Study Comparing Two Noninvasive Indicators of Fluid Responsiveness on Mechanically Ventilated Patients Finds Masimo PVi® Effective and Advantageous

Masimo (NASDAQ: MASI) announced today the findings of a study published in the Ain-Shams Journal of Anesthesiology in which Dr. Diaaeldin Aboelnile and colleagues at Ain-Shams University in Cairo, Egypt compared two noninvasive methods of assessing fluid responsiveness in mechanically ventilated patients, dIVC and Masimo PVi^®. They found both methods to be “effective,” but determined that PVi was advantageous because of being “continuous, operator-independent, and more reliable than dIVC.”¹ PVi, pleth variability index, is a measure of the dynamic changes in perfusion index that occur during the respiratory cycle.

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Noting the importance of predicting responsiveness prior to fluid administration and the drawbacks of invasive and static methods of assessing responsiveness, the researchers sought to assess the effectiveness and reliability of PVi—which is noninvasive, dynamic, continuous, and can be measured using a pulse oximetery sensor—by comparing it to another noninvasive, but non-continuous, static method, ultrasound calculation of inferior vena cava distensibility index (dIVC). dIVC represents the percentage of variation in the inferior vena cava diameter during inspiration versus expiration. To that end, they monitored 88 adult, sedated, mechanically ventilated, intubated surgical patients using both PVi and dIVC. The patients were classified as fluid responders (48) or non-responders (40) by using the passive leg raising (PLR) test; patients whose cardiac index (CI) increased by 15% or more were considered responders. PVi was monitored using a fingertip sensor and a Masimo Radical-7^® Pulse CO-Oximeter^®; dIVC was measured using a Mindray M5 ultrasound probe. To assess their performance against an invasive method, the researchers also measured central venous pressure (CVP).

The researchers calculated the following results for the three parameters:

Parameter	CVP	PVi	dIVC
Threshold value	≥ 5 mmHg	> 14%	> 19.42%
Sensitivity	70.83%	93.75%	79.17%
Specificity	47.5%	87.5%	80%
Area under the curve (95% confidence interval)	0.612 (0.502-0.714)	0.955 (0.889-0.988)	0.886 (0.801-0.944)
P-value	0.0648 (“not significant”)	< 0.0001 (“highly significant”)	< 0.0001 (“highly significant”)

Based on these findings, the researchers concluded, “The results of our study showed that assessment of PVi and dIVC noninvasively were good predictors for fluid management and responsiveness prediction using PLR technique in surgical ICU mechanically ventilated patients.” They continued, “PVi and dIVC can be used in the assessment of fluid responsiveness of intubated ventilated sedated patients with sinus rhythm in the ICU, and both methods are noninvasive and can be performed at the bedside, but PVi has the advantage of being continuous, operator-independent, and more reliable than dIVC.”

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The accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure, and device-related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient’s condition and should not be based solely on PVi.

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 according to the 2020-21 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^®, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and Masimo SafetyNet™. 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. Aboelnile D, Elseidy M, Kenawey Y, Elsherif I. Prediction of fluid responsiveness in mechanically ventilated patients in surgical intensive care unit by pleth variability index and inferior vena cava diameter. Ain-Shams J Anesth. 2020. 12:48. https://doi.org/10.1186/s42077-020-00097-4.
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 PVi^®. 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 PVi, 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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Contact information

Masimo
Evan Lamb
949-396-3376
elamb@masimo.com