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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
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Conflict of interest disclosure
Travel expenses TEM-international CSL-Behring Nordic Grants ESA & EACTA member
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Objectives Define guideline Composition of this ESA guideline group
Development of the first edition Recommendations Changes in the updated guideline 2017
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Definition of a medical guideline
Determine the course of action Streamline process based on current knowledge Produced by national or international associations/authorities
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Guidelines are NOT Reimbursement policies Performance measures
Legal precedents Measure of certification or licensing For provider selection For public reporting Recipes for cookbook medicine
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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:
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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
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Structure of the guideline
Summary & condensed recommendations First common topics (all with pre-/intra- & postoperative aspects) Coagulation monitoring-preoperative evaluation Anemia management Coagulation management
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Structure of the guideline
Second specific considerations Multimodal approach Anticoagulation & antiplatelet therapy Management of co-morbidities & hemostatic disorders
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Preoperative evaluation
Standardized screening preferred Pre-operative SLT’s not recommended Only upon clinical suspicion & known disorders TEG-ROTEM no advantage
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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.
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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)
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Anemia management Timely pre-op assessment (4-8 wks)
Identify & diagnose anemia Treat iron deficiency Apply erythropoietin if no iron deficiency
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Anemia management Autologous donation RBC’s not clear
FFP not recommended Platelet rich plasma not routinely Cell safer usage
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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
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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
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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
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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
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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)
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Specific recommendations
What influences perioperative bleeding? Antiplatelet agents (APA) LMWH therapy Heparin/protamin Antifibrinolytics Fibrinogen therapy PCC therapy
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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
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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
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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
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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
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Topical sealants Fibrin sealant & TXA
May be used but data quantity and quality low
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Standardized transfusion algorithm
Recommended Predefined transfusion triggers Usage of SLT’s acceptable POC tests may be better
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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
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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
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Anemia management Iron replacement intravenous better than oral
After the operation may be useful (2C) Continuous monitoring may be used
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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
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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
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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
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Transfusion algorithm
More evidence supports use of such VAH perioperative & platelet function tests preoperative
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Conclusion ESA guidelines very structured & detailed
Give clear recommendations Knowledge highly scattered Some details may not covered
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