Download Document

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
EHMC RBC Units Transfused
7000
6011
6000
5534
5394
5293
4975
Number of Units
5000
4470
3959
3571
4000
2902
3000
1892
2000
1000
0
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
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.
Human
error as
a risk
factor?
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
1:6,000
1:600,000
1:420,000*
1:200,000
1:2,500
1:500,000
1:500,000
Rare
1:1
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
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 O2 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
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 Arthroscopy0.43
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
Cooperation
is the Key
to Success!!!
Thank You !