Native Hemodynamic Measurement as Feedback Control for Mechanical Cardiac Support

天然血流动力学测量作为机械心脏支持的反馈控制

• 批准号: 10645215
• 负责人: John E Porterfield
• 金额: $ 118.96万
• 依托单位: BRIDGESOURCE MEDICAL CORPORATION
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-03 至 2025-06-14
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10645215
• 关键词: Acute; Acute myocardial infarction; Age; Agreement; Animal Model; Animals; Aorta; Blood; Cardiac; Cardiac Output; Cardiac Volume; Cardiogenic Shock; Cardiomyopathies; Catheterization; Catheters; Clinical; Congestive Heart Failure; Consultations; Device Removal; Devices; Echocardiography; Elderly; Electronics; Excision; Experimental Designs; Feedback; Goals; Grant; Heart; Heart Atrium; Heart failure; Hospitals; Human; Implant; In Vitro; Judgment; Left ventricular structure; Licensing; Marketing; Measurement; Measures; Medical; Medical Device; Methods; Monitor; Myocardial Infarction; Noise; Output; Patients; Phase; Physicians; Prevalence; Principal Investigator; Procedures; Process; Pump; Recovery; Research Personnel; Risk; Sepsis; Signal Transduction; Small Business Innovation Research Grant; Speed; Techniques; Technology; Testing; Time; Ventricular; Weaning; Work; aortic valve; ascending aorta; blood pump; cardiac device; cardiac implant; case-by-case basis; commercialization; design; design verification; experience; hemodynamics; improved; in vivo; instrumentation; manufacturability; mechanical circulatory support; mechanical load; mortality; older patient; overtreatment; pre-clinical; pressure; prototype; treatment duration; verification and validation

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.

抽象的 临时机械循环支持（MCS）设备已成为有效的手段 患者的临时支持有两个迹象：有或没有 心源性休克（CS）和急性代偿性心力衰竭（HF）。这些疾病袭击了 随着年龄的发展，老年人最困难，同时更加普遍。心源 在老年患者中，MI之后的休克比在年轻人中更普遍，而HF的震撼力增加 年龄的患病率（60-79岁，有6％的HF，超过80％，患有HF）。在这些患者中，短暂 术语MCS设备是可以放置在LV中的导管式泵，然后抽血 跨主动脉瓣，以帮助保持前进流，同时卸下失败的心脏。钥匙 优化这些设备使用的度量包括压力和体积的组合 测量。尽管压力通常是在设备上测量的，但MCS设备在 今天的市场无法估计心脏的总心输出量，这是心脏的关键组成部分 功率输出（CPO，CO x表示主动脉压力），现在已被充分接受为单一的单一 心源性休克死亡率的重要相关。也正在进行的治疗 就像何时断奶患者从MCS设备过渡到恢复（或更多 永久设备）当前缺乏对CO的实时，准确的量度（计算必要的必要 CPO）。我们建议整合经过验证的LV量测量（基于入学 技术）能够将CO直接确定到MCS设备上，从而允许该设备 积极改变泵速（从而实现CPO）以应对变化的患者 健康）状况。在这阶段2的努力中，Bridgesource Medical将证明基于入学的方式 可以重新开发技术以在现有的MCS设备平台上应用。