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 (CardioVol, Admittance Technologies, Austin, TX) 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 1 effort, BridgeSource Medical will demonstrate how CardioVol can be redeveloped for application on existing MCS device platforms.

Project Narrative Temporary Mechanical Circulatory Support (MCS) devices have a goal of assisting the failing heart to bridge a patient to recovery, or to a more durable ventricular pump. However, a key metric of optimal hemodynamic stabilization, the native cardiac output (CO) is not measured on these increasingly popular devices.