Publication in 'British Journal of Anaesthesia' reveals PVI has similar or
better accuracy compared to multiple invasive methods
IRVINE, Calif., July 10 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI),
the inventor of Pulse CO-Oximetry and Measure-Through-Motion-and-Low-Perfusion
pulse oximetry, today announced that a new clinical study, published in the
June 2008 issue of the British Journal of Anaesthesia, concluded that under
the study protocol Masimo's PVI measurement "can predict fluid responsiveness
in mechanically-ventilated patients under general anesthesia." PVI is a new
measurement available in the Masimo Rainbow SET technology platform that
allows noninvasive, automated, and continuous monitoring of the variation in
the pulse oximeter waveform amplitude during respiration.
During surgery, one of the biggest challenges anesthesiologists face is
deciding whether to administer fluid to increase cardiac index (amount of
blood the heart pumps each minute) and maintain an adequate delivery of oxygen
to the body. However, multiple studies have shown that traditional invasive
measurements are only 50 to 60% accurate at predicting an improvement in
cardiac index after volume administration.(1) Administration of unnecessary
fluid should be avoided because it is associated with increased morbidity and
mortality.(2) Newer invasive measurements that are based on dynamic changes
during the respiratory cycle have shown improved accuracy at predicting fluid
responsiveness, but market adoption has been slow due to complexity and cost.
Therefore, a noninvasive method to accurately assess fluid responsiveness and
guide fluid administration would provide tremendous value to clinicians and
patients alike.
In the British Journal of Anaesthesia study, a patient was defined as a
"responder" if their cardiac index increased by 15% or more after
administration of 500 ml of fluid. If cardiac index increased less than 15%
after volume administration, the patient was defined as a "non-responder". Of
the 25 patients evaluated in the study, 16 were considered responders and 9
were considered non-responders. PVI showed a similar accuracy (0.93 area
under the curve, AUC) at predicting fluid responsiveness when compared to
pulse pressure variation from an invasive arterial catheter (0.94 AUC) and
superior accuracy when compared to central venous (0.42 AUC) or pulmonary
capillary wedge pressure (0.40) (Click Below Link for Chart).(3)
(Photo: http://www.newscom.com/cgi-bin/prnh/20080710/LATH037)
"PVI demonstrated high accuracy in discriminating fluid responders from
non-responders-providing a unique opportunity to better manage a patient's
fluid volume to optimize cardiac performance and organ perfusion," stated
Maxime Cannesson, M.D., lead researcher and anesthesiologist, Louis Pradel
Hospital in Lyon, France. "14 of the 16 patients who responded to fluid
administration with a cardiac index increase of 15% or more had a PVI value of
>14% before volume administration. All 9 patients who did not respond to
fluid administration with a cardiac index increase of 15% or more had a PVI
value of <14% before volume administration."
According to a recent clinical study published in Critical Care,
monitoring pulse pressure variation with an arterial catheter showed an
ability "to decrease the duration of hospital stay, mechanical ventilation,
and post-operative morbidity in patients undergoing high-risk surgery".(4)
While pulse pressure variation from an arterial pressure catheter is
considered the gold standard for assessing fluid responsiveness, only a small
minority of patients receive this type of catheter during surgery due to its
invasiveness, complexity, and risk. In Dr. Cannesson's study, Masimo PVI
showed similar accuracy as pulse pressure variation at predicting fluid
responsiveness but offers clinicians an easy and noninvasive assessment of
fluid responsiveness in any patient undergoing surgery by simply using their
existing noninvasive Masimo SpO2 sensor with Masimo Rainbow SET monitors.
Joe E. Kiani, Chairman and CEO of Masimo, stated, "The excellent work of
Dr. Cannesson and colleagues adds to the growing body of evidence supporting
the use of PVI as a new standard of care to optimize fluid status in patients
both in the operating room and at the bedside. We are happy to see that yet
another one of our inventions has the potential to improve outcomes and
increase safety for patients."
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, 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 www.masimo.com.
Forward Looking Statements
This press release may include forward-looking statements. These forward-
looking statements are based on current expectations about future events
affecting us and are subject to uncertainties and factors, all of which are
difficult to predict and many of which are beyond our control, including:
risks related to our assumption that the positive results and clinical
outcomes presented on PVI will be repeated in other studies, risks related to
our assumption that PVI will deliver a sufficient level of clinical
improvement over alternative methods of monitoring respiratory variations in
the pulse oximetry plethysmographic waveform amplitude to allow for rapid
adoption of the technology, as well as other factors discussed in the "Risk
Factors" section of our quarterly report on Form 10-Q for the quarter ended
March 29, 2008, filed with the Securities and Exchange Commission on May 1,
2008. Although we believe that the expectations reflected in our forward-
looking statements are reasonable, we do not know whether our expectations
will prove correct. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. 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 quarter ended March 29, 2008, whether as a result of new information,
future events or otherwise, except as may be required under the federal
securities laws.
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.
(1) Michard F, Teboul JL. Predicting fluid responsiveness in ICU
patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8.
(2) Joshi G. "Intraoperative Fluid Restriction Improves Outcome After
Major Elective Gastrointestinal Surgery." Anesthesia Analgesia (2005)
101:601-5.
(3) Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O,
Lehot JJ. "Pleth variability Index to Monitor the Respiratory Variations in
the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid
Responsiveness in the Operating Theatre." British Journal of Anaesthesia 2008;
0:aen133v1-7.
(4) Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, Michard F.
"Goal-directed Fluid Management Based on Pulse Pressure Variation Monitoring
During High-risk Surgery: A Pilot Randomized Controlled Trial." Critical Care
2007; 11: R100.
SOURCE Masimo Corporation