Age of Transfused Blood: Short-Term Mortality and Long-Term Survival after Cardiac Surgery Mark Stafford-Smith, MD, CM, FRCPC, FASE Professor of Anesthesiology.

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Presentation transcript:

Age of Transfused Blood: Short-Term Mortality and Long-Term Survival after Cardiac Surgery Mark Stafford-Smith, MD, CM, FRCPC, FASE Professor of Anesthesiology Division of Cardiothoracic Anesthesia & Critical Care Medicine Duke Heart Center, Durham, NC Thursday May 1, 2008 FDA Blood Products Advisory Committee 91 st Annual Meeting Rockville, MD

Disclosure: No financial relationships to disclose pertinent to the content of this CME presentation Consultant for Polymedix Inc. Age of Transfused Blood: Short-term Mortality and Long-term Survival after Cardiac Surgery

Problems for Established Therapeutic Interventions Efficacy vs. Safety estrogen/medroxyprogesterone acetate vs. myocardial infarction SSRI antidepressants, teen suicide link cyclooxygenase 2 inhibitor (Vioxx) vs. myocardial infarction McEvoy et al. Anesth Analg 2007; 105: rosiglitazone (Avandia) vs. myocardial infarction aprotinin (Trasylol) vs. postop kidney dysfunction and mortality

Ho et al. Crit Care Med 2003;31:S UK – SHOT analysis, TRALI and plasma donor gender

Liberal versus Restrictive Transfusion Hébert et al. New Engl J Med 1999;340: N=838 critically ill patients Hb<9.0g/dL Randomized to one of two groups within 72h of ICU admission Transfusion Strategy Restrictive – trigger <7.0g/dL, target 7-9 Liberal – trigger <10g/dL, target 10-12

n=78,974 elderly (>65y) with MI crude 30-day mortality correlated with decreasing admission Hct 3,680 (4%) received a transfusion Wu W-C et al N Engl J Med 2001;345; Myocardial Infarction and Transfusion Odds ratio for 30 day mortality for patients who received a blood transfusion as compared to those who did not.

Ho et al. Crit Care Med 2003;31:S Mortality in-hosp, 30d.- meta-analysis (15 trials) 60d, 90d no association leukored vs. non Vox Sang 2002;82: Multiorgan failure- trauma patients, prospective cohort transfusion Arch Surg 1997;132:620-5 Mortality 24h/in-hosp- trauma patients, prospective and LOS ICU/Hosp transfusion J Trauma 2003;54: ICU mortality and - postop cardiac surgery patients, prospective cohort mechanical ventilation transfusion Anesthesiology 2003;98: Harm Associated with Transfusion 30 day mortality- critically ill patients, prospective RCT restrictive vs. liberal N Engl J Med 1999;340: day / ICU mortality- critically ill patients, prospective cohort and LOS transfusion JAMA 2002;288: (cardiac surgery subgroup (3RCTs) – leukoreduced reduced months mortality)

Age Distribution of Transfused Blood DeSimone et al. Anesth Analg 2005;100:SCA7 VanMatre et al. Anesth Analg 2007;104:SCA23 20% of packed red cells are transfused > 28 days old 10-38% packed red cells transfused within 2 days of expiry Vamvakas et al. Transfusion 2000;40:101-9 Ho et al. Crit Care Med 2003;31:S687-97

Adverse Changes (“Storage Lesion”) in Stored Red Blood Cells Bennett-Guerrero et al PNAS 2007;43:

Ho et al. Crit Care Med 2003;31:S Prolonged Storage and Outcomes after Red Cell Transfusion Length of ICU stay- 698 septic patients, retrospective blood >14days Clin Invest Med 1994;17:B21 Mortality- 31 septic patients, retrospective blood >16days Can J Anaesth 1997;44: Multiorgan failure- trauma patients, prospective cohort #units >14days, >21days Am J Surg 1999;178:570-2 Postop pneumonia- 416 CABG surgery patients, retrospective age of blood Transfusion 1999;39: Gastric pH- septic patients, prospective blood >16days JAMA 1993;269: Major infections- cardiac surgery patients, retrospective age of oldest unit Anesthesiology 2003;98:815-22

Longer storage of blood + WBC’s → greater accumulation of WBC-derived cytokines Interaction between Leukoreduction and Blood Storage Postop pneumonia- 416 CABG surgery patients, retrospective age of blood, non- vs. leukored Transfusion 1999;39:701-10

Hebert et al. Anesth Analg 2005;100: transfused ICU/cardiac surgery patients - Canadian Medical Centers Standard group - Median age transfusion 19 days Experimental group - Median age transfusion 19 days

Age of Stored Blood and Post-Cardiac Surgery Mortality Risk Koch et al. New Engl J Med 2008;358:

- single institution - transfused CABG, Valve or CABG/Valve surgery patients - June 30, January 30, ,872 patients - blood stored <14 days (8,802 units) - 3,130 patients - blood stored >14 days (10,782 units) Age of Stored Blood and Post-Cardiac Surgery Mortality Risk - Propensity-adjusted, multivariable logistic regression analysis to examine the association of storage age on postoperative mortality - Kaplan-Meier and Brownstone Decompensation method to assess association of storage age on long-term survival Koch et al. New Engl J Med 2008;358:

Age of Stored Blood and Post-Cardiac Surgery Mortality Risk Koch et al. New Engl J Med 2008;358:

Age of Stored Blood and Post-Cardiac Surgery Mortality Risk

Koch et al. New Engl J Med 2008;358: Age of Stored Blood and Post-Cardiac Surgery Mortality Risk

Koch et al. New Engl J Med 2008;358: Age of Stored Blood and Post-Cardiac Surgery Mortality Risk

Koch et al. New Engl J Med 2008;358: Age of Stored Blood and Post-Cardiac Surgery Mortality Risk

Koch et al. New Engl J Med 2008;358: Age of Stored Blood and Long-Term Survival

- single institution transfused CABG surgery patients - September June 2002 Age of Stored Blood and Post-Cardiac Surgery Mortality Risk DeSimone et al. Anesth Analg 2005;100:SCA7 VanMatre et al. Anesth Analg 2007;104:SCA23 30 Day MortalityN (deaths)P value All units ≤ (27)0.14 All units > (52) Oldest unit ≤ (27)0.003 Oldest unit > (94) Oldest unit ≤ (27)< Oldest unit >14, ≤ (43) Oldest unit > (51)

Age of Stored Blood and Post-Cardiac Surgery Mortality Risk - Propensity-adjusted, multivariable logistic regression analysis to examine the association of storage age of the oldest transfusion on postoperative mortality - Cubic-Splines analysis to assess for curvilinear relationships - Kaplan-Meier method to assess the association of storage age of the oldest transfusion on long-term survival DeSimone et al. Anesth Analg 2005;100:SCA7 VanMatre et al. Anesth Analg 2007;104:SCA23

DeSimone et al. Anesth Analg 2005;100:SCA7 Age of Stored Blood and Post-Cardiac Surgery Mortality Risk

VanMatre et al. Anesth Analg 2007;104:SCA23 Age of Stored Blood and Post-Cardiac Surgery Mortality Risk

“…the COX-2 saga has served to demonstrate that an approach (to drug development) based on studies powered to show effectiveness, no longer meets societal expectations for a comprehensive review of acceptable drug safety.” Stafford-Smith Can J Anaesth 2006;53: