Clinical study of ECG-based analytic shows average three-hour advance prediction of hemodynamic instability
The Analytic for Hemodynamic Instability (AHI) System™ from Weil Institute spin-off Fifth Eye, Inc. provides clinically significant lead time in predicting onset of instability before vital signs.
Contacts:
Tricia Strong,
Senior Director of Marketing,
Fifth Eye, Inc.
tstrong@fiftheye.com
Katelyn Murphy,
Marketing Communications Specialist,
Weil Institute
mukately@med.umich.edu
ANN ARBOR, MI – The results of a clinical study conducted at the University of Michigan and published in peer-reviewed BMC Anesthesiology showed that the Analytic for Hemodynamic Instability Predictive Indicator (AHI-PI) predicted episodes of hemodynamic instability (HI) with high levels of sensitivity and specificity within clinically significant timeframes.
According to the study, failure to recognize the need for re-evaluation and escalation of care can result in unplanned ICU admissions, added length of stay, and even death. The retrospective cohort study included 4,633 hospitalized, electrocardiogram (ECG)-monitored adult patients across ICU, ED, telemetry, step-down, and general population units. AHI-PI predicted signs of prolonged hemodynamic instability (HI) well ahead of what was displayed by vital signs: 2.9 hours earlier in patients monitored with noninvasive methods and 3.7 hours earlier among those with continuous arterial line monitoring.
“The first episode of HI often takes clinicians by surprise, so we focused on those incidents in this study,” explained Ashwin Belle, Chief Data Scientist and Co-founder of Fifth Eye. “This study demonstrates that AHI-PI is a highly accurate and robust model, able to predict future episodes of both patient stability and instability before they are evident through vital signs. The system even predicted the occurrence of hemodynamic instability in patients being continuously monitored in an ICU which is remarkable.”
"None of the patient monitoring platforms in use today provide continuous, real-time data analysis from the autonomic nervous system like AHI-PI does. Instead, they rely on traditional real-time vital signs such as heart rate and blood pressure or laboratory data which are lagging indicators of a patient’s condition."
Kevin Ward, MD
Executive Director, Weil Institute; Professor, Emergency Medicine and Biomedical Engineering
University of Michigan, Michigan Medicine
Shifts in vital signs occur prior to adverse events, but they are often recognized too late to avoid patient deterioration. With advance notice of emerging patient instability, clinical teams have time to plan, intervene, and prevent decompensation that can lead to adverse events. Clinicians also have greater confidence to upgrade care, downgrade care, or discharge patients sooner.
The AHI System™ combines real-time patient status with a future risk indicator (AHI-PI), giving clinicians a complete picture of emerging hemodynamic instability. Based on technologies developed and tested at the U-M Max Harry Weil Institute for Critical Care Research and Innovation and licensed to Fifth Eye, the AHI System is a software as a medical device (SaMD) cleared for use through the FDA’s De Novo and 510k processes. To date, it is the only noninvasive patient monitoring technology of its kind.
This study corroborates extensive previous clinical studies that AHI-PI gets ahead of vital signs using an analytic that leverages signal processing and machine learning to extract ECG features invisible to the human eye that are associated with impending hemodynamic instability. These ECG features are related to the changes in the body’s autonomic nervous system which regulate the body’s ability to hemodynamically compensate and control blood pressure.
According to Dr. Kevin Ward, Executive Director of the Weil Institute and U-M Professor of Emergency Medicine and Biomedical Engineering, predicting acute hemodynamic deterioration in a time window that allows for timely intervention has long presented a significant challenge. “None of the patient monitoring platforms in use today provide continuous, real-time data analysis from the autonomic nervous system like AHI-PI does. Instead, they rely on traditional real-time vital signs such as heart rate and blood pressure or laboratory data which are lagging indicators of a patient’s condition.”
Drs. Belle and Ward also noted that the technology can also leverage the same data from several FDA approved wearable ECG patches meaning the potential exists to provide an almost ICU level of monitoring in patients on the general ward who traditionally only have their vital signs measured and recorded every 4-6 hours.
Dr. Ward continued, “Fifth Eye is a Weil Institute-University of Michigan spin-off and fantastic industry partner that has taken technology developed at the Weil Institute, aggressively refined it, taken it to the FDA for approval, and continues to be strategically engaged with the Weil Institute to prove the value of this unique early warning technology. This collaboration represents the true essence of the Weil Institute’s motto of Transforming Critical Care through Innovation, Integration, and Entrepreneurship.”
The AHI System™ is intended for use by healthcare professionals managing patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography in hospitals. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Study Referenced
Further Reading
Disclosures
Dr. Ward is an inventor of the AHI technology and has equity in Fifth Eye.
About the Weil Institute, formerly MCIRCC
The team at the Max Harry Weil Institute for Critical Care Research and Innovation (formerly the Michigan Center for Integrative Research in Critical Care) is dedicated to pushing the leading edge of research to develop new technologies and novel therapies for the most critically ill and injured patients. Through a unique formula of innovation, integration and entrepreneurship that was first imagined by Weil, their multi-disciplinary teams of health providers, basic scientists, engineers, data scientists, commercialization coaches, donors and industry partners are taking a boundless approach to re-imagining every aspect of critical care medicine. For more information, visit weilinstitute.med.umich.edu.
About Fifth Eye Inc.
Fifth Eye Inc. based in Ann Arbor, MI develops intuitive, real-time clinical analytics based on physiologic waveforms to improve outcomes and reduce costs. The AHI System™ is the only FDA-cleared clinical decision support software that continuously predicts the risk of hemodynamic instability earlier than vital signs. Using real-time, continuous ECG lead II data feed, AHI automatically performs a series of advanced signal processing analyses, extracting HRV patterns that indicate a patient’s hemodynamic status. AHI System helps hospitals prevent adverse events, improve patient throughput, and better allocate valuable clinical staff resources to avoid nursing burnout. Fifth Eye's machine-learning technology is licensed from the University of Michigan.