Ron Travaglino Director Accommodating Patients Requests For

Ron Travaglino Director

Accommodating Patients’ Requests For Medical Treatment Without Allogeneic Blood

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

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

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

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

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

Bloodless Medicine and Surgery Why? • • Patient’s 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

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 patient’s rights and autonomy Good economics

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

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

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

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

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)

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

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

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

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

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

Transfusion Behavior (Survey) 1997 US physicians: 100 MD’s all ‘specialists’. At what Hb. would you be transfused? • • Hb. of 9 gms/dl Hb. of 7 gms/dl Hg. of 5 gms/dl Lower? 0% +/-5% +/-14% +/-19. 5% • > 78% have Tx. Patients with Hb. ~9. 0 gms • Role of guidelines in Transfusion Medicine Bifano et. al.

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

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

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

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)

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

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

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

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

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

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

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.

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

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*

When does a patient get transfused? • Really?

Risks of blood transfusion ( Per unit of blood U. S. A. ) • • • Minor allergic reactions Viral hepatitis (A, B, C, D, G) Hemolytic reactions Fatal hemolytic reactions HIV infection HTLV-I/II Bacterial infections Acute lung injury Anaphylactic shock Graft Vs. host disease Immunosuppression 1: 100 1: 50, 000 1: 600, 000 1: 420, 000* 1: 200, 000 1: 2, 500 1: 500, 000 Rare 1: 1

Infectious complications • • • Viruses HIV-1, 2 … HTLV-I, II Cytomegalovirus Epstein-Barr virus Parvovirus B 19 Creutzfeldt-Jakob disease(CJD) TTV West Nile Spirochetes Treponema pallidum Borrelia burgdorferi • • • Parasites Plasmodia Babesia microlti Trypanosoma crizi Toxoplasma gondii Leishmania donovani • • Bacteria Staphylococcus Salmonella Yersinia enterocolitica

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.

Risk versus Benefit • Known risks include disease transmission, reactions, immunomodulation • Benefit of blood unproven • Storage dramatically diminishes blood’s effectiveness as O 2 carrier • Known risks outweigh perceived benefits

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

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

NJ Institute of Bloodless Medicine and Surgery Patient Totals • • • Year 1994 1995 1996 1997 1998 1999 2000 2001 # pt 510 650 1, 057 1, 267 1, 949 2, 540 2, 751 3, 047 Mortality 0 1 1 1 1

Range of Low Hgb. Survivors • • 5 patients 16 patients 25 patients 69 patients <2. 0 gms* 2. 0 - 3. 0 gms 3. 0 - 4. 0 gms 4. 0 - 5. 0 gms *(4 @ 1. 7 gms – 1 @ 1. 3 gms!) 11/30/07

Clinical Outcomes • • • Our data only January 1997 to June 1999 Colectomy Total Hip Arthroplasty Total Knee Arthroplasty Abdominal Hysterectomy

Increased Length of Hospital Stay and Costs Transfused vs. Non Transfused Patients Selected Surgical Procedures Englewood Hospital and Medical Center, NJ January 1997 – June 1999 Procedure Average ^ LOS Colectomy Total Hip Arthroscopy Total Knee Arthroscopy Abdominal Hysterectomy 1. 86 0. 43 1. 19 Average ^ Cost (US Dollars) $8, 300. $990. $797. $6, 723.

Resources • www. bloodlessmed. com • www. sabm. org

COMMUNICATION COOPERATION NOT CONFRONTATION

Thank You !