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 1 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 2 Mayo Clinic Largest Transplant Entity in U.S. 1469 Total Transplants in 2006 717 800 700 446 600 306 500 400 300 200 100 0 MCR Heart Lung MCJ Liver Kidney MCA Pancreas BMT 3 MCA Abdominal Organ Transplant History Then and Now • Liver Transplant Program • Deceased Donor Liver Transplantation (1999) • Living Donor Liver Program (2001) – 1st in AZ • 2006 – 7th largest in the US • Kidney Transplant Program • Living Donor Kidney Program (1999) • 2006 – 15th 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 2003 • 2006 – 7th largest in the US 4 2006 Overview Summary • Total Annual Transplants Decreased by 6%* • 2005 – 238, 2006 - 224 • Transplant Annual Evaluations - 15% Increase* • 2005 – 548, 2006 - 630 • 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 2005 73.9% • Market Distinction • Leader in Living Donor Liver Transplant •Heart Transplant data removed for separate presentation 5 MCA Abdominal Transplant Program National & Regional Presence Academic & Research Activity 6 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 7 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 8 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 9 MCA Abdominal Transplant Program Publications, Presentations and Research • Publications By Transplant Program* • 2006 Unique Peer Reviewed Journal Articles - 36 • 2006 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 10 MCA Abdominal Transplant Program Education Programs • Hepatology MD Fellowship Program (1999-Present)* • Hepatology PA Fellowship Program (2003-2007) • 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 11 Liver Transplant Program 2006 12 MCA Liver Transplantation Program • 1999 to 2006 Volume Data • Liver Transplants - 345 • 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. 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 13 Mayo System and National Comparison % 1 Year Patient and Graft Survival 95 90 85 90.78 91.85 86.49 89.86 88.47 89.41 81.96 83.19 80 75 70 65 60 55 50 1 Yr Graft Surv 1 Yr Pt Surv MCR MCJ MCA National Mean SRTR National Data Base - January 2007 Release Deceased Donor Only for Appropriate Comparison 14 Mayo System and National Comparison Median Length of Stay Post Transplant 14 12 10 8 6 10 9 7 4 6 2 0 LOS Post Transplant MCR MCJ MCA National Mean SRTR National Data Base - January 2007 Release Median LOS for Deceased Donor 15 Liver Waitlist & Transplants 2001 - 2006 151 158 140 146 120 129 100 101 80 70 60 40 20 52 38 42 48 53 2001 2002 2003 2004 43 0 Waitlist 2005 2006 Transplants Wait List Size as of Last Day of Year 16 Etiology of Liver Disease Hepatitis C* HCC* PSC* Hemochromatosis Autoimmune Hepatitis* Graft Failure* Familial Amyloidosis A-1-A Deficiency Sec. Biliary Cirrhosis Primary Oxaluria Neuroendrocrine Tumor 0 10 20 30 * Liver disease transplanted Q1 2007 40 50 60 70 80 Number of Transplants 90 100 110 120 Q1 2007 130 17 Cold Ischemia Time (hours) Cumulative • Average CIT 6.02 hrs 13% 17% • Median CIT 5.75 hrs 18% 15% 13% • Range 1.5 -23 hrs 7% 1.5-2.9 6-6.9 10% 3-3.9 7-7.9 4-4.9 8-8.9 7% 5-5.9 9+ Q1 2007 18 Benchmarking: National Centers of Excellence UNOS Patient Survival Data (7/01/03 - 12/31/05 w/ 1 Mo. & 1 Yr. Cohorts; 01/01/01 - 6/30/03 w/ 3 Yr. Cohort) Program 1 Month (Actual) Mayo Arizona 95.65% 96.55% 91.85% 88.18% 83.33% 81.01% Pittsburgh Omaha Nebraska UCLA Mayo Rochester 1 Month 1 Year (Expected) (Actual) 1 Year 3 Year (Expected) (Actual) 3 Year (Expected) 95.48% 95.32% 82.22% 84.73% 74.30% 77.01 97.48% 96.28% 88.93% 87.63% 81.60% 79.47 95.74% 94.49% 85.32% 82.57% 75.00% 73.68 98.07% 95.92% 90.78% 86.38% 84.97% 78.50% ^ ^ * Significantly below expected rate (p < 0.05) ^ Significantly above expected rate (p < 0.05) Q1 2007 19 Benchmarking: National Centers of Excellence UNOS Graft Survival Data (7/01/03 - 12/31/05 w/ 1 Mo. & 1 Yr. Cohorts; 01/01/01 - 6/30/03 w/ 3 Yr. Cohort) Program Mayo Arizona Pittsburgh Omaha Nebraska UCLA Mayo Rochester 1 Month (Actual) 1 Month (Expected) 1 Year (Actual) 1 Year (Expected) 3 Year (Actual) 3 Year (Expected) 93.84% 94.14% 89.41% 84.43% 81.25% 76.11% 91.64% 91.37% 75.54% 78.16% 66.75% 69.96% 92.57% 92.94% 81.82% 81.69% 75.69% 73.73% 90.71% 90.93% 78.63% 77.24% 67.82% 67.77% 96.02% 93.76% 88.47% 83.60% 79.26% 72.64% ^ ^ * Significantly below expected rate (p < 0.05) ^ Significantly above expected rate (p < 0.05) Q1 2007 20 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 21 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. 22 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. 23 Methods • This is a retrospective study 70 living donor liver transplants completed at our institution between January 2001 and April 2007. • All grafts were right lobes, preserved with custodial HTK after the 15th transplant. 24 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. 25 Methods • Analyses of variance were carried out to assess differences between groups on the continuous variables. • Kruskal-Wallis tests were used for nonparametric continuous variables. • Chi-square analyses were used to assess differences between groups on the categorical variables. 26 Patient Demographics Demographic GM (32) MF (16) FM (22) P-value Age 17–68 (49) 30–66 (49) 30–67 (55) 0.27 GRWR 0.8–1.5 (1.19) 0.8–1.9 (1.42) 0.7–1.2 (0.94) 0.0001 Donor age 19–46 (33.3) 21–54 (36.8) 18–56 (41.7) 0.02 MELD 8–22 (14.3) 6–20 (11.7) 7–22 (14.1) 0.11 % HCV 48% 37.5% 50% 0.89 Operative time 3:25–10:17 (5:13) 2:52–6:59 (4:40) 3:26–8:09 (5:10) 0.3732 CIT (min) 150–285 (214) 150–270 (196) 150–285 (208) 0.35 27 Results Outcomes GM (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 rejection 3 (9.6%) 2 (12.5%) 1(4.5%) 0.59 HAT 4 (12.9%) 3 (18.75%) 6 (27.3%) 0.42 Bile Leak or Stricture 18 (58%) 10 (56.3%) 12 (54.5%) 0.95 Re-transplant 2 (6.5%) 2 (12.5%) 1 (4.5%) 0.63 Pt Survival (actual) 27 (87%) 12 (75%) 20 (91%) 0.37 28 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) 29 30 31 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. 32 Kidney / Pancreas Transplant Program 2006 33 MCA Kidney Transplantation Program • 1999 to 2006 Volume Data • Kidney Transplants - 705 • Living Donor Kidney Transplants - 367 (53%) • Pancreas Transplants - 65 • 2006 Volume Data • Kidney Transplants - 152 • Living Donor Kidney Transplants - 81 (53%) • Pancreas Transplants - 27 • 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 Release Combined Living and Deceased Donor Transplants 34 Mayo System and National Comparison % 1 Year Patient and Graft Survival 100 95 95.25 96.48 96.13 95.94 93.95 91.86 92.83 89.46 90 85 80 75 70 65 60 1 Yr Pt Surv MCR MCJ 1 Yr Graft Surv MCA National Mean * SRTR National Data Base - January 2007 Release Combined Living and Deceased Donor Transplants 35 Mayo System and National Comparison Length of Stay - Time on Wait List 38.3 40 35 30 25 20 15 10 5 0 11.1 6 5 4 MCJ 10.4 6 Median LOS Post Transplant (Days) MCR 12.5 Median Wait List Time (Months) MCA National Mean SRTR National Data Base - January 2007 Release LOS for Deceased Donor, Wait Times Includes Both Living and Deceased Donor Transplants 36 Kidney Waitlist & Transplants 2001 - 2006 296 300 250 209 200 191 150 100 152 137 109 50 0 140 37 46 2001 59 66 72 2002 2003 Waitlist 2004 2005 2006 Transplants Wait List Size as of Last Day of Year 37 Donor Source (N=654) Cumulative Living Related Donor 238 Living Unrelated Donor 154 Deceased Donor 262 Q1 2007 38 Pancreas Transplantation at MCA 30 Number 25 20 KP and solitary pancreas Txs 15 10 5 0 2003 2004 2005 2006 2007 Year 39 Pancreas Transplants at MCA by type of transplant 25 Number 20 15 Kidney-Pancreas Solitary Pancreas 10 5 0 2003 2004 2005 2006 2007 Year 40 Type of Surgical Procedure 60 50 Portal Enteric 40 30 20 SystemicEnteric Portal Enteric SystemicEnteric 10 0 KP Tx Solitary PTX 41 MCH Patient/Graft Survival for KP Txs (Kaplan-Meier) 100 95 90 85 80 75 70 65 60 55 50 Pt. Survival % Kidney Graft Survival Pancreas Graft Survival 0 30 90 150 260 365 700 Days 42 MCH Patient/Graft Survival for PAK & PTA (Kaplan-Meier) 100 95 90 85 80 75 70 65 60 55 50 % Pt. Survival Graft Survival 0 30 90 150 280 365 580 700 Days 43 Immunosuppression • • • • Thymoglobulin Prograf MMF Long-term steroids • • • • Campath Prograf MMF Rapid steroid taper 44 Acute Rejection during the first year • Kidney-Pancreas : 17% • Solitary Pancreas: 32% 45 Kidney-Pancreas : Steroid Avoidance • 37 patients • Patient survival 100% • Graft Survival • Kidney 97% • Pancreas 95% • Acute Rejection 11% 46 Historical Total Transplant Volumes 2001 to present 250 2 28 200 16 27 0 8 150 140 2 100 50 152 109 66 70 38 42 48 53 2001 2002 2003 2004 46 1 19 86 70 43 37 0 Liver Kidney 2005 Pancreas 2006 5/15/2007 Heart 47 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 48 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 49 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 50