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Comprehensive Patient Blood Management

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Presentation on theme: "Comprehensive Patient Blood Management"— Presentation transcript:

1 Comprehensive Patient Blood Management
Avoiding Allogeneic Transfusion: A Case Study in Patient Blood Management Irwin Gross, M.D. May, 2012

2 Disclosures Irwin Gross, MD
Medical Advisory Board, Strategic Healthcare Group

3 Learning Objectives Name the three pillars of patient blood management
Name three adverse outcomes associated with transfusion List four tools that can be used in patient blood management to limit the risk of transfusion Describe the role of parenteral iron in treating anemia Name two types of perioperative autologous blood collection List two relative contraindications to cell salvage

4 Optimize erythro-poieis Harness & optimize physiologic
What is Patient Blood Management: The Three Pillars 1st Pillar 2nd Pillar 3rd Pillar Optimize erythro-poieis Minimize bleeding & blood loss Harness & optimize physiologic tolerance of anemia © Axel Hofmann/Shannon Farmer – SHEF Meeting Perth August 2010

5 5-75% incidence in patients presenting for elective surgery
Anemia independently associated with increased: morbidity hospital length of stay likelihood of transfusion mortality Spahn DR. Anesthesiology 2010; 113(2) 1-14 Beattie WS, et al Anesthesiology 2009; 110(3) Dunne JR, et al J Surg Res 2002; 102: Shander A. Am J Med 2004; 116(7A) 58S-69S 5-75% incidence in patients presenting for elective surgery Shander 2004 Anemia Bleeding associated with increased Morbidity ICU and hospital length of stay Mortality Elective surgery ~0.1% Subgroups: Vascular 5–8% Up to 20% with severe bleeding Major organ damage 30–40% Causes On average 75 – 90% local surgical interruption or vessel interruption 10–25% acquired or congenital coagulopathy Shander A. Surgery 2007 Procedural bood loss & bleeding RBC transfusion independently associated in a dose-dependent relationship with increased: Morbidity ICU and hospital length of stay Mortality Beattie WA, et al Anesthesiology 2009 Murphy GJ, et al Circulation 2007 Salim A, et al J Am Coll Surg 2008 Bernard AC, et al J Am Coll Surg 2008 Bleeding Transfusion Hearnshaw SA, et al Aliment Pharmacol Ther 2010 Blair SD, et al Br J Surg 1986

6 Impact of Transfusion on Patient Outcomes
Author (year) Population n Impact of Blood Transfusion Koch et al (2005) Cardiac surgery 11,963 - Higher postop mortality rate - Higher postop morbidity rate (RF, prolonged ventilatory support, serious infection, cardiac complications, & neurologic events) Murphy et al (2007) 8,598 - Higher mortality rate - More ischemic complications - More infectious complications Surgenor et al (2009) 3,254 - Decreased survival after cardiac surgery Pedersen et al (2009) Total hip replacement 4,508 - More pneumonia Nikolsky et al (2009) PCI after MI 2,060 - Higher 30-day and 1-year mortality rate van Straten et al (2010) 10,435 - Worse early survival D’Ayala et al (2010) Lower extremity amputation 300 - More postop adverse events - Longer ICU/hospital stay O’Keeffe et al (2010) Lower extremity revascularization 8,799 - More pulmonary complications Veenith et al (2010) Elderly undergoing cardiac surgery 874 In multiple studies, transfusion is associated with an increase in mortality, and increase in length of stay, and increase in infections, and an increase in ischemic complications. Some data suggest a decrease in survival in oncologic patients who are transfused when matched to similar patients without transfusion

7 Physiologic Impact of Red Cell Transfusion
Author (year) Population n Blood Transfused ↑Hb ↑DO2 ↑VO2 ↓Lactate Babineau et al (1992) Postoperative 31 328 ± 9 mL Yes No Silverman et al (1992) Septic shock 21–88 yrs 21 2 units Marik et al (1993) Septic adults 23 3 units Lorente et al (1993) 16 ? Gramm et al (1996) Septic shock 46 ± 3 yrs 19 Casutt et al (1999) Postoperative 32–81 yrs 67 368 ± 10 mL Fernandes et al (2001) Septic shock 18–80 yrs 10 1 units Walsh et al (2004) Euvolemic anemic critically ill patients 22 Suttner et al (2004) Volume-res mechanically ventilated patients 51 1 or 2 units vs. 100% FiO2 Mazza et al (2005) SIRS/Sepsis 29 1–3 units While transfusion increases the delivery of oxygen, most studies fail to show and increase in oxygen utilization or an improvement in tissue ischemia as characterized by a decrease in lactate

8 What are “Transfusion Alternatives”?
Optimize hemodynamics and oxygenation Physiologic tolerance of anemia Use of erythropoietic stimulating agents Use of intravenous iron Minimizing blood loss Manage coagulopathy Anti-fibrinolytics Perioperative cell collection and reinfusion

9 Our Patient A 68 year old retired immunology professor requires revision of a prior right hip arthroplasty due to aseptic loosening with severe instability and functional limitation Past medical history is significant for rheumatoid arthritis and Type 1 vWD Patient underwent a recent hemicolectomy for T1N0M0 (Stage 1) colon cancer at another hospital without a blood management program

10 Our Patient The patient is referred to an orthopedic surgeon
A total hip arthroplasty is planned The patient, having read the article summarized on the next slide, requests that transfusion of allogeneic blood be avoided unless surgical bleeding is life threatening

11 Influence of Transfusion on Colorectal Cancer Recurrence
Cochrane meta-analysis involving 12,127 patients Evaluated role of transfusion in colorectal cancer recurrence Overall OR for recurrence was 1.41 (95% CI ) in transfused patients Amato, A, et al. Cochrane Database System Rev 2006;(1): CD005033

12 Reasons to Avoid Transfusion
Transfusion is associated with: Increased perioperative infections Increased length of stay Increased short term mortality Transfusion reactions, some life threatening Increased incidence of cancer recurrence and decreased disease-free and long term survival

13 Pre-operative Screening for Anemia
The patient should be screened for anemia -he is undergoing surgery with significant blood loss CBC If CBC shows anemia (< 13 g/dL) then additional lab tests required Iron, iron binding capacity, ferritin, Vitamin B12, creatinine, reticulocyte count Folate if MCV > 100 fl A preoperative hemoglobin less than 13 g/dl is used as a threshold for further evaluation of anemia regardless of gender. While women tend to have lower hgb levels than men, they are also at higher risk for transfusion regardless of hgb level due to lower blood volume and smaller body mass. Starting Hgb level < 13 g/dl is associated with an increase in mortality in the perisurgical population

14 Scheduling The ideal window to evaluate a patient for pre-operative anemia is days before surgery Medicare will not pay for lab studies > 30 days If commercial insurance or known history of anemia or co-morbidity associated with anemia, screen sooner (more time to treat anemia is better) Treatment of chronic anemia with iron, EPO or both requires (at least) 3-4 weeks The clinical condition may require the case to be scheduled sooner (unstable cardiac disease; cancer diagnosis)

15 Scheduling If procedure is truly elective, and anemia cannot be managed in the available time, surgery should be deferred Occasional patients will need referral to specialist: hematologist, gastroenterologist, etc.

16 Our Patient Surgery is scheduled to take place in 24 days. Lab results are as follows: Iron: ug/dL (28-170) Total iron binding: ug/dL ( ) % Saturation: % (15-45) Ferritin ng/mL (45-500) Hemoglobin g/dL (14-17) Reticulocyte count Th/uL (22-98) Ferritin may be elevated in patients with iron deficiency due to inflammation; ferritin is an acute phase reactant.

17 Our Patient Diagnoses Recommended Rx
Iron deficiency anemia (blood loss from recent chronic lower GI blood loss and colon surgery treated with enteral iron sulfate) Enteric iron is ineffective when there is inflammation, e.g. rheumatoid arthritis Anemia of Inflammation (functional iron deficiency – patient has rheumatoid arthritis) Recommended Rx Intravenous iron Consider erythropoietin Oral iron is poorly tolerated with a 30-40% non-compliance rate.

18 Anemia Management: Intravenous Iron / EPO
“Standard” regimen for perioperative anemia; hemoglobin between g/dL; non-vascular, non-cardiac surgery 40,000 units of erythropoietin on days 21, 14, and 7 pre-op, and on day of surgery Patient must have transferrin saturation > 20% and ferritin > 100 ng/ml to be reimbursed by Medicare 200 mg I.V. iron sucrose with each EPO dose 1 mg folate, p.o., daily 500 mg Vitamin C, twice daily Since the use of an ESA can result in functional iron deficiency, I recommend that IV iron be co-adminstered to a patient receiving ESA treatment unless there is iron oevrload or a history of hemochromatosis.

19 Should We Use EPO and Iron or Iron Alone?
Reasons to use EPO: Patient has only 24 days till surgery with Hgb of 10.1 g/dl EPO improves rate of response to iron Rheumatoid arthritis may result in decreased endogenous EPO production Reasons not to use EPO Increased VTE risk Some data suggests shortened survival and time to recurrence in some malignancies with EPO But, transfusion is associated with shortened survival and time to recurrence in malignancy and increased perisurgical mortality JAMA. 2008;299 (8): Anesthesiology Mar; 1 10(3):547-81

20 Our Patient After discussion of the risks and benefits of EPO (informed consent), the patient consents to the use of EPO Orders are written for three doses of EPO between now and surgery, by subcutaneous injection (600 units/kg) A fourth dose of EPO will be given on post-op day one if hemoglobin is less than 8.0 g/dL Goal: lowest dose to avoid transfusion

21 Iron Administration Intravenous iron should always be given during a course of treatment with EPO unless iron saturation is > 35% or ferritin > 1,000 ng/ml Three “classes” of IV iron available in U.S. Minimal cross reactivity re: reactions Iron sucrose and iron gluconate Ferumoxytol (paramagnetic nanoparticle) Iron dextrans Fewer ADE’s with low molecular weight iron dextran than high molecular weight iron dextran) David H et al Oncologist 12: , 2007 J Am Soc Nephrol 18: , 2007

22 Iron Sucrose vs. Iron Dextran vs. Ferumoxytol
Most appropriate for serial encounters or total dose of 300 mg or less Comes in 100 mg vials Maximum dose we use is 300 mg in 100 ml saline over 60 minutes Lowest rate of serious adverse drug reactions Characteristics and use of iron gluconate are similar

23 Iron Sucrose vs. Iron Dextran vs. Ferumoxytol
Low molecular weight iron dextran Best option for total dose iron replacement (TDI) Use when single encounter and iron required exceeds mg Requires administration of test dose Remaining dose given over 1 – 2.5 hours, up to 1,500 mg Low incidence of A.D.E.’s (3.3 / million doses) I recommend against high molecular weight iron dextran Low molecular weight iron dextran is the least expensive way to administer total dose iron replacement but with a somewhat higher adverse drug reaction rate.

24 Iron Sucrose vs. Iron Dextran vs. Ferumoxytol
Can administer 510 mg of iron in 17 seconds (30 mg/sec) No test dose required Least experience, but seems to have a good safety profile Higher drug cost than other options

25 What about Enteric Iron?
Hepcidin, Inflammation and Iron Metabolism 30-40% with significant GI side effects J Am Soc Nephrol 18: , 2007

26 Contraindications to Iron
Theoretical concern in infection / sepsis – some bacteria use iron as a growth factor But remember, transfused blood provides iron in the form of heme Immunomodulation increases risk of infection

27 S. aureus and Iron-regulated Surface Determinant (IsdB) .
Host Specificity of Staphylococcus aureus.  S. aureus uses the iron-regulated surface determinant (Isd) group of proteins to acquire iron from hemoglobin. It secretes a hemolytic toxin that releases hemoglobin from red cells. The released hemoglobin then binds to the staphylococcal receptor, iron surface determinant B (IsdB) on the bacterial cell surface. Heme is extracted from hemoglobin and is transported across the cell wall and cytoplasmic membrane by other Isd proteins. After its release from heme, iron becomes available as a nutrient within the bacterial cell. The increased affinity of the S. aureus IsdB for human hemoglobin (Panel A) versus mouse hemoglobin (Panel B) accounts for the enhanced availability of iron and, in part, for the host specificity of S. aureus. Lowy FD. N Engl J Med 2011;364:

28

29 Our Patient With each EPO dose, we decide to give our patient 200 mg of I.V. iron sucrose (600 mg total) Additional iron will be given post-op based on post-op hemoglobin Approximately 500 mg iron required to replace depleted stores Need additional 150 mg for each g/dL decrease in hemoglobin below 13 g/dL

30 Our Patient On the day of admission, our patient has a hemoglobin of 12.8 g/dL and an elevated reticulocyte count The patient signs informed consent for transfusion only if needed to prevent death from severe hemorrhage

31 Intraoperative Management – Day of Surgery
Acute normovolemic hemodilution (ANH) Intraoperative autologous blood collection and re-adminstration (“cell salvage”) DDAVP Anti-fibrinolytics (e.g. tranexamic acid Meticulous surgical hemostasis A multi-modal approach is most effective in reducing surgical blood loss.

32 Acute Normovolemic Hemodilution
Conservation of red cell mass by decreasing hematocrit of shed blood Fresh whole blood, with intact platelets and clotting factors, available at end of case for transfusion Studies show reduced blood loss in joint arthroplasty, spine surgery, cardiac, hepatic resection, major colon operations, and radical cystectomy ANH can contribute to a reduction in blood loss but the reduction, based on mathematical models, is relatively small when compared to some other perioperative blood management strategies

33 Acute Normovolemic Hemodilution – How Is It Done
Replace volume with crystalloid or colloid We generally use HES (tetrastarch) Usually requires 10 minutes / unit Proper labeling Blood typically remains at room temperature in O.R. prior to reinfusion Generally re-administered in reverse order of collection most hemodiluted given first unit with most clotting factors last

34 Our Patient We anticipate the possibility of 2 liters of blood loss
Based on the professor’s body weight and hemoglobin, up to four units might be collected before surgery; we collect two Replaced with 1,000 ml of hydroxyethyl starch We use tetrastarch His hemoglobin at the start of the procedure would be 10.0 g/dL

35 Intraoperative Cell Salvage
Indicated when significant blood loss is anticipated (may be as little as 250 ml in a small patient with anemia) Full set-up when significant blood loss is likely Collection only set-up when significant blood loss is possible Salvage efficiency is technique dependent Low suction pressure Eliminate skimming Wash sponges Avoidance of skimming and high suction pressures helps limit hemolysis and improves the efficiency of cell salvage.

36 Intraoperative Cell Salvage
Relative contraindications Bacterial contamination Some foreign material (antibiotics, topical hemostatic agents, methyl methacrylate) Malignancy Most contraindications can be addressed through a combination of increased wash volume and filtration Two suctions, one for waste Leukocyte reduction filter for bacteria and tumor cells Irradiation for tumor? Published data have failed to show any increase in metastatic disease when cell salvage is used in surgical oncology. Definitive randomized controlled trials are unlikely since the studies would require a very large number of patients with a very high cost to conduct the study.

37 Blood Salvage and Cancer Surgery: Meta-analysis
Conclusion: IBS is not inferior to traditional intraoperative allogeneic transfusion with regard to increased cancer recurrence or development of metastasis Waters et al, Transfusion doi: /j x

38 Our Patient We decide to set up the Cell Saver in anticipation of significant blood loss. If the patient was having surgery for tumor, a leukocyte reduction filter would be used Waste suction will be used to clear field if topical hemostatic agents used

39 Pharmacologic Agents to Limit Blood Loss
Desmopressin (DDAVP, Stimate) Releases von Willebrand’s factor from endothelial cells and increases factor VIII levels 0.3 mcg/kg in 50 mL over minutes Can be repeated several times Minimal evidence of efficacy in reducing surgical blood loss except in vWD

40 Pharmacologic Agents to Limit Blood Loss
Antifibrinolytic agents Amicar Tranexamic Acid Inhibits clot lysis 10-30 mg/kg loading dose, followed by 1-2 mg/kg/hr Decrease dose for renal insufficiency Good evidence base: 30% reduction in blood loss in major orthopedic cases including multilevel spine and TJA Studies have shown similar reductions in blood loss when amicar is compared to tranexamic acid. However, tranexamic acid is more widely used in Europe and Canada. Br J Anaesth 2004; 93:842-58

41 Pharmacologic and Other Agents to Limit Blood Loss
Topical hemostatic agents Fibrin glue (thrombin and fibrinogen concentrate) Mechanical hemostatic agents (collagen, cellulose, gelatins, etc.) Active hemostatic agents Bovine or human thrombin Gelatin plus thrombin Synthetic glues Saline-cooled radiofrequency “cautery”

42 Our Patient Surgeon plans to use topical hemostatic agents as needed
This patient has a history of mild type 1 vWD Plan to administer 30 mcg of DDAVP 15 minutes before surgery Will administer 20 mg/kg of tranexamic acid just before the start of surgery and begin an infusion of 2 mg/kg/hr Will discontinue infusion when surgery is completed Some surgeons use TXA topically

43 Day of Surgery Both the femoral and acetabular component require revision Unexpected surgical bleeding is encountered

44 Intraoperative Course
Four cell “salvage” runs return a total of 1,075 ml of processed blood with an average hematocrit of 55% (equivalent to about 3 units from the blood bank) The two ANH units are returned toward the end of surgery

45 Post-op Day One The patient’s post-op hemoglobin is 7.9 g/dL and our patient has been extubated He is hemodynamically stable As planned, a fourth dose of erythropoietin is administered The surgeon initiates the “minimum blood volume” phlebotomy protocol to minimize blood lost for diagnostic testing

46 Strategies for Reducing Phlebotomy Blood Loss
Eliminate “extra tubes” Eliminate under and over draws Individual nurse and phlebotomist education Selection of testing equipment with low requisite sample volume Increased point-of-care testing Reduce unnecessary testing Reduced tube size Selective use of microtainers

47 Highly Conservative Phlebotomy
Using a highly conservative protocol, median phlebotomy-associated blood loss (PBL) in the ICU was reduced 80% (40 ml vs. 8 ml) Mean drop in hemoglobin in ICU decreased from 2 gm/dl to 1.2 gm/dl Harber CR. Anesthesia and Intensive Care 34:4, 2006

48 If on post-op day one… What would you do?
Our patient’s hemoglobin is 6.7 g/dL His reticulocyte percentage is 7.8% His iron saturation is 13% He is walking 15 feet with assistance, but becomes short of breath and feels tired What would you do? No single hemoglobin level should be used as a transfusion “trigger.” The patient is hemodynamically stable with no evidence of active bleeding, cardiac, pulmonary, or neurocognitive dysfunction. Transfusion is not indicated.

49 Post-op Iron Therapy Post-op inflammatory response creates functional iron deficiency due to increased hepcidin (our patient also has RA) Labs show decreased transferrin saturation (% saturation) below 20% Oral iron salts (e.g. ferrous sulfate) are poorly absorbed and prolong post-op ileus

50 Our Patient We decide to administer 900 mg of low molecular weight iron dextran based on the patient’s IBW of 70 kg and hemoglobin deficit of 6 g/dL Daily folate, 1 mg for one month Daily Vitamin C for one month Patient is discharged home on post-op day 2 with a hemoglobin of 8.1 g/dL One month after surgery, the patient is recovering nicely with a hemoglobin is 11.9 g/dL Vitamin C seems to improve the “bioavailability” of iron in some studies.

51 Optimize erythro-poieis Harness & optimize physiologic
Patient Blood Management: The Three Pillars 1st Pillar 2nd Pillar 3rd Pillar Optimize erythro-poieis Minimize bleeding & blood loss Harness & optimize physiologic tolerance of anemia Pre-op anemia screening ESAs Intravenous Iron ANH Cell Salvage DDAVP TXA Topical hemostatics Meticulous surgical hemostasis Minimize phlebotomy Optimize hemodynamics Optimize oxygenation Low hemoglobin threshold for transfusion © Axel Hofmann/Shannon Farmer – SHEF Meeting Perth August 2010


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