1. Autotransfusion, an Underutilized Alternative to Allogeneic Transfusion Region 7 ASATT Meeting Honolulu, Hawaii John Rivera, BS, MA October 4, 2015

2. Realities of Blood The need for blood conservation in cardiac surgery is driven by three key factors: –Blood Shortages: Complex surgeries, low donation rate cause blood shortages –Blood Cost: Additional safety measures add costs to blood products –Patient Safety: Blood transfusion introduces patient risk Correlated to increased viral and bacterial infections Longer length of stay (LOS) Increased incidence of adverse reactions Blood Shortage Patient Safety Blood Cost

3. AABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma New Guidelines were issued in 2010 These Guidelines are a key document along with the 6 th Edition of AABB Standards for Perioperative Autologous Blood Collection and Administration There are significant updates in a variety of autotransfusion practices

4. Blood Recovery Recovery of shed blood, its processing and re-administration Washed and filtered or simply filtered Primarily washed intraoperatively and filtered postoperatively Centerpiece of a blood management program in combination with other techniques and modalities AABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma, 2010, pg. 1

5. Autotransfusion Triggers Anticipated blood loss is equal to or greater than 1000 ml Procedures where 2 units of blood are routinely cross matched Procedures where 20% of the patients are routinely transfused Emergency procedures Patients with rare blood types or incompatibilities Patients with religious objections to allogeneic blood component transfusion

6. What are the Real Costs of Transfusion? Activity-based costs of blood transfusion in surgical patients at four hospitals, Shander, A. et al, Transfusion 2010;50:753-756 Englewood Medical Center, Englewood, NJ, Rhode Island Hospital, Providence, RI, University Hospital, Lausanne, Switzerland and General Hospital, Linz, Austria COBCON (Costs of Blood Consensus) and ABC (Activity Based-Costing) Direct and indirect overhead costs, not just acquisition costs $552-$1183 with a mean of $761 +or- $294 3.2 to 4.8 fold higher than initial product costs “Blood costs have been underestimated”

7. “Indications for Use” Start with a “stand-by” setup to include a collection reservoir, reservoir connector, suction/anticoagulant line and anticoagulant Cost of the “stand-by” setup can be less expensive than cross-matching two (2) units of allogeneic blood If major blood loss is certain, collection and processing of recovered blood can occur Applicable in open-heart, vascular, total joint, spinal, liver transplant, ruptured ectopic pregnancy and trauma surgeries AABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma, 2010, pg. 2

8. Standby Collection System

9. “Product Quality” Per AABB Standards for Perioperative Autologous Blood Collection and Administration, 6 th Edition Adequately trained and qualified operators Periodic measurement of washout markers Testing collected blood in the reservoir versus the final washed product Frequent measurement of hematocrit or hemoglobin concentrations

10. Quality Control Issues Per the AABB Standards with the product: –Adequate testing of all components RBC: hematocrit, volume processed and returned, residual potassium, or residual plasma protein, or residual anticoagulant or free plasma hemoglobin (if available) The goal is to remove 95% or greater removal of all materials other than red blood cells A clear effluent line is not an adequate indicator of washout Resultant hematocrits should correlate with expected ranges per the device Operator’s Manual Periodic quality control testing must be performed Sampling techniques must be atraumatic and appropriate Collection Reservoir MUST be sampled for comparison to final washed product in the Holding Bag

11. 11 Autotransfusion Quality Control Samples Atraumatic and aseptic, avoid needles and negative pressure Personally visit the laboratory to advise them exactly what kind of blood sample is being delivered Transfer samples in containers that do NOT already contain anticoagulants or preservatives Perform testing in a timely manner, especially if using residual potassium as the measure of washout efficiency Use non-serum based Laboratory testing Label samples appropriately

12. Reservoir Y Connector

13. In-Line Reservoir Sampling

14. Sampling the Holding Bag

15. Autotransfusion Final Product 95% of supernatant and plasma is removed 90% of residual anticoagulant and free plasma hemoglobin is removed Most activated white cells and platelets are removed At 50% estimated blood volume loss, coagulation factor testing and plasma transfusion is indicated At 100% estimated blood volume loss, coagulation factor and platelet count and function testing and plasma and platelet transfusion are indicated ASA Transfusion Guidelines, 2007

16. Autotransfusion Final Product Washed red blood cells in a small volume of saline Attempting to perform coagulation testing is impossible ACT and other coagulation tests will always timeout 24 hour survival rate of washed red cells that have also been irradiated in cancer cases “exceeds the venous control, due to selective loss of aged RBCs during washing” This blood does not make patients bleed! E Hansen, J Altmeppen, J Marienhagen, K Taeger, Univ Hosp, Regensburg, Germany. Quality of Blood Salvaged and Irradiated During Cancer Surgery. Transfusion 1999-Vol. 39. Supplement, S256P

17. Contraindications Absolute – inadvertent blood exposure to “solutions that cause hemolysis”: sterile water, hydrogen peroxide, alcohol, hypotonic solutions or other solutions that are “incompatible with red cells” Relative – “blood aspirated from contaminated or septic wounds or obstetric/surgical fields, and areas of malignancy” Use of a double setup of two (2) collection reservoirs and suction/anticoagulant lines minimizing contamination of the recovered blood Filtration of the recovered, washed blood with leukocyte filtration AABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma, 2010, pp. 6 - 7

18. Contraindications Cesarean sections where amniotic fluid is present – tandem reservoirs and leukocyte reduction filters may be used and minimize aspiration of amniotic fluid Grossly contaminated wounds - tandem reservoirs and leukocyte reduction filters may be used and minimize aspiration of contaminants Malignancies (cancer, sepsis, tuberculosis, etc.) – avoid aspiration of contaminants, the surgeon and the medical director of the ATS program must discuss risks and benefits. Use leukocyte filter or irradiation Cellulose, collagen or fibrin based hemostatic agents, avoid aspiration. Consider use of a leukocyte reduction filter Confirmed sickle cell anemia or trait – potential for changes in red cell membranes, surgeon and medical director of ATS program should discuss the risks and benefits AABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma, 2010, Appendix 1

19. Contraindications The final decision on whether to salvage and process the blood is the autotransfusion team’s decision (e.g., Blood Bank, Surgeon, Anesthesiologist and Autotransfusionist) See the 2010 AABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma, Appendix 1: Complications of and Contraindications to Perioperative Blood Recovery Understand that some contraindications are not absolute or may be temporary in nature Read the product inserts regarding the approved use of that agent or device during autotransfusion

20. Tandem Collection Reservoirs Two (2) collection reservoirs, two (2) suction/anticoagulant lines and two (2) bags of anticoagulant solution Individual vacuum sources for each collection reservoir if possible Side by side or “Piggyback” collection reservoir configurations Waste suction system is still needed

21. Tandem Collection Reservoirs

22. Asahi Leukocyte Filter

23. Special Considerations Religious objections to allogeneic transfusion Rare blood types with a limited supply in the Blood Bank Previously transfused patients who are sensitive to transfusion and/or difficult to find compatible blood Low blood supply in the Blood Bank

24. 2011 Update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines 2007 – Initial Release Evidence based medicine guidelines Patients at risk-age; low pre-op Hct; small body size; pre-op drugs; complex cases; emergent; co-morbidities TRX triggers: Hgb, 7g/dl TRX based indicators: oxygenation/bleeding Drug Therapy: amicar; tranexamic acid Products and practices: –Pump type –Heparin management –Heparin coated circuits –Cell washers –Low prime circuits –Minimized circuits (RAP prime) –Hemofiltration –Transfusion algorithms 2011 – Update –Blood Salvage Interventions Expanded use of blood salvage (using centrifugation) to include patients with malignancy I.A. Pump salvage of residual blood in CPB circuit lla (C) Centrifugation of pump blood vs direct reinfusion llb (B) –Perfusion Interventions Microplegia to reduce hemodilution llb (B) Mini-circuits to reduce hemodilution I (A) Biocompatible CPB circuits to limit hemostatic activation and lime inflammatory response llb(A) Modified ultrafiltration l (A) Conventional or zero-balance ultrafilitration during CPB llb (A)

25. Autotransfusion Post- Operative Blood Processing Once the patient arrives in the Recovery Room, connect the reservoir vacuum line to an intermittent Vacuum Regulator, if available Vacuum pressure should be set at a maximum of 80 mm/Hg Mark the fluid level on the Collection Reservoir if not previously completed and note the patient arrival time in the Recovery Room Blood must be processed and transfused within six (6) hours from the start of blood collection If the reservoir is completely emptied during processing, another six (6) hour time period can be initiated. Maximum time that the disposable can be used is 24 hours. Monitor fluid levels in the anticoagulant bag and Collection Reservoir on a hourly basis Terminate post-operative blood collection if drainage volumes fall under 100 ml per hour or if six (6) hours has transpired without blood processing AABB 6 th Edition Standards for Perioperative Autologous Blood Collection and Administration

26. Conclusion Allogeneic blood is still in very short supply and the cost of blood will continue to increase Patients who are transfused with allogeneic blood experience more adverse consequences than patients not receiving donor blood Autotransfusion is an excellent clinical practice and is more cost effective than allogeneic transfusion In non-cardiovascular surgeries a variety of personnel may operate autotransfusion devices Autotransfusion can be used effectively in relatively contraindicated surgeries