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Safety of the first dose of mRNA SARS-CoV-2 vaccines in patients with rheumatic and musculoskeletal diseases [Letter]
Connolly, Caoilfhionn M; Ruddy, Jake A; Boyarsky, Brian J; Avery, Robin K; Werbel, William A; Segev, Dorry L; Garonzik-Wang, Jacqueline; Paik, Julie J
PMID: 33741555
ISSN: 1468-2060
CID: 5127052
Examination of Racial and Ethnic Differences in Deceased Organ Donation Ratio Over Time in the US
Kernodle, Amber B; Zhang, Wanying; Motter, Jennifer D; Doby, Brianna; Liyanage, Luckmini; Garonzik-Wang, Jacqueline; Jackson, Kyle R; Boyarsky, Brian J; Massie, Allan B; Purnell, Tanjala S; Segev, Dorry L
Importance:Historically, deceased organ donation was lower among Black compared with White populations, motivating efforts to reduce racial disparities. The overarching effect of these efforts in Black and other racial/ethnic groups remains unclear. Objective:To examine changes in deceased organ donation over time. Design, Setting, and Participants:This population-based cohort study used data from January 1, 1999, through December 31, 2017, from the Scientific Registry of Transplant Recipients to quantify the number of actual deceased organ donors, and from the Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research Detailed Mortality File to quantify the number of potential donors (individuals who died under conditions consistent with organ donation). Data were analyzed from December 2, 2019, to May 14, 2020. Exposures:Race and ethnicity of deceased and potential donors. Main Outcomes and Measures:For each racial/ethnic group and year, a donation ratio was calculated as the number of actual deceased donors divided by the number of potential donors. Direct age and sex standardization was used to allow for group comparisons, and Poisson regression was used to quantify changes in donation ratio over time. Results:A total of 141 534 deceased donors and 5 268 200 potential donors were included in the analysis. Among Black individuals, the donation ratio increased 2.58-fold from 1999 to 2017 (yearly change in adjusted incidence rate ratio [aIRR], 1.05; 95% CI, 1.05-1.05; P < .001). This increase was significantly greater than the 1.60-fold increase seen in White individuals. Nevertheless, substantial racial differences remained, with Black individuals still donating at only 69% the rate of White individuals in 2017 (P < .001). Among other racial minority populations, changes were less drastic. Deceased organ donation increased 1.80-fold among American Indian/Alaska Native and 1.40-fold among Asian or Pacific Islander populations, with substantial racial differences remaining in 2017 (American Indian/Alaska Native population donation at 28% and Asian/Pacific Islander population donation at 85% the rate of the White population). Deceased organ donation differences between Hispanic/Latino and non-Hispanic/Latino populations increased over time (4% lower in 2017). Conclusions and Relevance:The findings of this cohort study suggest that differences in deceased organ donation between White and some racial minority populations have attenuated over time. The greatest gains were observed among Black individuals, who have been the primary targets of study and intervention. Despite improvements, substantial differences remain, suggesting that novel approaches are needed to understand and address relatively lower rates of deceased organ donation among all racial minorities.
PMCID:7876622
PMID: 33566079
ISSN: 2168-6262
CID: 5126972
Clinical characteristics of COVID-19 in solid organ transplant recipients following COVID-19 vaccination: A multicenter case series
Saharia, Kapil; Anjan, Shweta; Streit, Judy; Beekmann, Susan E; Polgreen, Philip M; Kuehnert, Matthew; Segev, Dorry L; Baddley, John W; Miller, Rachel A
BACKGROUND:Solid organ transplant recipients (SOTR) have diminished humoral immune responses to COVID-19 vaccination and higher rates of COVID-19 vaccine breakthrough infection than the general population. Little is known about COVID-19 disease severity in SOTR with COVID-19 vaccine breakthrough infections. METHODS:Between 4/7/21 and 6/21/21 we requested case reports via the Emerging Infections Network (EIN) listserv of SARS-CoV-2 infection following COVID-19 vaccination in SOTR. Online data collection included patient demographics, dates of COVID-19 vaccine administration and clinical data related to COVID-19. We performed a descriptive analysis of patient factors and evaluated variables contributing to critical disease or need for hospitalization. RESULTS:Sixty-six cases of SARS-CoV-2 infection after vaccination in SOTR were collected. COVID-19 occurred after the second vaccine dose in 52 (78.8%) cases of which 43 (82.7%) occurred ≥14 days post-vaccination. There were 6 deaths, 3 occurring in fully vaccinated individuals (7.0%, n = 3/43). There was no difference in the percentage of patients who recovered from COVID-19 (70.7% vs 72.2%, p = 0.90) among fully and partially vaccinated individuals. We did not identify any differences in hospitalization (60.5% vs. 55.6%, p = 0.72) or critical disease (20.9% vs. 33.3%, p = 0.30) among those who were fully vs. partially vaccinated. CONCLUSIONS:SOTR vaccinated against COVID-19 can still develop severe, and even critical, COVID-19 disease. Two doses of mRNA COVID-19 vaccine may be insufficient to protect against severe disease and mortality in SOTR. Future studies to define correlates of protection in SOTR are needed. This article is protected by copyright. All rights reserved.
PMID: 34905269
ISSN: 1399-3062
CID: 5127782
Early Development and Durability of SARS-CoV-2 Antibodies Among Solid Organ Transplant Recipients: A Pilot Study
Boyarsky, Brian J; Ou, Michael T; Werbel, William A; Avery, Robin K; Clarke, William A; Tobian, Aaron A R; Massie, Allan B; Segev, Dorry L; Garonzik Wang, Jacqueline M
PMCID:8085060
PMID: 33617174
ISSN: 1534-6080
CID: 5126982
Safety of the First Dose of SARS-CoV-2 Vaccination in Solid Organ Transplant Recipients [Letter]
Boyarsky, Brian J; Ou, Michael T; Greenberg, Ross S; Teles, Aura T; Werbel, William A; Avery, Robin K; Massie, Allan B; Segev, Dorry L; Garonzik-Wang, Jacqueline M
PMCID:8084895
PMID: 33560728
ISSN: 1534-6080
CID: 5126962
Discovered cancers at postmortem donor examination: A starting point for quality improvement of donor assessment
Girolami, Ilaria; Neil, Desley; Segev, Dorry Lidor; Furian, Lucrezia; Zaza, Gianluigi; Boggi, Ugo; Gambaro, Giovanni; De Feo, Tullia; Casartelli-Liviero, Marilena; Cardillo, Massimo; Lombardini, Letizia; Zampicinini, Laura; D'Errico, Antonietta; Eccher, Albino
BACKGROUND:clinical and imaging investigations allow a detailed assessment of an organ donor, but a quota of cancer still elude detection. Complete autopsy of donors is even less frequently performed, due to economic issues and increasing availability of high-quality imaging. The aim of this study is to gather evidence from the literature on donor malignancy discovered at autopsy following organ donation and to discuss the utility and limitations of autopsy practice in the field of transplantation. METHODS:A systematic search according to PRISMA guidelines was carried out in Pubmed and Embase databases until September 2020 to select articles with reporting of cancer discovered in a donor at postmortem examination. Cancer discover in not-transplant setting were excluded. A descriptive synthesis was provided. RESULTS:Of 7388 articles after duplicates removal, 56 were included. Fifty-one studies reported on complete autopsy, while 5 dealt only with limited autopsy (prostate and central nervous system). The number of autopsies ranged between 1 and 246 with a total of 823 autopsies performed. The most frequent cancer discovered at autopsy was lymphoma (n = 13, 15%), followed by renal cell carcinoma (RCC) (n = 11, 13%), non-small cell lung cancer (NSCLC) (n = 10, 11%), melanoma (n = 10, 11%), choriocarcinoma (n = 6, 7%) and glioblastoma (GBM) (n = 6, 7%). CONCLUSIONS:Lymphoma and melanoma are still difficult-to-detect cancers both during donor investigation and at procurement, whilst prostate cancer and choriocarcinoma are almost always easily detected nowadays thank to blood markers and clinical examination. There have been improvements with time in pre-donation detection procedures which are now working well, particularly when complete imaging investigations are performed, given that detection rate of CT/MRI is high and accurate. Autopsy can play a role to help to establish the correct donor management pathways in case of cancer discover. Furthermore, it helps to better understand which cancers are still eluding detection and consequently to refine guidelines' assessment procedures.
PMID: 33647551
ISSN: 1557-9816
CID: 5127002
The Precise Relationship Between Model for End-Stage Liver Disease and Survival Without a Liver Transplant
VanDerwerken, Douglas N; Wood, Nicholas L; Segev, Dorry L; Gentry, Sommer E
BACKGROUND AND AIMS:Scores from the Model for End-Stage Liver Disease (MELD), which are used to prioritize candidates for deceased donor livers, are widely acknowledged to be negatively correlated with the 90-day survival rate without a liver transplant. However, inconsistent and outdated estimates of survival probabilities by MELD preclude useful applications of the MELD score. APPROACH AND RESULTS:Using data from all prevalent liver waitlist candidates from 2016 to 2019, we estimated 3-day, 7-day, 14-day, 30-day, and 90-day without-transplant survival probabilities (with confidence intervals) for each MELD score and status 1A. We used an adjusted Kaplan-Meier model to avoid unrealistic assumptions and multiple observations per person instead of just the observation at listing. We found that 90-day without-transplant survival has improved over the last decade, with survival rates increasing >10% (in absolute terms) for some MELD scores. We demonstrated that MELD correctly prioritizes candidates in terms of without-transplant survival probability but that status 1A candidates' short-term without-transplant survival is higher than that of MELD 40 candidates and lower than that of MELD 39 candidates. Our primary result is the updated survival functions themselves. CONCLUSIONS:We calculated without-transplant survival probabilities for each MELD score (and status 1A). The survival function is an invaluable tool for many applications in liver transplantation: awarding of exception points, calculating the relative demand for deceased donor livers in different geographic areas, calibrating the pediatric end-stage liver disease score, and deciding whether to accept an offered liver.
PMID: 33655565
ISSN: 1527-3350
CID: 5127012
Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients
Boyarsky, Brian J; Werbel, William A; Avery, Robin K; Tobian, Aaron A R; Massie, Allan B; Segev, Dorry L; Garonzik-Wang, Jacqueline M
PMID: 33720292
ISSN: 1538-3598
CID: 5127032
Development of a Patient Reported Measure of Experimental Transplants with HIV and Ethics in the United States (PROMETHEUS)
Seaman, Shanti; Brown, Diane; Eno, Ann; Yu, Sile; Massie, Allan B; Tobian, Aaron A R; Durand, Christine M; Segev, Dorry L; Wu, Albert W; Sugarman, Jeremy
BACKGROUND:Transplantation of HIV-positive (HIV+) donor organs for HIV+ recipients (HIV D+/R+) is now being performed as research in the United States, but raises ethical concerns. While patient-reported outcome measures are increasingly used to evaluate clinical interventions, there is no published measure to aptly capture patients' experiences in the unique context of experimental HIV D+/R+ transplantation. Therefore, we developed PROMETHEUS (patient-reported measure of experimental transplants with HIV and ethics in the United States). To do so, we created a conceptual framework, drafted a pilot battery using existing and new measures related to this context, and refined it based on cognitive and pilot testing. PROMETHEUS was administered 6-months post-transplant in a clinical trial evaluating these transplants. We analyzed data from the first 20 patient-participants for reliability and validity by calculating Cronbach's alpha and reviewing item performance characteristics. RESULTS:PROMETHEUS 1.0 consisted of 29 items with 5 putative subscales: Emotions; Trust; Decision Making; Transplant; and Decision Satisfaction. Overall, responses were positive. Cronbach's alpha was > 0.8 for all subscales except Transplant, which was 0.38. Two Transplant subscale items were removed due to poor reliability and construct validity. CONCLUSIONS:We developed PROMETHEUS to systematically capture patient-reported experiences with this novel experimental transplantation program, nested it in an actual clinical trial, and obtained preliminary data regarding its performance.
PMCID:7973329
PMID: 33738660
ISSN: 2509-8020
CID: 5127042
Transplanting Organs from Donors with HIV or Hepatitis C: The Viral Frontier
Boyarsky, Brian J; Strauss, Alexandra T; Segev, Dorry L
A wide gap between the increasing demand for organs and the limited supply leads to immeasurable loss of life each year. The organ shortage could be attenuated by donors with human immunodeficiency virus (HIV) or hepatitis C virus (HCV). The transplantation of organs from HIV+ deceased donors into HIV+ individuals (HIV D+ /R+) was initiated in South Africa in 2010; however, this practice was forbidden in the USA until the HIV Organ Policy Equity (HOPE) Act in 2013. HIV D+/R+ transplantation is now practiced in the USA as part of ongoing research studies, helping to reduce waiting times for all patients on the waitlist. The introduction of direct acting antivirals for HCV has revolutionized the utilization of donors with HCV for HCV-uninfected (HCV-) recipients. This is particularly relevant as the HCV donor pool has increased substantially in the context of the rise in deaths related to drug overdose from injection drug use. This article serves to review the current literature on using organs from donors with HIV or HCV.
PMID: 33471156
ISSN: 1432-2323
CID: 5126912