Skin-like, stretchable, and wearable sensors for monitoring QT interval and hemodynamic variables in Atrial Fibrillation

用于监测房颤 QT 间期和血流动力学变量的类肤、可拉伸和可穿戴传感器

• 批准号: 10580853
• 负责人: Andreas Tzavelis
• 金额: $ 4.41万
• 依托单位: NORTHWESTERN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-01 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10580853
• 关键词: Accelerometer; Adherence; Adult; Affect; Age; Ambulatory Care; Ambulatory Monitoring; American Heart Association; Amiodarone; Anti-Arrhythmia Agents; Arrhythmia; Atrial Fibrillation; Azithromycin; Biomechanics; Blood; Blood Pressure; Blood flow; Body Surface; Brain; COVID-19 pandemic; Cardiac; Cardiac Myocytes; Cardiac Output; Cardiac ablation; Caring; Chest; Chest Pain; Clinical; Complex; Congestive Heart Failure; Contracts; Critical Care; Dangerousness; Data; Dementia; Detection; Diagnosis; Disease; Dose; EFRAC; EKG P Wave; EKG QRS Complex; Elderly; Electric Countershock; Electrocardiogram; Event; Funding; Future; Health Care Costs; Healthcare Systems; Heart; Heart Atrium; Holter Electrocardiography; Hospitalization; Hospitals; Hour; Hydroxychloroquine; Individual; Inpatients; Intervention; Ion Channel; Lead; Left atrial structure; Life; Light; Lightheadedness; Limb structure; Location; Machine Learning; Measurement; Measures; Medical; Membrane Potentials; Methods; Monitor; Morbidity - disease rate; Operative Surgical Procedures; Organ; Outpatients; Patients; Perfusion; Pharmaceutical Preparations; Pharmacological Treatment; Photoplethysmography; Physiologic Monitoring; Physiological; Population; Potassium; Potassium Channel Blockers; Recommendation; Reporting; Research; Rest; Risk; Risk Reduction; Shortness of Breath; Signal Transduction; Skin; Sotalol; Stream; Stroke Volume; Surface; Symptoms; Syncope; System; Systolic Time Intervals; Tachyarrhythmias; Techniques; Technology; Therapeutic; Therapeutic Embolization; Thrombotic Stroke; Thrombus; Time; Torsades de Pointes; Universities; Ventricular; aging population; bioelectricity; clinical care; cohort; comorbidity; cost; data streams; dofetilide; dronedarone; flexibility; heart electrical activity; heart function; heart rate monitor; heart rate variability; heart rhythm; hemodynamics; high risk; human old age (65+); incremental cost; interest; lifetime risk; monitoring device; non-invasive monitor; personalized medicine; pharmacologic; prevent; research clinical testing; restoration; sensor; sex; side effect; standard of care; stroke risk; telemonitoring; treatment response; wearable device; wearable sensor technology; wireless

Project Summary Atrial Fibrillation (AF) is the most common sustained arrhythmia in adults, carries a lifetime risk of 25-33%, and cost the US healthcare system > 6 Billion dollars a year. Morbidities from AF include congestive heart failure, dementia, symptoms due to decreased cardiac output, and most importantly an elevated thrombotic stroke risk due to blood stasis. Recent advances in wearable technology have increased the capacity and accuracy of AF diagnosis through monitoring heart rate variability in an ambulatory setting. However, there remains no available ambulatory technologies that permit continuous assessment of the hemodynamic effects of AF nor measurements of cardiac repolarization that determine the proarrhythmic effects of antiarrhythmic drugs. Some treatment aspects of AF have remained controversial due to limited efficacy of rhythm control interventions including cardiac ablation and pharmacologic therapy, both of which have significant risks. Pharmacologic interventions using Class III antiarrhythmics are especially risky due to the proarrhythmic effects on ventricular repolarization which can lead to life-threatening ventricular tachyarrhythmias such as torsades de pointes. As a result of these issues, careful assessment of ventricular repolarization, as represented by the QT interval on the electrocardiogram (ECG), is required during drug initiation. This requires lengthy and costly inpatient monitoring during drug loading and difficulties in maintaining the narrow therapeutic window after discharge. Having a reliable method to quantify measures of hemodynamic instability that leads to some AF- related symptoms, as well as continuously monitoring the QT interval and other clinically important parameters in an ambulatory setting would allow clinicians to tailor their care to the individual. This proposal aims to refine a flexible, non-obtrusive wearable system to continuously monitor these key clinical parameters, help in predicting heart rhythm complications and regulate medication intervention for both rhythm control and rate control of AF. A sensor suite consisting of a small, wireless and flexible chest-worn patch that measures both ECG and accelerometer based seismocardiography (SCG) and a wirelessly time synchronized flexible limb unit capable of monitoring photoplethysmographic (PPG) signals will be used. Aim 1 will quantitatively define the optimal location for QT interval monitoring on the surface of the chest. Aim 2 will combine the ECG, SCG, and PPG data streams and extract both unique and time-relational parameters from the signal streams known to be related to cardiac function and hemodynamics, using machine learning to obtain predictions of hemodynamic instability from these complex relationships. Aim 3 will address the use and compliance of this wearable system in a clinical setting against the standard of care during Class III antiarrhythmic drug loading and pharmacologic cardioversion. The results from this study will provide the first ambulatory measures of AF symptoms and responses to treatment, informing future studies and clinical care teams of the dominant bioelectrical and biomechanical parameters that are the most important in the care of the growing, aging population with AF.

项目摘要 心房颤动（AF）是成人最常见的持续性心律失常，终身风险为25-33％， 每年损失美国医疗保健系统> 60亿美元。 AF的病态包括充血性心力衰竭， 痴呆，由于心输出量减少而引起的症状，最重要的是血栓形成率升高 由于血液停滞。可穿戴技术的最新进展提高了AF的能力和准确性 通过监测卧床环境中的心率变异性来诊断。但是，没有 可用的门诊技术，允许对血液动力学作用进行连续评估 心脏复极化的AF和测量，确定了心律失常的影响 抗心律失常药物。由于有限的功效，AF的某些治疗方面一直存在争议 节奏控制干预措施在内 风险。使用III级抗心律失常的药理干预措施由于心律不齐而尤为有风险 对心室复极化的影响，可能导致威胁生命的心室心律失常（例如 Torsades de Pointes。由于这些问题，仔细评估心室复极化，如表示 在药物启动期间，需要通过心电图（ECG）的QT间隔。这需要冗长的 在药物加载过程中，昂贵的住院监测和在保持狭窄治疗窗口后的困难 释放。具有可靠的方法来量化血液动力学不稳定性的度量，这导致某些AF- 相关症状，以及连续监测QT间隔和其他临床重要参数 在门诊环境中，临床医生可以为个人定制护理。该建议旨在完善 一个灵活的，不可感染的可穿戴系统，可连续监控这些关键的临床参数，帮助 预测心律并发症并调节节奏控制和 AF的速率控制。传感器套件，该套件由一个小型，无线和柔性的胸部贴片组成 基于ECG和加速度计的地震标志（SCG）和无线同步的柔性肢 将使用能够监视光杀解物学（PPG）信号的单元。 AIM 1将定义 QT间隔监视的最佳位置。 AIM 2将结合ECG，SCG和 ppg数据流并从已知为的信号流中提取独特的和时间关联的参数 与心脏功能和血流动力学有关，使用机器学习来获得血流动力学的预测 这些复杂的关系不稳定。 AIM 3将解决此可穿戴系统的使用和合规性 在III类抗心律失常药物和药理期间针对护理标准的临床环境中 心脏扭转。这项研究的结果将提供第一个AF症状的门诊措施和 对治疗的反应，为未来的研究和临床护理团队提供了主导的生物电机和临床护理团队 生物力学参数对于照顾AF的增长，老龄化人群最重要。