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Acumen Hypotension Prediction Index software

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References

  1. U.S. Food and Drug Administration. 2021. K203224 510k Summary, Acumen Hypotension Prediction Index.
  2. 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.
  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. 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.
  5. 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.
  6. Salmasi V, et al. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65.
  7. Mascha EJ, et al. Intraoperative Mean Arterial Pressure Variability and 30-day Mortality in Patients Having Noncardiac Surgery. Anesthesiology. 2015 Jul;123(1):79-91.
  8. Wijnberge M, et al. Association of intraoperative hypotension with postoperative morbidity and mortality: systematic review and meta-analysis. BJS Open. 2021 Jan 8;5(1):zraa018.
  9. 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.
  10. Walsh M, et al. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15.
  11. Sun LY, et al. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23.
  12. Wesselink EM, et al. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. BRJ Anaesth. 2018;121(4):706-721.

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.