Outcomes of Abdominal Organ Transplantation Using Custodial
HTK Preservation Solution
Outcomes of Abdominal Organ Transplantation Using Custodial
HTK Preservation Solution
David C. Mulligan, MD, FACS
Chair, Transplant, Hepatobiliary & Pancreatic Surgery
Professor of Surgery, Mayo Clinic School of Medicine
Mayo Clinic Arizona
David C. Mulligan, MD, FACS
Chair, Transplant, Hepatobiliary & Pancreatic Surgery
Professor of Surgery, Mayo Clinic School of Medicine
Mayo Clinic Arizona
Mayo ClinicLargest Transplant Entity in U.S.
Mayo ClinicLargest Transplant Entity in U.S.
0
100
200
300
400
500
600
700
800
MCR MCJ MCA
Heart Lung Liver Kidney Pancreas BMT
1469 Total Transplants in 2006
717
306
446
Mayo Clinic Data 2007Mayo Clinic Data 2007
293 296 301
14
35
0
270
280
290
300
310
320
330
340
MCR MCJ MCA
Lungs
Transplants
MCA Abdominal Organ Transplant HistoryThen and Now
MCA Abdominal Organ Transplant HistoryThen and Now
• Liver Transplant Program• Deceased Donor Liver Transplantation (1999)
• 2007 – 33rd out of 127 programs in US• Living Donor Liver Program (2001) – 1st in AZ
• 2006 – 7th largest in the US• 2007 – 5th largest out of 71 programs
• Kidney Transplant Program• 2007 – 22nd largest out of 245 programs overall• Living Donor Kidney Program (1999)
• 2006 – 15th largest in the US• 2007 – 12th largest out of 245 programs
• Laparoscopic Donor Procedure (1999)• First in the Foundation & Arizona
• Pancreas Transplant Program• November 2002 UNOS Certified• First K/P Transplant in July 2003
• 2006 – 7th largest in the US• 2007 – 3rd largest not factoring pancreas alone
• Liver Transplant Program• Deceased Donor Liver Transplantation (1999)
• 2007 – 33rd out of 127 programs in US• Living Donor Liver Program (2001) – 1st in AZ
• 2006 – 7th largest in the US• 2007 – 5th largest out of 71 programs
• Kidney Transplant Program• 2007 – 22nd largest out of 245 programs overall• Living Donor Kidney Program (1999)
• 2006 – 15th largest in the US• 2007 – 12th largest out of 245 programs
• Laparoscopic Donor Procedure (1999)• First in the Foundation & Arizona
• Pancreas Transplant Program• November 2002 UNOS Certified• First K/P Transplant in July 2003
• 2006 – 7th largest in the US• 2007 – 3rd largest not factoring pancreas alone
MCA Liver Transplantation ProgramMCA Liver Transplantation Program
• 1999 to 2007 Volume Data• Liver Transplants - 411• Living Donor Transplants - 77 (19%)
• 2007 Volume Data• Liver Transplants - 66• 13 of 66 Transplants - Living Donor
• 2006 Outcome Data* • 1 Year Patient Survival
• 91.85% Actual vs. 88.18% National Avg (Combined)• 1 Year Graft Survival
• 89.41% Actual vs. 84.43% National Avg (Combined)
• 1999 to 2007 Volume Data• Liver Transplants - 411• Living Donor Transplants - 77 (19%)
• 2007 Volume Data• Liver Transplants - 66• 13 of 66 Transplants - Living Donor
• 2006 Outcome Data* • 1 Year Patient Survival
• 91.85% Actual vs. 88.18% National Avg (Combined)• 1 Year Graft Survival
• 89.41% Actual vs. 84.43% National Avg (Combined)
* SRTR National Data Base - January 2007 Release
Mayo System and National Comparison % 1 Year Patient and Graft Survival
Mayo System and National Comparison % 1 Year Patient and Graft Survival
90.78
89.86
91.85
86.4988.47
83.19
89.41
81.96
50
55
60
65
70
75
80
85
90
95
1 Yr Pt Surv 1 Yr Graft Surv
MCR MCJ MCA National Mean
90.78
89.86
91.85
86.4988.47
83.19
89.41
81.96
50
55
60
65
70
75
80
85
90
95
1 Yr Pt Surv 1 Yr Graft Surv
MCR MCJ MCA National Mean
SRTR National Data Base - January 2007 ReleaseDeceased Donor Only for Appropriate Comparison
Mayo System and National ComparisonMedian Length of Stay Post Transplant
Mayo System and National ComparisonMedian Length of Stay Post Transplant
9
7 6
10
0
2
4
6
8
10
12
14
LOS Post Transplant
MCR MCJ MCA National Mean
9
7 6
10
0
2
4
6
8
10
12
14
LOS Post Transplant
MCR MCJ MCA National Mean
SRTR National Data Base - January 2007 ReleaseMedian LOS for Deceased Donor
Liver Waitlist & Transplants2001 - 2007
Liver Waitlist & Transplants2001 - 2007
5238
101
42
129
48
146
53
151
70
158
43
168
66
0
20
40
60
80
100
120
140
2001 2002 2003 2004 2005 2006 2007
Waitlist Transplants
5238
101
42
129
48
146
53
151
70
158
43
168
66
0
20
40
60
80
100
120
140
2001 2002 2003 2004 2005 2006 2007
Waitlist Transplants
Wait List Size as of Last Day of Year
0 10 20 30 40 50 60 70 80 90 100 110 120 130
Neuroendrocrine Tumor
Primary Oxaluria
Sec. Biliary Cirrhosis
A-1-A Deficiency
Familial Amyloidosis
Graft Failure*
Autoimmune Hepatitis*
Hemochromatosis
PSC*
HCC*
Hepatitis C*
Number of Transplants
0 10 20 30 40 50 60 70 80 90 100 110 120 130
Neuroendrocrine Tumor
Primary Oxaluria
Sec. Biliary Cirrhosis
A-1-A Deficiency
Familial Amyloidosis
Graft Failure*
Autoimmune Hepatitis*
Hemochromatosis
PSC*
HCC*
Hepatitis C*
Number of Transplants Q1 2007
Etiology of Liver DiseaseEtiology of Liver Disease
* Liver disease transplanted Q1 2007
Cold Ischemia Time (hours)Cumulative
Cold Ischemia Time (hours)Cumulative
15%
7%10%
18%
17%13%
7%
13%
1.5-2.9 3-3.9 4-4.9 5-5.9
6-6.9 7-7.9 8-8.9 9+
15%
7%10%
18%
17%13%
7%
13%
1.5-2.9 3-3.9 4-4.9 5-5.9
6-6.9 7-7.9 8-8.9 9+
• Average CIT 5.95 hrs
• Median CIT 5.75 hrs
• Range 1.5 -23 hrs
• Average CIT 5.95 hrs
• Median CIT 5.75 hrs
• Range 1.5 -23 hrs
Q1 2007
Benchmarking: National Centers of Excellence
UNOS Patient Survival Data(1/01/04 - 6/30/06 w/ 1 Mo. & 1 Yr. Cohorts; 01/01/01 - 6/30/03 w/ 3 Yr. Cohort)
Benchmarking: National Centers of Excellence
UNOS Patient Survival Data(1/01/04 - 6/30/06 w/ 1 Mo. & 1 Yr. Cohorts; 01/01/01 - 6/30/03 w/ 3 Yr. Cohort)
Program 1 Month (Actual)
1 Month (Expected)
1 Year (Actual)
1 Year (Expected)
3 Year (Actual)
3 Year (Expected)
Mayo Arizona
96.00% 96.62% 91.08% 88.43% 83.65% 80.49%
Pittsburgh
95.12% 95.32% 83.06% 84.66% 73.41% 76.41%
Omaha Nebraska
98.26% 96.29% 91.32% 87.65% 82.12% 79.17%
UCLA
96.00% 94.41% 86.52% 82.37% 73.75% 73.36%
Mayo Rochester
98.54% 95.92% 90.80% ^
86.33% 83.51% 78.99%
* Significantly below expected rate (p < 0.05) ^ Significantly above expected rate (p < 0.05)
Program 1 Month (Actual)
1 Month (Expected)
1 Year (Actual)
1 Year (Expected)
3 Year (Actual)
3 Year (Expected)
Mayo Arizona
96.00% 96.62% 91.08% 88.43% 83.65% 80.49%
Pittsburgh
95.12% 95.32% 83.06% 84.66% 73.41% 76.41%
Omaha Nebraska
98.26% 96.29% 91.32% 87.65% 82.12% 79.17%
UCLA
96.00% 94.41% 86.52% 82.37% 73.75% 73.36%
Mayo Rochester
98.54% 95.92% 90.80% ^
86.33% 83.51% 78.99%
* Significantly below expected rate (p < 0.05) ^ Significantly above expected rate (p < 0.05)
Q4 2007
Benchmarking: National Centers of Excellence
UNOS Graft Survival Data (1/01/04 - 6/30/06 w/ 1 Mo. & 1 Yr. Cohorts; 7/01/01 – 12/31/03 w/ 3 Yr. Cohort)
Benchmarking: National Centers of Excellence
UNOS Graft Survival Data (1/01/04 - 6/30/06 w/ 1 Mo. & 1 Yr. Cohorts; 7/01/01 – 12/31/03 w/ 3 Yr. Cohort)
Program 1 Month (Actual)
1 Month (Expected)
1 Year (Actual)
1 Year (Expected)
3 Year (Actual)
3 Year (Expected)
Mayo Arizona
93.98% 94.17% 88.49% 84.43% 82.73% 75.97%
Pittsburgh
92.01% 91.35% 75.94% 77.80% 65.67% 69.16%
Omaha Nebraska
94.18% 92.93% 84.32% 81.37% 76.79% 73.46%
UCLA
91.75% 91.28% 80.46% 77.68% 66.21% 67.23%
Mayo Rochester
96.44% 93.78% 88.49% ^
83.61% 79.31% ^
73.54%
* Significantly below expected rate (p < 0.05) ^ Significantly above expected rate (p < 0.05)
Program 1 Month (Actual)
1 Month (Expected)
1 Year (Actual)
1 Year (Expected)
3 Year (Actual)
3 Year (Expected)
Mayo Arizona
93.98% 94.17% 88.49% 84.43% 82.73% 75.97%
Pittsburgh
92.01% 91.35% 75.94% 77.80% 65.67% 69.16%
Omaha Nebraska
94.18% 92.93% 84.32% 81.37% 76.79% 73.46%
UCLA
91.75% 91.28% 80.46% 77.68% 66.21% 67.23%
Mayo Rochester
96.44% 93.78% 88.49% ^
83.61% 79.31% ^
73.54%
* Significantly below expected rate (p < 0.05) ^ Significantly above expected rate (p < 0.05)
Q4 2007
Kidney / Pancreas Transplant Program
2007
Kidney / Pancreas Transplant Program
2007
MCA Kidney Transplantation ProgramMCA Kidney Transplantation Program
• 1999 to 2007 Volume Data• Kidney Transplants - 890• Living Donor Kidney Transplants - 455 (51%)• Pancreas Transplants - 70
• 2007 Volume Data• Kidney Transplants - 185• Living Donor Kidney Transplants - 88 (51%) • Pancreas Transplants - 30
• 2006 Outcome Data Kidney Transplant*• 1 Year Patient Survival
• 96.13% Actual vs. 96.47% Expected
• 1 Year Graft Survival• 92.83% Actual vs. 93.34% Expected
• 1999 to 2007 Volume Data• Kidney Transplants - 890• Living Donor Kidney Transplants - 455 (51%)• Pancreas Transplants - 70
• 2007 Volume Data• Kidney Transplants - 185• Living Donor Kidney Transplants - 88 (51%) • Pancreas Transplants - 30
• 2006 Outcome Data Kidney Transplant*• 1 Year Patient Survival
• 96.13% Actual vs. 96.47% Expected
• 1 Year Graft Survival• 92.83% Actual vs. 93.34% Expected
* SRTR National Data Base - January 2007 ReleaseCombined Living and Deceased Donor Transplants
Mayo System and National Comparison % 1 Year Patient and Graft Survival
Mayo System and National Comparison % 1 Year Patient and Graft Survival
95.2596.48 96.13 95.94
89.46
93.9591.86
92.83
60
65
70
75
80
85
90
95
100
1 Yr Pt Surv 1 Yr Graft Surv
MCR MCJ MCA National Mean
95.2596.48 96.13 95.94
89.46
93.9591.86
92.83
60
65
70
75
80
85
90
95
100
1 Yr Pt Surv 1 Yr Graft Surv
MCR MCJ MCA National Mean
* SRTR National Data Base - January 2007 ReleaseCombined Living and Deceased Donor Transplants
Mayo System and National ComparisonLength of Stay - Time on Wait List
Mayo System and National ComparisonLength of Stay - Time on Wait List
6 5 4 611.1
12.510.4
38.3
0
5
10
15
20
25
30
35
40
Median LOS PostTransplant (Days)
Median Wait List Time(Months)
MCR MCJ MCA National Mean
6 5 4 611.1
12.510.4
38.3
0
5
10
15
20
25
30
35
40
Median LOS PostTransplant (Days)
Median Wait List Time(Months)
MCR MCJ MCA National Mean
SRTR National Data Base - January 2007 ReleaseLOS for Deceased Donor, Wait Times Includes Both Livingand Deceased Donor Transplants
Kidney Waitlist & Transplants2001 - 2007
Kidney Waitlist & Transplants2001 - 2007
3746 5966
137
72
191
109
209
140
296
152
345
185
0
50
100
150
200
250
300
350
2001 2002 2003 2004 2005 2006 2007
Waitlist Transplants
3746 5966
137
72
191
109
209
140
296
152
345
185
0
50
100
150
200
250
300
350
2001 2002 2003 2004 2005 2006 2007
Waitlist Transplants
Wait List Size as of Last Day of Year
Donor Source (N=654)Cumulative
Donor Source (N=654)Cumulative
Q1 2007
Living Related Donor 238
Living Unrelated Donor 154
Deceased Donor 262
Living Related Donor 238
Living Unrelated Donor 154
Deceased Donor 262
Pancreas Transplantation at MCAPancreas Transplantation at MCA
0
5
10
15
20
25
30
35
2003 2004 2005 2006 2007
Year
Num
ber
KP and solitarypancreas Txs
0
5
10
15
20
25
30
35
2003 2004 2005 2006 2007
Year
Num
ber
KP and solitarypancreas Txs
Pancreas Transplants at MCA by type of transplant
Pancreas Transplants at MCA by type of transplant
0
5
10
15
20
25
30
2003 2004 2005 2006 2007
Year
Num
ber
Kidney-Pancreas
Solitary Pancreas
0
5
10
15
20
25
30
2003 2004 2005 2006 2007
Year
Num
ber
Kidney-Pancreas
Solitary Pancreas
Type of Surgical ProcedureType of Surgical Procedure
Systemic-Enteric
Systemic-Enteric Portal Enteric
Portal Enteric
0
10
20
30
40
50
60
KP Tx Solitary PTX
Systemic-Enteric
Systemic-Enteric Portal Enteric
Portal Enteric
0
10
20
30
40
50
60
KP Tx Solitary PTX
MCH Patient/Graft Survival for KP Txs (Kaplan-Meier)
MCH Patient/Graft Survival for KP Txs (Kaplan-Meier)
50556065707580859095
100
0 30 90 150 260 365
Days
%
Pt. Survival
Kidney GraftSurvival
PancreasGraftSurvival
MCH Patient/Graft Survivalfor PAK & PTA (Kaplan-Meier)
MCH Patient/Graft Survivalfor PAK & PTA (Kaplan-Meier)
50556065707580859095
100
0 30 90 150 280 365 580
Days
%
Pt. Survival
GraftSurvival
ImmunosuppressionImmunosuppression
• Thymoglobulin
• Prograf
• MMF
• Long-term steroids
• Thymoglobulin
• Prograf
• MMF
• Long-term steroids
• Campath
• Prograf
• MMF
• Rapid steroid taper
• Campath
• Prograf
• MMF
• Rapid steroid taper
Acute Rejection during the first year Acute Rejection during the first year
• Kidney-Pancreas : 17%
• Solitary Pancreas: 32%
• Kidney-Pancreas : 17%
• Solitary Pancreas: 32%
Kidney-Pancreas : Steroid Avoidance
Kidney-Pancreas : Steroid Avoidance
• 37 patients
• Patient survival 100%
• Graft Survival• Kidney 97%• Pancreas 95%
• Acute Rejection 11%
• 37 patients
• Patient survival 100%
• Graft Survival• Kidney 97%• Pancreas 95%
• Acute Rejection 11%
Pancreas Experience with HTK(n=100)
Pancreas Experience with HTK(n=100)
• Mean CIT = 9.6hrs (4hrs – 22.9hrs)• Less than 12hrs – 77%• 12 to 15.9hrs – 18%• Greater than 16hrs – 5%
• No cases of graft pancreatitis or vascular thrombosis due to preservation
• Mean CIT = 9.6hrs (4hrs – 22.9hrs)• Less than 12hrs – 77%• 12 to 15.9hrs – 18%• Greater than 16hrs – 5%
• No cases of graft pancreatitis or vascular thrombosis due to preservation
Historical Total Transplant Volumes 2001 to present
Historical Total Transplant Volumes 2001 to present
38
46
42
66
48
70
2
53
109
80
70
140
282
43
152
2716
66
185
30
20
0
50
100
150
200
250
300
350
2001 2002 2003 2004 2005 2006 2007
Liver Kidney Pancreas Heart
38
46
42
66
48
70
2
53
109
80
70
140
282
43
152
2716
66
185
30
20
0
50
100
150
200
250
300
350
2001 2002 2003 2004 2005 2006 2007
Liver Kidney Pancreas Heart
ConclusionsConclusions
• Strong clinical academic solid organ transplant practice with complete conversion from UW to Custodial HTK in 2003 without any negative effect
• Improved outcomes using Custodial for Living Donor Liver Transplantation
• Recommendation for HTK for DCD donors to improve outcomes
• Strong clinical academic solid organ transplant practice with complete conversion from UW to Custodial HTK in 2003 without any negative effect
• Improved outcomes using Custodial for Living Donor Liver Transplantation
• Recommendation for HTK for DCD donors to improve outcomes
