NEUCHATEL, SWITZERLAND-- Masimo (NASDAQ: MASI) today announced that updated guidelines published by the European Society of Anaesthesiology and Intensive Care (ESAIC) highlight the value of noninvasive, continuous hemoglobin (Hb) monitoring in helping clinicians manage perioperative bleeding. Referencing studies using technologies such as Masimo SpHb®, the guidelines note that “the use of noninvasive Hb-monitoring methods may be a practical approach to monitor[ing] the Hb concentration continuously and without accumulating additional blood losses.”[1]

Noting that in this area of care it is “essential to remain informed by the latest evidence,” the ESAIC, which has pledged to revisit its perioperative blood management guidelines at least every five years, has just published its updated findings, the result of a systematic review of research published from 2015 to 2021. Noting that managing bleeding during surgery is complex and “involves multiple assessment tools and strategies to ensure optimal patient care,” the guidelines cover numerous modalities, disciplines, scenarios, and patient populations - including how noninvasive, continuous hemoglobin monitoring offers a valuable way to improve blood management.

In the updated guidelines, the ESAIC notes a major drawback to measuring hemoglobin during surgery using blood gas analyzers and invasive blood sampling: “single measurements taken at different time points may not depict accurate values.” In addition, they note, excess blood sampling can lead to iatrogenic blood loss and hospital-acquired anemia. While noninvasive hemoglobin monitoring is not intended to replace invasive blood sampling, it may offer a “practical approach to monitor[ing] the Hb concentration continuously and without accumulating additional blood losses.” The guidelines also note its value “for trend analysis and to monitor changes in addition to laboratory-measured Hb concentrations during the intervals between invasive blood sampling and Hb measurements.” The guidelines continue, “Having access to continuous measurements of Hb concentrations offers timely detection of changes in Hb concentrations and adjustment, if necessary, in the clinical setting.”

In their summary of the guidance derived from their systematic literature review, the guidelines also note that when severe bleeding and volume shifts are expected or occurring, “continuous noninvasive haemoglobin monitoring may be considered for trend analyses and for reducing blood sampling for invasive laboratory measurement of haemoglobin concentration, especially in children.”

Launched in 2008, Masimo SpHb is part of the rainbow® Pulse CO-Oximetry platform, available on a variety of Masimo Pulse CO-Oximeters® and on devices from numerous third-party manufacturers, including Draeger, GE, Philips, and ZOLL. Utilizing multiple wavelengths of light, SpHb provides real-time, continuous visibility to changes in the hemoglobin trend between invasive blood samples. As part of patient blood management programs, SpHb has been found to improve outcomes in both high- and low-blood loss surgeries, such as reducing the percentage of patients receiving allogeneic transfusions,[2,3] reducing the units of red blood cells transfused per patient,[4-6] reducing the time to transfusion,[7] reducing costs,[8] and even reducing mortality 30 and 90 days after surgery by 33% and 29%, respectively (when combined with a goal-directed fluid therapy algorithm using Masimo PVi®).[9] The evidence of SpHb’s impact on outcomes spans the globe, now representing 7 countries on 4 different continents.[2-10] Today, Masimo SpHb technology supports clinicians and patient care in more than 75 countries.

Professor Kai Zacharowski, past President of ESAIC and senior author of the guidelines, commented, “Noninvasive hemoglobin measurements now represent standard of care in many clinical scenarios. With their inclusion in the latest perioperative bleeding guidelines, we hope that more anesthesiologists around the world incorporate this technology into their daily practice to help improve overall patient blood management.”

Professor Edoardo De Robertis, current President of ESAIC and co-author of the guidelines, noted, “The ESAIC holds the most prominent position in the community of anaesthesiologists and intensivists in Europe and elsewhere. We are pleased to share the updated guidelines with the goal of improving patient outcomes by focusing on the quality of care and patient safety strategies. Noninvasive hemoglobin monitoring has an important role throughout the perioperative period and in acute care, as it can provide trend data for more informed decision making. We look forward to seeing it adopted more widely for better patient care.”

Dr. William C. Wilson, Chief Medical Officer, Masimo, added, “With laboratory measurements, and even with bedside point-of-care hemoglobin testing, results are intermittent, sampling errors can occur, and performing these tests can be distracting during complex cases and while caring for critically ill patients. SpHb monitoring provides real-time visibility to hemoglobin levels throughout the continuum of care and has the advantages of trend analysis as well as reductions in workload and delay, enabling clinicians to adjust blood management and observe results simultaneously.”

Joe Kiani, Founder and CEO of Masimo, said, “Since its introduction 15 years ago, we’ve been heartened to see more and more clinicians around the world adopt SpHb as their standard of care, more and more clinical studies demonstrate its utility, and more and more esteemed organizations like ESAIC recognize the benefits of noninvasive hemoglobin monitoring. The result of years of development and continued refinement, powered by our expertise in advanced signal processing techniques, SpHb plays a critical role in our mission to improve patient outcomes, reduce the cost of care, and ultimately, improve life.”

SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.