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).

Impact of COVID-19 crisis on disparities in living kidney donation in the US

Purpose: The COVID-19 pandemic resulted in a dramatic decrease in living kidney donation (LKD) in the U.S. This study investigated the effect of the COVID crisis on characteristics of LKD recipients in the U.S. Methods: We used OPTN transplant and LKD data to compare proportions of LKD recipients' race, SES (neighborhood income), sex, dialysis status, age, and recipient/ donor sex match during 3 eras: Pre-COVID (1/1/20-3/12/20, n=1294);COVID Shutdown (3/13/20-5/9/20, n=173);and COVID Stabilization (5/10/20-11/15/20, n=2331;Table 1). Results: Contrary to our expectations, LKD recipients' race, neighborhood income, and dialysis status at transplant did not differ by era (Figure 1a-c;Table 2). We did, however, find a significant relationship between recipient sex and era, with a higher proportion of male recipients in the COVID Shutdown and COVID Stabilization eras than in the Pre-COVID era (Figure 1d). We found a related significant association between recipient/donor sex match and era, with a higher proportion of male-recipient/female-donor transplants and a lower proportion of female-recipient/ female-donor transplants in the COVID Shutdown and COVID Stabilization eras than in the Pre-COVID era (Figure 1e). There was a marginally significant relationship between recipient age at transplant and era, with a higher proportion of younger recipients in the COVID Shutdown era than in the Pre-COVID and COVID Stabilization eras (Figure 1f). Conclusions: While we did not find expected differences in areas of current disparities such as LKD recipient race or SES, we did find that the drop in living donation caused by the COVID crisis exacerbated previously existing disparities in recipient sex and recipient/donor sex match, suggesting that COVID has not had an equal effect on all candidates. (Table Presented).

Disparities in living donor follow-up during the COVID-19 emergency suspension of optn follow-up reporting requirements

Purpose: The OPTN temporarily suspended follow-up reporting requirements on 4/3/20 (retroactive to 3/13/20) in response to the COVID-19 crisis. We assessed the policy's impact on living donor follow-up form (LDF) and lab data submission for donors who have historically been disadvantaged in the transplant system. Methods: We analyzed OPTN data as of 1/22/20 for all 6-, 12-, and 24-month LDFs expected between 3/13/20-12/31/20 (“COVID”) vs 3/13/19-12/31/19 (“pre-COVID”). We assessed status of COVID forms by donor demographics. We also compared proportions of validated forms with complete lab data by era and donor demographics. Results: 15.6% of kidney and 10.8% of liver LDFs were in amnesty status, with substantial variation by center. Kidney: We found significant differences in form status by race/ethnicity (p<0.001), gender (p=0.007), age group (p<0.001), neighborhood income quartile (p=0.001), and relationship to recipient (p<0.001), with greater proportions of forms in amnesty status for Black (Black: 19.3%;White: 15.6%;Hispanic: 13.7%;Other: 14.6%), male (male: 16.7%;female: 15.0%), younger (age 18-34: 16.9%;35-49: 16.4%;50-64: 13.9%;65+: 13.7%), lower-income (Q1: 18.3%;Q2: 15.6%;Q3: 15.9%;Q4: 14.6%), biologically related and paired donors (biologically related: 16.8%;paired: 17.6%;spousal: 12.1%;unrelated: 14.5%) (Table 1). Liver: Younger donors had greater proportions of forms in amnesty status (age 18-34: 12.9%;35-49: 10.0%;50-64: 6.4%;p=0.056). Pre-COVID demographic differences in forms with complete lab data persisted during COVID, compounded by amnesty forms (Figure 1). Conclusions: Centers have voluntarily submitted over 80% of expected LDFs under this emergency policy. However, our finding that a disproportionate number of forms are missing for donors who are Black, male, younger, lower SES, and biological relatives of their recipient is concerning. These groups are at greater risk of long-term complications after donation, and may have limited access to health services during the pandemic and risk being lost to follow-up. Centers should consider targeted follow-up efforts for at-risk groups. (Table Presented).