European Society of Anaesthesiology and Intensive Care (ESAIC) Recommends Noninvasive, Continuous Hemoglobin Monitoring

Technologies Like Masimo SpHb^® Offer a “Practical Approach” to Perioperative Blood Management and “Timely Detection of Changes”

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

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Masimo Root® with SpHb® (Graphic: Business Wire)

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.

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About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,¹² improve CCHD screening in newborns,¹³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^14-17 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius Tº^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Kietaibl S et al. Management of severe peri-operative bleeding: Guidelines from the European Society of Anaesthesiology and Intensive Care. Eur J Anaesthesiol 2023; 40:226-304.
2. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
3. Nakamori E et al. Geriatr Orthop Surg Rehabil. 2021 Nov 19;12:21514593211060575.
4. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
5. Merolle L, Marraccini C, Di Bartolomeo E, Montella M, Pertinhez T, Baricchi R, Bonini A. Postoperative patient blood management: transfusion appropriateness in cancer patients. Blood Transfus 2020; 18: 359-65 DOI 10.2450/2020.0048-20.
6. Saracoglu A, Abdullayez R, Sakar M, Sacak B, Incekoy F, Aykac Z. Continuous hemoglobin measurement during frontal advancement operations can improve patient outcomes. J Clin Mon Comp. 7 Mar 2022. https://doi.org/10.1007/s10877-022-00813-5.
7. Kamal AM et al. The Value of Continuous Noninvasive Hemoglobin Monitoring in Intraoperative Blood Transfusion Practice During Abdominal Cancer Surgery. Open J Anesth. 2016;13-19.
8. Ribed-Sánchez B et al. Economic Analysis of the Reduction of Blood Transfusions during Surgical Procedures While Continuous Hemoglobin Monitoring is Used. Sensors. 2018, 18, 1367; doi:10.3390/s18051367.
9. Cros J et al. Continuous hemoglobin and plethysmography variability index monitoring can modify blood transfusion practice and is associated with lower mortality. J Clin Monit Comp. 3 Aug 2019. https://doi.org/10.1007/s10877-019-00367-z.
10. Akdag S, Zengin SU, Cakmak G, Umuroglu T, Aykac ZZ, Saracoglu A. Targeted Bleeding Management Guided by Non-Invasive Haemoglobin Measurement in Surgical Patients. J Coll Physicians Surg Pak 2022; 32(10):1242-1248.
11. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
12. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
13. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
14. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
15. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
16. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
17. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
18. Estimate: Masimo data on file.
19. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb^® and rainbow^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb and rainbow^®, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

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