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1. Comparative epidemiology of five waves of COVID-19 in Mexico, March 2020–August 2022

   https://doi.org/10.1186/s12879-022-07800-w  

   Ascencio-Montiel, Iván de Jesús ; Ovalle-Luna, Oscar David ; Rascón-Pacheco, Ramón Alberto ; Borja-Aburto, Victor Hugo ; Chowell, Gerardo ( October 2022 , BMC Infectious Diseases)

   The Mexican Institute of Social Security (IMSS) is the largest health care provider in Mexico, covering about 48% of the Mexican population. In this report, we describe the epidemiological patterns related to confirmed cases, hospitalizations, intubations, and in-hospital mortality due to COVID-19 and associated factors, during five epidemic waves recorded in the IMSS surveillance system.

   We analyzed COVID-19 laboratory-confirmed cases from the Online Epidemiological Surveillance System (SINOLAVE) from March 29th, 2020, to August 27th, 2022. We constructed weekly epidemic curves describing temporal patterns of confirmed cases and hospitalizations by age, gender, and wave. We also estimated hospitalization, intubation, and hospital case fatality rates. The mean days of in-hospital stay and hospital admission delay were calculated across five pandemic waves. Logistic regression models were employed to assess the association between demographic factors, comorbidities, wave, and vaccination and the risk of severe disease and in-hospital death.

   A total of 3,396,375 laboratory-confirmed COVID-19 cases were recorded across the five waves. The introduction of rapid antigen testing at the end of 2020 increased detection and modified epidemiological estimates. Overall, 11% (95% CI 10.9, 11.1) of confirmed cases were hospitalized, 20.6% (95% CI 20.5, 20.7) of the hospitalized cases were intubated, and the hospital case fatality rate was 45.1% (95% CI 44.9, 45.3). The mean in-hospital stay was 9.11 days, and patients were admitted on average 5.07 days after symptoms onset. The most recent waves dominated by the Omicron variant had the highest incidence. Hospitalization, intubation, and mean hospitalization days decreased during subsequent waves. The in-hospital case fatality rate fluctuated across waves, reaching its highest value during the second wave in winter 2020. A notable decrease in hospitalization was observed primarily among individuals ≥ 60 years. The risk of severe disease and death was positively associated with comorbidities, age, and male gender; and declined with later waves and vaccination status.

   During the five pandemic waves, we observed an increase in the number of cases and a reduction in severity metrics. During the first three waves, the high in-hospital fatality rate was associated with hospitalization practices for critical patients with comorbidities.

    

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2. Sepsis subphenotyping based on organ dysfunction trajectory

   https://doi.org/10.1186/s13054-022-04071-4  

   Xu, Zhenxing ; Mao, Chengsheng ; Su, Chang ; Zhang, Hao ; Siempos, Ilias ; Torres, Lisa K. ; Pan, Di ; Luo, Yuan ; Schenck, Edward J. ; Wang, Fei ( December 2022 , Critical Care)

   Abstract Background Sepsis is a heterogeneous syndrome, and the identification of clinical subphenotypes is essential. Although organ dysfunction is a defining element of sepsis, subphenotypes of differential trajectory are not well studied. We sought to identify distinct Sequential Organ Failure Assessment (SOFA) score trajectory-based subphenotypes in sepsis. Methods We created 72-h SOFA score trajectories in patients with sepsis from four diverse intensive care unit (ICU) cohorts. We then used dynamic time warping (DTW) to compute heterogeneous SOFA trajectory similarities and hierarchical agglomerative clustering (HAC) to identify trajectory-based subphenotypes. Patient characteristics were compared between subphenotypes and a random forest model was developed to predict subphenotype membership at 6 and 24 h after being admitted to the ICU. The model was tested on three validation cohorts. Sensitivity analyses were performed with alternative clustering methodologies. Results A total of 4678, 3665, 12,282, and 4804 unique sepsis patients were included in development and three validation cohorts, respectively. Four subphenotypes were identified in the development cohort: Rapidly Worsening ( n  = 612, 13.1%), Delayed Worsening ( n  = 960, 20.5%), Rapidly Improving ( n  = 1932, 41.3%), and Delayed Improving ( n  = 1174, 25.1%). Baseline characteristics, including the pattern of organ dysfunction, varied between subphenotypes. Rapidly Worsening was defined by a higher comorbidity burden, acidosis, and visceral organ dysfunction. Rapidly Improving was defined by vasopressor use without acidosis. Outcomes differed across the subphenotypes, Rapidly Worsening had the highest in-hospital mortality (28.3%, P -value < 0.001), despite a lower SOFA (mean: 4.5) at ICU admission compared to Rapidly Improving (mortality:5.5%, mean SOFA: 5.5). An overall prediction accuracy of 0.78 (95% CI, [0.77, 0.8]) was obtained at 6 h after ICU admission, which increased to 0.87 (95% CI, [0.86, 0.88]) at 24 h. Similar subphenotypes were replicated in three validation cohorts. The majority of patients with sepsis have an improving phenotype with a lower mortality risk; however, they make up over 20% of all deaths due to their larger numbers. Conclusions Four novel, clinically-defined, trajectory-based sepsis subphenotypes were identified and validated. Identifying trajectory-based subphenotypes has immediate implications for the powering and predictive enrichment of clinical trials. Understanding the pathophysiology of these differential trajectories may reveal unanticipated therapeutic targets and identify more precise populations and endpoints for clinical trials. 

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3. Vascular comorbidities worsen prognosis of patients with heart failure hospitalised with COVID-19

   https://doi.org/10.1136/openhrt-2021-001668  

   Mok, Jacob ; Malpartida, Juan Carlos ; O'Dell, Kimberly ; Davis, Joshua ; Gao, Cuilan ; Manyam, Harish ( June 2021 , Open Heart)

   null (Ed.)

   Background Prior diagnosis of heart failure (HF) is associated with increased length of hospital stay (LOS) and mortality from COVID-19. Associations between substance use, venous thromboembolism (VTE) or peripheral arterial disease (PAD) and its effects on LOS or mortality in patients with HF hospitalised with COVID-19 remain unknown. Objective This study identified risk factors associated with poor in-hospital outcomes among patients with HF hospitalised with COVID-19. Methods Case–control study was conducted of patients with prior diagnosis of HF hospitalised with COVID-19 at an academic tertiary care centre from 1 January 2020 to 28 February 2021. Patients with HF hospitalised with COVID-19 with risk factors were compared with those without risk factors for clinical characteristics, LOS and mortality. Multivariate regression was conducted to identify multiple predictors of increased LOS and in-hospital mortality in patients with HF hospitalised with COVID-19. Results Total of 211 patients with HF were hospitalised with COVID-19. Women had longer LOS than men (9 days vs 7 days; p<0.001). Compared with patients without PAD or ischaemic stroke, patients with PAD or ischaemic stroke had longer LOS (7 days vs 9 days; p=0.012 and 7 days vs 11 days, p<0.001, respectively). Older patients (aged 65 and above) had increased in-hospital mortality compared with younger patients (adjusted OR: 1.04; 95% CI 1.00 to 1.07; p=0.036). Prior diagnosis of VTE increased mortality more than threefold in patients with HF hospitalised with COVID-19 (adjusted OR: 3.33; 95% CI 1.29 to 8.43; p=0.011). Conclusion Vascular diseases increase LOS and mortality in patients with HF hospitalised with COVID-19. 

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4. Imputation of the continuous arterial line blood pressure waveform from non-invasive measurements using deep learning

   https://doi.org/10.1038/s41598-021-94913-y  

   Hill, Brian L. ; Rakocz, Nadav ; Rudas, Ákos ; Chiang, Jeffrey N. ; Wang, Sidong ; Hofer, Ira ; Cannesson, Maxime ; Halperin, Eran ( August 2021 , Scientific Reports)

   In two-thirds of intensive care unit (ICU) patients and 90% of surgical patients, arterial blood pressure (ABP) is monitored non-invasively but intermittently using a blood pressure cuff. Since even a few minutes of hypotension increases the risk of mortality and morbidity, for the remaining (high-risk) patients ABP is measured continuously using invasive devices, and derived values are extracted from the recorded waveforms. However, since invasive monitoring is associated with major complications (infection, bleeding, thrombosis), the ideal ABP monitor should be both non-invasive and continuous. With large volumes of high-fidelity physiological waveforms, it may be possible today to impute a physiological waveform from other available signals. Currently, the state-of-the-art approaches for ABP imputation only aim at intermittent systolic and diastolic blood pressure imputation, and there is no method that imputes the continuous ABP waveform. Here, we developed a novel approach to impute the continuous ABP waveform non-invasively using two continuously-monitored waveforms that are currently part of the standard-of-care, the electrocardiogram (ECG) and photo-plethysmogram (PPG), by adapting a deep learning architecture designed for image segmentation. Using over 150,000 min of data collected at two separate health systems from 463 patients, we demonstrate that our model provides a highly accurate prediction of the continuous ABP waveform (root mean square error 5.823 (95% CI 5.806–5.840) mmHg), as well as the derived systolic (mean difference 2.398 ± 5.623 mmHg) and diastolic blood pressure (mean difference − 2.497 ± 3.785 mmHg) compared to arterial line measurements. Our approach can potentially be used to measure blood pressure continuously and non-invasively for all patients in the acute care setting, without the need for any additional instrumentation beyond the current standard-of-care.

    

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5. A prospective cohort study of preconception COVID-19 vaccination and miscarriage

   https://doi.org/10.1093/humrep/dead211  

   Yland, Jennifer J. ; Wesselink, Amelia K. ; Regan, Annette K. ; Hatch, Elizabeth E. ; Rothman, Kenneth J. ; Savitz, David A. ; Wang, Tanran R. ; Huybrechts, Krista F. ; Hernández-Díaz, Sonia ; Eisenberg, Michael L. ; et al ( October 2023 , Human Reproduction)

   To what extent is preconception maternal or paternal coronavirus disease 2019 (COVID-19) vaccination associated with miscarriage incidence?

   COVID-19 vaccination in either partner at any time before conception is not associated with an increased rate of miscarriage.

   Several observational studies have evaluated the safety of COVID-19 vaccination during pregnancy and found no association with miscarriage, though no study prospectively evaluated the risk of early miscarriage (gestational weeks [GW] <8) in relation to COVID-19 vaccination. Moreover, no study has evaluated the role of preconception vaccination in both male and female partners.

   An Internet-based, prospective preconception cohort study of couples residing in the USA and Canada. We analyzed data from 1815 female participants who conceived during December 2020–November 2022, including 1570 couples with data on male partner vaccination.

   Eligible female participants were aged 21–45 years and were trying to conceive without use of fertility treatment at enrollment. Female participants completed questionnaires at baseline, every 8 weeks until pregnancy, and during early and late pregnancy; they could also invite their male partners to complete a baseline questionnaire. We collected data on COVID-19 vaccination (brand and date of doses), history of SARS-CoV-2 infection (yes/no and date of positive test), potential confounders (demographic, reproductive, and lifestyle characteristics), and pregnancy status on all questionnaires. Vaccination status was categorized as never (0 doses before conception), ever (≥1 dose before conception), having a full primary sequence before conception, and completing the full primary sequence ≤3 months before conception. These categories were not mutually exclusive. Participants were followed up from their first positive pregnancy test until miscarriage or a censoring event (induced abortion, ectopic pregnancy, loss to follow-up, 20 weeks’ gestation), whichever occurred first. We estimated incidence rate ratios (IRRs) for miscarriage and corresponding 95% CIs using Cox proportional hazards models with GW as the time scale. We used propensity score fine stratification weights to adjust for confounding.

   Among 1815 eligible female participants, 75% had received at least one dose of a COVID-19 vaccine by the time of conception. Almost one-quarter of pregnancies resulted in miscarriage, and 75% of miscarriages occurred <8 weeks’ gestation. The propensity score-weighted IRR comparing female participants who received at least one dose any time before conception versus those who had not been vaccinated was 0.85 (95% CI: 0.63, 1.14). COVID-19 vaccination was not associated with increased risk of either early miscarriage (GW: <8) or late miscarriage (GW: 8–19). There was no indication of an increased risk of miscarriage associated with male partner vaccination (IRR = 0.90; 95% CI: 0.56, 1.44).

   The present study relied on self-reported vaccination status and infection history. Thus, there may be some non-differential misclassification of exposure status. While misclassification of miscarriage is also possible, the preconception cohort design and high prevalence of home pregnancy testing in this cohort reduced the potential for under-ascertainment of miscarriage. As in all observational studies, residual or unmeasured confounding is possible.

   This is the first study to evaluate prospectively the relation between preconception COVID-19 vaccination in both partners and miscarriage, with more complete ascertainment of early miscarriages than earlier studies of vaccination. The findings are informative for individuals planning a pregnancy and their healthcare providers.

   This work was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of Health [R01-HD086742 (PI: L.A.W.); R01-HD105863S1 (PI: L.A.W. and M.L.E.)], the National Institute of Allergy and Infectious Diseases (R03-AI154544; PI: A.K.R.), and the National Science Foundation (NSF-1914792; PI: L.A.W.). The funders had no role in the study design, data collection, analysis and interpretation of data, writing of the report, or the decision to submit the paper for publication. L.A.W. is a fibroid consultant for AbbVie, Inc. She also receives in-kind donations from Swiss Precision Diagnostics (Clearblue home pregnancy tests) and Kindara.com (fertility apps). M.L.E. received consulting fees from Ro, Hannah, Dadi, VSeat, and Underdog, holds stock in Ro, Hannah, Dadi, and Underdog, is a past president of SSMR, and is a board member of SMRU. K.F.H. reports being an investigator on grants to her institution from UCB and Takeda, unrelated to this study. S.H.-D. reports being an investigator on grants to her institution from Takeda, unrelated to this study, and a methods consultant for UCB and Roche for unrelated drugs. The authors report no other relationships or activities that could appear to have influenced the submitted work.

   N/A.

    

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