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Facing the Organ Shortage Crisis: Business as Usual vs Non-Conventional Solutions?

Facing the Organ Shortage Crisis: Business as Usual vs Non-Conventional Solutions?. Richard Perez MD Division of Transplant Surgery UC Davis Medical Center. Rationale for Transplantation. Survival benefit vs dialysis Improvement in quality of life Economic benefit to health care system.

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Facing the Organ Shortage Crisis: Business as Usual vs Non-Conventional Solutions?

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  1. Facing the Organ Shortage Crisis: Business as Usual vs Non-Conventional Solutions? Richard Perez MD Division of Transplant Surgery UC Davis Medical Center

  2. Rationale for Transplantation • Survival benefit vs dialysis • Improvement in quality of life • Economic benefit to health care system

  3. Merion, et al. JAMA 2005

  4. Survival benefit with use of extended criteria donor kidneys Merion, et al. JAMA 2006

  5. Our Goal To make transplantation a safe option for as many patients as possible

  6. Patients waiting for kidney transplantation on October 2, 2013 97,916

  7. A National Crisis Waiting list growing – 97,916 today Transplant rate flat – 16,000+/yr x 8yrs

  8. Transplantation - A victim of its own success:UC Davis waiting list California kidney wait list 18,219 2000 2005 2010 SRTR July 2012

  9. UC Davis Kidney TransplantationMore transplants but the donor gap widens

  10. Clinical J American Society of Nephrology 2009

  11. Crisis Response Business as usual vs non-conventional solutions?

  12. Deceased Donor Transplantation Making the most of every opportunity

  13. Organ preservation method matters Machine preservation may increase availability of organs for transplantation vs

  14. Hypothermic Pulsatile Pump Preservation:Rationale Hypothermic conditions with decreased metabolism Simulates normal circulation Continuous provision of micro-nutrients Removal of toxic waste products and free radicals Pulsatile flow stimulates endothelial expression of vasoprotective genes

  15. Pulsatile Pump Preservation • Rationale for initiation of pump preservation • Improved early allograft function • Lower DGF rates • Able to exclude kidneys at high risk for primary non-function • Particularly important in ECD and DCD kidneys • Shorter hospital stay?

  16. Improved graft survival with machine perfusion Moers, et al. N Engl J Med 2012

  17. Question American Transplant Congress 2009 How does pulsatile perfusion preservation impact long termExtended Criteria Donor allograft survival?

  18. Machine preservation improves survival of extended criteria donor kidneys Pulsatile Perfusion Cold Storage Patients at risk: PP 60 45 30 20 16 CS 31 21 13 9 9 American Transplant Congress 2009

  19. Options for Expanding the Deceased Donor Pool • Expanded Criteria Donors (ECD) • Donation after Circulatory Death (DCD) • Pediatric en-bloc kidneys (peds-en-bloc) • Dual Adult Kidneys • Donors with Acute Kidney Injury (AKI) • HCV positive donors • Hepatitis B core Ab positive donors

  20. Making more organs available:Extended Criteria Donors Age > 60 years old Or Age 50 -60 years old + 2 factors below: • Death by stroke • History of hypertension • High serum creatinine

  21. General evaluation of kidneys from extended criteria donors • All organ offers evaluated by txp surgeon • History • General health maintenance, lifestyle • Presence of co-morbidities • History of tobacco use • Inspection of organs at time of procurement • Biopsy results • Pump flow and resistance

  22. Selection of appropriate recipients of ECD or “non-conventional” kidneys • Wait list management important to maintain a pool of patients eligible for ECD kidneys • Ensure appropriate patients in all blood groups • For certain kidneys with limited renal mass consider allocation of organ to patients with: • Presumed lower metabolic needs • Older age group • Low BMI • Low immunologic risk • Primary transplants • Non-sensitized patients

  23. Extended Criteria vs Standard Criteria Donors: 2006-2011 84% SCD(n = 344) ECD (n = 133) 76% SCD = Standard Criteria Donor ECD = Expanded Criteria Donor p = 0.012; Log rank test

  24. Dual Transplantation of ECD Kidneys • Offered to patients who will accept ECD kidneys • Donor > 55 yo • CreatCl 50 – 90 ml/min • Must be able to tolerate longer surgical procedure • Standard immunosuppresion protocol

  25. Dual kidney transplantation with single arterial and venous anastomoses Ex vivo vascular reconstruction prior to transplantation D Nghiem, J Urol 2006

  26. Dual adult donation equivalent to standard criteria donationUCD graft survival (1996-2010) Dual-ECD (n = 15) SCD (n = 469) ECD (n = 101) p = 0.009, log-rank test 1 2 3 4 5

  27. Hepatitis B Core Ab+ Kidneys • Informed consent at time of listing • Offered to patients are immunized (HbsAb+) • All HbcAb+ donors are tested for viremia (HBV DNA by PCR) • Recipient prophylactic antiviral treatment: • Hepatitis B Immune Globulin pre-transplant. • Entecavir starting POD 1 • Continuation of Entecavir depends on results of donor HBV DNA and recipient quantitative HBsAb titer

  28. Deceased Donors with Acute Kidney Injury

  29. Deceased Donors with AKI: UC Davis Experience • AKI group: n= 83 • Control group: n= 620 • Outcome measures: - rate of DGF (dialysis during 1st week post-txp) - renal allograft function - acute rejection in the first year post-transplant - patient and graft survival Santhanakrishnan, et al. Amer Transplant Congress 2013

  30. Donor Demographics 2005-2012 Santhanakrishnan, et al. Amer Transplant Congress 2013

  31. Recipients of AKI kidneys were older and less sensitized Santhanakrishnan, et al. Amer Transplant Congress 2013

  32. More Delayed Graft Function in Recipients of Kidneys with Acute Injury Santhanakrishnan, et al. Amer Transplant Congress 2013

  33. Excellent survival of allografts with acute renal injury Donors with AKI (n = 83) Donors without AKI (n = 620) 1 year graft survival was 95.9% (AKI) vs 93.3% (control) p = 0.38 P = 0.38; Log rank test Santhanakrishnan, et al. Amer Transplant Congress 2013

  34. Excellent patient survival of allografts with acute kidney injury vs donors with normal function Donors with AKI (n = 83) Donors without AKI (n = 620) Pt survival at 1 yr – 98.2 (AKI) vs 96.4% Pt survival at 3 yr –89.9% (AKI) vs 92.1% P = 0.68; Log rank test Santhanakrishnan, et al. Amer Transplant Congress 2013

  35. Slower recovery of AKI kidneys p=.03 p=.4 p=.7 p=.017 p<.001 e-GFR (ml/min) AKI (n = 83) No-AKI (n = 608) 1 year 2 years 7 days 90 days 30 days Santhanakrishnan, et al. Amer Transplant Congress 2013

  36. Kidneys from Small Pediatric Donors

  37. Study Patient Cohort • Recipients of deceased donor kidneys from small pediatric donors (<20kg) from June 2007 to November 2012

  38. Results • 146 patients received kidneys from donors <20kg • 89% imported from distant OPOs • 88% transplanted en bloc • 55% donors age <6 months old • 35% donors weighed <5kg • 34% donors after circulatory death

  39. Graft survival of kidneys from small pediatric donors 93% 89% Patients 76 36 24

  40. Addressing the organ shortage crisis:Importing kidneys that require further assessment SRTR July 2012

  41. Demographic Data II p < 0.001, Chi-squared test

  42. Demographic Data: 1/2005-7/2012

  43. Delayed Graft and 90 Day Complications Hazard Ratio (95% Confidence Interval)

  44. Patient and Graft Survival, 3 yr eGFR *p-value is for eGFR for group vs SCD

  45. Graft Survival 2005 – 2012by Type of Donor SCD/AKI (n = 75) DCD (n = 103) Pediatric en-bloc (n = 114) Living Donors (n = 366) SCD (n = 412) ECD (n = 151) p < 0.001, log-rank test for trend (ECD)

  46. Estimated-GFRby Type of Deceased-Donor p=.9 p=.2 p<.001 p=.04 p<.001 p<.001 e-GFR (ml/min) NCD (n = 484) Conv (n = 372) 7 days 90 days 30 days 2 years 3 years 1 year 437 vs 404 429 vs 398 426 vs 392 291 vs 338 165 vs 249 111 vs 194

  47. Conclusions • The use of non-conventional donors (NCDD) is a viable option for expanding the deceased donor pool • Delayed graft function or slow graft function is more common with NCDD • Surgical complications are greater at 90 days with the pediatric en bloc • The long term outcome with NCDD transplants is comparable to SCD outcomes at 3 years.

  48. New technologies for deceased donor transplantation?

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