• Acute respiratory distress syndrome (ARDS) as an adverse event following immunization: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

      Serazin, Nathan A; Edem, Bassey; Williams, Sarah R; Ortiz, Justin R; Kawade, Anand; Das, Manoj Kumar; Šubelj, Maja; Edwards, Kathryn M; Parida, Shreemanta K; Wartel, T Anh; et al. (Elsevier Ltd., 2021-01-28)
      This is a Brighton Collaboration Case Definition of the term “Acute Respiratory Distress Syndrome – ARDS” to be utilized in the evaluation of adverse events following immunization. The Case Definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of vaccines for SARS-CoV-2 vaccines and other emerging pathogens. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by selected Expert Reviewers prior to submission. The comments of the reviewers were taken into consideration and edits incorporated in this final manuscript. © 2021 The Authors
    • Periprocedural complications in patients with SARS-CoV-2 infection compared to those without infection: A nationwide propensity-matched analysis

      Lal, B.K.; Prasad, N.K.; Englum, B.R.; Turner, D.J.; Siddiqui, T.; Carlin, M.M.; Lake, R.; Sorkin, J.D. (Elsevier Inc., 2020-12-28)
      Background: Reports on emergency surgery performed soon after a COVID-19 infection that are not controlled for premorbid risk-factors show increased 30-day mortality and pulmonary complications. This contributed to a virtual cessation of elective surgery during the pandemic surge. To inform evidence-based guidance on the decisions for surgery during the recovery phase of the pandemic, we compare 30-day outcomes in patients testing positive for COVID-19 before their operation, to contemporary propensity-matched COVID-19 negative patients undergoing the same procedures. Methods: This prospective multicentre study included all patients undergoing surgery at 170 Veterans Health Administration (VA) hospitals across the United States. COVID-19 positive patients were propensity matched to COVID-19 negative patients on demographic and procedural factors. We compared 30-day outcomes between COVID-19 positive and negative patients, and the effect of time from testing positive to the date of procedure (?10 days, 11-30 days and >30 days) on outcomes. Results: Between March 1 and August 15, 2020, 449 COVID-19 positive and 51,238 negative patients met inclusion criteria. Propensity matching yielded 432 COVID-19 positive and 1256 negative patients among whom half underwent elective surgery. Infected patients had longer hospital stays (median seven days), higher rates of pneumonia (20.6%), ventilator requirement (7.6%), acute respiratory distress syndrome (ARDS, 17.1%), septic shock (13.7%), and ischemic stroke (5.8%), while mortality, reoperations and readmissions were not significantly different. Higher odds for ventilation and stroke persisted even when surgery was delayed 11-30 days, and for pneumonia, ARDS, and septic shock >30 days after a positive test. Discussion: 30-day pulmonary, septic, and ischaemic complications are increased in COVID-19 positive, compared to propensity score matched negative patients. Odds for several complications persist despite a delay beyond ten days after testing positive. Individualized risk-stratification by pulmonary and atherosclerotic comorbidities should be considered when making decisions for delaying surgery in infected patients. Copyright 2020