新型可穿戴设备可实时监测与心力衰竭相关的生理参数

Novel wearable device can monitor physiological parameters associated with heart failure in real-time

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There are about 64 million cases of heart failure worldwide. According to the American Heart Association, 6.2 million adults in the United States have heart failure and that number is estimated to increase to 8 million by 2030. Heart failure is a progressive clinical syndrome characterized by a structural abnormality of the heart, in which the heart is unable to pump sufficient blood to meet the body's requirements.

There are currently two heart failure monitoring systems available. However, they are costly and pose risks because they are surgically implanted under the skin. Moreover, about half of patients with heart failure do not need an implantable device or do not qualify for the thoracic (area between the neck and abdomen) monitoring these devices provide. There is a critical need for non-invasive solutions to monitor heart failure progression around the clock.

Researchers from Florida Atlantic University's College of Engineering and Computer Science in collaboration with FAU's Christine E. Lynn College of Nursing have developed a prototype of novel wearable device that can continuously monitor all of the physiological parameters associated with heart failure in real-time.

The technology is based on sensors embedded in a lightweight belt conveniently worn around the waist to monitor thoracic impedance, electrocardiogram (ECG), heart rate and motion activity detection. The system uses different sensors for sensing these parameters. Thoracic impedance is a critical bio-signal to monitor heart failure progression. Similarly, ECG is a vital bio-signal to diagnose and predict cardiovascular diseases. ECG measures electrical signals through the heart using a Holter monitor, which is not suitable for point-of-care use.

For the study, published in Scientific Reports, researchers tested the wearable device in different conditions including sitting, standing, lying down and walking. For each condition, results were obtained for each of the sensors sequentially. The physiological parameters selected are significant in determining heart failure symptoms.

Findings showed that all of sensors kept track of the changes for all of the different conditions. The position sensor correctly highlighted the change in position in different conditions and could be used to identify different states of the wearer of the device. In addition, the heart rate sensor continually kept track of the heart rate. Importantly, the device correctly highlighted minute changes in thoracic impedance.

Like most ECG monitors, the ECG sensor in the wearable device was very sensitive to motion, particularly while walking. However, even while walking the ECG sensor retained its QRS complex (the electrical impulse as it spreads through the ventricles of the heart) along with R-peaks (intervals of the QRS complex), which are important indicators for left ventricular hypertrophy, indicative of an increase in the size of myocardial fibers in the main cardiac pumping chamber.

All of the sensors we integrated into our belt module can easily be worn for a long period of time without affecting the patient's daily activities. Importantly, continuous and real-time monitoring of heart failure symptoms could alert patients and their health care providers of the patient's declining health. In turn, health care providers could intervene with medications to avoid patient hospitalization."

Waseem Asghar, Ph.D., senior author and associate professor in FAU's Department of Electrical Engineering and Computer Science

The researchers expect that their technology will have higher predictive values for heart failure with increased specificity and high sensitivity.

Approximately 1 in 4 patients with heart failure are readmitted within 30 days of discharge from the hospital and about half are readmitted within six months. Health care wearable devices such as the prototype we have developed have the potential to decrease hospital readmissions in a cost-effective way that also is safe and convenient for the wearer."

Mary Ann Leavitt, Ph.D., co-author and assistant professor, FAU's Christine E. Lynn College of Nursing

Based on the study results, the researchers are currently testing the module over a set of diverse subjects to develop an algorithm to predict heart failure over the test set.

"This wearable device to monitor heart failure is my main project in Dr. Asghar's Micro and Nanotechnology Lab in Medicine, which has important social implications for the fastest-growing cardiovascular disease in the U.S.," said Sheikh Muhammad Asher Iqbal, first author, a research assistant and a Ph.D. student in FAU's Department of Electrical Engineering and Computer Science. "We are developing a noninvasive solution that can be used by all heart failure patients for better management, diagnosis and prognosis that will be able to serve the masses."

Study co-authors are Imadeldin Mahgoub, Ph.D., Tecore Professor; and Sarah E. Du, Ph.D., an associate professor, both in FAU's Department of Electrical Engineering and Computer Science.

This research was supported by FAU's Institute for Sensing and Embedded Network Systems Engineering (I-SENSE) and FAU's College of Engineering and Computer Science.

全文翻译（仅供参考）

全世界约有6400万例心力衰竭。根据美国心脏协会的数据，美国有620万成年人患有心力衰竭，预计到2030年该数字将增加到800万。心力衰竭是一种以心脏结构异常为特征的进行性临床综合征，心脏无法泵出足够的血液以满足身体需求。

目前有两种心力衰竭监测系统可供使用，然而，由于它们是通过外科手术植入皮肤下的，因此价格昂贵且存在风险，而且，大约一半的心力衰竭患者不需要植入式器械或不符合胸腔镜检查的条件（颈部和腹部之间的区域）监测这些设备提供。迫切需要非全天候监测心力衰竭进展的侵入性解决方案。

佛罗里达大西洋大学工程与计算机科学学院的研究人员与FAU的克莉丝汀E.林恩护理学院合作开发了一种新型可穿戴设备的原型，该设备可以实时连续监测与心力衰竭相关的所有生理参数。

该技术基于嵌入在轻便腰带中的传感器，腰带可以方便地佩戴在腰部，用于监测胸阻抗、心电图（ECG）、心率和运动活动检测。系统使用不同的传感器来感测这些参数。胸阻抗是监测心力衰竭进展的关键生物信号。类似地，ECG是诊断和预测心血管疾病的重要生物信号，ECG使用霍尔特监护仪测量通过心脏的电信号，不适合床旁使用。

该研究发表于科学报告，研究人员在不同的条件下测试了这款可穿戴设备，包括坐着、站着、躺下和行走。在每种条件下，每个传感器都会依次获得结果。所选的生理参数对判断心力衰竭症状至关重要。

研究结果表明，所有传感器都能跟踪所有不同条件下的变化。位置传感器能正确地突出显示不同条件下位置的变化，并可用于识别设备佩戴者的不同状态。此外，心率传感器能持续跟踪心率。重要的是，该设备能正确地突出显示胸部阻抗的微小变化。

与大多数ECG监护仪一样，可穿戴设备中的ECG传感器对运动非常敏感，尤其是在行走时。然而，即使在行走时，ECG传感器仍保留其QRS波群（通过心室传播的电脉冲）沿着R峰（QRS复合波的间期），其是左心室肥大的重要指标，指示主心脏泵血腔中心肌纤维尺寸的增加。

我们集成到腰带模块中的所有传感器都可以很容易地长时间佩戴，而不会影响患者的日常活动。重要的是，对心力衰竭症状的持续和实时监测可以提醒患者及其医疗保健提供者患者的健康状况正在恶化。反过来，医疗保健提供者可以通过药物干预，避免患者住院。”

Waseem Asghar博士，FAU电气工程和计算机科学系资深作者和副教授

研究人员预计他们的技术将对心力衰竭有更高的预测价值，特异性增加，灵敏度高。

约有1/4的心力衰竭患者在出院后30天内再次入院，约有一半在6个月内再次入院。医疗保健可穿戴设备（如我们开发的原型）有可能以经济高效的方式减少再次入院，同时对佩戴者来说也是安全和方便的。”

玛丽Ann Leavitt，博士，合著者，FAU克莉丝汀E.林恩护理学院助理教授

根据研究结果，研究人员目前正在一组不同的受试者身上测试该模块，以开发一种算法来预测测试集上的心力衰竭。

第一作者Sheikh Muhammad Asher Iqbal说：“这种监测心力衰竭的可穿戴设备是我在Asghar博士的医学微纳米技术实验室的主要项目，它对美国增长最快的心血管疾病具有重要的社会意义。”FAU电气工程和计算机科学系的研究助理和博士生。“我们正在开发一种无创解决方案，可供所有心力衰竭患者使用，以获得更好的管理、诊断和预后，从而能够服务于大众。”

研究的共同作者是Imadeldin Mahgoub博士，Tecore教授; Sarah E. Du博士，副教授，均就职于FAU电气工程与计算机科学系。

本研究得到了FAU传感与嵌入式网络系统工程研究所（I-SENSE）和FAU工程与计算机科学学院的支持。

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