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Prior to the start of the program, ensure you have the following printed program materials:

Prior to the start of the program, ensure you have the following printed program materials: Syllabus Pre-activity Survey Located at the front of your syllabus CME Evaluation with Post-activity Survey Located at the back of your syllabus. Disclosures.

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Prior to the start of the program, ensure you have the following printed program materials:

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  1. Prior to the start of the program, ensure you have the following printed program materials: • Syllabus • Pre-activity Survey • Located at the front of your syllabus • CME Evaluation with Post-activity Survey • Located at the back of your syllabus

  2. Disclosures • The relevant financial relationships reported by faculty that they or their spouse/partner have with commercial interests is located on page 5 of your syllabus • The relevant financial relationships reported by the steering committee that they or their spouse/partner have with commercial interests is provided on page 5 of your syllabus • The relevant financial relationships reported by the non-faculty content contributors and/or reviewers that they or their spouse/partner have with commercial interests is located on page 5 of your syllabus

  3. Off-label Discussion Disclosure This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. PCME does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

  4. Educational Objectives • Examine the most recent data on kidney disease outcomes after liver transplantation, and identify criteria that are currently being investigated to guide patient selection for liver alone vs dual organ transplant • Apply an up-to-date understanding of the mechanisms underlying antibody-mediated rejection to the initiation of evidence-based approaches to prevent rejection and minimize immunosuppressant-associated toxicity • Identify strategies to maximize adherence in patients undergoing solid organ transplant

  5. Pre-activity Survey • Please take out the Pre-activity Survey from your packet • Your answers are important to us and will be used to help shape future CME activities • It is important that you fill out the information at the top of the form: • Please select the best answer(s) for the questions below: • Degree: _MD/DO _ Nursing Professional _ PharmD _Other:_____________________________ • Specialty: _Hepatologist _Transplant Surgeon _ Nephrologist _Other:_____________________________

  6. Pre-activity Survey Question 1 How often do you think simultaneous liver/kidney (SLK) transplantation should be performed in non-ESRD patients needing a liver transplant? • >20% of the time • 10% to 19% of the time • 5% to 9% of the time • <5% of the time

  7. Pre-activity Survey Question 2 Which of the following liver failure patients should generally not be given an SLK transplant? • ESRD • Metabolic kidney disease • No ESRD but receiving hemodialysis for 2 months • Stage 4-5 CKD, with no proteinuria and 25% likelihood of developing ESRD after liver transplant alone • All of the above are good candidates for SLK • None of the above should be given a SLK

  8. Pre-activity Survey Question 3 Liver transplant candidates with stage4-5 chronic kidney disease (CKD) should be receiving an SLK? • Correct • Incorrect • I don’t know

  9. Pre-activity Survey Question 4 Please rate your level of confidence in your ability to select a candidate for SLK: 1 2 3 4 5 Not confident Expert

  10. Pre-activity Survey Question 5 Please rate your level of confidence in recognizing the signs and symptoms of antibody-mediated rejection (AMR): 1 2 3 4 5 Not confident Expert

  11. Pre-activity Survey Question 6 In your practice, what percentage of your transplant patients almost never miss doses of their immunosuppressive medications one year after transplantation? • 75% to 100% of my patients • 25% to 74% • 10% to 24% • <10% • I don’t know

  12. Pre-activity Survey Question 7 What strategies have you implemented in your practice to address patient adherence (select all that apply)? • Education • Modify/simplify treatment regimen • Schedule office visits, even when the patient feels well • I have not implemented any strategy yet

  13. Pre-activity Survey Question 8 A 60-year-old male with a history of type 2 diabetes mellitus (5-yr) and liver disease secondary to NASH is evaluated for liver transplantation. He has never been told he had kidney disease. Labs: Serum creatinine: 3.2 mg/dL (up from 1.2 mg/dL a year earlier, and 1.5 mg/dL 4 days ago); Urine output: 690 mL per day (down from 1.2 liters 4 days ago); Serum Na+ 129 mEq/L; Serum K+ 5.8 mEq/L; Urine: PCR 0.3 mg/g; Na+ 12 mEq/L. Is this patient a dual liver/kidney transplant candidate? • Yes • No • I don’t know

  14. Pre-activity Survey Question 9 In liver transplant recipients with eGFR >30 mL/min/1.73 m2, compared to standard tacrolimus dosing, the addition of everolimus to reduced tacrolimus did which of the following: • Prevented kidney function loss but increased the incidence of acute rejection, graft loss, and death • Prevented kidney function loss with similar impact on the incidence of acute rejection, graft loss, and death • Similarly reduced kidney function and the incidence of acute rejection, graft loss, and death • I don’t know

  15. Pre-activity Survey Question 10 The most common cause of AMR is? • Viral infection • Non-adherence to regimen • Age of recipient

  16. Case Report • 62-year-old male with 5-year history of T2DM • History of liver disease secondary to NASH • Presented to local hospital with abdominal pain, nausea, and coffee ground emesis • Transferred for liver transplant evaluation • Work-up revealed decompensated liver failure; ultrasound showed a cirrhotic liver; EGD esophagitis with varices

  17. Case Report: Laboratory Findings • Upon transfer, Cr 2.4 mg/dL • On admission, Cr 1.5 mg/dL • 1 year earlier, Cr 0.6 mg/dL • Urine output • 1.2 L at transfer • Over 3 days, decreased to 690 mL/day • Patient became encephalopathic • Cr 3.2 mg/dL, Na+ 129 mEq/L, K+ 5.8 mEq/L • Urinalysis bland • PCR 0.3 g/g, UrineNa+ 12 mEq/L • Patient placed on active list for a liver transplant • MELD: 34

  18. Case Report: Renal Ultrasound Renal ultrasound showed mild echogenicity, but was otherwise normal Figure 1A: normal Figure 1B: case Photos courtesy of Dr. F. Vincenti.

  19. Polling question Is this patient a dual liver/kidney transplant candidate? • Yes • No • I need more information

  20. Consequences of MELD Allocation System • Intended • Reduced waitlist mortality • Unintended • Livers often allocated on basis of kidney disease severity • Compared to pre-MELD era: • SLK listings have increased • SLK transplants increased Eason JD et al. Am J Transplant. 2008;8:2243-2251. Davis CL et al. Am J Transplant. 2007;7:1702-1709.

  21. Abnormal Kidney Function is More Common in Liver Candidates in MELD Era • Pre-MELD 1999-2002, n=11010; Post-MELD 2002-2004, n=13163, data from SRTR GonwaTA et al. Am J Transplant. 2006;6:2651-2659.

  22. Increasing Number of SLK in USA in MELD Era MELD introduced % SLK # SLK From 2012 Annual Report of OPTN/SRTR.

  23. Limited Utility of Estimating Equations in Candidates with eGFR <40 mL/min • 1447 OLT recipients, 1984–2001; *iothalamate GFR used as “gold-standard” Gonwa TA et al. Liver Transpl. 2004;10:301-309.

  24. Reasons That Centers Consider SLK • Avoid peri-operative dialysis • Potential to prevent • Non-recovery of pre-operative AKI • Early post-transplant ESRD • SubsequentESRD and need for later kidney from another donor • May protect center from risk of being exposed to poor outcomes based on LTA

  25. Wide Variation in Simultaneous Liver-Kidney Transplants Between Regions Nadim MK et al. Am J Transplant. 2012;12:3119-3127.

  26. Polling Question Independent of eGFR, all of the following factors at the time of LTA have been associated with ESRD except: • Older age • Diabetes mellitus • Duration of dialysis • Presence of abnormalities on kidney biopsy

  27. Polling Question Independent of eGFR, all of the following factors at the time of LTA have been associated with ESRD except: • Older age • Diabetes mellitus • Duration of dialysis • Presence of abnormalities on kidney biopsy

  28. Renal Criteria Used to Determine Need for SLK vs LTA in Liver Candidates Results of National Survey of US Transplant Centers Survey of 88 centers that perform SLK, 65% response Nadim MK et al. Am J Transplant. 2012;12:3119-3127.

  29. Risk of ESRD After LTA in Patients with Fluctuating eGFR Pre-transplant Ruebner R et al. Am J Transplant. 2012;12:2958-2965.

  30. ESRD by 6 Months Post-LTA and Pre-transplant Acute Dialysis Duration Sharma P et al. Clin J Am SocNephrol. 2013;8:1135-1142.

  31. Predictors of Non-recovery of Kidney Function Post-LTA Sharma P et al. Clin J Am SocNephrol. 2013;8:1135-1142.

  32. * RR of Death Duration of Dialysis (mos) Association of Pre-transplant Dialysis Duration and Survival After SLK P=0.05, SLK vs LTA Cox Proportional Hazard Analysis Comparing SLK and matched-control LTA recipients, matched for donor age, race, cause of death, recipient MELD and dialysis status Adapted from Locke JE et al, Transplantation 2008

  33. Poor Outcomes in Elderly Patients on Dialysis at Time of Liver Transplant >65, on dialysis Proportion of patients surviving Days post-transplantation ≥65, L ≥65, D, L ≥65, D, L/K <65, D, L/K <65, D, L <65, L UNOS data, n=9877, MELD era Dellon ES et al. Am J Transplant. 2006;6:2183-2190.

  34. Distribution of LTA Patients Based on RIFLE Classification • No AKI: 165 • Risk 34 • Injury 19 • Failure 65 • ATN 30 • HRS 35 • Retrospective, 283 pts • ATN based on clinical diagnosis Nadim MK et al. Liver Transpl. 2012;18:539-548.

  35. Nadim MK et al. Liver Transpl. 2012;18:539-548. Recovery of Kidney Function After OLT

  36. Limitations with Comparing SLK and LTA Outcomes in MELD Era • Only retrospective studies • Lack of: • Appropriate control groups • Standardized selection criteria for SLK • Pre-LTA kidney and/or dialysis data • Data on pre-txp comorbidity • Kidney outcomes after LTA not well characterized • Misclassification with registry data • Differences in liver disease severity?

  37. Kidney Biopsy in Liver Transplant Candidates • Pathological abnormalities common • High risk of bleeding complications • Not shown to be better than serum creatinine in predicting: • Post-txp reversibility • Post-txp kidney function • Rate of decline of GFR • Time to ESRD • Should be considered a research tool for now McGuire BM et al. Ann Intern Med. 2006;144:735-741. Wadei HM et al. Am J Transplant. 2008;8:2618-2626. Tanriover B et al. Transplantation. 2008;86:1548-1553.

  38. OPTN Policy Proposal Listing Criteria for SLK • ESRD • CKD with GFR <30 (MDRD-6 or iothalamate) and proteinuria >3 g/day • Sustained AKI requiring dialysis for >6 weeks • Sustained AKI (GFR <25) for >6 weeks not on dialysis • Sustained AKI: combination of time in (c) and (d) >6 weeks • Metabolic disease OPTN Kidney Transplantation Committee and the Liver and Intestinal Organ Transplantation Committee (OPTN Policy 3.5.10).

  39. OPTN Policy Proposal Priority local listing for KAL • If listed for SLK but received LTA OR • If required 2 weeks of pre-LTA dialysis and/or eGFR 30-40 mL/min for 4 weeks pre-LTA AND • Continued maintenance dialysis for >90 days post-LTA • non-recoverable kidney function • between 90-180 days post-LTA OPTN Kidney Transplantation Committee and the Liver and Intestinal Organ Transplantation Committee (OPTN Policy 3.5.10 and 3.5.10.1).

  40. SLK Allocation in MELD Era Summary of Issues • Inadequate characterization of pre-kidney function has limited the establishment of uniform criteria • 3 months duration of severe kidney disease is tipping point for worse outcomes after LTA • CKD defined by impaired kidney function for >3 months • Should restrict SLK to patients with stage 4-5 CKD • No clear benefit for patients not on dialysis • Selects patients with lowest likelihood of renal recovery

  41. Proposed Algorithm: SLK vs LTA in Liver Candidates with Kidney Dysfunction • Bloom RD et al. Adv Chronic Kidney Dis. 2009;16:268-277.

  42. Case Report: Liver Transplant • Transplant nephrology consulted to initiate CRRT • Decision made that patient did not require kidney transplant • Patient had a GI bleed requiring multiple transfusions; transferred to ICU • CRRT initiated • Urine Na <10 mEq/L; urine output decreased to 200-300 mL • 6 days later, underwent OLT • Continued on CVVHD for 48 hours • Remained oliguric on steroids and mycophenolate mofetil for 5 days, then started on tacrolimus 2 mg bid • Discharged, eGFR 20mL/min

  43. Polling Question In LTA with GFR <25mL/min, which would you NOT consider? • Continue the present immunosuppressive regimen • Reduce the dose of tacrolimus • Convert tacrolimus to mTor

  44. Polling Question In LTA with GFR <25mL/min, which would you NOT consider? • Discontinue tacrolimus • Reduce the dose of tacrolimus • Convert tacrolimus to mTor

  45. Everolimus in Liver Transplant Saliba F et al. Am J Transplant. 2013;13:1734-1745.

  46. Everolimus in Liver Transplant Saliba F et al. Am J Transplant. 2013;13:1734-1745.

  47. Case Report: Post-liver Transplantation • 9 months post-liver transplant, kidneys failed and patient received a kidney transplant from his 33-year-old son • T and B cell cytotoxicity crossmatches were negative • Kidney functioned immediately • At 1 month, Cr 1.3 mg/dL; on steroids, mycophenolate mofetil and tacrolimus

  48. Case Report: Post-liver Transplantation • At 3 months, Cr increased to 2.5 mg/dL • Biopsy revealed Type Ib Banff acute T cell rejection; thymoglobulin begun • Cr remained at 1.8 mg/dL • Patient did not return for follow-up; compliance concerns • Presented 9 months later complaining of fatigue and edema; Cr 2.6 mg/dL, a urine PCR 1.2 mg/g

  49. Case Report: Biopsy Figure 2B Figure 2A Figure 2C Figure 2D Photos courtesy of Dr. F. Vincenti.

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