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Good Bye TRALI, Good Morning TACO. From Hemovigilance to Pathophysiology P. Renaudier, on behalf of the CNCRH IHS Paris. March, 9 th 2016.
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Good Bye TRALI,
Good Morning TACO.From Hemovigilance to
Pathophysiology
P. Renaudier, on behalf of the CNCRH
IHS
Paris. March, 9th 2016.
In French HV reports, TRALI decrease
with male or
female without anti-HLA Abdonors,
whereas TACO are now stable.
Source : 2014 ANSM Hemovigilance Report
http://ansm.sante.fr/var/ansm_site/storage/original/application/8a2c3c478172fcf
be027742aed130adf.pdf
The new donor selection criteria for
plasma and apheresis platalets
concentrates were implemented in 2010
Source : 2014 ANSM Hemovigilance Report
http://ansm.sante.fr/var/ansm_site/storage/original/application/8a2c3c478172fcf
be027742aed130adf.pdf
Agenda• Epidemiology
– TACO vs TRALI
→ The case for immunologic TRALI
– Fatalities imputable to TACO
– The question of TACO incidence rate
• Pathophysiology
– Pulmonary oedema
– Fluids compartements
– Heart and Kidney
• Diagnostic and Prevention
TACO is now the most frequently
reported cause of Tx mortality
Source : 2014 ANSM Hemovigilance Report
http://ansm.sante.fr/var/ansm_site/storage/original/application/8a2c3c478172fcf
be027742aed130adf.pdf
TACO
TRALI
Total ARs (137,769) Deaths (495)
Most common types
FNHTR TACO 24.5%
Allergic TRALI 17.6%
DSTR TAD 13%
TACO Allergic 12.3%
DHTR AHTR 6.9%
TAD Other 10.3%
AHTR
Hypotensive
TRALI
ISTARE 2006-2014
TACO incidence rate in
HV reports
Country Incidence rate Study period
France 6.8/100.000 2000 - 2013
United Kingdom 3.4/100.000 2013
USA 6.0/100.000 Unknown
Quebec 28.3/100.000 2004 - 2011
Canada 15.2/100.000 2006 - 2012
Netherlands 6.6/100.000 2008 - 2012
Spain 1.67/100.000 2007 - 2012
Ireland 10.9/100.000 2000 - 2010
Australia 1.83/100.000 2000 - 2012
TACO incidence rate in
epidemiologic studiesStudy design # of Centers Patients Incidence rate Study period
RetrospectiveMonocentric
(Mayo clinic)
inpatients
miscellaneous1/708 1985
ProspectiveMulticentric
(USA)
orthopedic
surgery462/9327 1996 - 1997
Retrospective
Multicentric
(Massachussets –
5 Centers)
surgery 4/382 1992 - 1993
RetrospectiveMulticentric
(USA)ICU
25/135
(1/356)2003
Retrospective
Multicentric
(Ontario, Canada)
2 centers
miscellaneous 0.5/1000 2007 - 2012
Retrospective Monocentric
(USA)
platelet 1/5997 2000 - 2012
Prospective recipients 1/167 2013
RetrospectiveMonocentric
(Mayo clinic)}
non-cardiac
surgery with general
anesthesia
119/2162
57/1908
2004
2011
Agenda• Epidemiology
– TACO vs TRALI
→ The case for immunologic TRALI
– Fatalities imputable to TACO
– The question of TACO incidence rate
• Pathophysiology
– Pulmonary oedema
– Fluids compartements
– Heart and Kidney
• Diagnostic and Prevention
Pulmonary oedema
• Définition = pathophysiology
= Extra-vascular accumulation of fluid in
connection with an abnormal balance
between filtration and reabsorption
• Classification = 2 types
Overload ALI
Pulmonary oedema
• Définition = pathophysiology
= Extra-vascular accumulation of fluid in
connection with an abnormal balance
between filtration and reabsorption
• Classification = 2 types
• In the context of a transfusion = time
– < 6 heures : TACO or TRALI
– > 6 heures : other dyspneas
Fluid compartments• Include intracellular fluid (which makes up to 65 %
of the body water) and extracellular fluid (35 %).
• Extracellular fluid is divided into – Interstitial compartment
– Intravascular compartment
– Third space
A retrospective review of patients
factors, transfusion practices, and
outcomes in patients with TACOLieberman L et al. Transf Med Rev 2013 ; 27 : 206-12.
Patients n (=98) %
Hematology 32 32.7
pre-TACO Echo (n=44)
EF ≤ 60 % 13 29.5
Evidence of 24 54.5
diastolic dysfunction
Medical History
CHF 25 25.5
HTA 63 64.0
Diabetes 25 25.5
Renal dysfunction 43 44.3
Systolic heart failure.The heart muscle becomes weak and
enlarged. It can’t pump enough blood
forward when the ventricles contract.
Ejection fraction is lower than normal.
Diastolic heart failure.The heart muscle becomes stiff. It doesn’t
relax normally between contractions, which
keeps the ventricles from filling with blood.
Ejection fraction is often in the normal range.
Agenda• Epidemiology
– TACO vs TRALI
→ The case for immunologic TRALI
– Fatalities imputable to TACO
– The question of TACO incidence rate
• Pathophysiology
– Pulmonary oedema
– Fluids compartements
– Heart and Kidney
• Diagnostic and Prevention
Pulmonary
oedema
- Bilateral pulmonary infiltrates
- Bilateral crackles
- Abundant sputum
<6h /
transfusion
Overload
criteria
TACO
Pulmonary
oedema
ALI
criteria
ALI / SDRA
N
- PCWP > 18 mm Hg
- CVP > 15 mm Hg
- EKG signs
- Positive fluid balance or edemas
- Rapid improvement after Dcs or Vds
- BNP > 400 pg/mL
- NT-pro-BNP > 2,000 pg/mL
- Cardiomegaly on chest X-ray
- BP > 140/90 mm Hg
<6h /
transfusion
Overload
criteria
Other
diagnostic
Unclassified
TACO
N
Pulmonary
oedema
ALI
criteria
ALI / SDRA
<24h /
transfusion
Other dyspneaNN
N
N
Associate
diagnostic 3
Main
diagnostic
0
Worsening
condition
1
2
Associate
diagnostic
Immunologic
proof
Predominant
0
13
2
23Cellule Régionale d’Hémovigilance et de Sécurité Transfusionnelle – Dr Ph. Renaudier
HEMATOLOGIE – ONCOLOGIE (7)
GERIATRIE (âgé > 80 ans)
Modalités de transfusion et de surveillance
Avant toute transfusion, il est recommandé de s’assurer de la qualité de la voie d’abord
veineuse.
Le CGR est transfusé lentement, à une vitesse inférieure à 5 ml/min pendant les 15
premières minutes, puis la vitesse est adaptée à la tolérance clinique.
La durée moyenne de transfusion se situe autour de 2 heures.
AE
Les seuils suivants sont recommandés :
• 70 g/l en l’absence d’insuffisance cardiaque ou coronarienne et de
mauvaise tolérance clinique
• 80 g/l chez les patients insuffisants cardiaques ou coronariens
• 100 g/l en cas de mauvaise tolérance clinique.
Un âge supérieur à 80 ans n’est pas une contre-indication à la transfusion :
Les indications sont les mêmes qu’en population générale
Le risque de surcharge volémique est accru
24Cellule Régionale d’Hémovigilance et de Sécurité Transfusionnelle – Dr Ph. Renaudier
HEMATOLOGIE – ONCOLOGIE (8)
GERIATRIE (âgé > 80 ans)
AE
• La transfusion en protocole « phénotypé RH-KEL1 » n’est pas
recommandée sauf si des transfusions répétées sont prévues, comme c’est
le cas pour les syndromes myélodysplasiques.
AE
• Il est recommandé de ne prescrire qu’un seul CGR à la fois lorsque la
tolérance du patient à la transfusion n’est pas connue. Le taux d’hémoglobine
est alors contrôlé avant toute nouvelle prescription de CGR pour discuter une
éventuelle nouvelle transfusion.
• Il n’est pas recommandé d’associer préventivement un diurétique à la
transfusion.AE
AE
• Il est recommandé de surveiller, outre les paramètres habituelles (fréquence
cardiaque, pression artérielle, température), la fréquence respiratoire et, si
possible, la saturation en oxygène, pendant la transfusion à intervalles
réguliers de 15 à 30 minutes, et jusqu’à 1 à 2 heures après la transfusion.
AE
• En cas de transfusion en hôpital de jour, il est recommandé que
l’autorisation de sortie soit délivrée par un médecin, après information du
patient et de son entourage des symptômes d’alerte de l’œdème aigu du
poumon (dyspnée, toux, douleur thoracique…).
TACO Prevention• An induvidual basis
– HAS Guidelines
– Identifing at risk patients Haemovigilance data for transfusion
associated circulatory overload (TACO) provides a framework for informing patient-tailoredrate and volume of transfusion Source: Vox sanguinis [0042-9007] Grey S.L. yr:2015 vol:109 pg:41 -41
• A public health basis
– Education• HAS Guidelines
• Local experiences reported during the IHN meeting
– Look back studies• Experience Metz and Lorraine
– Discussion (MMR, CSTH)
Conclusion
• TACO is not a public health priority but a
transfusion priority
• Lung is the target but heart and kidney are
the key organs to be considered for
prevention
• TACO detection by hemovigilance is the
requirement for their analysis
