Abstract

Background: Clinicians rely on vital signs (tachycardia with hypotension) to identify hemodynamically unstable patients. The Analytic for Hemodynamic Instability (AHI) System provides an indication of hemodynamic deterioration before it is evident via vital signs. It uses only routinely collected ECG monitor data to generate a simple binary output (indicating signs of hemodynamic instability-Red or stability-Green) and is automatically updated every two minutes. Hypothesis: Continuous real-time hemodynamic status obtained from analysis of ECG signals can predict an episode of hemodynamic instability before it's evident via vital signs, with clinically actionable lead time. Methods: In this retrospective observational study, an episode of hemodynamic instability (EHI) was defined as 10 continuous minutes or more where hypotension (systolic BP<90 mmHg or mean BP<70 mmHg) combined with tachycardia (heart rate ≥ 100 bpm) was present. The AHI System processed continuous ECG data from 362 consecutive adult ICU patient encounters (146, 40.3% female) undergoing continuous BP and HR monitoring via arterial line and ECG, who experienced at least one EHI. In this analysis, only the first occurrence of an EHI per patient encounter was used to see if the AHI System predicted the episode before vital signs showed any indication. Results: Of the 362 patients, AHI correctly predicted the first EHI in 85% of the patients (308/362). Of those, AHI’s median lead time (predominantly repeating AHI-Red indications) was 57 minutes prior to first EHI, with 25th and 75th percentiles at 14 minutes and 3.2 hours, respectively. AHI’s average lead time was 4 hours. Conclusion: Results suggest that this ECG-based analytic can potentially notify healthcare providers of future patient deterioration with clinically actionable lead times. The benefit of this analytic could extend further for ECG monitored patients in lower levels of care where hemodynamic status is typically evaluated manually and intermittently. This potentially enables appropriate preemptive clinical action, thereby reducing failure to rescue and increasing vigilance for unseen at-risk patients. Footnote: AHI is an FDA-cleared device for sale in the US.

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