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

基本信息

批准号：
10482251
负责人：
John E Porterfield
金额：
$ 49.86万
依托单位：
BRIDGESOURCE MEDICAL CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-05-03 至 2024-06-14
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10482251
关键词：
Acute Acute myocardial infarction Age Agreement Animal Model Animals Blood Cardiac Cardiac Output Cardiac Volume Cardiogenic Shock Cardiomyopathies Catheterization Catheters Clinical Consultations Device Removal Devices Echocardiography Elderly Excision Experimental Designs Feedback Goals Grant Heart Heart Atrium Heart failure Hospitals Human Implant In Vitro Judgment Left ventricular structure Licensing 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 base blood pump cardiac device cardiac implant case-by-case basis design design verification experience hemodynamics in vivo instrumentation manufacturability mechanical circulatory support mechanical load mortality older patient overtreatment pre-clinical pressure prototype treatment duration verification and validation

项目摘要

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）装置已成为一种有效的手段为两种适应症的患者提供临时支持：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）。这些疾病困扰着老年人是最困难的，同时随着年龄的增长，这种情况也更加普遍。心源性 MI 后休克在老年患者中比年轻人更常见，并且 HF 也在增加患病率随年龄变化（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，短期术语 MCS 装置是一种导管输送泵，可放置在左心室中并泵送血液穿过主动脉瓣，以帮助维持向前流动，同时减轻衰竭心脏的负荷。关键优化这些设备使用的指标包括压力和体积的组合测量。虽然压力已经普遍在设备上测量，但 MCS 设备今天的市场无法估计心脏的总心输出量，这是心脏的关键组成部分功率输出（CPO、CO x 平均主动脉压）现已被广泛认为是最重要的指标心源性休克死亡率的重要相关因素。优化正在进行的治疗何时让患者脱离 MCS 设备以使他们过渡到康复（或更多）永久装置）目前缺乏实时、准确的 CO 测量（需要计算首席采购官）。我们建议集成经过验证的 LV 容积测量（基于导纳）技术）能够直接在 MCS 设备上测定 CO，从而使设备能够主动改变泵速（从而影响 CPO）以响应不断变化的患者健康）状况。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的 MCS 设备平台。