Published Study Demonstrates Patients with Low Hemoglobin Levels Can be Managed Without Blood Transfusions

IRVINE, Calif., Feb. 18 /PRNewswire-FirstCall/ -- A comparison study of nearly 1,900 patients published in Perfusion, a peer-reviewed academic journal, questions the long-standing practice of basing blood transfusion decisions on a single low hematocrit measurement result. In the study, titled Is it the Patient or the Physician who Cannot Tolerate Anemia?, researchers showed that a single measure of hematocrit is not a reliable indicator of transfusion need and that lower-than-normal hemoglobin levels have no adverse impact on patients. The study showed that a blood transfusion is largely administered because the physician deems it necessary, not because of quantified changes in the patient's physiology.

The study prospectively analyzed the outcomes of 1,854 patients with high (>21%) and low (</=21%) hematocrit levels who underwent coronary artery bypass graft surgery without receiving red blood cells at any time during their hospital stay.  In comparing outcomes between the two groups, researchers found that the rates were similar in both groups regarding time on ventilator, duration of intensive care unit stay, intensive care unit re-admission, hospital re-admission, reoperation for bleeding or tamponade, low cardiac output, postoperative atrial fibrillation, stroke, creatinine level at hospital discharge, new onset renal failure, mediastinitis, pulmonary complication, and mortality rates.  The study results showed that hematocrit levels that are considered "low" (between 17-21%) "are well tolerated and have no adverse impact on outcome," leading researchers to conclude "it is the physician, not the patient, who cannot tolerate low hematocrit levels."(1)

Despite mounting clinical evidence linking adverse patient outcomes to blood transfusions during cardiac surgery, including increased operative mortality and decreased long-term survival,(3,4) almost half of patients undergoing coronary artery bypass in the U.S. still receive at least one unit of packed red blood cells.(5,6)  In the Perfusion study researchers contend that the decision to unnecessarily transfuse blood in cardiac surgery patients is often based solely on a single low hematocrit level of below 20-22%—a clinical practice more than a half century old.  

According to the American Society of Anesthesiologists (ASA) practice guidelines: "red blood cell transfusions should not be dictated by a single hemoglobin 'transfusion trigger' but instead should be based on the patient's risk of developing complications of inadequate oxygenation." (2)

In fact, Dr. Aryeh Shander, President-Elect of the Society for the Advancement of Blood Management (SABM) and the Executive Medical Director for The Institute for Patient Blood Management & Bloodless Medicine and Surgery at Englewood Hospital and Medical Center in Englewood, New Jersey, says that "transfusion guidelines such as the ASA's are becoming increasingly important for the clinician.  The transfusion decision is quite complex because of mounting data surrounding risks and negative outcomes coupled with the unproven benefit of red cell transfusions.  Deciding to transfuse based on a single static measurement more often results in patients receiving unnecessary transfusions with increased risks, costs and the depletion of an already scarce blood supply.  New medical technologies and devices that continuously monitor hemoglobin, oxygen, and perfusion will become essential for transfusions."

One of the early pioneers of blood conservation and bloodless surgery techniques, Dr. Thomas Crimi, a founding member of SABM, Director of the Blood Conservation Program at Brookdale University Medical Center, and long-time proponent of single transfusion avoidance believes that "the lack of enabling medical technology to accurately and continuously measure key physiological parameters such as hemoglobin, fluid responsiveness, tissue oxygenation, and perfusion simultaneously has historically led physicians to make transfusion decisions based on single hemoglobin value reflecting measures obtained at a single point in time.  However, today with Masimo Pulse CO-Oximeters, I get the real-time hemoglobin, oxygenation, tissue perfusion, and fluid responsiveness measurements and trending data that I need," he confirmed.

Masimo Rainbow SET Pulse CO-Oximetry—a breakthrough noninvasive blood constituent monitoring platform capable of measuring multiple blood constituents that previously required invasive procedures, including: total hemoglobin (SpHb™), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and PVI®, in addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI).  Masimo SpHb, PVI, and SpO2 have been shown in multiple clinical studies to provide accurate, reliable, real-time measurements that help clinicians to proactively monitor and manage hemoglobin, fluid, and oxygen saturation levels more appropriately and conservatively.

(1) Senay S, Toraman F, Karabulut H, Alhan C. "Is it the Patient or the Physician who Cannot Tolerate Anemia?  A Prospective Analysis in 1854 Non-transfused Coronary Artery Surgery Patients."  Perfusion, November 2009; Vol. 24(6):373-80.  Available online:  http://prf.sagepub.com/cgi/content/abstract/24/6/373

(2) American Society of Anesthesiologists, "Practice guidelines for blood component therapy: a report by the American Society of Anesthesiologists Task Force on Blood Component Therapy." Anesthesiology 1996; 84: 732–747.

(3) Surgenor SD, DeFoe GR, Fillinger MP, et al. "Intraoperative Red Blood Cell Transfusion During Coronary Artery Bypass Graft Surgery Increases the Risk of Postoperative Low-output Heart Failure."  Circulation 2006; 114: I43-I48.

(4) Murphy GJ, Reeves BC, Rogers CA, Sizvi SIA, Culliford L, Angelini GD. "Increased Mortality, Postoperative Morbidity, and Cost after Red Blood Cell Transfusion in Patients Having Cardiac Surgery." Circulation 2007; 116: 2544-2552.

(5) Rawn JD. "Blood Transfusion in Cardiac Surgery: A Silent Epidemic Revisited." Circulation 2007; 116: 2523-2524.

(6) Koch CG, Li L, Duncan AI, et al. "Morbidity and Mortality Risk Associated with Red Blood Cell and Blood-Component Transfusion in Isolated Coronary Artery Bypass Grafting." Crit Care Med 2006; 34: 1608-1616.

About SABM

The Society for the Advancement of Blood Management (SABM) is an educational organization comprised of a network of practitioners from a wide variety of medical and scientific disciplines who are dedicated to improving patient outcomes and the advancement of optimal patient blood management in clinical practice through education, cooperation and research. The society works to facilitate cooperation among existing and future patient blood management/blood conservation, bloodless medicine and surgery programs, as well as to enhance the clinical and scientific aspects of transfusion practice. Patient blood management seeks to optimize and conserve the patient's own blood, reducing or avoiding the need for a blood transfusion. Stored donor blood should only be used as therapy, with patient consent, when there are no alternatives, and when the expected benefits exceed the negative consequences. Additional information is available at: www.sabm.org.

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®, 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® Pulse CO-Oximetry™, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb™), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and PVI®, in addition to SpO2, pulse rate, and perfusion index (PI).  In 2009, Masimo introduced Masimo Rainbow SET® Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa).  Masimo's Rainbow platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options.  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 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 belief that Masimo Rainbow SET Pulse CO-Oximetry technology will provide sufficient sensitivity and specificity to measure SpHb, SpOC, PVI , SpO2, SpCO, SpMet,  PI, and PR in real-time for all patients, risks related to our assumptions regarding the repeatability of clinical results, 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 forward-looking 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.

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, RRa, 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.

SOURCE Masimo

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