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Use of Extended Criteria Donor OrganUse of Extended Criteria Donor Organsfor Liver Transplantationfor Liver Transplantation
Antalya, Turkey
September 4, 2007
Charles B. Rosen, MD
Surgical Director, Liver Transplantation
Mayo Clinic Rochester Mayo Clinic College of Medicine
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Use of Extended Criteria Donor Organs forUse of Extended Criteria Donor Organs forLiver TransplantationLiver Transplantation
Liver Transplantation Strategy
Results with Liver Transplantation
Millenium Challenges(Performance, Allocation, ECD and DCD)
Organ Transplantation Breakthrough
Collaborative
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Liver TransplantationLiver TransplantationAims
• Prolong life
• Improve quality of life
For patients with acuteor chronic end-stage
liver disease
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Liver TransplantationLiver TransplantationIndications
• Ascites, SBP
• Variceal hemorrhage
• Encephalopathy
• Pruritus
• Hepatorenal syndrome
• Muscle wasting
• Growth failure
• Fatigue and weakness
• Hepatocellular carcinom
• Hilar cholangiocarcinom
• Metabolic disease
• Acute liver failure
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Liver TransplantationLiver TransplantationPatient Selection - Predictors of Success
• Technical difficulty – Prior abdominal operations
– Portal vein thrombosis
•
Severity of liver disease• Other medical issues
– Heart, lung, and kidney problems,diabetes
• Psychosocial status – Compliance
– Chemical dependency
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Mayo Clinic Rochester Mayo Clinic Rochester Liver Transplant ProgramLiver Transplant Program
1985 - 2007
*1773 transplants
* 1591 primary transplants
*70 living donor transplants
*1138 living patientsWaiting list 389 patients
80-109 transplants per year since mid 1990’s
**91% patient and 88% graft survival at 1 year
**84% patient and 79% graft survival at 3 years*August 30, 2007
**www.ustransplant.org (Tables 10 and 11)
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Mayo Clinic Rochester Liver Transplant ProgramMayo Clinic Rochester Liver Transplant ProgramAdult Patient Survival - Primary Transplantation
n = 1442
010
20
30
40
50
60
70
80
90100
0 1 2 3 4 5
1985 - 2006
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Mayo Clinic Rochester Liver Transplant ProgramMayo Clinic Rochester Liver Transplant ProgramAdult Patient Survival - Primary Transplantation
010
20
30
40
50
60
70
80
90100
0 1 2 3 4 5
1985-1990, n=227
1991-1995, n=335
1996-2000, n=408
2001-2005, n=407
92% 83%
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SUCCESS AT THE MAYO CLINIC
– A BIRD’S EYE VIEW
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Liver Transplant ProgramLiver Transplant ProgramAdult Patient Survival
010
20
30
40
5060
70
80
90
100
1 Year 3 Year
1985-1990
1991-1995
1996-2000
2001-2005
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Liver Transplant ProgramLiver Transplant ProgramMillennium Challenges
• Increase in waiting list – Deaths
– Morbidity
• MELD/PELD liver allocation
• Changes in organ donation – Increase in donor age
– Increase in medical vs trauma deaths
• Increasing competition – Patients
– Donor organs
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Liver Transplant ProgramLiver Transplant ProgramMillennium Strategy
• Increase use of extended criteriadonor organs –Marginal organs
–Higher risk donors• Living donor liver transplantation
• Waiting list management
• Accommodate the “cluster effect”
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Liver Transplant ProgramLiver Transplant ProgramOlder Donors
• Mayo Clinic Rochester 1998 - 2002
• 25 donors age 70-80 years
•95% one-year patient survival
• 1 retransplant for “small-for-size” graft – Avoid small grafts in large patients
• High risk for recurrent HCV
– Avoid older donor livers for HCV patients
Transpl Int 2005; 18:73
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Liver Transplant ProgramLiver Transplant ProgramOlder Donors
• Result of aim to use all transplantablelivers from older donors:
–Donors > 65 years: 15% of activity –Donors > 70 years: 10% of activity
–Actual patient survival remains high
–Decrease in expected patient survival
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Liver Transplant ProgramLiver Transplant ProgramWaiting List Management
• Maximize each and every patient’sopportunity to receive a deceased donor liver
• Donor organ acceptance decisions guidedonly by each patient’s best interest inorder on the waiting list
• Identify “disadvantaged” patients whom
would benefit from transplantation with anextended criteria donor liver
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Deceased Donor Liver AllocationDeceased Donor Liver AllocationFebruary 2002 Changes
OLD UNOS POLICY
• Local, regional, national
•Medical status
→ →
• Waiting time → →
• Regional sharing for status 1
• Status 2A for ICU → → patients
NEW UNOS POLICY
• Local, regional, national
•Probability of death
• No waiting time
• Regional sharing for status 1
• No preference for ICUpatients
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Deceased Donor Liver AllocationDeceased Donor Liver Allocation February 2002 Changes
OLD UNOS POLICY
Medical Status
Waiting Time
Child-Turcotte-Pugh Score
• Ascites
• Encephalopathy
• Bilirubin
• Protime INR
• Albumin
NEW UNOS POLICY
Probability of Death
No Waiting Time
→ → MELD Score
• Creatinine
• Protime INR
• Bilirubin
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Deceased Donor Liver AllocationDeceased Donor Liver AllocationPatients Awaiting Transplantation
ADVANTAGED
• High MELD score
• Renal failure,anticoagulation
• Hepatocellular carcinoma
• Special diseases:amyloidosis, oxalosis
• Special conditions: HPS
• ABO: AB
DISADVANTAGED
• Debilitating illness withlow MELD score: ascites,encephalopathy, pruritus
• Cholestatic liver diseases,chronic graft failure
• Special conditions: PPH,logistics, foreign nationalpatients
• Emerging indications:CCA, NET
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Deceased Donor Liver AllocationDeceased Donor Liver Allocation Patient Waiting List Management
• Coordinator responsibilities: – Arrange tests for score renewal and updates
– Notification for patients nearing time of transplantation
– Ongoing clinical care coordination • Identification of disadvantaged patients
– Living donor transplantation
– Expanded criteria donor organs
• Weekly list review
• Database
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Liver TransplantationLiver TransplantationExpanded Donor Criteria
High Risk Donors
• HCV Ab+
• HBcAb+
• Intracranial malignancies
• Remote malignancies• High risk behavior/exposure
• Infectious cause of death(HSV, meningitis)
• Older donors (malignancies)
•Familial amyloidosis
Marginal Organs
• Steatosis
• Ischemia
• Elevated enzymes
• High serum sodium• High pressor requirement
• Active infection, sepsis
• Prolonged preservation time
• Split liver grafts
• Donation after Cardiac Death(DCD)
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Liver Transplant ProgramLiver Transplant ProgramAccommodating the Cluster Effect
• Cluster effect: two or more transplantsoccurring during the same day
• 43% of transplants for a program
performing 100 deceased donor transplantsper year
• Opportunity cost of limited staffing:
–2 transplants per day limit: 10-15 –1 transplant per day limit: 20-25
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Liver Transplant ProgramLiver Transplant Program2001 - 2005 Strategy Summary
• Use of extended criteria donor organs
• Living donor liver transplantation
• Waiting list management
•Accommodate the “cluster effect”
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Liver Transplant ProgramLiver Transplant Program2001 – 2005 Results Summary
• Maintained high level of activity
• Maintained high patient survival
• Achieved statistically higher thanexpected patient and graft survival
Li T l t P
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Liver Transplant ProgramLiver Transplant ProgramTransplant Activity
0
20
40
60
80
100
120
1985 1987 1989 1991 1993 1995 1997 1999 2001 2003 2005
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US Center-Specific DataUS Center-Specific DataAdult Patient Survival – July 2007
0
10
20
30
40
50
60
70
80
90
100
1 Year 3 Year
Observed
Expected
* Statistically higher than expected patient survival at 1 year
www.ustransplant.org
90.886.3 83.5
79.0
US C t S ifi D t
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US Center-Specific DataUS Center-Specific DataAdult Patient Graft Survival – July 2007
0
10
20
30
40
50
60
70
80
90
100
1 Year 3 Year
Observed
Expected
* Statistically higher than expected graft survival at both 1and 3 years
www.ustransplant.org
88.583.6
79.373.5
Li T l t PLi T l t P
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Liver Transplant ProgramLiver Transplant ProgramStrategic Results
• Mayo Clinic identification as a“center of excellence”
• Attracts patients
• Lower cost of transplantation
• More transplants with higher
survival benefit helps more patients
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Organ Donation AwarenessOrgan Donation Awareness
• Hospital development• Donor designation legislation
• National priority
• HRSA National Collaboratives
–Organ Donation: 75% donation rate
–Organ Transplantation : 3.75 organs
per donor
HRSA O d D ti T l t tiHRSA O d D ti T l t ti
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HRSA Organ and Donation TransplantationHRSA Organ and Donation TransplantationCollaborativesCollaboratives
Government at its bestGovernment at its best
• HRSA – study best practices – Donor hospitals
– Organ procurement organizations
– Transplant centers
• Faculty – develop “change package”
• Learning congresses – widespread sharing andcollaboration
• Result – rapid implementation, breakthroughchanges, dramatic results
The Possibility – to Double Annual
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50% 6,000
3/D 18,000
75% 9,000
4/D 36,000
Donors/year
Recipients/year
The Possibility to Double Annual
Transplants
N b f O D b M th
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Number of Organ Donors by Month
400
450
500
550
600
650
700
750
1 4 7 1 0 1 4 7 1 0 1 4 7 1 0 1 4 7 1 0 1 4 7 1 0 1 4 7 1 0 1 4 7 1 0 1 4
Month
N u m b e r o
f o r g a n d o n o r s
1999 2000 2001 2002 2003 2004 2005 2006
1st Donation Collaborative
2nd Donation Collaborative
Transplant Collaborative
Old System
New System
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We have a lot more donorsand organs than we used tohave…
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…and a lot less sleep as well!
-notorious transplant surgeon
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Donation After Cardiac DeathDonation After Cardiac Death
• The norm for organ procurement during the early yearsof transplantation
• Nearly abandoned during the 1970’s and 1980’s – adoption of brain death criteria
– better organ function with heart-beating donors
– poor organ function:
» hypoxia and hypotension during process of death
» warm ischemia time
• Worsening donor organ crisis as a result of superbresults with transplantation and an increase in patientsawaiting transplantation
• Organ procurement from DCD donors regainingacceptance during late 1990’s
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Donation After Cardiac DeathDonation After Cardiac Death
DCD has emerged as a “standard of care”
• Institute of Medicine and DHHS endorsements
• HRSA OTBC – Increase DCD to 10% of all donation• JCAHO – Hospital protocol standard in 2007
• UNOS/OPTN – Membership requirement in 2007
Donation after Cardiac DeathDonation after Cardiac Death
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Donation after Cardiac DeathDonation after Cardiac DeathConsent
• Decision to withdraw support – No different than is current practice
– Decision made by patient, family, and medical team inaccord with hospital policy and procedure
– Decision is independent of decision to donate
• Decision to donate – Family discussion with procurement coordinator
» Education and Counseling
– Assessment for donation
» Suitability of organs
» Likelihood of cardiac death within one hour of withdrawal of support
Donation After Cardiac Death
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0
100
200
300
400
500
600
1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
7.4%
Donation After Cardiac Death1993 - 2005
WWW.USTRANSPLANT.ORG
Donation After Cardiac DeathDonation After Cardiac Death
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Liver Transplantation
UNOS• Inferior graft survival with DCD donors
– 70% versus 80% at 1 year
• Inferior patient survival with DCD donors
– 80% versus 85% at 1 year
• Association between preservation time and graft failure
– 30% at 8 hours, 58% at 12 hours and 17% increase eachadditional hour
• Poor results with older (age > 60 years) DCD donors
– 25% graft failure
Annals of Surgery 2004; 239:87
Donation after Cardiac DeathDonation after Cardiac Death
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Donation after Cardiac DeathDonation after Cardiac DeathMayo Clinic Experience
• 12 DCD multiorgan procurement procedures
• 7 Mayo Clinic liver recipients
– includes 1 pediatric recipient of pediatric DCD donor – no cholangiopathy
• 1 liver recipient at another transplant center
Li i D Ri ht H t tLi i D Ri ht H t t
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Living Donor Right HepatectomyLiving Donor Right Hepatectomy
Ex vivo Split Liver AllograftEx-vivo Split Liver Allograft
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Ex-vivo Split Liver AllograftEx-vivo Split Liver Allograft
Jason and Stephanie
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Jason and Stephanie
Jason and Stephanie
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Jason and Stephanie
Domino Liver TransplantationDomino Liver Transplantation
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Domino Liver TransplantationDomino Liver TransplantationAutosomal Dominant AmyloidosisAutosomal Dominant Amyloidosis
• Liver histologically normal
• Liver produces amyloid
• Problems from amyloid after 20 – 40 years
• Amyloid liver recipient selection – Disadvantaged patients > 60 years
• Donor / recipient interaction
• Several dozen cases world-wide
Amyloid and Domino Transplant Recipient
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Amyloid and Domino Transplant RecipientDecember 25-26, 2002
Focus on the FutureFocus on the Future
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Strategic Initiatives
• Expanded criteria donor organ utilization• Obesity – weight loss management protocol
• Hepatitis C – prevention and treatment of recurrent disease
• Chemical dependency – programmaticapproach to evaluation and treatment
• Transplant Center quality initiative
• Commitment to excellence – outcome,satisfaction
US Center-Specific DataUS Center-Specific Data
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ppAdult Patient Survival – July 2007
0
10
20
30
4050
60
70
80
90
100
1 Year 3 Year
Observed
Expected
* Statistically higher than expected patient survival at 1 year
www.ustransplant.org
90.886.3 83.5
79.0
US Center-Specific DataUS Center-Specific Data
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Deaths 1 year 3 year Observed 17 31
Expected 29 42Obs/Exp 60% 75%
US Center-Specific DataUS Center Specific DataAdult Patient Survival – July 2007
US Center-Specific DataUS Center-Specific Data
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Deaths 1 year 3 year Observed 17 31
Expected 29 42Obs/Exp 60% 75%
• 25 to 40% decrease in likelihood of
dying after liver transplantation at theMayo Clinic Rochester
US Center-Specific DataUS Center Specific DataAdult Patient Survival – July 2007
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