Native Hemodynamic Measurement as Feedback Control for Mechanical Cardiac Support

摘要 临时机械循环支持(MCS)装置已经成为一种有效的手段 两种适应症患者的临时支持：有或无急性心肌梗死(MI) 心源性休克(CS)和急性失代偿性心力衰竭(HF)。这些疾病侵袭了 老年人是最困难的，而且随着年龄的增长，老年人的比例也越来越高。心源性 心肌梗塞后休克在老年患者中比在年轻人中更常见，而且心衰有增加的趋势。 患病率随年龄增长(60-79岁，6%患有心力衰竭，80岁以上，10%患有心力衰竭)。在这些患者中，短期的- 术语MCS装置是一种导管输送的泵，可以放置在LV内，并抽出血液 穿过主动脉瓣，帮助维持前向血流，同时卸载衰竭的心脏。钥匙 优化这些设备使用的指标包括压力和体积的组合 测量。虽然压力已经通常在设备上测量，但MCS设备上的 今天的市场不能估计心脏的总心输出量，心脏是心脏的关键组成部分 功率输出(CPO，CO x平均主动脉压)，现在被广泛接受为最大 心源性休克死亡率的重要相关因素。同时优化正在进行的治疗 至于何时让患者脱离MCS设备以使他们恢复(或更多 永久设备)目前缺乏实时、准确的CO测量(计算所必需的 CPO)。我们建议集成经过验证的LV容量测量(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)以响应不断变化的患者 条件。在这一第二阶段的工作中，BridgeSource Medical将展示基于准入的 技术可以重新开发，以便在现有的MCS设备平台上应用。

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.