Masimo (NASDAQ: MASI) announced today that in a study published
in the Journal of Clinical Monitoring and Computing, researchers
investigated the effects of implementing a hospital-wide fluid and
blood administration protocol using two Masimo measurements:
noninvasive, continuous hemoglobin (SpHb®) and pleth variability
index (PVi®).1 To evaluate the impact of the implementation, they
collected data on transfusions and mortality 30 and 90 days after
surgery and compared the findings between two 11-month periods in
2013 and 2014.
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Masimo Root® with SpHb® and PVi® (Photo:
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In the study, Dr. Jérôme Cros, Prof. Nathalie Nathan, and
colleagues at Hôpital Dupuytren, part of the Centre Hospitalier
Universitaire of Limoges, France (CHU Limoges), sought to determine
if the use of a goal-directed therapy (GDT) algorithm based on
monitoring with SpHb and PVi could decrease blood requirements and
reduce mortality in common clinical practice. The researchers
divided 18,716 patients into 3 groups: G1 (9285 patients who
underwent surgery in 2013, before implementation of the
goal-directed therapy algorithm), G2 (5856 patients who underwent
surgery in 2014 without use of the algorithm), and G3 (3575
patients who underwent surgery in 2014 with use of the
algorithm).
For the 2014 patients, Masimo Radical-7® Pulse CO-Oximeters®
equipped with SpHb and PVi were installed in all operating rooms,
recovery rooms, and intensive care units. The entire anesthesiology
team, including nurses, was trained on use of the monitors and the
algorithm, and was free to decide whether or not to use
goal-directed therapy for each case. Transfusion and mortality data
were recorded for all patients.
Mortality Results
Using multivariate analysis and including age, ASA class,
surgical severity and emergency as co-variables, the risk of death
for G3 patients was 33% lower at 30 days and 29% lower at 90 days,
compared to G1 patients. By contrast, there was no difference in
the risk of death between G2 and G1 patients.
The authors also reported on mortality rate the year after the
study ended (2015), when the hospital no longer had access to SpHb
and PVi. Comparing 2015 patients to patients in the study, they
found that mortality at 30 and 90 days increased again to levels
similar to those found in 2013 (before implementation),
respectively 2.18% and 3.09%.
The authors noted, “Because patients who did not receive GDT
based on the PVi had similar mortality rates in 2014 and 2013, a
Hawthorne effect-inducing care improvement does not explain the
present results. The post-study increase in mortality, at the time
when monitors were no longer available, suggests that education of
the team to improve fluid management does not explain the present
results.”
Transfusion Results
After adjusting for surgical severity, age, and ASA class,
patients in G3 had reduced odds of being transfused within 48 hours
(odds ratio of 0.79, 95% CI of 0.68 – 0.93, p = 0.004). By
contrast, there was no difference in the odds of being transfused
between patients in G2 and G1.
The authors noted, “This study shows that using an algorithm
based on continuous Hb measurement and fluid responsiveness with
PVi in common clinical practice is associated with different
transfusion practices and a lower adjusted-mortality at 1 and 3
months. When considering confounding factors such as ASA class,
severity of surgery and emergency, the monitor-based algorithm
lowers transfusion probability by approximately 30% during surgery
and at 48 h. In non-cardiac surgeries, patients were transfused
sooner and more often but with less blood units in the GDT group.
In non-cardiac surgery, continuous Hb monitoring alerted
anesthesiologist on the anemia risk they might under-evaluated
without monitoring. This was the opposite, in cardiac surgery where
practitioners behave differently. When using continuous SpHb
monitoring, perioperative transfusion was reduced because
anesthesiologists probably less feared under-transfusion. The net
observed effect was an 11% and 6.5% reduction in blood units
transfused in the operating room and at 48 h.”
The researchers concluded, “Monitoring SpHb and PVi integrated
in a vascular filling algorithm is associated with earlier
transfusion and reduced 30 and 90-day mortality on a whole hospital
scale.” They continued, “In conclusion, this integrated
comparativei effectiveness study shows that using an algorithm of
fluid and blood transfusions based on continuous Hb measurement and
PVi is associated with reduced mortality.”
Joe Kiani, Founder and CEO of Masimo, commented, “We thank
Professor Nathan and her team for this outstanding study. All of
the outcome studies to date with continuous SpHb have shown its
benefits in transfusion management2-5 and numerous studies with PVi
have demonstrated its role in fluid management,6-7 but this is the
first time a study has shown how using goal-directed therapy with
SpHb and PVi can have such a big impact on mortality. As is central
to our mission, we encourage researchers to continue to study the
impact of SpHb and PVi to see if indeed these fantastic results can
be repeated in other institutions, for example those with different
mortality rates, and if so, help expand their use to improve
patient outcomes around the world.”
SpHb is not intended to replace laboratory blood testing.
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.
@MasimoInnovates | #Masimo
About Masimo
Masimo (NASDAQ: MASI) is a global medical technology company
that develops and produces a wide array of industry-leading
monitoring technologies, including innovative measurements,
sensors, patient monitors, and automation and connectivity
solutions. Our mission is to improve patient outcomes and reduce
the cost of care. Masimo SET® Measure-through Motion and Low
Perfusion™ pulse oximetry, introduced in 1995, has been shown in
over 100 independent and objective studies to outperform other
pulse oximetry technologies.8 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,9 improve CCHD screening in newborns,10 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.11-13 Masimo SET® is estimated to be used on
more than 100 million patients in leading hospitals and other
healthcare settings around the world,14 and is the primary pulse
oximetry at 9 of the top 10 hospitals listed in the 2018-19 U.S.
News and World Report Best Hospitals Honor Roll.15 Masimo continues
to refine SET® and in 2018, announced that SpO2 accuracy on RD SET™
sensors during conditions of motion has been significantly
improved, providing clinicians with even greater confidence that
the SpO2 values they rely on accurately reflect a patient’s
physiological status. 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®),
Pleth Variability Index (PVi®), RPVi™ (rainbow® PVi), and Oxygen
Reserve Index (ORi™). In 2013, Masimo introduced the Root® Patient
Monitoring and Connectivity Platform, built from the ground up to
be as flexible and expandable as possible to facilitate the
addition of other Masimo and third-party monitoring technologies;
key Masimo additions include Next Generation SedLine® Brain
Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography
with NomoLine® sampling lines. Masimo’s family of continuous and
spot-check monitoring Pulse CO-Oximeters® includes devices designed
for use in a variety of clinical and non-clinical scenarios,
including tetherless, wearable technology, such as Radius-7® and
Radius™ PPG, portable devices like Rad-67™, fingertip pulse
oximeters like MightySat® Rx, and devices available for use both in
the hospital and at home, such as Rad-97™. Masimo hospital
automation and connectivity solutions are centered around the Iris®
platform, and include Iris Gateway™, Patient SafetyNet, Replica™,
Halo ION™, UniView™, and Doctella™. Additional information about
Masimo and its products may be found at www.masimo.com. Published
clinical studies on Masimo products can be found at
www.masimo.com/evidence/featured-studies/feature/.
ORi and RPVi have not received FDA 510(k) clearance and are not
available for sale in the United States. The use of the trademark
Patient SafetyNet is under license from University HealthSystem
Consortium.
References
- Cros J, Dalmay F, Yonnet S, Charpeniter M, Tran-Van-Ho J,
Renaudeau F, Drouet A, Guilbaut P, Marin B, and Nathan N.
Continuous hemoglobin and plethysmography variability index
monitoring can modify blood transfusion practice and is associated
with lower mortality. J Clin Monit Comp. 3 Aug 2019.
https://doi.org/10.1007/s10877-019-00367-z.
- Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin
Monitoring during Orthopedic 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.
- Kamal AM et al. The Value of Continuous Noninvasive Hemoglobin
Monitoring in Intraoperative Blood Transfusion Practice During
Abdominal Cancer Surgery. Open J Anesth. 2016;13-19.
- Ribed-Sánchez B et al. Economic Analysis of the Reduction of
Blood Transfusions during Surgical Procedures While Continuous
Hemoglobin Monitoring is Used. Sensors. 2018, 18, 1367;
doi:10.3390/s18051367.
- Forget P et al. Goal-Directed Fluid Management Based on the
Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate
Levels and Improves Fluid Management. Anesth Analg. 2010;
111(4):910-4.
- Thiele RH et al. Standardization of Care: Impact of an Enhanced
Recovery Protocol on Length of Stay, Complications, and Direct
Costs After Colorectal Surgery. J Am Coll Surg. 2015. Doi:
10.1016/j.jamcollsurg.2014.12.042.
- Published clinical studies on pulse oximetry and the benefits
of Masimo SET® can be found on our website at
http://www.masimo.com. Comparative studies include independent and
objective studies which are comprised of abstracts presented at
scientific meetings and peer-reviewed journal articles.
- 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;Jan
8;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 A 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.
- Estimate: Masimo data on file.
-
http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
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; 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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Masimo Evan Lamb 949-396-3376 elamb@masimo.com
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