Non-Invasive Device to Remotely Monitor Cardiac Function and Reduce Cost of Managing Heart Failure Patients

摘要 心力衰竭(HF)是美国65岁以上成年人住院的主要原因 各州。2014年，美国有超过510万人被诊断患有心力衰竭， 每年高达九分之一的死亡可归因于这种疾病引发的并发症。这个 与心力衰竭相关的神经激素失衡会导致液体滞留，从而导致 心内充盈压、被动肺静脉压和动脉压升高，以及肺 液体堆积。在症状出现之前检测血流动力学充血可以进行早期干预 和预防住院治疗。各种参数已被用于患者的心脏自我监测 功能，包括体重跟踪，但在减少住院方面显示出有限的效果。中的更改 肺动脉压(PAP)和每搏输出量(SV)都能检测到心脏的变化 功能相对较早，但通常需要专门的设备，不适合在家中使用。近期 有证据表明，通过植入式传感器(心脏微机械系统)直接监测PAP可以提供 临床医生使用远程监控工具来确定何时需要调整用药以防止 失代偿，30天的再入院时间减少了37%。然而，成本(约25000美元)和侵入性 这一设备严重限制了其临床采用率。 TheraNova已经开发出一种非侵入性的手持呼吸监测仪(心脏起搏器)，能够直接 在远程环境中监测心脏功能。该设备检测自然呼出的气流中的微小变化 压力称为心源性振荡(COS)，与心脏周期相对应。降低服务质量 随着心衰程度的加重，PAP的增加均可使COS的幅度减小。在体内的先导研究中，我们 已证明COS是心功能的直接指标，因为它与SV和 与PAP成反比。该项目的总体目标是使用心脏起搏器测量COS 稳定失代偿期心力衰竭患者的装置。在目标1中，我们将验证设备的能力 对心力衰竭患者进行可重复的COS测量。在目标2中，我们将验证设备的能力 应用COS检测心衰患者心功能的临床显著变化 学习。这两个目标的结果将提供有关我们将使用的设备功能的基本信息 在一项更大的临床研究的第二阶段，评估作为一种家庭监测系统的心脏起搏器。最终， 心脏起搏器将允许医生远程监控患者的体液状况，并对患者的体液状况进行调整 为了防止住院，应采取药物治疗的措施。这种类型的非侵入性家庭监控可能会 防止因急性失代偿而导致许多不必要的住院治疗。

ABSTRACT Heart failure (HF) is the leading cause of hospitalization among adults over 65 years of age in the United States. In 2014, more than 5.1 million people in the United States were living with a diagnosis of HF, and as many as one in nine deaths each year can be attributed to complications stemming from this disease. The neurohormonal imbalance associated with heart failure leads to fluid retention, resulting in an increase in intracardiac filling pressures, passive elevation of pulmonary venous and arterial pressures, and pulmonary fluid accumulation. Detecting hemodynamic congestion prior to symptom onset allows for early intervention and prevention of hospitalizations. Various parameters have been utilized for patient self-monitoring of cardiac function, including weight tracking, but have shown limited efficacy in reducing hospitalizations. Changes in both pulmonary artery pressure (PAP) and stroke volume (SV) are capable of detecting changes in cardiac function relatively early, but typically require specialized equipment that is not feasible for at-home use. Recent evidence has shown that directly monitoring of PAP via an implantable sensor (CardioMEMS) can provide clinicians with a remote monitoring tool to determine when medication adjustments were needed to prevent decompensation, and reduced 30-day readmissions by 37%. However, the cost (~$25k) and invasive nature of this device severely restricts its clinical adoption rate. TheraNova has developed a non-invasive, handheld respiratory monitor (Cardiospire) that is capable of directly monitoring cardiac function in a remote setting. The device detects minor variations in naturally expired airflow pressure known as cardiogenic oscillations (COS), which correspond with the cardiac cycle. Decreasing SV and increasing PAP both act to diminish the amplitude of COS with worsening HF. In pilot in vivo studies, we have demonstrated that COS is a direct indicator of cardiac function through its direct correlation with SV and inverse proportionality to PAP. The overall objective of this project is to measure COS using the Cardiospire device in stabilized and decompensated HF patients. In Aim 1, we will validate the ability of the device to perform repeatable measurements of COS in HF patients. In Aim 2, we will validate the ability of the device to detect clinically significant changes in cardiac function in HF patients using COS in an observational clinical study. The results of these two aims will provide essential information about device function that we will use during Phase II in a larger clinical study to evaluate Cardiospire as an at-home monitoring system. Ultimately, Cardiospire will allow physicians to remotely monitor their patients’ fluid status and make adjustments to their medications in order to prevent hospitalizations. This type of non-invasive home monitoring could potentially prevent many unnecessary hospitalizations for acute decompensation.