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1.
American Journal of Transplantation ; 22(Supplement 3):919, 2022.
Article in English | EMBASE | ID: covidwho-2063543

ABSTRACT

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).

2.
American Journal of Transplantation ; 22(Supplement 3):651, 2022.
Article in English | EMBASE | ID: covidwho-2063521

ABSTRACT

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.

3.
American Journal of Transplantation ; 22(Supplement 3):533-534, 2022.
Article in English | EMBASE | ID: covidwho-2063398

ABSTRACT

Purpose: VCA transplantation has grown and changed, encountering challenges such as scarce funding sources and the COVID-19 pandemic. Method(s): The OPTN cohort includes 105 candidates listed and 62 recipients transplanted 7/4/14-10/31/21. Result(s): VCA candidates included 47 uterus, 26 upper limb (UL, 14 bilateral, 12 unilateral), 1 UL/face, 12 face, 1 scalp, 2 face/scalp, 1 trachea, 12 abdominal wall (AW), and 3 penis candidates. Waiting list additions increased in 2016 after uterus transplants began in the US. Head and neck and UL additions held relatively steady through 2019. The COVID-19 pandemic caused a decrease in VCA waiting list additions in 2020 - 1 AW, 1 uterus, and two UL candidates. In the first 10 months of 2021, 5 VCA candidates were added - 2 AW and 3 uterus candidates. In April 2020, 11 of 23 VCA candidates were inactive;on 10/31/2021, 8 of 21 were inactive. 62 candidates received 64 transplants (including 1 uterus re-transplant and 1 face/ UL transplant). Others refused transplant (n=7), became ineligible (n=4), could not be contacted (n=2), condition improved (n=1), were too sick (n=2), died (n=3), or were removed for other reasons (n=2). Median time on the waiting list for recipients was 217 days (IQR: 76.0-404.25 days). VCA transplants in the U.S. 7/3/14-10/31/21 include 14 UL (9 bilateral;5 unilateral), 9 face, 1 UL/face, 1 scalp, 1 trachea, 2 AW, 2 penis, and 33 uterus (12 deceased donor;21 living donor). In 2016, VCA shifted from mostly UL and face to a larger proportion of uterus transplants. UL and face transplants decreased in 2017, then increased and held steady through 2019. VCA transplants decreased in 2020 with the COVID-19 crisis and included 2 uterus transplants, the first U.S. face re-transplant, and the first successful UL/face transplant in the U.S. In the first 10 months of 2021, 2 living donor uterus, 1 bilateral UL, and the first trachea transplant in the US occurred. Out of 62 recipients, 21 were funded by the hospital, 15 by donations, 7 by Medicare/ Medicaid, 1 by Dept of Veterans Affairs, 3 by private insurance, and 2 by recipient. Conclusion(s): VCA transplantation continues to faces challenges such as the COVID-19 pandemic and chronic issues such as funding sources, but has shown signs of resilience in 2021. (Figure Presented).

4.
American Journal of Transplantation ; 22(Supplement 3):404, 2022.
Article in English | EMBASE | ID: covidwho-2063367

ABSTRACT

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).

5.
American Journal of Transplantation ; 22(Supplement 3):333, 2022.
Article in English | EMBASE | ID: covidwho-2063353

ABSTRACT

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).

6.
American Journal of Transplantation ; 22(Supplement 3):452, 2022.
Article in English | EMBASE | ID: covidwho-2063348

ABSTRACT

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).

7.
American Journal of Transplantation ; 21(SUPPL 4):824, 2021.
Article in English | EMBASE | ID: covidwho-1494565

ABSTRACT

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).

8.
American Journal of Transplantation ; 21(SUPPL 4):823-824, 2021.
Article in English | EMBASE | ID: covidwho-1494561

ABSTRACT

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).

9.
American Journal of Transplantation ; 21(SUPPL 4):332-333, 2021.
Article in English | EMBASE | ID: covidwho-1494473

ABSTRACT

Purpose: Vascularized Composite Allograft (VCA) transplantation has grown and changed rapidly in the past several years. This study investigates VCA waiting list and transplant trends in the U.S. Methods: We used OPTN VCA waiting list data from July 3, 2014 through November 15, 2020 and OPTN VCA transplant data from January 1 1998 through November 15, 2020. Results: Since the OPTN implemented the VCA waiting list on July 3, 2014, 99 candidates have been registered on the waiting list through November 15, 2020. VCA candidates were 60.6% female, 79.8% white, and 78.8% under 45 years old, but characteristics varied by organ type. The size of the VCA waiting list increased gradually over several years, largely due to the introduction of uterus transplants. In the past year, however, existing registrations for upper limb and head and neck candidates held steady while uterus registrations declined. New registrations were notably lower in 2020, likely due to the COVID-19 crisis. As of 11/15/20, the OPTN VCA waiting list included 4 head and neck (20%), 6 upper limb (30%), 4 abdominal wall (20%), and 6 uterus (30%) candidates. Median days on the list for those waiting for a deceased donor organ on 11/15/20 was 771 days (IQR: 524.8 - 971.0) - a large increase compared with analyses at the same time in 2019. Median days on the VCA waiting list for those transplanted with a deceased donor organ was 193 days (IQR: 71.25 - 376.5). A total of 109 VCA recipients have received VCA transplants in the US, including 59 since 7/3/14: 8 bilateral upper limb, 5 unilateral upper limb, 10 face, 1 scalp, 2 abdominal wall, 31 uterus (12 deceased donor;19 living donor), and 2 penis transplants. Conclusions: Continued monitoring of VCA trends is needed to support VCA donation and transplantation.

10.
American Journal of Transplantation ; 21(SUPPL 4):497, 2021.
Article in English | EMBASE | ID: covidwho-1494420

ABSTRACT

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).

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