National Tunisian Study of Cardiac Implantable Electronic Devices: Design and Protocol for a Nationwide Multicenter Prospective Observational Study.

BACKGROUND: In Tunisia, the number of cardiac implantable electronic devices (CIEDs) is increasing, owing to the increase in patient life expectancy and expanding indications. Despite their life-saving potential and a significant reduction in population morbidity and mortality, their increased numbers have been associated with the development of multiple early and late complications related to vascular access, pockets, leads, or patient characteristics. OBJECTIVE: The study aims to identify the rate, type, and predictors of complications occurring within the first year after CIED implantation. It also aims to describe the demographic and epidemiological characteristics of a nationwide sample of patients with CIED in Tunisia. Additionally, the study will evaluate the extent to which Tunisian electrophysiologists follow international guidelines for cardiac pacing and sudden cardiac death prevention. METHODS: The Tunisian National Study of Cardiac Implantable Electronic Devices (NATURE-CIED) is a national, multicenter, prospectively monitored study that includes consecutive patients who underwent primary CIED implantation, generator replacement, and upgrade procedure. Patients were enrolled between January 18, 2021, and February 18, 2022, at all Tunisian public and private CIED implantation centers that agreed to participate in the study. All enrolled patients entered a 1-year follow-up period, with 4 consecutive visits at 1, 3, 6, and 12 months after CIED implantation. The collected data are recorded electronically on the clinical suite platform (DACIMA Clinical Suite). RESULTS: The study started on January 18, 2021, and concluded on February 18, 2023. In total, 27 cardiologists actively participated in data collection. Over this period, 1500 patients were enrolled in the study consecutively. The mean age of the patients was 70.1 (SD 15.2) years, with a sex ratio of 1:15. Nine hundred (60%) patients were from the public sector, while 600 (40%) patients were from the private sector. A total of 1298 (86.3%) patients received a conventional pacemaker and 75 (5%) patients received a biventricular pacemaker (CRT-P). Implantable cardioverter defibrillators were implanted in 127 (8.5%) patients. Of these patients, 45 (3%) underwent CRT-D implantation. CONCLUSIONS: This study will establish the most extensive contemporary longitudinal cohort of patients undergoing CIED implantation in Tunisia, presenting a significant opportunity for real-world clinical epidemiology. It will address a crucial gap in the management of patients during the perioperative phase and follow-up, enabling the identification of individuals at particularly high risk of complications for optimal care. TRIAL REGISTRATION: ClinicalTrials.gov NCT05361759; https://classic.clinicaltrials.gov/ct2/show/NCT05361759. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/47525.

Role of depression in blood pressure control. A cross-sectional multicentric study.

RESEARCH PROBLEM: Hypertension is a multifactorial disease that affects approximately one third of the Tunisian adult population. It is a major risk factor for stroke and cardiovascular disease. Environmental and psychosocial factors play an important role in hypertension onset and control. The prevalence of depression among hypertensive patients is 26, 8% and its presence is associated with increased risk of cardiovascular related morbi-mortality. Our study aims to evaluate the role of depression in blood pressure control among ambulatory hypertensive patients. Investigative process: This study is a cross-sectional, multicentric and descriptive study. We intend to include three hundred and two patients. A 24-hour ambulatory blood pressure monitor will be used to evaluate blood pressure control. Depression will be assessed by the 9-item Patient Health Questionnaire (PHQ-9) in Tunisian dialect. Clinical, socio-environmental, psychosocial and therapeutic and prognosis data will be collected from medical records. Patients will be classified into two groups: Controlled versus non-controlled hypertension. PHQ-9 scores will be then compared between the two cohorts. RESEARCH PLAN: Ethical considerations will be undertaken and respected. All patients should express an informed oral consent before enrollment. This trial will run for three months from the 15th August 2022. TRIAL REGISTRATION: NCT05516173.

Prognostic value of ambulatory blood pressure monitoring in treated hypertensive patients.

INTRODUCTION: Ambulatory blood pressure monitoring (AMBP) has become a valuable tool for analyzing patient blood pressure (BP) pro-file to make a more accurate prognosis compared to clinical office BP. AIM: To identify the prognostic value of different parameters of ABPM and the future course of cardiovascular events (CVE) in treated hypertensive patients. METHODS: We conducted a prospective, descriptive study, including treated hypertensive patients which had consulted between 2015 and 2016 and had a systematic ABPM during their follow-up. Patients were followed at the outpatient clinics for 4 years, and we searched in the computerized medical file the occurrence of CVE. RESULTS: A total of 240 patients were included in our study with masculine predominance (57%). The mean age was 57.4±9.5 years. During 4 years of follow-up, 30 patients (12.5%) experienced a CVE. The total number of CVE was 32: acute heart failure (3), acute co-ronary syndrome (15), atrial fibrillation (12), stroke (2). Daytime systolic blood pressure (SBP), night-time SBP, 24-h SBP and 24-h pulse pressure (PP), had similar performances to predict CVE. Only the 24-h PP (OR= 1.072; 95% IC: 1.019-1.128; p= 0.007) was found to be an independent predictor of CVE. A 24-h PP> 55 mmHg increased the risk of CVE by 3.2. CONCLUSION: SBP and PP were associated with CVE in treated hypertensive patients. the 24-h PP was found to be an independent pre-dictor of CVE so it may serve as a therapeutic target in hypertension therapy.

The Design and Validation of a Self-Assessment Questionnaire of Critical Appraisal of Medical Literature Skills in Medical Students.

Introduction: Critical appraisal of medical literature is a challenging step of the evidence-based medicine practice. Many assessment questionnaires have been published in the literature, but they have mainly focused on all the evidence-based medicine practice process. The authors aimed to develop and validate a questionnaire assessing the critical appraisal skills of medical students from the same Faculty. Methods: The questionnaire was developed by item generation through a review of the literature and an expert committee. The questionnaire was validated in terms of content validity and construct validity. Fitness of data for analysis was checked through Kaiser-Meyer-Olkin (KMO) and Bartlett's sphericity. Construct validity was carried out using a principal axis exploratory factor analysis (EFA) with 'varimax' rotation to study the internal structure of the questionnaire and to extract the test major factors. The questionnaire was administrated to a cohort of under and postgraduate medical students (n=84) to evaluate the test reliability and select the best items. The reliability of the questionnaire was assessed by Cronbach's alpha coefficient to evaluate the internal consistency. The correlations between the self-confidence and satisfaction dimension score, the critical thinking dimension score, the learning style dimension score, the Fresno-adapted test scores and the total score were assessed using the Spearman's correlation test. Results: The questionnaire consisted of 31 items. A factorial analysis grouped the items into 3 dimensions that consisted of the self-confidence and satisfaction dimension, the critical thinking dimension and the learning style dimension. Cronbach's alpha accounted for 0.95, CI95% [0.9-1] for the entire questionnaire. The factor analysis explained 79.51% of the variance. The external validity assessment based on a Spearman's correlation study highlighted a weak correlation between the total scores and the critical thinking dimension and the self-perception and satisfaction dimension. Conclusion: In spite of the limitations of this study, mainly the small number of the students recruited, the questionnaire seems to measure with adequate reliability the competences of under and postgraduate medical students.