Breakout G 3 Increasing Pancreas and Islet Utilization

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Breakout G 3Increasing Pancreas and Islet
Utilization
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Presenters

• James Burdick, MD/DOT Faculty
• Bill Reitsma, NJOTSN/HRSA Faculty
• Ken Andreoni, MD/HRSA Faculty
• Ronald Ferguson, MD,PhD, Chief of Transplant Ohio
  State University
• Raquel Faradji, MD, Assistant Director of the
  Clinical Transplant Team at the Diabetes Research
  Institute,  Miller School of Medicine University
  of Miami.

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Abdominal Organ Utilization10/05 -9/06
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Organ Transplanted Per Donor by Donor Type
Source OPTN database 09/06
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The Active Pancreas Waitlists
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Questions to run on

• What are some actions you have taken to increase
  pancreas utilization in your DSA?"
• What has been effective in placing more pancreas
  for Islet transplantation?
• What surgical techniques/practice have increased
  pancreas availability?

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Pancreas Procurement UtilizationThe OSU
PerspectiveTransplant Collaborative
MeetingNew Orleans, LAOctober 2006
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Pancreas Procurement at OSU2000 - 2005
Mean 48.6 over 6 years
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Pancreas Procurement and Transplant2006

• Demand for pancreata is locally generated
• Most OPOs have either very low volume or no
  Kidney/Pancreas centers in their service area

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US Centers Active in Pancreas Transplant2005

• 132 Kidney/Pancreas programs 903
  transplants
• 24 programs did gt 10 in 2005 and performed 496 of
  903 transplants. 54.9
• 112 Pancreas alone programs 541
  transplants
• 18 programs did gt 10 in 2005 and performed 336 of
  541 transplants 62.1

18 of programs did 54.9 of Kidney/Pancreas 16
of programs did 62.1 of Pancreas alone. Only 10
programs did gt 10 Kidney/Pancreas and gt 10
pancreas.
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OSU Approach to Pancreas Transplantation

• Kidney/Pancreas
• Young lt 45 yr Type I diabetics
• Pancreas after Kidney
• Type I diabetic lt 60 yrs with Living Kidney Donor
• Wait 6 months
• Islet
• Type I diabetics with brittle control and no
  renal failure
• Selected diabetics with previous kidney
  transplant
• Steroid free, CNI sparing immunosuppressive
• protocol as standard of care therapy

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Pancreas Procurement and Transplantation at
OSU2000 - 2005
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Suggestions

• More cooperative efforts between OPOs
  Transplant Centers to increase the local
  demand for pancreata by increasing transplant
  volume at the centers
• OPOs could establish relationships with the more
  active pancreas transplant programs in their
  regions and therefore increase the number of
  pancreata procured
• Expand the criteria for pancreas donor
  acceptability
• More effectively utilize the facilitated pancreas
  allocation policy of UNOS

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What insights did you gain to improve pancreas
transplantation in your DSA?
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Questions to run on

• What are some actions you have taken to increase
  pancreas utilization in your DSA?"
• What has been effective in placing more pancreas
  for Islet transplantation?
• What surgical techniques/practice have increased
  pancreas availability?

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Increasing Pancreas Utilization for Islet
Transplantation

• Raquel N. Faradji, M.D.
• Assistant Professor of Medicine
• Assistant Director
• Clinical Islet Transplant Program

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Endocrine Replacement in Type 1 DM

• Insulin
• Pancreas Transplantation
• Islet Transplantation
• Artificial Pancreas

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(No Transcript)
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A New Era in Islet Transplantation!
1985-1998 10 Insulin Independence
37 Partial allograft function
EDMONTON PROTOCOL
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Islet Alone (IA) Trial
IA, Probability for Insulin Independence is -
75 at 1 year - 32 at 2 years - 20 at 3 years
- 8 at 4 years No severe hypoglycemia A1c
lt6.5 at 3 years
Islet After Kidney (IAK) Trial
n16
IAK, Probability for Insulin Independence is -
29 at 1 year - falls to 0 by 2 years. No
Severe Hypoglycemia, last A1c 6.10.5
Insulin Independence
n7
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North American Contributing Islet Transplant
Programs2006 Annual ReportN23
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Islet Transplant Experience in North America as
Reported by 31 Islet Transplant Programs via
Survey(1999-2005)
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Percent of Participants Ever Achieving Insulin
Independence
 
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• Phase III Licensure (2 trials)
• and Phase II Pilot Clinical Trials (5 trials)

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Inclusion Criteria

• 18 to 65 years old
• T1DM of gt5 years duration
• Absent Stimulated C-peptide
• Involved in Intensive Diabetes Management
• One episode of Severe Hypoglycemia in the last
  year
• Evidence of hypoglycemia unawareness and
  increased glycemic lability

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Procurement

• Keep cold
• Pancreas out first?
• Treat like an organ - not a lymph node

Yield Function (SI) Ice 223 35 IE
x103 4.4 0.3 No ice 103 26 IE x103 3.0
0.4 plt0.01 p lt0.05
Courtesy of James Shapiro
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SIGNIFICANT IMPROVEMENT IN HUMAN ISLET ISOLATION
FROM MARGINAL (OLDER) DONORS FOLLOWING THE
ADDITION OF OXYGENATED PERFLUOROCARBON TO THE
COLD STORAGE SOLUTIONCamillo Ricordi, Chris
Fraker, Rodolfo Alejandro et al. American
Journal of Transplantation, 2002
Human Islet Transplantation From Pancreases with
prolonged Cold Ischemia Using additional
Preservation By The Two Layer Cold-Storage
Method. Tsujimira t, Kuroda Y, Tatsuya K,Avila
JG,Rajotte RV, Korbutt GS, Ryan E, Shapiro JAM,
Lakey JRT Transplantation (2002) 741687-1691

• Perfluorocarbons (PFCs) can be saturated with O2
  that then is diffused to the neighbor solution
• The pancreas is placed at UW/PFC interface
• Increased Oxygen availability to the organ

UW
PFC
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Organ Procurement and Islet Isolation
Islet Transplantation

• Deceased multi-organ donors
• Pancreas stored in UW solution or TLM (UW-PFC)1
• Automated method for human islet isolation2
• Continuous Ficoll-diatrizoic acid gradients3,4
• Culture of islets in Miami-defined media for up
  to 72 hrs

• ABO compatibility and negative cross-match
  (T-Cell)
• A minimum of 5,000 IE/kg of body weight
• Percutaneous transhepatic catheterization of the
  portal vein5
• Islets infused by gravity drainage (bag system)
  over 20 minutes6

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Transplantability Rates
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Strategies to Increase Pancreas Utilization for
Islet Transplantation by the OPOs

• Provide well defined SOPs and personal training
  to the OPOs on Pancreas Procurement and
  Preservation for Islet Transplantation and
  Research
• On call 24 hours, 1-888 phone number
• Laminated card with donor inclusion/exclusion
  criteria and phone numbers.
• Airnet courier
• PFC kits
• Supply them when pancreas is shipped to Miami.
• Provide information on where to purchase
  components if not shipping the organ to Miami

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Donor Acceptance Criteria
Transplant 25-45(60) lt 8 hr No AIDS risk
factors No h/o DM
Research 0-65 lt12 hr
Donor Age (years) Cold Ischemia Time
Negative tests results for HIV I and II, HTLV
I, HBsAg, Anti-HBc, Anti-HCV, RPR or VDRL
Avoidance of transmission of Infections and/or
cancer
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Other Strategies

• Obtain Consent to use the organ for Research at
  the time of donation
• Participation in UNOS Annual Meetings through an
  educational booth
• Payment of SACs and surgical fees.
• Maintain and expand the use of current and future
  grants
• ICR
• CIT

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What insights did I gain from this presentation?
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What Actions Will You and Your Team Take From
These Presentations?
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(No Transcript)
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Percent Increase or Decrease8 month Comparison
11/04 7/05 to 11/05 -7/06
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SPK Waiting List
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SPK Waiting List
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PAK PTA Waiting List / Tx