Masimo (NASDAQ: MASI) announced today the findings of an
abstract presented at the American Society of Anesthesiologists’
(ASA) Annual Meeting in Chicago. In the study, researchers at
Hôpital Dupuytren, part of the Centre Hospitalier Universitaire of
Limoges, France (CHU Limoges), investigated the clinical utility of
noninvasive, continuous hemoglobin (SpHb®) and PVI® (a measure of
the dynamic changes in perfusion index that occur during the
respiratory cycle), two Masimo rainbow SET™ measurements. The
researchers’ goal was to determine, at the scale of a whole
hospital, improvement in mortality and transfusion needs.1
In the prospective, single-center, observational study,
Professor Nathalie Nathan and colleagues reviewed two sets of
patients over two eleven-month periods, before (2013) and after
(2014) implementation of a clinical algorithm to guide transfusion
and fluid administration. Anesthesiologists, nurses, and residents
were trained on the implementation of the clinical algorithm.
Masimo Radical-7® Pulse CO-Oximeters® were installed in all
operating rooms, recovery rooms, and intensive care units. The
Radical-7s were connected to Masimo Patient SafetyNet™* for trend
data collection. All surgical patients presenting to the hospital
were accepted, with these exceptions: EMT, ophthalmology,
odontology, radiology, neurosurgery, and patients less than 18
years of age.
The study included 18,867 patients (in the two groups), of whom
3450 underwent SpHb and PVI monitoring via Radical-7. The patients
in the monitoring group received vascular filling with crystalloids
or blood, according to the clinical algorithm. Demographic,
anesthesia, surgical, and transfusion data were collected in
electronic medical records. The researchers compared the percentage
of patients in the monitored group who received transfusions within
the first postoperative 48 hours to the percentage in the
non-monitored group. They also compared mortality rates for each
group at 30 days and 90 days following surgery.
Using the cox-proportional hazard model, the researchers found
that the patients in the group monitored with SpHb and PVI had a
30% reduction in mortality at 30 days and a 25% reduction in
mortality at 90 days. The proportion of patients receiving
transfusions did not change significantly between the two groups
(7.9% in 2013, 8.5% in 2014, p=0.1323), nor did the number of blood
units transfused within 48 hours (3.4 ± 2.7 in 2013, 3.4 ± 2.0 in
2014, p>0.05). However, in non-cardiac surgery, patients were
transfused sooner in the operative or recovery room (72.9% vs
56.1%, p=0.0002).
The researchers concluded that “Monitoring SpHb and PVI
integrated in a vascular filling algorithm allowed earlier
transfusion and reduces mortality at a scale of a whole hospital
with different clinical practices (and practitioners) and
unselected patients.”
“Access to continuous monitoring of Hb levels and fluid
responsiveness has changed the way we address blood and fluid
management. By lowering inadequate fluid filling at the beginning
of anesthesia, we are able to avoid diluting patients inadequately
and this data helps us to guide precisely the amount of fluids or
blood that must be given to patients on a case by case basis,”
stated Professor Nathan, Head of the Department of Anesthesiology
at CHU Limoges. “Patients are transfused earlier when needed and
hypovolemia is precisely treated with crystalloid. These two facts
may explain the decrease in mortality at one and three months that
we observed in this study. We strongly believe that surgeries of
intermediate severity such as hip or knee replacement procedures as
well as severe surgery will benefit from this technology. Because
it is easy to use, quick to administer, provides continuous data,
and does not harm the patient in any way, it is more applicable to
common clinical practice.”
Joe Kiani, Founder and CEO of Masimo, commented, “We have
created technologies that have been shown to save babies’
eyesight2, screen for CCHD in newborns3, and reliably monitor
patients in post-surgical wards4,5,6, but this is the first time a
study has shown that one of our technologies has such a big impact
on mortality. Needless to say, we are excited and thank Dr. Nathan
for her and her colleagues’ research. We look forward to more
studies like this that investigate the impact of SpHb and PVI on
other patients at other hospitals, and hope to see similar
results.”
SpHb monitoring may provide additional insight to the
directional trend of hemoglobin between invasive blood samplings –
when the SpHb trend is stable and the clinician may otherwise think
hemoglobin is decreasing; when the SpHb trend is rising and the
clinician may otherwise think hemoglobin is not rising fast enough;
or when the SpHb trend is decreasing and the clinician may
otherwise think hemoglobin is stable. SpHb monitoring, accompanied
by laboratory diagnostic testing, may thus help clinicians make
more timely and informed decisions, and has been shown to help
clinicians provide more timely blood transfusions** and reduce
blood transfusions in cases such as neurosurgery and orthopedic
surgery.7,8
@MasimoInnovates | #Masimo
*The use of the trademark SafetyNet is under license from
University HealthSystem Consortium.
**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
- Nathan N et al. Impact of Continuous
Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual
Meeting, Chicago. Abstract #A1103.
- 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.
- 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.
- 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.
- Taenzer AH et al. Postoperative
Monitoring – The Dartmouth Experience. Anesthesia Patient Safety
Foundation Newsletter. Spring-Summer 2012.
- 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.
- Ehrenfeld JM et al. Continuous
Non-invasive Hemoglobin Monitoring during Orthopedia Surgery: A
Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
- 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.
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 SpHb® and 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 SpHb and PVI, contribute to positive
clinical outcomes and patient safety; risks related to our belief
that Masimo noninvasive medical breakthroughs provide
cost-effective solutions and unique advantages; 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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version on businesswire.com: http://www.businesswire.com/news/home/20161022005012/en/
MasimoEvan Lamb, 949-396-3376elamb@masimo.com
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