Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure

The Acumen Hypotension Prediction Index is a software-based adjunctive tool designed for advanced hemodynamic monitoring, which aims to predict the likelihood of future hypotensive events in both surgical and non-surgical patients. By analyzing arterial pressure data to generate a predictive score alongside parameters like Dynamic Arterial Elastance and Systolic Slope, it offers clinicians additional physiological insight to potentially anticipate and manage hemodynamic instability.

The Acumen Hypotension Prediction Index (HPI) is a software feature designed to assist clinicians by providing insight into the likelihood of a patient experiencing a future hypotensive event, defined as a mean arterial pressure (MAP) below 65 mmHg for at least one minute. This adjunctive predictive cardiovascular indicator is intended for use in both surgical and non-surgical patients who are undergoing advanced hemodynamic monitoring. The system utilizes software running on compatible Edwards Lifesciences monitoring platforms (EV1000 Clinical Platform or HemoSphere Advanced Monitoring Platform) and is paired with an extravascular blood pressure transducer (FloTrac IQ or Acumen IQ) and a radial arterial catheter. It presents an HPI score from 0 (low likelihood) to 100 (high likelihood) of a hypotensive event occurring within the next 15 minutes. Beyond the primary HPI score, the feature also includes the Dynamic Arterial Elastance (Ea_dyn) and Systolic Slope (dP/dt) parameters, along with other graphical user interface enhancements, to provide a more comprehensive hemodynamic picture. It is crucial to note that the HPI is for informational reference only, and therapeutic decisions should not be based solely on this index; a full review of the patient's hemodynamics is always recommended. Clinical performance data demonstrated that the software's ability to predict hypotension in non-surgical patients is comparable to its previously established performance in surgical patients, supporting its expanded use in a broader patient population.

AI Regulatory Concerns

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• Q1. What specific physiological variables are used by the algorithm to calculate the Hypotension Prediction Index, and what is the relative weighting or importance of each?; How does the performance of the Acumen HPI (sensitivity, specificity, positive predictive value, negative predictive value) vary across different non-surgical patient populations (e.g., ICU medical patients vs. post-operative ICU patients)?; What is the typical lead time provided by the HPI before a hypotensive event in non-surgical patients, and how does this compare to surgical patients?; Are there known patient conditions, comorbidities, or concomitant medications that might affect the accuracy or reliability of the HPI, Ea_dyn, or dP/dt parameters?; What clinical studies have evaluated the impact of using the Acumen HPI feature on patient outcomes, such as a reduction in the incidence or duration of hypotensive episodes, or changes in therapeutic interventions?