Liver Transplantation: Fair and Equitable Access Jeffery L. Steers, MD FACS Objectives ❖ Discuss liver allocation past, present and future ❖ Outline disparities in liver allocation.
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Liver Transplantation: Fair and Equitable Access Jeffery L. Steers, MD FACS Objectives ❖ Discuss liver allocation past, present and future ❖ Outline disparities in liver allocation across the nation ❖ Review current national liver donor distribution Fair and Equitable ❖ fair ❖ adjective ❖ ❖ adverb ❖ ❖ in accordance with the rules or standards; legitimate without cheating or trying to achieve unjust advantage equitable ❖ adjective ❖ fair and impartial Liver Transplant Volumes Liver - Waiting List Post-Transplant Survival Titanic lifeboat Lifeboat Ethics Lifeboat Ethics in Transplantation ❖ Principles ❖ Respect for Persons (Autonomy) ❖ Harms and Benefits (Beneficience / Non-maleficence) ❖ Fairness (Justice) Lifeboat Ethics in Transplantation ❖ Fairness ❖ When there are not enough organs for people who need them, how should they be distributed? ❖ What is the fairest way to distribute organs? First in the Lifeboat ❖ Those who are: ❖ likely to live the longest if given the resource ❖ sickest ❖ youngest ❖ most valuable to society ❖ are least responsible for their disease ❖ win in a lottery http://science.education.nih.gov/supplements/nih9/bioethics/guide/teacher/module-3-activities.pdf US Liver Allocation History ❖ ❖ ❖ Pre-1984 ❖ Transplant center - private hospital affiliation ❖ SEOPF - Southeast Organ Procurement Foundation 1984 - NOTA ❖ UNOS incorporated and receives initial federal contract to operate the Organ Procurement and Transplantation Network (OPTN) ❖ OPO’s are established ❖ Previous affiliations allowed First liver allocation system determined by patient care setting and shared within OPO first, regionally and then nationally ❖ Recognized benefit of using local donor organs for local recipients ❖ ICU, Inpatient and Outpatient and waiting time at each location ❖ Tremendous opportunities for “gamesmanship” US Liver Allocation History ❖ 1998 Congressional Final Rule (implemented 2000) ❖ Deemphasize waiting time ❖ Focus on disease severity and mortality risk measured by objective scoring ❖ Geographic sharing over as broad a region as feasible Child-Turcotte-Pugh Score Measure 1 point 2 points 3 points Total bilirubin <2 2-3 >3 Serum Albumin >3.5 2.8-3.5 <2.8 PT / INR <1.7 1.71-2.30 >2.30 Mild Moderate to Severe Grade I-II Grade III-IV (or refractory) Ascites Hepatic encephalopathy None None Child CG, Turcotte JG (1964). "Surgery and portal hypertension". In Child CG. The liver and portal hypertension. Philadelphia: Saunders. pp. 50–64. CTP Score and Survival Points Class 1 Yr Survival 2 Yr Survival 5-6 Points A 100% 85% 7-9 Points B 81% 57% 10-15 Points C 45% 35% Child CG, Turcotte JG (1964). "Surgery and portal hypertension". In Child CG. The liver and portal hypertension. Philadelphia: Saunders. pp. 50–64. Child-Turcotte-Pugh ❖ Weaknesses in allocation ❖ 40% subjective (ascites & encephalopathy) ❖ Bilirubin weak indicator of prognosis in cholestatic liver disease ❖ Unable to categorize patients with preserved liver function (cancer, hepatopulmonary syndrome, hepatorenal syndrome etc.) MELD / PELD Score Allocation ❖ Scoring system developed at Mayo for patients undergoing TIPS procedures MELD Score and Survival Three Month Hospital Mortality 40 or more 71.3% 30-39 52.6% 20-29 19.6% 10-19 6.0% <9 1.9% Wiesner et al. Model for end-stage liver disease (MELD) and allocation of donor livers. Gastroenterology (2003) vol. 124 (1) pp. 91-6. Smith et. al. American Journal of Transplantation 2012; 12: 3191–3212 Adult Liver Allocation http://www.srtr.org/allocationcharts/files/Liver_adult_donor.pdf OPTN / SRTR 2011 Annual Data Report. HHS/HRSA/HSB/DOT. Effect of Allocation Changes ❖ Scoring system entirely objective ❖ Regional sharing for sickest patients ❖ Standard approved exceptions for commonly recognized conditions ❖ Significant waiting time discrepancy remains ❖ Cumbersome approval process for individual patients who don’t meet approved criteria Waiting Time Discrepancies Waiting Time Discrepancies Center Median Time to Transplant (Months) Loyola University Medical Center >72 Northwestern Memorial Hospital 5.6 Rush University Medical Center 5.1 University of Chicago Medical Center 15.4 University of Illinois Medical Center >72 OPTN / SRTR 2011 Center Specific Reports July 2013 HHS/HRSA/HSB/DOT. South Dakota Listed Patients Year Added 2006 2007 2008 2009 2010 2011 2012 2013 Listing Center AZMC-TX1 - Mayo Clinic Hospital 0 0 0 0 0 0 1 0 COPM-TX1 - Centura Porter Adventist Hosp 0 0 0 0 0 0 0 1 COUC-TX1 - University of Colorado Hospital/HSC 1 1 1 2 0 0 0 1 DEAI-TX1 - Alfred I duPont Hospital for Children 0 0 0 0 0 1 0 0 KSUK-TX1 - University of Kansas Hospital 0 0 0 0 0 0 1 0 MNMC-TX1 - Rochester Methodist Hosp- Mayo Clinic 5 4 6 0 8 7 5 9 MNSM-TX1 - St Marys Hospital (Mayo Clinic) 0 0 0 0 1 0 2 1 MNUM-TX1 - Univ. of Minnesota Medical Center 0 0 0 1 4 1 2 4 NEUN-TX1 - The Nebraska Medical Center 3 2 2 8 8 3 7 5 ORUO-VA1 - Portland VA Medical Center 0 0 0 0 2 0 0 0 PACH-TX1 - Children's Hosp of Pittsburgh of UPMC 0 1 0 0 0 0 0 0 PAVA-TX1 - VA Pittsburgh Healthcare System 0 0 0 1 0 1 0 0 TNVU-TX1 - Vanderbilt Univ Med Ctr 0 0 0 0 0 0 1 1 TXMH-TX1 - The Methodist Hospital 0 0 0 0 0 0 1 0 WISL-TX1 - Aurora St. Luke's Medical Center 0 0 0 1 12 11 15 10 Total 9 8 9 13 35 24 35 32 US Liver Transplant Centers ❖ 112 Active adult liver transplant programs in US ❖ Annual transplant procedures range from 5 - 170 / yr ❖ 51 of 112 perform 35 or less procedures / yr ❖ Median annual volume 41 transplants Conclusions ❖ Liver transplantation offers excellent benefit to patients with end stage liver disease ❖ Allocation of deceased donor livers has evolved to a more equitable system ❖ Dramatic waiting time discrepancies will exist regardless of future allocation changes ❖ Center and patient differences will never be completely eliminated