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
3Swisstransfusion, 06.09.2013
Life threatening and fatal cases
4Swisstransfusion, 06.09.2013
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)
5Swisstransfusion, 06.09.2013
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
6Swisstransfusion, 06.09.2013
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
7Swisstransfusion, 06.09.2013
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
Reports of TACO 2008 - 2013
8Swisstransfusion, 06.09.2013
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
Reports of TACO 2008 - 2013
9Swisstransfusion, 06.09.2013
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
10Swisstransfusion, 06.09.2013
49 TACO, imputability possible, probable or certain• 35 high Imputability• 14 possible
Patient demographicsProduct typeSeverityRisk factorsSigns and symptomsPreventability (transfusion rate?)
TACO reports 2012 & 2013
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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
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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
Grade 1Grade 2Grade 3Grade 4
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
Grade 1Grade 2Grade 3Grade 4
Product type
Num
ber o
f cas
esSeverity 2012 & 2013
13Swisstransfusion, 06.09.2013
Possibles:RBC 12RBC + PC 1RBC + FFP 1PC 1
Risk factors
14Swisstransfusion, 06.09.2013
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
Grade 1Grade 2Grade 3Grade 4
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
Severity of TACO by risk factors
Grade 1Grade 2Grade 3Grade 4
Risk factor
Num
ber o
f cas
esRisk factors
15Swisstransfusion, 06.09.2013
> 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
Severity of TACO by risk factors
Grade 1Grade 2Grade 3Grade 4
Risk factor
Num
ber o
f cas
esRisk factors
16Swisstransfusion, 06.09.2013
> 60y as only risk:~ 20 % life threatening events
Additional risk factors:30 - 50 % life threatening/fatal events
Reported TACO symptoms
17Swisstransfusion, 06.09.2013
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
Reported TACO symptoms
18Swisstransfusion, 06.09.2013
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
Reported TACO symptoms
19Swisstransfusion, 06.09.2013
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
Reported TACO symptoms
20Swisstransfusion, 06.09.2013
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
21Swisstransfusion, 06.09.2013
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
22Swisstransfusion, 06.09.2013
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
23Swisstransfusion, 06.09.2013
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
24Swisstransfusion, 06.09.2013
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
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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
26Swisstransfusion, 06.09.2013
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
27Swisstransfusion, 06.09.2013
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
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