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Ron Travaglino Director

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Accommodating Patients Requests For Medical Treatment Without Allogeneic Blood

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Bloodless Medicine and Surgery Defined Use of New and Existing Techniques, Procedures, Technology, and Equipment to reduce or eliminate the need to use allogeneic (donor) blood

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Englewood Hospital & Medical Center Bloodless Institute Patients from 40 States in USA Patients from 40 Countries Major Cardiac, Orthopedic, Vascular, Neurological, Gynecological, Hepatic, Thoracic, Urologic Surgery Hundreds of Transfers from Other Hospitals including those claiming to be Bloodless Centers

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Bloodless Medicine and Surgery - A Multidisciplinary Effort Surgeons Anesthesia Personnel Nurses Internists Hematologists Administrators Ancillary Staff Pharmacy Lab Blood Bank

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Englewood Hospital and Medical Center-Bloodless Institute 200+ Physicians Six dedicated staff members Patient Intake and care coordination Patient Education, Advance Directives Preoperative patient preparation Patient Advocacy Four Medical Directors Regular nursing, physician, staff education Regular community education

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Bloodless Medicine and Surgery Why? Crisis in Blood Supply and Availability Blood Borne Disease Risks Patient refusal/reluctance Cost Considerations

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Bloodless Medicine and Surgery - Why? Patients choice * Blood is a precious fluid Increasing Elderly Population By 2030, annual shortfall of 4 million units in USA Less than 5% of eligible population donates in USA Blood Transfusion is associated with Significant Cost

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Reasons That Support Bloodless Medicine and Surgery Blood therapy is expensive-proven risks and hazards Public health concerns Shortage of blood nationally Medical devices and pharmaceuticals facilitate bloodless care No significant increase of morbidity and mortality Overall decrease in healthcare costs Enhances practical clinical experience Growing patient population supplies data for more education Supports patients rights and autonomy Good economics

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Who are the Patients? Religious Motivation Primarily* Jehovahs Witnesses Non - Religious Motivation Concern over blood safety Personal/Family Member History of Problematic Transfusion Vegetarians

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Jehovahs Witnesses and Associates - World Population 1985 - 7,792,109 1995 - 13,147,201 2000 - 14,872,086 2007 - 16,675,113

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Jehovahs Witnesses Do Not Refuse Medical Care - only blood transfusions Refusal of Blood not a RIGHT TO DIE Issue Actively Pursue Non Blood Medical Management

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Jehovahs Witnesses Do Accept Various Surgical, Medical, Anesthesia, Nursing Modalities to Conserve/Preserve Blood All Other Types of Standard Medical Care

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Fractional Components Medical/Scientific Line of Reasoning Realistic consideration of physical Risks vs. Benefits Conscientious Line of Reasoning Thoughtful consideration of other Risks vs. Benefits (i.e. spiritual)

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Blood Fractions - Examples ALBUMIN (EPO) IMMUNE GLOBULINS CLOTTING FACTORS (some) CRYOPRECIPTATES HEMOGLOBIN BASED PRODUCTS More and More Available

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Making the Decisions - Medical Line of Reasoning Blood Fractions are fundamental tools in hands of Physicians Many non blood alternatives fit into these categories Some used only in the face of imminent loss of life, so small risk of disease is tolerable

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Accommodating Patients Legal and Ethical Principles Bodily Self Determination Upheld by US Supreme Court and State Courts Right to Refuse Treatment Special Considerations for Minors

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Risks of Blood Transfusions Incompatibility (ABO and other groups) (ABO and other groups) Infectious complications Infectious complications Immunomodulatory Immunomodulatory Resource availability Resource availability Risk to Benefit Ratio Risk to Benefit Ratio

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Blood Collection and Transfusion - US in 1999 13,225,000 allogeneic units collected 12,020,000 allogeneic units transfused 226,000 lost to screening (1.7%) 787,000 outdated (5.9%) 112/1709 (6.6%) of hospitals cancelled surgery because of no blood

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Transfusion Behavior (Survey) 1997 US physicians: 100 MDs all specialists. At what Hb. would you be transfused? Hb. of 9 gms/dl0% Hb. of 7 gms/dl+/-5% Hg. of 5 gms/dl+/-14% Lower?+/-19.5% > 78% have Tx. Patients with Hb. ~9.0 gms Role of guidelines in Transfusion Medicine Bifano et.al.

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Bloodless Institute & Risk Management No Legal Cases or Consequences attributable to Bloodless Program Patients sign Release of Liability Form on admission No change in Hospitals Liability Insurance Coverage

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Hospital Liability? The court allowed the plaintiff's negligence action against the hospital for not having given recipient notice of the danger of transfusions. Estate of Jane Doe v. Vanderbilt University, Inc. 1993

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Bloodless Care and Cost Savings Cost of acquiring ONE unit of Packed Red Blood Cells is approximately $225 US* TRUE cost much higher (transport, storage, administration, potential complications) Study found allogeneic transfusions associated with $1000-$1500 US incremental Hospital costs

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Management of Anemia Careful Evaluation and Diagnosis Accurate History and Physical Avoid and/or Manage Preoperatively if at all Possible Recombinant Human Erythropoietin (Epoetin Alfa)

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EPO DOSING REGIMEN 300-600 Units/Kilogram, from three to ten weeks before Surgery, Subcutaneously or Intravenously Postoperative Bleeding GI Bleeding Oncology Postpartum GYN Bleeding

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Adjuvants to EPO Folic Acid (1 mg/day) Vitamin B-12 Ascorbic Acid (500 mg/day) Iron (Oral or Intravenous )

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Bloodless Medicine and Surgery - Intraoperative Surgical Management Meticulous Hemostasis Electrocautery Laser Surgery Argon Beam Coagulation Tissue Adhesives Cell Salvage

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Bloodless Medicine and Surgery - Anesthesia Management Embolization Positioning of patient Hypotensive anesthesia Induced hypothermia ACUTE NORMOVOLEMIC HEMODILUTION Aprotinin, DDAVP, Tranexamic acid, conjugated estrogens

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Iatrogenic Blood Loss Average ICU Patient can lose 1000 ml or more of blood PER WEEK from phlebotomy for laboratory testing

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Routine Blood Testing Routine Blood Tests are often UNECESSARY in Patients who refuse transfusion, or if no changes in clinical management will result from information obtained

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Transfusion Immunomodulation Multiple studies show that transfusion is associated with increased risk of earlier cancer recurrence, lack of response to cancer treatment, and serious postoperative infection.

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SHOT - Serious Hazards Of Transfusions 24 month study in UK and Ireland (1996-1998) 424 hospitals surveyed 39% (164) responded Outcome measures Death wrong blood - wrong patient acute and delayed transfusion reactions Acute lung injury Graft vs. host reaction Purpura Infections

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SHOT - Serious Hazards Of Transfusions 366 major adverse events reported 52% were due to wrong blood to patient 22 total deaths 3 - ABO 12 - infections, 4 - bacterial*, 7- viral, 1 - malaria*

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When does a patient get transfused? Really?

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Risks of blood transfusion ( Per unit of blood U.S.A. ) Minor allergic reactions1:100 Viral hepatitis (A,B,C,D,G)1:50,000 Hemolytic reactions1:6,000 Fatal hemolytic reactions1:600,000 HIV infection1:420,000* HTLV-I/II1:200,000 Bacterial infections1:2,500 Acute lung injury1:500,000 Anaphylactic shock1:500,000 Graft Vs. host diseaseRare Immunosuppression1:1

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Infectious complications VirusesViruses HIV-1,2 HIV-1,2 HTLV-I,II HTLV-I,II Cytomegalovirus Cytomegalovirus Epstein-Barr virus Epstein-Barr virus Parvovirus B19 Parvovirus B19 Creutzfeldt-Jakob disease(CJD) Creutzfeldt-Jakob disease(CJD) TTV TTV West NileWest Nile SpirochetesSpirochetes Treponema pallidum Treponema pallidum Borrelia burgdorferi Borrelia burgdorferi Parasites Plasmodia Plasmodia Babesia microlti Babesia microlti Trypanosoma crizi Trypanosoma crizi Toxoplasma gondii Toxoplasma gondii Leishmania donovani Leishmania donovani Bacteria Staphylococcus Salmonella Yersinia enterocolitica

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To all who received blood from January 1991 to December 1996 in a New York/New Jersey hospital Here is important information from the New York Blood Center for anyone who received a transfusion of red blood cells, platelets, or plasma in a New York or New Jersey hospital between January 1991 and December 1996. During that period, there may have been a problem with the way New York Blood Center performed testing of blood for viral infections. As a result, recipients of donated blood products during that period may face a potential risk of transfusion-transmitted infections, such as HIV and hepatitis.

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Risk versus Benefit Known risks include disease transmission, reactions, immunomodulation Benefit of blood unproven Storage dramatically diminishes bloods effectiveness as O2 carrier Known risks outweigh perceived benefits

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What is Acceptable Risk? To patient To physician To society Age-based? Diagnosis-based?

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Blood Transfusion is Life Saving? NO proof except when used as volume replacement in resuscitation There are safer, equally effective alternatives such as saline and colloids NO trials that demonstrate better survival from blood transfusion

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NJ Institute of Bloodless Medicine and Surgery Patient Totals Year # pt Mortality 1994 5100 1995 6501 1996 1,0571 1997 1,2671 1998 1,9491 1999 2,5401 2000 2,7511 2001 3,0471

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Range of Low Hgb. Survivors 5 patients