American Journal of Transplantation 2015; 15: 581–582 Wiley Periodicals Inc.
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Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons doi: 10.1111/ajt.13102
Editorial
Share 35: A Liver in Time Saves Lives? S. Feng1,* and J. O’Grady2 1
University of California San Francisco, San Francisco, CA King’s College, London, UK Corresponding author: Sandy Feng, [email protected] 2
Received 15 October 2014, revised and accepted for publication 30 October 2014 Redesigning allocation policy for deceased donor livers is typically perceived as a zero sum game in that one’s gain is exactly balanced by another’s loss. As such, change in policy always generates heated controversy, with disagreements beginning with the guiding principles and ending with the specific provisions. In the United States, organ allocation policy serves administrative law embodied in The Final Rule (Code of Federal Regulations, Title 42, Part 121.8) that mandates ‘‘equitable allocation of organs among patients from most to least medically urgent’’ and ‘‘distributing organs over as broad a geographic area as feasible.’’ Adoption of the Model for End-stage Liver Disease (MELD) score in 2002 accomplished objective and transparent ordering of waitlisted candidates according to disease severity. However, the wide variation of MELD scores required to access a deceased donor liver and the concomitant disparities in waitlist mortality among different units of organ allocation clearly evidence uncomfortable geographic inequities. In June 2010, the United Network for Organ Sharing (UNOS) Board of Directors charged the Liver and Intestine Committee to reduce geographic disparities in waitlist mortality. The ‘‘Share 35’’ policy that emerged was approved and implemented in June 18, 2013, mandating that deceased donor livers are offered to regional candidates with MELD 35 before local candidates with MELD 30 candidates without an increase in mortality for AMELD 30 candidates. No change was detected in median length of stay or early posttransplant mortality rates. Lastly, crude overall mortality rates for waitlisted candidates decreased from 17.1 to 15.4 deaths per 100 person-years with Share 35. Overall mortality adjusted for baseline MELD dropped by 6% but this did not meet statistical significance. In broad strokes, based on the data provided in this timely manuscript, the Share 35 allocation policy appears to have achieved its goals. Share 35 directed deceased donor livers to those in greatest need—transplant candidates based on disease severity and OPOs based on relative organ availability. A positive and perhaps unexpected outcome was the increase in the number of transplants along with improved organ utilization/organ discard metrics. Redesigning allocation policy can precipitate practice changes that convert a zero-sum to a positive sum game. In the same vein, more waitlisted lives saved was not negated by more transplanted lives lost—another apparent gain. However, comparable short-term outcomes may not translate into comparable mid- or long-term outcomes, as effectively illustrated by the latest outcome analysis relative to the 2005 implementation of the lung allocation score (LAS) policy. Comparison of post- to pre-LAS cohorts shows comparable 1-year survival but significantly inferior 1-year conditional survival (2). A good start is, however, no more than half the battle! An in-depth assessment focused on utility, efficiency and cost 581
Feng and O’Grady
should follow this initial encouraging report to delineate the price that has been paid for broader sharing. Regional sharing leads to livers crisscrossing that consume resources without necessarily yielding incremental benefit. Median cold ischemia times are unlikely to detect meaningful differences. Broader access to livers will bestow top-ranking candidate(s) with multiple offers. Simultaneous acceptances hold livers hostage, creating system inefficiencies to the potential detriment of other candidates. Although median length of stay did not escalate, this metric is blunt. Finally, the fact remains that for every two transplants performed, one waitlisted candidate died (5660 and 3002, respectively in 2012) (3). There is clearly more work to be done. Looking beyond data, if that is possible, we strongly commend the prompt, detailed, and comprehensive scrutiny that the Share 35 policy is receiving from the liver transplant community. In addition to the beginnings of a vigorous print dialogue (1,4), the OPTN/UNOS Liver and Intestinal Committee held a public forum on September 16, 2014 in Chicago, IL. These interchanges highlight the iterative process by which allocation policy evolves—a never-ending circle of analysis and refinement aiming to
582
edge ever closer to the best possible embodiment of the principles that necessarily dictate the policy.
Disclosure The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation.
References 1. Massie AB, Chow EKH, Wickliffe CE, et al. Early changes in liver distribution following implementation of Share 35. Am J Transplant 2015; 15: 659–667. 2. Maxwell BG, Levitt JE, Goldstein BA, et al. Impact of the lung allocation score on survival beyond 1 year. Am J Transplant 2014; 14: 2288–2294. 3. Kim WR, Smith JM, Skeans MA, et al. OPTN/SRTR 2012 annual data report: Liver. Am J Transplant 2014; 14 (S1): 69–96. 4. Gentry SE, Chow EK, Wickliffe CE, et al. Impact of broader sharing on the transport time for deceased donor livers. Liver Transpl 2014; 20: 1237–1243.
American Journal of Transplantation 2015; 15: 581–582
Copyright of American Journal of Transplantation is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
C
Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons doi: 10.1111/ajt.13102
Editorial
Share 35: A Liver in Time Saves Lives? S. Feng1,* and J. O’Grady2 1
University of California San Francisco, San Francisco, CA King’s College, London, UK Corresponding author: Sandy Feng, [email protected] 2
Received 15 October 2014, revised and accepted for publication 30 October 2014 Redesigning allocation policy for deceased donor livers is typically perceived as a zero sum game in that one’s gain is exactly balanced by another’s loss. As such, change in policy always generates heated controversy, with disagreements beginning with the guiding principles and ending with the specific provisions. In the United States, organ allocation policy serves administrative law embodied in The Final Rule (Code of Federal Regulations, Title 42, Part 121.8) that mandates ‘‘equitable allocation of organs among patients from most to least medically urgent’’ and ‘‘distributing organs over as broad a geographic area as feasible.’’ Adoption of the Model for End-stage Liver Disease (MELD) score in 2002 accomplished objective and transparent ordering of waitlisted candidates according to disease severity. However, the wide variation of MELD scores required to access a deceased donor liver and the concomitant disparities in waitlist mortality among different units of organ allocation clearly evidence uncomfortable geographic inequities. In June 2010, the United Network for Organ Sharing (UNOS) Board of Directors charged the Liver and Intestine Committee to reduce geographic disparities in waitlist mortality. The ‘‘Share 35’’ policy that emerged was approved and implemented in June 18, 2013, mandating that deceased donor livers are offered to regional candidates with MELD 35 before local candidates with MELD 30 candidates without an increase in mortality for AMELD 30 candidates. No change was detected in median length of stay or early posttransplant mortality rates. Lastly, crude overall mortality rates for waitlisted candidates decreased from 17.1 to 15.4 deaths per 100 person-years with Share 35. Overall mortality adjusted for baseline MELD dropped by 6% but this did not meet statistical significance. In broad strokes, based on the data provided in this timely manuscript, the Share 35 allocation policy appears to have achieved its goals. Share 35 directed deceased donor livers to those in greatest need—transplant candidates based on disease severity and OPOs based on relative organ availability. A positive and perhaps unexpected outcome was the increase in the number of transplants along with improved organ utilization/organ discard metrics. Redesigning allocation policy can precipitate practice changes that convert a zero-sum to a positive sum game. In the same vein, more waitlisted lives saved was not negated by more transplanted lives lost—another apparent gain. However, comparable short-term outcomes may not translate into comparable mid- or long-term outcomes, as effectively illustrated by the latest outcome analysis relative to the 2005 implementation of the lung allocation score (LAS) policy. Comparison of post- to pre-LAS cohorts shows comparable 1-year survival but significantly inferior 1-year conditional survival (2). A good start is, however, no more than half the battle! An in-depth assessment focused on utility, efficiency and cost 581
Feng and O’Grady
should follow this initial encouraging report to delineate the price that has been paid for broader sharing. Regional sharing leads to livers crisscrossing that consume resources without necessarily yielding incremental benefit. Median cold ischemia times are unlikely to detect meaningful differences. Broader access to livers will bestow top-ranking candidate(s) with multiple offers. Simultaneous acceptances hold livers hostage, creating system inefficiencies to the potential detriment of other candidates. Although median length of stay did not escalate, this metric is blunt. Finally, the fact remains that for every two transplants performed, one waitlisted candidate died (5660 and 3002, respectively in 2012) (3). There is clearly more work to be done. Looking beyond data, if that is possible, we strongly commend the prompt, detailed, and comprehensive scrutiny that the Share 35 policy is receiving from the liver transplant community. In addition to the beginnings of a vigorous print dialogue (1,4), the OPTN/UNOS Liver and Intestinal Committee held a public forum on September 16, 2014 in Chicago, IL. These interchanges highlight the iterative process by which allocation policy evolves—a never-ending circle of analysis and refinement aiming to
582
edge ever closer to the best possible embodiment of the principles that necessarily dictate the policy.
Disclosure The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation.
References 1. Massie AB, Chow EKH, Wickliffe CE, et al. Early changes in liver distribution following implementation of Share 35. Am J Transplant 2015; 15: 659–667. 2. Maxwell BG, Levitt JE, Goldstein BA, et al. Impact of the lung allocation score on survival beyond 1 year. Am J Transplant 2014; 14: 2288–2294. 3. Kim WR, Smith JM, Skeans MA, et al. OPTN/SRTR 2012 annual data report: Liver. Am J Transplant 2014; 14 (S1): 69–96. 4. Gentry SE, Chow EK, Wickliffe CE, et al. Impact of broader sharing on the transport time for deceased donor livers. Liver Transpl 2014; 20: 1237–1243.
American Journal of Transplantation 2015; 15: 581–582
Copyright of American Journal of Transplantation is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
