LV SV using Admittance for Hemodynamically Unstable Arrhythmia Detection
使用导纳进行 LV SV 检测血流动力学不稳定心律失常
基本信息
- 批准号:8887475
- 负责人:
- 金额:$ 49.73万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2015
- 资助国家:美国
- 起止时间:2015-04-01 至 2019-02-28
- 项目状态:已结题
- 来源:
- 关键词:AcuteAlgorithmsAnimalsAreaArrhythmiaBackBlood PressureBlood VolumeCanis familiarisCardiacCessation of lifeChronicCicatrixDataDetectionDevelopmentDevicesElectric CountershockElectrocardiogramEpicardiumFibrosisFrightGoalsGrantHealth PersonnelHeartHeart failureHumanHypotensionImplantImplantable DefibrillatorsLaboratoriesLateralLeadLettersLicensingLifeMeasurementMedicalMedical DeviceModelingMonitorMorphologyMyocardialMyocardiumOperative Surgical ProceduresOutpatientsPacemakersPatientsPhysiciansPlayPreventionProblem SolvingPublishingQuality of lifeRecording of previous eventsResearchShockSignal TransductionSinusStroke VolumeTachycardiaTechnologyTestingTexasTimeUnited States National Institutes of HealthUniversitiesVeinsVentricularVentricular ArrhythmiaWidthWorkbaseblood pressure reductioncostemotional traumaexperiencefallshemodynamicsimplantable deviceimplantationimprovedinterestmaterial transfer agreementminiaturizemortalitynew technologypreventpublic health relevancesudden cardiac deathvoltage
项目摘要
DESCRIPTION (provided by applicant): Implantable cardioverter defibrillators (ICDs) are medical devices proven to prevent sudden cardiac death due to ventricular arrhythmias. Their decisions are based solely upon the intra--‐cardiac ECG. This is incomplete information since up to 1/3 of patients experience an "inappropriate" shock within the first 1-3 years of receiving the implant. Receiving a shock is associated with increased mortality as well as emotional trauma. In contrast, physicians determine whether to shock or medically convert a patient out of a rapid rhythm by determining if the arrhythmia is hemodynamically unstable or stable. An unstable arrhythmia is identified by decreased forward stroke volume (SV) and resultant low blood pressure (BP). A stable arrhythmia is identified by a forward SV or resultant BP close to the patient's baseline. It would be ideal to have beat‐by-beat SV available to the generator to assist in the determination of hemodynamic stability.
Our group has developed a new technology which can utilize pre-existing ICD and bi-ventricular pacing leads to input current between the RV septum and lateral LV vein, take the returning voltage signal, remove the myocardial component of this signal, and derive LV SV. Although we have validated the technology in acute large animal studies (see preliminary data), we have not validated the approach in chronic large animals which will require (a) demonstrating our technology is successful over months of time in a large animal heart failure model as lead fibrosis occurs, (b) developing an algorithm to incorporate beat-by-beat SV into current ECG detection algorithms, and (c) proving that the platform works in diseased human hearts. To achieve these goals, we propose the following specific aims:
Aim 1 - Purchase and validate a miniaturized, low power implantable version of our admittance circuit.
Aim 2 - Demonstrate that our admittance circuit developed for chronic implantation can successfully classify arrhythmias into those that can reduce SV, and those that do not in a chronic pacing induced canine model of heart failure. This will (a) determine the impact of lead fibrosis to the myocardium on the drift profile of the admittance signal, and (b) demonstrate that admittance SV will fall as echo SV and BP fall during the induction of VT, vfib, SVT and afib. Conversely, in hemodynamically stable arrhythmias defined by echo SV and BP, admittance SV will successfully mirror these same findings. The signals will be recorded for use in SA 3.
Aim 3 - Develop algorithms that can utilize steady state SV information in conjunction with traditional ECG rate, rhythm, and morphology algorithms to increase the accuracy of generator decisions to either deliver therapy to hemodynamically unstable arrhythmias, or withhold therapy from a stable hemodynamic arrhythmia. These algorithms will be tested in an iterative fashion in conjunction with SA 2 by playing back the recorded ECG and admittance SV signals to an AICD on the laboratory bench.
Aim 4 - Validate admittance SV measurement in patients undergoing battery changes with chronic scarred-in Cardiac Resynchronization Therapy-Defibrillation (CRT‐D) leads.
描述(申请人提供):植入式心律转复除颤器(ICD)是一种医疗设备,已被证明可以预防室性心律失常导致的心脏性猝死。他们的决定完全基于心内心电图。这是不完整的信息,因为多达三分之一的患者在接受植入物的头1-3年内经历了“不适当的”休克。接受电击会增加死亡率和情感创伤。相比之下,医生通过确定心律失常是血液动力学不稳定还是稳定,来确定是休克还是在医学上使患者脱离快节奏。一种不稳定的心律失常是通过前向搏出量(SV)的减少和由此产生的低血压(BP)来识别的。稳定的心律失常是由接近患者基线的前向室性心动过速或结果血压来识别的。理想的做法是让发电机提供逐搏动的SV,以帮助确定血流动力学稳定性。
我们团队开发了一项新技术,该技术可以利用现有的ICD和双室起搏在右室间隔和侧向LV静脉之间引入电流,提取返回的电压信号,去除该信号中的心肌成分,得出LV SV。虽然我们已经在急性大型动物研究中验证了该技术(见初步数据),但我们还没有在慢性大型动物中验证该方法,这需要(A)证明我们的技术在大型动物心力衰竭模型上几个月的时间内是成功的,因为铅纤维化的发生,(B)开发一种算法,将逐跳SV合并到当前的心电检测算法中,以及(C)证明该平台在患病的人类心脏中工作。为实现这些目标,我们提出了以下具体目标:
目标1-购买并验证我们的导纳电路的小型化、低功耗可植入版本。
目的2-证明我们开发的用于慢性植入的导纳电路可以成功地将心律失常分为可以减少SV的心律失常和不能减少SV的心律失常,在慢性起搏诱导的犬心衰模型中。这将(A)确定铅对心肌纤维化对导纳信号漂移曲线的影响,以及(B)在诱发VT、Vfib、SVT和afib的过程中,随着ECHO SV和BP的下降,导纳SV也会下降。相反,在由ECHO SV和BP定义的血流动力学稳定型心律失常中,导纳SV将成功地反映相同的发现。信号将被记录下来,以供SA 3使用。
目的3-开发可结合传统的心电图率、节律和形态算法利用稳态SV信息的算法,以提高发生器决策的准确性,以便为血流动力学不稳定的心律失常提供治疗,或者阻止对稳定的血流动力学心律失常的治疗。这些算法将与SA 2一起以迭代的方式进行测试,方法是在实验室工作台上将记录的心电和导纳SV信号回放到AICD。
目的4-验证慢性疤痕内心脏再同步治疗除颤(CRT-D)导联更换电池患者的导纳SV测量结果。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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MARC David FELDMAN其他文献
MARC David FELDMAN的其他文献
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