Lessons learned: Development of COVID-19 clinical staging models at a large urban research institution.

Background/Objective: The University of Illinois at Chicago (UIC), along with many academic institutions worldwide, made significant efforts to address the many challenges presented during the COVID-19 pandemic by developing clinical staging and predictive models. Data from patients with a clinical encounter at UIC from July 1, 2019 to March 30, 2022 were abstracted from the electronic health record and stored in the UIC Center for Clinical and Translational Science Clinical Research Data Warehouse, prior to data analysis. While we saw some success, there were many failures along the way. For this paper, we wanted to discuss some of these obstacles and many of the lessons learned from the journey. Methods: Principle investigators, research staff, and other project team members were invited to complete an anonymous Qualtrics survey to reflect on the project. The survey included open-ended questions centering on participants' opinions about the project, including whether project goals were met, project successes, project failures, and areas that could have been improved. We then identified themes among the results. Results: Nine project team members (out of 30 members contacted) completed the survey. The responders were anonymous. The survey responses were grouped into four key themes: Collaboration, Infrastructure, Data Acquisition/Validation, and Model Building. Conclusion: Through our COVID-19 research efforts, the team learned about our strengths and deficiencies. We continue to work to improve our research and data translation capabilities.

Catheter-Directed Thrombolysis vs Anticoagulation in Patients With Acute Intermediate-High-risk Pulmonary Embolism: The CANARY Randomized Clinical Trial.

Importance: The optimal treatment of intermediate-high-risk pulmonary embolism (PE) remains unknown. Objective: To assess the effect of conventional catheter-directed thrombolysis (cCDT) plus anticoagulation vs anticoagulation monotherapy in improving echocardiographic measures of right ventricle (RV) to left ventricle (LV) ratio in acute intermediate-high-risk PE. Design, Setting, and Participants: The Catheter-Directed Thrombolysis vs Anticoagulation in Patients with Acute Intermediate-High-Risk Pulmonary Embolism (CANARY) trial was an open-label, randomized clinical trial of patients with intermediate-high-risk PE, conducted in 2 large cardiovascular centers in Tehran, Iran, between December 22, 2018, through February 2, 2020. Interventions: Patients were randomly assigned to cCDT (alteplase, 0.5 mg/catheter/h for 24 hours) plus heparin vs anticoagulation monotherapy. Main Outcomes and Measures: The proportion of patients with a 3-month echocardiographic RV/LV ratio greater than 0.9, assessed by a core laboratory, was the primary outcome. The proportion of patients with an RV/LV ratio greater than 0.9 at 72 hours after randomization and the 3-month all-cause mortality were among secondary outcomes. Major bleeding (Bleeding Academic Research Consortium type 3 or 5) was the main safety outcome. A clinical events committee, masked to the treatment assignment, adjudicated clinical outcomes. Results: The study was prematurely stopped due to the COVID-19 pandemic after recruiting 94 patients (mean [SD] age, 58.4 [2.5] years; 27 women [29%]), of whom 85 patients completed the 3-month echocardiographic follow-up. Overall, 2 of 46 patients (4.3%) in the cCDT group and 5 of 39 patients (12.8%) in the anticoagulation monotherapy group met the primary outcome (odds ratio [OR], 0.31; 95% CI, 0.06-1.69; P = .24). The median (IQR) 3-month RV/LV ratio was significantly lower with cCDT (0.7 [0.6-0.7]) than with anticoagulation (0.8 [0.7-0.9); P = .01). An RV/LV ratio greater than 0.9 at 72 hours after randomization was observed in fewer patients treated with cCDT (13 of 48 [27.0%]) than anticoagulation (24 of 46 [52.1%]; OR, 0.34; 95% CI, 0.14-0.80; P = .01). Fewer patients assigned to cCDT experienced a 3-month composite of death or RV/LV greater than 0.9 (2 of 48 [4.3%] vs 8 of 46 [17.3%]; OR, 0.20; 95% CI, 0.04-1.03; P = .048). One case of nonfatal major gastrointestinal bleeding occurred in the cCDT group. Conclusions and Relevance: This prematurely terminated randomized clinical trial of patients with intermediate-high-risk PE was hypothesis-generating for improvement in some efficacy outcomes and acceptable rate of major bleeding for cCDT compared with anticoagulation monotherapy and provided support for a definitive clinical outcomes trial. Trial Registration: ClinicalTrials.gov Identifier: NCT05172115.

Comparison of Angiographic and Clinical Outcomes After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction Between Patients With and Without Concomitant COVID-19 Infection.

OBJECTIVE: COVID-19 infection can involve the cardiovascular system and worsen the prognosis of the patients. This study aimed to investigate the adverse effects of COVID-19 on angiographic and clinical outcomes of primary percutaneous coronary intervention (PCI) in patients with acute ST-elevation MI and compare results with those patients without COVID-19 disease. METHODS: The study was a retrospective observational cohort, in which patients presented with ST-elevation MI from February 2020 to April 2021, treated with primary PCI were divided into 2 groups based on the COVID-19 infection. Then, the procedural and angiographic indices and also clinical outcomes were compared between the 2 groups. RESULTS: A total of 1150 patients were enrolled in the study. Those with established COVID-19 infection had worse baseline thrombolysis in myocardial infarction flow grade and also were at higher risk for worse procedural outcomes such as lower thrombolysis in myocardial infarction frame count, myocardial blush grade, and slow-flow coronary disease, after the primary PCI. Additionally, the presence of COVID-19 at the time of primary PCI was related to a significantly higher duration of hospitalization and in-hospital mortality. Given the potential impact of other factors on outcomes, analysis for all of the primary endpoints was done again after adjustment of these factors and the results were the same as before, suggesting the independent effect of COVID-19 infection. CONCLUSIONS: The concomitant COVID-19 infection in the patients undergoing primary PCI is associated with significantly worse angiographic, procedural and clinical outcomes. Surprisingly, this finding is regardless of patients' baseline risk factors and demographical characteristics.

Surgical coronary revascularization in patients with COVID-19; complications and outcomes: A retrospective cohort study.

Background and Aims: Coronary artery disease is high-risk comorbidity of COVID-19 infection. Nonelective coronary artery revascularization in COVID-19 patients carries substantial risk. Therefore, it is essential to understand the risk factors and outcomes fully. This study aims to evaluate the prognosis of coronary artery bypass grafting (CABG) surgery in patients with COVID-19. Methods: This retrospective cohort study assesses 171 patients who underwent urgent and emergent CABG in Tehran Heart Center from March 2020 to September 2021. The patients were allocated to cases and controls based on COVID-19 infection status. Demographic and clinical features, alongside the complications and outcomes, were compared between the two groups. Results: According to diagnostic criteria, 62 patients were diagnosed with COVID-19 (Case) and 109 patients had no COVID diagnosis (Control). Regarding the demographics and risk factors, hypertension was more prevalent among patients with COVID-19 (64.5% compared to 43.1% p= 0.007). Length of hospital stay, ventilation time, and intensive care unit (ICU) stay time were significantly higher in patients infected with COVID-19. Postoperative complications, including stroke, atrial fibrillation, pleural effusion, blood transfusion, and Inotrope use, were significantly higher in the case group. Mortality rates were also higher in COVID-19 patients with an odds ratio of 1.53; however, this difference is not statistically significant (p: 0.44, 95% CI = 0.50-4.01). Conclusion: COVID-19 is associated with a significantly higher hospital stay, ventilation time, and ICU stay. Mortality rates are also higher, albeit insignificantly. Various postoperative complications are also higher with COVID-19.