Feasibility Study of Innovative Fiber Optic Technology to Suppress Inappropriate Discharges from Implantable Cardioverter-Defibrillators

抑制植入式心脏复律除颤器不当放电的创新光纤技术的可行性研究

• 批准号: 10254608
• 负责人: Jie Cheng
• 金额: $ 25.19万
• 依托单位: CHELAK MEDICAL SOLUTION INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10254608
• 关键词: Acute; Affect; Algorithmic Analysis; Algorithms; Arrhythmia; Atrial Fibrillation; Cardiac; Chronic; Clinical; Data; Detection; Discrimination; Echocardiography; Electromagnetics; Evaluation; Event; Feasibility Studies; Fiber Optics; Fracture; Government; Health Care Costs; Heart; Heart Arrest; Heart Atrium; Heart failure; Immune; Implant; Implantable Defibrillators; Intraventricular; Lead; Left Ventricular Ejection Fraction; Length; Longevity; Measurement; Measures; Mechanics; Morbidity - disease rate; Myocardial; Noise; Optics; Patients; Pattern; Persons; Phase; Physiologic intraventricular pressure; Physiological; Pressure Transducers; Relaxation; Research; Sample Size; Sensitivity and Specificity; Shock; Signal Transduction; Sinus; Supraventricular tachycardia; System; Tachyarrhythmias; Tachycardia; Technology; Update; Ventricular; Ventricular Fibrillation; Ventricular Function; Ventricular Tachycardia; base; commercialization; effective therapy; feasibility testing; head-to-head comparison; heart rhythm; hemodynamics; improved; innovation; innovative technologies; mortality; new technology; novel; optical sensor; porcine model; pressure; prevent; psychological trauma; public health relevance; response; sensor; sensor technology; sudden cardiac death

Project Summary Implantable Cardioverter/defibrillators (ICDs) have been proven to the most effective therapy to reduce mortality from sudden cardiac death. Today’s ICD technology exclusively relies on sophisticated algorithmic analysis of cardiac electric signals (electrograms, EGM) sensed by the ICD to detect fatal cardiac arrhythmias, such as ventricular tachycardia (VT) and ventricular fibrillation (VF), that trigger discharge of electrical energy (ICD shock) to restore normal rhythm. Despite decades of continuing effort and incremental technological advances, inappropriate shock (IAS), erroneously triggered by nonfatal events, remains a significant problem and represents an unmet clinical need. IAS often occurs during nonfatal events that are associated with stable hemodynamic status and most commonly include (1) electrical noises, from electromagnetic interference (external noise) or ICD lead fracture (internal noise), and (2) nonfatal tachyarrhythmias (TA) such as hemodynamically stable atrial fibrillation (AF) with rapid ventricular response . The objective of the project is to test the feasibility and eventual commercialization of an innovative technology with fiber optic sensors in the existing ICD system that assess the hemodynamic stability during arrhythmias and thereby reduce IAS. The proposed research in Phase I is to evaluate the feasibility of this novel technology in a swine model to determine hemodynamic stability during tachyarrhythmia, thereby separating hemodynamically stable TAs from those that are unstable, and will specifically focus on testing the feasibility of optical sensors embedded in the existing ICD system in assessing hemodynamics through detecting changes in cardiac strain parameters (Aim 1), the feasibility of such optical sensors in identifying electrical noises based on unchanged hemodynamics (Aim 2), and the feasibility of such optical sensors in differentiating hemodynamically stable AF with rapid ventricular response from unstable AF and from ventricular fibrillation (Aim 3).

项目摘要 植入式心脏复律器/除颤器（ICD）已被证明是最有效的治疗， 降低心源性猝死的死亡率。今天的ICD技术完全依赖于 通过对心脏传感器感知的心脏电信号（电描记图，EGM）进行复杂的算法分析， ICD用于检测致命性心律失常，如室性心动过速（VT）和室性心动过速（VT）。 房颤（VF），触发电能放电（ICD电击）以恢复正常节律。 尽管经过几十年的持续努力和技术进步， 由非致命事件错误触发的休克（IAS）仍然是一个重大问题， 代表未满足的临床需求。IAS通常发生在与以下事件相关的非致命事件期间： 具有稳定的血液动力学状态，最常见的包括（1）电噪声， 电磁干扰（外部噪声）或ICD电极导线断裂（内部噪声），以及（2） 非致命性快速性心律失常（TA），如血流动力学稳定的心房颤动（AF）伴快速性心律失常， 心室反应 .该项目的目的是测试可行性和最终 在现有ICD中使用光纤传感器的创新技术的商业化 评估心律失常期间血流动力学稳定性从而降低IAS的系统。的 第一阶段的拟议研究是评估这种新技术在猪身上的可行性。 模型，以确定快速性心律失常期间的血流动力学稳定性，从而分离 血流动力学稳定的TA与不稳定的TA，并将特别关注测试 嵌入现有ICD系统的光学传感器在评估 血流动力学通过检测心脏应变参数的变化（目的1）， 这种光学传感器在基于不变的血液动力学识别电噪声（Aim 2）、 以及这种光学传感器在区分血流动力学稳定的AF与 不稳定房颤和室颤引起的快速心室反应（目标3）。