prevention of taco – what haemovigilance data tell us

Swissmedic • Schweizerisches Heilmittelinstitut • Hallerstrasse 7 • CH-3000 Bern • www.swissmedic.ch

Prevention of TACO – what Haemovigilance data

tell us

Swisstransfusion, Genève6. Septembre 2013

Markus Jutzi, Morven RüeschClinical Reviewer Haemovigilance, Swissmedic

Current Haemovigilance data

2Swisstransfusion, 06.09.2013

43.5%

27.7%

18.1%

3.9%

2.3%

2.2% 1.0% 0.5% 0.5% 0.1% 0.2% 0.1%

Transfusion reactions 2012 by classification and frequency

FNHTRAllo-immunisationAllergic TRTACOHypotensive TROtherHaemolytic TRInfectionTADHyperkalaemiaTRALIPTP

59 % High imputability TR‘s

Imputability and severity

High imputability:• ~ 60 % of all reported transfusion reactions (TR‘s)• ~ 60 % of reported TACO

Severity grade 3 or 4 (life threatening or fatal)• 2.7 % of all reported TR‘s• 25 % of reported TACO


Life threatening and fatal cases


2008 2009 2010 2011 20120

5

10

15

20

25

30

35

2018 18

128

2 6 7

4

6

22 1

11

21

11

14 11

11

2

1

1

11

2

11

1

Grade 3&4 TRs 2008-2012

OtherHyperkalaemiaDelayed HTRTADHypotensive TRBacterial infectionTRALIAcute HTRTACOAllergic TR

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

0

1

2

3

Fatal TR's 2002 - 2012

TRALIBacterial infectionAcute haemolytic TRTACO

Year

Num

ber o

f cas

es

Comparison of cumulative incidence(reported TACO cases per blood components transfused)


Blood component

Québec2000 - 2008 *

Switzerland2008 - 2013

Ireland 2000 – 2008 **

France 2000 - 2006 **

All components 1: 3‘932 1: 9‘655 1:10‘000 1: 13‘210

Red cell concentrates 1: 2‘940 1: 7‘477 1:8‘000 1: 11‘450

* Robillard, P. et al; Transfusion associated circulatory overload: The new leading cause of transfusion associated fatalities reported to the Québec Haemovigilance system. Presentation IHS 2010 in Dubrovnik

** ANSM; Mise au point sur les oedèmes aigus pulmonaires de sucharge posttransfusionnels. Juillet 2012

Definition(s) of TACOISBT WP on Haemovigilance, July 2011:

• Acute respiratory distress • Tachycardia • Increased blood pressure • 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• Increased blood pressure• Pulmonary / pedal oedema

within several hours of transfusion

Nonspecific manifestations• Headache• Tightness in the chest• Dry cough

Occurrence of any 4 of the following: Occurrence of any or all of the following:

Reports of TACO 2008 - 2013


2008 2009 2010 2011 2012 20130

10

20

30

40

50

60

High imputability cases by severity

Grade 4Grade 3Grade 2Grade 1

Year

Num

ber o

f cas

es



2008 2009 2010 2011 2012 20130

10

20

30

40

50

60

All reported cases

possibleGrade 4Grade 3Grade 2Grade 1

Year

Num

ber o

f cas

es



2008 2009 2010 2011 2012 20130

10

20

30

40

50

60

All reported cases

possibleGrade 4Grade 3Grade 2Grade 1

Year

Num

ber o

f cas

es

Possible TACO: Only mild cases, except 1 severe in 2012

TACO reports 2012 & 2013


49 TACO, imputability possible, probable or certain• 35 high Imputability• 14 possible

Patient demographicsProduct typeSeverityRisk factorsSigns and symptomsPreventability (transfusion rate?)

TACO reports 2012 & 2013


40-49 50-59 60-69 70-79 80-89 90+0

2

4

6

8

10

12

14

1

1

2

8

8

2

23

5

21

Patient demographics of reported cases

FM

Age group

num

ber o

f cas

es b

y ge

nder

3

5

13

10

3

Severity 2012 & 2013


RBC only RBC + PC PC only0

2

4

6

8

10

12

14

16

18

20 19

1 1

4

1

7

11

Severity by blood component


Product type

Num

ber o

f cas

es

RBC only RBC + PC PC only0

2

4

6

8

10

12

14

16

18

20

Severity by blood component


Product type

Num

ber o

f cas

esSeverity 2012 & 2013


Possibles:RBC 12RBC + PC 1RBC + FFP 1PC 1

Risk factors


no kn

own r

isk fa

ctors

heart

dise

ase o

nly

> 60y o

nly

> 60y +

heart

dise

ase

> 60y +

heart

dise

ase +

rena

l failu

re0

2

4

6

8

10

12

Severity of TACO by risk factors


Risk factor

Num

ber o

f cas

es

no kn

own r

isk fa

ctors

heart

dise

ase o

nly

> 60y o

nly

> 60y +

heart

dise

ase

> 60y +

heart

dise

ase +

rena

l failu

re0

2

4

6

8

10

12



Risk factor

Num

ber o

f cas

esRisk factors


> 60y as only risk:~ 20 % life threatening events

no kn

own r

isk fa

ctors

heart

dise

ase o

nly

> 60y o

nly

> 60y +

heart

dise

ase

> 60y +

heart

dise

ase +

rena

l failu

re0

2

4

6

8

10

12



Risk factor

Num

ber o

f cas

esRisk factors


> 60y as only risk:~ 20 % life threatening events

Additional risk factors:30 - 50 % life threatening/fatal events

Reported TACO symptoms


feverchills

dyspnoeahypoxemia

hypertensiontachycardiachest pain

pulmonary oedemahypotension

nausea/vomitingabdominal pain

loss of consciousnessagitation

othersweating

0 5 10 15 20 25 30 35

1818

308

3321

1212

55

222

42

Signs and symptoms associated with TACO

Number of cases

Sign

s an

d sy

mpt

oms



Hypertension Tachycardia Dyspnoea Hypoxia pulmonary oedema

chest pain0%

10%

20%

30%

40%

50%

60%

70%

80%

Frequency of symptoms

All cases

observed symptoms

Perc

ent o

f cas

es



Hypertension Tachycardia Dyspnoea Hypoxia pulmonary oedema

chest pain0%

20%

40%

60%

80%

100%

120%

Frequency of symptoms

Grade 1Grade 2Grade 3 / 4

observed symptoms

Perc

ent o

f cas

es



Grade 1 Grade 2 Grade 3 / 40

10

20

30

40

50

60

70

80

90

100

combinations of symptoms

BP ↑ & dyspnoeaBP ↑ or dyspnoeaDyspnoea & hypoxia

Severity

perc

ent o

f cas

es

Grade 3 &4 TACO - Preventability


unknown 1-1.5 ml/Min >2 - >6 ml/Min0

1

2

3

Transfusion rate and risk factors

No Risk factor> 60y>60y + heart disease>60y + heart disease + renal failure

Transfusion rate

Num

ber o

f cas

es

Grade 3 & 4 TACO - Preventability


Absence of risk factors transfusion rate: 2-4 ml/minute

One known risk factor

Several risk factors

Recommended precautions:

• limit transfusion rate: 1 ml/kg bw/h• assess fluid balance• careful monitoring of patient• consider therapeutic options• evaluate patient for each transfusion

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 single risk factor

Several risk factors increased severity

Main clinical aspects


Presentation hypertension and dyspnoea are the most common but

non-specific symptoms The combination of dyspnoea and hypoxaemia indicate

an increased likelihood for a life-threatening or fatal course of the event ► measure saturation !

Management of TACO Recognise and act on unspecific symptoms In case of dyspnoea check O2-saturation Look out for additional symptoms Consider diuretics, nitrates and oxygen

Prevention


Assess risk factors

Base decision to transfuse on benefit/risk assessment

Take overall fluid balance into account

In presence of one or more risk factors:• Prescribe low transfusion rate of max. 1 ml/kg bw/h• Monitor patient carefully (BP, HR, respiration, SaO2)

Assess patient anew for each unit to be transfused

Conclusions


TACO is the major remaining preventable risk of transfusion in Switzerland

It is mainly observed in elderly patients receiving RBC transfusions

Pre-transfusion patient risk assessment is essential

Less restrictive definition than proposed by ISBT allows recognition of beginning TACO and probably prevention of a life threatening or fatal course of reaction

Conclusions


Preventive measures focus on • individualised prescription (medical staff)• Low transfusion rate in patients at risk for TACO• close monitoring of patient during transfusion (nursing staff)

Diuretics as premedication were found to have no effect on the severity of reaction*

* Robillard, P. et al; Transfusion associated circulatory overload: The new leading cause of transfusion associated fatalities reported to the Québec Haemovigilance system. Presentation at IHS 2010 in Dubrovnik

prevention of taco – what haemovigilance data tell us

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