SOURCE: Masimo

Masimo

September 19, 2014 08:03 ET

Masimo PVI® Helped Assess Fluid Responsiveness in Clinical Study of Adult, Noncardiac Patients

NEUCHATEL, SWITZERLAND--(Marketwired - Sep 19, 2014) - Masimo (NASDAQ: MASI) announced today a recent study published in the Journal of Cardiothoracic and Vascular Anesthesia in which Masimo's noninvasive PVI® parameter helped clinicians assess fluid responsiveness in mechanically ventilated adult noncardiac surgery patients under general anesthesia.1

Clinicians commonly use fluid administration to improve hemodynamics in the perioperative period. Assessment of fluid responsiveness -- the ability of the circulation system to increase cardiac output in response to volume expansion -- is essential to guide fluid therapy and optimize preload.2 Too little fluid administration can result in low perfusion in peripheral tissue, but too much fluid administration can result in patients failing to respond to any amount of volume expansion,3,4 as well as fluid overload postoperatively.5,6 PVI, available with any Masimo SET® or rainbow® sensor, provides clinicians with a continuous, non-invasive measure for assessing fluid responsiveness. 7-11

In the study conducted at Box Hill Hospital and St. Vincent's Hospital in Victoria, Australia, Dr. Andy Sisnata Siswojo and colleagues assessed fluid responsiveness in 29 patients undergoing noncardiac surgeries. Investigators used a Masimo Radical-7 rainbow SET Pulse CO-Oximeter®, which automatically calculated and displayed PVI, and a minimally invasive esophageal Doppler monitor (CardioQ-ODM™, Deltex Medical).

Patients received intravenous volume expansion with 500 mL of colloid following induction of general anesthesia. Patients were classified into fluid responders and nonresponders based on a stroke volume index increase of ≥10%. There were 17 responders (59%) to the 500-mL volume expansion. The baseline PVI value was significantly different between responders and nonresponders (16.5 ± 6.4% v 10.3 ± 2.7%, P = 0.004). Researchers reported that the receiver operating characteristic analysis demonstrated significant predictive ability of an increase in stroke volume index for PVI with area under the curve of 0.84 (95% confidence interval = 0.69-0.99). The optimal cut-off value for baseline PVI was 10.5%, with a sensitivity of 88% and a specificity of 67%.

"In this study, patients presented for a wider range of low-risk noncardiac surgeries for which invasive monitoring would not be indicated," researchers said. "The advantage of the noninvasive nature of PVI in this setting is, therefore, very appealing."

The investigators concluded: "PVI is predictive of fluid responsiveness in adult patients under general anesthesia undergoing noncardiac surgery when they are mechanically ventilated, in sinus rhythm, and free of pulmonary disease and cardiac dysfunction. It may serve as a useful tool for guiding intraoperative fluid therapy in circumstances in which more invasive monitoring is not indicated."

1 Siswojo A, Wong D, Phan T, Kluger R. "Pleth Variability Index Predicts Fluid Responsiveness in Mechanically Ventilated Adults During General Anesthesia for Noncardiac Surgery." Journal of Cardiothoracic and Vascular Anesthesia. Published online ahead of print, Aug 2014 doi:10.1053/j.jvca.2014.04.010
2 Cannesson M: Arterial pressure variation and goal-directed fluid therapy. J Cardiothorac Vasc Anesth 24:487-497,2010
3 Brandstrup B, TønnesenH, Beier-HolgersenR, etal: Effects of intravenous fluid restriction on postoperative complications: Comparison of two perioperative fluid regimens: A randomized assessor-blinded multicenter trial. AnnSurg 238:641-648,2003
4 Marik PE, Cavallazzi R, Vasu T, etal: Dynamic changes in arterial wave form derived variables and fluid responsiveness in mechanically ventilated patients: A systematic review of the literature. Crit Care Med 37:2642-2647,2009
5 Kita T, Mammoto T, Kishi Y. Fluid management and postoperative respiratory disturbances in patients with transthoracic esophagectomy for carcinoma. J Clin Anesth. 2002;14(4):252-6.
6 Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F, Danish Study Group on Perioperative Fluid T. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003;238(5):641-8. doi:10.1097/01.sla.0000094387.50865.23.
7 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.
8 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.
9 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.
10 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.
11 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 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 SET® 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®), and PVI®, in addition to SpO2, pulse rate, and perfusion index (PI). 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

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