Thrombelastograph® (TEG®) Coagulation Analyser Phillip Gray 25 January 2016 The TEG® System is indicated for use with adult patients when an evaluation of their blood hemostatic properties is desired. Results from the TEG analyser should not be the sole basis for a patient diagnosis; TEG results should be considered along with a clinical assessment of the patient’s condition and other coagulation laboratory tests. For Professional Use Only. Haemonetics, TEG, and Thrombelastograph are trademarks or registered trademarks of Haemonetics Corporation in the USA, other countries, or both. PlateletMapping is a registered trademark of Coramed Technologies, LLC. Effient is a registered trademark of Eli Lilly and Company. Plavix is a trademark of Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership. Please refer to the manuals for Indications for Use, Contraindications, Warnings, Precautions, and Potential Adverse Events. Individual Goal Directed Coagulation Management TEG 6s “Making the Complex Simple” 2 © Haemonetics Corporation What is TEG®? A real time analyser of whole blood allowing for individualised goal-directed therapy. Measures the viscoelastic properties of the haemostasis process functionally, with the endresult being a haemostatic plug, or clot. 3 © Haemonetics Corporation Clinical Practice: A Constant Struggle… 4 © Haemonetics Corporation Upsetting the balance Natural processes Injury Disease Aging Process Cholesterol Hardening of Arteries Vascular Constriction and Breakdown Blood Activation by Turbulence 5 © Haemonetics Corporation Upsetting the balance Human intervention Surgery Devices – LVADs, CPB, ECMO Trauma Drugs Stents Airplane Flights – DVT Smoking 6 © Haemonetics Corporation Complexity of haemostasis Multiple systems Cells 56+ proteins Dynamic Interactive 7 © Haemonetics Corporation The Coagulation Cascade Intrinsic Pathway Extrinsic Pathway Surface Contact Collagen FXII activator F XII Tissue/Cell Defect F XIIa F XI F IXa Ca2+ F VII F III (Tissue Thromboplastin) F VIIIa Platelet Factor 3 FX Ca2+ F Xa Ca2+ F Va Prothrombin II F XIIIa Crosslinked Fibrin Network Ca2+ F XIa Ca2+ F IX F VIII F VIIa Ca2+ FV Thrombin IIa F XIII Fibrin polymers Fibrin monomers Copyright © 2011 Haemonetics Corp. FX Fibrinogen Yellow lines indicate positive feedback loops lost in isolated tests Traditional haemostasis monitoring D-Dimer Traditional Hemostasis Tests 9 © Haemonetics Corporation Do not define the overall process, just provide pieces of the process! Cell-Based Model • • • Tissue factor bearing cells Reflects in vivo Occurring on cell surfaces Tissue factor bearing cells Platelets Overlapping phases: Initiation (TF bearing cells) Amplification (platelets) Propagation (platelets) 1. Initiation IIa 2. Amplification Platelets The coagulation cascades are still important, but are cell-based 3. Propagation extrinsic pathway: surface of tissue factor bearing cells intrinsic pathway: surface of platelets Routine coagulation tests do not represent the cell-based model of hemostasis IIa Activated platelets [Monroe, DM. et al. Arterioscler Thromb Vasc Biol. 2002;22:1381] 10 TEG Technology 11 © Haemonetics Corporation Haemostasis made simple with TEG 1- INITIATION Reaction INITIATION 1 12 © Haemonetics Corporation Haemostasis made simple with TEG (2/3) 1- INITIATION 2- STRENGTH Reaction INITIATION 1 13 © Haemonetics Corporation Maximum clot STRENGTH 2 Haemostasis made simple with TEG (3/3) 1- INITIATION 2- STRENGTH 3- STABILITY Reaction INITIATION 1 14 © Haemonetics Corporation Maximum clot STRENGTH 2 Clot degradation STABILITY 3 TEG® Core Assessment 1. INITIATION 1 2. STRENGTH INITIATION 3. STABILITY 2 15 STRENGTH © Haemonetics Corporation 3 STABILITY TEG® Trace – Diagnostic Complex 16 © Haemonetics Corporation Heparin/Enoxaparin Effect Heparinase cup Plain cup 5.8 17 2.2 © Haemonetics Corporation 59.1 0.0 56.2 6.4 Functional Fibrinogen TEG ® 18 © Haemonetics Corporation Fibrinogen/Platelet Ratio 19 © Haemonetics Corporation Fibrinogen/Platelet Ratio 20 © Haemonetics Corporation RapidTEG® Assay Tissue Factor and Kaolin Activation – RAPID test of CLOT STRENGTH and any FIBRINOLYSIS Also provides RAPID TEG® ACT Result 21 © Haemonetics Corporation Rapid TEG 22 © Haemonetics Corporation 4 TEST CONCEPT Kaolin Activated Heparinase Functional Fibrinogen Rapid TEG 23 © Haemonetics Corporation 4 TEST CONCEPT - Combination TEST Fast…Global…Sensitivity to All Phases… Rapid TEG Kaolin Activated Functional Fibrinogen Early Diagnosis ~10 Min 24 © Haemonetics Corporation The TEG5000 Today 25 © Haemonetics Corporation The TEG5000 Software Today 26 © Haemonetics Corporation The TEG6s………. TOMORROW 27 © Haemonetics Corporation TEG 6s “Making the Complex Simple! 28 © Haemonetics Corporation TEG 6s Test Procedure Patient Test Procedure 30 © Haemonetics Corporation TEG 6s Stand-Alone Device 31 © Haemonetics Corporation TEG 6s Complex Technology Resonance-frequency viscoelasticity measurements and disposable multi-channel microfluidic cartridges 32 © Haemonetics Corporation Sample Testing Sample ring subjected to external vibration 33 © Haemonetics Corporation Measurement Harmonic motion of sample measured optically Optical detection 34 © Haemonetics Corporation Sample Testing Animation Click to play 35 © Haemonetics Corporation Measurement As sample transitions from liquid to gel state, measurements are plotted: Clot strength vs. Time Clot strength Gel state Liquid state Time 36 © Haemonetics Corporation TEG 6s Tests 1. Global hemostasis cartridge (citrated tube - blue top) Kaolin TEG Contact activator in routine use Heparinase cups Neutralises heparin to allow you to see patients underlying haemostatic profile RapidTEG® Tissue Factor and Kaolin Activation – for rapid testing of clot strength and also provides TEG® ACT Result Functional Fibrinogen Functional fibrinogen reagent provides a functional measurement of patient fibrinogen level 2. PlateletMapping cartridge (heparin tube – green top) PlateletMapping® Gives personalised antiplatelet therapy for both haemorrhagic and thrombotic condition 3. QC cartridges Biological QC 37 © Haemonetics Corporation Level I and II The TEG 6s Making the Complex Simple Simplicity in Facilitating the Science of the Cell Based Model 38 © Haemonetics Corporation TEG 6s Advances the TEG 5000 legacy through simple, smart and reliable design Same Simple Assess same physical property/results Smart 39 © Haemonetics Corporation Reliable Global Haemostasis Assessment Kaolin TEG Heparinase effect Rapid TEG Functional Fibrinogen TEG 40 © Haemonetics Corporation TEG 6s COMBINATION TEST CONCEPT Global Impact: Fast and Specific Sensitivity Global Haemostasis Rapid TEG Kaolin Activated Functional Fibrinogen Early Diagnosis ~10 Min 41 © Haemonetics Corporation 1/17/2014 11:21 AM ID: patientID1 CM Citrated K,KH,RT,FF baseline 1/16/2014 11:21 80 CK 60 40 20 0 0 CRT 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 (min) CKH CFF results 42 next tracing device 1 User 1 1/17/2014 11:21 AM ID: patientID1 CM Citrated K,KH,RT,FF 1/16/2014 11:21 R K Angle (min) (min) (deg) 5.8 1.3 73.4 58.5 2.3 4.6-9.1 0.8-2.1 63-78 52-69 0-2.6 0.3 1.6 73.4 59.7 1.5 0.3-1.1 0.8-2.7 60-78 52-70 0-2.2 CK CRT MA LY30 (mm) (%) TEG-ACT (sec) 78.6 ! 82-152 5.5 1.2 74.9 58.5 4.3-8.3 0.8-1.9 64.3-77.1 52.3-68.9 FLEV 19.8- 361.3 15-32 278-581 CKH CFF done 43 baseline print (mg/dl) tracings 1/17/2014 11:21 AM ID: patientID1 CM Citrated K,KH,RT,FF baseline 1/16/2014 11:21 CK CRT 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 CKH CFF results 44 next tracing 1/17/2014 11:21 AM ID: patientID1 CM Citrated K,KH,RT,FF baseline 1/16/2014 11:21 CK 80 60 5.8 4.6-9.1 K 40 20 0 0 R (min) (min) 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 Angle 85 (deg) (min) MA 58.5 52-69 (%) 45 73.4 63-78 (mm) LY30 results 1.3 0.8-2.1 2.3 0-2.6 next tracing 1/17/2014 11:21 AM ID: patientID1 CM Citrated K,KH,RT,FF baseline 1/16/2014 11:21 CKH R 80 (min) 60 40 20 0 0 5 10 15 20 30 35 40 45 50 55 60 65 70 75 80 K 1.2 (min) 0.8-1.9 Angle 85 (deg) (min) results 46 25 5.5 4.3-8.3 74.9 64.3-77.1 MA 58.5 (mm) 52.3-68.9 next tracing 1/17/2014 11:21 AM ID: patientID1 CM Citrated K,KH,RT,FF baseline 1/16/2014 11:21 CRT 80 60 40 20 0 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 (min) R 0.3 (min) 0.3-1.1 K 1.6 (min) 0.8-2.7 Angle 73.4 (deg) 60-78 MA 59.7 (mm) 52-70 LY30 1.5 (%) 0-2.2 TEG-ACT 78.6 (sec) results 47 82-152 next tracing 1/17/2014 11:21 AM ID: patientID1 CM Citrated K,KH,RT,FF baseline 1/16/2014 11:21 CFF 80 60 40 20 0 0 5 10 15 20 30 35 40 45 50 55 60 65 70 75 80 85 (min) results 48 25 MA 19.8 (mm) 15-32 FLEV 361.3 (mg/dl) 278-581 next tracing 49 device 1 User 1 1/17/2014 11:21 AM ID: patientID2 CM Citrated K,KH,RT,FF 1/16/2014 11:21 R K Angle (min) (min) (deg) 5.8 1.3 73.4 58.5 2.3 4.6-9.1 0.8-2.1 63-78 52-69 0-2.6 0.3 1.6 73.4 59.7 1.5 0.3-1.1 0.8-2.7 60-78 52-70 0-2.2 CK CRT MA LY30 (mm) (%) TEG-ACT (sec) 78.6 ! 82-152 5.5 1.2 74.9 58.5 4.3-8.3 0.8-1.9 64.3-77.1 52.3-68.9 FLEV 19.8- 361.3 15-32 278-581 CKH CFF done 50 baseline print (mg/dl) tracings TEG 6s Case Studies 51 © Haemonetics Corporation Case Study 1: Re-warm sample pre-op INR 2.6 Case Study 1: Re-warm sample pre-op INR 2.6 Case Study 1: Post-protamine Case Study 1: Post-protamine Case Study 1: Post-protamine #2 Post-transfusion 1 x plasma, 1 x thrombocyte, additional protamine Case Study 1: Post-protamine #2 Post-transfusion 1 x plasma, 1 x thrombocyte, additional protamine Case Study 2: Post-protamine Case Study 2: Post-protamine Aorte Ascendante Post-0p (Dr. Braunberger) 60 © Haemonetics Corporation Aorte Ascendante Post 1,5 g Fibrinogene 61 © Haemonetics Corporation Platelet Mapping: Measuring the potential impact of ant-Platelet therapy Measures Individualized response to drugs! INDIVIDUAL haemostatic baseline Individually affected by ANTI-PLATELET DRUGS 62 © Haemonetics Corporation PlateletMapping® What drugs are monitored? Antiplatelet drugs ADP receptor inhibitors Examples: clopidogrel (Plavix®), ticlopidine (Ticlid®) prasugrel (Effient®), ticagrelor (Brilinta®) Thromboxane pathway inhibitors Example: aspirin GPIIb/IIIa inhibitors Examples: abciximab (Reopro®), tirofiban (Aggrastat®), eptifibatide (Integrilin®) 63 © Haemonetics Corporation Platelet Mapping – Combination Test Maximum (100% Aggregation) Platelet Function ZERO (0% Aggregation) Drug affect (60% Inhibition) 64 © Haemonetics Corporation Why PlateletMapping® Assay? Personalized Platelet Therapy What if they are all treated the same? (50% inhibition) 65 © Haemonetics Corporation Why PlateletMapping® Assay? Personalized Platelet Therapy All 50% Inhibition 66 © Haemonetics Corporation 1/17/2014 11:21 AM ID: patientID1 PM Platelet Mapping baseline 1/16/2014 11:21 80 HKH 60 40 20 0 0 ActF 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 (min) ADP AA results 67 next tracing device 1 user 1 1/17/2014 11:21 AM ID: patientID1 PM Platelet Mapping baseline 1/16/2014 11:21 R K Angle (min) (min) (deg) HKH 6.6 1.7 68.2 1-2.96 57-75 4.2-9.8 MA LY30 Inhibition (mm) (%) (%) 61.8 --- 54-70 0-2.4 ADP AA 7.6 ActF 2-19 AA 68 (%) 44-69 ADP 95.9 61.9 AA 100 37-71 done 0 Aggregation 59.6 ADP 4.1 print tracings 1/17/2014 11:21 AM ID: patientID1 PM Platelet Mapping baseline 1/16/2014 11:21 HKH R 80 (min) 60 K 40 20 0 0 (min) 5 10 15 20 30 35 40 45 50 55 60 65 70 75 80 85 (min) results 69 25 6.6 4.2- 9.8 1.7 1- 2.9 Angle 68.2 (deg) 57- 75 MA 61.8 (mm) 54- 70 LY30 --- (%) 0-2.4 next tracing 1/17/2014 11:21 AM ID: patientID1 PM Platelet Mapping baseline 1/16/2014 11:21 ActF 80 60 40 20 0 0 5 10 15 20 30 35 40 45 50 55 60 65 70 75 80 85 (min) results 70 25 MA 7.6 (mm) 2-19 next tracing 1/17/2014 11:21 AM ID: patientID1 PM Platelet Mapping baseline 1/16/2014 11:21 ADP 80 60 40 20 0 0 5 10 15 20 30 35 40 45 50 55 60 65 70 75 80 85 (min) results 71 25 MA 59.6 (mm) 44-69 next tracing 1/17/2014 11:21 AM ID: patientID1 PM Platelet Mapping baseline 1/16/2014 11:21 AA 80 60 40 20 0 0 5 10 15 20 30 35 40 45 50 55 60 65 70 75 80 85 (min) results 72 25 MA 61.9 (mm) 37- 71 next tracing TEG 6s COMBINATION TEST CONCEPT Global Impact: Fast and Specific Sensitivity Global Haemostasis Rapid TEG Kaolin Activated Functional Fibrinogen Platelet Function Maximum (100% Aggregation) Early Diagnosis ~10 Min ZERO (0% Aggregation) Drug affect (60% Inhibition) 73 © Haemonetics Corporation TEGManager TEG Viewer + Device Manager 74 © Haemonetics Corporation = TEG Manager TEG Viewer 75 © Haemonetics Corporation View real-time and historical TEG tests on remote monitors View multiple TEG tests per patient Color-coded by cartridge “Share” a view with others 10 languages to start TEGManager = Two applications TEG Viewer TEGViewer: TEGManager leverages the TEG 6s data One way communications pull from the device Stores clinical test results from a fleet of TEG devices Displays active and historical TEG test results Provides patient trending data across multiple TEG devices Available on various screen sizes from iPad to large screen monitor Provides clinical and research reports Allows viewing of active and historical results on multiple screens & View status of all TEG 6s devices in the institution (operation, calibration, status, logs, firmware, cartridge configuration TEG Viewer + Device Manager = TEG Manager TEG Viewer Main Screen TEGManager = Two applications Device Manager Device Manager: Manages: User credentials & different level of access Network connectivity Bi-directional connectivity to devices Connectivity to middleware for Patient Identification Device-specific reports (i.e., uptime, error logs, etc.) Aggregates TEG data from several Analyzers into a centralized data repository Provides centralized administration (i.e., User IDs) Connectivity between devices and middleware (HaemoCommunicator) TEG Viewer + Device Manager = TEG Manager TEG Device Manager View status of all TEG 6s devices in the institution (operation, calibration, status, logs, firmware, cartridge configuration) Manage users on devices, their permissions, full data access reporting Model for managing Haemonetics devices moving forward TEG : IT Architecture in Hospital Emergency Operating room Satellite Lab Etc. Hospital Network Operating room Biologist’s Office WEB Access anywhere Everywhere… Doctor’s office from any PC or tablet connect on the network With one of the following browser Or higher IT SERVICES Unrivalled performance with TEG6s Protocols When to Sample? How to Treat? Cardiac Surgery TEG Protocol TEG Protocol When Global Haemostasis or Either Day before or on induction: Prior to heparin and hemodilution Platelet Mapping Re-warm Post-Protamine Post Op 83 Blood Temperature 35-36 Degrees C (20 minutes prior to coming off bypass) Ten Minutes post protamine (Same time ACT drawn) Two Hour Post protamine (ICU sample) or upon bleeding Tube Blue Top: Patient Label and time sample drawn. Green Top: Patient Label and time sample drawn Blue Top: Patient Label and time sample drawn. Blue Top: Patient Label and time sample drawn. Blue Top: Patient Label and time sample drawn TEG-guided hemostasis algorithm in CV surgery Pre-Bypass Platelet Function Testing TEG® PlateletMapping Pre-Bypass Kaolin TEG® Pre-Bypass Functional Fibrionogen TEG® Operative Procedure – Liverpool Heart and Chest Hospital Liverpool, UK Post-Protamine Kaolin and Heparinase TEG® Post-Protamine Functional Fibrionogen TEG® Yes No Is the patient suffering from postoperative micro-vascular bleeding Check Pre-Bypass Platelet Function Test Resume standard care Check Kaolin and Heparinase TEG® Check Functional Fibrinogen TEG® ** Is the FLEV < 1g/l? No Is PLM ADP Inhibition >60%? No Yes Transfuse 1 pool platelets No Is PLM ADP Inhibition >70%? Is the Kaolin R time >2 Heparinase R time? Yes Yes Transfuse 2 pools platelets Administer 50mg Protamine No Is the R time ≥10 and < 14 min? Yes Transfuse 8ml/kg FFP No Is the R time > 14 min? Is MA <40 and ≥25mm? Yes Yes Transfuse 16ml/kg FFP Transfuse 1 pool platelets* No Is MA <25mm? Yes Yes Transfuse 1 pool platelets* Transfuse 10 units Cryoprecipitate No * If not already receiving platelet transfusion from TEG® PlateletMapping (PLM) ** Reverted to Clauss firbrinogen values after first 100 patients Adapted from: Agarwal S et al. J Cardiothorac Vasc Anesth. 2014 84 © Haemonetics Corporation If bleeding continues consider resternotomy No No ECLS et TEG 85 © Haemonetics Corporation COL-COPY-000864-IE(AA) TEG et CIVD 86 © Haemonetics Corporation COL-COPY-000864-IE(AA) Septic Patient – DIC? • Patient presented in ED with suspected Meningitis. • TEG shows classic Stage 1 DIC tracing Septic Patient – DIC? • 2 hours after administration of heparin 10u/kg iv followed by 10u/kg/hr drip. Note that the patient is no longer hypercoagulable under heparin, but when heparin is removed with heparinase, condition reverts (red tracing). Septic Patient – DIC? • 12 hours later the heparin effect is more pronounced (extended R) and normal values on heparinase tracing (red). Heparin dose can now be reduced. Septic Patient – DIC? • 36 hours after treatment with heparin begun. Dose has been reduced to 5u/kg/hr. Note no reversion to hypercoagulable values in heparinase (red tracing). Condition resolved. Patient subsequently extubated and transferred to the floor. Questions?