起搏器培训课件：CRT-P产品功能简介

1、CRT-P产品功能简介 For internal use only, Not for distribution 2 | MDT ConfidentialFor internal use only, Not for distribution q双心室相同输出 q双心室同时起搏 q 8个诊断功能 (选 1) q双心室独立输出 q双心室顺序起搏 q10个诊断功能 (3个心衰趋势图) 第一代 第二代 第三代 qOptiVol qA/RV/LVCM qLeadless ECG q q 3 | MDT ConfidentialFor internal use only, Not for distribut

2、ionFor internal use only, Not for distribution 规格 特性特性InSync IIISyncra CRT-PConsulta CRT-P 体积16cc 15cc with connector holes unplugged 15cc with connector holes unplugged 重量26 g26 g26 g 尺寸51x59x7mm57x59x6mm57x59x6mm 寿命6.8 yr *8.1 yr *8.1 yr * 电池lithium-hybrid cathode - delta 30H lithium silver vanadi

3、um oxide cell Tau28H lithium silver vanadium oxide cell Tau28H *600 ohms, 100% Atrial Pacing, 100% BiV Pacing, A and RV Amp = 2.5 V, LV Amp = 5.0 V *600 ohms; 100% Atrial pacing; 100% BiV pacing; A and RV Amp = 2.5V; LV Amp = 3.0V; Pre-EGM Storage ON 4 | MDT ConfidentialFor internal use only, Not fo

4、r distributionFor internal use only, Not for distribution 主要功能 InSync IIISyncra CRT-PConsulta CRT-P 3 LV Pacing Vectors VSR Capture Management LV 5 LV Pacing Vectors VSR, CAFR ATR Single EGM Storage 1 episodes, 5 Seconds 6 months HF trend EGM Storage 2 channel, 14.5 minutes 14 months Cardiac Compass

5、 Arrhythymia Detection Mode Switch Mode Switch PMOP AT/AF Monitor Quick Look Quick Look II Leadless ECG Therapy Guide CareLink Monitor 100% Atrial pacing; 100% BiV pacing; A and RV Amp = 2.5 V; LV Amp = 3.0 V; Pre-EGM Storage ON 寿命寿命： 8.1年 C2TR01 41 | MDT ConfidentialFor internal use only, Not for d

6、istributionFor internal use only, Not for distribution Syncra CRT-P 关键信息 o 更长的寿命 8.1年 o更多的选择保证连续的LV起搏实现可靠可靠CRT - 优化优化LV 起搏部位起搏部位 多种起搏矢量 LVCM - 在各种情形下在各种情形下确保CRT发放 VSR, CAFR, ATR o 进行有效的疾病管理有效的疾病管理 监测患者的临床状态 14 月 cardiac compass + 14,5 min EGM o体积更小，更薄 15cc, 57x59x6mm “Syncra CRT-P提供确保CRT 的必要功能及患者疾病的

7、详细信息” 独特的 ! Leadless ECG = 体表 ECG 42 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution 关键信息- 寿命更长 更长的寿命意味着更换次数的减少，感染机率下降，更高的性 价比；目前CRT适应证已拓展至NYHA II 的心衰患者，这部分 患者的生存期会更长，长寿命的装置对他们更有益 Syncra CRT-P 的寿命为8.1年1 如果配合LVCM，寿命还将延长 LV 阈值程控输出延长的寿命（月）寿命增加% 0

8、.5V2.0V12.820% 1.0V2.5V10.918% 1.5V3.0V8.714% 2.0V3.5V3.15% 与常规LV 4V设置比较 LVCM对脉冲发生器寿命的影响2 1.DDD, 100% Atrial, 100% BiventricularA and RV amplitude at 2.5 V, LV amplitude at 3.0 V. 2.Crossley GH, Mead H, Kleckner K, Sheldon T, et al. Automated left ventricular capture management. Pacing Clin Electrop

9、hysiol. 2007 Oct;30(10):1190-200. 43 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution 关键信息-LVCM LVCM自动检测阈值，调节输出，在保证双心室起搏的同 时： 尽可能降低输出，减少膈神经刺激发生，特别是对起搏阈值和膈 神经刺激阈值非常接近的患者 延长寿命 简化随访步骤，缩短随访时间 44 | MDT ConfidentialFor internal use only, Not for dist

10、ributionFor internal use only, Not for distribution 关键信息- 多种LV起搏矢量 增加了LVring to RVring和LVring to Can的起搏矢量选择 多种LV起搏矢量选择和灵活程控，尽可能解决膈神经刺激，避免创伤性 的电极导线重置 在植入和随访时选择最佳的极性配置优化阈值，降低输出，延长寿命 45 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution 关键信息- 提高房性心律

11、失常时的双心室起搏% 房性心律失常是降低双心室起搏%的主要原因 美敦力CRT装置中的三大功能- VSR，CAFR和ATR能针对不同的 情况， 提高双心室起搏%， 提高CRT疗效， 减少CRT无反应 46 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution 关键信息- 疾病管理 与ICD/CRT- D相同的14个月的Cardiac Compass和14.5 分钟的EGM储存 客观反映患者生理状态的变化 评估心律失常对心衰和双心室起搏的影响

12、评估器械和药物治疗方案对患者疾病的有效性 47 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution 关键信息- 第一个应用Leadless ECG的CRT-P Leadless ECG无需连接体表电极而获得近似的体表ECG 可以作为储存ECG，便于临床对发生的心律失常进行分析 简化随访的步骤，节约随访时间 如果有CareLink，实现真正完全的远程随访真正完全的远程随访 48 | MDT ConfidentialFor internal

13、use only, Not for distributionFor internal use only, Not for distribution 关键信息- 体积更小，更薄 Syncra和Consulta更小的体积和更薄的尺寸 更适合体格偏瘦的患者 手术的创伤减少 49 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution InSync III Consulta CRT-P 关键信息- 和其他产品统一的程控界面 和其他产品统一的程控界面

14、增加了对临床医生的亲和性 重要信息一目了然，方便随访操作 50 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution 主要功能 InSync IIISyncra CRT-PConsulta CRT-P 3 LV Pacing Vectors VSR Capture Management LV 5 LV Pacing Vectors VSR, CAFR ATR Single EGM Storage 1 episodes, 5 Seconds

15、6 months HF trend EGM Storage 2 channel, 14.5 minutes 14 months Cardiac Compass Arrhythymia Detection Mode Switch Mode Switch PMOP AT/AF Monitor Quick Look Quick Look II Leadless ECG Therapy Guide CareLink Monitor 30(10):1190-1200 53 | MDT ConfidentialFor internal use only, Not for distributionFor i

16、nternal use only, Not for distribution 53 Capture Management算法 节律评估确定阈值合适的程控 心房和右心室 Capture Management Medtronics Capture Management 遵循和遵循和 手动阈值测试相同的三个步骤手动阈值测试相同的三个步骤 参数回顾 稳定性检查Stability Check 降低幅度测试 RV应用刺激反应感知 心房应用Atrial Chamber Reset or AV Conduction 应用程控的 “Capture” 设置 54 | MDT ConfidentialFor int

17、ernal use only, Not for distributionFor internal use only, Not for distribution CRT治疗中的挑战 CRT Response 膈肌刺激 手术植入成功率 左室失夺获 左室失夺获 LVCM 55 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution LV失夺获 LV电极脱位LV起搏阈值升高 增加起搏输出增加起搏输出LV电极导线重置 双室起搏% 预防性提高起搏输出阈值

18、 CRT装置 寿命减少 LV失夺获的临床结果失夺获的临床结果 56 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution Left Ventricular Capture Management 临床问题 在两次随访之间LV阈值可能发生变化 优势 确保CRT的发放 最小化膈肌刺激 简化随访 观察LV表现 确保持续的心脏再同步治疗 57 | MDT ConfidentialFor internal use only, Not for distr

19、ibutionFor internal use only, Not for distribution LVCM 算法 可以在DDD, DDDR和VVIR模式下运作 在程控的脉宽下测试 在稳定性检查时分析12 周期 频率稳定 (R-R 变异 85 bpm不能启动) 如果不稳定，LVCM测试安排在 30分钟后 如果LV极性程控为 LV tip-RV ring 或 LV ring to RV ring, 当有阳极环 刺激出现时，LVCM 程控为OFF 节律和稳定性检查测量和测试阈值确定 Left Ventricular Capture Management 57 58 | MDT Confident

20、ialFor internal use only, Not for distributionFor internal use only, Not for distribution LVP RVS LV RVS RVS 测量 LVP-RVS 间期测量 AV 传导间期 AP AP AP RVS LV Test Pace Due to AV Due to VV 60 msec AP 节律和稳定性检查测量和测试阈值确定 Left Ventricular Capture Management 58 59 | MDT ConfidentialFor internal use only, Not for d

21、istributionFor internal use only, Not for distribution 失夺获后，升高幅度直至确认夺获。. 阈值成功确定了? (3 支持周期/测试周期) Support Test Support Test Rhythm and Stability Check Measurements and Tests Threshold Determined Left Ventricular Capture Management 59 60 | MDT ConfidentialFor internal use only, Not for distributionFor

22、internal use only, Not for distribution LVCM 运作方式概述 确认节律15(9):813. 2 Vollmann D, Ngele H, Schauert P, et al. Clinical utility of intrathoracic impedance monitoring to alert patients with an implanted device of deteriorating chronic heart failure. Eur Heart J. August 2007;28(15):1835-1840. 3 Catanzar

23、iti D, Lunati M, Landolina M, et al. Monitoring intrathoracic impedance with an implantable defibrillator reduces hospitalizations in patients with heart failure. PACE. March 2008;32(3):363-370. 4 Whellan DJ, Al-Khatib SM, Kloosterman EM, et al. Changes in intrathoracic fluid index predict subsequen

24、t adverse events: Results of the multi-site program to access and review Trending INformation and Evaluate CoRrelation to Symptoms in Patients with Heart Failure (PARTNERS HF) Trial. J Card Fail. November 6, 2008;14(9):799. 5 Perego GB, Landolina M, Vergara G, et al. Implantable CRT device diagnosti

25、cs identify patients with increased risk for heart failure hospitalization. J Interv Card Electrophysiol. December 2008;23(3):235-242. 6 Small RS, Wickemeyer W, Germany R, et al. Changes in intrathoracic impedance are associated with subsequent risk of hospitalizations for acute decompensated heart

26、failure: clinical utility of implanted device monitoring without a patient alert. J Card Fail. August 2009;15(6):475-481. 7 Yu CM, Wang L, Chau E, et al. Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospit

27、alization. Circulation. August 9, 2005;112(6):841-848. 86 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution OptiVol 胸腔内阻抗测定 每天中午至下午5点，每 隔20分钟 与当前的亚阈值测试方 法相同的阻抗计算方法 无手动测试功能 87 | MDT ConfidentialFor internal use only, Not for distributionFor inter

28、nal use only, Not for distribution OptiVol 1.0 Operation Highlights: 三极配置RV tip, RV ring和can Quick Look II 界面的 Observations 窗口会报告液体指数 达到或超过 OptiVol 阈值 88 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution Consulta CRT-P Diagnostics Diagnostics Op

29、tiVol 1.0 Histograms EGM Storage Arrhythmia Detection EGM Viewer AT/AF total hours/day, V Rate during AT/AF, % Pacing/day, Avg V Rate, Patient Activity, HRV 14 Month Lead Trends Cardiac Compass 89 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distributio

30、n % Pacing 为了确定心室起搏的数量，有几个功能可用 1.Quick Look II 界面界面 2.直方图报告直方图报告 (只可打印) 增加了VSR 起搏%详情, 同时可以看VS发生 的频率分类. 3.Cardiac Compass报告报告 - 14个月的每日起搏%分类. Cardiac Compass Report Sample 90 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution Consulta CRT-P Diagno

31、stics Diagnostics OptiVol 1.0 Histograms EGM Storage Arrhythmia Detection EGM Viewer AT/AF total hours/day, V Rate during AT/AF, % Pacing/day, Avg V Rate, Patient Activity, HRV 14 Month Lead Trends Cardiac Compass 91 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only,

32、 Not for distribution EGM 储存 EGM 储存的改进 4个实时的通道 (A, RV, LV, LECG) 仅 2 个通道可储存 程控Monitored 并选择2 个EGM通道进行储存 92 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution EGM 储存 93 | MDT ConfidentialFor internal use only, Not for distributionFor internal use

33、only, Not for distribution 心律失常前的EGM 心律失常前EGM运作与 Concerto/Virtuoso/Vision 3D ICD/Vision 3D ICD-CRT相同. 所有V3D 装置的心律失常前 EGM 默认为OFF. 94 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution Consulta CRT-P Diagnostics Diagnostics OptiVol 1.0 Histograms E

34、GM Storage Arrhythmia Detection EGM Viewer AT/AF total hours/day, V Rate during AT/AF, % Pacing/day, Avg V Rate, Patient Activity, HRV 14 Month Lead Trends Cardiac Compass 95 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution 趋势 提供A, RV, LV (基于装

35、置的功能) 的电极导线 阻抗和Capture Management 趋势 提供A和RV的感知幅度 趋势. 14 Month 趋势数据 96 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution Consulta CRT-P Diagnostics Diagnostics OptiVol 1.0 Histograms EGM Storage Arrhythmia Detection EGM Viewer AT/AF total hours/d

36、ay, V Rate during AT/AF, % Pacing/day, Avg V Rate, Patient Activity, HRV 14 Month Lead Trends Cardiac Compass 97 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution 直方图 仅在打印时可用 评估起搏%和心室感知 反应 (VSR起搏) 的发生 . 如果VSR起搏 10%, 重新评估起搏程控参数 的设置或频率控制的药 物治疗 Rat

37、e Histogram from Programmer Reports 98 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution 直方图 Consulta CRT-P Only Cardiac Compass图表报告相同 Syncra CRT-P没有 AT/AF时心室率直方图 99 | MDT ConfidentialFor internal use only, Not for distributionFor internal use o

38、nly, Not for distribution Consulta CRT-P Diagnostics Diagnostics OptiVol 1.0 Histograms EGM Storage Arrhythmia Detection EGM Viewer AT/AF total hours/day, V Rate during AT/AF, % Pacing/day, Avg V Rate, Patient Activity, HRV 14 Month Lead Trends Cardiac Compass 100 | MDT ConfidentialFor internal use

39、only, Not for distributionFor internal use only, Not for distribution Arrhythmia Detection Clinical Relevance 患者治疗决策的重要数据依据 VT监测和AT/AF监测都可用 101 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution Consulta CRT-P AF Management AF Management Atrial A

40、TP Post Mode Switch Overdrive Pacing (PMOP) Atrial Rate Stabilization (ARS) AT/AF Monitor Atrial Preference Pacing (APP) Mode Switch 102 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution AT/AF Monitor Clinical Relevance 准确和可靠的心律失常监测是很重要的 间断的和症状为

41、基础的监测策略不能准确识别AT/AF事件的发生 和负荷量6 AT/AF事件持续超过 1 天与栓塞事件独立相关7 房性心律失常时心率控制不佳与第一次住院时间有关8,9 心率控制不佳是降低CRT起搏的主要原因11 6 Ziegler PD, Koehler JL, Mehra R. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm. December 2006;3(12):1445-1452. 7 Capucci A, Santini M, Padeletti L,

42、 et al. Monitored atrial fibrillation duration predicts arterial embolic events in patients suffering from bradycardia and atrial fibrillation implanted with antitachycardia pacemakers. J Am Coll Cardiol. November 15, 2005;46(10):1913-1920. 8 Ousdigian KT, Johnson WB, Koehler JL, Wilkoff BL. Very po

43、or rate control during atrial tachyarrhythmias predicts cardiovascular hospitalizations. J Card Fail. August 2006;12(6)(suppl1):S57-S58. 9 Willems R, Morck ML, Exner DV, Rose SM, Gillis AM. Ventricular high-rate episodes in pacemaker diagnostics identify a high-risk subgroup of patients with tachy-b

44、rady syndrome. Heart Rhythm. October 2004;1(4):414-421. 11 Ousdigian KT, Thompson D, Qi D, et al. A single day of AF with poor rate control predicts a subsequent week of reduced CRT. abstract PO6-68. Heart Rhythm. 2007;4(Suppl 5S): S379. 103 | MDT ConfidentialFor internal use only, Not for distribut

45、ionFor internal use only, Not for distribution AT/AF 监测 算法 程控为Monitor or On ON 允许心房治疗的程控 AT/AF事件确认当: 每个心室间期内至少有2 心房感知事件 (自事件开始至少32 个间期 ) 最近的12个感知心房间期的中位数小于程控的AT/AF间期 104 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution Consulta CRT-P AF Managem

46、ent AF Management Atrial ATP Post Mode Switch Overdrive Pacing (PMOP) Atrial Rate Stabilization (ARS) AT/AF Monitor Atrial Preference Pacing (APP) Mode Switch Note: Of the features highlighted here, Syncra P offers PMOP Only 105 | MDT ConfidentialFor internal use only, Not for distributionFor intern

47、al use only, Not for distribution 房性心律失常干预 + 终止 Clinical Relevance AF患者死亡风险高于无AF患者50-90%1 AF患者中风的风险比无AF患者高65-126%2 血液动力学的结果导致心脏输出的减少 1 Benjamin EJ, Wolf PA, et al., The Framingham Study, Circulation. 1998;98:946-952 2 Wolf PA, Kannel WB, et al., JACC. 1996;27:312A. 106 | MDT ConfidentialFor internal

48、 use only, Not for distributionFor internal use only, Not for distribution 房性心律失常干预 + 终止 包括一组可程控的干预选择: PMOP 心房频率平稳化 (ARS) 心房优先起搏 (APP) 和终止: 心房 ATP (A-Burst+, A-Ramp, Reactive ATP) 注意: Syncra CRT-P没有ARS, APP和心房ATP 107 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only,

49、 Not for distribution 心房终止治疗 A-Burst+ 发放的脉冲略快于房性心动过速 A-Ramp 发放的脉冲略快于房性心动过速且顺序缩短 Reactive ATP 允许多次发放程控的; 确保在长AT/AF事件时 ATP治疗可用 108 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution 模式转换后的超速起搏 Clinical Relevancy: 在这27%中, 约20%是早期复发 (ERAF) 数据显示超速起搏心房

50、一段时 间可预防ERAF发生 算法算法 当PMOP程控为 On, 以程控的 频率和持续时间进行超速起搏. Triggers of AF Onsets From: Hoffman E, Janko S, Hahnewald N, et. al. Europace, July 2000 (Supp. D) Abstract 109 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution 心房优先起搏Atrial Preference Pacing

51、 (APP) Clinical Relevancy: 来自于一个部位的持续性的激 动顺序, 可抑制可能触发房性心 动过速的异位心跳 算法算法 当程控为ON,在患者不是处于房 性心动过速时，用频率略高于 自身心率持续激动，最大化心 房起搏% Triggers of AF Onsets From: Hoffman E, Janko S, Hahnewald N, et. al. Europace, July 2000 (Supp. D) Abstract 110 | MDT ConfidentialFor internal use only, Not for distributionFor int

52、ernal use only, Not for distribution 心房频率平稳化Atrial Rate Stabilization Clinical Relevancy: 房早(PAC)后短-长-短模式与房 性心动过速的发生有关. 算法算法 当ARS程控为On, 每个感知的 心房事开始一个ARS逸搏间期 等于上个 A-A间期加上程控的 百分比. Triggers of AF Onsets From: Hoffman E, Janko S, Hahnewald N, et. al. Europace, July 2000 (Supp. D) Abstract 111 | MDT Conf

53、identialFor internal use only, Not for distributionFor internal use only, Not for distribution 房性心律失常干预 程控 112 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution Consulta CRT-P Ease of Follow-Up Ease of Follow-Up CareLink Network Quick Look II Le

54、adless ECG Therapy Guide 113 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution CareLink Network Infrastructure 113 The patient holds the antenna of the Medtronic CareLink Monitor over the implanted device to collect the device data via interroga

55、tion Data are transferred from the patients implanted device to the Monitor Data are sent from the Monitor to a secure server via a standard telephone line 1 2 3 Clinicians review the patients device data using the Medtronic CareLink Clinician website 114 | MDT ConfidentialFor internal use only, Not

56、 for distributionFor internal use only, Not for distribution CareLink Network - Transmission Detail 114 Interrogation capabilities comparable to in-office follow-up All vital information provided in familiar, easy-to-read format Review information any time, anywhere via the web Comparable to the Pro

57、grammer 115 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution Consulta CRT-P Ease of Follow-Up Ease of Follow-Up CARELINK Quick Look II Leadless ECG Therapy Guide 116 | MDT ConfidentialFor internal use only, Not for distributionFor internal use

58、only, Not for distribution InSync IIIs QuickLook vs Consulta CRT-Ps QuickLook II InSync III Consulta CRT-P 117 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution Consulta CRT-P Ease of Follow-Up Ease of Follow-Up CARELINK Quick Look II Leadless E

59、CG Therapy Guide 118 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution Leadless ECG Leadless ECG的实现是通过装置 四周的电极技术 不需要体表电极获得ECG Leadless ECG在最初的 植入检测 时不可用 Leadless ECG 可被选为储存来源. 14天后储存来源 (LECG)会恢复到 EGM1 or EGM2. Leadless ECG 在ERI后不可用. 119 | MDT Co

60、nfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution Vector “A” RVtip-RVring LECG A Marker channel Canine Study Example LECG Feature 120 | MDT ConfidentialFor internal use only, Not for distributionFor internal use only, Not for distribution Knowledge Chec