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，有100多万人 每年的招生人数。入院的CHF患者通常需要静脉注射利尿剂来促进液体的排出。这个 再住院率很高--出院后30天超过20%，到90天超过30%。这还提供了一个 巨大的经济负担-在每年花费在以下方面的380亿美元中，住院治疗占了很大比例 心力衰竭。再入院率高的原因之一是，检测到 心脏充盈压升高，直到症状复发，促使返回医院。有很多东西 人们对远程非侵入性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度和特异度有限，或者是后来的指标。我们 开发了第一台可在国内使用的无创性心脏充盈压测定仪。 它连续记录手指的光体积图(PPG)，同时还引导和记录标准化的 瓦尔萨尔瓦进入呼气压力传感器。最新的原型是手持的，电池供电的， 并与能够远程传输的iPad进行无线通信。该设备使用方便，使用方便 坚固而廉价的技术，测试只需5分钟。我们已经证明了输出 测量与有创左心充盈压黄金标准测量--左心室末期相关 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，它识别了临床上有意义的LVEDP和PCWP升高的类别。最近，我们有 显示从出院当天的装置中得出的LVEDP对预测心脏有高度的特异性 再次入院失败，需要门诊静脉利尿，或在出院后30天内死亡。敏感性和 在家中随着时间的推移跟踪LVEDP可能会提高预测再入院的特异性。在这一速度中 Track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必需的原型。在……里面 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测试两次，以 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、需要门诊静脉利尿或 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、医疗器械原型制作、项目工程、心力衰竭临床研究以及 有过医疗器械初创企业的成功经验。如果我们的观察性临床研究结果是成功的， 下一步将进行一项多中心介入试验，以确定指导治疗是否基于每日 设备测试可减少出院后心力衰竭事件。该设备有可能提高 减少医疗费用，提高心力衰竭患者的存活率。

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.