全智能起搏系统Altrua.ppt

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1、Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,全智能起搏系统,全智能安全保障全智能生理起搏全智能节律管理全智能增值服务,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Di

2、splay or Distribute Externally,全智能安全保障,逐跳自动心房、心室感知逐跳自动智能夺获自动长期阻抗监测自动极性安全转换,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,逐跳自动心房、心室感知,*Emergence of atrial fibrilliation as a new comorbidity in pacemaker patients PACE 1992,22(Part I),临床问题:感知不足/过感知，尤其

3、是在房颤发作时，心房波的平均振幅可降低52%*,临床利益:避免感知噪音或漏感知,提高起搏器使用安全性并延长使用寿命,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,运算法则心房和心室均适用测量每次感知事件的振幅及当前的噪音水平，从而决定一个合适的感知灵敏度水平每一个心动周期更新一次,逐跳自动心房、心室感知,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display

4、 or Distribute Externally,自动感知趋势图,逐跳自动心房、心室感知,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,Automaticity,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,每个脉冲后自动测量ER波，判断心室起搏阈值，不受电极导线的任何限制。,逐搏智能夺获,临床利

5、益:在保证安全起搏输出的基础上延长起搏器使用寿命,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,安全的逐搏智能夺获,每跳检测状态,重试状态（21小时后）,起搏输出=2x 阈值，且必须在3.5 V和5.0 V之间,脉宽不变，保证安全,测试成功,动态的心室自动阈值测试,21小时后,起搏输出=阈值+0.5 V,脉宽 0.4 ms,阈值测试后的1小时内发生C-LOC*,每21小时或 C-LOC*,*C-LOC=确定失夺获,Boston Scientifi

6、c Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,独有的配对电容器独有的融合波管理独有的R波早期感知独有的ER感知环路,不受极化电位的影响,不受电极极性的影响,智能夺获是安全，灵活的,不受融合波的影响,鼓励自身传导,逐搏智能夺获,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,+,-,Cp,Cc,RL,独有的配对电容器,Stimulat

7、ionswitch,FastRechargeswitch,PaceAmplitudeGenerator,Battery,+,在发放起搏脉冲的短暂瞬间，使用并联在起搏环路上的配对电容器（Cc）吸收起搏脉冲在电极导线头端与心内膜之间产生的极化电位，从而使起搏脉冲后的刺激除极波的感知不受极化电位的影响,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,临床利益：融合波管理保证备用脉冲安全发放同时鼓励自身传导,使起搏器工作更生 理，使用寿命更长,独有的融合波

8、管理,10,mS,64,mS,Vpace,夺获,备用脉冲,融合波,Vpace,noise window,Vpace,失夺获,窗口内最低值,最低值落在采样窗口中，则AV间期或VV间期延长64ms,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,独有的R波的早期感知,在发放心室起搏脉冲之前,先在感知窗口中寻找自身R 波,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Di

9、splay or Distribute Externally,临床利益:R波早期感知鼓励更多自身传导,减少融合或假融合事件,使智能夺获更加安全,起搏更加生理,在发放心室起搏脉冲之前,先在感知窗口中寻找超过早期感知窗口阈值的自身R 波,独有的R波的早期感知,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,每日心室阈值测量值报告表,Boston Scientific Confidential-For Internal Use Only.Do Not C

10、opy,Display or Distribute Externally,每日心室阈值测量值报告图,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,自动心室阈值测试,临床利益:提供安全而舒适的心室阈值测试，消除心室阈值测试的潜在危险。,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,Automatici

11、ty,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,备用安全起搏,自动心室阈值测试,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,自动极性安全转换,临床利益:自动转换电极导线极性，提高逐搏心室夺获的安全性,Boston Scientific Confidential-For Internal Use

12、 Only.Do Not Copy,Display or Distribute Externally,自动阻抗监测,临床利益:提供自植入以来的起搏系统阻抗每日测量值,为准确回顾分析起搏系统完整 性提供可靠依据,自动阻抗监测,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,安全保障,想您所想-最大限度地实现起搏器全自动化安全保障,减少随访工作负荷:逐搏智能夺获 逐跳自动感知 自动阻抗监测 自动极性安全转换,全智能,供您所需-保证起搏器安全工作,并最大

13、程度减少电池消耗,延长使用寿命.使患者受益,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,全智能起搏系统,全智能安全保障全智能生理起搏全智能节律管理全智能增值服务,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,生理起搏,生理起搏是指人工心脏起搏器在保证患者基本心率的同时，通过起搏器不同类型、各种起搏

14、方式、电极导管的各种位置、不同间期的计算方法，获得各心腔之间最好的同步性、最理想的电生理稳定性、最佳的心输出量，保证起搏节律及血流动力学效果最大程度地近似心脏的正常生理状态。,摘自循证生理性起搏治疗,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,全智能生理起搏,独有的MV混合双传感器 独有的Autolifestyle(自动生活模式)频率滞后(Rate Hysteresis),AV搜索滞后(AV Search Hysteresis),“人工窦房结”

15、:根据人体生理需要,提供合适的心率,“人工房室结”:在有自身传导的基础上,恢复房室同步,其他:通过改变时间间期模拟人体正常生理状态,Dynamic AV Delay（动态AV间期）Dynamic PVARP（动态PVARP）,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,MV混合传感器=MV+加速度,测量胸腔阻抗独特的四极设计使用普通标准双极导线与潮式呼吸量和呼吸频率相关,加速度计传感器(XL),潮气量,呼吸间期,分钟通气量（MV）=潮气量 x

16、呼吸频率,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,活动量,标准化的传感器指示频率,1.3,.80,1.0,*Bruce L.Wilkoff,MD,“Cardiac Chronotropic Responsiveness”Clinical Cardiac Pacing,W.B.Saunders Company,p.436.,变时性反应的测量标准变时性反应的 Wilkoffs模型*,Boston Scientific Confidential-

17、For Internal Use Only.Do Not Copy,Display or Distribute Externally,频率适应性传感器的平均变时性反应,市场上销售的加速度传感器起搏器的变时性反应：0.60,活动量,标准化的传感器指示频率,1.3,.80,.60,1.0,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,MV混合传感器,1.0,0.92,0.80,1.30,Results from PULSAR MAX clinical

18、 PACE June 19991,0.83,1.01,Workload,Normalized SIR,唯一被临床证实可以帮助变时功能不全患者恢复的传感器!,Wilkoff BL,Corey J,Blackburn G.A mathematical model of cardiac chronotropic response to exercise.J Electrophysio.1989;3(3):176180.Boston Scientific Corporation.ALTRUA 60 Pacemaker System Guide.2008.1-20-1-28Ellenbogen K.,K

19、ay G.,Wilkoff B.Clinical Cardiac Pacing.Philadelphia,PA:W.B.Saunders Company;1995.,混合传感器,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,使用混合传感器,MV混合传感器,慢步走,快步走,乘电梯,下楼梯,上楼梯,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or D

20、istribute Externally,优化MV传感器?,临床问题:走廊行走花费太多时间随访时无法做最优化害怕不适当的高频率起搏结果:MV传感器没有被使用即便使用也未被最优化,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,AutoLifestyle,临床利益:使患者便捷从MV混合传感器中获得最生理的起搏支持,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Disp

21、lay or Distribute Externally,AutoLifestyle（自动生活方式）,活动度(与通气量相关),心率,LRL,正常心率区,低反应,粗调,微调,开始反应,最大通气量时的最大心率,MSR,高反应,APMHR=220 年龄,1.植入时 AutoLifestyle会根据患者年龄自动把初始反应因素设置在一个比较保守的水平。,2.植入后 AutoLifestyle会自动根据患者数周的活动度自动调整MV反应因素（粗调）,3.长期 AutoLifestyle会根据患者的活动度需要调整每分通气量和重力加速度计反应因素（微调）,注意：反应因素受MSR的限制。如果发现反应过度，Auto

22、Lifestyle会自动降低MV反应因素,休息,最大(MV max),Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,“一键式”程控界面（Expert Ease）,1.程控患者年龄,2.选择,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,Automaticity,Boston Scientific C

23、onfidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,在使用传感器频率或LRL起搏的同时,能否鼓励更多的自身活动出现，使起搏更加生理？,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,频率滞后（Rate Hysteresis）,临床利益：在使用传感器频率或LRL起搏心房的同时，鼓励窦房结自身传导，延长起搏器寿命,Boston Scientific

24、 Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,频率滞后（Rate Hysteresis）,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,全智能生理起搏,MV混合双传感器与Autolifestyle(自动生活模式)频率滞后(Rate Hysteresis),AV搜索滞后(AV Search Hysteresis),“人工窦房结”:根据

25、人体生理需要,提供合适的心率,“人工房室结”:在有自身传导的基础上,恢复房室同步,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,没有任何心室漏搏 AAI(R)起搏器,DDD(R)起搏器周期性搜索自身传导 每 32 1024间期进行搜索AV Delay较原程控值延长10100%进行搜索,自身AV传导,丧失自身AV传导,房室间期搜索（AVSH）,临床利益：提供动态的起搏器房室间期,适应人体自身传导的变化,鼓励自身传导.,Boston Scientif

26、ic Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,Intrinsic RV*目前最大的临床试验，证实AVSH 延长到300ms的算法有效性 显著减少RV 起搏.,108 中心,1580患者入选 INTRINSIC RV population was slightly sicker compared to the David trial population(21%NYHA class III/IV vs.12%)INTRINSIC RV study was conducted w

27、ith a 300ms max.AV delay.Extension to 400ms provides increased flexibility for pacing avoidance,*2 Olshansky B,Day J,Moore S,Gering L,Rosenbaum M,McGuire M,Brown S,Lerew D.Is Dual-Chamber Programming Inferior to Single-Chamber Programming in an ImplatableCardioverter-Defibrillator?Results of the INT

28、RINSIC RV(Inhibition of Unnecessary RV pacing with AVSH in ICDs)Study.Circulation.2007;115:9-16,2a Sharma AD,Rizo-Patron C,Hallstrom AP,ONeill GP,Rothbart S,Martins JB,Roelke M,Steinberg JS,Greene HL;DAVID Investigators Percent right ventricular pacing predicts outcomes in the DAVID trial.Heart Rhyt

29、hm.2005 Aug;2(8):830-4,房室间期搜索（AVSH）-临床证据,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,为何使用 400 ms AV delay？,1、满足有自身传导的患者对AV间期的设置要求,AV intervals during one week of MVP operations*42%200ms-300ms 15%300ms 400ms,*O.Sweeney M,B.Shea J,Fox V,Adler S,Nel

30、son L,J.Mullen T.,Belk P.,Casavant D,Sheldon T.Randomized pilot study of a new atrial-based minimal ventricular pacing mode in dual chamber implantable cardioverter-defibrillatrors.Heart Rhythm.2004;1:160-167,2、保证每跳都没有漏搏，从而避免短长短顺序起波带来的潜在风险,房室间期搜索（AVSH）-临床证据,Boston Scientific Confidential-For Interna

31、l Use Only.Do Not Copy,Display or Distribute Externally,全智能生理起搏,MV混合双传感器与Autolifestyle(自动生活模式)频率滞后(Rate Hysteresis),AV搜索滞后(AV Search Hysteresis),“人工窦房结”:根据人体生理需要,提供合适的心率,“人工房室结”:在有自身传导的基础上,恢复房室同步,其他:通过改变时间间期模拟人体正常生理状态,Dynamic AV Delay（动态AV间期）Dynamic PVARP（动态PVARP）,Boston Scientific Confidential-For

32、Internal Use Only.Do Not Copy,Display or Distribute Externally,生理起搏,想“您”所想-生理起搏支持最大化 MV混合双传感器 频率滞后 AV搜索滞后 Dynamic AV Delay Dynamic PVARP程控简单:Autolifestyle专家轻松程控界面,供“您”所需-通过起搏支持提高患者的生活质量,延长起搏器的使用寿命,全智能,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,全

33、智能起搏系统,全智能安全保障全智能生理起搏全智能节律管理全智能增值服务,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,医生认为3070的心动过缓的患者发生AF植入起搏器的病窦患者在植入后六年发生房颤的几率是50%*,*Bendit et al,PACE 1999；22：902,临床热点：房性心律失常,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display o

34、r Distribute Externally,全智能节律管理,控制心室率：ATR（Atrial Tachy Response）房性心动过速反应AFR(Atrial Flutter Response)：房扑反应VRR(Ventricular Rate Regulation)：心室节律规整,控制节律：RS(Rate Smoothing)：节律平滑APP(Atrial Pacing Preference)：心房起搏优先,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Ext

35、ernally,在房颤患者中应首先考虑室率控制疗法1，虽然在足够药 物的室率控制下，许多的患者能够忍受房颤，但还是有一些其它房颤发作时的症状来自于不规则的心室率2。因此更进一步说，房颤时不规则的心室率而导致了不良的血流动力学3,4。,1.N Engl J Med 2002;347:1825-18332.J Cardiovasc Electrophysiol 2002;13:667-6713.Am Heart J 1983;106:284-2914.J Am Coll Cardiol 1997;30:1039-1045,如何减少房颤的症状？,Boston Scientific Confident

36、ial-For Internal Use Only.Do Not Copy,Display or Distribute Externally,控制心室率,50,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,触发频率 100-200,房性心动过速反应,非跟踪模式(SR 或ATR LRL),MTR,房扑反应,触发频率 130-230,MTR,非跟踪模式(SR或ATR LRL),房性心动过速反应/房扑反应,Boston Scientific Confi

37、dential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,心室节律规整,VRR Off,VRR On,临床利益:减少因房性心律失常期间的不规则心室率而引起的症状,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,Objective of the studyThe objectives of the study are the evaluation:of the

38、 effectiveness of the ventricular rhythm regularization through the use of VRR,the impact on medium term effect of stimulation with VRR,the reduction of specific symptoms,Main findingsThe VRR algorithm effectively achieves a more favorable autonomic balance:it stabilizes the ventricular rateit signi

39、ficantly improves the heart rate recoveryafter exercisethough creating an“overdrive”in the ventricular rhythm,it did not produce an increase of the average rate.it showed a reduction of specific symptoms,in particular,those induced by palpitations.,13.8,6.7,p 0.001,Ventr.Rate Variability(RR30),300,3

40、50,p 0.001,Walking Test(m),85.5,77.7,p 0.001,Ventr.Rate 1 min after Walking Test(RR30),Ciaramitaro G,Sgarito G,Solimene F,Maglia G,Vicentini A,Di Donato G,Raciti G,Parrinello G,Battista Del Guidince G.Role of Rate Control and Regularization Through Pacing in Patients with Chronic Atrial Fibrillation

41、 and Preserved Ventricular Function:The VRR Study.Pace.2006 Aug;Vol 29:866-874,心室节律规整_VRR study,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,控制节律,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,节律平

42、滑,Rate Smoothing OFF,Rate Smoothing ON,临床利益:节律平滑可显著减少患者持续性室性快速心律失常的发生*,*Wietholt D,Kuehlkamp V,Meisel E,et.al,for the PREVENT study group.Prevention of sustained ventricular tachyarrhythmias in patients with implantable cardioverter-defibrillators-the PREVENT study.J Interv Card Electrophysiol.2003;

43、9(3):383-389.,患者A,患者B,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,窦性心律APP 频率,自身,心房起搏优先,临床利益:以略高于自身心律的频率起搏心房，预防房性快速心律失常,APP 最大频率,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,临床医生需要管理房颤患者的工具,阵发性房

44、颤中，无症状性事件的发生率是有症状性事件的12倍无症状性事件的危害性与症状性事件一样,Page RL，et acirculation1994；89：224-227,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,腔内EGM可以帮助医生管理房颤患者,能帮助鉴别和确诊AF事件，因为高达90起搏器患者发生AF时往往无症状 3,4高达23%由起搏器记录的模式转换事件最后经腔内EGM分析证实不是房性心律失常事件 5由EGM证实的房性心律失常可以帮助医生确定抗

45、心律失常药物的有效性以及是否需要抗凝治疗.6如果没有事件发作前EGM，那么高达61的存储EGM将无法帮助临床诊断.7,3 Orlov MV,PACE 2007;30:404-4114 Strickberger SA Heart Rhythm 2005;2:125-1315 De Simone A PACE 2005;28:S47-S496 Ghali JK PACE 2007;30:850-8577 Nowak B Europace 2003;5:103-109,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,D

46、isplay or Distribute Externally,按需定制事件间期/数量，触发事件多种触发条件室性心动过速(常规开)ATR(模式转换-常规开)/房性心动过速非持续性VT突发心动过缓反应 起搏器介导的心动过速患者触发110 秒可存储量，双通道同时记录可存储 31个事件常规打开，不影响电池寿命(2 周/6年),Altrua腔内心电图,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,Altrua腔内心电图,事件数量和触发类型可以根据医生的要

47、求定制,触发类型,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,Altrua腔内心电图,日期开始时间发作开始阶段频率最大频率触发机制,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,Altrua腔内心电图_打印,房率快&不规则房率 室率诊断:房颤,Boston Scientific Confident

48、ial-For Internal Use Only.Do Not Copy,Display or Distribute Externally,全视图和放大观察颜色编码，易于区别,Altrua腔内心电图_程控界面,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,节律管理,想“您”所想-全方位的节律管理:房性心动过速反应房扑反应心室节律规整 节律平滑心房起搏优先 为随时个性化的治疗方案,提供可靠的辅助诊断工具:110秒的全智能腔内EGM,全智能,供“您

49、”所需-在全面管理的同时,尽量维持AV同步起搏,不影响起搏器寿命,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,全智能起搏系统,全智能安全保障全智能生理起搏全智能节律管理全智能增值服务,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,*Altrua System Guide.,通过数据证实的长寿,且智

50、能夺获打开后，97%患者在植入后6个月不需要重新程控*，说明只要打开智能夺获，大部分患者均可受益,ALTRUA 60 settings:60 ppm,A=2.5 V,V=1.0 V,500 ohms,0.4 ms,100%dual-chamber pacing,Automatic Capture ON,MV blended sensor ON.,+12%,+9%,+10%,Boston Scientific Confidential-For Internal Use Only.Do Not Copy,Display or Distribute Externally,即使按照临床适应症进行的标准