OncologyTwo New Clinical Studies Show That Limited Exposure To Blood Transfusion Significantly Increases Morbidity And Mortality After Surgery
Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, announced 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 re 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."
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 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.
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