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Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

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Page 1: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Antithrombotic Therapy for Pediatric VAD Patients

Meloneysa Hubbard, MSN, CRNP, CCTC

Director of Heart Transplant Services

Children’s of Alabama

Page 2: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

I do not have any relevant financial relationships with any commercial interests to disclose.

Disclosure Statement

Page 3: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Objectives ?

Discuss the use of ventricular assist device (VAD) support in the pediatric population

Identify indications for antithrombotic therapy

Describe basic coagulation components

Discuss anticoagulation medications

Review our strategy for monitoring anticoagulation

Page 4: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Pediatric Ventricular Assist Devices Berlin Heart EXCOR

FDA approved pediatric VAD Pulsatile flow device RVAD, LVAD, BiVAD

Thoratec PVAD

HeartWare, HeartMate II

SynCardia

PumpKIN Trial

Page 5: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Berlin Heart Implants

Almond et al. Circulation 2013;127:1702-1711

Page 6: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama
Page 7: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Morbidity and Mortality

Almond et al. Circulation 2013;127:1702-1711

Page 8: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

这是凝血过程是很容易理解是否你一定要把它理解成你的理解。

Page 9: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Coagulation Cascade

• Feedback process of plasma protein activation

• Results in converting prothrombin to thrombin

• Thrombin • converts

fibrinogen to fibrin• Activates platelets

Page 10: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Balance

Thrombosis Bleeding

Page 11: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Considerations of Hemostasis

Immature coagulation vWB factor deficiency Heparin induced thrombocytopenia Baseline hematology Current hematology Changes in patient status Changes in nutrition

Page 12: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Laboratory Monitoring

Anti Xa

PTT

INR

TEG

Platelet Mapping / Platelet Aggregation

Page 13: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Thromboelastogram

Page 14: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Thromboelastogram

Maximum amplitude (MA)

-body of the clot formation

-represents the ultimate clot strength

-indicative of platelet activity

-target range 55-73

Page 15: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Platelet Mapping

Platelet Mapping Represents the inhibition present

between clot fibrin and thrombin Agent specific

ADP – clopidogrel, dipyridamole AA - aspirin

Inhibition 70-95%

Page 16: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Platelet Mapping

Page 17: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Antithrombotic Agents Unfractionated heparin

Antithrombin

Acetylsalicylic acid (ASA)

Dipyridamole

Clopidogrel

Low molecular weight heparin (enoxaparin)

Warfarin

Adjunctive Medications

Page 18: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Anticoagulation Therapy

Heparin Catalyzes the interaction between

thrombin and antithrombin Requires adequate ATIII level <70% Initiated 24-48 hours after implant

Platelet count 50,000 TEG MA >56 No significant bleeding

Therapeutic monitoring with anti Xa

Page 19: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Heparin Target DosingStage Age

(months)Anti-factor XA

(u/ml)PTT (sec)

Infusion rate

HoldUFH

%Rate Change

RepeatAnti-Xa(or PTT)

I Therapeutic Range

All 

  10-20 u/kg/h  

    After 6hrs  

II  

Adjustment  

<3 mo 

Max PTT85 sec

 

<0.1 (<50) 

No +15% 4hrs

0.1-0.34 (50-59) 

No +10% 6hrs

0.35-0.50 (60-

85)

 No 0

As per guideline

0.51-0.70 (86-

95)

 No -10% 6hrs

0.71-.89(96-120)   30 min. -10% 4hrs

≥ 0.90 (>120)   60 min. -15 % 4hrs 

II  

Adjustment  

≥ 3 mo 

Max PTT95 sec

 

<0.1 (<50)  

No +15% 4hrs

0.1-0.34 (50-59)  

No +10% 6hrs

0.35-0.70 (60-95)

  No 0 As per guideline

0.71-.89(96-120)   30 min. - 10% 4hrs

≥ 0.90 (>120)   60 min. -15 % 4hrs 

Page 20: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Long Term Anticoagulation Low molecular weight heparin

Catalyzes the interaction between thrombin and antithrombin

Monitor anti-Xa for target 0.6-1.0Anti-Factor Xa

level u/mlHold Next Dose?

 

Dose Change

 

Repeat Anti-Factor Xa

< 0.35 No Increase by 25% 4 hours after next dose 0.36 - 0.45 No Increase by 15% 4 hours after next dose0.46 - 0.59 No Increase by 10% 4 hours after next dose

6. - 1.0

No No 4 hours after next dose

1.1 - 1.25 No Decrease by 20% 4 hours after next dose

1.26 - 1.5 No Decrease by 30% 4 hours after next dose1.6 – 2.0 Yes, for 3 hours Decrease by 40% Before next dose then 4 hours

after next dose> 2.0 Yes, until anti-factor Xa

level is ≤ 0.6 u/mlDecrease by 50 % Before next dose, if anti-Xa level

>0.6 U/ml, repeat level q12h until ≤0.6 U/ml before re-starting at 50% of previous dose

Page 21: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Long Term Anticoagulation

Warfarin Vitamin K antagonist Monitor INR for target 2.5-3.5

Stage 

INR 

Action 

Day 1 1.0 – 1.8 0.2 mg/kg orally 

 

Day 2-4

1.1 – 1.3 Repeat day 1 loading dose1.4 – 1.9 50% of day 1 loading dose2.0 – 3.0 50% of day 1 loading dose3.1 – 3.5 25% of day 1 loading dose

> 3.5 Hold dosing until INR is < 3.5 

 

Maintenance ≥ Day 5 and long term

1.1 – 1.9 Increase dose by 40 – 50%2.0 – 2.6 Increase dose by 20 – 30%2.7 – 3.5 No change3.6 – 4.0 Administer next dose at 50%, then restart at 20% less

maintenance dose4.1 – 5.0 Hold one dose then repeat INR; if 2-3 decrease dose 50%

Page 22: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Antiplatelet Therapy Aspirin

Blocks arachidonic acid pathway of platelet activation

Usually started >48 hours after implant Monitored by TEG and platelet mapping or

aggregate studies May be indicated bidArachidonic acid platelet inhibition

Hold next dose?

Dose change? Repeat AA Test?

0-30% No Increase 100% Next day31-50% No Increase 50% Next day51-69% No Increase 25% 48 hours70-95% No No As per guideline96-100% No Decrease 10% 48 hours100% and patient is bleeding

Yes Hold next dose until bleeding stops, decrease 50%

Next day

Page 23: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Antiplatelet Therapy

Clopidogrel / Dipyridamole Binds to adenosine di-phosphate receptors

and prevents uptake Initiated after POD 4 Monitored by platelet mapping or aggregate

studiesADP platelet inhibition

Hold next dose?

Dose change? Repeat AA Test?

0-30% No Increase 100% Next day31-50% No Increase 50% Next day51-69% No Increase 25% 48 hours70-95% No No As per guideline96-100% No Decrease 10% 48 hours100% and patient is bleeding

Yes Hold next dose until bleeding stops, decrease 50%

Next day

Page 24: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Anticoagulation

Page 25: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Question

A 2 month old patient supported with Berlin Heart LVAD is stable with no signs of active bleeding or pump fibrin deposits. Anticoagulation

ASA 5mg/kg clopidogrel 0.2mg/kg Warfarin 0.5mg/kg

Labs TEG/PM: MA 68; AAI

80%; ADPI 53% INR 2.1

What would you anticipate for this patient? a) continue to monitor b) increase warfarin c) increase warfarin and

clopidogrel d) increase warfarin and

decrease aspirin

Page 26: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama
Page 27: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Anticoagulation Guidelines

Berlin Heart EXCOR Heparin Drip

Inhibits coagulation pathway started 24-48 hours after implant Titrated to goal Anti Xa 0.35-0.5 U/mL Stopped once Coumadin is

therapeutic

Coumadin Inhibits coagulation pathway Started once bleeding resolved and

tolerating PO Titrated to goal INR 2.5-3.5

Aspirin Blocks arachidonic acid pathway of

platelet activation Dosed for goal AA inhibition 70-95 %

Clopidogrel (Plavix) Blocks adenosine di-phosphate

pathway of platelet activation Dosed for goal ADP inhibition 70-90% May be used as long-term therapy

HeartWare HVAD Heparin Drip

Inhibits coagulation pathway

started 24-48 hours after implant

Titrated to goal Anti Xa 0.35-0.5 U/mL

Stopped once Coumadin is therapeutic

Coumadin Inhibits coagulation pathway

Started once bleeding resolved and tolerating PO

Titrated to goal INR 2.0-3.0

Aspirin Blocks arachidonic acid pathway of

platelet activation

Dosed for goal AA inhibition 70-95%

Clopidogrel (Plavix) Blocks adenosine di-phosphate pathway

of platelet activation

Dosed for goal ADP inhibition 70-90%

Stopped once Coumadin is therapeutic

Page 28: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Patient Assessment

Pump function

Flows/Parameters

Chamber assessment

Physical assessment

Page 29: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Patient Care Education Medication

Indication Administration/dosage Side effects Monitoring Interactions

Physical Activity Precautions

Dietary Considerations

Illness effects

Complications of device support/anticoagulation

Home monitoring

Page 30: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Question

Do you utilize INR Patient Home Monitoring for pediatric VAD patients?

a) yes

b) no

Page 31: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama
Page 32: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

Quality of Life

Page 33: Antithrombotic Therapy for Pediatric VAD Patients Meloneysa Hubbard, MSN, CRNP, CCTC Director of Heart Transplant Services Children’s of Alabama

References

Almond, C., Morales, D., Blackstone, E., Turrentine, M., Imamura, M., Massicotte, P., Jordan, L., Devaney, E., Ravishankar, C., Kanter, K., Holman, W., Kroslowitz, R., Tjossem, C., Thuita, L., Cohen, G., Buchholz, H., St. Louis, J., Nguyen, K., Neibler, R., Walters, H., Reemtsen, B., Wearden, P., Reinhartz, O., Guleserian, K., Mittchell, M., Bleiweis, M., Canter, C., Humpl, T., (2013). Berlin Heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children. Circulation, 127:1702-171

Zafar, F., Chasleberry, C., Khan, M., Mehta, V., Bryant, R., Lorts, A., Wilmot,I., Jefferies, J., Chin, C., Morales, D., (2015). Pediatric heart transplant waiting list mortality in the era of ventricular assist devices. Journal of Heart and Lung Transplantation, 34:1, 82-86.

Drews, T., Kupper, F., Stiller, B., Hubler, M., Weng, Y., Berger, F., Hetzer, R., (2007). Coagulation management in pediatric mechanical circulatory support. ASAIO Journal, 53: 640-645.

Moffett, B., Gabrera, A., Teruya, J., Bomgaars, L., (2014). Anticoagulation therapy trends in children supported by ventricular assist devices: a multi-institutional study. ASAIO Journal, 60:2, 211-215

Massicotte, M., Bauman, M., Murray, J., Almond, C., (2015). Antithrombotic therapy for ventricular assist devices in children: do we really know what to do?, (2015). 13, S343- 345.