IRVINE, Calif.--(BUSINESS WIRE)--Mar. 13, 2017--
Masimo (NASDAQ:MASI)
announced today the publication of a recent study conducted on adult
patients undergoing liver transplantation (LT), in which researchers
assessed the accuracy and trending ability of noninvasive Masimo SpHb®
(total hemoglobin) measurement, as compared to conventional laboratory
hemoglobin (HbL) measurements. The researchers found that
SpHb had “clinically acceptable accuracy of hemoglobin measurement
[compared] with a standard laboratory device when used during LT” and
that “[t]his technology can be useful as a trend monitor during all
surgical phases of LT and can supplement HbL to optimize
transfusion decisions or to detect occult bleeding.”1
Monitoring a patient’s hemoglobin (Hb) levels is essential during LT
because, as the researchers point out, “a serious loss of blood and
fluid shift causes great variations [in] the Hb level, and delayed blood
transfusion may cause graft dysfunction because of hypo-perfusion and
tissue hypoxia. Morever, more importantly, over-transfusion is
associated with end organ damage and graft dysfunction.” Recognizing
that the “benefits and clinical advantages of noninvasive, rapid, and
accurate determination of Hb in the operating room are obvious,” Dr.
Kayhan and colleagues sought to evaluate the accuracy and trending
ability of Masimo SpHb during LT by comparing its measurements to those
of a standard laboratory hematology analyzer.
To this end, the investigators enrolled fifty-five adult patients
undergoing orthotopic LT in the study. The patients’ Hb levels were
analyzed using a Beckman Coulter LH 780 Hematology Analyzer, with each
patient’s arterial blood being sampled six times, twice during each of
the three phases of the surgery: pre-anhepatic, anhepatic, and
neohepatic. SpHb values were recorded within 10 seconds of each blood
sample using a Masimo Radical-7® Pulse CO-Oximeter®
(software version 7.8.0.1) and Masimo rainbow® ReSposable
R2-25r and R2-25a sensors. A total of 282 paired measurements were
collected and analyzed. HbL values ranged from 5.4 to 17.1
g/dL (mean 10.58) and SpHb values ranged from 6.9 to 17.7 g/dL (mean
11.44).
To compare the accuracies of the two methods, the researchers used a
Bland-Altman plot and calculated absolute bias (the differences between
SpHb and HbL) of 0.86 (95% CI = 0.50-1.21), precision (one
standard deviation of the bias) of 1.58, and limits of agreement of
-2.25 to 3.96. Using Pearson’s correlation analysis, the researchers
found that the correlation between the two sets of values was “highly
significant”: Pearson’s correlation coefficient r=0.73; 95% confidence
interval = 0.67-0.78, R2=0.53, p < 0.001.
The researchers concluded that “[t]he results of this study show that
SpHb has clinically acceptable accuracy of Hb measurement as compared
with a standard laboratory device when used during LT. This technology
may provide more timely information on Hb status than intermittent blood
sample analysis and thus has the potential to improve blood management
during LT. The trending accuracy may not only detect occult bleeding but
can also prevent overtransfusion after bleeding; at least this method
has the potential to supplement detection of changes. Nevertheless, due
to underestimation in the lower Hb values, clinicians should be cautious
when making decisions based on SpHb alone. Instead of focusing on a
single value, SpHb may be considered an early warning system and a trend
monitor. Future studies should evaluate the utility of SpHb in terms of
overall clinical outcomes of transfusion decision.”
“In prior studies using SpHb monitoring, reductions in blood transfusion
were observed,2,3,4 and when used with PVi®,
another Masimo noninvasive measurement, a reduction in 30-day mortality
was observed5,” stated Joe Kiani, Founder and CEO of Masimo.
“Dr. Kayhan’s study adds to the evidence that SpHb may be a useful tool
during procedures such as liver transplantation.”
SpHb monitoring may provide additional insight to the directional trend
of hemoglobin between invasive blood samples. SpHb monitoring is
intended to supplement, not replace, laboratory measurements. Blood
samples should be analyzed by laboratory instruments when possible prior
to clinical decision making.
@MasimoInnovates |
#Masimo
References
1. Kayhan et al. Accuracy of Noninvasive Hemoglobin Monitoring by Pulse
CO-Oximeter During Liver Transplantation. Minerva Anestesiologica. 2017
Jan 20. DOI: 10.23736/S0375-9393.17.11652-4
2. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring
during Orthopedia Surgery: A Randomized Trial. J Blood Disorders
Transf. 2014. 5:9. 2.
3. Awada WN et al. Continuous and noninvasive hemoglobin monitoring
reduces red blood cell transfusion during neurosurgery: a prospective
cohort study. J Clin Monit Comput. 2015 Feb 4.
4. Imaizumi et al. Continuous and noninvasive hemoglobin monitoring may
reduce excessive intraoperative RBC transfusion. Proceedings from the
16th World Congress of Anaesthesiologists, Hong Kong, 2016. Abstract
#PR607.
5. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring.
Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.
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® 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 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. 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 studies with SpHb, reductions in blood transfusion* were
observed,6,7 and when used with PVi, a reduction in 30-day
mortality was observed.8 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.
*Clinical decisions regarding red blood cell transfusions should be
based on the clinician’s judgment considering, among other factors:
patient condition, continuous SpHb monitoring, and laboratory diagnostic
tests using blood samples.
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. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring
during Orthopedia Surgery: A Randomized Trial. J Blood Disorders
Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring
reduces red blood cell transfusion during neurosurgery: a prospective
cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring.
Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.
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 SpHb®. 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 SpHb, contribute to positive clinical
outcomes and patient safety; 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/20170313005339/en/
Source: Masimo
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com