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Transplantation in 2012: Optimizing Outcomes through Seamless Communication Kidney, Pancreas and Islet Breakout Session

Kidney Transplantation as a Treatment of Choice for ESRD Uday S. Nori, MD Assistant Professor of Medicine Division of Nephrology Comprehensive Transplant Center The Ohio State University Medical Center

Learning Objectives Indications for kidney transplantation Understand why kidney transplant is the treatment of choice for patients with advanced Chronic Kidney Disease Briefly discuss the main barriers for transplantation Discuss the novel strategies for unsuitable patients to have access to successful transplantation

Adjusted all-cause mortality in the ESRD & general populations, by age, 2007 ESRD: prevalent ESRD patients, 2007. General Medicare: non-esrd patients with at least one month of Medicare eligibility in 2007. Adjusted for gender & race. Medicare patients, 2007, used as reference cohort.

Kidney Transplantation offers Improved Patient Survival Wolfe RA et al. Al NEJM 1999

Indications for Kidney Transplantation Anyone with advanced chronic kidney disease GFR of <15 ml/min If acute kidney injury wait for renal recovery If living donor and not yet on dialysis: Okay to wait till symptomatic If no living donor refer when GFR is <25 ml/m Wait-list when GFR is <20 ml/min

Barriers to Transplantation That Are Amenable for Intervention Older age ABO incompatibility Highly sensitized pre-existing existing anti-hla antibodies Cardiovascular and other medical diseases Psychosocial

Older Patients with ESRD

..Have Improving Transplantation Rates Data from USRDS database Patients age at 1 st ESRD treatment Most

And Better Clinical Outcomes

PRE-EMPTIVE EMPTIVE TRANSPLANT Definition and outcomes Barriers Lack of timely referral Lack of education Financial issues Insurance Living i donor expenses Psychosocial issues

Pre-emptive emptive Transplant Meier-Kriesche et al, Am J Transplant 2004;4:1662.

OSUWMC Transplant Statistics Kidney Waiting times (median time to transplant) 25 months (national average > 72 months) Waitlist mortality: 8% (national average = 6%) Survival rates: July 2012 Scientific Registry of Transplant Recipients (SRTR) Survival rates: July 2012 Scientific Registry of Transplant Recipients (SRTR) One year = 96% (national average = 97%) Three year = 92% (national average = 92%)

Take Home Points Kidney transplant is the preferred choice of renal replacement therapy Majority of the patients approaching dialysis probably suitable for transplant evaluation Problems previously perceived to be barriers are being surmounted with novel approaches Pre-emptive emptive transplant and living donor transplants strongly encouraged

Transplantation and Living Kidney Donation at The OSUWMC Comprehensive Transplant Center Robin Petersen-Webster, LPN, CCTC Living Kidney Donation Coordinator Donor Exchange Program Coordinator The OSUWMC Comprehensive Transplant Center

Transplant Signature Program Teamwork committed to Quality and Quantity of Life OSUWMC

The Transplant Team The Ohio State University Wexner Medical Center Transplant Team Includes Transplant Surgeons (7) Transplant Nephrologists (4) Transplant Nurse Coordinators (19) Clinical Transplant Psychologist Nurse Practitioners and Physician Assistants Transplant Pharmacy Team Infectious Disease Team Social Workers Financial Coordinator Patient Rx Assistance Coordinator 17

Referral Process Individuals seeking kidney transplantation should be referred when GFR is approximately 20 ml/min. Referrals can be made by mail or fax. Patients may self-refer. Referral information should include: Demographics Current lab reports, including ABO Cardiac Stress Test / Echo (if available) H&P outlining pertinent medical history Psycho-social concerns Current dialysis information Contact Numbers: Pre-Transplant Office (614)293-6724 Pre-Transplant Fax (614)293-6710 18

Referral Process The OSUWMC PreTransplant Office will send a welcome package to potential candidates once a referral is received. A letter confirming receipt of referral is sent to the referring physician. Potential Recipients are scheduled for a mandatory education session, and will be given an appointment t for their formal pretransplant evaluation at conclusion of the education session. A living kidney donor team member contacts each referral to discuss the possibility of living kidney donation. The PreTransplant Office verifies benefits for transplantation at OSUWMC prior to full evaluation.

Psycho-Social Considerations Noncompliance with medical treatment Active Substance Abuse / Dependence Untreated Severe Mental Health Disorder Cognitive Limitations with Inadequate Social Support Inability to Afford Post Transplant Treatment

Living Kidney Donation The best option for a patient waiting for a kidney is to receive a kidney from a living donor. Living donor transplants can be arranged in as short as six weeks, versus years of waiting on the deceased donor list. Approximately half of all kidney transplants performed at the OSUWMC Transplant Center are from living donors. Our center welcomes non-directed / altruistic donors Incompatible kidney donors and recipients benefit from our donor exchange program. Our living kidney donation volumes are among the top 5% in the U.S. The CTC operates a specialized donor clinic to follow donors for two years after their donation. The OSUWMC Transplant Center has been recogni ed as a The OSUWMC Transplant Center has been recognized as a Best Practice Center by CMS for excellence in living kidney donor follow up care.

Donor Exchange Paired Donation Donor Exchange Chain 22

Donor Exchange Programs The OSUWMC Comprehensive Transplant Centers offers patients the option of donor exchange when a compatible donor is not available. We have a very active internal donor exchange program. We partner with The National Kidney Registry, Alliance for Paired Donation and The UNOS KPD Program to find matches for those we are unable to match internally. All surgeries are performed at The OSUWMC regardless of location of matched donor or recipient. Donor Exchange transplants accounted for 19.5% of the total kidney transplants completed at our center in FY 2011-2012. 17% were completed through our internal exchange program.

Post-Transplant Management Melissa Mazur RN, BSN, CCTC Post Transplant Coordinator

Post-Transplant Management Patients are managed here at OSU throughout the life of their transplanted organ. Patients are managed with the help of many other healthcare providers Primary Care Physician Referring Nephrologists Endocrinology Gastroenterology Other specialties

Post-Transplant Management Patients are assigned a transplant nurse coordinator following transplant. Coordinator will meet the patient prior to discharge from the hospital. Patients are encouraged to call the post transplant office with any questions or concerns. The post transplant coordinator is the first line of contact when patients call the office. Post transplant phone number 1-800-626-2538

Post-Transplant Management From transplant to 1 year patients are followed by a transplant surgeon Patients are typically seen in the clinic 1 month 3 months 6 months And 1 year post transplant prior to being transferred to a transplant nephrologist Patients >1 year post transplant are then transferred to a transplant nephrologist. P ti t d t f ll ith th i f i Patients are encouraged to follow up with their referring nephrologists and primary care physicians routinely.

Post-Transplant Management We manage more than just the transplant organ All aspects of the transplant patients care is managed by our transplant team with the help of the patients referring physician and the rest of their healthcare team. We routinely draw the following labs Cholesterol levels Iron studies liver and kidney functions Electrolytes CBC PTH

Post-Transplant Management Patients are given access to our transplant computer software- Transchart. This gives them the ability to enter and review their vital signs and labs. Enter Vital Signs Review Labs Review current medication list and Request medication refills This helps the patient to become more involved in their own care. Referring and treating physicians are also able to obtain access to Transchart to assist with coordinator of care for these patients.

Post-Transplant Management Post transplant office can be reached at 1-800-626-2538 Please call with any questions or concerns.

Type 1 Diabetes: Pancreas VS Islet Transplantation Clinical Trial IRB#2006H0200 Amer Rajab, MD, FACS, PhD Associate Professor of Surgery Director Pancreas and Islet Transplantation Director Pediatric Transplantation The Comprehensive Transplant Center The Ohio State University

Type 1 Diabetes Also known as juvenile diabetes Commonly diagnosed d in children, adolescents, or young adults Over reactive immune response destroys insulinproducing islet beta cells Therefore, the body does not, y produce insulin to properly control blood glucose levels

Tissue replacement: whole pancreas or Tissue replacement: whole pancreas or islet transplantation is currently the only way to restore physiologic glycemic control

Options The whole pancreas (standard of care) Simultaneous with kidney transplantation (KP) After kidney transplantation (PAK) Alone (PTA) The islets only (experimental/clinical trials)

Statistics Number of transplant centers performing pancreas transplant: 107 Total number of pancreas transplants: 17,888 The total prevalence of diagnosed Insulin Dependent Diabetes Mellitus (IDDM) in the United States (all ages, 2005) is approximately 1,400,000-2,800,000 people (http://diabetes.niddk.nih.gov/dm/pubs/statistics)

Statistics OSU (1988-2012): 927 total pancreas transplants K/P: 802 Pancreas: 125 Kidney/Pancreas Waiting times (median time to transplant) 6 months (national average = 14 months) Waitlist mortality: 8% (national average = 6%) Survival rates: July 2012 SRTR One year = 93% (national average = 97%)

Pancreas Waiting times (median time to transplant) 10 months (national average = 23 months) Waitlist W t mortality: 0% (national average = 3%) Survival rates: July 2012 SRTR y One year = 88% (national average = 98%)

Anatomy of the Pancreas 75-125 g 15-20 cm long 80-90% Exocrine: acinar cells and ductular network 2% Endocrine: islets of Langerhans Remaining: connective tissues: vascular, nervous, lymphatics

Islet Transplantation

Islet Sources Only pancreata not used for whole organ transplantation are considered for islets: Donors with significant atherosclerosis Donors with prolonged down time, hypotension and hyperglycemia Donors with extreme age Fatty pancreas Fibrotic pancreas Pancreatitis Pancreas with duodenal, parenchymal or splenic injury

Insulin Independence 70 60 50 Perce cent Insulin Independe ent 40 30 20 10 0 0 3 6 9 12 15 18 21 24 27 30 33 36 Months Post Last Inf usion Total Number of Infusions Received One Two Three

Pancreas VS Islet Pancreas Islet Standard of care Maximally Invasive Recipient Selection Limited Supply Immunosuppression Required Research (few elite centers) Minimally Invasive All Diabetics Qualify Potential for Unlimited Supply Manipulate Islets for Tolerance Can be repeated multiple times Re-Transplant is difficult Currently more successful

Who should be considered for transplant referral? Patients with type 1 diabetes and kidney failure (on dialysis or not) Patients with type 1 diabetes and successful kidney transplants

Who should be considered for transplant referral? Patients with type 1 diabetes without a kidney failure who have: Poor quality of life related to hypoglycemic unawareness and/or glycemic lability Failure of intensive insulin therapy to prevent progression of diabetes complications

Additional patient considerations for transplantation Demonstrated efforts to control their diabetes through intensive insulin therapy Age 18-65 years old No medical conditions that would make transplantation potentially unsafe or unsuccessful

What should my patients know? Pancreas transplantation is treatment of choice for diabetic patient with kidney failure Simultaneous with kidney Staged after kidney transplantation Pancreas transplantation alone can be beneficial in select patients with severe glycemic lability, hypoglycemic unawareness and recurrent hypoglycemia. Benefits include improved glycemic control, reduced frequency of hypoglycemia, and halted progression of diabetes complications

Summary Pancreas transplantation is currently the treatment of choice for diabetic patient with kidney failure Pancreas transplantation is also beneficial in diabetic patients t without t kidney failure who have severe glycemic lability, hypoglycemic unawareness and recurrent hypoglycemia. y

Conclusion Transplantation should be considered when despite medical management diabetes complications progress Islet transplantation is a promising alternative