Prevention of TACO what Haemovigilance data tell us

Transcription

1 Prevention of TACO what Haemovigilance data tell us Swisstransfusion, Genève 6. Septembre 03 Markus Jutzi, Morven Rüesch Clinical Reviewer Haemovigilance, Swissmedic Swissmedic Schweizerisches Heilmittelinstitut Hallerstrasse 7 CH-3000 Bern

2 Current Haemovigilance data Transfusion reactions 0 by classification and frequency,% 3.9%,3% 0,5%,0% 0,% 0,% 0,5% 0,% 8,% 7,7% 43,5% FNHTR Allo-immunisation Allergic TR TACO Hypotensive TR Other Haemolytic TR Infection TAD Hyperkalaemia TRALI PTP 59 % High imputability TR s

3 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).7 % of all reported TR s 5 % of reported TACO 3

4 Number of cases Life threatening and fatal cases Grade 3&4 TRs Fatal TR's Other Hyperkalaemia Delayed HTR TAD Hypotensive TR Bacterial infection TRALI Acute HTR 3 TRALI Bacterial infection Acute haemolytic TR TACO TACO Allergic TR 0 Year 4

5 Comparison of cumulative incidence (reported TACO cases per blood components transfused) Blood component All components Red cell concentrates Québec * Switzerland Ireland ** France ** : 3 93 : :0 000 : 3 0 : 940 : :8 000 : 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 00 in Dubrovnik ** ANSM; Mise au point sur les oedèmes aigus pulmonaires de sucharge posttransfusionnels. Juillet 0 5

6 Definition(s) of TACO ISBT WP on Haemovigilance, July 0: Occurrence of any 4 of the following: 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) Occurrence of any or all of the following: Dyspnoea Orthopnoea Cyanosis Tachycardia Increased blood pressure Pulmonary / pedal oedema within several hours of transfusion Nonspecific manifestations Headache Tightness in the chest Dry cough 6

7 Number of cases Reports of TACO High imputability cases by severity Grade 4 Grade 3 Grade Grade Year 7

8 Number of cases Reports of TACO All reported cases possible 30 0 Grade 4 Grade 3 Grade Grade Year 8

9 Number of cases Reports of TACO All reported cases Possible TACO: Only mild cases, except severe in possible Grade 4 Grade 3 Grade Grade Year 9

10 TACO reports 0 & TACO, imputability possible, probable or certain 35 high Imputability 4 possible Patient demographics Product type Severity Risk factors Signs and symptoms Preventability (transfusion rate?) 0

11 number of cases by gender TACO reports 0 & 03 Patient demographics of reported cases F M Age group

12 Number of cases Severity 0 & 03 Severity by blood component Grade Grade Grade 3 Grade RBC only RBC + PC PC only Product type

13 Number of cases Severity 0 & 03 Severity by blood component Possibles: RBC RBC + PC RBC + FFP PC Grade Grade Grade 3 Grade RBC only RBC + PC PC only Product type 3

14 Number of cases Risk factors Severity of TACO by risk factors Grade Grade Grade 3 Grade 4 0 no known risk factors heart disease only > 60y only > 60y + heart disease Risk factor > 60y + heart disease + renal failure 4

15 Number of cases Risk factors 0 8 > 60y as only risk: ~ 0 % life threatening events Severity of TACO by risk factors 6 4 Grade Grade Grade 3 Grade 4 0 no known risk factors heart disease only > 60y only > 60y + heart disease Risk factor > 60y + heart disease + renal failure 5

16 Number of cases Risk factors 0 8 > 60y as only risk: ~ 0 % life threatening events Severity of TACO by risk factors Additional risk factors: % life threatening/fatal events 6 4 Grade Grade Grade 3 Grade 4 0 no known risk factors heart disease only > 60y only > 60y + heart disease Risk factor > 60y + heart disease + renal failure 6

17 Signs and symptoms Reported TACO symptoms Signs and symptoms associated with TACO sweating other agitation loss of consciousness abdominal pain nausea/vomiting hypotension pulmonary oedema chest pain tachycardia hypertension hypoxemia dyspnoea chills fever Number of cases 7

18 Percent of cases Reported TACO symptoms Frequency of symptoms 80% 70% 60% 50% 40% 30% All cases 0% 0% 0% Hypertension Tachycardia Dyspnoea Hypoxia pulmonary oedema observed symptoms chest pain 8

19 Percent of cases Reported TACO symptoms Frequency of symptoms 0% 00% 80% 60% 40% Grade Grade Grade 3 / 4 0% 0% Hypertension Tachycardia Dyspnoea Hypoxia pulmonary oedema observed symptoms chest pain 9

20 percent of cases Reported TACO symptoms combinations of symptoms BP & dyspnoea BP or dyspnoea Dyspnoea & hypoxia Grade Grade Grade 3 / 4 Severity 0

21 Number of cases Grade 3 &4 TACO - Preventability 3 Transfusion rate and risk factors No Risk factor > 60y >60y + heart disease >60y + heart disease + renal failure 0 unknown -.5 ml/min > - >6 ml/min Transfusion rate

22 Grade 3 & 4 TACO - Preventability Absence of risk factors transfusion rate: -4 ml/minute One known risk factor Several risk factors Recommended precautions: limit transfusion rate: ml/kg bw/h assess fluid balance careful monitoring of patient consider therapeutic options evaluate patient for each transfusion

23 Key findings Most reported TACO cases occurred in patients > 60y TACO is mainly associated with RBC transfusion 5 % were life threatening or fatal Age > 60 is the most common single risk factor Several risk factors increased severity 3

24 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 O-saturation Look out for additional symptoms Consider diuretics, nitrates and oxygen 4

25 Assess risk factors Prevention 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. ml/kg bw/h Monitor patient carefully (BP, HR, respiration, SaO) Assess patient anew for each unit to be transfused 5

26 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 6

27 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 00 in Dubrovnik 7