Temporal Trends of Optn Hope Act Variance Participation

Purpose: The Organ Procurement and Transplantation Network (OPTN) created a research variance allowing for transplantation of HIV+ donor kidneys and livers into HIV+ recipients after passage of the HIV Organ Policy Equity (HOPE) Act legislation in 2013 and subsequent published research criteria in November 2015. In May 2020 the OPTN modified the variance to include all solid organs. Method(s): The OPTN database was used to analyze temporal trends in waiting list registrations, HIV+ donors, HOPE transplant recipients, and program participation in the OPTN HOPE Act variance. HIV+ donors were identified through HIV serology/ NAT fields collected by the OPTN;recipients of these organs are HOPE recipients. Result(s): Transplant program participation saw consistent growth but has remained stable for the two years (Fig A). Despite this, patient demand for HOPE kidneys has been simultaneously declining, perhaps driven by a decline in listings related to Hypertensive Nephrosclerosis and DM Type II (listings for HIV Nephropathy remained stable), while liver demand remains low but stable (Fig B). Concurrently, there has been a consistent volume of recovered HIV+ donors and organs transplanted (Fig C, D). Transplant volume recently exceeded 300 organs transplanted (300 deceased donor, 3 living donor), largely driven by kidney (236 kidney, 67 liver;11 SLK) from 187 recovered HIV+ donors. Living donation of HIV+ organs remains limited to kidney. Among HIV+ deceased donors, the kidney discard rate was 32% while the liver discard rate was 4%. Twenty-nine recovered deceased donors had no organs transplanted, and associated common discard reasons for these donors were exhausted match runs and biopsy findings. Conclusion(s): The OPTN database does not include HIV status at listing;therefore, the decline in demand cannot be attributed to potential access changes for HIV+ patients, but may be related to the impacts of the COVID-19 pandemic. The impacts of the COVID-19 pandemic have not noticeably affected HOPE Act transplant volumes, highlighting the resiliency of the US transplant system. Based on consistent activity and positive data and safety analyses through five years, the OPTN recommended removal of the research criteria as a potential barrier to expanded utilization of the HOPE Act to HHS, in turn making HIV-to-HIV transplantation standard of care;the result of that recommendation is pending. (Figure Presented).

Center Variation is the Major Driver of Geographic Disparities in Access to Kidney Transplants Among Waitlisted Candidates

Purpose: The OPTN's monitoring of equity in access to deceased donor kidney (KI) transplants (tx) among waitlisted candidates has consistently found service area (DSA) of listing as the factor most independently associated with access disparities. We extracted center-level from DSA-level effects to better characterize geographic disparities in the COVID-19 and KAS 250NM circle eras. Method(s): Poisson tx rate regression, with random DSA and center effects, was applied to 3 period-prevalent cohorts (KAS: 2018-2019;KAS COVID Onset: 1/2020-3/2021;KAS250: 4/2021-9/2021) of active KI waiting list registrations using OPTN data. Risk-adjusted, population-weighted, factor-specific disparities were quantified as the Winsorized standard deviation (SDw) of log(tx rate) among registrations, holding other factors constant. Geographic disparity was also quantified by median incidence rate ratios (MIRR), interpreted as the median increase in tx rate if a candidate switched to a random, higher tx rate center or DSA. The association between donor supply to demand ratios (S/D;# deceased kidney donors / # prevalent WL candidates) and residual (after removing center effects) DSA effects was assessed with Spearman's rho. Result(s): Pre-COVID, variation in tx rates was markedly higher for centers (MIRR 1.72) vs. DSAs (MIRR 1.32). Under COVID, center-level MIRR rose to 1.94 and has remained high. The DSA-level MIRR fell to 1.20 in the early KAS250 era (Fig 1). As measured by population-weighted SDw, tx center (0.62) is the factor most associated with unintended disparities in the KAS250 era, with residual DSA-level variation (0.25) ranked 4th (Fig 2). Residual DSA effects were positively correlated (rho=0.55, p<0.001) with local S/D. Conclusion(s): DSA-level variation declined under KAS250, but disparities remain and are associated with differential local S/D. Tx center-level variation is the top driver of access disparities and may have been exacerbated by COVID. Further reductions in geographic disparities may be possible through allocation policy changes, although other interventions - such as reducing center variation in offer acceptance decisions and maximizing the recovery of potential deceased donors - may have greater impacts.

Prevalence and Characteristics of Covid-19-Associated Pulmonary Diagnoses in Lung Transplant Patients in the United States

Purpose: Lung transplant may be a viable treatment option for select patients with non-recoverable COVID-19-associated acute respiratory distress syndrome (ARDS) and COVID-19-associated pulmonary fibrosis. This study aims to characterize the utilization and outcomes of lung transplant among patients with COVID-19- associated ARDS and pulmonary fibrosis. Method(s): We analyzed the Organ Procurement Transplant Network database to characterize the prevalence and characteristics of patients with COVID-19-associated ARDS and pulmonary fibrosis who were added to the waiting list and/or received a lung transplant between March 13, 2020 and July 31, 2021. Result(s): We found that 207 lung candidate registrations were added to the waiting list and 182 lung transplants were conducted for patients with COVID-19-associated ARDS or pulmonary fibrosis. The majority of lung candidates and lung transplant recipients with COVID-19-associated diagnoses were male, had private insurance, were disproportionately Hispanic and had a higher lung allocation scores (LAS) compared to patients with non-COVID-19 diagnoses. There was no significant difference in 30-day post-transplant survival among recipients with COVID-19- associated diagnoses compared to non-COVID-19 diagnoses. Conclusion(s): Future research on post-transplant outcomes among lung transplant recipients with COVID-19-associated diagnoses is warranted. Further study of outcomes may assist in refining the appropriate LAS waitlist mortality and posttransplant survival scoring for these patients. (Figure Presented).

18 Month Review of Liver Acuity Circles Allocation

Purpose: Acuity circles (AC) allocation was implemented on 2/4/2020 with a goal of removing DSA and region from liver allocation and broadening the distribution of livers, particularly for highly medically urgent candidates. Method(s): OPTN waitlist and transplant data was analyzed 18 months pre- (8/6/2018- 2/3/2020) and post- (2/4/2020-8/3/2021) AC implementation. Result(s): Post-policy, there were 448 more adult (age 18+ at listing) and 83 less pediatric (<18 at listing) waitlist additions, 570 more adult (age 18+ at transplant) and 4 less pediatric (<18 at transplant) deceased donor liver-alone transplants, and 121 less adult and 12 less pediatric removals for death or too sick. Transplant rates significantly increased overall post-policy, notably in the most medically urgent groups (Figure 1). The national median transplant score for adults remained unchanged at 28 and decreased from 35 to 30 for pediatric transplant recipients, likely due to the increased number of adolescents (age 12-17) transplanted at MELD scores under 29. There was a noticeable shift in the distribution of distance between donor hospital and transplant program, particularly for the most medically urgent groups where larger proportions of livers are coming from 250-500 NMs (Figure 2). Despite this change, median cold ischemia time increased only 11 minutes for adult recipients and 33 minutes for pediatric recipients post-policy. One year post transplant patient survival decreased from 94% pre-policy to 93% post-policy (p=0.02). Conclusion(s): Broader allocation increased transplant rates and livers are traveling longer distances for candidates with greater medical urgency with little effect on cold ischemia time and post-transplant survival. Unfortunately, AC implementation was followed shortly by COVID-19 making it difficult to parse out COVID-19 from potential policy effects. Metrics will continue to be monitored as more data become available. (Figure Presented).

Data quality and monitoring completion rates are similar between clinic-applied and self-applied continuous ECG monitoring patches prior to and during COVID-19

Introduction: Prior to COVID-19, ECG patches (ECGp) were applied almost exclusively in-clinic (CA) by technicians which required an office visit and fee. Since the pandemic, direct-to-patient, self-applied patch use (SA) has substantially increased, though the metrics surrounding SA are unknown. This study compares monitoring completion rates and data quality between CA and SA ECGp prior to and during COVID-19. Hypothesis: CA and SA ECGp have similar data quality and monitoring completion metrics. Methods: We performed a retrospective cohort analysis of patients prescribed an iRhythm Zio XT patch at Northwestern Memorial Hospital during the “pre-COVID” (3/1/2019-3/1/2020) and “COVID” (4/1/2020-4/1/2021) timeframes. Differences in ECGp with data available, actual vs prescribed wear time, and analyzable data between groups were assessed. ECGp without data was defined as devices which were not returned or not activated. Results: The cohort included 29,118 ECGp prescriptions;13,180 pre-COVID (45%). The cohort was 56% female with mean age of 59.3 + 17.7 years. Palpitations (29%) and atrial fibrillation (19%) were the most common indications. In the pre-COVID cohort, there were no (0%) SA ECGp and data were available for 12,932 CA patches. In the COVID cohort, 34% of ECGp were SA;data were available for 10,231 CA ECGp and 4,902 SA ECGp. Average delay between prescription and SA ECGp activation was 8.1 ± 12.2 days. Comparisons between percent analyzable data, wear times, and ECGp with data available are shown in figure 1. Conclusions: COVID-19 resulted in a rapid adoption of SA ECGp use. Compared to CA, SA was associated with an inherent delay in ECGp application and a higher proportion of ECGp without data. However, there was no difference in actual vs prescribed wear time and a small but statistically significant decrease in percent analyzable data. These differences must be balanced with the additional cost and need for in-person visit for CA vs SA. (Figure Presented).

Summary of the OPTN's policy and system modifications in response to the COVID-19 pandemic

Purpose: In April 2020, the OPTN made several policy and system modifications in response to the growing COVID-19 pandemic including updates to candidate lab data, relaxing data submission requirements, incorporation of donor COVID-19 infectious disease testing, and the addition of new COVID-19 specific offer refusal and candidate cause of death codes. The changes were intended to reduce institutional burden in a time of unprecedented challenge to the US healthcare system and to protect transplant candidates/recipients from unnecessary potential COVID-19 exposure. Methods: OPTN candidate, donor, and recipient data was analyzed by week from March-November 8, 2020. Results: The percent of candidates that appeared to carry labs forward to maintain waiting list status has been low and varied by organ and candidate age group (0-17% in any given week). The number and percent of TRF and LDF forms in amnesty status at form due date has grown since policy implementation, remaining at ∼25- 30%, and varied by OPTN Region and organ. There continues to be a decline in the percent of matches with at least one COVID-19 refusal reason for all organs from a peak of over 60% in March to <20% in November. The proportion of COVID-19 related waiting list deaths among all reported deaths was highest for kidney, and decreased from a high of 26% in mid-April to an average of 6% per week in October. All OPOs that recovered deceased donors reported COVID-19 donor testing results through the optional donor infectious disease fields in DonorNet or via free response donor text fields or attachments. At the time of this analysis, no donors with a known active COVID-19 infection were transplanted. Conclusions: As the COVID-19 pandemic continues to evolve, the OPTN Executive Committee has been committed to monitoring the usage and impact of these modifications and is weighing committee feedback and public comment responses in determining a path forward. There was broad support from the community during public comment to maintain these changes until the healthcare system is able to resume normal operations despite concerns regarding missing data from follow-up forms in amnesty status. There continues to be remarkable transplant community involvement in responding to the evolving challenges faced by the nation's healthcare system. (Table Presented).

Equity in access to kidney transplants by race/ethnicity in the COVID-19 era

Purpose: The direct impact of the COVID-19 pandemic on minority populations has been well documented, and it is conceivable that disparities in access to kidney transplants by race and ethnicity have been exacerbated during the pandemic. Barriers to transplant may have emerged due to concerns about increased susceptibility to COVID-19 among racial/ethnic minorities. Methods: We examined quarterly trends in deceased donor kidney transplants per patient-year on the waiting list over time (1/2017-9/2020) among 4 major racial/ ethnic groups (White;Black;Hispanic;Asian). Unadjusted and adjusted Poisson regressions were used to estimate transplant rates pre-COVID-19 (1/2019-3/2020) and during COVID-19 (4/2020-9/2020). In addition to race/ethnicity, adjusted models included 17 factors such as blood type, CPRA, age, gender, diagnosis, and transplant center. Median KDPI was calculated among recipients. Results: For all 4 racial/ethnic groups, transplant rates rose steadily prior to COVID- 19, declined initially during the pandemic, and rebounded sharply in Jul-Sep '20. However, the decline was sharpest for Hispanic candidates, and the COVID-19-era rebound was greatest for White and Asian candidates (Fig 1). Relative to Whites, the transplant incidence rate ratio (IRR) declined in the COVID- 19 era for minorities (race by era interaction, p=0.0006, Fig 2a). Racial/ethnic transplant rate differences, and the race by era interaction, were both substantially attenuated in risk-adjusted modeling (Fig 2b). Median KDPI remained unchanged or improved during the pandemic for both White and minority recipients. Conclusions: Remarkably, the overall transplant rate surpassed pre-pandemic levels, as the transplant community has adapted remarkably well to the pandemic. But early COVID-19-era data suggest racial/ethnic disparities may have increased, particularly for Hispanic candidates. As the community continues to adapt and plan for the possibility of further pandemic impact, practices to ensure safe and equitable access to transplantation for vulnerable groups should be further developed and disseminated. (Table Presented).

E-learning Practice at Medical Universities in Poland in the Perspective of the SARS-CoV-2 Pandemic

The epidemiological situation resulting from the SARS-CoV-2 pandemic caused the Polish universities to fully switch to distance education in March 2020. Medical e-learning has not yet been broadly implemented into the education process. Therefore, examples of successful e-learning implementations or the organization of the process of medical e-learning offer a valuable source of knowledge today, which is needed immediately. The article presents e-learning practices at the Polish medical universities during the SARS-CoV-2 epidemic during the period from March to September 2020, covering seven universities in Poland that offer medical and health studies. The organization and implementation of e-learning classes is presented, including knowledge evaluation practices, providing example decisions issued by university rectors, on which the teaching process was based. A detailed presentation of the schools' organizational units or workgroups that played an important role in the process of coordination of measures supporting e-education is also included. The article also presents a description of the software applications, utilities, and services used at the schools in the course of the process of online education. Below are some examples of specific such implementations in selected university courses. © 2020 Piotr K. Leszczyński et al., published by Sciendo.