1. The ESA guidelines on severe perioperative bleeding
25 minuten slides
Marcus D. Lancé MD, PhD
Associate Professor of Anesthesiology
Weill-Cornell-Medicine Qatar
Dept. of Anesthesiology & Intensive Care Medicine
Hamad Medical Corporation
Doha-Qatar

2. Conflict of interest disclosure
Travel expenses
TEM-international
CSL-Behring
Nordic
Grants
ESA & EACTA member

3. Objectives Define guideline Composition of this ESA guideline group
Development of the first edition
Recommendations
Changes in the updated guideline 2017

4. Definition of a medical guideline
Determine the course of action
Streamline process based on current knowledge
Produced by national or international associations/authorities

5. Guidelines are NOT Reimbursement policies Performance measures
Legal precedents
Measure of certification or licensing
For provider selection
For public reporting
Recipes for cookbook medicine

6. Composition of the guideline group
Chair of the subcommittee transfusion & hemostasis
Subcommittee chair circulation, intensive care resuscitation & emergency medicine, evidence based medicine, transfusion & hemostasis
Invited 15 experts to the task force
Member of trial unit for evidence based search
ESA guideline committee asked:

7. First edition ESA guideline 2013
Structured literature search (MEDLINE/Embase) by experienced researcher/epidemiologist
9376 publications
After refining 2nd search
20664 citations
Final search for systematic reviews
11869 citations
2686 publications for possible inclusion
Headings

8. Structure of the guideline
Summary & condensed recommendations
First common topics (all with pre-/intra- & postoperative aspects)
Coagulation monitoring-preoperative evaluation
Anemia management
Coagulation management

9. Structure of the guideline
Second specific considerations
Multimodal approach
Anticoagulation & antiplatelet therapy
Management of co-morbidities & hemostatic disorders

11. Preoperative evaluation
Standardized screening preferred
Pre-operative SLT’s not recommended
Only upon clinical suspicion & known disorders
TEG-ROTEM no advantage

12. Estimating bleeding risk
Structured questionnaire
PANE-study
35000 pts screened
240 reported bleeding symptoms & 95 control pts
10% of both groups coag. abnormalities
ISTH-BAT did not distinguish
None of the questionnaires is valid
Vries MJ et al. Res Pract Thromb Haemost. 2018;2:767–777.

13. Coagulation monitoring
SLT
May or may not be applied
ROTEM/TEG
Both recommended to guide intraoperatively
Platelet function tests
Perioperative PFT’s associated with improved outcome
MEA/TEG platelet mapping
Perioperative a minimal platelet count is needed (> /µl)

14. Anemia management Timely pre-op assessment (4-8 wks)
Identify & diagnose anemia
Treat iron deficiency
Apply erythropoietin if no iron deficiency

15. Anemia management Autologous donation RBC’s not clear
FFP not recommended
Platelet rich plasma not routinely
Cell safer usage

16. Macro & Microcirculation
Timely restoration
Avoidance of hyper- & hypovolemia
Dynamic cardiac output assessment
Choice of fluid
Crystalloid above colloid (2C)
Balanced solutions?
Oxygen therapy
Avoidance of hypoxemia & hyperoxia
Surrogate markers for microcirculation
Lactate, Hb, BE

17. Labile blood products Implementation of a hemovigilance program
First initiated in France in 1991
Centre National d’Hemovigilance in 1992
French Hemovigilance System in 1994
Serious Hazards of Transfusion(SHOT) in UK
Transfusion Transmitted Injuries Surveillance System was introduced by the Public Health Agency of Canada
International Hemovigilance Network (IHN)
Evolved from the European Hemovigilance Network established in 1998

18. Blood transfusion chain
Donor
Product
Recipient
Outcome
Recruitment
Eligibility screening
Donation
4. Processing &Testing
5. Modification
6. Decision to transfuse
7. Compatibility testing & Blood administration
8. Look back
9. Blood utilization review
10. Audit

19. Transfusion of labile blood products
Restrictive transfusion strategy 1A
Pathogen inactivation 1C
Leucodepletion 1B
Plasma donors restricted to males 1C
RBC transfusion Hb 7-9 g/dl during bleeding
Plasma transfusion ratio driven may be considered 2C
Platelet transfusion <50000/µl

20. Coagulation management
Use factor concentrates
Fibrinogen
Trigger level of < g/L
Dose (concentrate) mg/kg
Alternatively use cryoprecipitate
Factor XIII <30-60% activity it might be helpful
Prothrombin concentrate complex/ r-FVIIa (could be considered)

21. Specific recommendations
What influences perioperative bleeding?
Antiplatelet agents (APA)
LMWH therapy
Heparin/protamin
Antifibrinolytics
Fibrinogen therapy
PCC therapy

22. Antiplatelet agents (APA’s)
Aspirin
Should be continued
Bleeding could be increased
Extra measures should be taken
Clopidogrel
Should be discontinued
But no difference between 3-5 days

23. Heparin management LMWH preoperatively 8-12 hrs before operation
Intraoperatively
Heparin concentration based approach better than ACT
Heparin reversal with protamine
Ratio based is worse than concentration based
Ratio’s are to high  to much protamine
1.5:1 or 1.3:1 (H:P) ratio seem better

24. Hemostatic agents Antifibrinolyitcs DDAVP
Recommendations more direction TXA vs EACA
Doses vary
bolus only
bolus plus continuous
continuous only
DDAVP
No recommendation for pre-operative use
Intraoperatively not effective to reduce blood loss
2-10 g or mg/kg bolus

25. Factor replacement AT Fibrinogen PCC rFVIIa FXIII
May be used in case of heparin “resistance”
No recommendation for intraoperative use
Fibrinogen
Not recommendation before operation
Intraoperatively reduced blood loss
PCC
Reversal of VKA
All other bleedings need more research
rFVIIa
As rescue therapy only
FXIII
May be effective

26. Topical sealants Fibrin sealant & TXA
May be used but data quantity and quality low

27. Standardized transfusion algorithm
Recommended
Predefined transfusion triggers
Usage of SLT’s acceptable
POC tests may be better

28. What changed in 2016/2017 Authors Focus on update Structure is kept
Some new authors
Delegate from EACTA
Delegate from surgery
New literature search (delegate from DUK)
Focus on update
Structure is kept
18334 references reviewed 733 included

29. Laboratory tests
POC (Viscoelastic Haemostatic Assays) recommended above SLT’s
Fibrinogen levels weak to moderate predictive for bleeding
Cut-off 2.5 g/L
Platelet function tests

30. Anemia management Iron replacement intravenous better than oral
After the operation may be useful (2C)
Continuous monitoring may be used

31. Coagulation management
FFP is not sufficient to correct hypofibrinogenemia
Fibrinogen recommended (25-50 mg/kg)
PCC for VKA associated bleeding
FXIII usage if activity <30%
No prophylactic use of r-FVIIa

32. APA’s in cardiac surgery
ASA & clopidogrel
Increase bleeding risk
Decrease thrombosis risk
Both may be continued until surgery
But not combined…
No recommendation for other APA’s

33. Hemostatic agents Antifibrinolytics DDAVP Aprotinin revised
May increase the mortality risk in low to moderate risk procedures
TXA is at lower doses equally effective (10mg/kg bolus plus infusion 2mg/kg)
May be used topically
DDAVP
Lower blood 6 hrs post OP, but not 24 hrs

34. Transfusion algorithm
More evidence supports use of such
VAH perioperative & platelet function tests preoperative

35. Conclusion ESA guidelines very structured & detailed
Give clear recommendations
Knowledge highly scattered
Some details may not covered