Low absolute risk of thrombotic and cardiovascular events in outpatient pregnant women with COVID-19.

INTRODUCTION: Pregnancy may contribute to an excess risk of thrombotic or cardiovascular events. COVID-19 increases the risk of these events, although the risk is relatively limited among outpatients. We sought to determine whether outpatient pregnant women with COVID-19 are at a high risk for cardiovascular or thrombotic events. MATERIALS & METHODS: We analyzed pregnant outpatients with COVID-19 from the multicenter CORONA-VTE-Network registry. The main study outcomes were a composite of adjudicated venous or arterial thrombotic events, and a composite of adjudicated cardiovascular events. Events were assessed 90 days after the COVID-19 diagnosis and reported for non-pregnant women ≤45 years, and for men ≤45 years, as points of reference. RESULTS: Among 6585 outpatients, 169 were pregnant at diagnosis. By 90-day follow-up, two pregnant women during the third trimester had lower extremity venous thrombosis, one deep and one superficial vein thrombosis. The cumulative incidence of thrombotic events was 1.20 % (95 % confidence interval [CI]: 0.0 to 2.84 %). Respective rates were 0.47 % (95 % CI: 0.14 % to 0.79 %) among non-pregnant women, and 0.49 % (95 % CI: 0.06 % to 0.91 %) among men ≤45 years. No non-thrombotic cardiovascular events occurred in pregnant women. The rates of cardiovascular events were 0.53 % (95 % CI: 0.18 to 0.87) among non-pregnant women, and 0.68 % (95 % CI: 0.18 to 1.18) in men aged ≤45 years. CONCLUSIONS: Thrombotic and cardiovascular events are rare among outpatients with COVID-19. Although a higher event rate among outpatient pregnant women cannot be excluded, the absolute event rates are low and do not warrant population-wide cardiovascular interventions to optimize outcomes.

Contemporary trends in mortality related to high-risk pulmonary embolism in US from 1999 to 2019.

BACKGROUND: Population-based data on high-risk pulmonary embolism (PE) mortality trends in the United States (US) are scant. OBJECTIVES: To assess current trends in US mortality related to high-risk PE over the past 21 years and determine differences by sex, race, ethnicity, age and census region. METHODS: Data were extracted from the Centers for Disease Control and Prevention (CDC) Wide-ranging ONline Data for Epidemiologic Research (WONDER) to determine trends in age-adjusted mortality rates (AAMR) per 100,000 people, due to high-risk PE. To calculate nationwide annual trends, we assessed the average (AAPC) and annual percent change (APC) with relative 95 % confidence intervals (CIs) using Joinpoint regression. RESULTS: Between 1999 and 2019, high-risk PE was listed as the underlying cause of death in 209,642 patients, corresponding to an AAMR of 3.01 per 100,000 people (95 % CI: 2.99 to 3.02). AAMR from high-risk PE remained stable from 1999 to 2007 [APC: -0.2 %, (95 % CI: -2.0 to 0.5, p = 0.22)] and then significantly increased [APC: 3.1 % (95 % CI: 2.6 to 3.6), p < 0.0001], especially in males [AAPC: 1.9 % (95 % CI: 1.4 to 2.4), p < 0.001 vs AAPC: 1.5 % (95 % CI: 1.1 to 2.2), p < 0.001]. AAMR increase was more pronounced in those <65 years, Black Americans, and residents of rural areas. CONCLUSIONS: In an US population analysis, high-risk PE mortality rate increased, with racial, sex-based, and regional variations. Further studies are needed to understand root causes for these trends and to implement appropriate corrective strategies.

Major cardiovascular events after COVID-19, event rates post-vaccination, antiviral or anti-inflammatory therapy, and temporal trends: Rationale and methodology of the CORONA-VTE-Network study.

BACKGROUND: Coronavirus disease 2019 (COVID-19) is associated with excess risk of cardiovascular and thrombotic events in the early post-infection period and during convalescence. Despite the progress in our understanding of cardiovascular complications, uncertainty persists with respect to more recent event rates, temporal trends, association between vaccination status and outcomes, and findings within vulnerable subgroups such as older adults (aged 65 years or older), or those undergoing hemodialysis. Sex-informed findings, including results among pregnant and breastfeeding women, as well as adjusted comparisons between male and female adults are similarly understudied. METHODS: Adult patients, aged ≥18 years, with polymerase chain reaction-confirmed COVID-19 who received inpatient or outpatient care at the participating centers of the registry are eligible for inclusion. A total of 10,000 patients have been included in this multicenter study, with Brigham and Women's Hospital (Boston, MA) serving as the coordinating center. Other sites include Beth Israel Deaconess Medical Center, Anne Arundel Medical Center, University of Virginia Medical Center, University of Colorado Health System, and Thomas Jefferson University Health System. Data elements will be ascertained manually for accuracy. The two main outcomes are 1) a composite of venous or arterial thrombotic events, and 2) a composite of major cardiovascular events, defined as venous or arterial thrombosis, myocarditis or heart failure with inpatient treatment, new atrial fibrillation/flutter, or cardiovascular death. Clinical outcomes are adjudicated by independent physicians. Vaccination status and time of inclusion in the study will be ascertained for subgroup-specific analyses. Outcomes are pre-specified to be reported separately for hospitalized patients versus those who were initially receiving outpatient care. Outcomes will be reported at 30-day and 90-day follow-up. Data cleaning at the sites and the data coordinating center and outcomes adjudication process are in-progress. CONCLUSIONS: The CORONA-VTE-Network study will share contemporary information related to rates of cardiovascular and thrombotic events in patients with COVID-19 overall, as well as within key subgroups, including by time of inclusion, vaccination status, patients undergoing hemodialysis, the elderly, and sex-informed analyses such as comparison of women and men, or among pregnant and breastfeeding women.

Anticoagulation-Associated Adverse Drug Events in Hospitalized Patients Across Two Time Periods.

PURPOSE: Anticoagulants often cause adverse drug events (ADEs), comprised of medication errors and adverse drug reactions, in patients. Our study objective was to determine the clinical characteristics, types, severity, cause, and outcomes of anticoagulation-associated ADEs from 2015-2020 (a contemporary period following implementation of an electronic health record, infusion device technology, and anticoagulant dosing nomograms) and to compare them with those of a historical period (2004-2009). METHODS: We reviewed all anticoagulant-associated ADEs reported as part of our hospital-wide safety system. Reviewers classified type, severity, root cause, and outcomes for each ADE according to standard definitions. Reviewers also assessed events for patient harm. Patients were followed up to 30 days after the event. RESULTS: Despite implementation of enhanced patient safety technology and procedure, ADEs increased in the contemporary period. In the contemporary period, we found 925 patients who had 984 anticoagulation-associated ADEs, including 811 isolated medication errors (82.4%); 13 isolated adverse drug reactions (1.4%); and 160 combined medication errors, adverse drug reactions, or both (16.2%). Unfractionated heparin was the most frequent ADE-related anticoagulant (77.7%, contemporary period vs 58.3%, historical period). The most frequent anticoagulation-associated medication error in the contemporary period was wrong rate or frequency of administration (26.1%, n = 253), with the most frequent root cause being prescribing errors (21.3%, n = 207). The type, root cause, and harm from ADEs were similar between periods. CONCLUSIONS: We found that anticoagulation-associated ADEs occurred despite advances in patient safety technologies and practices. Events were common, suggesting marginal improvements in anticoagulant safety over time and ample opportunities for improvement.

A Systematic Review of Passing as Non-autistic in Autism Spectrum Disorder.

While long described in anecdotal accounts of the lived experiences of autistic individuals, the phenomenon of behaving in ways that appear inconsistent with the presence of autism (or passing as non-autistic; PAN) has recently seen a dramatic increase in scrutiny in the published scientific literature. Increased research attention has coincided with a proliferation of methods, definitions, measures, and population assumptions associated with PAN. To date, however, no review has sought to systematically identify and synthesize the literature on PAN. This systematic review reflects the state of the PAN literature as of May 2020. Ninety articles were screened, 66 were identified for evaluation, and 46 met inclusion criteria and were reliably coded for study characteristics and participant characteristics. Results reveal that the PAN literature includes a relatively even mix of qualitative, quantitative, and mixed-method studies, and that a variety of terms are used for PAN (with masking and camouflage being the most frequent). Sample sizes varied widely (from one to 832 participants), with 63.06% of participants being categorized as autistic. Nearly all studies reported methods for confirming autism diagnoses, with community and clinical diagnoses being most common. The majority of studies reported participant gender, with slightly more females included than males on average, but fewer than half of all studies compared PAN across genders. Nearly all studies reported participant age, demonstrating a wide range of 2 to 79 years, with a mean age of 23.85. Conversely, only 23.91% of studies provided participant race or ethnicity data. Nearly all studies formally or informally excluded participants with intellectual disability. Finally, measures of internalizing symptoms, which are often thought to be linked to PAN, were reported in only 17.4% of studies. Implications for gaps in understanding of PAN and future directions for the field are discussed.