The Christ Hospital Health Network Kidney Transplant Program

1. The Christ Hospital Health NetworkKidney Transplant Program Kidney Transplant Recipient Education Class 8/2016, 7/2017

2. Welcome! The Christ Hospital Kidney Transplant Center is recognized nationally as a Transplant Center of Excellence and regionally as Top in Nephrology The Christ Hospital Health Network​ is home to one of the most successful kidney transplant and tissue transplant programs in the country. The Christ Hospital began doing transplants in 1972, and has completed a total of 1940 successful kidney transplants. Our transplant surgeons and multidisciplinary team of specialists are involved every step of the way, guiding you on what to expect and how to achieve the best outcome. You are in good hands. . .

3. PURPOSE OF THIS CLASS Introduction to Transplant Program, transplant referral and work-up process Waitlist process and ongoing expectations Living donor process Donor Champion Educate on costs related to transplant

4. MULTI-DISCIPLINARY TRANSPLANT TEAM • Nephrologist • Primary nephrologist • Transplant nephrologist • Surgeon/Nurse Practitioner • Specialty physicians • Cardiology • Pulmonology • Infectious Disease • Hematology • Additional specialty physicians (endocrinology, urology, neurology, etc) • Pharmacist • Dietitian • Transplant Administrator • Assistant Clinical Manager • Transplant Clinic Coordinator • Transplant Assistant • Transplant coordinator • Pre-transplant Recipient • Waitlist • Donor • National Kidney Registry (NKR) • Desensitization • Social Work (SW) • Pre-transplant recipient • Waitlist • Donor • Independent Living Donor Advocate • Financial Coordinator (FC) • Quality Coordinator • Data Coordinator • Research staff

5. Center statistics as of 7/6/17 National 1 year patient survival – 97.34% The Christ Hospital 1 year patient survival, adjusted for patient and donor characteristics – 97.52% National 1 year graft (transplanted kidney) survival – 95.18% The Christ Hospital 1 year graft (transplanted kidney) survival, adjusted for patient and donor characteristics – 96.25% www.unos.org www.srtr.org

6. Transplant is not a cure for Kidney Disease TRANSPLANT DIALYSIS Hemodialysis Peritoneal Dialysis • Living related • Living un-related • Deceased donor • Proceeding with kidney transplant is voluntary

7. ABSOLUTE CONTRAINDICATIONS to receiving a kidney transplant Non-compliance/non-adherence with prescribed medical therapy, including dialysis and medications Unstable cardiac disease Severe pulmonary disease, including uncontrolled/untreated pulmonary hypertension Currently smoking and/or using smokeless tobacco/vaporizers/e-cigs, etc. Active abuse of drugs, alcohol, or other substances Severe vascular disease Active infections Age equal to or greater than 80 Recent diagnosis or on-going treatment for cancer Exception: non-melanoma skin cancers Uncontrolled psychiatric disorders Lack of adequate insurance coverage or an inability to cover the expenses involved with a kidney transplant and subsequent care

8. RELATIVE CONTRAINDICATIONS to receiving a kidney transplant Acute or chronic liver disease Obesity • BMI > 35 Age with associated co-morbidities Financial or insurance concerns Untreated or inadequate treatment for mental illness History of cancer (other than non-melanoma skin cancers) Inadequate social support

9. BENEFITS OF TRANSPLANT SURVIVAL

11. Evaluation process prior to approval for waitlisT Referral Phase • Nephrologist sends referral to transplant center • Referral is sent to financial coordinator to confirm adequate insurance coverage to move forward with transplant work-up • Scheduled for transplant education class • If evaluation authorization received, referral is given to transplant coordinator to schedule one-on-one meeting with transplant coordinator and social work • Pre-evaluation Phase • Attend transplant education class • One-on-One meeting with transplant coordinator to provide additional education, review medical history and obtain consents • Designate a Donor Champion if eligible for a living donor transplant • Meet with Social Work for complete psychosocial evaluation

12. PROCESS CONTINUED Evaluation Phase Complete basic testing required by transplant center • To be completed in 30-60 days Meet with the surgeon

13. Testing Requirements- to be done in 30-60 days Standard testing requirements Additional testing may be required dependent on individual medical history Bloodwork Blood counts, kidney function, liver function, cholesterol, diabetes, HIV, Hep B, Hep C, additional infectious studies (Endemic testing) Urine 24 hour urine Urine culture Urinalysis Required vaccines Hepatitis A HPV Hepatitis B Zostavax (shingles) Tdap Influenza Pneumococcal (23 & 13) Imaging Chest x-ray Abdominal Ultrasound CT scan Vascular studies • Colonoscopy and/or upper endoscopy • Mammogram/pap smear • Prostate exam • Cardiac testing • Specific testing related to individual’s medical history • Dental clearance

14. TESTING REQUIREMENTS Primary Coordinator will review specific work-up requirements during your individual meeting Clearance letters from individual specialty physicians may be required Based on age and past medical history

15. Process continued Approval RN will present transplant work-up to transplant team for review • At this time, additional testing may be requested to further evaluate abnormal test results Waitlist Activation to waitlist occurs once approved by the transplant team

16. ONCE APPROVED BY TEAM… All candidates approved for transplant will be added to United Network for Organ Sharing (UNOS) waitlist • Waiting list for all organs and all transplant centers throughout the United States • www.unos.org If a living donor has been approved, the transplant can be scheduled.

17. Allocation for the waitlist Wait times have been affected by allocation system • Dialysis start date = waitlist date • Time on dialysis • If you have not yet started dialysis the date you are activated on waitlist is when your time starts Estimated post-transplant survival (EPTS) • Time on dialysis • Age • History of diabetes • Prior transplant Kidney Donor Profile Index (KDPI)

18. UNITED NETWORK FOR ORGAN SHARING (UNOS) WAITLIST Local Average wait time: 57 months National Average wait time: 72 months There is no way to know when a kidney is going to become available • Must be able to be reached at all times • Working phone numbers • Voicemail box available to leave messages by transplant center staff • Email contact

19. Active Status on waitlist Ready to be transplanted at any given moment Must be able to be reached at all times Have working contact numbers and voicemail boxes ready to receive messages

20. HOLD STATUS ON WAITLIST • Reasons to contact coordinator when active on waitlist: • Active infections • Change in health status • Hospitalization • Inability to arrive at transplant center within designated time frame • If you do not call us, we could be made aware by… • Name listed on hospital census • Physician offices notify Centers of illnesses, change in health status, active infections • Communication with dialysis centers

21. MULTIPLE LISTING Active on more than 1 center’s waitlist in different OPO (organ procurement organization) Additional information regarding multi-listing will be reviewed with your individual coordinator Examples: • Life Center is OPO for The Christ Hospital, University Hospital & Children’s Hospital • Kentucky Organ Donor Affiliates is OPO for University of Kentucky (UK) (Lexington, KY), Jewish Hospital (Louisville, KY), and Kosair Children’s Hospital (Louisville, KY)

22. Multiple Listing Options Indiana has 1 OPO Called: Indiana Donor Network Indiana University Lutheran Hospital of Fort Wayne St Vincent Hospital University of Toledo Cleveland Clinic University of Cleveland Ohio has 4 OPO’s. Ours is called: LIFE CENTER Children's Hospital Ohio State University Children’s Hospital University Hospital Kentucky has 1 OPO Called: KODA The Christ Hospital Jewish Hospital Children's Hospital University of Kentucky

23. Donor champion Person or team of people identified to help advocate for you in your search for a living donor Spouse Sibling(s) Parent(s) Friend(s) Prior donor Work with donor coordinators Information packets available to send to Champions to aide them in your search for living donors

24. THE SURGERY Becky Parks, Transplant Surgery Nurse Practitioner

25. What to expect the day of surgery Living donor transplant (scheduled) Admitted through Same Day Surgery IVs, labs drawn Will proceed to OR from SDS when both donor and recipient surgeon ready to proceed Deceased donor transplant Admitted to 2 South EXPECT A LOT OF ACTIVITY!!! IVs, Labs, EKG, Chest X-Ray, sign consents, update history, possible dialysis, other tests Wait……

26. THE SURGERY

27. The surgery Surgical procedure overview

28. The surgery Procedure lasts 3-4 hours (on average) Recovery room for 1-2 hours SICU overnight for close observation Transfer to 2 South on POD #1 or #2

29. RISKS RELATED TO TRANSPLANT There are inherent medical and surgical risks with all surgeries/invasive procedures, especially those conducted under general anesthesia, up to and including risk of death Most complications are minor and improve over time Post op nausea/vomiting Constipation Ileus Wound infection Some complications are more serious and may require additional surgery or procedure Bleeding/Hematoma development Hernia DVT/Pulmonary embolism

30. RISKS RELATED TO TRANSPLANT

31. Once you’ve had the transplant Follow-up 3 days a week for 3-4 weeks Urology for stent removal Possible kidney biopsy for suspected rejection

32. Medications Induction (At time of Transplant) • Thymoglobulin • Steroids • Simulect • Campath Prophylaxis (Preventative) • Stomach protection • Nystatin • Valcyte/Valtrex • Bactrim Maintenance Immunosuppression (Life-Long) • Prograf • Cellcept • Belatacept • Rapamune • Myfortic

33. Donor selection and associated risks Organ Donor Risk Factors -- Rigorous screening of all donors to ensure the organs are appropriate to be transplanted --May have risk factors that potentially could affect your long term health Donor age History HIV, other infectious diseases, cancers not yet detected “We only know what we know”

34. Donor selection and associated RISKS Living donor evaluation and screening consists of: General and kidney specific donor history General and kidney specific family history Social history Physical exam General and kidney specific labs and imaging tests Transmissible disease screening Endemic transmissible disease screening Cancer screening

35. Donor selection and associated RISKS Deceased donor evaluation and screening consists of: Attempt to obtain the deceased donor’s medical and behavioral history from one or more individuals familiar with the donor Deceased Donor Medical and Behavioral History, to screen for medical conditions that may affect the decision to use the donated organ Review the deceased donor’s medical record Complete a physical exam of the deceased donor, including the donor’s vital signs Transmissible disease transmission screening

36. Donor selection and associated RISKS If donor disease or malignancy transmission risk is identified pre-transplant, the transplant team and surgeon will explain those risks and obtain informed consent from you prior to the transplant taking place Risks and benefits will be discussed If you decide to proceed with transplant you will be closely monitored post-transplant to assess for transmission of disease and/or malignancy

37. Use of increased risk donors There is an Organ Donor Shortage There are many more patients who need a kidney than there are kidneys available The United Network for Organ Sharing (UNOS) & the transplant team at The Christ Hospital have been working to identify practices & policies that will maintain transplant quality and safety, while giving patients options & access to more donors including acceptance of PHS increased risk donors, HCV antibody positive donors or HBV core antibody positive donors

38. Use of increased risk donors The Public Health Service has established criteria that determine if a donor should be listed as increased risk for exposure to Hepatitis and HIV What make a donor PHS Increased Risk? History of or active IV drug use Sex with a person with history of IV drug use Incarceration Males who have had sex males How many donors in our area meet PHS Increased Risk criteria? PHS donors comprise 20% of the local donor pool One of every five donors is considered a PHS increased risk donor

39. Use of increased risk donors Why should I accept a PHS Increased Risk Donor? You may be transplanted sooner than if you elect to wait only on the standard criteria donor list In our region PHS Increased Risk Donors are an average 13 years younger than standard donors; therefore, kidneys from such donors tend to be very high quality with a lower risk of loss of the organ and successful transplant Some patients may have up to 10% better kidney survival 5 years after transplant Your yearly risk associated with staying on dialysis may be higher than the risks associated with PHS donor transplants

40. Use of increased risk donors What are the risks associated with PHS Increased Risk Donor transplant? No type of transplant has zero risk of transmission Non-PHS donor transmission risk is 2.4/100,000 (0.0024%) The possibility that a PHS increased risk donor is actually infected and would transmit that infection is less than 46 out of 100,000 or .046% It is important to realize that even treatments that you may need while waiting for a kidney involve some degree of risk of disease transmission Even hemodialysis involves risk of transmission, and is considered a PHS Increased Risk category for transmission of Hepatitis C

41. Interpreting Hepatitis C Test Results Albeldawi M et al. Cleve Clin J Med 2010;77:616-626.

42. Use of increased risk donors What does HCV Antibody positive, HCV PCR or NAT negative mean for a kidney donor? Many patients who contract HCV spontaneously clear the virus These patients are anti-HCV antibody positive, yet HCV RNA (DNA) negative in the blood With the recent availability of new anti-HCV drugs with >95% cure rates Kidney donation from anti-HCV Ab positive, HCV RNA PCR or NAT negative individuals is safe and carries a low risk of viral transmission to the kidney transplant recipient

43. Use of increased risk donors What is the Risk of HCV Transmission to the Transplant Recipient? Very small chance for transmission (<0.5%) of HCV to an HCV-negative recipient with transplantation of a kidney from a treated or cleared HCV-positive donor

44. Use of increased risk donors How do We Monitor for Transmission Post-Transplant? HIV, HCV, and HBV testing will occur in these transplant recipients at the following time points: 1 month 3 month 6 months

45. Use of increased risk donors Is the Risk worth the Benefit? Small transmission risk needs to be weighed against the risk of staying on dialysis, which carries a mortality rate of 6.5-7.4 times that of the general population and 4.6-5.9 times that of the renal transplant population Using kidneys from HCV-antibody donors for transplantation in -HCV-negative patients is a safe approach in the long-term as the risk of infection transmission is largely overweighed by the shorter waiting times

46. Social work evaluation Pre-transplant evaluation Phase – Initial meeting with Social Work • Family Background and supportive relationships • Education and employment status • Income/financial status insurance • Overall understanding of your illness • Diagnosis and past medical history • Dialysis history and compliance • Current level of functioning • Mental Health status • Social History (smoking/alcohol usage) • Legal issues/drug history • Emotional/Spiritual status • Discussion of living donors/kidney champion program • Reach out to family and friends to be your champion!

47. Social Work Evaluation Transplant Phase – During your work up • Insurance coverage • Up to date at all times • Adequate for transplant • Review plans for applying for Medicare • Concerns • Support • Financial • Compliance • Checking with the dialysis center • Medications • Work with the pharmacy post transplant to obtain all of your medications

48. Importance of social support Transportation 3x / week for the first 3 weeks Who will bring you here? Financial Out of Pocket Expenses Medications Who will pick up your medications? Emotional Anxiety Depression Who is going to care for you at home? There are very few programs available to help with transportation or financial assistance following a transplant. Any assistance you receive from the American Kidney Foundation stopsafter you receive a transplant.

49. INSURANCE COVERAGE MEDICARE Federal Health insurance for people over age 65, young people with certain disabilities, and ESRD patients. What coverage you need and Why: • Part A -Hospital insurance • Part B -Preventive care/DME • Premium for this is $134/month • Lifetime donor coverage • 80% coverage of immunosuppressant medications • Part D -Prescription coverage • Only need if you do not have another prescription coverage Medicare ends three years after a successful transplant Always Remember to contact the SW or Financial Coordinator if your insurance changes

50. INSURANCE COVERAGE MEDICAID Government insurance program for people with low income • Medication Costs • Hospital stay • Transportation PRIVATE INSURANCE Insurance through your employer, spouse, parents, or the ACA • Out of Pocket costs • How will it work with Medicare Always Remember to contact the SW or Financial Coordinator if your insurance changes