Non-invasive liver function monitoring

LiMON_E_V02_03_02.PPT

PULSION LiMON

Page 1

PICG0025 ICG-PULSION 25 mg PICG0050 ICG-PULSION 50 mg Setup Configuration PC5000 LiMON PC50150 LiMON reusable sensor for adults and infants PV50100 LiMON disposable sensor for adults and infants PV50200 LiMON disposable sensor for neonates

Page 2 LiMON_E_V02_03_02.PPT

Pulse Densitometry Based on Pulse Oximetry

LEDs 805 nm & 905 nm Sensor C ICG mg/l 40 30 20 10 0 0 10 20 30 40 50 [s] LiMON_E_V02_03_02.PPT

pulsatile 805 nm non pulsatile 805 nm pulsatile 905 nm non pulsatile 905 nm pulsatile 905 nm C ICG = non pulsatile 905 nm pulsatile 805 nm non pulsatile 805 nm Page 3

C ICG mg/l ICG Dilution Curve Analysis calculation of half life time and elimination rate of ICG-PULSION dynamically determined range for back extrapolation

LiMON_E_V02_03_02.PPT

Page 4

Parameters Global liver function from elimination of ICG-PULSION:

• Plasma Disappearance Rate of ICG PDR (%/min) • ICG Retention Rate after 15 min

R15 (%)

• ICG Clearance

CB (ml/min)

• Circulating Blood Volume

BV (ml) Pulse oximetry

• Oxygen Saturation • Heart Rate

SpO2 (%) HR (bpm)

Page 5 LiMON_E_V02_03_02.PPT

Calculations and Normal Ranges Parameter PDR (%/min) R15 (%) CBI (ml/min/m 2 ) BVI (ml/m 2 ) Calculation ln2/t 1/2



100 C ICG15m / C ICG t=0



100 BV



PDR / BSA [ICG] inj / C ICG t=0 / BSA Normal Range 18 – 25 0 – 10 500 – 750 2600 - 3200

Page 6 LiMON_E_V02_03_02.PPT

Validation Invasive COLD System vs non-invasive LiMON (16 pts, n=54)

Sakka S, Meier-Hellmann A: International Journal of Intensive Care, 2002 LiMON_E_V02_03_02.PPT

Page 7

Fields of Clinical Application

• All critically patients, especially those with sepsis, acute

liver or multi-organ failure, and after multiple trauma

• Patients with chronically reduced hepatic function

(hepatitis, liver cirrhosis)

• Evaluation of liver function in organ donors and recipients • Monitoring of liver function during liver or abdominal

surgery (resection, porto-caval shunt)

• Diagnosis and monitoring of congenital liver failure in

children and neonates

Page 8 LiMON_E_V02_03_02.PPT

Application in Intensive Care More than 50% of surgical ICU patients exhibit reduced PDR accompanied with a higher mortality normal range

Sakka S, Meier-Hellmann A: International Journal of Intensive Care, 2002 LiMON_E_V02_03_02.PPT

Page 9

Prognosis of Survival in ICU Patients Significantly reduced liver function in non-survivors

45 40 35 30 25 20 15 10 5 0

*

Survivors n= 168 Non-survivors n= 168 Sakka SG, Meier-Hellmann A: Yearbook of Intensive Care and Emergency Medicine, 2001 LiMON_E_V02_03_02.PPT

* (p< 0.001) Page 10

Prognosis of Survival in ICU Patients Clear indicator of probability of survival in septic shock (Survivors) (Non-survivors) Conclusion:

Increase of reduced ICG elimination during the first 120 hours of septic shock predicts survival, whereas no change or even further decrease of ICG elimination predicts non-survival Kimura S et al: Crit Care Med 2001 LiMON_E_V02_03_02.PPT

Page 11

Value as Liver Function Test in Intensive Care Higher sensitivity and specificity than bilirubin

BILIRUBIN ICG-PDR 100 80 (>15.2) n= 336 p= 0.06

(>33.8) 60 40 20 0 0 20 40 60 100-Specificity [%] 80 100 Sakka SG, Meier-Hellmann A: Yearbook of Intensive Care and Emergency Medicine, 2001 LiMON_E_V02_03_02.PPT

Page 12

Liver Function in Organ Donors Clear borderline for transplantation suitability

Wesslau C et al: Transplantology 1994 LiMON_E_V02_03_02.PPT

Page 13

Application After Liver Transplantation Clear borderline for probability of graft function

Jalan R et al: Transplantation 1994 LiMON_E_V02_03_02.PPT

Page 14

Value as Liver Function Test in Liver Surgery Better correlation with prognosis than laboratory parameters in cirrhotic patients

Hemming AW et al: Am J Surg 1992 LiMON_E_V02_03_02.PPT

Page 15

Value as Liver Function Test in Liver Surgery Correlation between parenchymal cell volume and ICG elimination

Hashimoto M and Watanabe G: J Surg Res 2000 LiMON_E_V02_03_02.PPT

Page 16

Advantages

Non-invasive measurement

Uses a 4 wavelength near-infra red finger clip sensor and any peripheral or central venous access for injection of ICG-PULSION

Quick information

Bed-side results are obtained within a few minutes (approx. 6-8 min.).

Specific parameters

ICG-PULSION elimination is well established for quantification of liver function and has prognostic value

Simple application

Results not user dependent, up to 10 measurements per 24 hours

Time and cost saving

Reduces the numbers of laboratory blood/plasma samples Page 17 LiMON_E_V02_03_02.PPT