Serious adverse event following immunization and thromboembolic events associated with COVID19 vaccination: An analysis of nationwide causality assessment from India

Background: Vaccines against the COVID-19 pandemic were introduced in late 2020. The present study has been conducted to study the serious Adverse Events Following Immunization (AEFIs) reported for COVID-19 vaccines from India. Methods: Secondary data analysis of the causality assessment reports for the 1112 serious AEFIs published by the Ministry of Health & Family Welfare, Government of India, was conducted. For the current analysis, all the reports published till 29.03.2022 were included. The primary outcome variables analyzed were the consistent causal association and the thromboembolic events. Results: The majority of the serious AEFIs assessed were either coincidental (578, 52%) or vaccine product related (218, 19.6%). All the serious AEFIs were reported among the Covishield (992, 89.2%) and COVAXIN (120, 10.8%) vaccines. Among these, 401 (36.1%) were deaths, and 711 (63.9%) were hospitalized and recovered. On adjusted analysis, females, the younger age group and non-fatal AEFIs showed a statistically significant consistent causal association with COVID-19 vaccination. Thromboembolic events were reported among 209 (18.8%) of the analyzed participants, with a significant association with higher age and case fatality rate. Conclusion: Deaths reported under serious AEFIs were found to have a relatively lower consistent causal relationship with the COVID-19 vaccines than the recovered hospitalizations in India. No consistent causal association was found between the thromboembolic events and the type of COVID-19 vaccine administered in India

Meta-analysis of the efficacy and safety of tranexamic acid for hemostasis in cancer patients before and during surgery / 中国药房

OBJECTIVE To systematically review the efficacy and safety of tranexamic acid （TXA） for hemostasis in cancer patients before and during surgery， and to provide evidence-based reference for clinical drug use. METHODS Retrieved from PubMed， Embase， the Cochrane Library， CNKI， VIP and Wanfang databases， randomized controlled trials （RCTs） about tranexamic acid （trial group） versus 0.9% Sodium chloride injection， Lactated Ringer’s solution， Compound electrolyte solution or placebo （control group） for cancer surgery were electronically searched from the inception to June 9， 2022. After literature screening and data extraction， the quality of included RCTs were evaluated by bias risk assessment tool recommended by Cochrane system evaluator manual 5.1.0. RevMan 5.3 software was used for meta-analysis or descriptive analysis， sensitivity analysis and publication bias analysis. RESULTS A total of 2 032 patients in 22 RCTs were included for meta-analysis. Results of meta-analysis showed that the blood transfusion rate [RR＝0.59， 95%CI （0.50， 0.69）， P＜0.000 01] and the volume of erythrocyte suspension infusion [MD＝－0.53， 95%CI （－0.92， －0.14）， P＝0.007] in trial group were significantly lower than control group； there was no statistical significance in the incidence of thromboembolic events [RR＝0.44， 95%CI （0.16， 1.17）， P＝0.10] or post-operative mortality [RR＝1.27， 95%CI（0.32，5.08）， P＝0.73] between two groups. Results of descriptive analysis showed that the total blood loss and postoperative drainage volume were still controversial between two groups. The results of sensitivity analysis showed that the results were basically stable. The results of publication bias analysis showed that there was little possibility of publication bias in this study. CONCLUSIONS TXA can significantly decrease the blood transfusion， reduce the volume of erythrocyte suspension infusion， whereas does not increase the incidence of thromboembolic events and post-operative mortality in cancer surgery.

Study of thrombotic complications in COVID-19

Background:In December of 2019, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)began to infect humans in the city of Wuhan and has rapidly become pandemic. Recent clinical trials suggested that COVID-19 related thromboembolic complications are the major cause for increased incidence of morbidity and mortality. We conducted a prospective observational study to evaluate the prevalence of vascular complications due to COVID-19 and to analyse the difference in the inflammatory markers before and after the events.Methods:Prospective observational study, conducted at department of general medicine, Bangalore Medical College, Bangalore Karnataka from 3 months, 01 August2021 to 30 October2020. The incidence of thrombotic events was 70.7% (53/75). The incidence of arterial thromboembolic events was 48%, involving 36 patients of the overall study population. Of these 36 patients, majority of them were suffering from cerebrovascular accident (CVA)accounting for about 12 (16%) of the patients followed by 11 (14.7%) with ischemic heart disease(IHD). About 22.66% (17/75) of patients had developed venous thromboembolic events. Of which, 13 (17.3%) patients had developed deep-vein thrombosis(DVT).Results:We observed that all the inflammatory markers had significantly increased after the onset of thrombotic events. Serum ferritin, lactate dehydrogenase (LDH), interleukin-6 (IL-6)and fibrinogen were almost raised by 50% of the pre-event values. We could not calculate the sensitivity, specificity, positive predictive value and negative predictive value for each parameter as the severity of the disease was widely distributed. Majority of these thrombotic events were observed among the patients aged >60 years and those with comorbid conditions. But there no statistically significant difference observed.Conclusions:We concluded that COVID-19 causes significantly increased surge of inflammatory markers and thereby the significantly increased prevalence of arterial and venous thrombotic events.

The correlation between left atrial sphericity and thromboembolic events in patients with atrial fibrillation / 中华内科杂志

Objective@#To study the correlation between left atrial sphericity (LASP) and thromboembolic events (TE) in patients with atrial fibrillation (AF).@*Methods@#This study was conducted in patients with AF underwent radiofrequency ablation in the Department of Cardiology of First Affiliated Hospital of Zhengzhou University from January 2011 to October 2018. The AF patients with TE (study group, n=157) and the AF patients without TE (control group, n=157) were matched for age and gender. The differences of LASP and other related indexes between the two groups were compared, and the correlation between LASP and TE was analyzed by conditional logistic regression. The receiver operating characteristic (ROC) curve was drawn to analyze the diagnostic value of LASP for TE.@*Results@#(1) The LASP in the study group was significantly higher than that in the control group [ (87.5±7.1) % vs. (82.8±6.1) %, P=0.001]. (2) Conditional logistic regression analyses showed that LASP (OR=1.10, 95%CI 1.05-1.16, P=0.001), left atrial volume index (OR=1.01, 95%CI 1.00-1.02, P=0.016) and CHA2D-VASc score (OR=1.77, 95%CI 1.30-2.41, P=0.001) were independently and positively correlated with TE. (3) The ROC curve analysis showed that the area under the curve (AUC) of left atrial sphericity (AUC=0.712, 95%CI 0.656-0.768, P=0.001) was larger than the AUC of either left atrial volume index (AUC=0.650, 95%CI 0.589-0.710, P=0.001) or CHA2D-VASc score (AUC=0.612, 95%CI 0.550-0.674, P=0.001). (4) CHA2D-VASc-LASP2 score was positively correlated with TE (OR=1.95, 95%CI 1.55-2.42, P=0.001).@*Conclusion@#LASP is independently and positively correlated with TE in patients with AF.

Evaluation of Quality of Anticoagulation Therapy Among Neurological Patients: An Institutional Based Study

Background: Oral anticoagulation (OAC) is used in neurology practice for primary and secondary stroke prevention in atrial fibrillation (AF), prosthetic mechanical valve; dilated cardiomyopathy (DCMP) and cerebral venous sinus thrombosis (CVST). This study evaluates the quality of oral anticoagulation therapy in neurology patients. Methods: Patients attending neurology service in KPC Medical College and Hospital, Jadavpur, Kolkata, West Benga (India); who were prescribed oral anticoagulant (OAC) were included. The international normalized ratio (INR) values of the patients who were already on OAC were analyzed. The level of anticoagulation, factors interfering with OAC and complications were noted. Results: Total 90 patients were included in study with median age 35±10 years. Ten were excluded as follow up was not done properly. Final study involves 80 patients. Fifty-eight patients received OAC for stroke prevention, 17 for cerebral venous sinus thrombosis (CVST) and 5 for deep vein thrombosis (DVT). Follow up was done for 2 years. Of the total 947 INR reports, 362 were below and 231 were above the therapeutic level. Stable INR was obtained in 36 patients only. INR level was improved by dose adjustment in 25 patients, and dietary adjustment in eight patients. Five patients were sensitive and three were resistant to OAC. Complications were noted in 14 instances. Conclusions: Stable therapeutic INR is difficult to maintain in neurological patients. However, modification of diet, drug and dose of oral anticoagulant may help in stabilization of INR. The findings support the need for educational interventions to improve the knowledge regarding OAT and, thereby, prevention of stroke.

Recombinant factor VIIa is associated with an improved 24-hour survival without an improvement in inpatient survival in massively transfused civilian trauma patients

OBJECTIVE: To determine whether recombinant factor VIIa (rFVIIa) is associated with increased survival and/or thromboembolic complications. INTRODUCTION: Uncontrollable hemorrhage is the main cause of early mortality in trauma. rFVIIa has been suggested for the management of refractory hemorrhage. However, there is conflicting evidence about the survival benefit of rFVIIa in trauma. Furthermore, recent reports have raised concerns about increased thromboembolic events with rFVIIa use. METHODS: Consecutive massively transfused (> 8 units of red blood cells within 12 h) trauma patients were studied. Data on demographics, injury severity scores, baseline laboratory values and use of rFVIIa were collected. Rate of transfusion in the first 6 h was used as surrogate for bleeding. Study outcomes included 24-hour and in-hospital survival, and thromboembolic events. A multivariable logistic regression analysis was used to determine the impact of rFVIIa on 24-hour and in-hospital survival. RESULTS: Three-hundred and twenty-eight patients were massively transfused. Of these, 72 patients received rFVIIa. As expected, patients administered rFVIIa had a greater degree of shock than the non-rFVIIa group. Using logistic regression to adjust for predictors of death in the regression analysis, rFVIIa was a significant predictor of 24-hour survival (odds ratio (OR) = 2.65; confidence interval 1.26-5.59; p = 0.01) but not of in-hospital survival (OR = 1.63; confidence interval 0.79-3.37; p = 0.19). No differences were seen in clinically relevant thromboembolic events. CONCLUSIONS: Despite being associated with improved 24-hour survival, rFVIIa is not associated with a late survival to discharge in massively transfused civilian trauma patients.

Terapia antitrombótica en la fibrilación auricular no valvular, a la luz de la medicina basada en la evidencia / Antithrombotic therapy in non-valvular atrial fibrillation

La fibrilación auricular (FA) afecta a más de dos millones de personas en Estados Unidos y se calcula que afectará a más de tres millones para el año 2020. Se caracteriza por la presencia en el electrocardiograma de ondas rápidas e irregulares sobre la línea de base, que varían de tamaño, morfología y tiempo. Es particularmente frecuente en los ancianos. Se produce por múltiples circuitos de microrreentrada que salen de la aurícula, colisionan, se extinguen y reaparecen; es necesaria una masa critica de tejido auricular para sostener un mínimo de circuitos que permitan perpetuar la arritmia. Dos estudios recientes permiten concluir que la terapia dirigida solamente al control de la respuesta ventricular es igualmente efectiva para el control del ritmo cardíaco, lo que desvirtúa la conducta de intentar restablecer el ritmo sinusal en todos los pacientes con FA.Una de las complicaciones más severas de la FA son los eventos tromboembólicos sistémicos que se presentan principalmente al sistema nervioso central; a la FA se le atribuye ser el factor causal en el 15 por ciento de todos los casos y en el 30 por ciento de los que ocurren en personas mayores de 80 años. Se revisan y analizan diferentes estudios de prevención tanto primaria como secundaria en pacientes con FA no valvular, los cuales sustentan las recomendaciones de consensos internacionales para su tratamiento basado en anticoagulación o antiagregación

The number of people with atrial fibrillation (AF) in the United States has been projected to increase from the current 2.2 million to 3 million in 2020. It is characterized by the presence of rapid and irregular waves on the base line that vary in size, shape and timing. It is particularly frequent in the elderly. In AF multiple, small microreentrant circuits are constantly arising in the atria, colliding, being extinguished, and arising again; a critical mass of atrial tissue is required to sustain the minimal number of simultaneous circuits necessary for the perpetuation of the arrhythmia. Two recent studies permit to conclude that the rhythm control strategy offers no survival advantage over the rate control strategy, and there are potential advantages, such as the lower risk of adverse drug effects, with the rate control strategy. One of the most severe complications of AF are the thromboembolic events mainly to the central nervous system. AF is an important independent risk factor for the embolic stroke, responsible for as many as 15% of strokes and for 30% in the group 80 to 89 years old. We analyzed different primary and secondary prevention studies in patients with non-valvular FA, which support the recommendations of guidelines developed by the American College of Cardiology, the American Heart Association, the European Society of Cardiology and ACCP.