Atrial fibrillation is one of the most common arrhythmias encountered in clinical practice, associated with a higher risk of cardioembolic stroke and systemic embolism. Oral anticoagulant therapy is needed to prevent stroke, based on a structured risk assessment of each patient, to decide whether this therapy should be prescribed. The selection of the optimal therapy for patients with atrial fibrillation is sometimes difficult, because of the lack of a proper prediction of benefits and risks. To facilitate this decision, the 2020 European Society of Cardiology Guidelines for the diagnosis and management of atrial fibrillation recommend the use of CHA2DS2-VASc (Congestive heart failure, Hypertension, Age 75 years, Diabetes mellitus, Stroke, Vascular disease, Age 65-74 years, Sex category – female) and HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly > 65 years, Drugs/Alcohol concomitantly) scores1. These scores take into consideration only clinical variables, that can limit their power of prediction and calibration. Due to the heterogeneity of the population of patients with atrial fibrillation, recent research has focused on identifying new biomarkers for a better prediction of an individualized risk of stroke.

Introduction. Sponsors of clinical trials propose variations of home visits and virtual contact points with the patients instead of visits at the clinical sites, as well as other digital and remote solutions. The objective of the study was to search and analyse the experience and practice of European countries on applying decentralized elements and a hybrid approach of conducting clinical trials’ activities and procedures, as well as to establish the applicable rules and regulation. Material and methods. A questionnaire survey was conducted among European countries in the period December 2020 – February 2021, by email communication. Results. In most of the countries, it was not forbidden, and respondents indicated the opportunity of medical specialists to help patients at their home. 37.50% of the countries indicated that the applicable legislation cannot be related to the medical or clinical trials legislation or national commercial law but “Other”. Based on the practice, all or some of the activities can be done as a home care. 68.75% responded negatively to the application of the “site-less” model, but 81.25% considered that the combination of on-site and home visits can be better than only visits at sites. Conclusion. Based on this research, the implementation of decentralized elements in the clinical trials in Europe is often based on a case-by-case evaluation only. Notwithstanding the application of various national requirements and acts, they are either fragmentary, or not specifically applicable for such cases.

Introduction. Group B Streptococcus (GBS) is the most frequent cause of early onset neonatal sepsis. The objective of the study was to assess antibiotic resistance of GBS in pregnant women at 35-37 weeks of gestation in South Vietnam. Materials and methods. A descriptive cross-sectional study was conducted between April 2018 and May 2019 in Can Tho University of Medicine and Pharmacy Hospital and Can Tho Maternity Hospital (Vietnam) to determine the incidence of GBS infection. Anorectal and vaginal samples were taken from 203 pregnant women attending an antenatal examination at 35-37 weeks of gestation. Specimens showing a positive result for GBS were evaluated to identify antibiotic resistance using the Kirby-Bauer test. Results. The positive GBS rate in pregnant women was 16.3%. The rate of antibiotic resistance in the GBS-positive samples analysed was as follows: Vancomycin (resistant 18.2%, sensitive 81.8%), Cefazolin (resistant 30.3%, sensitive 69.7%), Erythromycin (resistant 24.2%, intermediate 9.1%, sensitive 63.7%), Clindamycin (resistant 63.7%, intermediate 3% and sensitive 33.3%), and Ampicillin (resistant 87.9%, sensitive 12.1%). In Vietnam, antibiotic prophylaxis for infection prevention in pregnant women with positive GBS includes Cefazolin and Vancomycin. Conclusions. Pregnant women should be tested for GBS infection, ideally between weeks 35 and 37 of pregnancy. During labour, antibiotics such as Cefazolin and Vancomycin are most effective for preventing infections.

Introduction. The objective of the study was to determine the incidence of neuroendocrine tumours in patients undergoing appendectomy because of acute appendicitis and to investigate the treatment and follow- up of these tumours. Materials and methods. The data of 6592 patients who were operated for acute appendicitis in two different health centers, between January 2012 and May 2020, were obtained from an electronic database. Fourteen patients with neuroendocrine pathologies were included in the study. Results. Of the 6592 patients undergoing appendectomy, 14 had neuroendocrine tumours. Of these 14 patients, six were male and eight were female. The mean age of the patients was 36.71 years. Six of the tumours were distal, seven were medial and one was in the appendix radix. The mean tumour size was 1.17 cm. Right hemicolectomy was performed in two patients with appendix radix tumours (2 cm in size) and the remaining 12 patients underwent appendectomy. The mean follow-up duration was 36.4 months. Conclusions. The pathologies of the patients who undergo appendectomy for acute appendicitis should be closely monitored, cases with neuroendocrine tumours should be reevaluated, and treatment and follow-up of these cases should be done based on the tumour characteristics.

Introduction. The composition of gut microbiota can be affected by type 2 diabetes mellitus (T2DM) and metabolic syndrome (MS), its improvement is frequently ignored in metabolic disorders. The objective of the study was a comparative evaluation of the faecal microbiota of healthy controls and of T2DM and MS patients (n = 150). Materials and methods. A retrospective crosssectional study was performed, between July 2019- December 2020 in the Bio-standard laboratory Oradea, Romania. A group of 75 patients with non-insulin dependent T2DM and MS (study group = SG) and 75 healthy subjects (control group = CG) has been included in the study. The composition of the microbiome and the influence of oral antidiabetic treatment on the microbiome in SG patients were compared. Results. 8 out of 19 species of the analysed bacteria had a different relative abundance in the SG, compared to CG; Enterococcus spp. were significantly higher (3.18x106 vs 1.94x106, p=0.004), while Akkermansia muciniphila (2.55x109 vs. 4.66x109, p<0.001) and Eubacterium spp. (3.51x108 vs 4.16x108, p=0.047) had significantly lower values in the SG vs. CG. Conclusions. The results indicated differences in the relative abundance of microbial species between the two groups, with significant changes in gut microbiome in the SG.

Introduction. Patients with arterial hypertension have a higher rate of morning blood pressure surge (MBPS) than non-hypertensive patients. MBPS increases the risk of stroke, myocardial infarction, sudden cardiac death, arterial stiffness, left ventricular hypertrophy, carotid atherosclerosis, and vascular inflammation. The prevalence and predictors of MBPS may vary significantly between geographic regions. The objective of the study was to determine the incidence of MBPS and associated factors in patients with primary hypertension. Material and methods. A cross-sectional descriptive study was conducted in patients =35 years old, diagnosed with primary arterial hypertension, and hospitalized in the Department of Cardiology of Thanh Vu Hospital, Bac Lieu, Vietnam, between March 2019 and May 2020. Results. Among 126 hypertensive patients, 80 had MBPS (63.5%): 66 had systolic MBPS (52.4%), 65 had diastolic MBPS (51.6%), and 51 had both systolic and diastolic MBPS (40.5%). Nocturnal hypertension, left ventricular hypertrophy, and stroke were statistically associated with MBPS. Since there is a high prevalence of MBPS, associated with multiple complications in patients with grade 2 or 3 hypertension, 24-hour ambulatory blood pressure measurement must be used in clinical practice in this group of patients, to ensure the timely detection and treatment of MBPS.

Introduction. Postoperative atrial fibrillation (POAF) is a frequent arrhythmic complication in cardiac surgery. Studies of this potential complication have not been able to elucidate its etiology nor to identify the predictors of its occurrence. The objective of the study was to evaluate the predictive role of renal dysfunction for POAF in patients undergoing cardiac surgery interventions. We also aimed to determine the role of renal dysfunction in improving diagnostic accuracy of Hypertension, Age, Transitory attack/stroke, Chronic obstructive pulmonary disease, Heart failure (HATCH) score for POAF. Material and methods. This prospective monocentric observational study included 178 consecutive patients who underwent cardiac surgery interventions in the State University Clinic of Cardiac Surgery of Skopje, Republic of North Macedonia, between September 2017- September 2018. Patients were divided in two groups, according to the absence or occurrence of POAF. HATCH score was calculated and recorded for each patient. A new R-HATCH score was derived by addition of renal dysfunction to the existing HATCH score and its predictive value for POAF was tested and compared to HATCH. Results. POAF occurred in 90 of 178 patients (50.56%). The average eGFR in the group developing POAF was significantly lower, 78.4 26.9 vs 93.0 29.0 ml/min/1,73m2 (p=0.0005). Patients with GFR <60ml/min/1.73m2 had almost a 5 times greater risk of developing POAF. The addition of renal dysfunction to HATCH score improved its predictive accuracy in our study. The area under the receiver operating characteristic curve increased from 0.73 to 0.76 (p < 0.001). Conclusions. The addition of preoperative renal dysfunction could improve the diagnostic accuracy of HATCH score for POAF.

Introduction. Metabolism is the key factor underlying the cardiomyocyte function. The inadequate coronary perfusion results in tissue acidosis due to elevated lactate production, which is considered a sensitive marker of myocardial ischemia. Isoproterenol is a synthetic catecholamine that produces diffuse myocardial necrosis at high doses. The aim of the study was to assess the changes of serum and tissue lactate content in isoproterenol-induced acute myocardial infarction to evaluate the lactate potential as an early diagnosis marker of cardiac ischemia. Materials and methods. Forty adult male rats were divided into 5 groups: sham (L1=11), control 0.9% NaCl (L2=11), and with experimental myocardial infarction (L3=6, L4=6; L5=6), induced by the subcutaneous injection of Isoproterenol Hydrochloride solution 100 mg/kg, and sacrificed over 6 hours, 24 hours and 7 days post infarction. The results were presented by median and interquartile range. The groups were compared using Kruskal-Wallis and Mann-Whitney nonparametric tests, and the Spearman correlation coefficient was calculated (SPSS 23.0). A p=0.05 was considered statistically significant. Results. Both glucose and lactate serum levels presented a slight decrease in L3, followed by a significant increase in L4, with a repeated fall in L5 group. In homogenate glucose content initially expressed an elevation in L3, with relevant decrease in L4, and inconsistent increase in L5, while lactate values significantly decreased in L3, returned to baseline levels in L4 and slightly declined in L5 compared to sham and control groups. Conclusion. The collected data suggest the utility of lactate assessment in early diagnosis and risk stratification in acute myocardial infarction.