Acumen Hypotension Prediction Index (HPI) software is a first-of-its-kind technology that detects the likelihood of a patient trending towards hypotension.

Multiple studies have shown Acumen HPI software:

Achieves statistically significant reduction of hypotension when combined with a treatment protocol in noncardiac surgery vs. standard of care.1,2

Demonstrates accuracy to predict the likelihood of hypotension.4

Demonstrates superior predictive abilities for hypotension over common hemodynamic parameters such as cardiac output (CO), stroke volume (SV), and changes in mean arterial pressure (MAP).3

*
A hypotensive event is defined as MAP <65 mmHg for a duration of at least one minute.

Clinical evidence

2020 Wijnberge, et al.

Publication in JAMA: “Effect of a Machine Learning–Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial."

This clinical trial included 68 noncardiac surgery patients and studied the time-weighted average of hypotension for those randomized to the early warning system with Acumen HPI software vs those receiving standard care. The 34 patients monitored with Acumen HPI had a cumulative median time of hypotension of 8 minutes compared to 32.7 minutes in the control group.

The median time-weighted average of hypotension showed a difference of 0.38 mmHg between the interventional and control group.1

2019 Schnek, et al.

Publication in the Journal of Clinical Monitoring and Computing: "Hypotension Prediction Index based protocolized haemodynamic management reduces the incidence and duration of intraoperative hypotension in primary total hip arthroplasty: a single centre feasibility randomised blinded prospective interventional trial."

In this single center feasibility study, Acumen HPI software combined with protocolized treatment was shown to reduce the relative and absolute duration of hypotension in 99 total hip arthroplasty patients, in comparison to a historical and prospective control group.2

2019 Davies, et al.

Publication in Anesthesia and Analgesia: "Ability of an Arterial Waveform Analysis–Derived Hypotension Prediction Index to Predict Future Hypotensive Events in Surgical Patients"

In this 255 patient, 2-center retrospective analysis study, when compared with hemodynamic parameters such as SV, CO, SVV, and MAP, Acumen HPI software showed a higher predictive performance at 5 and 10 minutes before hypotension.3

2018 Hatib, et al.

Publication in Anesthesiology: "Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis".

Acumen HPI software demonstrated high accuracy in predicting hypotension.

At 10 minutes before an event, Acumen HPI software predicted hypotension with a specificity and sensitivity of 89% and 90% respectively, and with an AUC of 0.95 in this study. A database of 1,538 patient records was used for training and external validation of the software's algorithm.4

Risk of hypotension

Research findings have revealed strong associations between intraoperative hypotension (IOH) and elevated risk of both acute kidney injury (AKI) and mycardial injury after noncardiac surgery (MINS).6,9,10

Acumen HPI software is effective in detecting hemodynamic instability and substantially reducing the amount of intraoperative hypotension when used in surgical patients who require hemodynamic monitoring during noncardiac surgery.8

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IOH is
common6

88% of patients continuously monitored with an arterial line still experienced hypotension, defined as MAP <65 mmHg for 1 minute.5
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IOH has elevated risks

Prolonged exposures below MAP thresholds of 65 mmHg are associated with increased risk of mortality, myocardial injury and AKI after noncardiac surgery.6,7
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IOH can
be reduced

Acumen HPI software has demonstrated a reduction* in the duration of IOH by 57%.8
*
Single arm, multicenter, prospective-to-historical control where patients received arterial line monitoring.

Acumen intelligent decision support suite

The Acumen intelligent decision support suite offers both predictive and retrospective decision support for the management of hypotension.

Acumen IQ cuff*
(noninvasive)
Acumen IQ cuff unlocks the Acumen HPI software while delivering continuous blood pressure monitoring and advanced hemodynamic parameters noninvasively.
Learn more »
Acumen IQ cuff (noninvasive)
*
Surgical patient use only
Acumen IQ sensor**
(minimally-invasive)
Acumen IQ sensor unlocks the Acumen HPI software and automatically updates advanced parameters every 20 seconds, reflecting rapid physiological changes in patients.
Learn more »
Acumen IQ sensor (minimally-invasive)
**
Surgical and nonsurgical patient use
HemoSphere advanced monitoring platform
The only modular hemodynamic monitoring platform to offer full-range cuff, sensor, and catheter compatibility. HemoSphere monitor enables proactive, individualized patient management.
Learn more >>
Acumen HPI software
Acumen Analytics software
Acumen Analytics software enables you to retrospectively view and analyze hemodynamic parameters, including mean arterial pressure, providing you insights into the frequency, duration and prevalence of intraoperative hypotension in your practice.
Learn more >>
Acumen Analytics software

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With a long-term commitment to improving the quality of care for surgical and critical care patients through education, Edwards clinical education meets you no matter where you are in the learning process — with a continuum of resources and tools that continuously support you as you solve the clinical challenges facing you today, and in the future.

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References
  1. Wijnberge, M., Geerts, B., Hol, L., Lemmers, N., Mulder, M., Berge, P., Schenk, J., Terwindt, L., Hollman, M., Vlaar, A., Veelo, D. (2020) Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA Online, February 17, 2020.
  2. Schneck, E., Schulte, D., Habig, L., Ruhrmann, S., Edinger, F., Markmann, M., Habicher, M., Rickert, M., Koch, C., Sander, M. (2019) Hypotension Prediction Index based protocolized haemodynamic management reduces the incidence and duration of intraoperative hypotension in primary total hip arthroplasty: a single centre feasibility randomized blinded prospective interventional trial. Journal of Clinical Monitoring and Computing online, November 29, 2019.
  3. Davies SJ, Vistisen ST, Jian Z, et al. Ability of an arterial waveform analysis-derived hypotension prediction index to predict future hypotensive events in surgical patients. Anesth Analg 2019.
  4. Hatib, F., Zhongping, J., Buddi, S., Lee, C., Settels, J., Sibert, K., Rinehart, J., Cannesson, M. (2018). Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology 129, 663-74.
  5. Shah, N., Mentz, G., Kheterpal, S. The incidence of intraoperative hypotension in moderate to high risk patients undergoing non-cardiac surgery: A retrospective multicenter observational analysis. Journal of Clinical Anesthesia. 2020: 66; 1-12.
  6. Salmasi, V., Maheshwari, K., Yang, G., Mascha, E.J., Singh, A., Sessler, D.I., & Kurz, A. (2017). Relationship between intraoperative hypotension, defined by either reduction from baseline or absolute thresholds, and acute kidney injury and myocardial injury. Anesthesiology, 126(1), 47-65.
  7. Wesselink EM, et al. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018;121(4):706-721. 42 studies’ noncardiac surgery patient number ranged from 40 to 152,445, with a median of 1,523 patients (inter-quartile range 261-17,739).
  8. U.S. Food and Drug Administration. 2021. K203224 510k Summary, Acumen Hypotension Prediction Index, viewed August 24, 2021. https://www.accessdata.fda.gov/ cdrh_docs/pdf20/K203224.pdf.
  9. Sun, L.Y., Wijeysundera, D.N., Tait, G.A., & Beattie, W.S. (2015). Association of Intraoperative Hypotension with Acute Kidney Injury after Elective non-cardiac Surgery. Anesthesiology, 123(3), 515-523.
  10. Walsh, M., Devereaux, P.J., Garg, A.X., Kurz, A., Turan, A., Rodseth, R.N., Cywinski, J., Thabane, L., & Sessler, D.I. (2013). Relationship between Intraoperative Mean Arterial Pressure and Clinical Outcomes after non-cardiac Surgery. Anesthesiology, 119(3), 507-515.

Important safety information

CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician.
See Instructions For Use (IFU) / Directions For Use (DFU) for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

Important safety information

CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician.
See Instructions For Use (IFU) / Directions For Use (DFU) for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

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