Study Investigates Performance of Masimo PVi® As Part of Goal-Directed Fluid Therapy During Laparoscopic Bariatric Surgery

Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Firat University in Turkey evaluated the performance of Masimo PVi^®, a noninvasive and continuous measurement of the dynamic changes in perfusion index (Pi) that occur during respiratory cycles, as the basis of a goal-directed fluid therapy (GDFT) protocol during laparoscopic bariatric surgery on mechanically-ventilated patients.¹

In the study, Dr. Demirel and colleagues sought to evaluate whether using GDFT guided by PVi on morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass (RYGB) surgery might result in less intravenous fluid use without compromising outcomes. They enrolled 60 patients and divided them randomly into control and GDFT groups. The control group’s fluid levels were managed by standard fluid therapy, using mean arterial pressure (MAP) and central venous pressure (CVP) measured via a central venous access catheter as indicators of fluid responsiveness. The GDFT group’s fluid status was monitored using a GDFT protocol based on PVi as a noninvasive, dynamic indicator of fluid responsiveness.

Both groups were initially administered 500 mL bolus colloid fluid at the beginning of surgery, followed by a continuous infusion of crystalloid fluid (4-8 mL/kg/h in the control group, or 2 mL/kg/h in the GDFT group per the protocol). In the control group, if CVP was less than 6 mmHg or MAP less than 65 mmHg, a 250 mL additional bolus of colloid fluid was administered. In the GDFT group, if PVi was greater than 14% for five minutes, the 250 mL colloid bolus was administered.

The researchers found that there was a significantly higher mean volume of crystalloid fluid administered in the control group (1499 mL ± 516.87 mL) compared to the GDFT group (1126 mL ± 234.98 mL) (p = 0.001). There were no significant differences in blood lactate levels (p > 0.05) or creatinine levels before and after surgery (p > 0.05) between the two groups.

The researchers concluded that, “Utilization of GDFT protocols based on PVi may prevent excessive intraoperative infusion of fluids in laparoscopic bariatric surgery. This method when intending to prevent intraoperative excessive fluid loading in RYGB surgery appears to have no effect on either renal functions or lactate levels. While this study shows the adequacy of PVi for fluid therapy in mechanically ventilated patients undergoing bariatric surgery, further research is warranted to assess adequacy of optimization of PVi.”

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Reference

1. Demirel I, Bolat E, Altun AY, Özdemir M, and Beştaş A. Efficacy of Goal-Directed Fluid Therapy via Pleth Variability Index During Laparoscopic Roux-en-Y Gastric Bypass Surgery in Morbidly Obese Patients. Obes Surg. 31 July 2017. DOI: 10.1007/s11695-017-2840-1.

About Masimo

Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,¹ improve CCHD screening in newborns,² and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.^3,4,5 Masimo SET^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,⁶ and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.⁷ 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^®), and more recently, Oxygen Reserve Index^™ (ORi™), in addition to SpO₂, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root^®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO₂ ^® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. 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.
2. 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;338.
3. 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.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. 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.
6. Estimate: Masimo data on file.
7. 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; 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