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

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Presentation on theme: "Peter Mazolewski, MD, FACS LtCol USAR Cynosure Summit May 21, 2012 Peter Mazolewski, MD, FACS LtCol USAR Cynosure Summit May 21, 2012 Blood Management."— Presentation transcript:

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

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

3 My Army 3

4 What is Blood Management? Blood Management is evidence-based transfusion practices which result in safe 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 Blood Management is evidence-based transfusion practices which result in safe 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

5 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 risk BENEFIT What we learned in residency and medical school is far different than what the present literature states 5

6 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 RISK benefit In most clinical situations in which we are administering blood, the risk of transfusion far exceeds the benefit of transfusion 6

7 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 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

8 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 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

9 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 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

10 Why Difficult to Change? Crosses all specialties and all doctors who were taught the same thing: risk BENEFIT Crosses all specialties and all doctors who were taught the same thing: risk BENEFIT 10

11 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 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

12 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 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 12 *Vamvakas EC. Transfusion 1996.

13 Benefit (Historical) Enhanced Oxygen Delivery Improved overall Morbidity and Mortality Prevent Cardiac morbidity (angina and MI) Enhanced Oxygen Delivery Improved overall Morbidity and Mortality Prevent Cardiac morbidity (angina and MI) 13

14 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 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 Reynolds et, Proc Natl Acad Sci 2007

15 Quality Issues: Storage Defects and Microvascular Perfusion  Decreased 2,3- DPG, ADP  Build-up of cytokines, free Hgb, K+, debris (BRMs) 1,2  Poor deformability 3  Decreased 2,3- DPG, ADP  Build-up of cytokines, free Hgb, K+, debris (BRMs) 1,2  Poor deformability 3 15 * * * * ** 1 Kristiansson- ActaAnesthScand 1996;40 2 Fransen- Chest 1999;116 3 Hovav- Transfusion 1999; 39 3

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

17 Schechter, Gladwin, NEJM April 10, 2003

18 Tissue oxygenation after Transfusion In Trauma 18 Kiraly. J Trauma. July 2009

19 Blood Transfusion Video

20 Benefit (Historical) Enhanced Oxygen Consumption (NO!!!) Improved overall Morbidity and Mortality –Trauma is exception with MTP (Massive Transfusion Protocol) Less Cardiac Events Enhanced Oxygen Consumption (NO!!!) Improved overall Morbidity and Mortality –Trauma is exception with MTP (Massive Transfusion Protocol) Less Cardiac Events 20

21 Current Risk/Benefit Ratio RISK BENEFIT RISK BENEFIT 21

22 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 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 22 *Vamvakas EC. Transfusion 1996.

23 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 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

24 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. 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

25 25 Infection and Transfusion in Surgical Procedures No TransfusionTransfusion * Significant in Multivariate Analysis Edna Triulzi Jensen Vignal Murphy Incidence of Infection (%) N=868 N=589 N=197 N=343 N=267 N=238 N=109 * * * * * Tartter Cardiac Spinal Trauma Colorectal Adapted from: Despotis G.

26 4892 Patients at initial ICU admission 1518 mechanically ventilated >48hrs VAP in 20.5% Multivariate Analysis transfusion independently increased risk for VAP OR Patients at initial ICU admission 1518 mechanically ventilated >48hrs VAP in 20.5% Multivariate Analysis transfusion independently increased risk for VAP OR

27 Transfusion and Nosocomial Infections 27 Carson et al, Transfusion 1999;39 n=9598 Units Transfused

28 n = 576 Units Transfused Transfusion and Length of Stay 28 Shapiro et al, J Trauma 2003;55

29 Quality Issues: Duration of Blood Storage and Outcomes 29 In Hospital Mortality ARF LOS 1 Basran et al- Anesth Analg 2006;103 2 Koch et al- NEJM 2008;358

30 30 Transfusion Requirements in Critical Care (TRICC) Study Outcomes Restrictive <7 g/dl Liberal <10 g/dlp-Value Overall 30-day Mortality18.7%23.3%p=0.11 Pts < 55 years old5.7%13.0%p=0.02 APACHE II score ≤208.7%16.1%p=0.03 Cardiac Disease20.5%22.9%p=0.69 In-hospital mortality22.2%28.1%p=0.05

31 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. 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. 31 Tsai, et al. Transf Apher Sci August.

32 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 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 Corwin et al. Crit Care Med Vol 3, No 1

33 Transfusion and Mortality in Trauma (Pre MTP era) 33 Malone et al. J Trauma. May 2003

34 NSQIP Data (adjusted odds ratio) 0 PRBC1PRBCS2PRBCS # pts 120,3891,3431,903 SSI Reference UTI Reference Pneumonia Reference Sepsis or Septic Shock Reference Mortality <30 days Reference Bernard AC, et al. jamcollsurg 2008

35 Surgical Outcomes: one unit transfusion 35 Ferrarris, et al. Arch Surg. 2012;147:49-55

36 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 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

37 Current Risk/Benefit Ratio RISK benefit RISK benefit 37

38 TRALI Transfusion Related Acute Lung Injury –An acute event within 4-6 hours of transfusion associated with changes in oxygenation Highly underreported, but felt by many to be the number one complication of blood transfusions –Overt cases currently reported 1:5000 but the reality is sub-clinical TRALI occurs often and must be thought of as occurring with each transfusion –The insult/injury is along a spectrum and not “all or none" Transfusion Related Acute Lung Injury –An acute event within 4-6 hours of transfusion associated with changes in oxygenation Highly underreported, but felt by many to be the number one complication of blood transfusions –Overt cases currently reported 1:5000 but the reality is sub-clinical TRALI occurs often and must be thought of as occurring with each transfusion –The insult/injury is along a spectrum and not “all or none" 38

39 Blood Transfusion & Percutaneous Coronary Intervention 39 Doyle,et al. JACC Vol 53

40 STEMI and Blood Transfusion Shishehbor and colleagues Jan 2009 in JACC evaluated pts with stemi and blood transfusion Evaluated 30 day, 6 month and 1 year all cause mortality in 4131 stemi pts enrolled in GUSTO trial 2 groups: blood transfusion vs no transfusion Cox proportional hazards for whole group and for Propensity-matched controls (2:1) Multiple “sensitivity analysis” to account for bias –Both Overt and Hidden Biases Shishehbor and colleagues Jan 2009 in JACC evaluated pts with stemi and blood transfusion Evaluated 30 day, 6 month and 1 year all cause mortality in 4131 stemi pts enrolled in GUSTO trial 2 groups: blood transfusion vs no transfusion Cox proportional hazards for whole group and for Propensity-matched controls (2:1) Multiple “sensitivity analysis” to account for bias –Both Overt and Hidden Biases 40

41 STEMI and Blood Transfusion Results: Mortality significantly higher in transfused patients –30 day (13.7% vs. 5.5%) –6 month (19.7% vs. 6.9%) –1 year (21.8% vs. 8.7%) After adjustment for 25 variables: –HR Mortality 30d (3.89), 6mo (3.63), 1yr (3.03) Propensity-Matched Controls show similar results as Multivariate Analysis Please note that mortality persists after 1year! Results: Mortality significantly higher in transfused patients –30 day (13.7% vs. 5.5%) –6 month (19.7% vs. 6.9%) –1 year (21.8% vs. 8.7%) After adjustment for 25 variables: –HR Mortality 30d (3.89), 6mo (3.63), 1yr (3.03) Propensity-Matched Controls show similar results as Multivariate Analysis Please note that mortality persists after 1year! 41

42 Cardiac Surgery and Blood Transfusion Northern New England Cardiovascular Disease Study Group 8 Centers evaluated 9079 consecutive patients between 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 Northern New England Cardiovascular Disease Study Group 8 Centers evaluated 9079 consecutive patients between 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

43 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 30days (HR for each add’l unit 1.2) Avoid transfusion solely to correct low hgb 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 30days (HR for each add’l unit 1.2) Avoid transfusion solely to correct low hgb

44 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 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

45 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 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 45

46 Variation of Blood Transfusions in CABG Observational Study Hospitals >100 on-pump CABGs/yr (82,446pts) RBC Variation: 7.8%-92.8% FFP Variation: % Platelets: 0.4%-90.4% Academic Institution (OR 1.32) Lower Volume Centers higher transfusion Institutionally no difference in mortality Observational Study Hospitals >100 on-pump CABGs/yr (82,446pts) RBC Variation: 7.8%-92.8% FFP Variation: % Platelets: 0.4%-90.4% Academic Institution (OR 1.32) Lower Volume Centers higher transfusion Institutionally no difference in mortality

47 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 ( ) 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 Patient’s perspective RBC and Component transfusion therapy and functional health-related Quality of Life 7321/12536 pts over 4yr period ( ) 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

48 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!!! 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!!! 48

49 Current Risk/Benefit Ratio RISK benefit RISK benefit 49

50 PROBLEM OF MATURE PROGRAM We now have the Cardiovascular Surgeons ordering blood less than 14 days old.

51 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 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

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

53 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 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.

54 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: Pape, A., et al: Blood Transfus 7:250-8, 2009

55 What are signs or symptoms of inadequate oxygen delivery? Signs 1. ScvO 2 < 70% [nl=80%] (central line) 2. SvO 2 < 65% [nl=75%] (PA catheter) 3. Low cerebral or tissue oximetry 4. Base deficit – ABG 5. Lactic acidosis - lab 6. ST changes - EKG 7. ↓ LV contractility by trans esoph echo SYMPTOMS SYMPTOMS 1.Mental status alteration 2.Dyspnea 3.Chest pain 4.New arrhythmias 5.Tachycardia (VERY RELATIVE) -Main Provider Excuse Napolitano et al. Critical Care Medicine 2009;37: Pape, A., et al: Blood Transfus 7:250-8, 2009

56 Possible exceptions to hgb 7.0 Hematologic disease Hematologic disease Selected patients with chronic anemia Selected patients with chronic anemia Bone marrow failure Bone marrow failure Myelosuppressive/myeloablative therapy Myelosuppressive/myeloablative therapy Infiltrative bone marrow disease Infiltrative bone marrow disease Generally as an outpatient Generally as an outpatient

57 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.” 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.” 57

58 Benefits (Current) Survival? –Trauma. Yes, emerging in the setting of a Massive Transfusion Protocol 1:1:1 ratio (FFP:RBC:Plts) But data emerging that 1:1:1 is resulting in excessive MODS without survival benefit 1:2-3 Ratio considered optimal by some at this time…but literature quickly evolving Evidence indicates that in the setting of MTP, less blood is used on each pt during an entire hospitalization. Dente, et al. J of Trauma, 2009 Survival? –Trauma. Yes, emerging in the setting of a Massive Transfusion Protocol 1:1:1 ratio (FFP:RBC:Plts) But data emerging that 1:1:1 is resulting in excessive MODS without survival benefit 1:2-3 Ratio considered optimal by some at this time…but literature quickly evolving Evidence indicates that in the setting of MTP, less blood is used on each pt during an entire hospitalization. Dente, et al. J of Trauma,

59 Massive Transfusion (MTP) Improves Survival Instituted a MTP in 1:1:1 ratio PRBC:FFP:PLTS Prospective Non Randomized (“Unethical”) No faculty turnover and no other significant changes in treatment Compared Pre-MTP with MTP 73 MTP vs 84 similar pre-MTP patients 24hr mort: 17% vs 36%, MTP vs Pre-MTP 30day mort: 34% vs 55% Early deaths from coagulopathic bleeding: 4/13 MTP, 21/31 Pre-MTP Instituted a MTP in 1:1:1 ratio PRBC:FFP:PLTS Prospective Non Randomized (“Unethical”) No faculty turnover and no other significant changes in treatment Compared Pre-MTP with MTP 73 MTP vs 84 similar pre-MTP patients 24hr mort: 17% vs 36%, MTP vs Pre-MTP 30day mort: 34% vs 55% Early deaths from coagulopathic bleeding: 4/13 MTP, 21/31 Pre-MTP 59 Dente, et al. J of Trauma. 2009

60 MTP Questions Remain Optimal ratios of blood component resuscitation? Trying to mimic military experience of fresh whole blood Vanderbilt experience 3:2 PRBC:FFP, 5:1 PRBC:Plts showed survival experience No dose dependent survival beyond these ratios Grady 1:1and 2:1for both FFP and Plts; showed similar survival advantage for pts who received 2:1 and 3:1 Late effects of excessive blood leading to later mortality? MODS, ARDS, Infection, etc Call it early and diminish amount of uncrossmatched blood Turn it off immediately and institute restrictive approach (<7gm hgb/dl) to blood component therapy Optimal ratios of blood component resuscitation? Trying to mimic military experience of fresh whole blood Vanderbilt experience 3:2 PRBC:FFP, 5:1 PRBC:Plts showed survival experience No dose dependent survival beyond these ratios Grady 1:1and 2:1for both FFP and Plts; showed similar survival advantage for pts who received 2:1 and 3:1 Late effects of excessive blood leading to later mortality? MODS, ARDS, Infection, etc Call it early and diminish amount of uncrossmatched blood Turn it off immediately and institute restrictive approach (<7gm hgb/dl) to blood component therapy 60

61 Current Risk/Benefit Ratio RISK benefit RISK benefit 61

62 THANK YOU

63 Correcting Coagulopathy– Plasma Why do we transfuse? Replace volume and coagulation factors during massive transfusion Prevent further or future bleeding in patients undergoing invasive procedures Reverse Coumadin therapy in patients with or without bleeding Address isolated coagulation factor abnormalities Replace volume and coagulation factors during massive transfusion Prevent further or future bleeding in patients undergoing invasive procedures Reverse Coumadin therapy in patients with or without bleeding Address isolated coagulation factor abnormalities 63

64 INR and FFP INR Established to monitor Coumadin effectiveness Estimated INR of FFP is 1.3 – 1.7 (mean about 1.4) Deitcher showed INR 1.3 – 1.9 mean factor: –FII 31-65% –FV 40-70% –FVII 22-60% –All levels consistent with adequate concentrations for hemostasis Makes sense since “therapeutic” INR is at least 2.5 or 3.0 INR INR Established to monitor Coumadin effectiveness Estimated INR of FFP is 1.3 – 1.7 (mean about 1.4) Deitcher showed INR 1.3 – 1.9 mean factor: –FII 31-65% –FV 40-70% –FVII 22-60% –All levels consistent with adequate concentrations for hemostasis Makes sense since “therapeutic” INR is at least 2.5 or 3.0 INR

65 Understanding Derivation of INR Most thromboplastins in use in the US prior to 2000, had an ISI of greater than 2.0 Based on this understanding, equivalent INRs pre-2000 and post-2000 was 1.5 = 2.25 This certainly fits with the literature and clinically Most thromboplastins in use in the US prior to 2000, had an ISI of greater than 2.0 Based on this understanding, equivalent INRs pre-2000 and post-2000 was 1.5 = 2.25 This certainly fits with the literature and clinically Tavares, et al. Transfusion April 2011;51:

66 FFP Effect on INR Holland and Brooks –INR change =.37 (pretransfusion INR) –INR > 1.7 before transfusion 50% of patients showed improvement in INR after FFP transfusion –INR 1.3 – 1.6 Supportive treatment of underlying medical condition lowers PT the same as FFP Holland and Brooks –INR change =.37 (pretransfusion INR) –INR > 1.7 before transfusion 50% of patients showed improvement in INR after FFP transfusion –INR 1.3 – 1.6 Supportive treatment of underlying medical condition lowers PT the same as FFP

67 FFP Effect on INR Abdel-Wahab, prospective transfusions in patients with INR 1.1 – 1.85 –324 plasma units given –121 patients –Less than 1% normalization of INR –15% corrected only half way to normal –No retrospective correlational to bleeding Abdel-Wahab, prospective transfusions in patients with INR 1.1 – 1.85 –324 plasma units given –121 patients –Less than 1% normalization of INR –15% corrected only half way to normal –No retrospective correlational to bleeding

68 INR and bleeding CVT Surgery Pawan, et al –Cardiac Surgical Literature –4 groups based on INR: 2.5 No evidence of increased bleeding in group 2 pts, i.e. those with INR Pawan, et al –Cardiac Surgical Literature –4 groups based on INR: 2.5 No evidence of increased bleeding in group 2 pts, i.e. those with INR

69 Roger Williams Hospital Providence RI With the concept that 2.0 INR is the “new” 1.5, they built an evidence based program around this transfusion “threshold.” Dropped their FFP usage 80%!!!! Not one reported adverse event attributed to bleeding or lack of use of FFP to prevent bleeding Inpatient Mortality decreased over this time period---cause and effect????? With the concept that 2.0 INR is the “new” 1.5, they built an evidence based program around this transfusion “threshold.” Dropped their FFP usage 80%!!!! Not one reported adverse event attributed to bleeding or lack of use of FFP to prevent bleeding Inpatient Mortality decreased over this time period---cause and effect?????

70 Why Blood Management? Perceptions are NOT aligned with current data Patients are suffering with increased morbidity and mortality Therefore, we need an organized, evidence- based approach to making change Perceptions are NOT aligned with current data Patients are suffering with increased morbidity and mortality Therefore, we need an organized, evidence- based approach to making change 70

71 John Muir Health NSQIP data (unadjusted outcomes) May 2007 – October PRBC1-2 PRBC3+ PRBC # pts 4852 (120,389)143 (3,246)74 (2,117) SSI3.8% (4.8%) 10.5% (15.5%) 14.9% (21.2%) Pneumonia1.2% (1.4%) 6.9% (9.7%) 12.1% (14.2%) On Vent > 48hrs2.2%20.2%29.7% UTI0.8% (1.4%) 3.4% (6.6%) 6.7% (8.6%) Sepsis & Septic Shock3.3% (3.2%) 16.1% (19.6%) 20.3% (29.1%) Mortality <30 days1.6% (1%) 16% (10.1%) 22.9% (15.4%) NSQIP data in parenthesis


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