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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

Preventionof TACO – what Haemovigilance datatellus

Swisstransfusion, Genève

6. Septembre 2013

Markus Jutzi, Morven Rüesch

ClinicalReviewerHaemovigilance, Swissmedic

current haemovigilance data
Current Haemovigilance data

59 % High imputabilityTR‘s

Swisstransfusion, 06.09.2013

slide3

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

life threatening and fatal cases
Life threateningand fatal cases

Swisstransfusion, 06.09.2013

slide5

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

slide6

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

reports of taco 2008 2013
Reports of TACO 2008 - 2013

Swisstransfusion, 06.09.2013

reports of taco 2008 20131
Reports of TACO 2008 - 2013

Swisstransfusion, 06.09.2013

reports of taco 2008 20132
Reports of TACO 2008 - 2013

Possible TACO:

Only mild cases,

except 1 severe in 2012

Swisstransfusion, 06.09.2013

slide10

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

slide11

TACO reports 2012 & 2013

Swisstransfusion, 06.09.2013

slide12

Severity 2012 & 2013

Swisstransfusion, 06.09.2013

slide13

Severity 2012 & 2013

Possibles:

RBC 12

RBC + PC 1

RBC + FFP 1

PC 1

Swisstransfusion, 06.09.2013

slide14

Riskfactors

Swisstransfusion, 06.09.2013

slide15

Riskfactors

> 60y asonlyrisk:

~ 20 % lifethreateningevents

Swisstransfusion, 06.09.2013

slide16

Riskfactors

> 60y asonlyrisk:

~ 20 % lifethreateningevents

Additional riskfactors:

30 - 50 % lifethreatening/fatal events

Swisstransfusion, 06.09.2013

slide17

Reported TACO symptoms

Swisstransfusion, 06.09.2013

slide18

Reported TACO symptoms

Swisstransfusion, 06.09.2013

slide19

Reported TACO symptoms

Swisstransfusion, 06.09.2013

slide20

Reported TACO symptoms

Swisstransfusion, 06.09.2013

slide21

Grade 3 &4 TACO - Preventability

Swisstransfusion, 06.09.2013

slide22

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

slide23

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

slide24

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

slide25

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

slide26

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

slide27

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