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Peter Mazolewski , MD, FACS LtCol USAR Cynosure Summit May 21, 2012

Blood Management The Impact of Blood Transfusions on Surgical Outcomes. Peter Mazolewski , MD, FACS LtCol USAR Cynosure Summit May 21, 2012. Disclosures . NO pharmacy Paid consultant for Strategic Healthcare Group Comprehensive Provider for Blood Management Consultation.

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Peter Mazolewski , MD, FACS LtCol USAR Cynosure Summit May 21, 2012

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  1. Blood Management The Impact of Blood Transfusions on Surgical Outcomes Peter Mazolewski, MD, FACS LtCol USAR Cynosure Summit May 21, 2012

  2. Disclosures • NO pharmacy • Paid consultant for Strategic Healthcare Group • Comprehensive Provider for Blood Management Consultation

  3. What is Blood Management? • Blood Management is evidence-based transfusion practices which result insafe and efficient use of blood products • Why Blood Management? • Inappropriate and excessive transfusions • No formal blood management training for clinicians • Measurable risks associated with EACH transfusion • Judicious use of blood reduces patient complications • Blood is a limited resource

  4. What We Have Learned is Not What We Now Know risk BENEFIT • What we learned in residency and medical school is far different than what the present literature states

  5. Current Understanding of Transfusion Practices RISK benefit In most clinical situations in which we are administering blood, the risk of transfusion far exceeds the benefit of transfusion

  6. Patient Populations • Hemodynamically stable patients with blood component deficiencies, i.e. anemia, low platelets, abnormally elevated INR • Acutely injured trauma patients with immediate life threatening hemorrhage • Consider GI hemorrhage which is life threatening • Consider Post operative life threatening bleeding • Consider person with unresponsive lactic acidosis

  7. Changing Dogma Creates Confusion Two developing dogmas which are different than what we had learned previously: • Hemodynamic stable anemic pts even with cardiac disease: OBSERVE • Acutely bleeding trauma: EARLY RESUSCITATION with BLOOD COMPONENTS • Then turn off after resuscitation

  8. How Can We Make a Change? • Medicine is always changing—not only at periphery, but also at its core • Treatment with blood is only one example • Other examples • Hyperventilation in Head Injury • B-blockade in CHF • Hormonal Replacement Therapy • Radiation Therapy in Breast Cancer?? • But this particular change is going to be difficult

  9. Why Difficult to Change? • Crosses all specialties and all doctors who were taught the same thing: risk BENEFIT

  10. Risks (Historical) • Primary Infectious (vs. secondary) • Viral (HBV, HCV, and HIV) • Bacterial (plts, 1:1000 – 1:2000) • Transfusion Reactions • Fever, Flushing • Tachycardia • Aggressive Immune response that is life threatening (RARE) • Perception of “Episodic” Risk • Few and far between • Clinicians have not taken seriously--in the sense that the benefit always outweighs these episodic rare complications

  11. Risks (Current) • TRIM (Transfusion Related ImmunoModulation) • Immunosuppression • Secondary Infection • Pneumonia, wound site infections, central line sepsis, etc • Reduced Survival in Cancer?* • Increased ICU and Hospital length of stay • Immunostimulation? • TRALI (Transfusion Related Acute Lung Injury) • ARDS, MODS • Late Mortality, most notably from cardiac literature • Vs. Early Mortality which may be also mechanical in nature (plugging, acute pathophysiology) • Dose Response Pattern (as opposed to episodic) • Each transfusion carries a measurable insult • Insults increase with number of transfusions • Also dose-dependent with respect to storage time *Vamvakas EC. Transfusion 1996.

  12. Benefit (Historical) • Enhanced Oxygen Delivery • Improved overall Morbidity and Mortality • Prevent Cardiac morbidity (angina and MI)

  13. Paradoxical Reality • While O2 delivery (DO2) is increased, tissue oxygen consumption (VO2)either stays the same or worsens* • VO2 independent of D02 • “RBC STORAGE LESION” (This is NOT fresh BLOOD!!!) • Loss of 2,3 DPG which shifts Oxy-hgb curve making it difficult to unload oxygen in the tissues • Discoid RBC now spherical, broken (rheologic properties)^ • Increased RBC clumping and aggregation • Decoupling of NO-Hgb** (free Hgb scavenges also NO) • Pro-Inflammatory Nature of Stored Blood • Which is pro thrombotic in nature • Increase 3-6fold PAI after 35 days, increased ADP which stimulates platelets, Nitric Oxide inhibits platelet activation *Tsai et al, Transfusion 2004 ^Almac et al, Best Pract Res Clin Anesth 2007 **Crawford et al. Blood 2006. Reynolds et, Proc Natl Acad Sci 2007

  14. ** * * * * Quality Issues: Storage Defects and Microvascular Perfusion • Decreased 2,3- DPG, ADP • Build-up of cytokines, free Hgb, K+, debris (BRMs) 1,2 • Poor deformability3 3 1 Kristiansson- ActaAnesthScand 1996;40 2 Fransen- Chest 1999;116 3 Hovav- Transfusion 1999; 39

  15. Stored PRBCs behave in this manner! Anemic patients with NL RBCs can at least behave in these ways

  16. Schechter, Gladwin, NEJM April 10, 2003

  17. Tissue oxygenation after Transfusion In Trauma Kiraly. J Trauma. July 2009

  18. Blood Transfusion Video

  19. Benefit (Historical) • Enhanced Oxygen Consumption (NO!!!) • Improved overall Morbidity and Mortality • Trauma is exception with MTP (Massive Transfusion Protocol) • Less Cardiac Events

  20. Current Risk/Benefit Ratio RISK BENEFIT

  21. Risks (Current) • TRIM (Transfusion Related ImmunoModulation) • Immunosuppression • Secondary Infection • Pneumonia, wound site infections, central line sepsis, etc • Reduced Survival in Cancer?* • Increased ICU and Hospital length of stay • Immunostimulation? • TRALI (Transfusion Related Acute Lung Injury) • ARDS, MODS • Late Mortality, most notably from cardiac literature • Vs. Early Mortality which may be also mechanical in nature (plugging, acute pathophysiology) • Dose Response Pattern (as opposed to episodic) • Each transfusion carries a measurable insult • Insults increase with number of transfusions • Also dose-dependent with respect to storage time *Vamvakas EC. Transfusion 1996.

  22. Immunosuppression of PRBCs Effect of blood transfusions on subsequent kidney transplants. Opelz G, Sengar DP, Mickey MR, Terasaki PI. Transplant Proc 1973; 5:253-9 Opelz reevaluated again in 1997 (prospective randomized) with modern immunosuppressive therapy and still found a significant impact of PRBC transfusion on renal allograft acceptance

  23. Did this Information Initiate Quality Controls in Blood Banking? • I argue “NO.” (With respects to immunomodulation) • The only current measure of “quality” with regards to RBC transfusion is if 70% of the RBCs survive in the circulation at 24hrs post transfusion. (Developed in 1940’s) • Except for leukoreduction (which is not universal),there has been no attempt to diminish or to measure cellular debris or mediators • Therefore it is not surprising that we see a multitude of complications as a result of PRBC transfusions.

  24. Infection and Transfusion in Surgical Procedures No Transfusion Transfusion 40 N=589 * 35 * N=267 * 30 N=343 * N=868 N=197 25 N=109 Incidence ofInfection (%) 20 * 15 N=238 10 5 0 Tartter Trauma Spinal Cardiac Colorectal * Significant in Multivariate Analysis Edna Triulzi Vignal Jensen Jensen Murphy Adapted from: Despotis G.

  25. 4892 Patients at initial ICU admission • 1518 mechanically ventilated >48hrs • VAP in 20.5% • Multivariate Analysis transfusion independently increased risk for VAP • OR 1.89

  26. Transfusion and Nosocomial Infections n=9598 Units Transfused Carson et al, Transfusion 1999;39

  27. n = 576 Units Transfused Transfusion and Length of Stay Shapiro et al, J Trauma 2003;55

  28. Quality Issues: Duration of Blood Storage and Outcomes ARF In Hospital Mortality LOS 1 Basran et al- Anesth Analg 2006;103 2 Koch et al- NEJM 2008;358

  29. Transfusion Requirements in Critical Care (TRICC) Study

  30. Is Anemia beneficial?? • Yes it is. • Anemia lessens viscosity and therefore lessens resistance. • Diminished venous resistance results in improved venous return. • Diminished arterial resistance results in lower SVR. • Together both these mechanisms result in a significantly higher cardiac output. Tsai, et al. Transf Apher Sci. 2010 August.

  31. CRIT Study • 2004, 284 ICUs, 4892 Pts in prospective, observational cohert • Transfusion was an independent predictor of ICU length of stay, increased complications, and increased mortality (1.65 adjusted mortality ratio) with propensity scoring (1059 pts transfused to 1059 matched no transfusion) • 65% pts received transfusions with hgb>8.0 gm/dl • <10% pts received transfusions with hgb<7.0 gm/dl

  32. Transfusion and Mortality in Trauma (Pre MTP era) Malone et al. J Trauma. May 2003

  33. NSQIP Data (adjusted odds ratio) Bernard AC, et al. jamcollsurg 2008

  34. Surgical Outcomes: one unit transfusion Ferrarris, et al. Arch Surg. 2012;147:49-55

  35. Benefit (Historical) • Enhanced Oxygen Delivery (NO!!!) • Improved overall Morbidity and Mortality (NO!!!) • Because we are transfusing too many patients where there is simply no benefit. If there is a benefit, we cannot see it. • Overall, trend for outcomes is significantly worse • Trauma is exception with MTP (Massive Transfusion Protocol) Less Cardiac Events

  36. Current Risk/Benefit Ratio RISK benefit

  37. Blood Transfusion & Percutaneous Coronary Intervention Doyle,et al. JACC. 2009. Vol 53

  38. Cardiac Surgery and Blood Transfusion • Northern New England Cardiovascular Disease Study Group • 8 Centers evaluated 9079 consecutive patients between 2001-2004 • Cox Proportional Hazard and Propensity Analysis • 3254 patients exposed to one or two units PRBCs and compared to those who had none • 16% increased mortality out to 6mos • Surgenor et al. Cardiovascular Anesthesiology. 2009

  39. TRACS • Prospective Randomized Trial in Cardiac Elective Surgery • JAMA Oct 13, 2010 • Compared Liberal (>10gm/dl) and Restrictive (>8gm/dl) strategies in Blood Management • 250pt each arm • 78% (liberal) vs 47% (restrictive) pts transfused • No difference in outcomes • When looking at those transfused, independent risk factor for clinical complications or death @ 30days (HR for each add’l unit 1.2) • Avoid transfusion solely to correct low hgb

  40. FOCUS Trial • 2016 high risk cardiovascular pts undergoing hip fracture surgery prospectively randomized into a restrictive vs. liberal transfusion policy • Restrictive 8gm/dl and symptomatic • Liberal 10gm/dl • Median Age 82 • Non-inferiority study Carson, et al. NEJM. Dec 2011.

  41. FOCUS Trial—RESULTS • Primary Outcome: inability to walk 10ft unassisted at 60d and mortality • 34.7% restrictive and 35.2% liberal • All other secondary measures of morbidity did not reach statistical significance (trend towards restrictive group) • Very similar percentages seen in other high powered observational studies using propensity scoring. • 65% less blood used in restrictive group • 97% of patients transfused in liberal group

  42. RBC Transfusion in CVT Surgery and Quality of Life • Patient’s perspective • RBC and Component transfusion therapy and functional health-related Quality of Life • 7321/12536 pts over 4yr period (1995-99) completed self administered DASI preop and postop (6-12mos) • Regression analysis showed that postoperative functional status after CVT surgery was incrementally worse with more PRCs and platelets transfused Kock, et al. Soc Th Surg. 2006

  43. Benefit (Historical) • Enhanced Oxygen Delivery (NO!!!) • Improved overall Morbidity and Mortality (NO!!!) • Because we are transfusing too many patients where there is simply no benefit. If there is a benefit, we cannot see it. • Trauma is exception with MTP (Massive Transfusion Protocol) • Less Cardiac Events (NO!!!) • Actually more!!!

  44. Current Risk/Benefit Ratio RISK benefit

  45. Difficult Dilemma • Anemia and acute coronary events carry a high mortality • However, transfusion has not been shown to confer a benefit or improvement in survival • IN FACT, many studies show that patients do worse with transfusion • What to do? • This data should provide enough comfort for clinicians NOT to feel need to transfuse in anemic hemodynamically stable patients with cardiac disease

  46. Is Hgb 7.0 the trigger? It is “the trigger to CONSIDER” transfusion…..

  47. TASK FORCE-EAST AND ACCM • NO “TRANFUSION TRIGGER” based on hgb level • Critically ill patients, HD stable anemia, except possibly those w/acute myocardial ischemia, a “restrictive” strategy (hgb < 7gm/dl) is equally as effective as a “liberal” strategy (hgb < 10gm/dl) LEVEL I evidence • In critically ill pts on the ventilator, the above also holds true. LEVEL II • In resuscitated, critically ill trauma pts, the above holds true. LEVEL II • In critically ill patients with stable cardiac disease, the above holds true. LEVEL II. (very important: prevention of ischemia not supported by literature) • RBC transfusions should be given as single unit. LEVEL II • RBC transfusions should not be considered as an absolute method to improve tissue oxygen consumption in critically ill. LEVEL II • Napolitano Crit Care Med. Dec 2009.

  48. Indicators for Considering RBC Transfusion (in absence of bleeding) Normovolemic anemia (Hgb≤7) WITH signs or symptoms of inadequate oxygen delivery Napolitano et al. Critical Care Medicine 2009;37:3124-3157 Pape, A., et al: Blood Transfus 7:250-8, 2009

  49. What are signs or symptoms of inadequate oxygen delivery? Signs ScvO2 < 70% [nl=80%] (central line) SvO2 < 65% [nl=75%] (PA catheter) Low cerebral or tissue oximetry Base deficit – ABG Lactic acidosis - lab ST changes - EKG ↓ LV contractility by trans esoph echo SYMPTOMS Mental status alteration Dyspnea Chest pain New arrhythmias Tachycardia (VERY RELATIVE) -Main Provider Excuse Pape, A., et al: Blood Transfus 7:250-8, 2009 Napolitano et al. Critical Care Medicine 2009;37:3124-3157

  50. How Can we immediately improve the situation? • If we follow transfusion guidelines published by large societies (and remove less blood), we will transfuse far less blood (>50%) than currently given. • This will diminish the need to store blood for 42 days and perhaps we can survive with a smaller pool of blood which is younger, fresher, and significantly safer (goal < 21days). • In addition, we need to improve our science regarding blood banking which ameliorates the effects of the “storage lesion.”

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