Download - TEG 6s presentation

Phillip Gray

25 January 2016

Thrombelastograph® (TEG®)

Coagulation Analyser

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 condit ion 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.

2 © Haemonetics Corporation

Individual Goal Directed

Coagulation Management

TEG 6s

“Making the Complex Simple”


A real time analyser of whole blood allowing for

individualised goal-directed therapy.

Measures the viscoelastic properties of the

haemostasis process functionally, with the end-

result being a haemostatic plug, or clot.

What is TEG®?


Clinical Practice: A Constant Struggle…


Injury

Disease

Aging Process

Cholesterol

Hardening of Arteries

Vascular Constriction

and Breakdown

Blood Activation by

Turbulence

Upsetting the balance

Natural processes


Surgery

Devices – LVADs,

CPB, ECMO

Trauma

Drugs

Stents

Airplane Flights –

DVT

Smoking

Upsetting the balance

Human intervention


Multiple systems Cells

56+ proteins

Dynamic

Interactive

Complexity of haemostasis

Copyright © 2011 Haemonetics Corp.

F X

F IXaF IX

F XIaF XI

Surface Contact

Collagen

FXII activator

F XIIaF XII

Intrinsic Pathway

Ca2+

Ca2+

Ca2+ F X

F VIIF VIIa

F III (Tissue

Thromboplastin)

Tissue/Cell Defect

Extrinsic Pathway

Ca2+

Ca2+

FibrinogenFibrin

monomers

Fibrin

polymers

Thrombin IIaProthrombin II

F Xa

Ca2+

Platelet Factor 3

Crosslinked

Fibrin Network

F XIIIa F XIII

F VF Va

F VIIIaF VIII

Yellow lines

indicate

positive

feedback

loops lost in

isolated tests

The Coagulation Cascade


Traditional haemostasis monitoring

Traditional

Hemostasis

Tests

Do not define the overall process, just provide pieces of the process!

D-Dimer

10

Cell-Based Model• Reflects in vivo

Occurring on cell surfaces

Tissue factor bearing cells

Platelets

Overlapping phases:

Initiation (TF bearing cells)

Amplification (platelets)

Propagation (platelets)

• The coagulation cascades are still

important, but are cell-based

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

[Monroe, DM. et al. Arterioscler Thromb Vasc Biol. 2002;22:1381]

Tissue factor

bearing cells

1. Initiation

Platelets

Activated

platelets

2. Amplification

3. Propagation

IIa

IIa


TEG Technology


1- INITIATION

Haemostasis made simple with TEG

Reaction

INITIATION

1


1- INITIATION 2- STRENGTH

Haemostasis made simple with TEG (2/3)

Maximum clot

STRENGTH

2

Reaction

INITIATION

1


1- INITIATION 2- STRENGTH 3- STABILITY

Haemostasis made simple with TEG (3/3)

Maximum clot

STRENGTH

2

Reaction

INITIATION

1

Clot degradation

STABILITY

3


TEG® Core Assessment

1. INITIATION

2. STRENGTH

3. STABILITY

1 INITIATION

2 STRENGTH 3 STABILITY


TEG® Trace – Diagnostic Complex


Heparin/Enoxaparin Effect

Plain cup

5.8 2.2 59.1 0.0 56.2 6.4

Heparinase cup


Functional Fibrinogen TEG ®


Fibrinogen/Platelet Ratio


Tissue Factor and Kaolin Activation –

RAPID test of CLOT STRENGTH and any FIBRINOLYSIS

Also provides RAPID TEG® ACT Result

RapidTEG® Assay


Rapid TEG


4 TEST CONCEPT

Kaolin Activated

Functional Fibrinogen

Rapid TEG

Heparinase


4 TEST CONCEPT - Combination TEST

Kaolin Activated Rapid TEG


Early Diagnosis ~10 Min

Fast…Global…Sensitivity to All Phases…


The TEG5000 Today


The TEG5000 Software Today


The TEG6s………. TOMORROW


TEG 6s

“Making the Complex Simple!

TEG 6s Test Procedure


Patient Test Procedure


TEG 6s Stand-Alone Device


TEG 6s

Complex Technology

Resonance-frequency viscoelasticity measurements and

disposable multi-channel microfluidic cartridges


Sample ring subjected to external vibration

Sample Testing


Harmonic motion of sample measured optically

Measurement

Optical detection


Click to play

Sample Testing Animation


As sample transitions from liquid to gel state,

measurements are plotted: Clot strength vs. Time

Measurement

Time

Clot

strength

Liquid

state

Gel

state


TEG 6s

Tests

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

1. Global hemostasis cartridge (citrated tube - blue top)

2. PlateletMapping cartridge (heparin tube – green top)

PlateletMapping® Gives personalised antiplatelet therapy for both haemorrhagic and

thrombotic condition

3. QC cartridges

Biological QC Level I and II


The TEG 6s

Making the Complex Simple

Simplicity in Facilitating the Science of the Cell Based Model


TEG 6s

Advances the TEG 5000 legacy through simple,

smart and reliable designSame Simple

Smart Reliable

Assess same physical property/results


Kaolin TEG

Rapid TEG


TEG

Heparinase effect

Global Haemostasis Assessment


TEG 6s COMBINATION TEST CONCEPT

Global Impact: Fast and Specific Sensitivity




Global Haemostasis

42

1/17/201411:21 AMID: patientID1

CM Citrated K,KH,RT,FF baseline1/16/2014

11:21

results next tracing

CK

CRT

CKH

CFF

80

60

40

20

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85

(min)

43

CM Citrated K,KH,RT,FF baseline

R(min)

K(min)

Angle(deg)

MA(mm)

device 1User 1


done tracingsprint

LY30(%)

CK

CRT

CFF

CKH

5.84.6-9.1

2.30-2.6

73.463-78

58.552-69

59.752-70

58.552.3-68.9

19.8-

15-32

1.30.8-2.1

73.460-78

74.964.3-77.1

1.60.8-2.7

1.20.8-1.9

0.30.3-1.1

5.54.3-8.3

1.50-2.2

78.6 !82-152

TEG-ACT(sec)

361.3278-581

FLEV(mg/dl)

1/16/2014

11:21

44



11:21


CK

CRT

CKH

CFF

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85

45



CK

80

60

40

20

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85

R 5.8(min) 4.6-9.1

K 1.3(min) 0.8-2.1

Angle 73.4(deg) 63-78

MA 58.5(mm) 52-69

LY30 2.3(%) 0-2.6

(min)


11:21

46



CKH

80

60

40

20

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85

(min)


11:21

R 5.5(min) 4.3-8.3

K 1.2(min) 0.8-1.9

Angle 74.9(deg) 64.3-77.1

MA 58.5(mm) 52.3-68.9

47



CRT

80

60

40

20

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85

(min)


11:21

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) 82-152

48



CFF

80

60

40

20

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85

MA 19.8(mm) 15-32

FLEV 361.3(mg/dl) 278-581

(min)


11:21

50

CM Citrated K,KH,RT,FF baseline

R(min)

K(min)

Angle(deg)

MA(mm)

device 1User 1


done tracingsprint

LY30(%)

CK

CRT

CFF

CKH

5.84.6-9.1

2.30-2.6

73.463-78

58.552-69

59.752-70

58.552.3-68.9

19.8-

15-32

1.30.8-2.1

73.460-78

74.964.3-77.1

1.60.8-2.7

1.20.8-1.9

0.30.3-1.1

5.54.3-8.3

1.50-2.2

78.6 !82-152

TEG-ACT(sec)

361.3278-581

FLEV(mg/dl)

1/16/2014

11:21


TEG 6s Case Studies

Case Study 1: Re-warm sample

pre-op INR 2.6

Case Study 1:

Post-protamine

Case Study 1: Post-protamine #2

Post-transfusion 1 x plasma, 1 x thrombocyte,

additional protamine

Case Study 2: Post-protamine


Aorte Ascendante Post-0p (Dr. Braunberger)


Aorte Ascendante Post 1,5 g Fibrinogene


Platelet Mapping: Measuring the potential impact of ant-Platelet therapy

Measures Individualized response to drugs!

INDIVIDUAL haemostatic baseline

Individually affected by ANTI-PLATELET DRUGS


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®)

PlateletMapping®What drugs are monitored?


Platelet Mapping – Combination Test

Platelet

Function

Maximum

ZERO

Drug affect

(60% Inhibition)

(100% Aggregation)

(0% Aggregation)


What if they are all treated the same? (50% inhibition)

Why PlateletMapping® Assay?

Personalized Platelet Therapy


All 50% Inhibition

Why PlateletMapping® Assay?

Personalized Platelet Therapy

67


PM Platelet Mapping baseline1/16/2014

11:21


HKH

ActF

ADP

AA

80

60

40

20

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85

(min)

68

PM Platelet Mapping baseline

HKH

ActF

AA

ADP

6.64.2-9.8

---0-2.4

68.257-75

61.854-70

R(min)

K(min)

Angle(deg)

MA(mm)

device 1user 1


done tracingsprint

7.62-19

59.644-69

61.937-71

1.71-2.96

LY30(%)

0

95.9

100

4.1

Inhibition(%)

Aggregation(%)

ADP

AA

ADP

AA

1/16/2014

11:21

69



HKH

80

60

40

20

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85

R 6.6(min) 4.2- 9.8

K 1.7(min) 1- 2.9

Angle 68.2(deg) 57- 75

MA 61.8(mm) 54- 70

LY30 ---(%) 0-2.4

(min)


11:21

70



ActF

80

60

40

20

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85

(min)


11:21

MA 7.6(mm) 2-19

71



ADP

80

60

40

20

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85

(min)


11:21

MA 59.6(mm) 44-69

72



AA

80

60

40

20

00 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85

(min)


11:21

MA 61.9(mm) 37- 71


TEG 6s COMBINATION TEST CONCEPT

Global Impact: Fast and Specific Sensitivity




Platelet Function

Maximum

ZERO

Drug affect

(60% Inhibition)

(100%

Aggregation)

(0%

Aggregation)

Global Haemostasis


TEGManager

TEG Viewer

+Device Manager

= TEG Manager


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

TEG Viewer

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

Hospital Network

IT SERVICESWEB Access anywhere from any PC or tablet connect on the network

Or higher

With one of the following browser

Operating room Biologist’s Office Doctor’s officeEverywhere…

Emergency Operating room Satellite Lab Etc.

TEG : IT Architecture in Hospital

http://www.google.fr/url?url=http://frawin.com/actualites-news-blog-generales/2014/26339_chrome-version-64-bit-disponible-en-version-stable-windows-7-8.html&rct=j&frm=1&q=&esrc=s&sa=U&ei=BXTwVNXPDcnoaI2vgJAK&ved=0CB4Q9QEwBA&usg=AFQjCNG5b6vHAuaBlvu0wYOipyDxDZDQpw

http://www.google.fr/url?url=http://frawin.com/actualites-news-blog-generales/2014/26339_chrome-version-64-bit-disponible-en-version-stable-windows-7-8.html&rct=j&frm=1&q=&esrc=s&sa=U&ei=BXTwVNXPDcnoaI2vgJAK&ved=0CB4Q9QEwBA&usg=AFQjCNG5b6vHAuaBlvu0wYOipyDxDZDQpw

http://www.google.fr/url?url=http://www.clubic.com/os-mobile/iphone-os/actualite-483430-safari-mobile-ios-faille-phishing-indetectable.html&rct=j&frm=1&q=&esrc=s&sa=U&ei=YnTwVI29DIniapnYgUg&ved=0CCgQ9QEwCQ&usg=AFQjCNFesr0Wl-9qLHf4mYwAlWK6o3a9LQ

http://www.google.fr/url?url=http://www.clubic.com/os-mobile/iphone-os/actualite-483430-safari-mobile-ios-faille-phishing-indetectable.html&rct=j&frm=1&q=&esrc=s&sa=U&ei=YnTwVI29DIniapnYgUg&ved=0CCgQ9QEwCQ&usg=AFQjCNFesr0Wl-9qLHf4mYwAlWK6o3a9LQ

http://www.google.fr/url?url=http://www.dator.fr/forcer-ie8-a-interpreter-les-pages-comme-ie7/&rct=j&frm=1&q=&esrc=s&sa=U&ei=2nPwVOi8OIixaYrZgtAG&ved=0CCIQ9QEwBg&usg=AFQjCNG_31mrkFgBz8DbeqUA-mZGUYQ67A

http://www.google.fr/url?url=http://www.dator.fr/forcer-ie8-a-interpreter-les-pages-comme-ie7/&rct=j&frm=1&q=&esrc=s&sa=U&ei=2nPwVOi8OIixaYrZgtAG&ved=0CCIQ9QEwBg&usg=AFQjCNG_31mrkFgBz8DbeqUA-mZGUYQ67A

https://www.google.fr/url?url=https://www.mozilla.org/en-US/styleguide/identity/firefox/wordmarks/&rct=j&frm=1&q=&esrc=s&sa=U&ei=KHTwVOejOZXmaofsglg&ved=0CB4Q9QEwBA&usg=AFQjCNHBc7coZcgBt_VqjGmy80VSB4gAqg

https://www.google.fr/url?url=https://www.mozilla.org/en-US/styleguide/identity/firefox/wordmarks/&rct=j&frm=1&q=&esrc=s&sa=U&ei=KHTwVOejOZXmaofsglg&ved=0CB4Q9QEwBA&usg=AFQjCNHBc7coZcgBt_VqjGmy80VSB4gAqg

http://www.google.fr/url?url=http://www.expert-digital.fr/veille-digitale/499-la-tablette-l-objet-incontournable-des-francais.html&rct=j&frm=1&q=&esrc=s&sa=U&ei=h3rwVMTXGcLkUsLNgxg&ved=0CCQQ9QEwBw&usg=AFQjCNF_0Xm8LB3l9XmfuuKWHzpEIynDjA

http://www.google.fr/url?url=http://www.expert-digital.fr/veille-digitale/499-la-tablette-l-objet-incontournable-des-francais.html&rct=j&frm=1&q=&esrc=s&sa=U&ei=h3rwVMTXGcLkUsLNgxg&ved=0CCQQ9QEwBw&usg=AFQjCNF_0Xm8LB3l9XmfuuKWHzpEIynDjA

Unrivalled performance with TEG6s

ProtocolsWhen to Sample?

How to Treat?

83

Cardiac Surgery TEG Protocol

TEG Protocol When Tube

Global Haemostasis

or

Platelet

Mapping

Either Day before or on induction:

Prior to heparin and hemodilution

Blue Top: Patient Label and

time sample drawn.

Green Top: Patient Label and

time sample drawn

Re-warm Blood Temperature 35-36 Degrees

C (20 minutes prior to coming off

bypass)


time sample drawn.

Post-Protamine

Ten Minutes post protamine (Same

time ACT drawn) Blue Top: Patient Label and

time sample drawn.

Post Op Two Hour Post protamine (ICU

sample) or upon bleeding


time sample drawn


Adapted from: Agarwal S et al. J Cardiothorac Vasc Anesth. 2014

Pre-Bypass Platelet Function Testing TEG® PlateletMapping

Pre-Bypass Kaolin TEG®

Pre-Bypass Functional Fibrionogen TEG®

Check Kaolin and Heparinase TEG®

Post-Protamine Functional Fibrionogen TEG®

Check Pre-Bypass

Platelet Function Test

Transfuse 2 pools

platelets

Transfuse 1 pool

platelets

Administer 50mg

Protamine

Transfuse 8ml/kg

FFP

Transfuse 16ml/kg

FFP

Transfuse 1 pool

platelets*

Transfuse 1 pool

platelets*

Check Functional Fibrinogen TEG® **

Is

PLM ADP Inhibition

>70%?

Is

PLM ADP Inhibition

>60%?

Transfuse 10 units

Cryoprecipitate

Post-Protamine Kaolin and Heparinase TEG®

Is the

Kaolin R time

>2 Heparinase

R time?

Is the

R time ≥10 and

< 14 min?

Is the R time

> 14 min?

Is MA <40 and

≥25mm?Is MA <25mm?

Is the FLEV < 1g/l?

Is the patient suffering from post-

operative micro-vascular bleeding

Operative Procedure

Resume standard care

If bleeding continues

consider resternotomy

Yes No

No No NoNo

Yes Yes Yes Yes Yes Yes Yes

Yes

No

No

No

No

No

* If not already receiving platelet transfusion from TEG® PlateletMapping (PLM)

** Reverted to Clauss firbrinogen values after first 100 patients

TEG-guided

hemostasis

algorithm in CV

surgery– Liverpool Heart and

Chest Hospital

Liverpool, UK

Septic Patient – DIC?

• Patient presented in ED with suspected Meningitis.

• TEG shows classic Stage 1 DIC tracing


• 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).


• 12 hours later the heparin effect is more pronounced

(extended R) and normal values on heparinase tracing

(red). Heparin dose can now be reduced.


• 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?