1、ICD术后电击管理,美敦力ICD术后电击管理周淑娴 中山大学孙逸仙纪念医院,南方医科大学附属南方医院 黄晓波,高达21%的ICD患者会发生不恰当的电击,1 Kadish A, Dyer A, Daubert JP, et al, for the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiom
2、yopathy. N Engl J Med. May 20, 2004;350(21):2151-2158. 2 Daubert JP, Zareba W, Cannom DS, et al, for the MADIT II Investigators. Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol. April 8, 2008;51(14):13
3、57-1365. 3 Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. September 4, 2008;359(10):1009-1017. 4 Mitka M. New study supports lifesaving benefits of implantable defibrillation devices. JAMA. July 8, 2009;302(2):134
4、-135.,减少疼痛，焦虑 增加ICD的接受度1,减少医疗费用，提高患者生活质量1,避免电击的重要性,避免电击 提高生存率 降低心衰的发生2,1 Wathen MS, DeGroot PJ, Sweeney MO, et al, for the PainFREE Rx II Investigators. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patient
5、s with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial results. Circulation. October 26, 2004;110(17):2591-2596. 2 Sweeney MO, et al. Differences in effects of electrical therapy type on health care utilization in the MVP IC
6、D Trial. HRS, 2010.,引起电击的原因,4,Poole JE, et al. Heart Rhythm Society. 2004.,SCD- HeFT sample episode,Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. September 4, 2008;359(10):1009-1017,Poster: Poole JE, et al. Analy
7、sis of ICD Shock Electrograms in the SCD-HeFT Trial. Heart Rhythm Society Conference. 2004.,不必要,恰当,不恰当,美敦力减少电击的完整管理方案,ATP During ChargingTM,优化的ATP无痛治疗,Biv & RV ATP, Oversensing/Artifact- T波识别- 可程控的RV感知环路- 导线完整性报组合警,智能电击技术SmartShock,ATP During Charging 组合减少不必要的电击治疗 特有的多位点ATP(Biv, Lv, Rv)提高无痛治疗成功率,最大限
8、度减少不必要的电击治疗 若ATP无效，不延误电击治疗的发放,优化的ATP无痛治疗减少不必要的电击,ATP During Charging 组合减少不必要的电击治疗 特有的多位点ATP(Biv, Lv, Rv)提高无痛治疗成功率,BIV-ATP在室速区的成功率高达89%，在慢室速区的成功率100%，而传统的RV-ATP分别为72%和74%，且加速和晕厥的风险更高！,Efficacy and safety of different antitachycardia pacing sites in the termination of ventricular tachycardia in patien
9、ts with biventricular implantable cardioverter-defibrillator. Europace (2011) 13, 509513,优化的ATP无痛治疗减少不必要的电击,Poster: Poole JE, et al. Analysis of ICD Shock Electrograms in the SCD-HeFT Trial. Heart Rhythm Society Conference. 2004.,SmartShock 智能电击减少不恰当的电击, Oversensing/Artifact- T波识别- 可程控的RV感知环路- 导线完整性
10、组合报警,SmartShock 6大核心技术,T-波过感知新方法: 频率分析 vs 手动感知调整 全自动 不会因为T-波过感知触发电击 不影响VF检测的敏感性,感知EGM: 在目前的ICD中，信号被过滤而分离R波，这可能过感知T波.,SmartShock, 感知EGM的不同增加R波与T波振幅之比，识别R-T模式.,T波过感解决方案一：T-波识别技术,在保证VT/VF检测敏感性前提下，识别T-波过感知且抑制治疗的发放,第一个也是唯一的,实际运行,T波过感知,如果没有鉴别出T波过感知会有电击的风险!,算法抑制治疗,T波识别技术相关临床研究,Cao, J., Gillberg, J.M., Swer
11、dlow, C.D., A Fully-Automatic Implantable Cardioverter-Defibrillator Algorithm to Prevent Inappropriate Detection of Ventricular Tachycardia or Fibrillation due to T-wave oversensing in Spontaneous Rhythm, Heart Rhythm(2011), doi: 10.1016/j.hrthm.2011.11.023,100% VT/VF识别的敏感性96.6% TWOS识别的特异性,RVtip to
12、 RVring,RVtip to RVcoil,非创伤的程控帮助解决过感知或感知不良 传统ICD的RV感知环路默认为Bipolar，无法程控,T波过感的另一解决方案 可程控的RV感知环路,该患者感知环路为 Rvtip to Rvring时，有T波过感知，从腔内图可以看到高大的T波； 程控感知环路为 RVtip to Rvcoil时，T波过感知消除，从腔内图可以看到低矮的T波 - (Case Example device sensing vector: RVtip to ring, 0.45 mV sensitivity),T波过感知,该案例程控感知环路为Rvtip to Rvcoil即可彻底解
13、决T波过感知,程控感知环路解决T波过感知,电极导线完整性报警预警电极导线故障并延长VF的检测时间（30/40）,电极导线噪音识别+ 报警识别由于噪音信号导致的过感知并抑制治疗的发放 不影响 VT/VF 检测敏感性通知临床潜在的电极导线噪音,RV电极导线完整性组合预警,结合2种算法，对电极导线故障进行检测，报警及抑制不恰当治疗,*LIA for Vision 3D devices Abstract: Patel AS, et al. Modification to Lead Integrity Alert Improves Performance. HRS Conference. 2009.,电
14、极导线完整性报警：LIA,LIA 减少由于过感知/噪音引起的电击,75%由于电极导线问题引起的干扰的患者能在不恰当电击发生前3天得到警告 *1,285 患者中每年只有1例假阳性发生*,* Patel AS, Gunderson BD, Swerdlow CD, et al. Modification to LIA improves Performance. HRS Conference 2009,电极导线过感知具有局限在近场感知信号的特征 通过对腔内远场和近场信号的对比分析，识别电极导线噪音,Medtronic Confidential and Proprietary. Internal Us
15、e Only.,17,电极导线噪音识别,实际运行,噪音,如果没有鉴别出噪音会有电击的风险!,算法抑制治疗,在VF区的鉴别 (出厂值)SVT Limit = 260 msVF 高频超时,PR Logic有效鉴别窦速和大部分的房 颤/房扑,PR Logic + Wavelet 结合波形和A-V之间的模式识别，更好地鉴别所有SVT- 即使非常快的事件,+,Wavelet应用EGM波形提高SVT的鉴别(如：AF下传，和突发的SVT),实际运行,20,SVT,如果没有鉴别出SVT有电击风险!,算法抑制治疗,Confirmation+ 更好识别ATP终止的或在充电时自动终止的心动过速 避免在ATP治疗或充
16、电结束时单个室早或单个快速事件引起的不恰当电击,Confirmation + 根据持续心律失常的自身节律调整诊断的标准 vs 程控的诊断频率 (同步间期),Confirmation now available after ATP During Charging sequence,再确认的“心律失常窗口” 老算法：由程控的VT/VF最低诊断频率决定 新算法：由事件自身频率决定,偏慢，易误触发,不易受PVC，快心率影响,22,Case Study: Operation in Marqius7230ICD,Current Confirmation Interval = TDI + 60 ms420
17、ms = 360 ms + 60 ms,Reconfirm,Sync,Shock,目前应用的Confirmation,23,Case Study: Operation in ProtectaICD,Abort,Confirmation Interval = Rhythm Cycle length + 60 ms310 ms = 250 ms + 60 ms,VT zone programmed ON at 360 ms (Old CI = 420 ms) Rhythm cycle length = 250 ms Shock would be aborted with Protecta Conf
18、irmation Interval = 250 ms + 60 = 310 ms Intervals after ATP During Charging used in confirmation,Confirmation +,SmartShock 临床表现如何？,背景：证实 ICD功能需要大量患者进行数年长期的随访 进行前瞻性，随机研究评估几个程控策略的组合是一个挑战 (费用, 时间, ) 目的: 应用计算机模型和长期临床研究的ICD事件数据预测策略/功能组合减少电击的结果,J Cardiovasc Electrophysiol. 2011 Mar;22(3):280-9.,Combining
19、 Shock Reduction Strategies to Enhance ICDTherapy : A Role for Computer ModelingKENT J.VOLOSIN.M.DF.A.C.CF.H.R.S*DEREK V.EXNER.M.DM.P.HF.A.CCF.H.R.S+MARK S.WATHEN.M.DF.A.C.CLOU SHERFESEE,PH.D+ANTHONY P.SCINICARIELLO.PH.Dand JEFFREY M.GILLNERG.M.S+From the *University of pennsylvania.Philadelphia.Pen
20、nsylvania.USA:+Libin Cardiovascular Institute of Alberta.Canada; and +Medtronic IncMinneapolis.Minnesota.USA,26,应用SmartShock 98%患者 1年内，92%患者5年内没有不恰当的电击1,1 Virtual ICD: A Model to Evaluate Shock Reduction Strategies. Presented at HRS 2010 (P03-125).,PainFree SST Trial Primary Results,PainFree SST研究为证
21、实新检测算法和出厂设置可以降低不恰当电击率而设计,PainFree SST Trial Primary Results,27,主要目的: 评估植入一年后Medtronic Protecta DR-ICD/ CRT-D 和 VR-ICD不恰当电击率,Low Shock Rates in Patients with Dual and Triple Chamber ICDs Using Novel Detection Algorithms,Study overview1,1. Auricchio 2011 Europace, 2. Heintze 2011 ACC poster, 3. Schlos
22、s 2013 HRS presentation,PainFree SST Trial Primary Results,28,一级终点：无不恰当电击率,DR/CRT-D： 一年98.2%患者 无不恰当电击率,VR： 一年97.6%患者无不恰当,Confidential and Proprietary; Do Not Copy or Distribute,29,97.6% (CI: 96.4% - 98.8%),98.2% (C.I. 97.4% -99.0%),SmartShock 在确保敏感性的同时显著减少不恰当电击的发生1,2,1 Predicted from Virtual ICD: A
23、Model to Evaluate Shock Reduction Strategies. Presented at HRS 2010 (P03-125). 2 Protecta Clinical Study, Medtronic data on file. 3 Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. September 4, 2008;359(10):1009-1017.t,Poster: Poole JE, et al. Analysis of ICD Shock Electrograms in the SCD-HeFT Trial. Heart Rhythm Society Conference. 2004.,不必要,恰当,不恰当,美敦力减少电击的完整管理方案,ATP During ChargingTM,优化的ATP无痛治疗,Biv & RV ATP, Oversensing/Artifact- T波识别- 可程控的RV感知环路- 导线完整性报警- 导线噪声识别,智能电击技术SmartShock,谢谢！,南方医科大学附属南方医院,
