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New Study Evaluates Masimo PVI® as a Predictor of Fluid Responsiveness in Patients Undergoing Liver Transplantation

07/21/16

IRVINE, Calif.--(BUSINESS WIRE)--Jul. 21, 2016-- Masimo (NASDAQ: MASI) announced today that a new study of patients undergoing liver transplantation evaluated the relationship of PVI® to right ventricular end-diastolic volume (RVEDVI) and concluded that PVI provided a “reliable estimate of [cardiac] preload status and may be a useful predictor of fluid responsiveness.”1 PVI measures the dynamic changes in perfusion index that occur during one or more complete respiratory cycles, using the Masimo pulse oximetry plethsymographic waveform.

Because of hemodynamic instability during orthotopic liver transplantation (OLT), estimating cardiac preload to optimize fluid management is essential. There are several methods for estimating cardiac preload. Two conventional static measurements of cardiac filling pressure are pulmonary artery occlusion pressure (PAOP) and central venous pressure (CVP). The standard invasive method is RVEDVI, obtained from thermodilution using a pulmonary artery catheter (PAC).

In the prospective study, published in Transplantation Proceedings and conducted at Chang Gung Memorial Hospital in Taiwan, Dr. H.-C. Lee and colleagues compared methods of estimating cardiac preload, with the aim of evaluating the relationship between a dynamic hemodynamic parameter, PVI (derived from pulse oximetry), and RVEDVI (using a PAC), as well as comparing PVI to the static measures CVP and PAOP. They measured the four hemodynamic parameters–CVP, PAOP, RVEDVI, and PVI–on 18 patients undergoing OLT at 10 defined time points before, during, and at the conclusion of surgery.

Analyzing the 180 measurements from each of the parameters, the Receiver Operating Characteristic (ROC) determined in this study to distinguish different thresholds of RVEDVI showed an area under the curve (AUC) of 0.702 for CVP, 0.748 for PAOP, and 0.762 for PVI.

The researchers concluded that “PVI may serve as a reliable estimate of cardiac preload status in patients undergoing OLT, explicitly, higher PVI values correlated with lower RVEDVI values,” so that “an increase in ventricular preload status could be inferred from a decrease in PVI during OLT.” They also noted that “RVEDVI was better correlated with PVI than with other static filling pressure[s], such as CVP or PAOP,” therefore giving a “safer, faster, and better estimate of fluid responsiveness.”

The researchers noted as a limitation that the quality of the signal from which PVI is calculated is “critically based on peripheral perfusion, which may be significantly affected by factors such as extreme low cardiac output, drug-induced vasoconstriction, and hypothermia.” The researchers also noted that further studies are needed to investigate the application and effectiveness of additional dynamic hemodynamic parameters such as SVV and PPV during OLT.

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Reference

  1. Lee HC, Tsai YF, Tsai HI, Chung PC, Yu HP, Lee WC, Lin CC. Pulse Oximeter-Derived Pleth Variability Index is a Reliable Indicator of Cardiac Preload in Patients Undergoing Liver Transplantation. Transplant Proc. 2016 May;48(4):1055-8.

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 by taking noninvasive monitoring to new sites and applications. 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® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. 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®), and more recently, Pleth Variability Index (PVI®) and 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. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

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 with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; 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.

Source: Masimo

Masimo
Irene Paigah, 858-859-7001
irenep@masimo.com