Association of Emotional Response Indicators with the Risk of Recurrence and Hospitalization in Coronavirus Patients.

Anxiety, stress, and fear can adversely affect the mental and physical health of people. The present study aimed to examine the association of these emotional response indicators with outcomes (recurrence, hospitalization, and mortality) in coronavirus 2019 (COVID-19) patients. A prospective cohort study was conducted between February 2020 and July 2021 in three hospitals in Tehran, Iran. The included patients (n=350) completed three questionnaires on COVID-19-related anxiety, stress, and fear. Patients with at least one emotional response indicator were assigned to the exposed group (n=157) and those without to the unexposed group (n=193). After one month of follow-up, the medical condition of all participants was determined through phone calls. Data were analyzed with logistic and multivariate regression models using STATA 9 software. The number of patients with COVID-19 recurrence in the exposed and unexposed groups was 71 (45%) and 16 (8%), respectively, and for hospitalization 79 (50%) and 16 (8%), respectively. The relative risk of recurrence and hospitalization due to COVID-19 in the exposed group was 5.62 and 6.25 higher than in the unexposed group, respectively (P<0.001 for both). The results of regression analysis showed that underlying diseases were not significantly associated with recurrence and hospitalization. The total number of deaths was six, all of which were in the exposed group. Given the greater risk of recurrence and hospitalization in COVID-19 patients with anxiety, stress, or fear, there is a need to devise and implement appropriate strategies to prevent and manage mental disorders.

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.

Anxiety, Knowledge and Lived Experiences of Families with COVID-19 Patients: A Mixed-Method Multi-Center Study in Iran.

Background: During community-wide outbreaks, patients and their families may suffer from anxiety after making behavioral changes. This study aimed to investigate the anxiety, knowledge, and lived experiences of families with COVID-19 patients admitted to medical centers. Methods: The present multi-center study was conducted by a mixed method using convenient sampling in hospitalized COVID-19 patients in Firoozgar and Rajaie Hospitals between May and July 2020. Anxiety was measured using a short form of the State-Trait Anxiety Inventory. The participants' level of knowledge was assessed by an online questionnaire. The lived experiences of the families were explained through semi-structured interviews. Data were analyzed by Chi square, ANOVA, independent-samples t test, Kruskal Wallis, and Mann-Whitney tests in SPSS 16. P values≤0.05 were considered statistically significant. Results: The mean age of the 324 family members, who participated in the study was 45.1±13.3 years. The mean anxiety score of the subjects was 13.5±4.1, and 63.6% of the participants had moderate to severe anxiety. The subjects' mean score for knowledge on COVID-19 was 7.15±1.32. The highest mean percentage of data received by the subjects on COVID-19 (42.7%) was obtained through radio and television broadcasting. A total of 251 important phrases were obtained from interview analysis and code extraction, out of which five main themes and 17 sub-themes were extracted. Conclusion: Our findings showed that anxiety was relatively high in families with COVID patients during the pandemic, and it was associated with age, sex, income, and familial relationships. The level of knowledge on the COVID-19 disease in families was moderate. Therefore, relevant interventions and raising people's awareness are recommended.

Reliability and validity of a satisfaction questionnaire on virtual education in the coronavirus disease 2019 pandemic era aimed at cardiology faculty members.

BACKGROUND: In the coronavirus disease 2019 pandemic era, clinical programs and mandatory hands-on activities have been supplanted by remote teaching to maintain the fundamental capabilities of medical training and to furnish medical students with quality education. Nonetheless, the satisfaction of faculty members with this training method in the current pandemic has yet to be assessed. The aim of this study was to design a Persian questionnaire with appropriate validity and reliability on cardiology professors' satisfaction level with virtual education. MATERIALS AND METHODS: In this cross-sectional study, a questionnaire was devised drawing upon scientific sources and Iranian medical educators' expertise. Seventeen faculty members in various specialties evaluated the questionnaire concerning face and content validity. Content validity was assessed through the calculation of the content validity ratio (CVR) (values >0.62 were considered acceptable) and the content validity index (CVI) (values >0.79 were considered acceptable), construct validity was evaluated through principal component factor analysis by the Kaiser-Meyer-Olkin (KMO) statistic and Bartlett's sphericity test, internal reliability was measured through the calculation of Cronbach's alpha coefficient, and consistency was appraised through the use of test-retest reliability at two different time points. RESULTS: The questionnaire had a reliability rate of 95%, indicating high internal validity. Concerning test-retest reliability, the intraclass correlation coefficient was 0.96 (P < 0.001), demonstrating relatively good stability. The CVI was 0.81, and the CVR was 0.85. The KMO measure of sampling adequacy was 0.954, indicating the acceptability of the degree of common variance among the all items. CONCLUSIONS: This Persian questionnaire on virtual education aimed at cardiology faculty members in the current pandemic with its low question count and appropriate domains had high reliability and validity. By knowing the level of professors' satisfaction with the new method of education, it is possible to take steps to better provide specialized medical education to cardiology residents.

Validity and reliability of a virtual education satisfaction questionnaire from the perspective of cardiology residents during the COVID-19 pandemic.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has prompted the further virtualization of medical education. The satisfaction level of specific users such as cardiology residents with virtual education can augment its quality; hence, the significance of a valid and reliable questionnaire to obtain feedback is needed. This study aimed to design and measure validity and reliability of a satisfaction questionnaire for virtual education of cardiology residents during COVID-19 pandemic. MATERIALS AND METHODS: In this cross-sectional study, a self-administered questionnaire was developed by the faculty members of Rajaie Cardiovascular Medical and Research Center. Reliability was tested utilizing Cronbach's alpha and intercorrelation which was tested using Pearson's correlation coefficient test (ICC). Factor analysis was done by the Kaiser-Meyer-Olkin measure of sampling adequacy and Bartlett's sphericity test. The statistical analyses were performed with the SPSS software version 22. RESULTS: The face validity index was determined via an assessment of the relevance, clarity, and simplicity of each item, and values >0.79 were accepted. The total Cronbach's alpha coefficient was calculated 0.93. Concerning test-retest reliability, the correlation between two rounds of evaluation was >80 (P > 0.001) and ICC was 0.99 (P = 0.001). The content validity evaluation yielded an index of 0.95 and a ratio of 0.91. The principal component factor analysis, conducted to investigate construct validity, generated four domains. CONCLUSIONS: The study results confirmed the validity and reliability of the designed questionnaire to evaluate the level of satisfaction of cardiology residents with virtual learning in COVID-19 pandemic.

Effect of Intermediate-Dose vs Standard-Dose Prophylactic Anticoagulation on Thrombotic Events, Extracorporeal Membrane Oxygenation Treatment, or Mortality Among Patients With COVID-19 Admitted to the Intensive Care Unit: The INSPIRATION Randomized Clinical Trial.

Importance: Thrombotic events are commonly reported in critically ill patients with COVID-19. Limited data exist to guide the intensity of antithrombotic prophylaxis. Objective: To evaluate the effects of intermediate-dose vs standard-dose prophylactic anticoagulation among patients with COVID-19 admitted to the intensive care unit (ICU). Design, Setting, and Participants: Multicenter randomized trial with a 2 × 2 factorial design performed in 10 academic centers in Iran comparing intermediate-dose vs standard-dose prophylactic anticoagulation (first hypothesis) and statin therapy vs matching placebo (second hypothesis; not reported in this article) among adult patients admitted to the ICU with COVID-19. Patients were recruited between July 29, 2020, and November 19, 2020. The final follow-up date for the 30-day primary outcome was December 19, 2020. Interventions: Intermediate-dose (enoxaparin, 1 mg/kg daily) (n = 276) vs standard prophylactic anticoagulation (enoxaparin, 40 mg daily) (n = 286), with modification according to body weight and creatinine clearance. The assigned treatments were planned to be continued until completion of 30-day follow-up. Main Outcomes and Measures: The primary efficacy outcome was a composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days, assessed in randomized patients who met the eligibility criteria and received at least 1 dose of the assigned treatment. Prespecified safety outcomes included major bleeding according to the Bleeding Academic Research Consortium (type 3 or 5 definition), powered for noninferiority (a noninferiority margin of 1.8 based on odds ratio), and severe thrombocytopenia (platelet count <20 ×103/µL). All outcomes were blindly adjudicated. Results: Among 600 randomized patients, 562 (93.7%) were included in the primary analysis (median [interquartile range] age, 62 [50-71] years; 237 [42.2%] women). The primary efficacy outcome occurred in 126 patients (45.7%) in the intermediate-dose group and 126 patients (44.1%) in the standard-dose prophylaxis group (absolute risk difference, 1.5% [95% CI, -6.6% to 9.8%]; odds ratio, 1.06 [95% CI, 0.76-1.48]; P = .70). Major bleeding occurred in 7 patients (2.5%) in the intermediate-dose group and 4 patients (1.4%) in the standard-dose prophylaxis group (risk difference, 1.1% [1-sided 97.5% CI, -∞ to 3.4%]; odds ratio, 1.83 [1-sided 97.5% CI, 0.00-5.93]), not meeting the noninferiority criteria (P for noninferiority >.99). Severe thrombocytopenia occurred only in patients assigned to the intermediate-dose group (6 vs 0 patients; risk difference, 2.2% [95% CI, 0.4%-3.8%]; P = .01). Conclusions and Relevance: Among patients admitted to the ICU with COVID-19, intermediate-dose prophylactic anticoagulation, compared with standard-dose prophylactic anticoagulation, did not result in a significant difference in the primary outcome of a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or mortality within 30 days. These results do not support the routine empirical use of intermediate-dose prophylactic anticoagulation in unselected patients admitted to the ICU with COVID-19. Trial Registration: ClinicalTrials.gov Identifier: NCT04486508.

Chapter 40 - COVID-19 Infection: A Novel Fatal Pandemic of the World in 2020

In the last days of 2019, a new coronavirus was found in Wuhan, China, in the patients with the signs of an unknown respiratory syndrome for the first time. It was called COVID-19 and in just a few months the biggest pandemic happened in the world. In several months of this outbreak, many studies were published and different aspects of this infection were evaluated. In this chapter, a review of the infection with COVID-19 including signs, symptoms, and methods of diagnosis, with the emphasis on the cardiovascular complications and management of the patients are mentioned. Unfortunately, until now, no definite treatment or vaccination is found and the prevalence of this fatal infection is increasing each day. The best way to prevent COVID-19 is still self-protection and education to all members of society.

Deep COVID DeteCT: an international experience on COVID-19 lung detection and prognosis using chest CT.

The Coronavirus disease 2019 (COVID-19) presents open questions in how we clinically diagnose and assess disease course. Recently, chest computed tomography (CT) has shown utility for COVID-19 diagnosis. In this study, we developed Deep COVID DeteCT (DCD), a deep learning convolutional neural network (CNN) that uses the entire chest CT volume to automatically predict COVID-19 (COVID+) from non-COVID-19 (COVID-) pneumonia and normal controls. We discuss training strategies and differences in performance across 13 international institutions and 8 countries. The inclusion of non-China sites in training significantly improved classification performance with area under the curve (AUCs) and accuracies above 0.8 on most test sites. Furthermore, using available follow-up scans, we investigate methods to track patient disease course and predict prognosis.

Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo in critically-ill patients with COVID-19: Rationale and design of the INSPIRATION/INSPIRATION-S studies.

BACKGROUND: Microvascular and macrovascular thrombotic events are among the hallmarks of coronavirus disease 2019 (COVID-19). Furthermore, the exuberant immune response is considered an important driver of pulmonary and extrapulmonary manifestations of COVID-19. The optimal management strategy to prevent thrombosis in critically-ill patients with COVID-19 remains unknown. METHODS: The Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) and INSPIRATION-statin (INSPIRATION-S) studies test two independent hypotheses within a randomized controlled trial with 2 × 2 factorial design. Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation. The 600 patients undergoing this randomization will be screened and if meeting the eligibility criteria, will undergo an additional double-blind stratified randomization to atorvastatin 20 mg daily versus matching placebo. The primary endpoint, for both hypotheses will be tested for superiority and includes a composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death within 30 days from enrollment. Key secondary endpoints include all-cause mortality, adjudicated VTE, and ventilator-free days. Key safety endpoints include major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL) for the anticoagulation hypothesis. In a prespecified secondary analysis for non-inferiority, the study will test for the non-inferiority of intermediate intensity versus standard dose anticoagulation for major bleeding, considering a non-inferiority margin of 1.8 based on odds ratio. Key safety endpoints for the statin hypothesis include rise in liver enzymes >3 times upper normal limit and clinically-diagnosed myopathy. The primary analyses will be performed in the modified intention-to-treat population. Results will be tested in exploratory analyses across key subgroups and in the intention-to-treat and per-protocol cohorts. CONCLUSIONS: INSPIRATION and INSPIRATON-S studies will help address clinically-relevant questions for antithrombotic therapy and thromboinflammatory therapy in critically-ill patients with COVID-19.

Preparation, escalation, de-escalation, and normal activities.

Iran is one of the earliest countries involved with coronavirus disease 2019 (COVID-19) pandemic. In the present short report, we have presented our experiences as a cardiovascular tertiary center during the COVID-19 outbreak. At the beginning, we have pursued our activities in four field of administrative, preventative, therapeutic, and research. Then by gaining new experiences, we have tailored our strategies. Finally, we have described our challenges and future strategies on returning to normal activities.

Effects of the COVID-19 Pandemic on the Management of Patients With ST-elevation Myocardial Infarction in a Tertiary Cardiovascular Center.

BACKGROUND: In the Coronavirus Disease 2019 (COVID-19) pandemic, the appropriate reperfusion strategy in patients with ST-segment elevation myocardial infarction (STEMI) is unclear. METHODS: This retrospective single-center study consecutively enrolled patients who presented with STEMI and scheduled for primary percutaneous coronary intervention (PPCI) during the outbreak of COVID-19. Due to the delay in the reporting of the polymerase chain reaction test results, our postprocedural triage regarding COVID-19, followed by the isolation strategy, was based on lung computerized tomography scan results. RESULTS: Forty-eight patients with STEMI referred to our center. PPCI was done for 44 (91%) of these patients. The mean symptom-to-device time was 490.93 ± 454.608 minutes, and the mean first medical contact-to-device time was and 154.12 ± 36.27 minutes. Nine (18%) patients with STEMI were diagnosed as having typical/indeterminate features indicating COVID-19 involvement. During hospitalization, 1 (2.0%) patient died of cardiogenic shock. The study population was followed for 35.9 ± 12.7 days. Two patients expired in another centers due to COVID-19. No cardiac catheterization laboratory staff members were infected by COVID-19 during the study period. CONCLUSIONS: Our small report indicates that by taking the recommended safety measures and using appropriate PPE, we can continue PPCI as the main reperfusion strategy safely and effectively.