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The unprecedented COVID-19 virus has brought to the forefront many challenges associated with exclusive rights in information, data, and know-how, all of which may constitute protected trade secrets. While patents have received more attention, trade secret information has limited the ability to perform research, develop, test, gain regulatory approval for, manufacture, and distribute globally and at sufficient scale and affordable prices the needed vaccines, therapeutics, diagnostics, medical devices, and personal protective equipment. Voluntary licensing efforts have proven inadequate to supply pandemic needs. Thus, compelling the sharing or licensing of trade secrets is needed not only to properly address COVID-19, but more importantly to address future pandemics and other serious global problems such as climate change. This Article explains the nature of trade secrets and their protection. It then describes the failures in COVID-19 responses resulting from trade secrets that were not voluntarily licensed. It explains why patent law disclosures have been inadequate to assure competitive global research, development, and production. Given the need for compelled trade secret sharing, this Article surveys the relevant international intellectual property law treaties addressing trade secrets. It demonstrates that, consistent with international law obligations, governments are free to compel trade secret sharing. Further, governments may not be obliged to award compensation for such sharing when regulating to address public health. Given this national freedom to act, this Article then provides numerous examples of existing United States, European, and other authorities that have been or could be used to compel the sharing or licensing of trade secrets. It also notes the potential to adopt more explicit legislation authorizing compelled or induced behaviors. This survey of authorities illustrates that compelling trade secret sharing or licensing should be unobjectionable whenever there is a need to protect lives, health, or the economy. Accordingly, this Article provides a first critical step toward rethinking the nature of international trade secret protections and seeks to develop the political will for governments to protect the global public from the harms that trade secret rights can generate.
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The negative impact of COVID on the respiratory system is well characterized in a general population. The increased complexity of COVID in lung transplant recipients (LTRs) and assessment of injury severity is less defined. We compared allograft injury as measured by donor derived cell-free DNA (dd-cfDNA) in LTRs with post-transplant COVID. We hypothesized more severe COVID infection would be associated with higher lung injury, as evidenced by higher dd-cfDNA. All LTRs positive for COVID with peri-infection dd-cfDNA (%, AlloSure, CareDx) from Memorial Hermann Hospital (MHH) and University of Texas Health Science Center San Antonio (UTHSC-SA) were evaluated. LTRs were stratified on hospitalized vs not hospitalized for COVID. Time between dd-cfDNA result and COVID infection was calculated and graphed. LTRs with concurrent immune events (acute cellular rejection or antibody mediated rejection) were excluded. Twenty-eight LTRs had post-COVID dd-cfDNA results available (MHH 18, UTHSC-SA 10). Peri-COVID infection dd-cfDNA trends are shown in Figure 1. Seventeen (61%) were hospitalized and 39% (n=11) were not. Median max dd-cfDNA in hospitalized LTRs was 1.10% (IQR 0.82, 2.40) drawn at median 50 days (IQR 35, 151) post-COVID. Median max dd-cfDNA in not hospitalized LTRs was 0.94% (IQR 0.45, 1.80) drawn at median 81 days (IQR 43, 235). As dd-cfDNA levels were not drawn at the same times post-COVID between hospitalized and not hospitalized patients, differences cannot be directly compared. However, there are clear elevations in median dd-cfDNA among COVID hospitalized LTRs indicating a higher degree of allograft injury in those patients. Both the dd-cfDNA elevation preceding date of COVID positivity and the following decay between hospitalized and not hospitalized LTRs could be important prognostically. Investigation into effect of COVID treatment on dd-cfDNA, time to return to dd-cfDNA baseline levels, and resolution of pulmonary function are warranted. [ FROM AUTHOR] Copyright of Journal of Heart & Lung Transplantation is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)
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Purpose: Infection is the leading cause of death within 1 year post lung transplant. Graft injury secondary to infection is affected by both source and organism. Donor derived cell-free DNA (dd-cfDNA) is a consistent marker of graft injury, but previously reported dd-cfDNA levels with infections have been inconsistent. We compared dd-cfDNA concentrations across different infection types. Method(s): We reviewed infections in lung transplant recipients (LTR) between 5/2019-6/2021 with paired dd-cfDNA at time of infection. All were confirmed infections (i.e. requiring therapy). Infection source (respiratory vs non-respiratory) and organism were collected. Samples were excluded if there was concurrent ACR, AMR or CLAD at time of dd-cfDNA. The primary endpoint was dd-cfDNA levels across cohorts. Result(s): Fifty paired samples from 20 LTR were identified;31 samples were excluded due to concurrent diagnoses. Infections included viral (n=18, 36%), bacterial (n=18, 36%), and fungal (n=10, 20%). Four cultures (8%) had multiple organisms. Most common within each group were CMV (n=4) and COVID (n=4) for viral, Pseudomonas aeruginosa (n=4) for bacterial, and Aspergillus (n=7) for fungal. Median dd-cfDNA was 1.30% in viral infections, 1.93% in bacterial, and 0.99% in fungal;respiratory infections (n=42) was 1.42% and 0.95% in non-respiratory (n=8). Conclusion(s): There was a statistically significant increase in dd-cfDNA between each infection compared to a normal cohort, but no statistical differences between infection groups. The trend towards significance of respiratory vs non-respiratory indicates that dd-cfDNA may be a useful marker of injury specific to the graft caused by infection. Further investigation with serial samples prior to and following treatment of the infection will be important to better understand this trend. (Figure Presented).
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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).
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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).
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CASE: A 60-year-old woman with past medical history including hypertension, nephrolithiasis, and Covid-19 4 months prior presented to the emergency department with 3 days of substernal chest pain radiating toward the back and shoulders 6 days after receiving her second dose of the BNT162b2 mRNA Covid-19 vaccine (Pfizer/BioNTech) in her left deltoid. The patient tested negative for Covid-19 and denied shortness of breath, cough, fever, or dyspnea on exertion. Her ECG was notable for more pronounced t-wave inversions in III and aVF, but further cardiac workup was unremarkable, and she was discharged the next day. The patient re-presented to care 6 days later with left arm pain, erythema, edema, and warmth. Her left bicep circumference was 31cm versus 28cm on the right. Upper extremity duplex ultrasound (US) was remarkable for deep venous thrombosis (DVT) of the left internal jugular, subclavian, axillary, and basilic veins. MRI angiogram was confirmatory. Other than her occupation as a hairdresser, the patient did not have known risk factors for DVT: no personal or family history of thromboembolism, no tobacco use, took no prescription medications, and had received all ageappropriate cancer screening. Her thrombophilia workup was negative. The patient was discharged on apixaban. Eleven days later, a venogram showed persistent clot burden in the left axillary, mid-subclavian, and brachiocephalic veins. Thrombectomy, overnight tPA infusion, and left subclavian vein stenting were performed and the patient was discharged on daily apixaban and aspirin. IMPACT/DISCUSSION: As of December 10th, 2021, the vaccine adverse event reporting system yielded 464 reports of “thrombosis” after the Pfizer/ BioNTech vaccine in individuals with no reported current illness, 32 of which occurred in the upper extremity. To our knowledge, our patient represents the first report of upper extremity deep venous thrombosis (UEDVT) shortly after receipt of the Pfizer vaccine in an otherwise healthy person. UEDVT is relatively rare: it occurs in about 0.4 to 1 per 10,000 people per year and less than 20% of incidents are idiopathic. Given the scarcity of potential causes, our case may simply reflect expected background incidence. Nevertheless, the literature includes multiple case reports of DVT after mRNA Covid-19 vaccination, including cases of lower extremity DVT and DVT with pulmonary embolism (PE) after the Pfizer vaccine, and cases of lower extremity DVT, PE, and UEDVT after the mRNA-1273 (Moderna) vaccine. Given the similar mechanism of action between the Moderna and Pfizer vaccines, it is possible that the same pathophysiology underlies the reports of DVT in these vaccine recipients. CONCLUSION: Upper extremity deep venous thrombosis after Covid-19 mRNA vaccination should remain on the differential as clinicians assess chest and arm pain following vaccination. There is a possible association between the BNT162b2 mRNA Covid-19 vaccine and upper extremity deep venous thrombosis that requires further research.
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Rationale “Home hospital” is hospital-level substitutive care delivered at home for acutely ill patients who would traditionally be cared for in the hospital. Despite years of successful operations and evidence from randomized controlled trials, to our knowledge outcomes in the U.S. specifically for patients with respiratory disease have not been evaluated. Methods We performed a retrospective evaluation of all patients who were cared for in our home hospital program between 2016 and 2021. We compared patients requiring admission with respiratory disease (asthma exacerbation, COPD exacerbation, and any non-COVID pneumonia) to all other patients who received home hospital care (other general medical conditions such as heart failure and infectious processes). Patients entered the program either from the emergency department after it was determined they required admission or from the general medical ward after it was determined they required additional days of acute care. Patients were risk-stratified using peak flow (asthma), BAP-65 (COPD), and CURB- 65 (pneumonia), among other scores to prognosticate against the ICU. Upon admission at home, patients received 2 nurse/paramedic visits daily, 1 physician visit daily, IV medications, advanced respiratory therapies, continuous heart and respiratory rate monitoring, and other hospital-level treatments/diagnostics as needed. Results Among 1,166 admissions, 25% were for respiratory disease (38% COPD, 38% pneumonia, and 24% asthma) and 75% were for non-respiratory disease (48% infection, 27% heart failure). Both groups had similar sociodemographic characteristics: mean age 72 years (SD, 17), 63% female, 44% White, 39% partnered, 71% English-speaking, 52% Medicare beneficiary, and 58% retired. Groups differed by education, with less attainment in the respiratory group (34% high school vs 29%;p=0.034), smoking status (20% active smoker vs 9%;p<0.001), and more outpatient medications (median number, 10 vs 8;p<0.001). During home hospital, respiratory patients had less utilization: length of stay (mean days, 3.4 vs 4.8;p<0.001), laboratory orders (median, 0 vs 2;p<0.001), consultations (1% vs 7%;p=0.004), and physical/occupational therapy (2% vs 7%;p=0.032). Both groups had a similar escalation rate (i.e., requiring transfer back to the hospital) of 4% and no mortality during home hospital. Within 30-days of discharge, both groups were similar: 14% readmission, 9% ED presentation, and 4% mortality. Conclusions Home hospital care is safe and effective for patients with acute respiratory illness compared to other general medical conditions. If scaled, it can serve to generate significant high-value capacity creation for health systems and communities, with opportunities to advance the complexity of care delivered.
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A short time ago the debate over the proposal to temporarily waive intellectual property rights on Covid-19 vaccines was raging worldwide;and the suspension of those rights seemed imminent. Public attention reached its peak in May 2021 when the Biden administration endorsed the idea and committed itself to pursuing it under the World Trade Organization–World Intellectual Property Organization (WTO-WIPO) procedural rules for waiving intellectual property (IP) protection. By suspending IP rights, the administration sought to help low-income countries to start producing vaccines more quickly, reducing the rising and dramatic worldwide vaccine inequality. © Cato Institute. All rights reserved.
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Purpose: US Solid organ transplantation rates significantly decreased during the initial wave of the COVID-19 pandemic. The concern for potential donor derived COVID-19 was one of many contributing factors. We describe the early experience of the Organ Procurement and Transplantation Network (OPTN) Disease Transmission Advisory Committee (DTAC) Coronavirus disease 2019 (COVID-19) investigations. Methods: COVID-19 cases reported to DTAC between January 2020 and October 2020 as potential donor-derived transmission events (PPDTE) were included. All of the events were investigated by the Centers for Disease Control and Prevention and adjudicated by the DTAC based on consensus definitions. Results: Eighteen PDTE COVID-19 events were reported during the study period. 12 PDTE reports have completed DTAC adjudication (Table 1). These included 12 donors with 44 recipients. Ten investigations were initiated by the transplant center due to recipient testing (36 total recipients). The median time to presentation in these index cases was 11 days (IQR 7-16). Nine donors in these events (35 recipients) had a prospective or retrospective pre-recovery negative SARS-CoV-2 PCR result. In all of these events, the index recipient had either a possible or confirmed community or hospital exposure. In one recipient index case (5 total recipients), the positive SARS-CoV-2 PCR result post-transplant was ultimately deemed a false positive and considered not a case by the committee. Two investigations were initiated by an OPO (8 recipients). In both events, the OPO performed SARS-CoV-2 PCR was negative, but a post-procurement nasopharyngeal SARS-CoV-2 PCR performed by the tissue collector was reported as positive and retrospectively deemed false positives. None of these recipients developed COVID-19;the events were adjudicated as not cases. Conclusions: The initial DTAC experience reflecting the early pandemic era emphasizes the need to implement hospital prevention measures to avoid nosocomial transmission, provide patient education to avoid community exposure and to recognize the possibility of post-procurement SARS-CoV-2 false positive testing. Vigilance for the possibility of a SARS-CoV-2 donor derived event remains important as the pandemic continues. (Table Presented) .
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Background: In-center hemodialysis patients have high rates of depression and anxiety. Pharmacologic interventions to ameliorate psychological burdens have proven to be limited in efficacy. Alternative therapies are increasingly used for those with chronic disease. A small number of studies have looked at the impact of meditation and yoga to improve symptoms of anxiety and depression and to promote a better quality of life. The aim of this study was to test the feasibility of implementing a chairside intradialytic yogabased breathing and relaxation technique. A secondary goal was assessing the efficacy of such an intervention. Methods: Eligible subjects were patients with a below average score on the Mental Component Summary (MCS) of a previously completed Kidney Disease Quality of Life (KDQOL-36) survey. Following consent, each subject was provided with an MP3 player, pre-loaded with a 12-minute recording of a specific yogic breathing and relaxation exercise, the Three-Part Breath. The intervention consisted of listening to the recording at each dialysis treatment over a 12-treatment period. Subjects completed a KDQOL-36 survey both at the start and the end of the study. A Likert scale to measure anxiety was completed at each dialysis treatment both pre-and post-intervention. Results: 11 subjects were enrolled over a 10-month period in 2020;10 completed the study. As measured by the Likert scale, anxiety was significantly reduced after listening to the recording. Notably, there was a larger reduction in anxiety on a per treatment basis in the period after the start of the Covid-19 pandemic compared to the pre-pandemic period. Over the study period, there was a significant improvement in the scores of the Effects of Kidney Disease on Quality of Life component of the KDQOL-36, and a trend toward significant improvement in the Mental Component Summary scores. Conclusions: A chairside intradialytic breathing and relaxation program can be integrated into a dialysis treatment session. The study demonstrates an improvement in scores related to anxiety, depression, and measures of quality of life. Larger and randomized trials using this intervention are needed to better understand its benefits and adverse effects, as well as the obstacles to large scale implementation.
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Study Objectives: Emergency physicians (EPs) are always on the frontlines and many EPs thrive on the unpredictable. Despite this, the COVID-19 pandemic posed unprecedented challenges to all EPs, including the challenge of how to prepare for and cope with a pandemic. This subset analysis aimed to evaluate the impact of the COVID-19 pandemic specifically on the lives of EP fathers. Methods: From May 2 through June 16, 2020, a convenience sample of physician fathers was surveyed on their personal and professional preparedness for COVID-19. Surveys were distributed via the Physician Dads Group (PDG), an international Facebook group covering all medical specialties, LinkedIn, via personal contacts and professional organizations. Results: 260 surveys were completed by EP fathers (Table 1). Of the respondents, 77% were between 30-49 years, 84% were White, 9% Asian, 1% Black;31 U.S. states were represented. 98% reported they had a partner. At the time of the survey, 63% felt they were in a high-density area with 88% having cared for a COVID+ patient. About half had taken steps to prepare personally or professionally for the local impact of COVID-19 (46% and 67%, respectively). EP fathers’ top two concerns were exposing their partner or their child(ren) to COVID-19, followed by personally acquiring COVID-19. 44% of fathers didn’t have to change their schedule to care for children, while 37% did;other fathers did not have school-aged children or already had care in the home. In terms of preparation, about 67% made sure they had adequate food, 60% made sure they were financially prepared, while 46% and 41% obtained PPE for self or family, respectively. To prepare professionally, almost all (97%) educated themselves about COVID-19, 68% self-educated about pandemics, and 72% reviewed critical care literature. The three biggest professional concerns were morale of staff (48%), financial challenges (45%), and health of staff (43%). 37% of fathers felt that the balance between their professional and personal responsibilities worsened, while 17% felt the balance improved. When EP fathers were asked if they wished they did not go into medicine, 67% disagreed/strongly disagreed. When asked if they wished they had not gone into their specialty, 89% disagreed/strongly disagreed. Conclusions: EP fathers felt more prepared professionally than personally for the pandemic. The findings highlight that EP fathers were concerned about their family becoming sick but also concerned with the health and morale of staff at work. [Formula presented]
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Study Objectives: The ongoing COVID-19 pandemic has affected frontline health care workers significantly at work and at home, with recent studies suggesting the pandemic negatively affecting physicians in both spheres. Only a few studies have examined the attitudes and conflicts faced by physician fathers, the majority of current practitioners. This work is a subset analysis of responses to qualitative questions on the impact of the COVID-19 pandemic on the lives of emergency physician (EP) fathers. Methods: A convenience sample of physician fathers was obtained from May 2 to June 16, 2020, via social media and email. The survey contained questions on personal and professional struggles during the start of the pandemic and including several free test questions. Free responses were analyzed and coded. Several themes emerged related to experiences described: (1) self;(2) social;(3) home life;(4) work life;(5) financial;(6) immediate family. Under each main theme were subthemes that provided a more detailed match for each comment. Results: There were 260 surveys completed by EP fathers from 31 states. 84% were White, 9% Asian, 1% Black, 5% other. 78% were between 30-49 years;98% reported having a partner. Most fathers had younger children (infants through middle-school aged) living in the household with them at the time of the survey. The three most common themes were “work life” (38%), “immediate family” (20%), and “social” (15%). In “work life” the most common subthemes were “general change in responsibilities” (29%), “decrease in workload/unemployed” (21%), and “concerns/negative feelings towards work” (18%). In “immediate family” both “positive change in family life” (45%) and “negative change in family life” (19%) predominated. Under “social,” “missing/lacking social interaction” (49%) and “missed/cancelled events” (33%) were most common. Of note in other themes in “self,” the two most common subthemes were “negative mental state” (45%) and “decreased productivity” (12%). In “home life,” “change in usual routine/structure/schedule” was the most common (42%) followed by “difficulty caring/assisting children” (28%). The “financial” theme was dominated by the subtheme “financial issues/loss” (94%). Conclusions: This study examined reported concerns and attitudes of EP fathers during the COVID-19 pandemic. EP fathers reported a variety challenges affecting both their personal and professional lives with positive and negative changes. Further research is needed to better understand how to support EP fathers during future pandemics.
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Purpose Prior observational data suggest that donor-derived cell-free DNA (dd-cfDNA) increases in lung transplant acute rejection and infection. The performance of dd-cfDNA in routine clinical care remains undefined. In response to the COVID-19 pandemic, to mitigate the risk of exposing patients to infection, four centers used dd-cfDNA for surveillance instead of surveillance bronchoscopy, providing a unique opportunity to assess the performance of dd-cfDNA in routine clinical care. Methods As part of routine care during the COVID-19 pandemic, four lung transplant centers implemented a home-based surveillance program using plasma dd-cfDNA (Allosure®) in preference to surveillance bronchoscopy. Based on prior data, dd-cfDNA > 1% triggered further work-up including bronchoscopy. dd-cfDNA testing was also performed in response to a decline in forced expiratory volume in 1 second (FEV1), symptoms or treatment follow up. Data was retrospectively analyzed from 4/1/2020 - 9/1/2020 to assess the performance of dd-cfDNA in diagnosing a composite of ACR, AMR and/or infection. Results 169 patients underwent 380 dd-cfDNA measurements over the study period. The mean age was 58.5 years, 54% of patients were male and 82% bilateral lung transplants. 99 (58%) patients were <1 year post-transplant. 327 of 380 dd-cfDNA values were drawn for surveillance reasons. 31 patients had a surveillance level > 1%. Of these, 19/31 (61%) had evidence of ACR, AMR or infection. 115 patients had surveillance levels that remained < 1% over the study period with 109/115 (95%) displaying no clinical evidence of ACR, AMR, infection or decline in FEV1 or symptoms. The remaining 23 patients had levels drawn for clinical indications (non-surveillance). 45 surveillance bronchoscopies were performed with concomitant dd-cfDNA (23 triggered by dd-cfDNA > 1%). For diagnosis of ACR, AMR or infection in these patients, dd-cfDNA > 1% yielded a sensitivity of 84%, specificity of 77%, positive predictive value of 73% and negative predictive value of 87%. Conclusion In this study, dd-cfDNA identified ACR, AMR and/or infection in asymptomatic lung transplant patients that may not have been identified by clinically indicated biopsy alone. Low levels of dd-cfDNA may also be useful in ruling out AMR, ACR and/or infection, supporting its use as a potential non-invasive marker for surveillance monitoring.
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Background: COVID-19 infected more than 1.6 million Americans (0.48%) and more than 15,000 of the 500,000 (3%) Americans with chronic kidney disease treated by dialysis. The Rogosin Institute operates nine dialysis centers in New York City (NYC), the epicenter of the COVID-19 US Public Health Emergency (PHE). We followed guidance from the Centers for Disease Control and Prevention and the New York State Department of Health throughout the PHE. We screened all patients and staff for signs and symptoms of COVID-19 by measuring temperature and inquiring about symptoms on presentation to our dialysis centers. Infected patients who did not require hospitalization were treated in our centers on a dedicated shift by dedicated staff. We used a symptom-based approach to discontinuing isolation. Methods: We created a COVID-19 tool in REDCap to track the spread of Coronavirus. We surveyed our Electronic Health Record weekly using a direct data connection and automated scripting to identify patients infected with COVID-19. We reviewed demographic and clinical data for each infected patient. We used descriptive statistics to analyze our population of infected patients. Results: On February 28, 2020, 1,559 patients received dialysis at our centers. By May 11, 241 (15.5%) had been infected. Our mortality rate was 22.8% compared to general populations in NYC (10-12%), US (6.0%) and worldwide (6.5%) and rates for dialysis patients reported between 7-20%. We had a disproportionate occurrence of COVID-19 among residents of Brooklyn (49% of infections, 44% of patients) and Queens (29%;25%). Most of the infected patients were male (53%) and Black (51%). Common co-morbidities included hypertension (98%), diabetes mellitus (60%), heart failure (25%) and coronary artery disease (25%). Common outpatient medications included statins (64%) ACE inhibitors/ARBs (80%) and calcium channel blockers (63%). Fever was the only common presenting symptom (94% of patients). A significant proportion (12%) of patients were in the hospital within 14 days prior to diagnosis of COVID-19 infection. Conclusions: COVID-19 infection was common and associated with high mortality rate in our NYC population of dialysis patients despite adherence to governmental guidelines for control of disease spread. We hypothesize community spread was common in our patients residing in the epicenter of the US COVID-19 PHE.