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：
MARC David FELDMAN
金额：
$ 49.73万
依托单位：
UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
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：
https://reporter.nih.gov/project-details/8887475
关键词：
Acute Algorithms Animals Area Arrhythmia Back Blood Pressure Blood Volume Canis familiaris Cardiac Cessation of life Chronic Cicatrix Data Detection Development Devices Electric Countershock Electrocardiogram Epicardium Fibrosis Fright Goals Grant Health Personnel Heart Heart failure Human Hypotension Implant Implantable Defibrillators Laboratories Lateral Lead Letters Licensing Life Measurement Medical Medical Device Modeling Monitor Morphology Myocardial Myocardium Operative Surgical Procedures Outpatients Pacemakers Patients Physicians Play Prevention Problem Solving Publishing Quality of life Recording of previous events Research Shock Signal Transduction Sinus Stroke Volume Tachycardia Technology Testing Texas Time United States National Institutes of Health Universities Veins Ventricular Ventricular Arrhythmia Width Work base blood pressure reduction cost emotional trauma experience falls hemodynamics implantable device implantation improved interest material transfer agreement miniaturize mortality new technology prevent public health relevance sudden cardiac death voltage

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（由申请人提供）：植入式心律转复除颤器 (ICD) 是一种被证明可以预防室性心律失常引起的心源性猝死的医疗设备，其决定仅基于心内心电图。这是不完整的信息，因为多达 1/3。的患者在接受植入物后的前 1-3 年内经历“不适当的”电击，这会导致死亡率增加以及情感创伤。相比之下，医生通过确定心律失常是血流动力学不稳定还是稳定来确定是否对患者进行电击或通过药物改变其快速心律。不稳定的心律失常是通过前向输出量（SV）减少和由此产生的低血压（BP）来识别的。稳定的心律失常是通过接近患者基线的前向 SV 或合成血压来识别的。理想情况下，发生器可以使用逐搏 SV 来帮助确定。血流动力学稳定性。我们课题组开发了一种新技术，可以利用已有的ICD和双心室起搏导线，在右室间隔和左室外侧静脉之间输入电流，获取返回的电压信号，去除该信号中的心肌成分，得出左室SV尽管我们已经在急性大型动物研究中验证了该技术（参见初步数据），但我们尚未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中经过数月的时间是成功的，带领纤维化发生，(b) 开发一种算法，将逐搏 SV 纳入当前的心电图检测算法，以及 (c) 证明该平台适用于患病的人类心脏。为了实现这些目标，我们提出以下具体目标：目标 1 - 购买并验证我们的导纳电路的小型化、低功耗植入式版本。目标 2 - 证明我们为慢性植入开发的导纳电路可以成功地将心律失常分为可减少 SV 的心律失常和不会减少 SV 的心律失常，这将 (a) 确定铅纤维化的影响。 (b) 证明导纳 SV 将随着回波 SV 和 BP 在 VT、vfib、 SVT 和心房颤动，在由回波 SV 和 BP 定义的血流动力学稳定的心律失常中，导纳 SV 将成功反映这些相同的结果，以便在 SA 3 中使用。目标 3 - 开发能够利用稳态 SV 信息与传统心电图速率、心律和形态算法相结合的算法，以提高发生器决策的准确性，以对血流动力学不稳定的心律失常进行治疗，或对稳定的血流动力学心律失常算法停止治疗。将通过将记录的 ECG 和导纳 SV 信号回放到实验室工作台上的 AICD 来与 SA 2 结合以迭代方式进行测试。目标 4 - 验证使用慢性疤痕心脏再同步治疗除颤 (CRT-D) 导线进行电池更换的患者的导纳 SV 测量。