Ron Travaglino

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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 PatientsLegal 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)
• Infectious complications
• Immunomodulatory
• Resource availability
• 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/dl 0
• Hb. of 7 gms/dl /-5
• Hg. of 5 gms/dl /-14
• Lower? /-19.5
• gt 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 reactions 1100
• Viral hepatitis (A,B,C,D,G) 150,000
• Hemolytic reactions 16,000
• Fatal hemolytic reactions 1600,000
• HIV infection 1420,000
• HTLV-I/II 1200,000
• Bacterial infections 12,500
• Acute lung injury 1500,000
• Anaphylactic shock 1500,000
• Graft Vs. host disease Rare
• Immunosuppression 11

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Infectious complications

• Viruses
• HIV-1,2
• HTLV-I,II
• Cytomegalovirus
• Epstein-Barr virus
• Parvovirus B19
• 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

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To all who received blood fromJanuary 1991 to
December 1996 in aNew 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 510 0
• 1995 650 1
• 1996 1,057 1
• 1997 1,267 1
• 1998 1,949 1
• 1999 2,540 1
• 2000 2,751 1
• 2001 3,047 1

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Range of Low Hgb. Survivors

• 5 patients lt2.0 gms
• 16 patients 2.0 - 3.0 gms
• 25 patients 3.0 - 4.0 gms
• 69 patients 4.0 - 5.0 gms
• (4 _at_ 1.7 gms 1 _at_ 1.3 gms!)
• 11/30/07

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Clinical Outcomes

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

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Increased Length of Hospital Stay and
CostsTransfused vs. Non Transfused
PatientsSelected Surgical ProceduresEnglewood
Hospital and Medical Center, NJJanuary 1997
June 1999

• Procedure Average LOS Average Cost (US
  Dollars)
• Colectomy 1.86 8,300.
• Total Hip Arthroscopy 0.43 990.
• Total Knee Arthroscopy 0.43 797.
• Abdominal Hysterectomy 1.19 6,723.

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Resources

• www.bloodlessmed.com
• www.sabm.org

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COMMUNICATIONCOOPERATIONNOT CONFRONTATION
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• Thank You !