SedLine Was Also Associated with Reduction in Bleeding During Surgery and Shorter Duration on Mechanical Ventilation

Masimo (NASDAQ: MASI) today announced the findings of a retrospective study published in the Journal of Cardiothoracic and Vascular Anesthesia in which Dr. André Denault and colleagues at the Montreal Heart Institute and Centre Hospitalier de l’Université de Montréal investigated the impact of anesthesia during cardiac surgery guided by Masimo SedLine Brain Function Monitoring, in particular by SedLine’s processed electroencephalography (pEEG) feature, the Patient State Index (PSi). This study is the first to primarily explore the impact of pEEG-guided anesthesia on vasoactive and inotropic drugs—drugs that affect the diameter of blood vessels and that modify the force of the heart’s contractions, respectively—in the ICU. The researchers found that pEEG-guided anesthesia was associated with a reduction in the use of such drugs, as well as less use of anesthetic agents and opioids in the OR, lower central venous pressure (CVP), less fluid administration, less intraoperative bleeding, and shorter duration on mechanical ventilation.¹

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Masimo Root® with SedLine® Brain Function Monitoring (Photo: Business Wire)

Noting that pEEG-guided anesthesia may improve hemodynamic stability and that high postoperative doses of vasoactive and inotropic drugs have been associated with mortality and renal dysfunction, the researchers sought to determine whether use of pEEG-guided anesthesia might improve outcomes by reducing use of such agents during cardiac surgery and at arrival in the ICU. Their primary goal was to determine whether pEEG-guided anesthesia would be associated with reduced hemodynamic instability during cardiopulmonary bypass (CPB) separation, measured by stratifying the operation into three categories: “easy” (use of only one vasoactive or one inotropic agent), “difficult” (use of at least two different classes of agents), or “complex” (requiring a return to CPB or use of mechanical circulatory support). Their secondary goal was to determine if pEEG-guided anesthesia would lead to the hypothesized reduction in vasoactive and inotropic drug administration in the ICU, measured by vasoactive and inotropic score (VIS).

The researchers compiled a retrospective cohort of 300 adult patients who underwent cardiac surgery using CPB between 2013 and 2020 at the Montreal Heart Institute. The patients were divided into two groups, depending on whether anesthesia was guided by pEEG, which became a standard of care in 2017. Patients in the pEEG group (n=150) had their brain function monitored, from the moment they entered the OR to arrival in the ICU, using Masimo SedLine.

In the pEEG group, patients received fewer vasoactive and inotropic drugs in the first hour after ICU admission, resulting in lower VIS scores (pEEG: 5 [0-10], control: 8 [2-15], p=0.003). Being in the pEEG group reduced the odds of being in a higher VIS category by 57% (OR=0.43; 95% confidence interval: 0.26-0.73; p=0.002). In addition, in the pEEG group, several additional outcomes were lower: duration of mechanical ventilation (pEEG: 3 hours [2-4 hours], control: 4 hours [3-7 hours], p<0.001), intraoperative fluid balance (pEEG: 758 mL [351-1329 mL], control: 500 mL [300-700 mL], p=0.002), and the amount of bleeding (pEEG: 400 mL [282-500 mL], control: 500 mL [300-700 mL], p=0.002).

A lower proportion of patients experienced unsuccessful (difficult or complex) CPB separation in the pEEG group than the control group (60% vs. 72%, p=0.028). However, after adjusting for other parameters using multiple logistic regression, use of pEEG-guided anesthesia was not independently associated with successful CPB separation; instead, as the researchers note, unsuccessful separation was associated with several independent known predictors of hemodynamic complications.

The researchers concluded, “pEEG-guided anesthesia is associated with a reduction in the use of inotropic or vasoactive drugs at arrival in the ICU. In addition, its implementation was associated with lower requirements of anesthetic agents and opioids in the OR, lower CVP, fluid requirements, intraoperative bleeding, and shorter duration of mechanical ventilation. However, its use did not facilitate weaning from CPB compared to a group where pEEG was unavailable. Future research is needed to confirm these results in prospective randomized clinical trials.”

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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. Our mission is to 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.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns,⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^5-8 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2021-22 U.S. News and World Report Best Hospitals Honor Roll.¹⁰ Masimo continues to refine SET^® and in 2018, announced that SpO₂ accuracy on RD SET^® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO₂ values they rely on accurately reflect a patient’s physiological status. 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^® and Radius PPG™, 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 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^®. In 2022, Masimo acquired Sound United, a leading developer of premium consumer sound and home integration technologies. 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 and RPVi 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. Jarry S, Halley I, Calderone A, Momei M, Deschamps A, Richebé P, Beaubien-Souligny W, Denault A, Couture E. Impact of Processed Electroencephalography in Cardiac Surgery: A Retrospective Analysis. J Cardio Vasc Anesth. March 2022. DOI: 10.1053/j.jvca.2022.03.030
2. 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.
3. 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.
4. 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.
5. 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.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7. 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.
8. 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.
9. Estimate: Masimo data on file.
10. 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 SedLine^®. 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 technologies, including SedLine, contribute to positive clinical outcomes and patient safety; risks that the researchers’ conclusions and findings may be inaccurate; 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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