Acumen Hypotension Prediction Index (HPI) Feature Software
Edwards Lifesciences LLCThe Acumen Hypotension Prediction Index (HPI) Feature Software is a clinical decision support tool that uses arterial blood pressure waveform data and patient demographics to predict the likelihood that a patient will experience hypotension within 15 minutes. It provides clinicians real-time, adjunctive physiological insights to help anticipate and manage hypotensive events in operating room patients with advanced hemodynamic monitoring.
Intended Use
The device analyzes cardiovascular vital signs using software algorithms to provide clinicians with information on the likelihood of a patient experiencing hypotension (mean arterial pressure < 65 mmHg for at least one minute), adjunctive to other vital sign parameters in operating room patients with advanced hemodynamic monitoring.
Technology
The device is software running on the EV1000 Platform combined with a FloTrac IQ sensor connected to a radial arterial catheter. It uses features extracted from arterial waveform data compared to a baseline determined in the first 10 minutes and applies a data-driven model developed from a retrospective database of annotated hypotensive and non-hypotensive events to generate the Hypotension Prediction Index (HPI) from 0 to 100, indicating probability of hypotension within 15 minutes. It also includes related parameters Eadyn and dP/dt for afterload and contractility assessment and features alerts and graphical interfaces to assist clinicians.
Performance
The device performance was validated using two databases from OR and ICU patients with annotated hypotensive events, achieving sensitivities ranging from 65.8% to 83.7%, specificities above 99%, and AUCs of 0.88-0.95. Nonclinical bench testing included electromagnetic compatibility and software testing including algorithm unit tests, regression and translation testing. Animal studies in swine hemorrhagic and vasodilation models support device output reliability. Usability testing with clinicians demonstrated clear understanding of the adjunctive nature of HPI and appropriate responses to alerts.
Device Timeline
- 1
Submission
9/26/2016
1 year, 5 months - 2
FDA Approval
3/16/2018
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