Two New Clinical Studies Show That Limited Exposure to Blood Transfusion Significantly Increases Morbidity and Mortality After S
June 08 2009 - 10:20AM
PR Newswire (US)
Studies Advocate Blood Conservation and Appropriate Indicators for
Transfusion IRVINE, Calif., June 8 /PRNewswire-FirstCall/ -- Masimo
(NASDAQ:MASI), the inventor of Pulse CO-Oximetry(TM) and
Measure-Through Motion and Low-Perfusion pulse oximetry, announced
today that two new studies - one conducted in patients undergoing
general surgery and published in the Journal of American College of
Surgeons and another conducted in patients undergoing cardiac
surgery and published in the Anesthesia & Analgesia - provide
additional new evidence that transfusion of just one or two units
of blood significantly increases infection, pneumonia, sepsis, and
mortality after surgery.(1,2) These studies suggest that
transfusions and their associated risks could be "largely avoided"
through implementation of better blood management techniques and
"more appropriate indicators" for transfusions. Blood transfusions
may be necessary to ensure survival when a patient is bleeding
heavily or has severe symptomatic anemia. However, transfusions are
also given in the presence of stable anemia or when significant
blood loss is expected but does not occur. These two new studies
add to the growing evidence that transfusions carry
life-threatening risks and urge that in the absence of benefit from
transfusion, avoidance of transfusions through the use of more
restrictive transfusion practices could improve patient outcomes.
In the general surgery study, researchers evaluated 125,177
patients from 121 hospitals and showed that after adjusting for all
risk variables, transfusion of a single unit of blood increased
30-day mortality by 32% and morbidity (pneumonia, sepsis, or
surgical site infection) by 23%. Transfusion of two units of blood
increased the mortality risk by 38% and morbidity risk by 40%. In
the cardiac surgery study, researchers evaluated long-term survival
of 9,079 patients at eight hospitals and showed that transfusion of
one or two units of blood increased six-month mortality 67% and
five-year mortality 16% . "These two new studies demonstrate that
the risk of blood transfusion is significant and thus we should
avoid transfusions when ever possible," stated Dr. Aryeh Shander,
Clinical Professor of Anesthesiology, Medicine and Surgery at Mt.
Sinai School of Medicine in New York, NY. "The current practice of
using intermittent, invasive measurements of hemoglobin to help
guide transfusion decisions may contribute to unnecessary blood
transfusions. Blood transfusion should not simply be based on any
particular level of hemoglobin but rather a thorough evaluation of
the patient, including whether hemoglobin levels are stable or
changing. The ability to continuously and noninvasively trend a
patient's hemoglobin level offers a breakthrough in blood
management. Continuous and noninvasive SpHb(TM) monitoring has the
potential to greatly improve clinical decision-making and reduce
patient exposure to allogeneic transfusion, reduce complications,
and preserve a precious resource and costs." Masimo continuous and
noninvasive hemoglobin monitoring (SpHb) technology is available as
part of the upgradeable Masimo Rainbow SET(R) Pulse CO-Oximetry
platform. (1) Bernard AC et al. Intraoperative transfusion of 1U to
2U of packed red blood cells is associated with increased 30-day
mortality, surgical site infection, pneumonia, and sepsis in
general surgery patients. Journal of the American College of
Surgeons. 2009; 208:931-937. (2) Surgenor SD et al, for the
Northern New England Cardiovascular Disease Study Group. The
Association of Perioperative Red Blood Cell Transfusions and
Decreased Long-Term Survival After Cardiac Surgery. Anesthesia
& Analgesia 2009; 108:1741-1746. About Masimo Masimo
(NASDAQ:MASI) develops innovative monitoring technologies that
significantly improve patient care--helping solve "unsolvable"
problems. In 1995, the company debuted Measure-Through Motion and
Low-Perfusion pulse oximetry, known as Masimo SET(R), which
virtually eliminated false alarms and increased pulse oximetry's
ability to detect life-threatening events. More than 100
independent and objective studies demonstrate Masimo SET provides
the most reliable SpO2 and pulse rate measurements even under the
most challenging clinical conditions, including patient motion and
low peripheral perfusion. In 2005, Masimo introduced Masimo Rainbow
SET(R) Pulse CO-Oximetry(TM), a breakthrough noninvasive blood
constituent monitoring platform that can measure many blood
constituents that previously required invasive procedures. Masimo
Rainbow SET continuously and noninvasively measures total
hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin
(SpCO(R)), methemoglobin (SpMet(R)), and PVI(TM), in addition to
oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI),
allowing early detection and treatment of potentially
life-threatening conditions. Founded in 1989, Masimo has the
mission of "Improving Patient Outcomes and Reducing Cost of Care by
Taking Noninvasive Monitoring to New Sites and Applications."
Additional information about Masimo and its products may be found
at http://www.masimo.com/. 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 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 accuracy and repeatability of the
Capgemini results; risks related to our assumption that Masimo SpHb
technology and products will provide faster, easier and safer means
for measuring total hemoglobin and will deliver a sufficient level
of clinical improvement over alternative measurement capabilities
to enable more restrictive transfusion practices, as well as other
factors discussed in the "Risk Factors" section of our Quarterly
Report on Form 10-Q for the fiscal quarter year ended April 4,
2009, filed with the Securities and Exchange Commission ("SEC") on
May 6, 2009, which may be obtained for free at the SEC's website at
http://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
forward-looking statements or the "Risk Factors" contained in our
Quarterly Report on Form 10-Q for the fiscal quarter ended April 4,
2009, whether as a result of new information, future events or
otherwise, except as may be required under the applicable
securities laws. Media Contact: Dana Banks, Masimo Corporation
949-297-7348 Masimo, SET, Signal Extraction Technology, Improving
Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring
to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet,
PVI, Radical-7, Rad-87, Rad-57,Rad-9, Rad-8, Rad-5,Pulse
CO-Oximetry and Pulse CO-Oximeter are trademarks or registered
trademarks of Masimo Corporation. DATASOURCE: Masimo Corporation
CONTACT: Dana Banks of Masimo Corporation, +1-949-297-7348 Web
Site: http://www.masimo.com/
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