Study Investigates Effects of Patient Blood Management Program with Masimo SpHb®, Noninvasive, Continuous Hemoglobin Monitor...
November 16 2020 - 1:00AM
Business Wire
Patient Blood Management with Masimo SpHb
Increased Transfusion Appropriateness and Decreased RBC Units
Transfused per Patient
Masimo (NASDAQ: MASI) announced today the findings of a study
published in Blood Transfusion in which Dr. Lucia Merolle and
colleagues at the Azienda USL-IRCCS of Reggio Emilia, Italy
investigated the impact of applying a patient blood management
program, including use of noninvasive and continuous hemoglobin
monitoring, Masimo SpHb®, to the care of postoperative cancer
patients.1 The study found that using SpHb as part of a patient
blood management program not only increased how often postoperative
blood transfusions were appropriate, but decreased the total and
mean number of blood units transfused per patient.
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Masimo Radical-7® with SpHb® (Photo:
Business Wire)
Patient blood management (PBM) is “an evidence-based,
multidisciplinary approach aimed at optimizing the care of patients
who might need blood transfusions.” Recognizing that PBM might have
specific benefits for surgical oncology patients, the researchers
implemented a two-step PBM program and compared three groups of
postoperative adult cancer patients who underwent major surgery
between 2014 and 2017. Step 1 PBM included seminars and training
designed to teach semi-intensive post-surgical personnel the
principles of PBM. Step 2 PBM added the use of SpHb monitored with
Masimo Radical-7® Pulse CO-Oximeters® with SpHb. Audit 1 reviewed
data for 200 patients whose post-surgical care did not incorporate
PBM. Audit 2 was of 200 patients whose care incorporated Stage 1
PBM, and Audit 3 was of 200 patients whose care incorporated Stage
2 PBM along with continuous SpHb monitoring.
Using guidelines developed by the Italian Society of Transfusion
Medicine and Immunohaematology (SIMTI), the researchers found that
transfusion appropriateness rose from 38% in Audit 1 patients, to
75% in Audit 2 patients (Step 1 PBM), to 79% in Audit 3 patients
(Step 2 PBM, with SpHb). The total number of red blood cell (RBC)
units transfused was similar for Audit 1 and Audit 2 patients (52
and 58 units, respectively), but dropped to 39 units with the
addition of SpHb monitoring to PBM (Audit 3). The mean number of
RBC units transfused was the same for Audit 1 and Audit 2 patients
(1.8 units/patient), but again, with the addition of SpHb
monitoring (Audit 3), the mean dropped to 1.3 units/patient.
The researchers concluded, “Our PBM bundle positively impacted
RBC transfusion appropriateness in post-surgical cancer patients,
both in terms of quality and quantity. A structured PBM program
specifically dedicated to surgical oncology should cover the entire
perioperative period and might further improve transfusion
appropriateness in these patients. The publication of guidelines on
the management of anemia in surgical oncology should be a
priority.”
In other clinical studies, continuous monitoring with SpHb as
part of PBM programs has been found to improve outcomes, such as
reducing the percentage of patients receiving transfusions,2
reducing the units of red blood cells transfused per patient,3-4
reducing the time to transfusion,5 reducing costs,6 and even
reducing mortality 30 and 90 days after surgery by 33% and 29%,
respectively.7 With the addition of the Italian study, the evidence
of SpHb’s impact on outcomes spans the globe, representing 6
countries on 4 different continents.1-7 Today, SpHb technology
supports clinicians in over 75 countries around the world.8
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.
@Masimo | #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.9 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,10 improve CCHD screening in newborns,11 and, when used
for continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.12-15 Masimo SET® is estimated to be used on
more than 200 million patients in leading hospitals and other
healthcare settings around the world,16 and is the primary pulse
oximetry at 9 of the top 10 hospitals according to the 2020-21 U.S.
News and World Report Best Hospitals Honor Roll.17 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
Masimo Hospital Automation™ platform, and include Iris Gateway®,
Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and
Masimo SafetyNet™. 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
- Merolle L, Marraccini C, Di Bartolomeo E, Montella M, Pertinhez
T, Baricchi R, Bonini A. Postoperative patient blood management:
transfusion appropriateness in cancer patients. Blood Transfus
2020; 18: 359-65 DOI 10.2450/2020.0048-20.
- 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.
- Imaizumi et al. Continuous and noninvasive hemoglobin
monitoring may reduce excessive intraoperative RBC transfusion.
Proceedings from the 16th World Congress of Anaesthesiologists,
Hong Kong. Abstract #PR607.
- 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.
- Cros J et al. 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.
- Masimo data on file.
- 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 A 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 S 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.
- McGrath S et al. Inpatient Respiratory Arrest Associated With
Sedative and Analgesic Medications: Impact of Continuous Monitoring
on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14
Mar. DOI: 10.1097/PTS.0000000000000696.
- 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; risks related to
COVID-19; 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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