2000;6:276-285.4 Abraham W,et al.N Engl J Med.2002;346:1845-1853.5 Young J,et al.JAMA.2003;289:2685-2694.6 Linde C,et al.JACC.2008

2、;52:1834-1843.7 Tang A,et al.N Engl J Med.2010;363:2385-2395.8 Moss A,et al.N Engl J Med.2009;361:1329-1338.NA=Not powered,not collected,or not blinded for specific end point.*Post-hoc analysis.MortalityHF or CVHospitalizationsCardiac Function/StructureQoL or NYHACARE-HF1,2+NACOMPANION3+NANAMIRACLE4

3、NANA+MIRACLE ICD5NANANA+REVERSE6NA+*+=RAFT7+NANAMADIT CRT8+*+*NACRT疗法的临床研究汇总CRT疗法被大规模临床研究证明是有效的1-8传统CRT疗法反应率的统计但仍有多达1/3的患者不能受益CRT1-6*AV optimized only1 Abraham WT,et al.N Engl J Med.2002;346:1845-1853.4 Chung ES,et al.Circulation.2008;117:2608-2616.2 Young JB,et al.JAMA.2003;289:2685-2694.5 Abraham

4、WT,et al.Heart Rhythm.2005;2:S65.3 Abraham WT,et al.Circulation.2004;110:2864-2868.6 Abraham WT,et al.Late-Breaking Clinical Trials,HRS 2010.Denver,Colorado.67%58%67%MIRACLE1 MIRACLE MIRACLE II InSync III PROSPECT5 FREEDOM6 ICD2 ICD3 Marquis4*100%67%69%52%90%80%70%60%50%40%30%20%10%0%ImprovedClinica

5、l Composite Score1Mullens W,et al.JACC.2009;53:765-773.CRT反应率的各种影响因素影响CRT反应率不是单一问题，与多种因素有关。其中排在第一位的就是不合适的AV间期。下图列举了影响CRT反应的诸多因素1Percentage of Nonresponder Patients with These FindingsSuboptimalAV TimingArrhythmiaAnemiaSuboptimalLV LeadPosition 100 bpm1,or2.延迟的房室传导2,orAS-VS 200 msAP-VS 250 ms3.LVCM确认

6、左室没有夺获如与单LV起搏条件其中一个或以上不符时1.Vollman D,et al.Circulation.2006;113:953-959.2.Kurzidim et al.,PACE 2005;28:754-761.运作步骤：1.评估自身传导AV间期测量AV间期：每分钟测量自身下传间期(1 beat)延长AV间期到300ms来测量测量时可以通过发放VSR来满足同步起搏需要AV间期=median of last 3 measurementsIs AV interval measured normal or prolonged?运作步骤：2.评估自身传导波宽测量测量波宽（P波和QRS波）：每

7、16小时钟测量即2:10am,6:10pm和 10:10am(5 beats)延长AV间期到300ms来测量Median of middle 3 of 5 beatsEGM 1 调整为 Can to SVC(或 Can to Aring)测量时不会发放VSR波宽=median of last 3 measurementsExisting suspend condition?HR 100bpm?AV intervalPhysiologic?RemainAp or As for 5 beats?Update waveform measurementsYesYesYesYesNoNoNoNoChec

8、k every 16 hours Intrinsic AV conduction present?Any HR?窦律?yesARVsLVpnonoyes自身传导是否正常l?HR100 bpm?运作步骤：3.决定起搏模式（LV or BiV）适应性单LV起搏BiV pacing动态双室起搏Medtronic Viva XT CRT-D manual.相互转换运作步骤：4.优化起搏间期适应性左室起搏(Adaptive LV)自适应优化AV间期提前起搏左室，同步右室。动态双室起搏(Adaptive BiV)动态优化AV间期和VV间期同步起搏。Intrinsic AV conduction prese

9、nt?Any HR?窦律?yesARVsLVpnonoyes自身传导是否正常l?HR100 bpm?AdaptivCRT 算法1-6适应性单LV起搏AV=两者较短的:70%自身PR 自身PR 40ms以上BiV pacingAV=两者较短的:As-Pend+30ms/Ap-Pend+20ms自身PR 50ms以上 VV如果融合以及QRS150ms,LV 优先起搏；;如果不融合 双室起搏动态BiV起搏相互转换1 Bailey R,et al.JACC.2008:51(10s1):A22(Abstract 1022-101).2。Jones RC,et al.JCE.2010;21:1226-12

10、32.3.Khaykin,et al.Europace 2011;13:1464-70.4Levin V,Europace 2013(Abstract).5Jones RC,et al.JCE.2010;21:1226-1232.6St John J Am Coll Cardiol.2003;41:187A.AdaptivCRT 临床研究结果1-51 Martin et al.,Heart Rhythm.2012 Nov;9(11):1807-14.2 Krum H,et al.Am Heart J.2012;163:747-752.e1.3 Singh JP,et al.Presentati

11、on at European Society of Cardiology Congress August 2012.4 Birnie D.et al.,Presented at the American Heart Association Scientific Sessions 2012.Abstract#:116725Randall C.Starling.Presented at Heart Rhythm Socity Sessions 2014.AdaptivCRT 临床研究方案目的:比较AdaptivCRT算法和超声优化方法:522名患者，前瞻，多中心，随机，双盲临床研究入选标准：1.N

12、YHA Class III/IV2.QRS 120 ms3.LVEF 35%4.Randomized(2:1 ON vs.OFF)一级终点(6 Months):1.临床综合评分(non-inferiority)2.Cardiac Performance/VTI(non-inferiority)二级终点(6 Months):右室起搏百分比，LV ESVi，LV EF，NYHA，6分钟步行，QoL。1 Birnie D,.Heart Rhythm.September 2013;9(10):1368-1374.2 Krum H,et al.Am Heart J.2012;163:747-752.e1

13、.AdaptivCRT和超声优化6个月临床综合得分无差异Heart Rhythm.November 2012;9(11):1807-1814.AdaptiveCRT 临床研究结论74%12%14%73%16%11%ImprovedUnchangedWorsenedAdaptivCRTEcho controlNon-inferiority P 0.001AdaptiveCRT 临床研究结论Heart Rhythm.September 2013;9(10):1368-1374.AdaptivCRT减少了44%RV起搏Treatment arm subjectsAdaptiveCRT的房颤关联分析0

14、%10%20%30%40%50%0 6 12 18 24%Patients with 48 Hours of AT/AF Months Since Randomization Number 160 141 126 109 33 remaining 312 280 260 241 83 p=0.03HR=0.54(0.31-0.93)aCRTEcho8.8%16.2%AdaptivCRT 降低 46%AF风险 与超声优化的患者相比适应性单LV起搏临床结果分析组内比较LogrankP=0.003AdaptivCRT组内比较：高LV起搏%（50%）降低21%HF住院率及全因死亡率Heart Rhyt

15、hm.September 2013;9(10):1368-1374Multivariate Predictors of All-Cause Death and HF Hospitalization at 12-m FU*在aCRT组中，同步LV起搏%是改善临床反应的预测因子CovariateValueHazard Ratio(95%CI)p-valueRenal dysfunctionYes2.22(1.30,3.81)0.0036LV EF(%)Per 1%increase0.93(0.90,0.97)0.0003QRS duration(ms)156 ms 2.34(1.33,4.10)0

16、.0030%LV only pacing50%2.06(1.17,3.60)0.0118*Multivariate Cox proportional hazard model with stepwise approach,covariates entered at p-value=0.3 and remain if p-value 0.05.Variables considered at the model:baseline QRS duration,LBBB,age,gender,BMI,ischemic etiology,LV EF,NYHA,renal dysfunction,beta-

17、blocker use,ACE/ARB use,AV interval at randomization.适应性单LV起搏临床结果分析.Birnie D,Lemke B,Aonuma K,et al.Clinical outcomes with synchronized left ventricular pacing:Analysis of the adaptive CRT trial.Heart Rhythm.September 2013;9(10):1368-1374.AdaptivCRT 反应率对比分析比较研究方法：根据22个基线特征线性对比研究，采用Propensity score m

18、odel。目标：比较AdaptivCRT（318）和CRT历史临床数据（1003）的反应率AdaptivCRT比传统CRT提高12%的反应率12%7%-10%-5%0%5%10%15%20%25%aCRTEcho CCS Improved aCRTEchoAdaptivCRT 反应率对比分析Singh JP et al.Europace.2013 Nov;15(11):1622-895%CI:2.7%to 19.2%AdaptivCRT 30天再入院分析结论1Randall C.Starling.Presented at Heart Rhythm Socity Sessions 2014.Ad

19、aptivCRT比传统CRT减少40%的30天全因再入院率临床获益安全性有效性提高反应率减少右室起搏减少AF减少HF住院率和死亡率减少30天再入院率AdaptivCRT12%44%46%21%40%AdaptivCRT 的临床获益1-51 Martin et al.,Heart Rhythm.2012 Nov;9(11):1807-14.2 Krum H,et al.Am Heart J.2012;163:747-752.e1.3 Singh JP,et al.Presentation at European Society of Cardiology Congress August 2012

20、.4 Birnie D.et al.,Presented at the American Heart Association Scientific Sessions 2012.Abstract#:116725Randall C.Starling.Presented at Heart Rhythm Socity Sessions 2014.AdaptivCRT总结 以后CRT参数会增加一个LV起搏百分比参数，并且这个参数是改善CRT反应的预测因子1。VIVA XT所有CRTD适应证患者的最佳选择。适应性左室起搏，最大化疗效 AV/VV动态调整，个性化治疗 减少不必要的右室起搏，延长使用寿命.Birnie D,Lemke B,Aonuma K,et al.Clinical outcomes with synchronized left ventricular pacing:Analysis of the adaptive CRT trial.Heart Rhythm.September 2013;9(10):1368-1374.