心脏起搏器培训资料：AutoCapture 起搏系统

1、AutoCapture Pacing Systems AutoCapture起搏系统 AutoCapture Pacing Systems Clinical Relevance Capture Verification Algorithm Overview Fusion Avoidance Capture Recovery Automatic Threshold Search Test Evoked Response (E/R) Sensitivity Test Reduction of Polarization Diagnostics Case Study AutoCapture起搏系统 临

2、床相关信息 夺获确认 运算法则 融合波排除 夺获恢复 自动阈值搜索测试 E/R感知灵敏度测试 降低极化信号 诊断 病例讨论 AutoCapture Pacing Systems Clinical Relevance AutoCapture起搏系统 临床相关信息 Clinical Relevance Patient Issues Longevity Size Safety 临床相关信息 患者的关注点: 使用寿命 大小 安全性 Clinical Relevance Device Longevity Many advancements have taken place to increase dev

3、ice longevity Improved lead technology Improved more efficient circuitry Automatic capture verification 临床相关信息 许多改进延长了起搏器的使用寿命 改进的导线技术 改进的更有效电路 自动夺获确认 Clinical Relevance Device Size Smaller devices are needed to provide more comfort and cosmetic appeal to patients 患者相关信息 起搏器大小: 小的体积对患者来说更舒适和美观 Clini

4、cal Relevance Patient Safety Ensure capture at all times for the patient Providing a safety margin to maintain capture requires clinical judgement without the benefit of a crystal ball 患者相关信息 患者安全性: 在所有时间内确认夺获 需要一个临床的判断来提供一个安全范围， 而非通过一个水晶球获知 AutoCapture Pacing Systems Capture Verification AutoCaptur

5、e起搏系统 夺获确认 Capture Verification Clinical Issues Capture Safety Margins 夺获确认 临床的关注点: 夺获 安全范围 Capture Verification Capture The effective induction of a cardiac depolarization by an electrical stimulus Capture Threshold The lowest output delivered by the pacemaker that consistently results in capture L

6、ead Maturation The evolution of capture and sensing thresholds in the early post-implant period 夺获确认 夺获 通过电刺激使心肌有效除极 夺获阈值 稳定夺获心脏的最低起搏器输出 导线成熟 在植入后早期，夺获和感知阈值的演变过程 Capture Verification Rheobase Chronaxie Point Stimulation Threshold 6 5 4 3 2 1 0.25 0.51.01.52.0 Pulse Duration (ms) Pulse Amplitude (V)

7、Capture Noncapture Strength Duration Curve A description of the capture threshold at multiple pulse widths Rheobase - the lowest voltage threshold at an infinitely wide pulse width Chronaxie Point - the pulse width at twice the rheobase voltage 夺获确认 强度时间曲线 对多种脉宽情况下的 夺获阈值的一种描述 基强度 在无限宽的 脉宽时的最小电压阈 值 时

8、值 - 两倍基强度电 压时的脉宽 基强度 时值点 刺激阈值 6 5 4 3 2 1 0.25 0.51.01.52.0 脉宽 (ms) 脉冲振幅 (V) 夺获 失夺获 Capture Verification Safety Margin A ratio of the programmed output to the measured capture threshold Clinical Standard 2:1 夺获确认 安全范围 程控的输出与测得的夺获阈值之比 临床标准 2:1 Capture Verification Acute Changes in pacing threshold Ad

9、apted from: Furman, Hayes, Holmes, A Practice of Cardiac Pacing, 1993 % Implant Current Threshold Weeks Months 123423456 100 200 300 夺获确认 急性期起搏阈值的变化 Adapted from: Furman, Hayes, Holmes, A Practice of Cardiac Pacing, 1993 植入电流阈值% 周周 月月 123423456 100 200 300 Capture Verification Excitable Tissue Non-e

10、xcitable Tissue Virtual Electrode Electrode Lead Maturation 夺获确认 可兴奋组织 不可兴奋组织 虚拟电极 电极 导线成熟 Capture Verification Other Factors Impacting Capture Thresholds Activity Level Posture Time of Day Co-morbid illness Heart Failure Elevated K+ Eating Drugs Disease progression Patient Threshold Changes 2.5 V F

11、ixed Output Time Amplitude (V) 4.8 3.9 3.0 2.1 1.2 0.3 夺获确认 其它影响夺获阈值的因素 活动度水平 体位 一天内的不同时间 伴发疾病 心衰 血钾升高 进食 药物 疾病进展 患者阈值改变 2.5V固定输出 时间 振幅(V) 4.8 3.9 3.0 2.1 1.2 0.3 Capture Verification The incidence of non-capture is estimated to be approximately 1% - 5% Non-capture may have serious clinical conseque

12、nces to the pacemaker dependent patient Stimulation thresholds may change not only from acute to chronic but on a daily basis as well 确认夺获 失夺获的发生率估计约为1% - 5% 对于起搏依赖的患者来说，失夺获可能导致严 重后果 刺激阈值的变化不仅发生在从急性期至慢性期， 而且发生在每日的生活中 Capture Verification “In view of our data, 100% (2:1) voltage safety margin may not

13、 be regarded as truly safe, and 150% - 200% voltage margins appear more appropriate”1 (Medtronic/Intermedics Leads) “5/16 patients (31%) had transient abrupt three- fold rises in stimulation threshold during active pacing”2 (SJM Leads) “These findings question whether the 100% safety margin is reall

14、y safe.”3 (Biotronik Leads) 1.Danilovic and Ohm, PACE 1999; 22: 567-587 2.Syed J, PACE 1999; 22: 757 (abstract 229) 3.Schuchert A, CIRC 2000; 102: II-623 (abstract 3023) 夺获确认 “根据我们的数据，100% (2:1)电压安全范围不 能被认为是绝对安全，150% - 200%电压安全范 围显示更合适。”1 (Medtronic/Intermedics导线) “在积极起搏期间，5/16(31%)患者的刺激阈值会 短暂急速上升至3

15、倍。”2 (St. Jude Medical导线) “这些发现对100%安全范围是否真正安全提出了 质疑。”3 (Biotronik导线) 1.Danilovic and Ohm, PACE 1999; 22: 567-587 2.Syed J, PACE 1999; 22: 757 (abstract 229) 3.Schuchert A, CIRC 2000; 102: II-623 (abstract 3023) Capture Verification Patient Safety Without capture, all the other features of a pacemak

16、er are meaningless as the device cannot support the patient! 导线确认 无夺获 如果起搏器不能支持患者，那么所有起搏器的其 他功能失去意义! Capture Verification The Challenge Reduce battery current drain to an absolute minimum in order to maximize device longevity Provide patient safety for the uncommon patient with a late unexpected thr

17、eshold rise Accomplish all of this in as small a pulse generator as possible 夺获确认 面临的挑战 将电池的耗用电流降到绝对最低，以使电池 寿命最大化 为以后可能发生无法预料的阈值上升的患者 提供安全 在尽可能小的起搏器内实现这些目标 AutoCapture Pacing Systems Algorithm Overview AutoCapture起搏系统 运算法则 Algorithm Overview A system designed to confirm a response to each and every

18、pacing stimulus as well as automatically adjusting the output to the patients changing threshold, thereby, minimizing energy consumption. 运算法则 该设计用于确认每一次起搏刺激的反应，同 时根据患者的阈值改变，自动调整输出，从 而使能量消耗最小 Algorithm Overview Capture is determined by detecting an Evoked Response (ER) from the lead tip Looking for

19、Evoked Response on Every Beat If an Evoked Response is not seen a back-up pulse is delivered 4.5 V and at least 0.5 ms Pulse Width Initial Pulse Loss of Capture Back up Pulse 运算法则 通过检测导线头端的刺激除极波(ER波)来决定夺获 寻找每一次心跳的ER波 如果没有看到ER波，则将发放一个安全备用脉冲 4.5V和至少为0.5ms的脉宽 失夺获脉冲 备用脉冲 Algorithm Overview CAPTURE Non C

20、APTURE Evoked Response Initial Pulse Back up Pulse 运算法则 夺获 失夺获 ER波 初始脉冲 备用脉冲 ER Detector 46 ms 14 ms OpenClosed Algorithm Overview Evoked Response Detection ER波检测 46ms 14ms 打开关闭 运算法则 ER波检测 46 ms14 ms Open Closed Backup Safety Pulse ER Detector Auto-programmed Amplitude Stimulation Pulse Pulse Amplit

21、ude = 4.5 V Pulse Width = 0.5 ms Processing window Automatic Delivery of Back-Up Safety Pulse Algorithm Overview 46ms14ms 打开 关闭 安全备用脉冲 ER波检测 自动程控振幅 的刺激脉冲 脉冲振幅 = 4.5 V 脉宽 = 0.5 ms 处理窗口 自动发放安全备用脉冲 运算法则 Initial Pulse Back-Up Safety Pulse Algorithm Overview Loss of Capture, One Beat 起始脉冲 备用安全脉冲 运算法则 失夺获

22、，一跳 AutoCapture Pacing Systems Fusion Avoidance AutoCapture起搏系统 融合波排除 Fusion Avoidance The AV/PV delay is extended 100 ms on next beat after loss of capture This extension minimizes fusion-induced threshold searches 融合波排除 在失夺获之后，下一个AV/PV间期将延长100ms 该延长减少了融合波引起的阈值搜索 Extension of the PV delay by 100 ms

23、 Initial Pulse Fusion Avoidance PV间期延长100ms 初始脉冲 融合波排除 Programmed AV/PV delay 100 ms Extension Fusion Avoidance 程控的AV/PV间期 100ms延长 融合波排除 In the patient with intact AV nodal conduction, the Fusion Avoidance Algorithm may result in sustained pacemaker inhibition PV Extension Sustained PV ExtensionPseu

24、dofusion Beat Fusion Avoidance 在有完整AV传导的患者中，融合波排除的运 算法则可能造成持续的起搏器抑制 PV延长 持续的PV延长 假性融合波 融合波排除 AutoCapture Pacing Systems Capture Recovery AutoCapture起搏系统 夺获恢复 Capture Recovery If two consecutive initial pulses indicate loss of capture The amplitude is increased by 0.25 V for one beat If capture is co

25、nfirmed, the pacemaker delivers the same amplitude again to re-confirm capture After capture is confirmed a Threshold Search is initiated 夺获恢复 如果连续两次初始脉冲均提示失夺获，那么: 下一次的输出振幅将增加0.25V 如果夺获被确认，那么起搏器将再发放一个 同样振幅的脉冲来再次确认夺获 夺获确认之后，启动阈值搜索 Capture Recovery If capture is not confirmed, the amplitude is increas

26、ed one step at a time by 0.125 V increments until two consecutive captured beats are present A Threshold Search is then initiated 夺获恢复 如果夺获未确认，那么接下来的每一次输出振 幅将增加 0.125V ，直至出现连续两次夺获 然后启动阈值搜索 Capture Recovery Loss of Capture Recovery 夺获恢复 没有夺获恢复 Capture Recovery Capture has been regained by increasing

27、the Voltage just like you would do if you had a patient who had lost capture Now the capture threshold needs to be determined by decreasing the Voltage. 夺获恢复 通过增加输出电压，使心肌重新被夺获 现在，需要通过降低输出电压，来决定夺获阈值 AutoCapture Pacing Systems Automatic Stimulation Threshold Search AutoCapture起搏系统 自动刺激阈值搜索 Automatic S

28、timulation Threshold Search The pulse amplitude is decreased by 0.25 V two beats at a time, until loss of capture occurs for two consecutive beats The pulse amplitude is then increased one step at a time by 0.125 V until two consecutive capture beats are present The amplitude is then set 0.25 V abov

29、e threshold 自动刺激阈值搜索 首先，脉冲振幅每两个心跳降低0.25V，直至 连续两次失夺获 然后，每次增加0.125V，直至连续两次夺获 最后，输出振幅被设置为阈值+0.25V Automatic Stimulation Threshold Search Automatic Threshold Search 自动刺激阈值搜索 Automatic Threshold Search Automatic Stimulation Threshold Search Threshold Search Initiation Automatically every 8 hours Sudden i

30、ncrease in pacing threshold (2 consecutive loss of capture beats) Magnet removal (if magnet has been applied for at least 5 seconds) Telemetry wand removal By Programmer 自动刺激阈值搜索 阈值搜索启动 每8h自动进行 阈值突然升高（连续两次失夺获） 移去磁铁（如果磁铁放置了5秒以上） 移去程控头 通过程控仪 Automatic Stimulation Threshold Search During Threshold Sear

31、ch AV delay shortens to 50 ms PV delay shortens to 25 ms Insures ventricular pacing, minimizing the chance of fusion beats Some patients may feel this loss of AV synchrony 自动刺激阈值搜索 当进行阈值搜索时， AV间期缩短至 50ms PV间期缩短至 25ms 确保心室起搏，最大程度减少融合波 有些患者会感觉到该AV失同步 Automatic Stimulation Threshold Search 自动刺激阈值搜索 Aut

32、oCapture Pacing Systems Implant like any other device Test sensing and capture thresholds in the usual manner Clinician chooses when to utilize the AutoCapture Pacing Systems Time of implant Discharge follow-up Scheduled follow-up visit AutoCapture起搏系统 植入同其他起搏器 用常规方法进行感知和夺获阈值测试 临床医师选择何时打开AutoCapture

33、起搏系统 植入时 出院随访 出院后的常规随访 AutoCapture Pacing Systems Evoked Response (E/R) Sensitivity Test AutoCapture起搏系统 E/R感知灵敏度测试 Evoked Response (E/R) Sensitivity Test To determine if AutoCapture Pacing Systems is recommended, an Evoked Response (E/R) Sensitivity Test must be performed using the programmer E/R感知

34、灵敏度测试 AutoCapture起搏系统是否建议打开，取决于 用程控仪进行的E/R感知灵敏度测试结果 Evoked Response (E/R) Sensitivity Test Evoked Response (E/R) Sensitivity Test must be performed using the programmer During this test the Evoked Response (E/R) and Polarization signals are being simultaneously measured This test should be performed

35、 prior to programming AutoCapture Pacing Systems On E/R感知灵敏度测试 必须用程控仪进行E/R感知灵敏度测试 测试期间，ER波和极化信号将同时被测量 必须在打开AutoCapture功能前进行测试 Evoked Response (E/R) Sensitivity Test During the test 10 to 20 double pulses will be delivered to enable simultaneously testing of the polarization and evoked response All p

36、ules will be delivered at 4.5 Volts and at least 0.5 ms Pulse Width The AV / PV will be shortened to 50 ms and 25 ms during the testing E/R感知灵敏度测试 该测试期间，将发放10-20个双重脉冲，以同 时测试极化值和ER值 所有发放的脉冲为4.5V和至少0.5ms脉宽 测试期间，AV/PV间期将会缩短至50ms/25ms Evoked Response (E/R) Sensitivity Test Evoked Response Defined: Elect

37、rical response of the myocardium resulting from a pacemaker stimulus that results in capture E/R感知灵敏度测试 ER波定义 起搏器发出的刺激夺获了心肌后的电反应 Evoked Response (E/R) Sensitivity Test Polarization / After Potential The concentration of ions on or near the stimulating electrode following a pacemaker stimulus Polariz

38、ation is consistent whether there is capture or noncapture In order for AutoCapture Pacing Systems to work properly polarization must dissipate quickly E/R感知灵敏度测试 极化值 起搏器发出刺激后，电极上或附近的离子聚 集 极化值是恒定的（不论是否夺获） 为使AutoCapture起搏系统工作正常，极化 信号必须很快消失 Pulse amplitude 2.1 V Pulse width 0.49 ms Pulse amplitude 4.5

39、 V Pulse width 0.49 ms Evoked Response (E/R) Sensitivity Test Capture on both examples but more polarization with higher outputs 脉冲振幅 2.1 V 脉宽 0.49 ms 脉冲振幅 4.5 V 脉宽 0.49 ms E/R感知灵敏度测试 两者都夺获，但是较高电压输出产生更多极化信号 Capture NoncaptureCapture Noncapture Polarization and ERPolarizationPolarization and ERPolari

40、zation Polarization Effects on Evoked Response Signal Evoked Response (E/R) Sensitivity Test 高极化信号 低极化信号 夺获 失夺获夺获 失夺获 极化信号和ER波极化波极化信号和ER波极化波 ER波与极化信号的比较 E/R感知灵敏度测试 Evoked Response (E/R) Sensitivity Test E/R感知灵敏度测试 Evoked Response (E/R) Sensitivity Test Completion of Test Evoked Response and Polariza

41、tion signals are reported Programmer recommends an ER sensitivity setting Automatically recommends turning AutoCapture Pacing Systems ON or OFF E/R感知灵敏度测试 完成测试后 ER波和极化信号的值被报告 程控仪上会显示E/R感知灵敏度设置的建议 自动建议打开或关闭AutoCapture起搏系统 Evoked Response (E/R) Sensitivity Test E/R感知灵敏度测试 Evoked Response (E/R) Sensiti

42、vity Test E/R感知灵敏度测试 mV 20 15 10 5 0 Polarization = 2.0 mV ER signal = 20 mV AutoCapture Pacing Systems Recommended ER Sensitivity = 10.0 mV Evoked Response (E/R) Sensitivity Test mV 20 15 10 5 0 极化信号 = 2.0 mV ER波 = 20 mV AutoCapture起搏系统建议打开 ER感知灵敏度 = 10.0 mV E/R感知灵敏度测试 Evoked Response (E/R) Sensiti

43、vity Test E/R感知灵敏度测试 mV 20 15 10 5 0 ER signal = 20 mV AutoCapture Pacing Systems NOT recommended ER Sensitivity = 10.00 mV Polarization Signal =7.0 mV Evoked Response (E/R) Sensitivity Test mV 20 15 10 5 0 ER波 = 20 mV AutoCapture起搏系统不建议打开 ER感知灵敏度 = 10.00 mV 极化信号 =7.0 mV E/R感知灵敏度测试 AutoCapture Pacin

44、g Systems Reduction of Polarization AutoCapture起搏系统 降低极化信号 Reduction of Polarization Increase the active surface area of the electrode Fractal surface Separate pacing and sensing polarity 降低极化信号 增加电极的有效表面积 不规则碎片状表面 分别程控起搏和感知的极性 Reduction of Polarization The addition of Titanium Nitride on the lead c

45、an reduce polarization 降低极化信号 在导线上增加氮化钛可以降低极化信号 Reduction of Polarization Titanium Nitride is used on all St. Jude Medical Leads 降低极化信号 氮化钛被用在所有SJM的导线上 Reduction of Polarization Titanium Nitride Surface on Lead Tip 降低极化信号 在导线头端的氮化钛 Reduction of Polarization Polarity Pacing polarity for the Initial p

46、acing pulse is Unipolar Pacing Polarity for the Backup Safety Pulse can be programmed to either Unipolar or Bipolar in some devices Sensing polarity is always bipolar with AutoCapture Pacing Systems programmed on 降低极化信号 极性 初始起搏脉冲的起搏极性设为单极 备用安全脉冲的起搏极性在某些起搏器中 可设为单极或双极（Integrity以后的产品） 感知极性常规设为双极 Reduct

47、ion of Polarization Evoked Response Stability Regency / Microny N = 44 ptsImplant1 mo 3 mo6 mo ER (mV)8.49.08.99.3 Pol (mV)1.01.11.11.1 ER Sens.3.74.04.14.1 Evoked Response evolution over 6 months No change in 14 Reduced sensitivity in 21 (2.9 mV to 4.3 mV) Increased sensitivity in 9 (4.1 mV to 2.5

48、mV) Schuchert A, PACE 1999; 22: 872 (NASPE 99) 降低极化信号 ER波的稳定性 Regency / Microny N = 44名患者 植入时1m3m6m ER波(mV) 8.49.08.99.3 极化波(mV) 1.01.11.11.1 ER感知灵敏度 3.74.04.14.1 6个月后的ER波演变情况 14例无变化 21例升高 (从2.9mV到4.3mV) 9例降低 (从4.1mV到2.5mV) Schuchert A, PACE 1999; 22: 872 (NASPE 99) Reduction of Polarization Lead Co

49、mpatibility Requires the use of a bipolar, low polarization ventricular pacing lead Before programming AutoCapture Pacing Systems ON, the Ventricular Evoked Response Sensitivity Test should be performed to confirm that it will operate with the implanted lead AutoCapture as implemented in the Affinit

50、y family of pacemakers appears to be compatible with most current leads 降低极化信号 导线兼容性 需要使用双极、低极化心室起搏导线 在打开AutoCapture起搏系统之前，需要 进行心室ER感知灵敏度测试，以确认其可 与植入的导线一起工作 在Affinity系列起搏器中，AutoCapture已实 现了与目前大多数导线兼容 AutoCapture Pacing Systems Diagnostics AutoCapture起搏系统 诊断 Diagnostics Long Term Threshold Record Thi

51、s diagnostic tool is a record of threshold searches performed by the pacer plotted over time The sampling interval is programmable Only available when AutoCapture Pacing Systems is programmed ON 诊断 长期阈值记录 该诊断工具通过图形记录一段时间内的阈值 搜索情况 采样间期可程控 仅当AutoCapture起搏系统打开时才可获得 Diagnostics Long Term Threshold Recor

52、d Programmer displays Results are displayed with a “” mark Top and bottom represent the minimum and maximum measured capture thresholds Cross-hatch is the mean threshold (in Volts) An “I” above the data points indicates Device inhibition Insufficient data 诊断 长期阈值记录 程控仪显示 结果用“”标记显示 顶部和底部代表测得的最大和最小的夺获

53、阈值 交叉的平行线代表阈值(V) 数据点上方的“I”提示 起搏器抑制 数据不充分 Diagnostics 诊断 Case Study Clinical History 83 year old Pacemaker implanted 8 months earlier Acute gastroenteritis Cardiac condition was stable The following Long Term Threshold Record was acquired at a routine follow up 病例讨论 临床病史 83岁 8个月前植入起搏器 因急性胃肠炎住院治疗 心脏情况

54、稳定 在之后的常规随访中获得长期阈值记录 Case Study 病例讨论 Case Study 3:1 2:1 A B C D A Onset of gastroenteritis B Hospitalized for IV fluid C Discharged D Scheduled visit with cardiologist 病例讨论 3:1 2:1 A B C D A 胃肠炎开始 B 因需静脉补液而住院治疗 C 出院 D 心脏科医生安排的随访 Case Study The Long Term Threshold Record shows the patients threshold

55、had been just under 1.0 volt from October to the beginning of December A and B: The patient developed gastroenteritis and was hospitalized for IV fluids Notice how the patients pacing threshold increased at this time With Auto Capture the patient never lost capture If standard 2 to 3 times safety ma

56、rgins had been programmed the patient could have lost capture 病例讨论 长期阈值记录显示了从10月至12月初，该患者 的阈值在1.0V以下 A和B: 患者发生了胃肠炎，并住院行静脉补液 治疗 注意患者的起搏阈值在这时升高 因有AutoCapture功能，患者不会发生失夺获 如果仅程控2-3倍的安全范围，该患者仍将发 生失夺获 Case Study C and D: The patient was discharged and then went to their regularly scheduled pacemaker follow up visit Notice how the threshold has come back to the previous value of just under 1.0 volt Without the Long Term Threshold Record the Physician would not have ev