A national assessment of one-year heart outcomes after the 2018 adult heart allocation change.

PURPOSE: On 10/18/2018 the Organ Procurement and Transplantation Network (OPTN) implemented modifications to adult heart allocation to better stratify the most medically urgent candidates by WL mortality. This paper reviews two years of post-policy monitoring with focus on post-transplant outcomes, especially for recipients with MCSDs. METHODS: Cohorts of WL additions and recipients pre (10/18/16-10/17/18) and post (10/18/18-10/17/20) policy implementation were compared using the OPTN database. Competing risks analyses of waitlist mortality and Kaplan-Meier one-year post-transplant survival were performed by medical urgency statuses and policy era. Similar analyses were performed for subsets of candidates and recipients on devices. RESULTS: Pre-implementation status 1A candidates had the highest cumulative incidence of removal from the waitlist due to death or too sick to transplant and the highest cumulative incidence of transplant, followed by statuses 1B and 2. Median time to transplant decreased from 226 to 85 days for those transplanted. There was no difference in one-year patient survival (pre=91.3% [90.2, 92.4]; post=91.8% [90.8, 92.9]; p=0.44) overall, or for recipients transplanted with an LVAD (pre=91.7% [90.1, 93.2]; post=91.4% [89.7, 93.2]; p=0.85) or IABP (pre=91.7% [88.1, 95.4]; post=92.1% [90.1, 94.0]; p=0.92). CONCLUSION: The policy improved stratification of the most medically urgent candidates according to risk of death on the WL with decreased median wait times, higher transplant rates and no observed adverse effect on 1-year patient survival. No adverse effects for candidates listed or transplanted on IABP, ECMO, or LVAD were observed.

Ethics-by-design: efficient, fair and inclusive resource allocation using machine learning.

The distribution of crucial medical goods and services in conditions of scarcity is among the most important, albeit contested, areas of public policy development. Policymakers must strike a balance between multiple efficiency and fairness objectives, while reconciling disparate value judgments from a diverse set of stakeholders. We present a general framework for combining ethical theory, data modeling, and stakeholder input in this process and illustrate through a case study on designing organ transplant allocation policies. We develop a novel analytical tool, based on machine learning and optimization, designed to facilitate efficient and wide-ranging exploration of policy outcomes across multiple objectives. Such a tool enables all stakeholders, regardless of their technical expertise, to more effectively engage in the policymaking process by developing evidence-based value judgments based on relevant tradeoffs.

Do Organizational Characteristics of Lung Procurement Operations Matter: The Association Between Transplant Center Centrality and Volume With Total Ischemic Time.

BACKGROUND: To understand the association of 2 organizational characteristics of transplant center (TXC), volume and closeness centrality, with total ischemic time for deceased donor lung transplants in conjunction with the removal of donation service area (DSA) lung allocation policy. The organization of donor procurements has received increased attention since DSA was removed from allocation policy. Consistent with network theories of organization, organizational characteristics of a TXC could affect procurement efficiency, as volume and closeness centrality (measuring how connected a TXC is within the Organ Procurement and Transplantation Network) could be associated with total ischemic time. These associations could have changed because of the removal of DSA from allocation policy. METHODS: We conducted a retrospective, pooled cross-sectional study of total ischemic time for nonperfused deceased donor lung transplants (n = 9281) between 2015 and 2019, using within-between regression. RESULTS: Higher volume TXCs exhibited lower total ischemic times after the removal of DSA from lung allocation policy (P = 0.011); however, all TXCs that had increased volumes, after the removal of DSA from lung allocation policy, exhibited higher levels of total ischemic time (P ≤ 0.001). Before the removal of DSA, TXCs that had increased volumes exhibited lower levels of ischemic time (P ≤ 0.001). Both within and between closeness centrality exhibited u-shaped associations with total ischemic time (P = 0.012; P = 0.006) and the effect of closeness centrality on total ischemic time was different after DSA removal (P < 0.001). CONCLUSIONS: Organizational characteristics were associated with the efficiency of deceased organ procurements. The effects on total ischemic time were dependent on whether DSA was used for lung allocation.

The Lung Allocation Score and Its Relevance.

Lung transplantation in the United States, under oversight by the Organ Procurement Transplantation Network (OPTN) in the 1990s, operated under a system of allocation based on location within geographic donor service areas, wait time of potential recipients, and ABO compatibility. On May 4, 2005, the lung allocation score (LAS) was implemented by the OPTN Thoracic Organ Transplantation Committee to prioritize patients on the wait list based on a balance of wait list mortality and posttransplant survival, thus eliminating time on the wait list as a factor of prioritization. Patients were categorized into four main disease categories labeled group A (obstructive lung disease), B (pulmonary hypertension), C (cystic fibrosis), and D (restrictive lung disease/interstitial lung disease) with variables within each group impacting the calculation of the LAS. Implementation of the LAS led to a decrease in the number of wait list deaths without an increase in 1-year posttransplant survival. LAS adjustments through the addition, modification or elimination of covariates to improve the estimates of patient severity of illness, have since been made in addition to establishing criteria for LAS value exceptions for pulmonary hypertension patients. Despite the success of the LAS, concerns about the prioritization, and transplantation of older, sicker individuals have made some aspects of the LAS controversial. Future changes in US lung allocation are anticipated with the current development of a continuous distribution model that incorporates the LAS, geographic distribution, and unaccounted aspects of organ allocation into an integrated score.

Navigating the COVID-19 pandemic: Initial impacts and responses of the Organ Procurement and Transplantation Network in the United States.

COVID-19 has been sweeping the globe, hitting the United States particularly hard with a state of emergency declared on March 13, 2020. Transplant hospitals have taken various precautions to protect patients from potential exposure. OPTN donor, candidate, and transplant data were analyzed from January 5, 2020 to September 5, 2020. The number of new waiting list registrations decreased, with the Northeast seeing over a 50% decrease from the week of 3/8 versus the week of 4/5. The national transplant system saw near cessation of living donor transplantation (-90%) from the week of 3/8 to the week of 4/5. Similarly, deceased donor kidney transplant volume dropped from 367 to 202 (-45%), and other organs saw similar decreases: lung (-70%), heart (-43%), and liver (-37%). Deceased donors recovered dropped from 260 to 163 (-45%) from 3/8 compared to 4/5, including a 67% decrease for lungs recovered. The magnitude of this decrease varied by geographic area, with the largest percent change (-67%) in the Northeast. Despite the pandemic, discard rates across organ has remained stable. Although the COVID-19 pandemic continues to evolve, OPTN data show recent evidence of stabilization, an indication that an early recovery of the number of living and deceased donors and transplants has ensued.

A change of heart: Preliminary results of the US 2018 adult heart allocation revision.

In 2018, the Organ Procurement and Transplantation Network (OPTN) modified adult heart allocation to better stratify candidates and provide broader access to the most medically urgent candidates. We analyzed OPTN data that included waiting list and transplant characteristics, geographical distribution, and early outcomes 1 year before (pre: October 18, 2017-October 17, 2018) and following (post: October 18, 2018-October 17, 2019) implementation. The number of adult heart transplants increased from 2954 pre- to 3032 postimplementation. Seventy-eight percent of transplants in the post era were for the most medically urgent (statuses 1-3) compared to 68% for status 1A in the pre era. The median distance between the donor hospital and transplant center increased from 83 to 216 nautical miles, with an increase in total ischemic time from 3 to 3.4 hours (all P < .001). Waiting list mortality was not different across eras (14.8 vs 14.9 deaths per 100 patient-years pre vs post respectively). Posttransplant patient survival was not different, 93.6% pre and 92.8% post. There is early evidence that the heart allocation policy has enhanced stratification of candidates by their medical urgency and broader distribution for the most medically urgent candidates with minimal impact on overall waiting list mortality and posttransplant outcomes.