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.
@MasimoInnovates
| #Masimo
Reference
-
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160721005448/en/
Source: Masimo
Masimo
Irene Paigah, 858-859-7001
irenep@masimo.com