Native Hemodynamic Measurement as Feedback Control for Mechanical Cardiac Support

摘要 临时性机械循环支持（MCS）装置是一种有效的手段， 两种适应症患者的临时支持：急性心肌梗死（MI）伴或不伴 心源性休克（CS）和急性失代偿性心力衰竭（HF）。这些疾病打击了 老年人是最难的，同时随着年龄的增长更普遍。心源 心肌梗死后休克在老年患者中比年轻患者更常见，并且心力衰竭有所增加 患病率随年龄增长（60-79岁，6%患有HF，80岁以上，10%患有HF）。在这些患者中，短- 术语MCS器械是一种导管输送泵，可放置在LV中，泵送血液 穿过主动脉瓣，以帮助维持向前流动，同时卸载衰竭的心脏。关键 用于优化这些设备的使用的度量包括压力和体积的组合 测量.虽然压力通常已经在设备上测量，但MCS设备 今天的市场无法估计心脏的总心输出量，这是心脏的一个关键组成部分。 功率输出（CPO、CO x平均主动脉压），现在被公认为最单一的 心源性休克死亡率重要相关因素。同时优化正在进行的治疗 当患者从MCS器械上撤机过渡到恢复期（或更长时间）时， 永久性设备）目前缺乏实时、准确的CO测量（计算 CPO）。我们建议整合一个经过验证的左心室容积测量（基于导纳 技术）能够直接在MCS设备上确定CO，允许设备 主动改变泵速（从而影响CPO），以响应患者的变化 条件在第二阶段的工作中，BridgeSource Medical将展示如何基于准入 可以重新开发技术以应用于现有MCS设备平台。

Abstract Temporary Mechanical Circulatory Support (MCS) devices have been an effective means of temporary support in patients for two indications: acute myocardial infarction (MI) with or without cardiogenic shock (CS), and acute decompensated heart failure (HF). These ailments strike the elderly the hardest and are simultaneously more prevalent as age progresses. Cardiogenic shock after MI is more common in elderly patients than in the young, and HF has increasing prevalence with age (60-79, 6% have HF, for over 80, 10% have HF). In these patients, a short- term MCS device is a catheter delivered pump that can be placed in the LV, and pump blood across the aortic valve, to help maintain forward flow while unloading the failing heart. The key metric for optimizing the use of these devices includes a combination of pressure, and volume measurement. While pressure is already commonly measured on-device, MCS devices on the market today cannot estimate the total Cardiac Output of the heart, a key component of Cardiac Power Output (CPO, CO x mean aortic pressure) which is now well accepted as the single most important correlate of mortality in cardiogenic shock. Optimization of ongoing treatment as well as when to wean the patient from the MCS device to transition them to recovery (or a more permanent device) currently lacks a real-time, accurate measure of CO (necessary to calculate CPO). We propose integrating a proven LV volume measurement (admittance-based technology) capable of determining CO directly onto the MCS device, allowing the device to actively change pump speed (and therefore effect CPO) to respond to changing patient condition. In this phase 2 effort, BridgeSource Medical will demonstrate how admittance-based technology can be redeveloped for application on existing MCS device platforms.