Clinical Need

Heart failure
Heart failure is a disease that results in recurrent decompensation and the need for inpatient medical treatment. Heart failure is the leading reason for hospital admission in the United States. The signs and symptoms are often non-specific. Physical exam signs of heart failure decompensation are absent in over 35% of patients at any given time. Technologies to help diagnose heart failure include chest x-rays, echocardiography, and lab tests. Nearly 30% of patients admitted to the hospital have no pulmonary congestion on chest x-ray, and 50-55% will have a normal ejection fraction on echocardiography. Lab tests are often chronically abnormal and difficult to obtain in real time.

Furthermore, vital signs of pulse, blood pressure, and pulse oximetry, and variables like weight are often unreliable or not useful in patients who are on multiple medications and are chronically ill. Even when patients are hospitalized, it is difficult to track a patient’s metrics to determine when they are truly ready for medical discharge from hospital and transition to outpatient care. Patients often feel slightly better with a small amount of medical treatment, and providers are anxious to discharge them from the hospital, when in fact the hemodynamics of their decompensation have not been corrected. When this occurs, it is only a matter of time before the patient is readmitted to the hospital.

These methods ignore systemic vascular resistance (SVR). SVR is the hemodynamic hallmark of heart failure exacerbation and the number to which treatments are targeted in critically ill patients. We need a new technology to provide SVR data in real time for patients who are not critically ill. The impact on health and costs savings will be felt by millions of patients, at a potential savings of billions of dollars to health systems and insurers.

As a result of current primitive methods for diagnosis and tracking a patient’s true hemodynamic state, patients are misdiagnosed, underdiagnosed, and present for hospital care instead of being identified in an outpatient setting for up-titration of medications and closer outpatient monitoring. Patients are discharged from the hospital based on a set of “guesses” as to how well compensated they have become with inpatient care. The result of these “guesses” is a readmission rate of over 50% within six months of a heart failure diagnosis.

Seventy-five percent of patients hospitalized for heart failure have been previously hospitalized. Hospitalization is a predictor of death from heart failure. The 60-day mortality after hospitalization for heart failure is between 8-20%.

The opportunity for improvement is enormous. Over one million people are hospitalized with heart failure exacerbations each year. The price of these admissions is over $20 billion annually. This problem is only expected to grow, as a 46% increase in prevalence of heart failure will occur by 2030. Shock Analytics’ technology can improve office-based diagnosis. Our technology has the potential to detect heart failure exacerbations before hospitalization is required. It may also improve clinical decision making as to when a patient is truly ready for discharge from the hospital. It may be integrated into chronic disease management systems to improve the usefulness of such systems for heart failure management.

Shock Analytics seeks to transform heart failure from a condition that is characterized by recurrent hospitalization, extremely high costs, and profound debility into a condition in which changes within the cardiovascular system are detected before decompensation, treated aggressively in an outpatient setting, and tracked over time.

We are inventing a new vital signs to include SVR as part of any thorough cardiovascular exam. It is the lynchpin of improved care for heart failure patients.

Sepsis
Sepsis is an illness characterized by a severe systemic inflammatory response to an infection. Sepsis is a clinical diagnosis based on history, physical, and labs tests. These symptoms can include an elevated heart rate and respiratory rate, temperature disturbance, blood glucose changes, white cell count abnormalities, and/or an altered mental state. A patient diagnosed early has more ability to compensate. Early sepsis has a 10-20% mortality rate. Patients diagnosed at a later stage have severe sepsis with mortality ranging from 20-50%. Patients diagnosed with septic shock (hypoperfusion despite fluid resuscitation) have a mortality rate between 40-80%.

Every hour of delay in sepsis diagnosis means a greater likelihood of death. One reason for missed or late diagnosis is that the tools used to diagnose sepsis are non-specific. Days may pass before a patient is given a correct diagnosis of sepsis. Every hour lost means an increased risk of death.

The Surviving Sepsis Campaign has spent fifteen years advocating for early diagnosis and goal-directed therapy. Because of these efforts, mortality from sepsis dropped from 56% to 42%. These mortality rates are on par with rare viruses like Ebola that command worldwide attention and resources.

Furthermore, delayed sepsis diagnosis is the leading cause of preventable death after emergency room visits. Several studies demonstrate that 30-35% of deaths after being sent home from an emergency room are due to non-diagnosis of sepsis. More severe sepsis costs more to treat and is more likely to cause death. Sepsis costs over $20 billion annually in the United States, and costs increase by 11% annually. We urgently need improved diagnostic capabilities that can flag sepsis as a potential concern in all care settings at the earliest point possible. Missed sepsis diagnosis is also a leading driver of malpractice litigation against physicians and health systems.

The opportunity for improvement is enormous. Sepsis is an increasingly incident illness. Over one million people are hospitalized each year with sepsis. It accounts for 17% of US hospital deaths, but only 2% of hospitalizations.

The mortality rate is much higher than mortality rates from heart attacks or cancer. Interviews with experts demonstrate that current technologies for diagnosing sepsis are inadequate. There is an urgent need to improve early diagnose. Shock Analytics has invented technology to reliably estimate SVR at the bedside in real time. This technology can be enormously useful in prompting a serious consideration of sepsis in patients in the office, in an emergency room, or admitted to wards throughout the hospital. This technology can transform sepsis from a disease characterized by high death rates, late diagnosis, and tremendous costs to an illness that is detected at initial presentation to any level of care and treated early, with reduced death rates and lower costs.

We believe there should be zero cases of misdiagnosis of sepsis. Low SVR is the hemodynamic hallmark of sepsis. Over 80% of instances of low SVR are attributable to sepsis. Inclusion of this vital sign in all patients presenting for care can revolutionize treatment of this deadly disease that affects millions worldwide.

Advertisements