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• W1489746467 abstract "Although the initial experience with Share 35 liver allocation has enhanced regional sharing for sick liver transplant candidates while increasing organ utilization and national transplant volume, potential costs with regard to system efficiency and the impact on mid- to long-term posttransplant outcomes remain to be delineated. See article by Massie et al on page 659. Although the initial experience with Share 35 liver allocation has enhanced regional sharing for sick liver transplant candidates while increasing organ utilization and national transplant volume, potential costs with regard to system efficiency and the impact on mid- to long-term posttransplant outcomes remain to be delineated. See article by Massie et al on page 659. 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 <35. Massie et al now report multiple outcomes observed during the first 12 months under the new policy, compared to the 12 months immediately preceding (1.Massie AB Chow EKH Wickliffe CE Early changes in liver distribution following implementation of Share 35.Am J Transplant. 2015; 15 (et al): 659-667Abstract Full Text Full Text PDF PubMed Scopus (97) Google Scholar). Comparison of the pre- and post-Share 35 study periods showed no significant changes in waitlist numbers or characteristics such as the median MELD at initial listing or the number of MELD ≥35 listing. Liver quality, as assessed by the donor risk index (DRI), was stable. As would reasonably be expected, regional liver allocation increased significantly (19.1–30.7%; p < 0.001) with corresponding increases, in median transport distance and time (30 miles and 0.37 hours, respectively) but cold ischemia time was unaffected. Importantly, crude organ discard rates decreased (10.9–9.8%; p = 0.046) and the likelihood of organ discard, adjusted for DRI, dropped (odds ratio 0.780.880.99, p = 0.04). Nationally, the absolute number, relative proportion and transplant rate of candidates with allocation MELD (AMELD) ≥35 increased. Transplant rates for the highest AMELD candidates increased steeply for organ procurement organizations (OPOs) with low organ availability and decreased for OPOs with high organ availability. In spite of these leveling changes, transplant rates for the sickest candidates remained highest in high organ availability OPOs, evidencing the magnitude of the pre-existing inequities. In analyses accounting for the competing risk of transplantation and adjusted for AMELD, overall waitlist mortality fell by 8% (sub-hazard ratio [SHR] 0.870.920.97, p = 0.03). Waitlist mortality fell steeply (30%; SHR 0.590.700.83, p < 0.001) for AMELD >30 candidates without an increase in mortality for AMELD ≤30 candidates. No change was detected in median length of stay or early post-transplant 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. Re-designing 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.Maxwell BG Levitt JE Goldstein BA Impact of the lung allocation score on survival beyond 1 year.Am J Transplant. 2014; 14 (et al): 2288-2294Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar). A good start is, however, no more than half the battle! An in-depth assessment focused on utility, efficiency and cost 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.Kim WR Smith JM Skeans MA OPTN/SRTR 2012 annual data report: Liver.Am J Transplant. 2014; 14 (et al): 69-96Abstract Full Text Full Text PDF PubMed Scopus (170) Google Scholar). 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.Massie AB Chow EKH Wickliffe CE Early changes in liver distribution following implementation of Share 35.Am J Transplant. 2015; 15 (et al): 659-667Abstract Full Text Full Text PDF PubMed Scopus (97) Google Scholar, 4.Gentry SE Chow EK Wickliffe CE Impact of broader sharing on the transport time for deceased donor livers.Liver Transpl. 2014; 20 (et al): 1237-1243Crossref PubMed Scopus (34) Google Scholar), 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 edge ever closer to the best possible embodiment of the principles that necessarily dictate the policy. The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation." @default.
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• W1489746467 title "Share 35: A Liver in Time Saves Lives?" @default.
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