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Prevention of TACO – what Haemovigilance data tell us

Prevention of TACO – what Haemovigilance data tell us. Swisstransfusion, Genève 6. Septembre 2013. Markus Jutzi, Morven Rüesch Clinical Reviewer Haemovigilance , Swissmedic. Current Haemovigilance data. 59 % High imputability TR‘s. Swisstransfusion, 06.09.2013.

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Prevention of TACO – what Haemovigilance data tell us

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  1. Preventionof TACO – what Haemovigilance datatellus Swisstransfusion, Genève 6. Septembre 2013 Markus Jutzi, Morven Rüesch ClinicalReviewerHaemovigilance, Swissmedic

  2. Current Haemovigilance data 59 % High imputabilityTR‘s Swisstransfusion, 06.09.2013

  3. Imputabilityandseverity • High imputability: • ~ 60 % of all reportedtransfusionreactions (TR‘s) • ~ 60 % ofreported TACO • Severity grade 3 or 4 (lifethreateningor fatal) • 2.7 % of all reportedTR‘s • 25 % ofreported TACO Swisstransfusion, 06.09.2013

  4. Life threateningand fatal cases Swisstransfusion, 06.09.2013

  5. Comparisonofcumulativeincidence (reportedTACO cases per bloodcomponentstransfused) * Robillard, P. et al; Transfusion associatedcirculatoryoverload: The newleadingcauseoftransfusionassociatedfatalitiesreportedtothe Québec Haemovigilance system. Presentation IHS 2010 in Dubrovnik ** ANSM; Mise au pointsur les oedèmesaiguspulmonaires de suchargeposttransfusionnels. Juillet 2012 Swisstransfusion, 06.09.2013

  6. Definition(s) of TACO • ISBT WP on Haemovigilance, July 2011: • Acuterespiratorydistress • Tachycardia • Increasedbloodpressure • Acute or worsening pulmonary • oedema on frontal chest X-ray • Evidence of positive fluid balance • within 6 hours of transfusion. • An elevated BNP is supportive of TACO • Transfusion reactions • (Popovsky et al, AABB Press, 3rd edition) • Dyspnoea • Orthopnoea • Cyanosis • Tachycardia • Increasedbloodpressure • Pulmonary / pedal oedema • withinseveralhoursof transfusion • Nonspecificmanifestations • Headache • Tightness in thechest • Dry cough Occurrence of any or all of the following: • Occurrence of any 4 of the following: Swisstransfusion, 06.09.2013

  7. Reports of TACO 2008 - 2013 Swisstransfusion, 06.09.2013

  8. Reports of TACO 2008 - 2013 Swisstransfusion, 06.09.2013

  9. Reports of TACO 2008 - 2013 Possible TACO: Only mild cases, except 1 severe in 2012 Swisstransfusion, 06.09.2013

  10. TACO reports 2012 & 2013 • 49 TACO, imputabilitypossible, probable orcertain • 35 highImputability • 14 possible • Patient demographics • Product type • Severity • Riskfactors • Signsandsymptoms • Preventability (transfusion rate?) Swisstransfusion, 06.09.2013

  11. TACO reports 2012 & 2013 Swisstransfusion, 06.09.2013

  12. Severity 2012 & 2013 Swisstransfusion, 06.09.2013

  13. Severity 2012 & 2013 Possibles: RBC 12 RBC + PC 1 RBC + FFP 1 PC 1 Swisstransfusion, 06.09.2013

  14. Riskfactors Swisstransfusion, 06.09.2013

  15. Riskfactors > 60y asonlyrisk: ~ 20 % lifethreateningevents Swisstransfusion, 06.09.2013

  16. Riskfactors > 60y asonlyrisk: ~ 20 % lifethreateningevents Additional riskfactors: 30 - 50 % lifethreatening/fatal events Swisstransfusion, 06.09.2013

  17. Reported TACO symptoms Swisstransfusion, 06.09.2013

  18. Reported TACO symptoms Swisstransfusion, 06.09.2013

  19. Reported TACO symptoms Swisstransfusion, 06.09.2013

  20. Reported TACO symptoms Swisstransfusion, 06.09.2013

  21. Grade 3 &4 TACO - Preventability Swisstransfusion, 06.09.2013

  22. Grade 3 & 4 TACO - Preventability transfusion rate: 2-4 ml/minute Absence ofriskfactors • Recommended precautions: • limittransfusion rate: 1 ml/kg bw/h • assess fluid balance • carefulmonitoringofpatient • considertherapeuticoptions • evaluatepatientforeachtransfusion Oneknownriskfactor Severalriskfactors Swisstransfusion, 06.09.2013

  23. Key findings • Most reported TACO cases occurred in patients > 60y • TACO is mainly associated with RBC transfusion • 25 % were life threatening or fatal • Age > 60 is the most common singlerisk factor • Several risk factors  increased severity Swisstransfusion, 06.09.2013

  24. Main clinical aspects • Presentation • hypertensionanddyspnoeaarethemostcommonbut non-specificsymptoms • Thecombinationofdyspnoeaandhypoxaemiaindicate an increasedlikelihoodfor a life-threateningor fatal courseoftheevent ► measuresaturation ! • Management of TACO • Recogniseandact on unspecificsymptoms • In caseofdyspnoeacheck O2-saturation • Look out foradditional symptoms • Considerdiuretics,nitratesandoxygen Swisstransfusion, 06.09.2013

  25. Prevention • Assessriskfactors • Base decisiontotransfuse on benefit/riskassessment • Take overall fluid balanceintoaccount • In presenceofoneormoreriskfactors: • Prescribelowtransfusion rate of max. 1 ml/kg bw/h • Monitor patientcarefully (BP, HR, respiration, SaO2) • Assesspatientanewforeachunittobetransfused Swisstransfusion, 06.09.2013

  26. Conclusions • TACO isthemajorremainingpreventableriskoftransfusion in Switzerland • Itismainlyobserved in elderlypatientsreceiving RBC transfusions • Pre-transfusionpatientriskassessmentis essential • Lessrestrictivedefinitionthanproposedby ISBT allowsrecognitionofbeginning TACO andprobablypreventionof a lifethreateningor fatal courseofreaction Swisstransfusion, 06.09.2013

  27. Conclusions • Preventivemeasuresfocus on • individualisedprescription(medicalstaff) • Low transfusion rate in patientsatriskfor TACO • closemonitoringofpatientduringtransfusion(nursingstaff) • Diureticsaspremedicationwerefoundtohavenoeffect on theseverityofreaction* * Robillard, P. et al; Transfusion associatedcirculatoryoverload: The newleadingcauseoftransfusionassociatedfatalitiesreportedtothe Québec Haemovigilance system. Presentationat IHS 2010 in Dubrovnik Swisstransfusion, 06.09.2013

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