Study Demonstrates Reduction in Mortality Using Masimo Noninvasive, Continuous Hemoglobin (SpHb®) and Pleth Variability Index (PVi®) Monitoring

NEUCHATEL, Switzerland--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today that in a study published in the Journal of Clinical Monitoring and Computing, researchers investigated the effects of implementing a hospital-wide fluid and blood administration protocol using two Masimo measurements: noninvasive, continuous hemoglobin (SpHb^®) and pleth variability index (PVi^®).¹ To evaluate the impact of the implementation, they collected data on transfusions and mortality 30 and 90 days after surgery and compared the findings between two 11-month periods in 2013 and 2014.

In the study, Dr. Jérôme Cros, Prof. Nathalie Nathan, and colleagues at Hôpital Dupuytren, part of the Centre Hospitalier Universitaire of Limoges, France (CHU Limoges), sought to determine if the use of a goal-directed therapy (GDT) algorithm based on monitoring with SpHb and PVi could decrease blood requirements and reduce mortality in common clinical practice. The researchers divided 18,716 patients into 3 groups: G1 (9285 patients who underwent surgery in 2013, before implementation of the goal-directed therapy algorithm), G2 (5856 patients who underwent surgery in 2014 without use of the algorithm), and G3 (3575 patients who underwent surgery in 2014 with use of the algorithm).

For the 2014 patients, Masimo Radical-7^® Pulse CO-Oximeters^® equipped with SpHb and PVi were installed in all operating rooms, recovery rooms, and intensive care units. The entire anesthesiology team, including nurses, was trained on use of the monitors and the algorithm, and was free to decide whether or not to use goal-directed therapy for each case. Transfusion and mortality data were recorded for all patients.

Mortality Results

Using multivariate analysis and including age, ASA class, surgical severity and emergency as co-variables, the risk of death for G3 patients was 33% lower at 30 days and 29% lower at 90 days, compared to G1 patients. By contrast, there was no difference in the risk of death between G2 and G1 patients.

The authors also reported on mortality rate the year after the study ended (2015), when the hospital no longer had access to SpHb and PVi. Comparing 2015 patients to patients in the study, they found that mortality at 30 and 90 days increased again to levels similar to those found in 2013 (before implementation), respectively 2.18% and 3.09%.

The authors noted, “Because patients who did not receive GDT based on the PVi had similar mortality rates in 2014 and 2013, a Hawthorne effect-inducing care improvement does not explain the present results. The post-study increase in mortality, at the time when monitors were no longer available, suggests that education of the team to improve fluid management does not explain the present results.”

Transfusion Results

After adjusting for surgical severity, age, and ASA class, patients in G3 had reduced odds of being transfused within 48 hours (odds ratio of 0.79, 95% CI of 0.68 – 0.93, p = 0.004). By contrast, there was no difference in the odds of being transfused between patients in G2 and G1.

The authors noted, “This study shows that using an algorithm based on continuous Hb measurement and fluid responsiveness with PVi in common clinical practice is associated with different transfusion practices and a lower adjusted-mortality at 1 and 3 months. When considering confounding factors such as ASA class, severity of surgery and emergency, the monitor-based algorithm lowers transfusion probability by approximately 30% during surgery and at 48 h. In non-cardiac surgeries, patients were transfused sooner and more often but with less blood units in the GDT group. In non-cardiac surgery, continuous Hb monitoring alerted anesthesiologist on the anemia risk they might under-evaluated without monitoring. This was the opposite, in cardiac surgery where practitioners behave differently. When using continuous SpHb monitoring, perioperative transfusion was reduced because anesthesiologists probably less feared under-transfusion. The net observed effect was an 11% and 6.5% reduction in blood units transfused in the operating room and at 48 h.”

The researchers concluded, “Monitoring SpHb and PVi integrated in a vascular filling algorithm is associated with earlier transfusion and reduced 30 and 90-day mortality on a whole hospital scale.” They continued, “In conclusion, this integrated comparativei effectiveness study shows that using an algorithm of fluid and blood transfusions based on continuous Hb measurement and PVi is associated with reduced mortality.”

Joe Kiani, Founder and CEO of Masimo, commented, “We thank Professor Nathan and her team for this outstanding study. All of the outcome studies to date with continuous SpHb have shown its benefits in transfusion management^2-5 and numerous studies with PVi have demonstrated its role in fluid management,^6-7 but this is the first time a study has shown how using goal-directed therapy with SpHb and PVi can have such a big impact on mortality. As is central to our mission, we encourage researchers to continue to study the impact of SpHb and PVi to see if indeed these fantastic results can be repeated in other institutions, for example those with different mortality rates, and if so, help expand their use to improve patient outcomes around the world.”

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. 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.⁸ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁹ improve CCHD screening in newborns,¹⁰ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^11-13 Masimo SET^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,¹⁴ and is the primary pulse oximetry at 9 of the top 10 hospitals listed in the 2018-19 U.S. News and World Report Best Hospitals Honor Roll.¹⁵ 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 Iris^® platform, and include Iris Gateway™, Patient SafetyNet, Replica™, Halo ION™, UniView™, and Doctella™. 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. Cros J, Dalmay F, Yonnet S, Charpeniter M, Tran-Van-Ho J, Renaudeau F, Drouet A, Guilbaut P, Marin B, and Nathan N. 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.
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. 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.
4. 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.
5. 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.
6. Forget P et al. Goal-Directed Fluid Management Based on the Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid Management. Anesth Analg. 2010; 111(4):910-4.
7. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs After Colorectal Surgery. J Am Coll Surg. 2015. Doi: 10.1016/j.jamcollsurg.2014.12.042.
8. 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.
9. 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.
10. 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.
11. Taenzer AH 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.
12. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
13. McGrath SP 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.
14. Estimate: Masimo data on file.
15. 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^®. 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, 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; 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.