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BackgroundIn 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. ObjectiveThe 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. MethodsThe 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). ResultsThe 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. ConclusionsThis 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 RegistrationClinicalTrials.gov NCT05361759; https://classic.clinicaltrials.gov/ct2/show/NCT05361759 International Registered Report Identifier (IRRID)RR1-10.2196/47525

Abstract Background Heart failure (HF) is a serious and frequent pathology. It represents a major public health problem. We have few data about this pathology in our country. The aim of our study is to determine the epidemiological, clinical, therapeutic, and prognostic characteristics of new-onset HF with reduced left ventricular ejection fraction (HFrEF) and to study the degree of conformity of the management of HF with international recommendations. Results Our study population includes 210 patients hospitalized for HFrEF newly diagnosed. The average age of our patients was 64 ± 12 years. A male predominance was noted with a sex ratio of 2.8. The main etiology of HF was ischemic heart disease noted in 97 patients (46.2%). The average LVEF is 33 ± 6%. The triple combination (angiotensin-converting enzyme inhibitors + beta blockers + Mineralocorticoid Receptor Antagonists) was prescribed in 75 patients (35.7%). The quadruple combination (angiotensin-converting enzyme inhibitors + beta blockers + Mineralocorticoid Receptor Antagonists + Sodium-Glucose Co-Transporter 2 inhibitors) was prescribed in 17 patients (8.1%). Myocardial revascularization was indicated in 97 patients (46.6%) and valve surgery was indicated in 49 patients (23.3%). Hospital mortality was 3.8% and at 1 year 18.1%. Among the 192 patients followed during the first year after discharge from hospital, 81 patients had to be re-hospitalized, i.e., a 1-year rehospitalization rate of 42.2%. Conclusions Our study highlighted the epidemiological and clinical features of HF in a Tunisian care center, revealing our patient management deficiency. This pushes us to have a new Tunisian register to enable a better statistical analysis and lead to more relevant conclusions.

BackgroundThis study was designed to evaluate the care of hypertensive patients in daily clinical practice in public and private centers in all Tunisian regions. ObjectiveThis study will provide us an overview of hypertension (HTN) management in Tunisia and the degree of adherence of practitioners to international recommendations. MethodsThis is a national observational cross-sectional multicenter study that will include patients older than 18 years with HTN for a duration of 4 weeks, managed in the public sector from primary and secondary care centers as well as patients managed in the private sector. Every participating patient signed a consent form. The study will exclude patients undergoing dialysis. The parameters that will be evaluated are demographic and anthropometric data, lifestyle habits, blood pressure levels, lipid profiles, treatment, and adherence to treatment. The data are collected via the web interface in the Dacima Clinical Suite. ResultsThe study began on April 15, 2019 and ended on May 15, 2019. During this period, we included 25,890 patients with HTN. Data collection involved 321 investigators from 24 Tunisian districts. The investigators were doctors working in the private and public sectors. ConclusionsObservational studies are extremely useful in improving the management of HTN in developing countries. Trial RegistrationClinicalTrials.gov NCT04013503; https://clinicaltrials.gov/ct2/show/NCT04013503 International Registered Report Identifier (IRRID)DERR1-10.2196/21878

BackgroundThe frequency of heart failure (HF) in Tunisia is on the rise and has now become a public health concern. This is mainly due to an aging Tunisian population (Tunisia has one of the oldest populations in Africa as well as the highest life expectancy in the continent) and an increase in coronary artery disease and hypertension. However, no extensive data are available on demographic characteristics, prognosis, and quality of care of patients with HF in Tunisia (nor in North Africa). ObjectiveThe aim of this study was to analyze, follow, and evaluate patients with HF in a large nation-wide multicenter trial. MethodsA total of 1700 patients with HF diagnosed by the investigator will be included in the National Tunisian Registry of Heart Failure study (NATURE-HF). Patients must visit the cardiology clinic 1, 3, and 12 months after study inclusion. This follow-up is provided by the investigator. All data are collected via the DACIMA Clinical Suite web interface. ResultsAt the end of the study, we will note the occurrence of cardiovascular death (sudden death, coronary artery disease, refractory HF, stroke), death from any cause (cardiovascular and noncardiovascular), and the occurrence of a rehospitalization episode for an HF relapse during the follow-up period. Based on these data, we will evaluate the demographic characteristics of the study patients, the characteristics of pathological antecedents, and symptomatic and clinical features of HF. In addition, we will report the paraclinical examination findings such as the laboratory standard parameters and brain natriuretic peptides, electrocardiogram or 24-hour Holter monitoring, echocardiography, and coronarography. We will also provide a description of the therapeutic environment and therapeutic changes that occur during the 1-year follow-up of patients, adverse events following medical treatment and intervention during the 3- and 12-month follow-up, the evaluation of left ventricular ejection fraction during the 3- and 12-month follow-up, the overall rate of rehospitalization over the 1-year follow-up for an HF relapse, and the rate of rehospitalization during the first 3 months after inclusion into the study. ConclusionsThe NATURE-HF study will fill a significant gap in the dynamic landscape of HF care and research. It will provide unique and necessary data on the management and outcomes of patients with HF. This study will yield the largest contemporary longitudinal cohort of patients with HF in Tunisia. Trial RegistrationClinicalTrials.gov NCT03262675; https://clinicaltrials.gov/ct2/show/NCT03262675 International Registered Report Identifier (IRRID)DERR1-10.2196/12262

The NATURE-HF registry was aimed to describe clinical epidemiology and 1-year outcomes of outpatients and inpatients with heart failure (HF). This is a prospective, multicenter, observational survey conducted in Tunisian Cardiology centers. A total of 2040 patients were included in the study. Of these, 1632 (80%) were outpatients with chronic HF (CHF). The mean hospital stay was 8.7 ± 8.2 days. The mortality rate during the initial hospitalization event for AHF was 7.4%. The all-cause 1-year mortality rate was 22.8% among AHF patients and 10.6% among CHF patients. Among CHF patients, the older age, diabetes, anemia, reduced EF, ischemic etiology, residual congestion and the absence of ACEI/ ARBs treatment were independent predictors of 1-year cumulative rates of rehospitalization and mortality. The female sex and the functional status were independent predictors of 1-year all-cause mortality and rehospitalization in AHF patients. This study confirmed that acute HF is still associated with a poor prognosis, while the mid-term outcomes in patients with chronic HF seems to be improved. Some differences across countries may be due to different clinical characteristics and differences in healthcare systems.