SBIR-STTR Award

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.

Public Health Relevance Statement:
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.

Project Terms:
Age; ages; Elderly; senior citizen; older person; older adult; later life; late life; geriatric; elders; advanced age; aortic valve; ascending aorta; Blood; Blood Reticuloendothelial System; Cardiac Output; heart output; Cardiac Volume; intracardiac volume; Heart Volume; Cathetergram; Catheterization; Clinical Trials; heart sonography; Transthoracic Echocardiography; Echocardiogram; Echocardiography; Electrodes; Engineering; Feedback; Goals; Grant; Health; Heart; atrium; Cardiac Atrium; Atrial; Heart Atrium; cardiac failure; Heart failure; hemodynamics; Laboratories; Methods; mortality; heart infarction; heart infarct; heart attack; coronary infarction; coronary infarct; coronary attack; cardiac infarct; Myocardial Infarct; Cardiac infarction; Myocardial Infarction; Noise; Patients; Physicians; pressure; Research; Researchers; Investigators; Research Personnel; Research Resources; Resources; Risk; Cardiogenic Shock; biological signal transduction; Signaling; Signal Transduction Systems; Intracellular Communication and Signaling; Cell Signaling; Cell Communication and Signaling; Signal Transduction; Technology; Texas; Time; Universities; Weaning; Measures; Catheters; Acute myocardial infarction; Acute myocardial infarct; base; blood pump; Pump; Procedures; Three-Dimensional Echocardiography; 3D Echocardiography; 3-D Echocardiography; Acute; Clinical; Phase; Medical; Left ventricular structure; Left Ventricles; Recovery; Measurement; Mechanics; mechanical; Frequencies; treatment duration; treatment days; Treatment Period; Techniques; Consult; experience; Animal Model; model organism; model of animal; Animal Models and Related Studies; austin; Speed; Devices; Excision; resection; Surgical Removal; Removal; Extirpation; Abscission; Device Removal; Cardiomyopathies; myocardium disorder; myocardium disease; Myocardiopathies; Myocardial Disorder; Myocardial Diseases; in vivo; Small Business Innovation Research Grant; Small Business Innovation Research; SBIR; Monitor; Principal Investigator; Process; Ventricular; Cardiac; Development; developmental; Output; Sepsis; bloodstream infection; blood infection; older patient; elderly patient; Prevalence; Implant; commercialization; in vitro testing; operation; case-by-case basis; mechanical load; cardiac device; cardiodevice

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.

Public Health Relevance Statement:
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.

Project Terms:
Age; ages; Elderly; advanced age; elders; geriatric; late life; later life; older adult; older person; senior citizen; Animals; aortic valve; ascending aorta; Blood; Blood Reticuloendothelial System; Cardiac Output; heart output; Cardiac Volume; Heart Volume; intracardiac volume; Catheterization; Cathetergram; Consultations; Echocardiography; Echocardiogram; Transthoracic Echocardiography; heart sonography; Experimental Designs; Feedback; Goals; Grant; Heart; Heart Atrium; Atrial; Cardiac Atrium; atrium; Heart failure; cardiac failure; hemodynamics; Hospitals; Human; Modern Man; In Vitro; instrumentation; Judgment; Medical Device; Methods; mortality; Myocardial Infarction; Cardiac infarction; Myocardial Infarct; cardiac infarct; coronary attack; coronary infarct; coronary infarction; heart attack; heart infarct; heart infarction; Noise; Patients; Physicians; pressure; Investigators; Researchers; Research Personnel; Risk; Cardiogenic Shock; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Signal Transduction; Technology; Testing; Time; Weaning; Work; Measures; Catheters; Acute myocardial infarction; Acute myocardial infarct; base; blood pump; Pump; Procedures; Acute; Clinical; Phase; Medical; Left Ventricles; Left ventricular structure; Recovery; Licensing; Measurement; Treatment Period; treatment days; treatment duration; Techniques; experience; Animal Models and Related Studies; model of animal; model organism; Animal Model; Speed; Agreement; Devices; Abscission; Extirpation; Removal; Surgical Removal; resection; Excision; Device Removal; Myocardial Diseases; Myocardial Disorder; Myocardiopathies; myocardium disease; myocardium disorder; Cardiomyopathies; in vivo; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Monitor; Principal Investigator; Process; Ventricular; Cardiac; Output; pre-clinical; preclinical; design; designing; Sepsis; blood infection; bloodstream infection; older patient; elderly patient; Prevalence; Implant; prototype; verification and validation; case-by-case basis; mechanical load; manufacturability; overtreatment; over-treatment; cardiac implant; cardiac device; cardiodevice; mechanical circulatory support; mechanical cardiac support; mechanical circulatory assist; mechanical circulatory therapy; mechanical heart support; design verification; design validation