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The Role of Continuous Hemoglobin Monitoring to Optimize Transfusion Decision

The Role of Continuous Hemoglobin Monitoring to Optimize Transfusion Decision. Joseph Rinehart, MD Department of Anesthesiology & Perioperative Care University of California, Irvine. Disclosures. No personal disclosures

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The Role of Continuous Hemoglobin Monitoring to Optimize Transfusion Decision

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  1. The Role of Continuous Hemoglobin Monitoring to Optimize Transfusion Decision Joseph Rinehart, MD Department of Anesthesiology & Perioperative Care University of California, Irvine

  2. Disclosures • No personal disclosures • Research within department at UCI has been funded by Masimo for internal use

  3. Overview • The current state of non-invasive hemoglobin monitoring • Accuracy & precision, UCI meta-analysis • Alternative evaluation strategies • The current role of these technologies

  4. “It is important to consider that a new technique for the bedside measurement of hemoglobin should demonstrate that it is either superior to that one we use daily (e.g., HemoCue®, Cypress, California) or at least equivalent if another advantage can be demonstrated, such as a continuous measurement.” Riou, B., Continuous measurement of hemoglobin: methodological approach and lessons for the future. Anesthesiology, 2013. 118(3): p. 497-9.

  5. “In the near future, we need to answer the following questions: • Do we need continuous hemoglobin monitoring? The answer is probably yes, but for which patients? • What price are we ready to pay to obtain trend information (decreased accuracy, increased cost)?” Riou, B., Continuous measurement of hemoglobin: methodological approach and lessons for the future. Anesthesiology, 2013. 118(3): p. 497-9.

  6. Future studies should focus on: Riou, B., Continuous measurement of hemoglobin: methodological approach and lessons for the future. Anesthesiology, 2013. 118(3): p. 497-9.

  7. Commercially Available Continuous Non-invasive Devices • Radical-7 (Masimo) • NBM-200 (OrSense)

  8. What is the accuracy of the current generation of devices? • Many small case series comparing new devices to lab measurement showing a wide range of results • Variable biases & SD’s, variable populations, variable methodologies

  9. UCI Meta-Analysis

  10. Meta-Analysis • Random effects model to summarize overall bias & SD • Forest plots and funnel plots to visualize individual results and assess for publication bias, respectively

  11. Forest Plot of Results

  12. Bottom Line Bias across studies & devices: 0.08 ± 1.35 g/dl Subgroup analyses not significantly different (devices, populations) How does this compare?

  13. The HemoCueportable hemoglobinometer (HemoCue; HemoCue AB, Sweden) when tested against lab standards has been shown to have bias and precision of around of -0.1 ± 1.21-6 1. Shah, N., E.A. Osea, and G.J. Martinez, Accuracy of noninvasive hemoglobin and invasive point-of-care hemoglobin testing compared with a laboratory analyzer.Int J Lab Hematol, 2013. 2. Kim, M.J., et al., Comparison of the accuracy of noninvasive hemoglobin sensor (NBM-200) and portable hemoglobinometer (HemoCue) with an automated hematology analyzer (LH500) in blood donor screening. Ann Lab Med, 2013. 33(4): p. 261-7. 3. Adam, I., et al., Comparison of HemoCue(R) hemoglobin-meter and automated hematology analyzer in measurement of hemoglobin levels in pregnant women at Khartoum hospital, Sudan.DiagnPathol, 2012. 7: p. 30. 4. Naftalovich, R. and D. Naftalovich, Error in noninvasive spectrophotometric measurement of blood hemoglobin concentration under conditions of blood loss. Med Hypotheses, 2011. 77(4): p. 665-7. 5. Mimoz, O., et al., Reliability of the HemoCue(R) hemoglobinometer in critically ill patients: a prospective observational study. Minerva Anestesiol, 2011. 77(10): p. 979-85. 6. Skelton, V.A., et al., Evaluation of point-of-care haemoglobin measuring devices: a comparison of Radical-7 pulse co-oximetry, HemoCue((R)) and laboratory haemoglobin measurements in obstetric patients*.Anaesthesia, 2013. 68(1): p. 40-5.

  14. Why so much variability?

  15. Why so much variability? Measurement methodology: HiCN vs. Coulter/CO-Ox/Spectrophotometric “None of the available devices is perfect and all have inherent variation…”

  16. Why so much variability?

  17. Why the intense scrutiny of non-invasive measures? • They are relatively new • The availability of bedside invasive tests provides an instantaneous comparison to the non-invasive measure

  18. Alternative Evaluation Methodologies

  19. Clarke Error Grid Clarke, W.L., et al., Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care, 1987. 10(5): p. 622-8.

  20. What is the current role of continuous, non-invasive hemoglobin monitoring?

  21. Continuity “Masimohas always described continuous SpHb as a supplemental monitoring tool that derives its primary value from continuous monitoring, not as a complete replacement for invasive blood draws.” Michael O’Reilly MD MS, “Understanding Noninvasive and Continuous Hemoglobin Monitoring” Critical Care Medicine; Issue: Volume 41(5), May 2013

  22. Clinical Study on SpHb • 327 Patients in a randomized prospective trial, SpHb vs. standard care • Similar characteristics and invasive blood hgb tests in both groups • SpHb group received fewer blood transfusions (4.5% vs. 1%) Impact of Continuous and Noninvasive Hemoglobin Monitoring on Intraoperative Blood Transfusions Jesse M. Ehrenfeld, MD, MPH, Justin P. Henneman, MS

  23. SpHb Monitoring Impact on Frequency of >3 RBC Unit Transfusions in Neurosurgery * Prospective cohort study in 106 neurosurgery surgery pts, 61 Standard Care & 45 SpHb *p<0.01 vs. Standard Care Group Awada W et al. STA. 2013 (abstract).

  24. SpHb Monitoring Impact on Average RBC Units Transfused per Patient in Neurosurgery ** Prospective cohort study in 106 neurosurgery surgery pts, 61 Standard Care & 45 SpHb **p<0.001 vs. Standard Care Group Awada W et al. STA. 2013 (abstract).

  25. Do we need continuous hemoglobin monitoring? The answer is probably yes, but for which patients? Open question, but may be as simple as “patients at moderate to high risk of blood loss” What price are we ready to pay to obtain trend information (decreased accuracy, increased cost)?” Accuracy is nearly equivalent to current bedside tools. Further study needed to evaluate cost data.

  26. Summary • Current non-invasive monitors are not meant to replace invasive lab measurements • Clinical evaluation needs to be expanded beyond accuracy/precision • Limited data suggests reduction in PRBC transfusions

  27. Thank You

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