Swissmedic Schweizerisches Heilmittelinstitut Hallerstrasse 7 CH-3000 Bern Prevention of TACO – what Haemovigilance data tell us Swisstransfusion, Genève 6. Septembre 2013 Markus Jutzi, Morven Rüesch Clinical Reviewer Haemovigilance, Swissmedic

Current Haemovigilance data 2 Swisstransfusion, % 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 3 Swisstransfusion,

Life threatening and fatal cases 4 Swisstransfusion,

Comparison of cumulative incidence (reported TACO cases per blood components transfused) 5 Swisstransfusion, Blood component Québec * Switzerland Ireland 2000 – 2008 ** France ** All components 1: 3‘9321: 9‘6551:10‘0001: 13‘210 Red cell concentrates 1: 2‘9401: 7‘4771:8‘0001: 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 TACO ISBT 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 6 Swisstransfusion, 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 Swisstransfusion,

Reports of TACO Swisstransfusion,

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

TACO reports 2012 & Swisstransfusion, TACO, imputability possible, probable or certain 35 high Imputability 14 possible Patient demographics Product type Severity Risk factors Signs and symptoms Preventability (transfusion rate?)

TACO reports 2012 & Swisstransfusion,

Severity 2012 & Swisstransfusion,

Severity 2012 & Swisstransfusion, Possibles: RBC12 RBC + PC 1 RBC + FFP 1 PC 1

Risk factors 14 Swisstransfusion,

Risk factors 15 Swisstransfusion, > 60y as only risk: ~ 20 % life threatening events

Risk factors 16 Swisstransfusion, > 60y as only risk: ~ 20 % life threatening events Additional risk factors: % life threatening/fatal events

Reported TACO symptoms 17 Swisstransfusion,

Reported TACO symptoms 18 Swisstransfusion,

Reported TACO symptoms 19 Swisstransfusion,

Reported TACO symptoms 20 Swisstransfusion,

Grade 3 &4 TACO - Preventability 21 Swisstransfusion,

Grade 3 & 4 TACO - Preventability 22 Swisstransfusion, 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 23 Swisstransfusion,  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 24 Swisstransfusion, 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 25 Swisstransfusion,  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 26 Swisstransfusion,  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 27 Swisstransfusion,  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