New Published Clinical Study Shows Masimo PVI® Helps Clinicians Assess Fluid Responsiveness in Pediatric Patients

IRVINE, Calif., May 15, 2013 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today a new study in the British Journal of Anesthesia demonstrates that Masimo's noninvasive PVI^® can be used to help clinicians accurately assess fluid responsiveness in mechanically ventilated children under general anesthesia,¹ adding to the growing body of evidence that shows the efficacy of PVI across a wide range of patient populations.

Hemodynamic instability is a common challenge in surgical and critically ill patients. When necessary, fluid administration is critical to optimizing patient status and enabling end organ preservation,² but unnecessary fluid administration is associated with increased morbidity and mortality.³ The decision whether to administer fluid in an attempt to improve cardiac output can be challenging because traditional invasive methods can be inaccurate at predicting fluid responsiveness while newer dynamic indicators for assessing fluid responsiveness are accurate but are either invasive, operator-dependent, or costly.^4,5

In the study conducted at Seoul National University Hospital in Seoul, South Korea, researchers evaluated 33 pediatric patients undergoing neurosurgery, ranging in age from 6 months to 9 years. Investigators evaluated measurements from commonly used invasive and complex techniques including: central venous pressure (CVP), systolic pressure variation (SPV), pulse pressure variation (PPV), change in inferior vena cava diameter measurement (∆IVCD), and respiratory aortic blood flow velocity (ΔV peak), while also evaluating Masimo's noninvasive and automated PVI (Masimo Radical-7^®). All measurements were compared before volume expansion and whether their values were associated with a significant change in stroke volume index (SVI). There were 15 volume responders (≥10% increase in SVI after volume expansion) and 18 non-responders (<10% increase in SVI after volume expansion). Researchers found that only PVI >11% (with sensitivity of 73.3% and specificity of 86.7%) and ΔV peak of >11% (with sensitivity of 86.7% and specificity of 72.2%) predicted fluid responsiveness. All other measures (CVP, SPV, PPV, ∆IVCD) were not associated with an improvement in SVI and therefore were poor predictors of fluid responsiveness.

The researchers noted that while both ΔV peak and PVI are noninvasive and have been shown to be good indicators of fluid responsiveness in various clinical settings, ΔV peak is dependent on a skilled operator with costly imaging equipment, while PVI can be used by clinicians who can use a pulse oximeter.

PVI is a dynamic noninvasive measurement of changes over the respiratory cycle that provides clinicians with a continuous, easy-to-use, and cost-effective measure for assessing whether patients will benefit from fluid administration—enabling personalized and goal-directed fluid therapy.^6-10

Michael O'Reilly, M.D., Chief Medical Officer of Masimo, stated: "As previous studies have shown with adult patients, this study demonstrates that PVI monitoring can noninvasively and continuously assess fluid status in children and be more effective than common invasive technologies and is similar to newer, costlier techniques. Masimo pulse oximetry technology offers automated assessment of fluid responsiveness with PVI, providing clinicians a cost-effective alternative to help improve patient outcomes."

1 Byon H., Lim C., Lee J., Park Y., Kim H., Kim C., Kim J.; "Prediction of fluid responsiveness in mechanically ventilated children undergoing neurosurgery." Br J Anaesth. 2013 Apr;110(4):586-91.
2 Dellinger RP, Levy MM, Carlet JM, et al.  Surviving sepsis campaign: International guidelines for management of severe sepsis and septic shock: Crit Care Med. 2013 Feb;41(2):580-637.
3 Brandstrup B, Tonnesen H, Beier-Holgersen R, et al: Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: A randomized assessor-blinded multicenter trial. Ann Surg 2003; 238:641–648 36:296–327.
4 Michard F, Teboul JL: Predicting fluid responsiveness in ICU patients: A critical analysis of the evidence. Chest 2002; 121:2000–2008
5 Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: A systematic review of the literature.  Crit Care Med 2009; 37:2642–2647.
6 Loupec T., Nandoumgar H., Frasca D., Petitpas F., Laksiri L., Baudouin D., Debaene B., Dahyot-Fizelier C., Mimoz O. "Pleth Variability Index Predicts Fluid Responsiveness in Critically-Ill Patients." Crit Care Med 2011 Feb;39(2):294-9. Available online here.
7 Zimmerman M., Feibicke T., Keyl C., Prasser C., Moritz S., Graf B., and Wiesenack C. "Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically-ventilated Patients Undergoing Major Surgery."  Eur J Anaesthesiol. 2010 Jun;27(6):555-61. Available online here.
8 Feissel M., Kalakhy R., Badie J., Robles G., Faller J., Teboul JL. "Plethysmography Variability Index: A New Fluid Responsiveness Parameter." Presented at the 29th International Symposium on Intensive Care and Emergency Medicine (ISICEM) Annual Meeting, March 25, 2009, Brussels, Belgium. Available online here.
9 Cannesson M., Desebbe O., Rosamel P., Delannoy B., Robin J., Bastien O., Lehot JJ. "Pleth variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre." Br J Anaesth. 2008 Aug;101(2):200-6. Available online here.
10 Forget P, Lois F, De Kock M. "Goal-Directed Fluid Management Based on the Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid Management." Anesth Analg. 2010 Oct;111(4):910-4. Published online here.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care—helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET^®, which virtually eliminated false alarms and increased pulse oximetry's ability to help clinicians detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET^® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow ^® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures; total hemoglobin (SpHb^®), oxygen content (SpOC^™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), PVI^®, and perfusion index (PI), in addition to measure-through motion SpO₂, and pulse rate. In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow^® Acoustic Monitoring^™, the first-ever commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo SET^® and Masimo rainbow^® technologies also can be found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care … by Taking Noninvasive Monitoring to New Sites and Applications^®." Additional information about Masimo and its products may be found at www.masimo.com.

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 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 of the repeatability of clinical results obtained using Masimo PVI, risks related to our belief that PVI is an easy-to-use and cost-effective measure for assessing whether patients will benefit from fluid administration, risks related to our assumptions that PVI enables personalized and goal-directed fluid therapy, and that PVI is a preferred noninvasive indicator of fluid responsiveness in children, 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.

Media Contacts:
Mike Drummond
Masimo Corporation
(949) 297-7434
[email protected]

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