outcomes of abdominal organ transplantation using custodial htk preservation solution david c....

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