New Study Shows Masimo Noninvasive & Continuous Total Hemoglobin (SpHb®) Monitoring Significantly Reduces Blood Transfusions and Costs in High Blood Loss Surgery

IRVINE, Calif., Jan. 10, 2013 /PRNewswire/ -- Noninvasive and continuous total hemoglobin (SpHb) monitoring technology from Masimo (NASDAQ: MASI) helps clinicians reduce intra-operative red blood cell (RBC) transfusions during high blood-loss surgery,  speeds time to transfusion when indicated, and saves significant costs, according to a new study unveiled at the Society for Technology in Anesthesia (STA) annual meeting.¹  The study was one of just five receiving the distinguished 2013 award for the best research at the STA meeting.

RBC transfusion is one of the most frequent procedures performed in U.S. hospitals, with one in ten inpatients receiving one or more blood units.² While blood loss during surgery is a known risk factor, RBC transfusion overuse can increase patient risk and cost of care. Meta-analysis of pooled results from multiple observational studies, each of which adjusts for risks between patients, shows patients receiving RBC transfusions have an 88% higher mortality, 69% higher infection rate, and 250% higher rate of ARDS.³  While some clinicians are concerned with the idea of withholding RBC transfusions, multiple randomized controlled trials indicate that restrictive transfusion practices – those in which significantly lower hemoglobin triggers are used to determine need for transfusion – are safe.⁴  In addition, the cost of each RBC unit is estimated between $522 and $1,183 per unit, without including morbidity-associated costs.⁵ 

Hemoglobin levels are used as a primary indicator for RBC transfusion, but laboratory measurements are only available intermittently and results can be delayed in the period between blood draw and laboratory analysis. This time gap of information can lead to sub-optimal transfusion decisions.⁶  Given the risks and costs of RBC transfusions, there is a growing recognition of the need to implement strategies to reduce transfusions.  The American Medical Association and The Joint Commission recently identified RBC transfusions as one of the top five overused procedures in medicine,⁷ and The Joint Commission has introduced Patient Blood Management Measures that encourage hospitals to evaluate appropriateness of transfusions as a continuous quality indicator.⁸  A previous study conducted at Massachusetts General Hospital during orthopedic surgery (a low blood loss setting) showed that SpHb monitoring helped clinicians reduce RBC transfusion frequency (from 4.5% to 0.6% of patients, an 87% reduction) and average RBC units per patient (from 0.10 to 0.01 units per patient, a 90% reduction),⁹ but the current study is the first to report the impact of SpHb in high blood loss surgery.

Drs. N.A. Wael and Fawzy Mahmoued at Cairo University in Egypt conducted a prospective cohort study in patients scheduled for neurosurgery.  One patient scheduled for neurosurgery the next day was randomly selected using the sealed envelope method to be screened for SpHb Group inclusion, and following enrollment into the SpHb Group, the other patients also scheduled for surgery on the same day were screened for inclusion into the Standard Care Group.  The SpHb Group received typical anesthesia care plus SpHb monitoring (Masimo Radical-7^®, v7748 & R2-25 adult rainbow^® ReSposable sensor).  The SpHb Group followed the same transfusion practice as the Standard Care Group except the anesthesiologist was guided by the addition of SpHb, with blood samples still taken before and after transfusion.

A total of 106 patients were enrolled – one group with SpHb monitoring and one group without SpHb monitoring. The SpHb Group had a 56% reduction in the frequency of multi-unit RBC transfusions (from 73% to 32% of patients receiving three or more units, p<0.01), and 47% reduction in average number of RBC units transfused (from 1.9 to 1.0 units per patient, p<0.001).  Moreover, once clinicians determined a transfusion was needed, they were able to initiate transfusions 82% faster (in about 9 minutes, compared to about 50 minutes for those not being monitored by SpHb, p<0.001).

The researchers noted that noninvasive and continuous SpHb monitoring provides real-time directional trends in hemoglobin, such as indicating stable hemoglobin when it may be perceived to be dropping, and rising hemoglobin when it may be perceived to not be rising fast enough, thus changing transfusion decision making.

"Based on the average 0.9 RBC unit reduction per patient in the SpHb Group, SpHb monitoring could save $470 to $1,065 per patient monitored and $469,800 to $1,064,700 per 1,000 surgeries performed," the researchers said. They concluded: "SpHb monitoring reduced intra-operative RBC transfusions during high blood-loss surgery. Based on the RBC reduction shown with SpHb monitoring, hospitals could significantly reduce costs with this approach."

"Hospitals looking to increase quality and reduce costs are now starting to see RBC transfusion overuse as a major target," said Masimo founder and CEO Joe Kiani. "This high blood loss study from Cairo and the low blood loss study from Boston, show that SpHb can be a valuable tool in reducing unnecessary blood transfusion, and the Cairo study shows that for those who need transfusion, SpHb can speed up its delivery.  This, along with the data that shows blood transfusion increases mortality and morbidity is why we launched our Blood Transfusion Related Cost Reduction (BTR-CR, "Better Care") Guarantee, which guarantees a hospital's blood-transfusion related cost reductions will be greater than the cost of SpHb monitoring – representing a win for all involved, especially the patients."

For more information about SpHb or BTR-CR, contact 888-44BTRCR or http://masimo.custhelp.com/ci/documents/detail/2/Better_Care_Guarantee

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive 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 rainbow® SET Pulse CO-Oximetry™ technology, 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 Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo's rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices. Masimo SET and Masimo rainbow SET technologies can be also found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. 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 assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including total hemoglobin (SpHb), contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; 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 Patient Outcome and Reducing Cost of Care… by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57,Rad-8, Rad-5,Pulse CO-Oximetry, Pulse CO-Oximeter, Adaptive Threshold Alarm, and SEDLine  are trademarks or registered trademarks of Masimo Corporation. The use of the trademarks Patient SafetyNet and PSN are under license from University HealthSystem Consortium.

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Masimo Corporation
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SOURCE Masimo Corporation