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PiCCO plus

PULSION Medical Systems AG. PiCCO plus. PiCCOplus_highLevel_R10_EN_020205. Contents. Page:. What is the PiCCO-Technology? 3 What are the advantages of the PiCCO-Technology? 5 How does the PiCCO-Technology work? 6 How to use the PiCCO-Technology? 57

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PiCCO plus

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  1. PULSION Medical Systems AG PiCCOplus PiCCOplus_highLevel_R10_EN_020205

  2. Contents Page: • What is the PiCCO-Technology? 3 • What are the advantages of the PiCCO-Technology? 5 • How does the PiCCO-Technology work? 6 • How to use the PiCCO-Technology? 57 • Which disposables do I need for the PiCCO-Technology? 58 • References 60 • Where can I get what I need? 61 • Philips PiCCO – Module 62 • Other PULSION Products 63 • PiCCO-Technology in USA 64

  3. T injection t P t 1.What is the PiCCO-Technology? • The PiCCO-Technology is a unique combination of 2 techniques • for advanced hemodynamic and volumetric management without • the necessity of a right heart catheter in most patients: Transpulmonary Thermodilution CV Bolus injection CALIBRATION PULSIOCATH Pulse Contour Analysis

  4. Parameters measured with the PiCCO-Technology The PiCCO measures the following parameters: • Thermodilution Parameters • Cardiac Output CO • Global End-Diastolic Volume GEDV • Intrathoracic Blood Volume ITBV • Extravascular Lung Water EVLW* • Pulmonary Vascular Permeability Index PVPI* • Cardiac Function Index CFI • Global Ejection Fraction GEF • Pulse Contour Parameters • Pulse Contour Cardiac Output PCCO • Arterial Blood Pressure AP • Heart Rate HR • Stroke Volume SV • Stroke Volume Variation SVV • Pulse Pressure Variation PPV • Systemic Vascular Resistance SVR • Index of Left Ventricular Contractility dPmx* * not available in the USA (p 63)

  5. 2.What are the advantages of the PiCCO-Technology? • Less Invasiveness - Only central venous and arterial access required - No pulmonary artery catheter required - Also applicable in small children • Short Set-up Time - Can be installed within minutes • Dynamic, Continuous Measurement - Cardiac Output, Afterload and Volume Responsiveness are measured Beat by Beat • No Chest X-ray - To confirm correct catheter position • Cost Effective -Less expensive than continuous pulmonary artery catheter - Arterial PiCCO catheter can be in place for 10 days - Potential to reduce ICU stay and costs • More Specific Parameters - PiCCO parameters are easy to use and interpret even for less experienced caregivers • Extravascular Lung Water* - Lung edema can be excluded or quantified at the bed-side * not available in the USA (p 63)

  6. 3.How does the PiCCO-Technology work? • Most of hemodynamic unstable and/or severely hypoxemic patients are • instrumented with: Central venous line (e.g. for vasoactive agents administration…) Arterial line (accurate monitoring of arterial pressure, blood samples…) • The PiCCO-Technology uses any standard CV-line and a thermistor- • tipped arterial PiCCO-catheter instead of the standard arterial line.

  7. PiCCO Catheter • Central venous line(CV) • PULSIOCATH thermodilution catheter with lumen for arterial pressure measurement • Axillary: 4F (1,4mm) 8cm • Brachial: 4F (1,4mm) 22cm • Femoral: 3-5F (0,9-1,7mm) 7-20cm • Radial: 4F (1,4mm) 50cm CV A B R F No Right Heart Catheter !

  8. PiCCOplus setup Central Venous Catheter Injectate temperature sensor housing 13.03 16.28TB37.0 AP AP 140 117 92 (CVP) 5 SVRI 2762 PC CI 3.24 HR 78 SVI 42 SVV 5% dPmx 1140 (GEDI) 625 PCCI Pressure cable Injectate temperature sensor cable Temperature interface cable PULSION disposable pressure transducer PULSIOCATH thermodilution catheter

  9. Right Heart Left Heart EVLW* RV PBV LV RA LA EVLW* A. Thermodilution parameters PiCCO Catheter e.g. in femoral artery Bolus Injection • Transpulmonary thermodilution • measurement only requires • central venous injection of a cold • (< 8°C) or room-tempered • (< 24°C) saline bolus… Lungs * not available in the USA (p 63)

  10. Transpulmonary thermodilution: Cardiac Output • After central venous injection of the indicator, the thermistor at the tip of the arterial • catheter measures the downstream temperature changes. • Cardiac output is calculated by analysis of the thermodilution curve using a modified • Stewart-Hamilton algorithm: injection Tb CO Calculation:  Area under the Thermodilution Curve t Tb = Blood temperature Ti = Injectate temperature Vi = Injectate volume ∫ ∆ Tb .dt = Area under the thermodilution curve K = Correction constant, made up of specific weight and specific heat of blood and injectate • For correct calculation of CO, only a fraction of the total injected indicator needs to pass • the detection site. Simplified, only the change of temperature over time is relevant.

  11. Transpulmonary thermodilution: Volumetric parameters 1 • All volumetric parameters are obtained by advanced analysis of the thermodilution curve: For the calculations of volumes… Advanced Thermodilution Curve Analysis Tb Mtt: Mean Transit time time when half of the indicator has passed the point of detection in the artery injection recirculation ln Tb …and… -1 e DSt: Down Slope time exponential downslope time of the thermodilution curve t DSt MTt …are important.

  12. LAEDV Transpulmonary thermodilution: Volumetric parameters 2 After injection, the indicator passes the following intrathoracic compartments: ITTV PTV Thermodilution curve measured with arterial catheter CV Bolus Injection RVEDV LVEDV RAEDV Lungs Left Heart Right Heart • The intrathoracic compartments can be considered as a series of “mixing chambers” • for the distribution of the injected indicator (intrathoracic thermal volume). • The largest mixing chamber in this series are the lungs, here the indicator (cold) has its • largest distribution volume (largest thermal volume).

  13. LAEDV Transpulmonary thermodilution: Newman Model ITTV PTV injection detection RVEDV LVEDV RAEDV Lungs Left Heart Right Heart flow • Multiplication of MTt (Mean Transit time) with CO results in the complete • Inttrathoracic Thermal Volume (ITTV) which is the whole needle to needle volume. ITTV =RAEDV + RVEDV + Lungs + LAEDV + LVEDV = MTt x Flow (CO) • Multiplication of DSt (Downslope time) with CO yields the largest mixing volume • which is the lungs. PTV =Thermal Volume of the Lungs= DSt x Flow (CO) Newman et al, Circulation 1951

  14. Global End-Diastolic Volume GEDV • Global End-Diastolic Volume (GEDV) • is the volume of blood contained in • the 4 chambers of the heart, in the • end-diastoly, each. GEDV • GEDV is calculated by subtraction of • PTV from ITTV. PTV RVEDV LVEDV RAEDV LAEDV GEDV = ITTV - PTV ITTV

  15. PBV LVEDV RVEDV LAEDV Intrathoracic Blood Volume • Intrathoracic Blood Volume (ITBV) • is Global End-Diastolic Volume (GEDV) • + the blood volume in the pulmonary • vessels (PBV). ITBV= PBV + GEDV RAEDV ITBV can be directly measured with thermal dye dilution technique (COLD System) and has shown to be consistently 25% greater than GEDV measured by single thermodilution technique (PiCCO). Therefore it is possible to compute ITBV based on measurement of GEDV: ITBV = 1,25 x GEDV ITBVTD (ml) r = 0.96 ITBV = 1.25 * GEDV – 28.4 [ml] GEDV vs. ITBV in 57 intensive care patients Sakka et al, Intensive Care Med 26: 180-187, 2000

  16. LAEDV LVEDV RAEDV RVEDV PTV PBV LVEDV RAEDV RVEDV LAEDV EVLW* EVLW* Extravascular Lung Water* • Extravascular Lung Water (EVLW*) represents the amount of water content of the • lungs and is calculated by subtraction of ITBV from ITTV. ITTV ITBV = EVLW* * not available in the USA (p 63)

  17. PBV LVEDV RAEDV RVEDV LAEDV EVLW* EVLW* Calculation of volumes - Summary ITTV = CO * MTtTDa LAEDV RAEDV RVEDV LVEDV PTV PTV = CO * DStTDa PTV GEDV= ITTV - PTV LAEDV RAEDV RVEDV LVEDV ITBV= 1.25 * GEDV EVLW* = ITTV - ITBV * not available in the USA (p 63)

  18. Pulmonary Vascular Permeability Index • Pulmonary Vascular Permeability Index (PVPI*) is the ratio of Extravascular • Lung Water (EVLW*) to pulmonary blood volume (PBV). It allows to identify the • type of pulmonary oedema. normal EVLW* EVLW*  PBV Normal Lungs PVPI* = PBV normal Extra Vascular Lung Water Pulmonarv Blood Volume normal elevated EVLW* EVLW* Hydrostatic pulmonary edema  PBV PVPI *= PBV normal elevated elevated Permeability pulmonary edema EVLW* EVLW*  PVPI* = PBV PBV elevated normal * not available in the USA (p 63)

  19. SV SV RVEF = LVEF = RVEDV LVEDV Global Ejection Fraction • Ejection Fraction: Stroke Volume related to End-Diastolic Volume Lungs Left Heart Right Heart EVLW* PBV RAEDV RVEDV EVLW* LAEDV LVEDV Stroke Volume SV 3 2 1 &  4 x SV GEF = GEDV Global Ejection Fraction (GEF) (transpulmonary thermodilution) RV ejection fraction (RVEF) (pulmonary artery thermodilution) LV ejection fraction (LVEF) (echocardiography) * not available in the USA (p 63)

  20. b. Arterial Pulse Contour Analysis P [mm Hg] t [s]

  21. -∆T -∆T t t P [mm Hg] SV t [s] Pulse Contour Analysis - Principle • Arterial pulse contour analysis provides continuous Beat by Beat parameters • obtained from the shape of the arterial pressure wave. • The algorithm is capable of computing each single strokevolume (SV) after • being calibrated by an initial transpulmonary thermodilution. Reference CO value from thermodilution Measured blood pressure(P(t), MAP, CVP) Calibration

  22.  P(t) dP PCCO = cal • HR • ( + C(p) • ) dt SVR dt Systole Calculation of Beat by Beat Pulse Contour Cardiac Output • Rise and fall of the blood pressure curve is • also dependent on the patient´s individual • aortic compliance. P(t), Diastole P(t), Systole • After calibration, the pulse contour Algorithm is able to follow the cardiac output • Beat by Beat. P [mm Hg] t [s] Heart rate Shape of pressure curve Aortic compliance Patient-specific calibration factor (determined by thermodilution) Area under pressure curve

  23. P [mm Hg] t [s] Index of Left Ventricular Contractility* • dPmx* = dP/dtmax of arterial pressure curve • dPmx* represents left ventricular pressure velocity increase and thus is a • parameter of myocardial contractility * not available in the USA (p 63)

  24. SVmax – SVmin SVV = SVmean Stroke Volume Variation: Calculation • Stroke Volume Variation (SVV) represents the variation of stroke volume (SV) over the • ventilatory cycle. SVmax SVmin SVmean • SVV is... • ... measured over last 30s window • … only applicable in controlled mechanically ventilated patients with regular heart rhythm

  25. Pulse Pressure Variation: Calculation • Pulse pressure variation (PPV) represents the variation of the pulse pressure • over the ventilatory cycle. PPmean PPmax PPmin PPmax – PPmin PPV = PPmean • PPV is... • …measured over last 30s window • …only applicable in controlled mechanically ventilated patients with regular beat rhythm

  26. Validation of PiCCO - Parameters a. Cardiac Output

  27. Validation of Transpulmonary Thermodilution

  28. Validation of Pulse Contour Analysis • These tables are only an excerpt of publications, in total there are more than 200 articles on the PiCCO-Technology.

  29. Validation of PiCCO - Parameters b. Volumetric Parameters

  30. Thermodilution ITBVIST vs. double indicator dilution ITBVITD • ITBV (thermodilution) is calculated by GEDV x 1,25 (see also page 15). • ITBV significantly correlates to ITBV (dye dilution), which is the Gold-Standard. ST ST TD n = 209 r = 0.97 Bias = -7.6 ml/m2SD = 57.4 ml/m2 ITBVIST vs. ITBVITD in 209 critically ill patients Sakka et al, Intensive Care Med 26: 180-187, 2000

  31. Validation of Extravascular Lung Water* 1 • Extavascular Lung Water (EVLW*) by double indicator dilution (COLD-SystemTM) • compared to gravimetric EVLW* measurement in brain-dead humans. Sturm, In: Practical Applications of Fiberoptics in Critical Care Monitoring Springer Verlag Berlin - Heidelberg - NewYork 1990, pp 129-139 * not available in the USA (p 63)

  32. R = 0,97 P < 0,001 Validation of EVLW* 2 • PiCCO – EVLW* vs. gravimetric EVLW* • in animals with cardiogenic + noncardiogenic Pulmonary Edema Katzenelson et al,Crit Care Med 32 (7), 2004 in 15 dogs R = 0,85 P < 0,0001 Kirov et al, Crit Care 8 (6), 2004 in 18 sheep * not available in the USA (p 63)

  33. EVLW* measurement with thermodilution technique TM • Validation of Extravascular Lung Water* measurement with the COLD System: • Dye dilution (EVLW ) vs. single thermodilution technique (EVLW ) ST TD n = 209 r = 0.96 Bias = -0.2 ml/kgSD = 1.4 ml/kg EVLWI*ST vs. EVLWI*TD in 209 intensive care patients Sakka et al, Intensive Care Med 26: 180-187, 2000 * not available in the USA (p 63)

  34. Clinical Application Volume Drugs

  35. Drugs Volume PiCCO answers all relevant questions: CO GEDV SVV SVR EVLW* • What is the current situation?.………..……..………….Cardiac Output! • What is the preload?.……………….....…Global End-Diastolic Volume! • Will volume increase CO?....………...……….Stroke Volume Variation! • What is the afterload?……………..…..Systemic Vascular Resistance! • Are the lungs still dry?...…….……...…..….Extravascular Lung Water!* * not available in the USA (p 63)

  36. PiCCO preload indicators • Global End-Diastolic Volume, GEDV andIntrathoracic Blood Volume, ITBV have shown to be far more sensitive and specific to cardiac preload compared to • the standard cardiac filling pressures CVP + PCWP as well as right ventricular enddiastolic volume. 2,3,6,7,9,10,12,15,16,25 • The striking advantage of GEDV and ITBV is that they are not adversely influenced • by mechanical ventilation and give correct information of the preload status under any condition. 2,3,7,8,9,10,15,16, 25 • Following charts 12,16 show a highly significant correlation of PiCCO preload volume to cardiac index or stroke volume index, whereas filling pressure show lack of correlation.

  37. Pressure or volume as indicator of Cardiac Preload? 1 Relationship between changes in cardiac index (ΔCI) and changes in central venouse pressure (ΔCVP), pulmonary capillary wedge pressure (ΔPCWP), or intrathotracic blood volume index (ΔITBI) in patients with acute respitarory failure and mechanical ventilation. 16 Lichtwarck-Aschoff et al, Intensive Care Med 18: 142-147, 1992

  38. Pressure or volume as indicator of Cardiac Preload? 2 “GEDV is a more reliable preload parameter than PCWP and CVP“ Goedje et al, Chest 2000

  39. Extravascular Lung Water* • Extravascular Lung Water, EVLW* assessment by transpulmonary thermodilution • has been validated against dye dilution and the reference gravimetric method.13,14, 19,24,26 • Extravascular Lung Water, EVLW* has shown to have a clear correlation to • severity of ARDS, length of ventilation days, ICU-Stay and Mortality and is • superior to assessment of lung edema by chest x-ray and clearly indicates fluid overload. 8,9,18,23,26,27 * not available in the USA (p 63)

  40. Comparison of EVLW* to Chest X-ray Source Comparison Correlation Baudendistel et al, 1982, J Trauma 22: 983 X-ray score vs.EVLW*77 % Sibbald et al, 1983, Chest 83: 725comparison cardiac edemar = 0,66 comparison non cardiac edemar = 0,7 Sivak et al, 1983, Crit Care Med. 11: 498X-ray score vs EVLW*64 %  X-ray score vs.  EVLW*42 % Laggner et al, 1984, Intensive Care Med. 10: 309X-ray score vs. EVLW*r = 0,84 no / low / high PE, estimated by radiologists Halperin et al, 1985, Chest 88: 649 X-ray score vs.  EVLW* r = 0,51 Haller et al, 1985, Fortschr. Röntgenstr. 142: 68 X-ray score vs. EVLW*66 % Eisenberg et al, 1987, Am Rev Resp Dis 136: 662 X-ray score vs. EVLW*76 % Takeda et al, 1995, JVet Med Sci 57 (3): 481 X-ray score vs. EVLW* X-ray insensitive • Chest X-ray is often influenced by pleural effusion and technical problems of • radiography at the bedside. * not available in the USA (p 63)

  41. EVLW* and oxygenation Capillary Alveola Erythrocyte 1 * 2 Alveola Interstitial space Moderate to high lungwater values are not necessarily related to a decrease in oxygenation. Lung water accumulates first in the free interstitial space (1). If lung water increases further, it penetrates into the restricted interstitial space (2) and the gas exchange is affected 26. Böck, Lewis, In: Practical Applications of Fiberoptics in Critical Care Monitoring, Springer Verlag Berlin - Heidelberg - NewYork 1990, pp 129-139 * not available in the USA (p 63)

  42. EVLW* and mortality 1 • There is a direct relationship between the amount of lung edema and patient prognosis. • An increase of mortality to more than 70% can be observed with increasing EVLW*. > Mortality as function of EVLW* in 81 critically ill ICU patients. Sturm, In: Practical Applications of Fiberoptics in Critical Care Monitoring, Springer Verlag Berlin - Heidelberg - NewYork 1990, pp 129-139 * not available in the USA (p 63)

  43. EVLW* and mortality 2 ELWI* [ml/ kg] Mortality as function of ELWI* in 373 critically ill ICU patients: 193 sepsis, 49 ARDS, 48 head trauma, 83 hemorrage and hemorrhagic shock. Patients were classified into four groups according to their highest EVLW* value. Sakka et al , Chest 2002 * not available in the USA (p 63)

  44. Relevance of EVLW* - Management Ventilation days ICU days n=101 * * PAC group EVLW* group PAC group EVLW* group 22 days 9 days 15 days 7 days 101 patients with pulmonary edema were randomized to a pulmonary artery catheter (PAC) management group in whom fluid management decisions were guided by PCWP measurements and to an Extravascular Lung Water (EVLW*) management group using a protocol based on the bedside measurement of EVLW *. ICU days and ventilator-days were significantly shorter in patients of the EVLW* group. Mitchell et al, Am Rev Resp Dis 145: 990-998, 1992 * not available in the USA (p 63)

  45. ELWI* and GEDI in septic patients ELWI* , [ml/kg] ELWI * [ml/kg] ELWI* [ml/kg] 500 1000 1500 2000 CVP [mmHg] PCWP [mmHg] GEDI [ml/m2] Intravascular volume monitoring and ELWI* in septic patients with pulmonary oedema. No significant correlation between ELWI* and CVP or PCWP was found. There was a significant correlation between ELWI* and GEDI. Boussat et al, Intensive Care Med, 2002 * not available in the USA (p 63)

  46. Pulmonary Vascular Permeability Index* 1 Normal GEDI PVP increased ELWI* [ml/kg] PVP normal 560 680 800 960 GEDI [ml/m2] Relationship of ELWI* to volume status in a patient with increased pulmonary vascular permeability (PVP) and in a patient with normal permeability: High PVP leads to increased ELWI* even with moderate volume loading and increases dramatically if the patient is volume overloaded. Unpublished data * not available in the USA (p 63)

  47. Pulmonary Vascular Permeability Index* 2 4 PVPI* 3 CAP CHF 2 Pulmonary vascular permeability Index (PVPI*) in 16 patients with congestive heart failure (CHF) and community acquired pneumonia (CAP). ELWI* was 16 ml/kg in both groups, PVPI* allowed to identify patients suffering from capillary leakage. from Benedikz et al ESICM 2002 * not available in the USA (p 63)

  48. Global Ejection Fraction and Cardiac Function Index GEF and CFI provide a reliable evaluation of LV systolic function. Low CFI and GEF can be considered as an indicator to perform an echocardiography to discriminate between right and left ventricular dysfunction.5 Combes et al, Intensive Care Med 30, 2004

  49. 3 l/min 30min. PCCO Aortic flow probe 0 PiCCO - Cardiac Output during Off-Pump Coronary Surgery • PCCO is fast responding, Beat by Beat! Cardiac output monitoring during off-pump CABG. PiCCO derived continuous cardiac output (PCCO) closely follows the flow measured with an aortic Doppler flow probe. data from Dr. S. Thierry Henri Mondor Hospital, Créteil, France, 2003

  50. Stroke Volume Variation - SVV In controlled mechanically ventilated patients without arrhythmia, • SVV reflects the sensitivity of the heart to the cyclic changes in cardiac • preload induced by mechanical ventilation.1,17,20,21,22 • SVV can predict whether stroke volume will increase with volume • expansion and by this avoid time consuming volume challenge.1,17,20,21,22 • SVV = ON-LINE CARDIAC VOLUME RESPONSIVENSS

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