Impact of COVID-19 lockdown on maternal psychological status, the couple's relationship and mother-child interaction: a prospective study.

BACKGROUND: To compare the rate of postpartum depression (PPD) during the first COVID-19 lockdown with the rate observed prior to the pandemic, and to examine factors associated with PPD. METHODS: This was a prospective study. Women who gave birth during the first COVID-19 lockdown (spring 2020) were offered call-interviews at 10 days and 6-8 weeks postpartum to assess PPD using the Edinburgh Postnatal Depression Scale (EPDS). Post-traumatic symptoms (Perinatal Post-traumatic Stress Disorder Questionnaire, PPQ), couple adjustment, and interaction and mother-to-infant bonding were also evaluated. The observed PPD rate was compared to the one reported before the pandemic. Factors associated with an increased risk of PPD were studied. The main outcome measures were comparison of the observed PPD rate (EPDS score > 12) to pre-pandemic rate. RESULTS: Of the 164 women included, 27 (16.5% [95%CI: 11.14-23.04]) presented an EPDS score > 12 either at 10 days or 6-8 weeks postpartum. This rate was similar to the one of 15% reported prior to the pandemic (p = 0.6). Combined EPDS> 12 or PPQ > 6 scores were observed in 20.7% of the mothers [95%CI: 14.8-0.28]. Maternal hypertension/preeclampsia (p = 0.007), emergency cesarean section (p = 0.03), and neonatal complications (p = 0.008) were significantly associated with an EPDS> 12 both in univariate and multivariate analysis (OR = 10 [95%CI: 1.5-68.7], OR = 4.09[95%CI: 1.2-14], OR = 4.02[95%CI: 1.4-11.6], respectively). CONCLUSIONS: The rate of major PPD in our population did not increase during the first lockdown period. However, 20.7% of the women presented with post-traumatic/depressive symptoms. TRIAL REGISTRATION: NCT04366817.

Previous SARS-CoV-2 infection or a third dose of vaccine elicited cross-variant neutralising antibodies in vaccinated solid-organ transplant recipients.

Objectives: The SARS-CoV-2 pandemic poses a great threat to global health, particularly in solid organ transplant recipients (SOTRs). A 3-dose mRNA vaccination protocol has been implemented for the majority of SOTRs, yet their immune responses are less effective compared to healthy controls (HCs). Methods: We analyzed the humoral immune responses against the vaccine strain and variants of concern (VOC), including the highly mutated-omicron variant in 113 SOTRs, of whom 44 had recovered from COVID-19 (recovered-SOTRs) and 69 had not contracted the virus (COVID-naïve). In addition, 30 HCs, 8 of whom had recovered from COVID-19, were also studied. Results: Here, we report that three doses of the mRNA vaccine had only a modest effect in eliciting anti-viral antibodies against all viral strains in the fully vaccinated COVID-naive SOTRs (n = 47). Only 34.0% of this group of patients demonstrated both detectable anti-RBD IgG with neutralization activities against alpha, beta, and delta variants, and only 8.5% of them showed additional omicron neutralizing capacities. In contrast, 79.5% of the recovered-SOTRs who received two doses of vaccine demonstrated both higher anti-RBD IgG levels and neutralizing activities against all VOC, including omicron. Conclusion: These findings illustrate a significant impact of previous infection on the development of anti-SARS-CoV-2 immune responses in vaccinated SOTRs and highlight the need for alternative strategies to protect a subset of a lesser-vaccine responsive population.

TV, computer, tablet and smartphone use and autism spectrum disorder risk in early childhood: a nationally-representative study.

BACKGROUND: Screen media use in early childhood has largely increased in recent years, even more so during the COVID-19 epidemic, and there is much discussion regarding its influence on neurodevelopment, including Autism Spectrum Disorder (ASD). METHODS: We examined the relationship between use of TV, computer, tablet and smartphone at age 2 years and risk of ASD assessed in telephone-based questionnaires among 12,950 children participating in the nationally representative ELFE ('Etude Longitudinale Française sur les Enfants') birth cohort study in France. RESULTS: In inverse-probability weighted (IPW) multinomial regression analyses, children's weekly or daily screen media use was associated with an increased likelihood of an intermediate risk of ASD (IPW-controlled OR for weekly use:1.07, 95% CI 1.02-1.12; IPW-controlled OR for daily use:1.05, 95% CI 1.02-1.08) but inversely associated with a high risk (IPW-controlled OR for weekly use: 0.60, 95% CI 0.50-0.73; IPW-controlled OR for daily use: 0.75, 95% CI 0.62-0.91), as ascertained by the M-CHAT. This was confirmed when studying TV as well as computer/tablet exposure separately. CONCLUSIONS: Overall, our nationally-representative study conducted among a large sample of 2-year-old children, indicates a complex relationship between screen exposure and ASD risk.

A Randomized Double-Blinded Placebo Controlled Trial of Clazakizumab for the Treatment of COVID-19 Pneumonia With Hyperinflammation.

OBJECTIVES: We designed this study to test whether clazakizumab, a direct interleukin-6 inhibitor, benefits patients hospitalized with severe or critical COVID-19 disease accompanied by hyperinflammation. DESIGN: Multicenter, randomized, double-blinded, placebo-controlled, seamless phase II/III trial. SETTING: Five U.S. medical centers. PATIENTS: Adults inpatients with severe COVID-19 disease and hyperinflammation. INTERVENTIONS: Eighty-one patients enrolled in phase II, randomized 1:1:1 to low-dose (12.5 mg) or high-dose (25 mg) clazakizumab or placebo. Ninety-seven patients enrolled in phase III, randomized 1:1 to high-dose clazakizumab or placebo. MEASUREMENTS AND MAIN RESULTS: The primary outcome was 28-day ventilator-free survival. Secondary outcomes included overall survival, frequency and duration of intubation, and frequency and duration of ICU admission. Per Data Safety and Monitoring Board recommendations, additional secondary outcomes describing clinical status and status changes, as measured by an ordinal scale, were added. Bayesian cumulative proportional odds, logistic, and Poisson regression models were used. The low-dose arm was dropped when the phase II study suggested superiority of the high-dose arm. We report on 152 patients, 74 randomized to placebo and 78 to high-dose clazakizumab. Patients receiving clazakizumab had greater odds of 28-day ventilator-free survival (odds ratio [OR] = 3.84; p [OR > 1] 99.9%), as well as overall survival at 28 and 60 days (OR = 1.75; p [OR > 1] 86.5% and OR = 2.53; p [OR > 1] 97.7%). Clazakizumab was associated with lower odds of intubation (OR = 0.2; p [OR] < 1; 99.9%) and ICU admission (OR = 0.26; p [OR < 1] 99.6%); shorter durations of ventilation and ICU stay (risk ratio [RR] < 0.75; p [RR < 1] > 99% for both); and greater odds of improved clinical status at 14, 28, and 60 days (OR = 2.32, p [OR > 1] 98.1%; OR = 3.36, p [OR > 1] 99.6%; and OR = 3.52, p [OR > 1] 99.8%, respectively). CONCLUSIONS: Clazakizumab significantly improved 28-day ventilator-free survival, 28- and 60-day overall survival, as well as clinical outcomes in hospitalized patients with COVID-19 and hyperinflammation.

Are COVID-19 mRNA vaccine side effects severe enough to cause missed work? Cross-sectional study of health care-associated workers.

ABSTRACT: The Coronavirus Disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome-coronavirus-2, has claimed 5,587,549 lives worldwide as of January 20, 2022. Fortunately, large-scale vaccination can mitigate the impact of COVID-19 by making the disease milder and less common. Although 75.2% of the United States population has received at least 1 dose of a COVID-19 vaccines thus far, concerns regarding vaccine side effects have contributed to vaccine hesitancy. Furthermore, nearly 50% of adults in the United States are concerned not only about side effects, but about their downstream impact, including missed work.The goal of this cross-sectional study was to investigate the effect of messenger RNA vaccine adverse effects on the propensity to miss work among employees associated with a single, large academic health center.Using Qualtrics, all employees, including faculty, staff, and trainees, of 5 large departments were surveyed to determine whether they received the COVID-19 vaccine and which type, and any symptoms they experienced after receipt of either vaccine dose. We hypothesized that vaccine recipients would be more likely to miss work or feel sick enough to miss work following the second dose.Thirty-seven percent of respondents experienced events severe enough that they needed to miss work from either of the doses, with the majority (27.8%) related to the second dose. These findings are consistent with and expand on the results from the phase 3 trials for Pfizer-BionTech and Moderna, which showed that vaccine side effects were more common after the second dose than after the first dose. Our statistically significant finding was more common among Asians, women, trainees/house staff, and nonphysician clinical employees.With an increasing number of individuals taking the vaccine, employers will need to account for the impact of adverse effects on their employees' ability to work. These findings will further help organizations better plan for staffing as vaccinations increase to mitigate the spread of COVID-19.

Overweight/Obesity and Time Preference: Evidence from a Survey among Adults in the UK.

INTRODUCTION: Overweight and obesity is a global problem incurring substantial health and economic implications. This has also been highlighted by the ongoing COVID-19 pandemic which has disproportionately affected overweight and obese individuals. Most of the interventions have concentrated on promotion of physical activities and healthy eating which may involve current sacrifices for future health gains. The purpose of this study was to explore the relationship between bodyweight and how individuals state they would trade-off immediate income for higher amounts in the future (time preference). METHODS: An online survey was conducted targeting adults aged >16 years in the UK (England, Northern Ireland, Scotland, and Wales) from January 1, 2016 to July 31, 2016. Using paid online adverts, as well as personal and professional networks for distribution of links to the online survey, the questionnaire asked respondents to report socio-economic and demographic information, height, and weight and to complete a time preference exercise. Data were analysed using descriptive statistics; associations were explored between BMI and respondents' characteristics and time preference using Spearman rank-order correlation and χ2 tests as appropriate. We adopted STROBE guidelines for the reporting of the study. RESULTS: A total of 561 responses were analysed (female = 293, males = 268). The relationship between time preference and overweight/obesity, using BMI as the measure is highly significant (χ2 = 95.92: p < 0.001). Individuals of normal weight have low time preferences and are more likely to invest in activities in a bid to reap future health benefits. There are also significant relationships between BMI and employment status (χ2 = 37.03; p < 0.001), physical activities (p < 0.0001), income levels (χ2 = 6.68; p < 0.035), family orientation, i.e., with or without children (χ2 = 12.88; p < 0.012), and ethnicity (χ2 = 18.31; p < 0.001). These imply that individuals in employment and with children in their families are less likely to be overweight or obese compared to those who do not. People from black backgrounds are also more likely to be overweight or obese and have higher time preferences compared to people from white backgrounds. DISCUSSIONS/CONCLUSIONS: People's preventive behaviours today can be predicted by their time preference and this understanding could be vital in improving population's uptake and maintenance of overweight and obesity prevention actions. People who have low time preference are more likely to invest time and resources in physical activities and healthy lifestyles to reap future health benefits hence value utilities-in-anticipation. Public health programmes should therefore use the knowledge of the association between time preference and overweight/obesity to inform designs of intervention programmes.

Effect of intensive versus limited monitoring on clinical trial conduct and outcomes: A randomized trial.

BACKGROUND: Regulatory agencies have endorsed more limited approaches to clinical trial site monitoring. However, the impact of different monitoring strategies on trial conduct and outcomes is unclear. METHODS: We conducted a patient-level block-randomized controlled trial evaluating the effect of intensive versus limited monitoring on cardiovascular clinical trial conduct and outcomes nested within the CoreValve Continued Access and Expanded Use Studies. Intensive monitoring included complete source data verification of all critical datapoints whereas limited monitoring included automated data checks only. This study's endpoints included clinical trial outcome ascertainment as well as monitoring action items, protocol deviations, and adverse event ascertainment. RESULTS: A total of 2,708 patients underwent transcatheter aortic valve replacement (TAVR) and were randomized to either intensive monitoring (n = 1,354) or limited monitoring (n = 1,354). Monitoring action items were more common with intensive monitoring (52% vs 15%; P < .001), but there was no difference in the percentage of patients with any protocol deviation (91.6% vs 90.4%; P = .314). The reported incidence of trial outcomes between intensive and limited monitoring was similar for mortality (30 days: 4.8% vs 5.5%, P = .442; 1 year: 20.3% vs 21.3%, P = .473) and stroke (30 days: 2.8% vs 2.4%, P = .458), as well as most secondary trial outcomes with the exception of bleeding (intensive: 36.3% vs limited: 32.0% at 30 days, P = .019). There was a higher reported incidence of cardiac adverse events reported in the intensive monitoring group at 1 year (76.7% vs 72.4%; P = .019). CONCLUSIONS: Tailored limited monitoring strategies can be implemented without influencing the integrity of TAVR trial outcomes.

COVID-19 Significantly Impacted Hospital Length of Stay and Discharge Patterns for Adult Spinal Deformity Patients.

STUDY DESIGN: Retrospective review. OBJECTIVE: The primary aim was to compare length of stay (LOS) and discharge disposition of adult spinal deformity (ASD) patients undergoing surgery before and during the pandemic. Secondary aims were to compare the rates of 30-day complications, reoperations, readmissions, and unplanned emergency department (ED) visits. SUMMARY OF BACKGROUND DATA: ASD patients often require extended LOS and non-routine discharge. Given resource limitations during the Coronavirus Disease 2019 (COVID-19) pandemic and caution regarding hospital stays, surgeons modified standard postoperative protocols to minimize patient exposure. METHODS: We identified all patients who underwent elective thoracolumbar ASD surgery with more than or equal to five levels fusion at a tertiary care center during two distinct time intervals: July to December 2019 (Pre-COVID, N = 60) and July to December 2020 (During-COVID, N = 57). Outcome measures included LOS and discharge disposition (home vs. non-home), as well as 30-day major complications, reoperations, readmissions, and ED visits. Regression analyses controlled for demographic and surgical factors. RESULTS: Patients who underwent ASD surgery during the pandemic were younger (61 vs. 67 yrs) and had longer fusion constructs (nine vs. eight levels) compared with before the pandemic (P < 0.05 for both). On bivariate analysis, patients undergoing surgery during the pandemic had shorter LOS (6 vs. 9 days) and were more likely to be discharged home (70% vs. 28%) (P < 0.05 for both). After controlling for age and levels fused on multivariable regression, patients who had surgery during the pandemic had shorter LOS (IRR = 0.83, P = 0.015) and greater odds of home discharge (odds ratios [OR] = 7.2, P < 0.001). Notably, there were no differences in major complications, reoperations, readmissions, or ED visits between the two groups. CONCLUSION: During the COVID-19 pandemic, LOS for patients undergoing thoracolumbar ASD surgery decreased, and more patients were discharged home without adversely affecting complication or readmission rates. Lessons learned during the pandemic may help improve resource utilization without negatively influencing short-term outcomes.Level of Evidence: 3.

Kidney allograft biopsy findings after COVID-19.

COVID-19 has been associated with acute kidney injury and published reports of native kidney biopsies have reported diverse pathologies. Case series directed specifically to kidney allograft biopsy findings in the setting of COVID-19 are lacking. We evaluated 18 kidney transplant recipients who were infected with SARS-CoV-2 and underwent allograft biopsy. Patients had a median age of 55 years, six were female, and five were Black. Fifteen patients developed COVID-19 pneumonia, of which five required mechanical ventilation. Notably, five of 11 (45%) biopsies obtained within 1 month of positive SARS-CoV-2 PCR showed acute rejection (four with arteritis, three of which were not associated with reduced immunosuppression). The remaining six biopsies revealed podocytopathy (n = 2, collapsing glomerulopathy and lupus podocytopathy), acute tubular injury (n = 2), infarction (n = 1), and transplant glomerulopathy (n = 1). Biopsies performed >1 month after positive SARS-CoV-2 PCR revealed collapsing glomerulopathy (n = 1), acute tubular injury (n = 1), and nonspecific histologic findings (n = 5). No direct viral infection of the kidney allograft was detected by immunohistochemistry, in situ hybridization, or electron microscopy. On follow-up, two patients died and most patients showed persistent allograft dysfunction. In conclusion, we demonstrate diverse causes of kidney allograft dysfunction after COVID-19, the most common being acute rejection with arteritis.

P79. The COVID-19 pandemic significantly impacted hospital length of stay and discharge patterns for ASD surgery

BACKGROUND CONTEXT During the COVID-19 pandemic, surgeons found ways to provide appropriate care while conserving inpatient resources and limiting potential exposure. For patients with adult spinal deformity (ASD), spine surgery often requires extended LOS and non-routine discharge. Given resource limitations during the COVID-19 pandemic and caution regarding hospital stays, surgeons have modified standard postoperative protocols to minimize patient exposure. PURPOSE The primary aim of this study was to compare LOS and discharge disposition of ASD patients undergoing surgery before and during the pandemic. Secondary aims were to compare the rates of 30-day complications, readmissions, and ED visits. STUDY DESIGN/SETTING Retrospective review of an institutional surgical registry. PATIENT SAMPLE A total of 117 patients with adult thoracolumbar deformity. OUTCOME MEASURES Outcome measures included LOS and discharge disposition (home vs non-home), as well as 30-day major complications, reoperations, readmissions and ED visits. METHODS We identified all patients who underwent elective thoracolumbar ASD surgery with ≥5 levels fusion at a tertiary care center during two distinct time intervals: Jul-Dec 2019 (Pre-COVID, N=60) and Jul-Dec 2020 (During-COVID, N=57). Outcome measures included LOS and discharge disposition (home vs non-home), as well as 30-day major complications, reoperations, readmissions, and ED visits. Regression analyses controlled for demographic and surgical factors. RESULTS Patients who underwent ASD surgery during the pandemic were younger (61 vs 67 years) and had longer fusion constructs (9 vs 8 levels) compared to before pandemic (p<0.05 for both). On bivariate analysis, patients undergoing surgery during the pandemic had significantly lower LOS (6 vs 8 days) and were more likely to be discharged home (70% vs 28%) (p<0.05 for both). After controlling for age and levels fused on multivariable regression, patients who had surgery during the pandemic continued to demonstrate a significantly lower LOS (IRR=0.83, p=0.015) and greater odds of home discharge (OR=7.2, p<0.001). Notably, there were no significant differences in reoperations, readmissions, ED visits, or major complications between the two groups (p>0.05 for all). CONCLUSIONS During the COVID-19 pandemic, the LOS for patients undergoing thoracolumbar ASD surgery decreased, and more patients were discharged home without adversely affecting complication or readmission rates. Lessons learned during the pandemic may help improve resource utilization without negatively influencing outcomes. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Perspectives on COVID-19 vaccination among kidney and pancreas transplant recipients living in New York City.

PURPOSE: Solid organ transplant recipients are at increased risk of morbidity and mortality from coronavirus disease 2019 (COVID-19), but limited vaccine access and vaccine hesitancy can complicate efforts for expanded vaccination. We report patient perspectives and outcomes from a vaccine outreach initiative for a vulnerable population of transplant recipients living in New York City. METHODS: This was a retrospective review of qualitative perspectives from a COVID-19 vaccine outreach initiative. In the outreach effort, kidney and pancreas transplant recipients under care at the transplant center at NewYork-Presbyterian Hospital were initially contacted electronically with educational material about vaccination followed by telephone outreach to eligible unvaccinated patients. Calls were used to schedule vaccine appointments for patients who agreed, answer questions, and assess attitudes and concerns for patients not yet ready to be vaccinated, with conversational themes recorded. RESULTS: Of the 1,078 patients living in the 5 New York City boroughs who had not reported receiving COVID-19 vaccination, 320 eligible patients were contacted by telephone. Of these, 210 patients were scheduled for vaccination at our vaccine site (including 13 who agreed to vaccination after initially declining), while 110 patients were either not ready or not interested in being vaccinated. The total number of patients willing to be vaccinated was 554 when also including those already vaccinated. Unwillingness to be vaccinated was associated with younger age (median age of 47 vs 60 years, P < 0.001), Black race (P = 0.004), and residence in Bronx or Brooklyn counties (P = 0.018) or a zip code with a medium level of poverty (P = 0.044). The most common issues raised by patients who were ambivalent or not interested in vaccination were regarding unknown safety of the vaccines in general, a belief that there was a lack of data about the vaccines in transplant recipients, and a lack of trust in the scientific process underlying vaccine development, with 34% of the patients contacted expressing vaccine hesitancy overall. CONCLUSION: Our qualitative summary identifies determinants of COVID-19 vaccine hesitancy in a diverse transplant patient population, supporting the need for transplant centers to implement tailored interventions to increase vaccine acceptance in this vulnerable population.

Prevalence and predictors of SARS-CoV-2 antibodies among solid organ transplant recipients with confirmed infection.

It remains uncertain whether immunocompromised patients including solid organ transplant (SOT) recipients will have a robust antibody response to SARS-CoV-2 infection. We enrolled all adult SOT recipients at our center with confirmed SARS-CoV-2 infection who underwent antibody testing with a single commercially available anti-nucleocapsid antibody test at least 7 days after diagnosis in a retrospective cohort. Seventy SOT recipients were studied (56% kidney, 19% lung, 14% liver ± kidney, and 11% heart ± kidney recipients). Thirty-six (51%) had positive anti-nucleocapsid antibody testing, and 34 (49%) were negative. Recipients of a kidney allograft were less likely to have positive antibody testing compared to those who did not receive a kidney (p = .04). In the final multivariable model, the years from transplant to diagnosis (OR 1.26, p = .002) and baseline immunosuppression with more than two agents (OR 0.26, p = .03) were significantly associated with the antibody test result, controlling for kidney transplantation. In conclusion, among SOT recipients with confirmed infection, only 51% of patients had detectable anti-nucleocapsid antibodies, and transplant-related variables including the level and nature of immunosuppression were important predictors. These findings raise the concern that SOT recipients with COVID-19 may be less likely to form SARS-CoV-2 antibodies.

COVID-19 may affect male fertility but is not sexually transmitted: a systematic review.

OBJECTIVE: To determine if SARS-CoV-2, which has led to the rapidly spreading COVID-19 global pandemic, is sexually transmitted. Since the putative receptor for the virus is identified in reproductive organs, it is also important to examine if COVID-19 may affect human fertility. EVIDENCE REVIEW: A systematic review of English publications was conducted up to December 11, 2020 in PubMed, NIH iCite COVID-19 portfolio, Cochrane Library, and Google Scholar databases, searching for SARS-CoV-2 in the testes; seminal, prostatic, and vaginal fluids; and cervical smears. A total of 1,997 records were identified, duplicates were removed, and 1,490 records were reviewed for eligibility by examining titles and abstracts. Subsequently, 202 full-text relevant articles were reviewed by 2 independent reviewers. Forty-seven studies (literature reviews, editorials, and guidelines) were assessed qualitatively, and 23 studies that tested the male and female reproductive tracts of patients with COVID-19 for SARS-CoV-2 were quantitatively analyzed. RESULTS: No epidemiological investigations to date have described evidence suggesting that COVID-19 is an STD. While angiotensin-converting enzyme 2 receptor is found in the reproductive organs, the lack of co-expression of the TMPRSS2 modulatory protein, required for SARS-CoV-2 cell entry, in testicular cells, sperm, or oocytes, argues against the hypothesis that gametes transmit SARS-CoV-2. Molecular detection studies of SARS-CoV-2 RNA in the male and female reproductive tracts were summarized: 98.0% (293/299) of the seminal fluids, 16/17 testicular biopsies, all 89 prostatic fluids, 98.3% (57/58) of the vaginal fluids, all 35 cervical smears, and all 16 oocyte samples tested negative for SARS-CoV-2. None of the studies confirmed sexual transmission of SARS-CoV-2. Nonetheless, COVID-19 may have detrimental effects on male reproduction by inducing orchitis and/or decreasing testosterone levels, sperm counts, and motility. CONCLUSION: On the basis of the current worldwide published information, COVID-19 is not an STD. This information is important for clinicians, proposed guidelines for public health, U.S. Food and Drug Administration guidelines for gamete and tissue donor eligibility, and fertility treatments. Universal precautions, currently practiced worldwide, are adequate and sufficient at this time to prevent the transmission of known or unknown viral infections. We suggest that recovered patients of COVID-19, especially those with infertility, should be evaluated for their ovarian and testicular function.

STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement.

The STS-ACC TVT Registry (Society of Thoracic Surgeons-American College of Cardiology Transcatheter Valve Therapy Registry) from 2011 to 2019 has collected data on 276,316 patients undergoing transcatheter aortic valve replacement (TAVR) at sites in all U.S. states. Volumes have increased every year, exceeding surgical aortic valve replacement in 2019 (72,991 vs. 57,626), and it is now performed in all U.S. states. TAVR now extends from extreme- to low-risk patients. This is the first presentation on 8,395 low-risk patients treated in 2019. In 2019, for the entire cohort, femoral access increased to 95.3%, hospital stay was 2 days, and 90.3% were discharged home. Since 2011, the 30-day mortality rate has decreased (7.2% to 2.5%), stroke has started to decrease (2.75% to 2.3%), but pacemaker need is unchanged (10.9% to 10.8%). Alive with acceptable patient-reported outcomes is achieved in 8 of 10 patients at 1 year. The Registry is a national resource to improve care and analyze TAVR's evolution. Real-world outcomes, site performance, and the impact of coronavirus disease 2019 will be subsequently studied. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528).

Autism and COVID-19: A Case Series in a Neurodevelopmental Unit.

BACKGROUND: COVID-19 has become pandemic and can impact individuals with autism as well. Here, we report a case series admitted to a neurobehavioral unit dedicated to challenging behaviors in patients with autism. METHODS: We describe 16 patients (mean age 20.8 years; range 12-43 years; 76% male) with autism hospitalized between March 2020 and mid-April 2020 for challenging behaviors, for which COVID-19 disease has been suspected and who needed both psychiatric and medical care. A close cooperation with the Infectious and Tropical Diseases Department was organized to limit viral spread and training sessions (e.g., hygiene, clinical COVID-19 monitoring, virus testing) were given to staff members. RESULTS: Most patients had severe autism and severe/moderate intellectual disability. Eleven patients were already in the unit when it was hit by the pandemic, and five were admitted from the community. Based on a virus search via reverse transcriptase polymerase chain reaction (RT-PCR) or serology at the 2-month follow-up, we had 11 confirmed COVID-19 cases. The main COVID-19 symptoms included benign upper respiratory infection signs (N = 9, 81.8%), diarrhea (N = 7, 63.6%), fatigue (N = 7, 63.6%), and respiratory signs (N = 5, 45.5%), including one patient who needed oxygen therapy. Three patients remained asymptomatic and COVID-19-free (including two under immunosuppressive treatments). Among the symptomatic patients, five showed atypical behaviors that we understood as idiosyncratic manifestations (e.g., irrepressible licking behavior). On day 14, only one patient with respiratory dysfunction still had a positive RT-PCR SARS-CoV-2 test. CONCLUSIONS: Organizing a COVID+ unit for patients with autism is realistic and requires close collaboration with infectologists. We believe that this initiative should be promoted to limit both the spread of the virus and the ostracism of patients with autism and challenging behaviors.

Tocilizumab for severe COVID-19 in solid organ transplant recipients: a matched cohort study.

The safety and efficacy of tocilizumab for the treatment of severe respiratory symptoms due to COVID-19 remain uncertain, in particular among solid organ transplant (SOT) recipients. Thus, we evaluated the clinical characteristics and outcomes of 29 hospitalized SOT recipients who received tocilizumab for severe COVID-19, compared to a matched control group who did not. Among a total of 117 total SOT recipients hospitalized with COVID-19, 29 (24.8%) received tocilizumab. The 90-day mortality was significantly higher among patients who received tocilizumab (41%) compared to those who did not (20%, P = .03). When compared to control patients matched by age, hypertension, chronic kidney disease, and administration of high dose corticosteroids, there was no significant difference in mortality (41% vs 28%, P = .27), hospital discharge (52% vs 72%, P = .26), or secondary infections (34% vs 24%, P = .55). Among patients who received tocilizumab, there was also no difference in mortality based on the level of oxygen support (intubated vs not intubated) at the time of tocilizumab initiation. In this matched cohort study, tocilizumab appeared to be safe but was not associated with decreased 90-day mortality. Larger randomized studies are needed to identify whether there are subsets of SOT recipients who may benefit from tocilizumab for treatment of COVID-19.

Impact of COVID-19 on Stroke Caseload in a Major Hyperacute Stroke Unit.

Northwick Park Hospital in London, United Kingdom (UK) is one of the busiest stroke units in the country and is located in one of the areas most heavily affected by the COVID-19 pandemic in the first half of 2020. Admissions to the stroke unit and changes during the peak of COVID-19 were reviewed. Compared with the previous year, mean 96 patients were admitted with suspected stroke during April and May 2020 compared with mean 116 per month in non-COVID periods, ratio 0.82, P = 0.01. This reduction involved both strokes and mimics and was unlikely to have occurred by chance. Numbers of patients thrombolysed and of patients referred for thrombectomy decreased dramatically during this time. Mechanisms by which the COVID-19 pandemic and the March lockdown may have affected admissions to the unit are discussed. Reduced admissions to the stroke unit allowed it to contribute its resources to the care of patients with COVID-19 during the peak of admissions.