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1 JOSEPH BYLICA LIVER TRANSPLANT RECIPIENT I used to have to take naps four times a day, but when I got home after the procedure, the fatigue went away instantly, my color was back and I just felt normal again. Joseph Byclia, 57, Lorain, Ohio. Joseph was diagnosed with primary sclerosing cholangitis in Ten years later he began to experience jaundice, fatigue and generalized itching. Just a day after his transplant, he began walking, and three months later he was back on the golf course.

2 LIVER TRANSPLANTATION Leadership 2010 Highlights In 2010, we performed 133 liver transplants, with improved outcomes and survival rates. Accordingly, our program is one of the largest in the country and the largest in the region, finishing in the top four for volume in the United States. We completed our first adult liver transplant on Nov. 8, Since that date, we have completed more than 1,500 liver transplants, including the first lungliver transplant in Ohio, in Wait-list deaths at six and 12 months were below regional and national norms. The program maintains graft and patient survival above the national averages. In fact, the newest Scientific Registry of Transplant Recipients (SRTR) special report recognized the Cleveland Clinic liver transplant program as one of only five out of 126 programs that have statistically better-than-expected three-year survival rates was a time of continued growth and adjustment for the hepatology team as we experienced an increased demand for our services and changes in staff. A total of 477 patients underwent liver transplant evaluation, and 214 patients were listed for transplantation. Charles Miller, MD Program and Surgical Director, Liver Transplant Nizar N. Zein, MD Medical Director, Liver Transplant; Chief, Section of Hepato-biliary Diseases LIVER TRANSPLANTATION The Multidisciplinary Liver Tumor Clinic, under the direction of Federico Aucejo, MD, continues to offer state-of-the-art medical care to patients with hepatic tumors through a multidisciplinary team of experienced healthcare professionals in the fields of hepatic surgery, hepatology, radiology and oncology that includes Charles Miller, MD; Robert Pelley, MD; K.V. Narayanan Menon, MD; Gordon McLennan, MD; Abraham Levitin, MD; James Spain, MD; and Amanjit Gill, MD. The Liver Tumor Clinic enables patients, within a single visit, to be seen by a board-certified hepatologist, oncologist, surgeon and interventional radiologist. Vera Hupertz, MD Director, Pediatric Liver Transplantation 50 51

3 Fast facts Initiated: 1984 First adult liver transplant: Nov. 8, 1984 UNOS approval: March 21, 1988 Medicare approval: Oct. 14, 1992 Performed first lungliver transplant in Ohio, in Active living donor program established for liver transplants. As of Dec. 31, 2010, 1,570 liver transplants have been performed at Cleveland Clinic. During the last six months of 2010, the Liver Tumor Clinic reported the following activity: 231 visits 152 total patients 127 new patients, with 87 internally referred, 33 externally referred and seven self-referred With the large number of patients on the waiting list for liver transplantation and the relative scarcity of organs for transplantation, liver transplant programs have focused on the use of organs from donors that were once considered not suitable/high-risk as Expanded Criteria Donors. One group of these donors is non-heart-beating donors (donation after cardiac death, or DCD), who are not brain-dead, as donation occurs after the withdrawal of support and complete arrest of the cardiac and circulatory system. One of the main complications following use of the liver from these donors is biliary strictures. This is thought to be secondary to formation of thrombi in the peribiliary vascular system at the time of lack of perfusion of the organs. As a new center protocol to lower the risk of ischemic-type biliary stricture (ITBS) after DCD transplant, we have injected tissue plasminogen activator into the donor hepatic artery on the backtable. We have applied this protocol in 33 patients, with only one graft failure related to ITBS, which has been reported to be up to 33 to 50 percent. We have now embarked on a randomized control trial to prove these initial findings. Awards and Achievements Children s Hospital First pediatric liver transplant: Aug. 26, 1986 Five pediatric liver transplants were performed in John J. Fung, MD, PhD, received the International Congress of the Transplantation Society s Award for Worldwide Impact in Transplantation. The award was presented at the XXIII International Congress of the Transplantation Society in Vancouver, Canada, in August. Renee Bennett, BSN, CCTC, CCTN was named President-Elect of the International Transplant Nurses Society. Kym Houchin was named Co-Director of the Administrative Professional Career Academy.

4 Survival analysis: For patients receiving their first transplant of this type between July 1, 2007, and Dec. 31, 2009, and for the one-month and one-year models; between Jan. 1, 2005, and June 30, 2007, for the three-year model. Single-organ transplants only; re-transplants excluded. (Source: Scientific Registry of Transplant Recipients, January 2011.) Phone number Adult survival 1 month 1 year 3 years Patient survival percent Graft survival percent Pediatric survival 1 month 1 year 3 years Patient survival percent Graft survival percent Number of liver transplants by donor type in 2010 Organ Number Deceased Living/Related Living/Unrelated Liver Liver/kidney Liver/intestine/ pancreas 2 2 Total 133* LIVER TRANSPLANTATION * Includes 6 re-transplants. Type of liver transplant in 2010 Number Percent Whole Split Reduced/partial

5 Liver transplant mortality 2010 Hospital deaths (within 30 days post-transplant) 5* * Includes 1 liver/intestine/pancreas. Days on waiting list and post-transplant length of stay (LOS) for liver patients transplanted in 2010 Mean Median Number Days waiting Post-transplant LOS * * 9 died during initial hospitalization. Primary diagnoses for liver patients transplanted in 2010 Diagnosis Number Percent Hepatoma, hepatocellular carcinoma NASH Chronic active hepatitis with cirrhosis Alcoholic cirrhosis Hepatoma and cirrhosis Re-transplant graft failure Primary sclerosing cholangitis Primary sclerosing cholangitis with ulcerative colitis Alcoholic cirrhosis with hepatitis C Autoimmune cirrhosis PBC Benign tumor: polycystic liver disease Cryptogenic cirrhosis Metabolic disease Crohn s disease Other cirrhosis Other Total 133

6 Research Principal Investigators Dr. Bijan Eghtesad and Dr. John Fung IRB : A Randomized Controlled Trial of Low Dose Thymoglobulin and Extended Delay of Calcineurin Inhibitor Therapy for Renal Protection after Liver Transplant (Sponsor - Genzyme) Full enrollment of 30 patients (enrolled full contingent over one-year period) 26 of 30 enrollees currently on follow-up Interim analysis completed and abstracts submitted to American Transplant Congress and International Liver Transplant Society Principal Investigator Dr. John Fung IRB : A 24-Month, Multicenter, Open-Label, Randomized, Controlled Study to Evaluate the Efficacy and the Safety of Concentration-Controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in De Novo Liver Transplant Recipients (Sponsor: Novartis) Three patients enrolled; one lost to follow-up, two on follow-up Principal Investigator Dr. Bijan Eghtesad IRB : Enhancing DCD Utilization with Thrombolytic Therapy (Sponsor: HRSA) Two liver patients enrolled to date Selected Publications Berber E, Akyildiz HY, Aucejo F, Gunasekaran G, Chalikonda S, Fung J. Robotic versus laparoscopic resection of liver tumours. HPB (Oxford) Oct;12(8): LIVER TRANSPLANTATION Gunasekaran G, Bencsath K, Hupertz V, Fung JJ, Pettersson G, Miller C. Deep hypothermia with circulatory arrest to aid in the management of suprahepatic vena cava stenosis after liver transplantation. Liver Transpl Dec;16(12): Hashimoto K, Eghtesad B, Gunasekaran G, Fujiki M, Uso TD, Quintini C, Aucejo FN, Kelly DM, Winans CG, Vogt DP, Parker BM, Irefin SA, Miller CM, Fung JJ. Use of tissue plasminogen activator in liver transplantation from donation after cardiac death donors. American Journal of Transplantation. 2010;10: Hashimoto K, Miller CM, Quintini C, Aucejo FN, Hirose K, Uso TD, Trenti L, Kelly DM, Winans CG, Vogt DP, Eghtesad B, Fung JJ. Is impaired hepatic arterial buffer response a risk factor for biliary anastomotic stricture in liver transplant recipients? Surgery Sep;148(3):

7 Hashimoto K, Miller C, Hirose K, Diago T, Aucejo F, Quintini C, Eghtesad B, Corey R, Yerian L, Lopez R, Zein N, Fung J. Measurement of CD4+ T-cell function in predicting allograft rejection and recurrent hepatitis C after liver transplantation. Clin Transplant Sep-Oct;24(5): Srinivas TR, Stephany BR, Budev M, Mason DP, Starling RC, Miller C, Goldfarb DA, Flechner SM, Poggio ED, Schold JD. An emerging population: kidney transplant candidates who are placed on the waiting list after liver, heart, and lung transplantation. Clin J Am Soc Nephrol Oct;5(10): Carey WD. Current Clinical Medicine. 2nd ed. Philadelphia: Saunders/Elsevier, Dasarathy S, McCullough A. Malnutrition and nutrition in liver disease. In: Dancygier H, ed. Clinical Hepatology: Principles and Practice of Hepatobiliary Diseases. Berlin: Springer, Chapter 91. p Eghtesad B, Miller CM, Fung JJ. Post-liver transplantation management. In: Carey WD, ed. Current Clinical Medicine. 2nd ed. Philadelphia: Saunders/Elsevier,

8 Staff Talal Adhami, MD Federico Aucejo, MD Robin Avery, MD David Barnes, MD Ana Bennett, MD Mary Bronner, MD William Carey, MD Jacek Cywinski, MD Srinivasan Dasarathy, MD Robert O Shea, MD, MSCE Brian M. Parker, MD Cristiano Quintini, MD Kadakkal Radhakrishnan, MD Mangalakaraipudur Ramachandran, MD Mark Sands, MD Brian Stephany, MD Ralph Tuthill, MD Claudene Vlah, MD David Vogt, MD Bijan Eghtesad, MD Kyrsten Fairbanks, MD John J. Fung, MD, PhD Michael Geisinger, MD John Goldblum, MD Koji Hashimoto, MD, PhD Robert Helfand, MD Jamile Wakim-Fleming, MD Charles Winans, MD Lisa Yerian, MD Nizar Zein, MD LIVER TRANSPLANTATION Vera Hupertz, MD Samuel Irefin, MD Dympna Kelly, MD Jia Lin, MD, PhD Theodore Marks, MD, PhD Arthur McCullough, MD Charles Miller, MD Sherif Mossad, MD 56 57