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Noninvasive Home Assessment of Cardiac Filling Pressure to Identify Heart Failure Patients at High Risk for Readmission

对心脏充盈压进行无创家庭评估，以识别再入院高风险的心力衰竭患者

基本信息

批准号：
9912819
负责人：
HARRY A. SILBER
金额：
$ 58.6万
依托单位：
VIXIAR MEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-01 至 2022-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9912819
关键词：
Address Admission activity Affect Algorithmic Analysis Algorithms Android Apple Arrhythmia Atrial Fibrillation Blood Pressure Cardiac Categories Cellular Phone Cessation of life Charge Clinical Clinical Research Clinical Trials Congestive Congestive Heart Failure Coupled Data Databases Devices Diagnostic Diastolic blood pressure Diuresis Diuretics Economic Burden Engineering Enrollment Epidemic Event Excision Fingers Goals Gold Hand Health Care Costs Health Insurance Portability and Accountability Act Heart Heart failure Home environment Hospitalization Hospitals Intervention Trial Left Liquid substance Measurement Measures Medical Device Medicare Methods Microprocessor Monitor Observational Study Outcome Outcome Study Outpatients Output Patients Performance Pharyngeal structure Phase Photoplethysmography Physiologic pulse Plant Roots Pressure Transducers Pulmonary Capillary Wedge Pressure Quality of life Records Secure Sensitivity and Specificity Signs and Symptoms Specificity Standardization Symptoms System Technology Testing Time Training Valsalva Maneuver Ventricular Weight Wireless Technology automated algorithm base clinical investigation cost data exchange design financial incentive high risk hospital readmission hospitalization rates improved non-invasive monitor non-invasive system point of care pressure prototype readmission rates readmission risk smartphone Application software development standard measure success tool transmission process

项目摘要

Congestive heart failure (CHF) is the most common reason for hospitalization in the U.S., with over 1 million admissions per year. Patients admitted with CHF usually need IV diuretics to promote fluid removal. The readmission rate is high – over 20% by 30 days, and 30% by 90 days post-discharge. This also presents an enormous economic burden - hospitalizations account for a large percentage of the $38 billion spent yearly on heart failure. One of the reasons for the high readmission rate is that it can be very challenging to detect elevated cardiac filling pressure until symptoms recur that prompt a return to the hospital. There is much enthusiasm for the potential of remote noninvasive monitoring to predict and reduce heart failure readmissions, but daily weights, vital signs and symptoms have limited sensitivity and specificity or are later indicators. We have developed the first device for assessing cardiac filling pressure noninvasively that can be used at home. It records finger photoplethysmography (ppg) continuously while also guiding and recording a standardized Valsalva maneuver into an expiratory pressure transducer. The latest prototype is hand-held, battery-powered, and communicates wirelessly with an iPad capable of remote transmission. The device is easy to use, employs technology that is robust and inexpensive, and testing takes only 5 minutes. We have shown that the output measure correlates with the invasive gold standard measures of left heart filling pressure - left ventricular end diastolic pressure (LVEDP) and pulmonary capillary wedge pressure (PCWP). More importantly, we have shown that it identifies clinically meaningful categories of elevated LVEDP and PCWP. Most recently, we have shown that LVEDP derived from the device on the day of discharge has high specificity for predicting heart failure readmission, need for outpatient IV diuresis, or death within 30 days after discharge. Sensitivity and specificity for predicting readmission may be improved by following LVEDP over time at home. In this Fast Track project, we intend in Phase I to develop further the automated waveform analysis algorithms, remote transmission capabilities, and prototyping necessary to conduct a home-based observational clinical study. In the clinical study in Phase II, post-discharge heart failure patients will test themselves at home twice a day for up to 30 days, and the data will be transmitted remotely. We will determine if LVEDP obtained twice daily predicts heart failure events (a combination of heart failure readmission, need for outpatient IV diuresis, or death) within 30 days after discharge. Our team has extensive combined expertise in waveform analysis, software development, medical device prototyping, project engineering, heart failure clinical investigation, and prior success in medical device start-ups. If the outcome of our observational clinical study is successful, the next step would be to conduct a multi-center interventional trial to determine if guiding therapy based on daily device testing reduces post-discharge heart failure events. The device has the potential to improve quality of life, reduce health care costs, and improve survival in patients with heart failure.

充血性心力衰竭 (CHF) 是美国最常见的住院原因，超过 100 万人因充血性心力衰竭 (CHF) 住院每年招生。患有 CHF 的患者通常需要静脉注射利尿剂来促进液体排出。这再入院率很高，出院后 30 天再入院率超过 20%，出院后 90 天再入院率超过 30%。这也提出了一个巨大的经济负担——每年 380 亿美元的医疗支出中，住院治疗占很大比例心脏衰竭。再入院率高的原因之一是检测起来非常困难心脏充盈压升高，直到症状再次出现并提示返回医院。有很多对远程无创监测预测和减少心力衰竭再入院的潜力充满热情，但每日体重、生命体征和症状的敏感性和特异性有限，或者是较晚的指标。我们开发了第一台可在家使用的无创评估心脏充盈压的设备。它连续记录手指光电体积描记法 (ppg)，同时还引导和记录标准化瓦尔萨尔瓦动作进入呼气压力传感器。最新的原型是手持式、电池供电的、并与可远程传输的iPad进行无线通信。该设备使用方便，采用该技术强大且廉价，测试只需 5 分钟。我们已经证明了输出测量值与左心充盈压（左心室末端）的侵入性金标准测量值相关舒张压（LVEDP）和肺毛细血管楔压（PCWP）。更重要的是，我们有结果表明，它可以识别具有临床意义的 LVEDP 和 PCWP 升高类别。最近，我们有表明出院当天从设备得出的 LVEDP 对于预测心脏具有高度特异性失败再次入院、需要门诊静脉注射利尿、或出院后 30 天内死亡。灵敏度和通过在家中长期跟踪 LVEDP，可以提高预测再入院的特异性。在这快 Track项目，我们打算在第一阶段进一步开发自动化波形分析算法、远程传输能力以及进行家庭观察性临床研究所需的原型设计。在在第二阶段的临床研究中，出院后的心力衰竭患者将每天在家进行两次自我测试最长30天，数据将远程传输。我们将确定 LVEDP 是否每天获得两次预测心力衰竭事件（心力衰竭再入院、门诊静脉利尿需求的组合，或死亡）出院后 30 天内。我们的团队在波形分析方面拥有广泛的综合专业知识，软件开发、医疗设备原型设计、项目工程、心力衰竭临床研究以及之前在医疗器械初创企业中取得过成功。如果我们的观察性临床研究的结果是成功的，下一步将进行多中心介入试验，以确定是否可以根据日常情况指导治疗设备测试可减少出院后心力衰竭事件。该设备有潜力提高质量生命，降低医疗费用，提高心力衰竭患者的生存率。