Noninvasive, Continuous PVi Performed Well; Pressure-based Invasive Techniques Performed Poorly

Masimo (NASDAQ: MASI) today announced the findings of a prospective study published in Pediatrics International in which Dr. Ya-Fei Liu and colleagues at Peking University First Hospital in Beijing evaluated the ability of noninvasive, continuous Masimo PVi^®, alongside other dynamic parameters, to predict fluid responsiveness in children 1-3 years old who were undergoing major neurosurgery. The researchers concluded, “Volume-based PVi and ∆Vpeak [respiratory variation in aortic blood flow peak velocity] showed acceptable reliabilities for fluid responsiveness prediction in young children undergoing major neurosurgery, while pressure-based SVV [stroke volume variation] using FloTrac/Vigileo, Ea_dyn [dynamic arterial elastance], and PPV [pulse pressure variation] [did] not.”¹

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Masimo Root® with PVi® (Photo: Business Wire)

Noting that dynamic variables have been shown to predict fluid responsiveness more accurately than static variables, and the critical importance of optimizing fluid administration in pediatric surgical patients, the researchers sought to evaluate and compare the performance of a variety of dynamic variables in such a scenario. The parameters evaluated were noninvasive, continuous PVi (pleth variability index, obtained from the photoplethysmographic waveform measured by fingertip pulse oximetry sensors and, in this study, the Masimo Radical-7^® Pulse CO-Oximeter^®), ∆Vpeak (obtained intermittently by Doppler echocardiography), SVV (measured by the Edwards Lifesciences FloTrac/Vigileo system), PPV (obtained from the peripheral arterial pressure waveform), and Ea_dyn (an index of arterial load).

The researchers enrolled 60 patients, aged 1-3, who were undergoing major neurosurgery with mechanical ventilation set at a fixed tidal volume of 8 ml/kg. Following induction of anesthesia, during a hemodynamically stable period, the patients were administered 10 ml/kg of Ringer’s lactate solution, over 10 minutes; all variables were measured before and within five minutes of fluid loading. Patients with an increase in cardiac index (CI) of 10% or more were identified as a fluid responder. (CI was defined as stroke volume index multiplied by heart rate.)

The researchers identified 26 of the 60 patients as fluid responders. They found that baseline PVi showed “fair diagnostic accuracy” for CI-fluid responsiveness, with an area under the receiver operating characteristic curve (AUROC) of 0.775, p < 0.001. A baseline PVi cutoff value of 15% predicted CI-fluid responsiveness with 77% sensitivity and 68% specificity. Baseline ∆Vpeak was an “excellent predictor” of a CI increase, with AUROC of 0.982, p < 0.001, and a cutoff value of 9.6%. However, ∆Vpeak, which is dependent on the timing of echocardiograms, can only be obtained intermittently; the authors also note, as a practical drawback, that the limited availability of echocardiographic professionals “decreases its wide use in routine clinical settings.” The researchers found the other methods were either “poor” or “were not” predictors.

The researchers concluded, “Volume-based PVI and ∆Vpeak showed acceptable reliabilities to predict fluid responsiveness, defined by a CI increase, after anesthesia induction in mechanically ventilated young children undergoing major neurosurgery. However, pressure-based FloTrac/Vigileo-derived SVV, Ea_dyn, PI, PPV, and SVIc were not or [were] poorly reliable predictors. PVi’s noninvasiveness, continuity and acceptable predictability for fluid responsiveness could make it a potential aid in evaluating hemodynamic status, facilitating fluid administration, and developing optimal fluid management protocols in young children undergoing neurosurgery.”

Joe Kiani, Founder and CEO of Masimo, said, “From its inception, Masimo has focused on developing technologies that improve outcomes for the very youngest and most fragile of patients. This latest study on PVi – the second we are reporting on just this week! – adds to the body of evidence that PVi can help clinicians predict fluid responsiveness.”²

In the U.S., PVi is FDA 510(k) cleared as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. 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.

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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.³ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁴ improve CCHD screening in newborns,⁵ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^6-9 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁰ 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.¹¹ 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. Liu YF, Song LL, Ma W, Wang DX. Dynamic variables to predict fluid responsiveness in young children. Pediatrics International. 18 Jan 2023. DOI: 10.1111/ped.15477.
2. Published clinical studies on PVi can be found on our website at http://www.masimo.com.
3. 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.
4. 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.
5. 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.
6. 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.
7. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
8. 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.
9. 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.
10. Estimate: Masimo data on file.
11. 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^® and Radical-7^®. 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 and Radical-7, 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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