课件文稿案例extendlife-physiocurve adaptivcrt cheng

1、Evera、Viva新产品介绍Medtronic Technical Field Engineer 程建卫PhysioCurve全新流线型设计ICD装置形状的发展体积越小，寿命越长，功能越智能PhysioCurveTM 的临床益处特殊设计的形状能够带来多种益处5-9提高患者舒适度提高患者植入部位的美观更换时更容易处理囊袋减少30%的装置对皮肤的压力，进而提高患者的舒适度和美观，也更降低了囊袋干扰的风险。*1-4 1-9See slide notes for references.流线性形状让患者更加舒适1-3Device ADevice BDevice CEvera XT DR1 Gold M

2、R, et al. J Am Coll Cardiol. 1996;28:1278-1282.2 Kolker AR, et al. Ann Plast Surg. 2007;59:26-29.3 Sowell LV, et al. J Womens Health (Larchmt). 2006;15:830-835.皮肤压力测试分析结果-CRTD1对比不同装置，皮肤压力的减少比例:XXXX CRT-DXXXX CRT-D MDT Protecta CRT-DViva XT Body31%30% 24% Viva XT Header46%35% 42%1Flo, Daniel. CRT-D I

3、S4/DF4 Device Shape Analysis. January 2013. Medtronic data on file. Other1Other2lMedtronic ProtectaMedtronic VivaTM XT皮肤压力测试分析结果-ICDPhysioCurve流线型外形全新流线型形状的装置能够提高患者术后的舒适性。由于亚洲人普遍偏瘦，流线型形状高能量ICD装置，植入后增加美观。由于高能量装置的体积较大，ICD囊袋死腔可导致积液，破溃，感染等并发症，流线型形状能够降低30%囊袋压力进而减少囊袋并发症的发生，给医生减少了很多的麻烦。1Flo, Daniel. CRT-D

4、IS4/DF4 Device Shape Analysis. January 2013. Medtronic data on file. extend life.谈谈VIVA CRTD& EVERA ICD的通过开源节流 to extend life电池电容减少起搏降低发射功率常见的ICD一次锂电池阳极材料SVOCFx钒酸银氟化碳能量少，驱动力高能量多，驱动力低+通过提高电量密度来延长使用寿命容积降低25%容量增加10%可靠性设计和开发过程中设计了10,000个电池对使用寿命进行了建模测试可预测的患者管理可靠的RRT指征 预留90天设备使用时间以及6次全幅充电独有的高频混合化学电池能达到：延长

5、使用寿命、提高可靠性以及可预测性。混合SVO CFx阳极电池1,2 1 Medtronic VivaTM CRT-D and EveraTM device manuals.2Snell, E. Battery Discharge. August 2012. Medtronic Data on File.美敦力Advanced Valve Metal（AVM）电容器尺寸更小形状更灵活锥形阳极及叠加的外观设计使装置具有三维形状的灵活性，提供更高的封装密度。这项技术允许装置成任何形状，这样促成了新的PhysioCurve 形状设计。AVM电容依然保持与现有电容器一样的35J输出能量，但却缩减了38%

6、的体积以及87%的组件，此外省去了额外的内部电器连接。2 全新AVM电容优势三重电容机器侧视图1 Medtronic VivaTM CRT-D and EveraTM device manuals.2 Sawchuk R. Battery and Capacitor Design Confidence Testing. October 2012. Version 2. Medtronic data on file.Viva/Evera充电对于以往的机器，在植入时必须进行电容器充电测试以确定系统的完整性。通过运用新型电容器，Viva 和Evera无需再进行充放电测试。 每一次不必要的电容器充电将

7、耗费22天CRTD装置的使用寿命，DR装置33天，VR装置47天。 Viva、Evera系列充电时间稳定可预测1:在植入初期 (BOS)标准充电时间为：CRT-D及DR设备8.3 s；VR 设备8.4 s临近更换时(RRT)标准充电时间为：CRT-D, DR、VR ICD均为12.3 s 1 Medtronic VivaTM CRT-D and EveraTM device manuals.钽电容无需重整在Adaptive CRT临床试验中减少了44%右室起搏Adaptive CRT的减少右室起搏1 Martin DO, et al. Investigation of a Novel Algo

8、rithm for Synchronized Left-ventricular Pacing and Ambulatory Optimization of Cardiac Resynchronization Therapy: Results of the Adaptive CRT Trial. Heart Rhythm 2012; 9:1807-14.剩余寿命预估1剩余寿命预估不仅仅基于电池电压。EveraTM 采取新算法预估剩余寿命，可以迅速准确确定RRT的时间。 寿命预估基于测得的电池电压、已植入时长、参数设置以及事件记录。1 Medtronic Evera XTTM DR device

9、manual.全新电池，结合SVO和CFx优点全新电容器，生理形状，小体型，无需重整更少电流损耗全新无线遥测模块全新AdaptivCRT起搏算法*VivaTM 及EveraTM 增强寿命1*1 Viva and Evera DR/VR ICD Manuals.2 Limited lifetime warranty, some restrictions may apply. The limited lifetime warranty applies to the performance of the device and includes some reimbursement to patien

10、ts of unreimbursed medical expenses. The warranty is limited to the provisions in the written Limited Warranty document that panies each product. Consult the written limited warranty document for details, a copy of which will be provided upon request.*Projected service life estimates are based on ac

11、celerated battery discharge data and device modeling as specified. Do not interpret these values as precise numbers.* Viva XT CRT-D OnlyEvera XT VR 理论寿命10年2Evera XT DR 理论寿命8年2Viva XT CRTD 理论寿命6年2智能电击，炫亮生命-ICD术后电击管理高达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 N

12、on-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. 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

13、 implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol. April 8, 2008;51(14):1357-1365. 3 Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Me

14、d. 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):134-135.引起电击的原因20Poole JE, et al. Heart Rhythm Society. 2004.SCD- HeFT sample episode Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importa

15、nce of defibrillator shocks in patients with heart failure. N Engl J Med. September 4, 2008;359(10):1009-1017Poster: 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Shock Reduction方案减少不恰当的电击Medtronic PainFREE Rx StudiesATP D

16、uring 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 - 导线噪声识别特殊算法/功能SmartShock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):280-9.23应用SmartShock 98%患者 1年内，92%患者

17、5年内没有不恰当的电击1 Virtual ICD: A Model to Evaluate Shock Reduction Strategies. Presented at HRS 2010 (P03-125). PainFree SST Trial Primary ResultsPainFree SST研究为证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 24主要目的: 评估植入一年后Medtronic Protecta DR-ICD/ CRT-D 和 VR-ICD无不恰当电击率Low Shock Rates in Pa

18、tients with Dual and Triple Chamber ICDs Using Novel Detection Algorithms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 Distribute2597.6% (CI: 96.4% - 98.8%)15位患者有19 个不恰当电击98.2% (C.I. 97.4% -99.0%) 21例患者有36个不恰当电击1 Volosin JCE 2011 临床结果证实计算机模型1Pain

19、Free SST Trial Primary Results 26真实患者群SCD-HeFT8.0% at 1 year真实患者群PainFree SST 1.8% at 1 year计算机模拟SCD-HeFT2.4% at 1 yearSmartShock 在确保敏感性的同时显著减少不恰当电击的发生1,21 Predicted from Virtual ICD: A Model to Evaluate Shock Reduction Strategies. Presented at HRS 2010 (P03-125).2 Protecta Clinical Study, Medtronic

20、 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 CRT的生理性起搏模式AdaptivCRTTM 动态优化，随心所跳1 Cleland J, et al. N Engl J Med. 2005;352:1539-1549.2 Cleland J, et al. Eur He

21、art 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;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;36

22、1:1329-1338.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+NANAMIRACLE4NANA+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

23、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 WT, et al. Heart Rhythm. 2005;2:S65.3 Abraham WT, et al. Circulation. 2004;110:2

24、864-2868.6 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% ImprovedClinical Composite Score1Mullens W, et al. JACC. 2009;53:765-773.CRT反应率的各种影

25、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 bpm, or延迟的房室传导, orAS-VS 200 msAP-VS 250 msLVCM确认左室没有夺获如与单LV起搏条件其中一个或以上不符时AdaptivCRT 临床研究结果1-51 Martin et al., Heart R

26、hythm. 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. 4 Birnie D. et al., Presented at the American Heart Association Scientific Sessions 2012. Abstract #: 116725Randall C. Starling. Pr

27、esented 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：NYHA Class III/IVQRS 120 msLVEF 35%Randomized (2:1 ON vs. OFF)一级终点 (6 Months): 临床综合评分 (non-inferiority) Cardiac Performance/ VTI (non-inferiority)二级终点(6 Months):右室起搏百分比， LV ESVi，LV EF

28、， 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.AdaptiveCRT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.AdaptivCRT 临床研究结论Non-inferiority P =50% 和50%的临床获益(6个月全因死亡率、心衰住院率H以及复合临床得分改善) 。AdaptivCRT组和对照组间比较：

29、正常传导患者的临床获益差异。Birnie D, Lemke B, Aonuma K, et al. Clinical es with synchronized left ventricular pacing: Analysis of the adaptive CRT trial. Heart Rhythm. September 2013; 9 (10): 1368-1374.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 Rhythm. September 2013; 9 (10

30、): 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)0.0030%LV only pacing50%2.06 (1.17, 3.60)0.01