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CLINICAL EVIDENCE GUIDE
NO OTHER REGIONAL OXIMETER HAS BEEN EVALUATED MORE.1
When it comes to clinical evidence, the INVOSTM regional oximeter stands alone.1
The INVOSTM regional oximeter has been shown to improve patient outcomes through rigorous, peer-reviewed clinical research. By detecting cerebral oxygen desaturation and facilitating timely interventions under normal practice conditions, the device may help prevent adverse outcomes and improve the patient experience. Accumulating evidence has demonstrated that INVOSTM regional oximetry values may be predictive of or potentially guide interventions to reduce postoperative adverse outcomes, including:
Cognitive decline2,3 Major organ morbidity4,5 Delirium6 Mortality4
Compared to other oximeters, the INVOSTM regional oximeter has a significantly greater body of evidence demonstrating its performance and positive impact on patient outcomes. Hundreds of studies have evaluated the unique characteristics of the INVOSTM system for monitoring real-time changes in regional oxygen saturation (rSO2). These studies include a multitude of patient populations, settings, and interventions.1 Because the INVOSTM system's algorithm reacts differently to acute alterations in hemodynamics, oxygen saturation, and oxygen metabolism -- this evidence may not apply to other regional oximeters.7�11 The American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus states that NIRS devices from different manufacturers have significantly different measurements and thus are not interchangeable.11 Use this guide to review the evidence evaluating the uniqueness of the INVOSTM system's algorithm compared to other commercially available regional oximeters.

Significant differences in rSO2 measurements suggest NIRS devices are not interchangeable

Evaluation of different near-infrared spectroscopy devices for assessing tissue oxygenation with a vascular occlusion test in healthy volunteers

CHUNG J, JI SH, JANG YE, ET AL. (South Korea)

100%

80%

Mean rSO2 (%)

60% *
40%
20%

INVOSTM O3TM* (25:75) O3TM* (30:70)

0% Baseline rSO2

Minimum rSO2

Maximum rSO2

Figure: Comparison of INVOSTM system and Masimo O3TM* system (25:75 and 30:70) in baseline rSO2 measurement, minimum and maximum rSO2 measurement during vascular occlusion test

*INVOSTM regional oximeter measurements were significantly different from both Masimo O3TM* regional oximeter settings (P < 0.05). The two Masimo O3TM* regional oximeter settings were not significantly different.

Compared to the Masimo O3TM* regional oximeter, the INVOSTM regional oximeter had:

Significantly different
measurements of the
same clinical state

44%
faster reaction time during cuff release

Study of 20 healthy volunteers evaluating the Masimo O3TM* regional oximeter and INVOSTM regional oximeter in the measurement of tissue oxygenation during vascular occlusion
The Masimo O3TM* regional oximeter can measure arterial and venous blood at a 25:75 ratio or 30:70 ratio depending on the setting chosen. The INVOSTM regional oximeter measures arterial and venous blood at a 25:75 ratio.
The objective of the study was to compare the tissue rSO2 measurements recorded by the INVOSTM and the Masimo O3TM* regional oximeters (at both ratio settings - 25:75 & 30:70) during states of perfusion and occlusion.
Three sensors (INVOSTM, O3TM* - 25:75, O3TM* - 30:70) were placed on the arm simultaneously. Measurements were taken at baseline, following blood pressure cuff inflation (occlusion), and following blood pressure cuff deflation (reperfusion).
The findings
There were significant differences in the tissue rSO2 measurements between the devices during the same physiologic change (perfusion- occlusion- reperfusion), suggesting that these devices are not interchangeable.
� The INVOSTM regional oximeter's baseline rSO2 was higher than the Masimo O3TM* regional oximeter
� The INVOSTM regional oximeter's measurement decreased more rapidly during occlusion than the other device
� The lowest measurement of rSO2 by the INVOSTM regional oximeter was significantly higher than the lowest measurement of rSO2 by the Masimo O3TM* regional oximeter
� The peak measurement of rSO2 by the INVOSTM regional oximeter was significantly higher than the peak measurement of rSO2 by the Masimo O3TM* regional oximeter
� The INVOSTM regional oximeter's measurement increased more rapidly during cuff release (reperfusion) getting to its peak value faster than the comparison device
There were no significant differences between the Masimo O3TM* regional oximeter's settings (25:75 & 30:70). This indicates that different ratios of arterial and venous blood do not seem to be contributing to the difference in measurements from varying NIRS devices.

NIRS devices from different manufacturers demonstrate unique responses to changes in cerebral desaturation during hypoxia
Detection of critical cerebral desaturation thresholds by three regional oximeters during hypoxia: a pilot study in healthy volunteers.
TOMLIN KL, NEITENBACH AM, BORG U. (US)

Median rates of desaturation (%/min)

4.5

3.5

2.5

1.5

0 Desaturation 1

Desaturation 2

Figure: Median rates of absolute oxygen saturation change during desaturation

*P < 0.05; significant differences between device measurements

INVOSTM Nonin EQUANOXTM*

The INVOSTM regional oximeter detected a 10% relative change
28�43s
earlier than the Nonin EQUANOXTM* and Edwards Fore-SightTM* regional oximeters

Only the INVOSTM
regional oximeter detected a 20% relative decrease in rSO2
in all subjects

Pilot study of 10 healthy volunteers comparing cerebral rSO2 measurements from the INVOSTM regional oximeter to both the Nonin EQUANOXTM* and the Edwards ForeSightTM* regional oximeters during periods of hypoxia.
The findings
During both desaturation and resaturation, the INVOSTM regional oximeter had a significantly greater median rate of absolute rSO2 change, compared to the Nonin EquanoxTM* regional oximeter.
There was a trend towards greater median rate of absolute rSO2 change in the INVOSTM regional oximeter compared to the Edwards ForeSightTM* regional oximeter. However, the study was underpowered to detect a significant difference.
In subjects (n = 6) with both the INVOSTM and Nonin EquanoxTM* regional oximeter sensors, the INVOSTM regional oximeter detected a 20 percent relative decrease from baseline in all subjects and a decrease to the absolute threshold of 50 percent in four subjects, while the Nonin EquanoxTM* regional oximeter only detected the 20 percent decrease in one subject.
In subjects (n = 4) with both the INVOSTM and the Edwards ForeSightTM* regional oximeter sensors, the INVOSTM regional oximeter detected a 20 percent relative decrease from baseline in all subjects and a decrease to an absolute threshold of 50 percent in three subjects while the Edwards ForeSightTM* regional oximeter only detected the 20 percent decrease in two subjects.

Peripheral rSO2 measurements by the INVOSTM regional oximeter and Nonin EquanoxTM* regional oximeter vary significantly in absolute change and rate of change during vascular occlusion tests
Dynamic evaluation of near-infrared peripheral oximetry in healthy volunteers: a comparison between INVOS and Equanox
FELLAHI JL, BUTIN G, FISCHER MO, ET AL. (France)

Mean rSO2 (%)

100

INVOSTM

Nonin EQUANOXTM* 60

0 Baseline

Hyperoxia

Ischemia

Reperfusion

Figure: Mean measurements of peripheral left leg rSO2 with both INVOSTM and Nonin EQUANOXTM* regional oximeters following hyperoxia, ischemia, and reperfusion

The INVOSTM regional oximeter had a
significantly quicker
desaturation and resaturation rate
compared to the Nonin EQUANOXTM*
regional oximeter

No significant correlation
between measurements by the two devices

Study of 20 healthy volunteers undergoing vascular occlusion testing in their left leg comparing measurements of rSO2 from the INVOSTM regional oximeter and Nonin EQUANOXTM* regional oximeter.
The findings
Inducement of ischemia resulted in a significant reduction from baseline in both monitors. Subsequent reperfusion resulted in significant increase above baseline in both monitors. The INVOSTM regional oximeter decreased 33 percent and the Nonin EQUANOXTM* regional oximeter decreased 21 percent
from baseline during the occlusive vascular test.
The rate of desaturation (3.65 percent vs. 2.36 percent, P = 0.027) and resaturation (30.42 percent vs. 16.28 percent P = 0.004) per minute was significantly greater in the INVOSTM regional oximeter compared to the Nonin EQUANOXTM* regional oximeter.

The INVOSTM regional oximeter and the Edwards ForeSightTM* regional oximeter demonstrated significant differences in absolute values and degree of responsiveness to hemodynamic changes
Relation between mixed venous oxygen saturation and cerebral oxygen saturation measured by absolute and relative near-infrared spectroscopy during off-pump coronary artery bypass grafting
MOERMAN A, VANDENPLAS G, BOVE T, ET AL. (Belgium)

INVOSTM Edwards ForeSightTM*

rSO2 (%)

Figure: Distribution of the regional cerebral oxygen saturation (rSO2) data measured with the Edwards ForeSightTM* regional oximeter and INVOSTM regional oximeter

The INVOSTM regional oximeter measurements had a
significantly more positive correlation
with MAP and SvO2 than the Edwards ForeSightTM* regional oximeter measurements
Study of 42 patients undergoing off-pump coronary artery bypass graft surgery comparing measurements of cerebral rSO2 by the INVOSTM regional oximeter and Edwards ForeSightTM* regional oximeter with mixed venous oxygen saturation (SvO2).
The findings
Changes in the INVOSTM regional oximeter measurements in response to hemodynamic changes resulting from placement of deep pericardial stitches were significantly greater than those by the Edwards ForeSightTM* regional oximeter (P < 0.001).
When both sensors were running simultaneously, the Edwards ForeSightTM* regional oximeter experienced interference from the INVOSTM regional oximeter sensor causing more variability in its measurements.
For each percent change in SvO2, there was a significantly greater percentage change in the INVOSTM regional oximeter measurements compared to the Edwards ForeSightTM* regional oximeter
There was a significantly more positive slope of rSO2 versus MAP for the INVOSTM regional oximeter measurements compared with the Edwards ForeSightTM* regional oximeter (P = 0.001).
The ratio of changes in rSO2 to changes in MAP was significantly greater for the INVOSTM regional oximeter (21 versus 11, P < 0.001).

Evidence generated with one NIRS device may not be applied to other manufacturer's devices due to measurement variation

The effects of systemic oxygenation on cerebral oxygen saturation and its relationship to mixed venous oxygen saturation: a prospective observational study comparison of the INVOS system and ForeSight Elite cerebral oximeters
SCHMIDT C, HERINGLAKE M, KELLNER P, ET AL. (Germany)

Mean rSO2 (%)

58
* 56

High Inspiratory Oxygen

Low Inspiratory Oxygen

Figure: Mean minimum measurement of rSO2 during high and low inspiratory oxygen *P < 0.01 ; rSO2 measurements significantly different during low inspiratory oxygen

INVOSTM
Edwards ForeSightTM* Elite

During low oxygen levels, the INVOSTM regional oximeter had
significantly lower
readings of rSO2 compared to the Edwards ForeSightTM* Elite regional oximeter

Study of 48 extubated postcardiac surgery patients exposed to high and low oxygen delivery comparing rSO2 measurements by the INVOSTM regional oximeter and the Edwards ForeSightTM* Elite regional oximeter to mixed venous oxygen saturation (SvO2). The findings
The INVOSTM regional oximeter reported significantly lower median and mean minimum rSO2 during low oxygen delivery data collection only.
During individual measurement periods, rSO2 measured by the INVOSTM regional oximeter during low and high oxygen delivery showed significant correlations with SvO2. No significant correlation was seen between the Edwards ForeSightTM* Elite regional oximeter measurements and SvO2.
When the high and low data were combined for each device, the correlation coefficients (based on minimum rSO2 measured versus minimum SvO2 measured) were significantly different (P = 0.008) � INVOSTM regional oximeter: r = 0.59 (P = 0.001) � Edwards ForeSightTM* Elite regional oximeter: r = 0.28 (P = 0.006)
The area under the receiver-operating curve for detecting low SvO2 with the minimum rSO2 value was also different between the two devices: � SvO2 <50 percent: INVOSTM regional oximeter = 0.83 (P = 0.005); Edwards ForeSightTM* Elite regional oximeter = 0.51 (P = 0.12) � SvO2 <60 percent: INVOSTM regional oximeter = 0.76 (P < 0.001); Edwards ForeSightTM* Elite regional oximeter = 0.61 (P = 0.92)
6

Device-specific thresholds determined by interventional trials are required to guide interventions
Direct comparison between cerebral oximetry by INVOSTM and EquanoxTM* during cardiac surgery: a pilot study
PISANO A, GALDIERI N, LOVINO TP, ET AL. (Italy)

Table: Type of surgery and number of desaturations 20 percent from baseline (displayed by one or both of the two devices)

Patient Type of Surgery

AVR

CABG

OPCAB

MVR

CABG

AVR

MVR

OPCAB

MVR

# of Desaturations 20% from Baseline

INVOSTM

Nonin EQUANOXTM* Both

AVR = aortic valve replacement; CABG = coronary artery bypass graft; OPCAB = off-pump coronary artery bypass; MVR = mitral valve replacement

Cerebral desaturation
events (CDE) are defined as
20%
decrease in rSO2
from baseline

The INVOSTM regional oximeter
detected almost
7x
more CDEs than the Nonin
EQUANOXTM* regional oximeter

Study of 10 patients undergoing cardiac surgery on and off pump comparing simultaneous measurements of rSO2 by INVOSTM and Nonin EQUANOXTM* regional oximeters.
The findings
The INVOSTM regional oximeter captured 20 instances in four patients where oxygen saturation reduction was greater than or equal to 20 percent from the baseline value.
The Nonin EQUANOXTM* regional oximeter captured three instances in one patient where oxygen saturation reduction was greater than or equal to 20 percent from the baseline value.
The mean bias between the INVOSTM and Nonin EQUANOXTM* regional oximeters was -5.10 percent. The limits of agreement between the INVOSTM regional oximeter and Nonin EQUANOXTM* regional oximeter were
�16.37 percent.

REFERENCES 1. Medtronic Inc. Data on file. 2. Colak Z, Borojevic M, Bogovic A, Ivancan V, Biocina B, Majeric-Kogler V. Influence of intraoperative cerebral oximetry
monitoring on neurocognitive function after coronary artery bypass surgery: a randomized, prospective study. Eur J Cardiothorac Surg. 2015;47(3)447�454. 3. Slater JP, Guarino T, Stack J, et al. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009;87(1):36�44; discussion 44�35. 4. Heringlake M, Garbers C, Kabler JH, et al. Preoperative cerebral oxygen saturation and clinical outcomes in cardiac surgery. Anesthesiology. 2011;114(1):58�69. 5. Murkin JM, Adams SJ, Novick RJ, et al. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007;104(1):51�58. 6. Schoen J, Husemann L, Tiemeyer C, et al. Cognitive function after sevoflurane- vs propofol-based anaesthesia for onpump cardiac surgery: a randomized controlled trial. Br J Anaesth. 2011;106(6):840�850. 7. Tomlin KL, Neitenbach AM, Borg U. Detection of critical cerebral desaturation thresholds by three regional oximeters during hypoxia: a pilot study in healthy volunteers. BMC Anesthesiol. 2017;17(1):6. 8. Schmidt C, Heringlake M, Kellner P, et al. The effects of systemic oxygenation on cerebral oxygen saturation and its relationship to mixed venous oxygen saturation: A prospective observational study comparison of the INVOS and ForeSight Elite cerebral oximeters. Can J Anaesth. 2018 Jul;65(7):766�775. 9. Chung J, Ji SH, Jang YE, et al. Evaluation of Different Near-Infrared Spectroscopy Devices for Assessing Tissue Oxygenation with a Vascular Occlusion Test in Healthy Volunteers [published online ahead of print, 2020 Sep 7]. J Vasc Res. 2020;1�7. 10. Fellahi JL, Butin G, Fischer MO, Zamparini G, G�rard JL, Hanouz JL. Dynamic evaluation of near-infrared peripheral oximetry in healthy volunteers: a comparison between INVOS and EQUANOX. J Crit Care. 2013;28(5):881.e1�881.e8816. 11. Thiele RH, Shaw AD, Bartels K, et al. Perioperative Quality Initiative (POQI) 6 Workgroup. American society for enhanced recovery and perioperative quality initiative joint consensus statement on the role of neuromonitoring in perioperative outcomes: cerebral near-infrared spectroscopy. Anesth Analg. 2020 Nov;131(5):1444�1455. 12. Moerman A, Vandenplas G, Bov� T, Wouters PF, De Hert SG. Relation between mixed venous oxygen saturation and cerebral oxygen saturation measured by absolute and relative near-infrared spectroscopy during off-pump coronary artery bypass grafting. Br J Anaesth. 2013;110(2):258-265. 13. Pisano A, Galdieri N, Iovino TP, Angelone M, Corcione A. Direct comparison between cerebral oximetry by INVOSTM and EQUANOXTM during cardiac surgery: a pilot study. Heart Lung Vessel. 2014;6(3):197-203.
The INVOSTM monitoring system should not be used as the sole basis for diagnosis or therapy and is intended only as an adjunct in patient assessment. Reliance on the INVOSTM system alone for detecting cerebral desaturation events is not recommended
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