Donor Derived Transmissions 2020: Analysis of the OPTN Ad Hoc Disease Transmission Advisory Committee (DTAC) with a Focus on COVID-19

Purpose: The OPTN DTAC, a multidisciplinary group, evaluates potential donor derived transmission events (PDDTE) to assess the likelihood of disease transmission. Method(s): Retrospective study of PDDTE cases reported to the OPTN between 01/20 and 12/20. DTAC reviewed cases using a standardized classification algorithm. Result(s): During 2020, there were 18,318 donors and 37,583 unique recipients. DTAC reviewed 261/427 PDDTE from donor (111) or recipient (150) findings. 64/261 (25%) donors had proven/probable transmission (P/P Tr) of infection, malignancies or other to 84/206 (41%) exposed recipients [figure]. 12 involved living donors. Infection occurred with 44/64 P/P cases affecting 63 recipients. Viruses were most frequent P/P infections with 29 recipients having P/P Tr from 19 donors. COVID-19 PDDTE represented 11% (29/261) of all cases reviewed involving 29 donors and 15 lung and 76 non-lung recipients. One lung recipient had P/P Tr and died;none of the non-lung recipients developed P/P Tr. For bacteria, 20 recipients had P/P Tr from 14 donors. Deaths from infection (N=10) occurred at a median of 20 days (5-89 days). Attributable death was highest for fungal (4/12, 33%) and bacterial infections (6/20, 30%). 7 donors with malignancies were classified as P/P impacting 15 recipients with 1 attributable death. 53 non-infection, non-malignancy PDDTE were reported;13 resulted in P/P Tr to 14 recipients. Conclusion(s): Although P/P events remain rare, 1/4 reviewed cases resulted in unanticipated P/P Tr. This is a conservative estimate due to passive reporting and empiric interventions. In 29 COVID-19 PDDTE only 1 lung recipient had P/P Tr. The DTAC continues to evaluate PDDTE to maximize organ use and minimize the risk of transmission. (Table Presented).

Organs from Donors with Positive SARS-CoV-2 NAT+ Testing: A Report from the Ad Hoc Disease Transmission Advisory Committee

Purpose: Decision to transplant organs from SARS-CoV-2 NAT+ donors(N+D) balances risk of donor-derived infection with the scarcity of available organs to meet the needs of waitlisted candidates. Method(s): OPTN Ad Hoc Disease Transmission Advisory Committee (DTAC) reports on the use of organs from N+D from the onset of required SARS-CoV-2 lower respiratory tract(LRT) testing for lung donors (May 27, 2021) through August 31, 2021. OPTN data were analyzed for donors with a positive LRT or upper respiratory tract (URT) test reported in DonorNet discrete data fields (N+D), compared with donors who did not have positive LRT or URT in the discrete data fields (N-D). Result(s): Organs were recovered from 120 N+D (all OPTN Regions and 40/57 OPOs (70%)). Median donor age was 42 (IQR: 32-52) for N+D and 43 (30-56) for N-D. There was a greater proportion of DCD N+D than N-D (37.5% vs 28.3%, p=0.04). Underlying COD of anoxia and other were different (N+D 31.7%, 16.7% vs N-D 48%, 2.7%, respectively). Transplanted N+D and N-D did not differ by KDPI, LDRI or LVEF for kidney(KT), liver(LT) or heart(HT), respectively (Table 1). Median time from donor admission to first reported test (any result) was 0 and 4 days for URT and LRT, respectively. N+D recovery occurred a median of 2 (IQR: 1-6) days from last positive test. 246 organs (152KT, 50LT, 22HT, 22other) were transplanted from 107 N+D compared to 8969 organs from 3348 N-D. Recipients from N+D and N-D were similar in age, MELD/PELD (LT) and medical urgency status (HT). Median time from listing to transplant similar for N+D for all organs. The match run sequence number for final acceptor was higher for N+D for all organ types (Table 2). Median length of stay was similar for N+D and N-D for KT and LT (5d and 12-13d, respectively). For HT, median stay was shorter for N+D (30 vs 34d). For N+D, 3 of 50 LT died within 30d of transplant. During this timeframe, no PDDTEs were reported for any N+D at the time of transplant. Conclusion(s): N+D and N-D were similar in terms organ quality characteristics. Recipients receiving organs from N+D had higher match run sequence numbers, suggesting use of organs from N+D is not widespread across centers;however, with small numbers, this data will need to be verified. We cannot assess the relatedness of the three early mortality events in N+D recipients to donor or recipient characteristics. However, these data highlight the importance of ongoing outcome review of N+D recipients. (Figure Presented).

OPTN Required SARS-CoV-2 Lower Respiratory Testing for Lung Donors: Early Impact on Patient Safety and Organ Utilization

Purpose: The OPTN implemented emergency policy on 5/27/21 requiring lower respiratory testing (LRT) by nucleic acid test (NAT) for SARS-CoV-2 (COVID-19) for all potential deceased lung donors. Our objective was to assess the policy's impact on organ utilization and patient safety. Method(s): OPTN data were analyzed for LRT information reported in discrete data fields or attachments in DonorNet for deceased lung donors recovered 5/27/21- 10/31/21. We used natural language processing to identify donor attachments with terminology related to COVID-19 (e.g., "COVID", "SARS-COV-2") and LRT (e.g., "BAL", "tracheal aspirate") in the attachment filename or description. Result(s): In the first 5 months since implementation, lungs were transplanted from 1037 donors (963 (92.9%) non-DCD, 74 (7.1%) DCD) (Figure). Lung utilization decreased slightly from pre- to post-policy for both non-DCD and DCD donors (overall: 17.7% vs 16.2%;non-DCD: 22.9% vs 21.7%;DCD: 5.1% vs 3.8%). 99.8% (N=1035/1037) of transplanted lung donors had LRT;the majority (99.2%) had LRT results reported in DonorNet on/before day of lung transplant. There have been no reported potential donor-derived SARS-CoV-2 transmissions to lung recipients since implementation. 58 donors had a positive LRT (LRT+), including 27 (46.6%) with a negative upper respiratory test. Lungs were not transplanted from 57/58 LRT+ donors;1 LRT+ donor was believed to be a false positive based on confirmatory test results and had lungs transplanted. Non-lung organs were recovered and transplanted from LRT+ donors without evidence of disease transmission (Table). While the kidney discard rate was higher for LRT+ donors relative to donors without LRT+ (30.2% vs 24.8%), liver discards were lower (5.6% vs 9.9%), and heart utilization was similar (27.6% vs 28.0%). Conclusion(s): Early results suggest that the LRT policy has minimized the risk of donor-derived COVID-19 transmission to lung recipients with minimal impact on lung utilization and allowing transplantation of non-lung organs from LRT+ donors. (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).