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

充血性心力衰竭（CHF）是美国最常见的住院原因，超过100万 每年招生。患有CHF的患者通常需要IV利尿剂以促进液体排出。的 再入院率很高-出院后30天超过20%，出院后90天超过30%。这也提出了一个 巨大的经济负担-住院治疗占每年380亿美元的大部分， 心衰再入院率高的原因之一是， 心脏充盈压升高，直到症状复发，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的热情， 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 已经开发出第一个可以在家里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术（PPG），同时还引导和记录标准化的 Valsalva动作进入呼气压力传感器。最新的原型是手持的，电池供电， 并与能够远程传输的iPad进行无线通信。该装置使用方便， 该技术坚固耐用，价格低廉，测试只需5分钟。我们已经证明，输出 测量与左心室充盈压-左心室末的侵入性金标准测量相关 舒张压（LVEDP）和肺毛细血管楔压（PCWP）。更重要的是我们有 表明它识别了LVEDP和PCWP升高的临床有意义的类别。最近，我们 显示在出院当天从装置获得的LVEDP对于预测心脏具有高特异性 失败再入院，需要门诊IV利尿，或出院后30天内死亡。灵敏度和 通过在家中随时间跟踪LVEDP可以提高预测再入院的特异性。在这个快 跟踪项目，我们打算在第一阶段进一步开发自动波形分析算法，远程 传输能力，以及进行基于家庭的观察性临床研究所需的原型设计。在 在II期临床研究中，出院后心力衰竭患者将在家中每天两次进行自我测试， 最多30天，数据将远程传输。我们将确定是否每天两次获得LVEDP 预测心力衰竭事件（心力衰竭再入院、需要门诊IV利尿或 出院后30天内死亡。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、医疗器械原型设计、项目工程、心力衰竭临床研究，以及 在医疗器械初创企业中取得成功。如果我们的观察性临床研究的结果是成功的， 下一步将是进行多中心干预试验，以确定是否基于每日 设备测试减少了出院后心力衰竭事件。该设备有潜力提高 生活，降低医疗费用，提高心力衰竭患者的生存率。

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.