1 Abdominal Organ Transplant Program Mayo Clinic Arizona 2006 Review Annual Report to CPC / Board of Governors David D. Douglas, MD Raymond L. Heilman, MD David C. Mulligan, MD Pamela L. Gillette, MPH, RN Todd E. Wilkening / Duffy Suba / Susanne M. Gauthier Annual Report to CPC / Board of Governors David D. Douglas, MD Raymond L. Heilman, MD David C. Mulligan, MD Pamela L. Gillette, MPH, RN Todd E. Wilkening / Duffy Suba / Susanne M. Gauthier

2 Presentation Outline Overview and History Academic/Research Activity Liver Transplant Program Kidney/Pancreas Transplant Program DSS Financial Analysis for 2005 Strategic Plan and Targets for 2007 Overview and History Academic/Research Activity Liver Transplant Program Kidney/Pancreas Transplant Program DSS Financial Analysis for 2005 Strategic Plan and Targets for 2007

3 Mayo Clinic Largest Transplant Entity in U.S Total Transplants in

4 MCA Abdominal Organ Transplant History Then and Now Liver Transplant Program Deceased Donor Liver Transplantation (1999) Living Donor Liver Program (2001) – 1 st in AZ 2006 – 7 th largest in the US Kidney Transplant Program Living Donor Kidney Program (1999) 2006 – 15 th largest in the US Laparoscopic Donor Procedure (1999) First in the Foundation & Arizona Pancreas Transplant Program November 2002 UNOS Certified First K/P Transplant in July – 7 th largest in the US Liver Transplant Program Deceased Donor Liver Transplantation (1999) Living Donor Liver Program (2001) – 1 st in AZ 2006 – 7 th largest in the US Kidney Transplant Program Living Donor Kidney Program (1999) 2006 – 15 th largest in the US Laparoscopic Donor Procedure (1999) First in the Foundation & Arizona Pancreas Transplant Program November 2002 UNOS Certified First K/P Transplant in July – 7 th largest in the US

Overview Summary Total Annual Transplants Decreased by 6%* 2005 – 238, Transplant Annual Evaluations - 15% Increase* 2005 – 548, Waitlist Growth Increased in Kidney, Pancreas and Liver Transplant Program Quality Maintained Graft and Patient Survival Rates Exceed Expected Patient Satisfaction in PRC Survey 80.2% in Overall “Top Box” Score in 2006, up from % Market Distinction Leader in Living Donor Liver Transplant Total Annual Transplants Decreased by 6%* 2005 – 238, Transplant Annual Evaluations - 15% Increase* 2005 – 548, Waitlist Growth Increased in Kidney, Pancreas and Liver Transplant Program Quality Maintained Graft and Patient Survival Rates Exceed Expected Patient Satisfaction in PRC Survey 80.2% in Overall “Top Box” Score in 2006, up from % Market Distinction Leader in Living Donor Liver Transplant Heart Transplant data removed for separate presentation

6 MCA Abdominal Transplant Program National & Regional Presence Academic & Research Activity

7 MCA Abdominal Transplant Program National / Regional Leadership AASLD and ILTS Journal “Liver Transplantation” Co-Editor: Dr. Rakela Associate Editor: Dr. Vargas, Dr. Kusne, Dr. Mulligan AASLD Chair, Education Committee Dr. Vargas ASTS Chair, Standards on Organ Transplantation Committee Dr. Mulligan AST Liver and Intestinal Committee member Dr. Douglas Kidney Pancreas Committee member Dr. Heilman AASLD and ILTS Journal “Liver Transplantation” Co-Editor: Dr. Rakela Associate Editor: Dr. Vargas, Dr. Kusne, Dr. Mulligan AASLD Chair, Education Committee Dr. Vargas ASTS Chair, Standards on Organ Transplantation Committee Dr. Mulligan AST Liver and Intestinal Committee member Dr. Douglas Kidney Pancreas Committee member Dr. Heilman

8 MCA Abdominal Transplant Program National / Regional Leadership United Network for Organ Sharing (UNOS) Councilor Region 5, Board of Directors Chair, MPSC Workgroup for Organ Allocation Dr. Mulligan Region 5 Liver Transplant Regional Review Board Dr. Douglas Region 5 Transplant Administrator / TAC Kevin Paige Region 5 Finance Pam Gillette Donor Network Arizona Board of Directors Dr. Mulligan United Network for Organ Sharing (UNOS) Councilor Region 5, Board of Directors Chair, MPSC Workgroup for Organ Allocation Dr. Mulligan Region 5 Liver Transplant Regional Review Board Dr. Douglas Region 5 Transplant Administrator / TAC Kevin Paige Region 5 Finance Pam Gillette Donor Network Arizona Board of Directors Dr. Mulligan

9 MCA Abdominal Transplant Program National / Regional Leadership Intermountain End-Stage-Renal-Disease Network Board of Directors Dr. Heilman American Liver Foundation, AZ Chapter Board of Directors Pam Gillette Arizona Coalition for Transplantation Board of Directors Kevin Paige Pam Gillette Arizona Transplant House Board of Directors Victoria Miller-Cage, Todd Wilkening, Tom Byrne, Paul Hottenstein, Mandy Impson, Susan Misztal, Kevin Paige Intermountain End-Stage-Renal-Disease Network Board of Directors Dr. Heilman American Liver Foundation, AZ Chapter Board of Directors Pam Gillette Arizona Coalition for Transplantation Board of Directors Kevin Paige Pam Gillette Arizona Transplant House Board of Directors Victoria Miller-Cage, Todd Wilkening, Tom Byrne, Paul Hottenstein, Mandy Impson, Susan Misztal, Kevin Paige

10 MCA Abdominal Transplant Program Publications, Presentations and Research Publications By Transplant Program* 2006 Unique Peer Reviewed Journal Articles Authored Book Chapters - 3 Presentations at National Meetings 2006 ATC - 4 Oral and 6 Poster Presentations ILTS – 3 Oral and 2 Poster Presentations AASLD - 3 Oral and 9 Poster Presentations UNOS Administrator's Forum 2006: 1 Oral and 3 Poster Presentations AGA - 6 Poster Presentations Research Activity 30 Ongoing Protocols Publications By Transplant Program* 2006 Unique Peer Reviewed Journal Articles Authored Book Chapters - 3 Presentations at National Meetings 2006 ATC - 4 Oral and 6 Poster Presentations ILTS – 3 Oral and 2 Poster Presentations AASLD - 3 Oral and 9 Poster Presentations UNOS Administrator's Forum 2006: 1 Oral and 3 Poster Presentations AGA - 6 Poster Presentations Research Activity 30 Ongoing Protocols * MCA Librarian Database

11 MCA Abdominal Transplant Program Education Programs Hepatology MD Fellowship Program (1999-Present)* Hepatology PA Fellowship Program ( ) Both Programs AASLD Funded Hepatobiliary & Liver Transplant Rotation General Surgery Residents, Internal Medicine Residents, Gastroenterology Fellows Social Worker Internship Program ASU Collaboration Liver Transplant CME Course: 1995, 1997, 1999, 2001, 2003, 2005, 2006 and 2007 Hepatology MD Fellowship Program (1999-Present)* Hepatology PA Fellowship Program ( ) Both Programs AASLD Funded Hepatobiliary & Liver Transplant Rotation General Surgery Residents, Internal Medicine Residents, Gastroenterology Fellows Social Worker Internship Program ASU Collaboration Liver Transplant CME Course: 1995, 1997, 1999, 2001, 2003, 2005, 2006 and 2007 *Pending initial ACGME accreditation 2007

12 Liver Transplant Program 2006

13 MCA Liver Transplantation Program 1999 to 2006 Volume Data Liver Transplants Living Donor Transplants - 64 (18%) 2006 Volume Data Liver Transplants - 43 (Target 73) 8 of 43 Transplants - Living Donor 2006 Outcome Data* 1 Year Patient Survival 91.85% Actual vs % National Avg (Combined) 1 Year Graft Survival 89.41% Actual vs % National Avg (Combined) 1999 to 2006 Volume Data Liver Transplants Living Donor Transplants - 64 (18%) 2006 Volume Data Liver Transplants - 43 (Target 73) 8 of 43 Transplants - Living Donor 2006 Outcome Data* 1 Year Patient Survival 91.85% Actual vs % National Avg (Combined) 1 Year Graft Survival 89.41% Actual vs % National Avg (Combined) * SRTR National Data Base - January 2007 Release

14 Mayo System and National Comparison % 1 Year Patient and Graft Survival SRTR National Data Base - January 2007 Release Deceased Donor Only for Appropriate Comparison

15 Mayo System and National Comparison Median Length of Stay Post Transplant SRTR National Data Base - January 2007 Release Median LOS for Deceased Donor

16 Liver Waitlist & Transplants Wait List Size as of Last Day of Year

17 Q Etiology of Liver Disease * Liver disease transplanted Q1 2007

18 Cold Ischemia Time (hours) Cumulative Average CIT 6.02 hrs Median CIT 5.75 hrs Range hrs Average CIT 6.02 hrs Median CIT 5.75 hrs Range hrs Q1 2007

19 Benchmarking: National Centers of Excellence UNOS Patient Survival Data (7/01/ /31/05 w/ 1 Mo. & 1 Yr. Cohorts; 01/01/01 - 6/30/03 w/ 3 Yr. Cohort) Q1 2007

20 Benchmarking: National Centers of Excellence UNOS Graft Survival Data (7/01/ /31/05 w/ 1 Mo. & 1 Yr. Cohorts; 01/01/01 - 6/30/03 w/ 3 Yr. Cohort) Q1 2007

21 The Impact of Gender Mismatch on Living Donor Liver Transplantation Kristin L. Mekeel, Adyr A. Moss, David D. Douglas, M.E. Harrison, Hugo E. Vargas, Thomas J. Byrne, Vijay Balan, Elizabeth J. Carey, Jorge Rakela, Kunam S. Reddy and David C. Mulligan Divisions of Transplant Surgery and Hepatology Mayo Clinic Arizona Kristin L. Mekeel, Adyr A. Moss, David D. Douglas, M.E. Harrison, Hugo E. Vargas, Thomas J. Byrne, Vijay Balan, Elizabeth J. Carey, Jorge Rakela, Kunam S. Reddy and David C. Mulligan Divisions of Transplant Surgery and Hepatology Mayo Clinic Arizona

22 Background In liver transplantation Gender mismatch has been associated with decreased graft survival, especially female to male transplantation. In adult living donor liver transplantation The ratio between graft size and recipient weight (GRWR) has been shown to be essential to graft function, preventing small graft for size syndrome. In liver transplantation Gender mismatch has been associated with decreased graft survival, especially female to male transplantation. In adult living donor liver transplantation The ratio between graft size and recipient weight (GRWR) has been shown to be essential to graft function, preventing small graft for size syndrome.

23 Purpose The combination of smaller graft size and gender mismatch could lead to inferior results for female to male LDLT. The purpose of this study is to compare the outcomes of female to male LDLT with male to female and gender matched transplants. The combination of smaller graft size and gender mismatch could lead to inferior results for female to male LDLT. The purpose of this study is to compare the outcomes of female to male LDLT with male to female and gender matched transplants.

24 Methods This is a retrospective study 70 living donor liver transplants completed at our institution between January 2001 and April All grafts were right lobes, preserved with custodial HTK after the 15th transplant. This is a retrospective study 70 living donor liver transplants completed at our institution between January 2001 and April All grafts were right lobes, preserved with custodial HTK after the 15th transplant.

25 Methods GRWR was estimated pre-operatively with CT volumetry and the graft was weighed after resection to determine actual GRWR, which is used for this presentation. The right paramedian sectoral vein was routinely preserved starting after the 26th transplant.

26 Methods Analyses of variance were carried out to assess differences between groups on the continuous variables. Kruskal-Wallis tests were used for non- parametric continuous variables. Chi-square analyses were used to assess differences between groups on the categorical variables. Analyses of variance were carried out to assess differences between groups on the continuous variables. Kruskal-Wallis tests were used for non- parametric continuous variables. Chi-square analyses were used to assess differences between groups on the categorical variables.

27 Patient Demographics DemographicGM (32)MF (16)FM (22) P-value Age17–68 (49)30–66 (49)30–67 (55)0.27 GRWR0.8–1.5 (1.19)0.8–1.9 (1.42)0.7–1.2 (0.94) Donor age19–46 (33.3)21–54 (36.8)18–56 (41.7)0.02 MELD8–22 (14.3)6–20 (11.7)7–22 (14.1)0.11 % HCV48%37.5%50%0.89 Operative time3:25–10:17 (5:13)2:52–6:59 (4:40)3:26–8:09 (5:10) CIT (min)150–285 (214)150–270 (196)150–285 (208)0.35 DemographicGM (32)MF (16)FM (22) P-value Age17–68 (49)30–66 (49)30–67 (55)0.27 GRWR0.8–1.5 (1.19)0.8–1.9 (1.42)0.7–1.2 (0.94) Donor age19–46 (33.3)21–54 (36.8)18–56 (41.7)0.02 MELD8–22 (14.3)6–20 (11.7)7–22 (14.1)0.11 % HCV48%37.5%50%0.89 Operative time3:25–10:17 (5:13)2:52–6:59 (4:40)3:26–8:09 (5:10) CIT (min)150–285 (214)150–270 (196)150–285 (208)0.35

28 Results OutcomesGM (32)MF (16) FM(22)P-value LOS (days)5–17 (7.84)4–22 (9.88)2–23 (8.9)0.47 FU (months)0.7–64.2 (24)0.3–62 (19.9)0.3–63.5 (20.4)0.16 Acute rejection3 (9.6%)2 (12.5%)1(4.5%) 0.59 HAT4 (12.9%)3 (18.75%)6 (27.3%) 0.42 Bile Leak or 18 (58%)10 (56.3%)12 (54.5%)0.95 Stricture Re-transplant2 (6.5%)2 (12.5%)1 (4.5%)0.63 Pt Survival 27 (87%)12 (75%)20 (91%)0.37 (actual) OutcomesGM (32)MF (16) FM(22)P-value LOS (days)5–17 (7.84)4–22 (9.88)2–23 (8.9)0.47 FU (months)0.7–64.2 (24)0.3–62 (19.9)0.3–63.5 (20.4)0.16 Acute rejection3 (9.6%)2 (12.5%)1(4.5%) 0.59 HAT4 (12.9%)3 (18.75%)6 (27.3%) 0.42 Bile Leak or 18 (58%)10 (56.3%)12 (54.5%)0.95 Stricture Re-transplant2 (6.5%)2 (12.5%)1 (4.5%)0.63 Pt Survival 27 (87%)12 (75%)20 (91%)0.37 (actual)

29 Results Causes of Death GM (4) Recurrent hepatocellular carcinoma (2) Fungal sepsis after biliary leak (1) Hepatic artery thrombosis and graft failure (1) MF (4) Recurrent hepatitis C virus (2) Systemic aspergillosis (1) Hepatic artery thrombosis, re-transplantation and graft failure (1) FM (2) Intra-operative cardiac arrest after re-perfusion (1) Fungal pneumonia and sepsis (1) Causes of Death GM (4) Recurrent hepatocellular carcinoma (2) Fungal sepsis after biliary leak (1) Hepatic artery thrombosis and graft failure (1) MF (4) Recurrent hepatitis C virus (2) Systemic aspergillosis (1) Hepatic artery thrombosis, re-transplantation and graft failure (1) FM (2) Intra-operative cardiac arrest after re-perfusion (1) Fungal pneumonia and sepsis (1)

30

31

32 Conclusions Despite a lower graft to recipient weight ratio, female to male LDLT recipients do not have an increased risk of complications or diminished graft or patient survival compared to gender matched or male to female cohorts Gender should not be a factor in determining suitability for living donation. Despite a lower graft to recipient weight ratio, female to male LDLT recipients do not have an increased risk of complications or diminished graft or patient survival compared to gender matched or male to female cohorts Gender should not be a factor in determining suitability for living donation.

33 Kidney / Pancreas Transplant Program 2006

34 MCA Kidney Transplantation Program 1999 to 2006 Volume Data Kidney Transplants Living Donor Kidney Transplants (53%) Pancreas Transplants Volume Data Kidney Transplants Living Donor Kidney Transplants - 81 (53%) Pancreas Transplants Outcome Data Kidney Transplant* 1 Year Patient Survival 96.13% Actual vs % Expected 1 Year Graft Survival 92.83% Actual vs % Expected 1999 to 2006 Volume Data Kidney Transplants Living Donor Kidney Transplants (53%) Pancreas Transplants Volume Data Kidney Transplants Living Donor Kidney Transplants - 81 (53%) Pancreas Transplants Outcome Data Kidney Transplant* 1 Year Patient Survival 96.13% Actual vs % Expected 1 Year Graft Survival 92.83% Actual vs % Expected * SRTR National Data Base - January 2007 Release Combined Living and Deceased Donor Transplants

35 Mayo System and National Comparison % 1 Year Patient and Graft Survival * SRTR National Data Base - January 2007 Release Combined Living and Deceased Donor Transplants

36 Mayo System and National Comparison Length of Stay - Time on Wait List SRTR National Data Base - January 2007 Release LOS for Deceased Donor, Wait Times Includes Both Living and Deceased Donor Transplants

37 Kidney Waitlist & Transplants Wait List Size as of Last Day of Year

38 Donor Source (N=654) Cumulative Q Living Related Donor238 Living Unrelated Donor154 Deceased Donor262 Living Related Donor238 Living Unrelated Donor154 Deceased Donor262

39 Pancreas Transplantation at MCA

40 Pancreas Transplants at MCA by type of transplant

41 Type of Surgical Procedure

42 MCH Patient/Graft Survival for KP Txs (Kaplan-Meier)

43 MCH Patient/Graft Survival for PAK & PTA (Kaplan-Meier)

44 Immunosuppression Thymoglobulin Prograf MMF Long-term steroids Thymoglobulin Prograf MMF Long-term steroids Campath Prograf MMF Rapid steroid taper

45 Acute Rejection during the first year Kidney-Pancreas : 17% Solitary Pancreas: 32% Kidney-Pancreas : 17% Solitary Pancreas: 32%

46 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%

47 Historical Total Transplant Volumes 2001 to present

48 Support for Organ Donation in AZ Active Mayo Participation in Multiple Organizations AKF, ALF, ACT, DNA DNA, ACT and Mayo Collaborations AZ Medal Ceremony for Donors Active Participation in National Donor Week Continue Participation in National Collaborative Bronze Level Sponsor of Team AZ at Transplant Games Active Mayo Participation in Multiple Organizations AKF, ALF, ACT, DNA DNA, ACT and Mayo Collaborations AZ Medal Ceremony for Donors Active Participation in National Donor Week Continue Participation in National Collaborative Bronze Level Sponsor of Team AZ at Transplant Games

49 Program Summary High Quality Transplant Program Distinguished by Mayo Model of Care Living Donor Liver Transplant Controlled Growth Strong Education Focus Strong Research Focus National and Regional Presence Financial Enhancement to MCA High Quality Transplant Program Distinguished by Mayo Model of Care Living Donor Liver Transplant Controlled Growth Strong Education Focus Strong Research Focus National and Regional Presence Financial Enhancement to MCA

50 Conclusions 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