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.

Design and Rationale of the National Tunisian Registry of Heart Failure (NATURE-HF): Protocol for a Multicenter Registry Study.

BACKGROUND: The 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). OBJECTIVE: The aim of this study was to analyze, follow, and evaluate patients with HF in a large nation-wide multicenter trial. METHODS: A 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. RESULTS: At 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. CONCLUSIONS: The 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 REGISTRATION: ClinicalTrials.gov NCT03262675; https://clinicaltrials.gov/ct2/show/NCT03262675. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12262.

Epidemiology of heart failure and long-term follow-up outcomes in a north-African population: Results from the NAtional TUnisian REgistry of Heart Failure (NATURE-HF).

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.

Evaluation of left ventricular function by 2D Strain in acute coronary syndrome.

BACKGROUND: The 2D Strain is a new echo-cardiographic technique allowing the study of the myocardial deformation based on a follow-up of the acoustic markers of the LV wall. The aim of our study was to validate the contribution of this technique in the detection of the ischemia and in the prediction of the culprit coronary axis and the number of vessels affected and also we analyzed the correlation of this parameter with the Left Ventricle Ejection Fraction (LVEF) and the Wall Motion Score Index (WMSI). METHODS: This is a prospective study included 173 consecutive patients admitted for acute coronary syndrome (ACS) during the period between January 2015 and October 2016.  All the patients had echocardiography with analysis of function by 2DStrain and a coronary angiography .The data have been listed on an SPSS database. CONCLUSION: The 2D Longitudinal Strain represents an excellent parameter which allows a reliable detection of an alteration in the systolic function of the LV in ischemic heart disease and it's very useful to predict the culprit coronary axis and the number of vessels affected.

Incidence and treatment of congenital coronary artery anomalies.

BACKGROUND: Congenital coronary arteries anomalies are a rare entity. Although their identification started in the 60th, there is a lack of data concerning their frequency and clinical significance in Tunisia. AIM: To characterize clinical and imaging features and mid-term follow up data of congenital coronary artery anomalies in a population of Tunisian adults. METHODS: We reviewed the records of 6358 adult patients who underwent coronary angiography between 2009-2015 years in Mongi Slim hospital La Marsa, Tunisia. Multidetector computed tomography was performed on all patients diagnosed having these anomalies and Angelini classification was used for their arrangement. Patients, having intramural coronary artery, were excluded from this study. RESULTS: Thirteen patients had congenital coronary arteries anomalies (seven females and six males). Ten had anomalies of origination and course while the others had anomalies of coronary termination. The right coronary artery was the vessel involved most frequently. It originated from an anomalous coronary ostium in four patients and a unique right coronary artery was reported in one case. An anomalous left main coronary artery was seen in four cases. One patient had the left anterior descending artery originating from the right Valsalva sinus. Four patients underwent coronary revascularization, one died before the intervention and the remainder received medical management. The mean follow up was 54.1±20 months. CONCLUSION: Congenital coronary arteries anomalies have a low incidence in adults. Coronary revascularization is actually indicated in anomalous aortic origin with inter aorto-pulmonary course.

[In hospital mortality of ST segment elevation myocardial infarction treated with primary angioplasty: monocentric Tunisian study of 250 patients]. / Mortalité intra-hospitalière de l'infarctus du myocarde avec sus-décalage persistant du segment ST traité par angioplastie primaire: étude monocentrique tunisienne de 250 patients.

BACKGROUND: Myocardial reperfusion is the « corner stone ¼ in the treatment of myocardial infarction. Primary percutaneous coronary intervention has proved its superiority upon intravenous thrombolysis. aim: To evaluate in hospital mortality of acute myocardial infarction treated with primary angioplasty and to determine its predictive factors. METHODS: We performed a retrospective study including 250 patients admitted to Mongi Slim university Hospital at la Marsa between January the 1st, 2006 and June the 30th, 2011. All these patients had an ST segment elevation myocardial infarction and underwent primary percutaneous coronary intervention within 24 hours after symptom onset. RESULTS: In our study, males were predominant with a sex-ratio of 4.55. Our patients were aged 59.8± 11.19 years old. Diabetes mellitus was present in 42% of our population. In 60.4% of the cases, myocardial infarction was located in the anterior wall. Cardiogenic shock was present in 13.6% of patients. The culprit coronary artery was the left anterior descending artery in 57.6% of the cases. The coronary flow in the culprit artery was TIMI 0 in 64% of the patients and TIMI 1 in 13.2% of the patients. Angiographic success (TIMI 3 flow and residual stenosis <20%) was achieved in 84% of cases. Our in-hospital mortality rate (cardiogenic shock excluded) was 6.9%. Predictive factors of in-hospital mortality were: female gender, diabetes mellitus, hypertension, renal failure, multi-vessel lesion,TIMI flow before percutaneous coronary intervention, proximal left anterior descending artery lesion, initial cardiogenic shock and acute stent thrombosis. CONCLUSION: In our local context, primary percutaneous coronary intervention is an efficient and safe treatment of myocardial infarction with persistent ST-segment elevation.

[Results of cardiac pacing: report of 188 patients]. / Résultats de la stimulation cardiaque définitive: a propos de 188 malades.

BACKGROUND: Indications for permanent pacing are currently well codified. This treatment may, however, present complications AIM: To report the results of cardiac pacing and to identify predictive factors of pacing's complication. METHODS: We conducted a retrospective study of 188 consecutive patients admitted to the cardiology department of Mongi Slim university hospital in La Marsa between January 2005 and June 2011 and implanted with a single or dual chamber pacemaker. RESULTS: In our study, we had 92 men and 96 women (sexratio= 0.95). The mean age was 70.21 ± 13 years. The indication for cardiac pacing was a high degree heart block in 74.46% of cases and a sick sinus syndrome in 15.95% of cases. The degeneration conduction tissue was the main etiology (72.34% of patients). Success implantation was obtained in 98.4%of cases. The main operative complication was the pneumothorax in 3 patients (1.59% of cases). At Long term, cumulative survival rate was 78.95%. Only operating time affects significantly the rate of early complications (p<0.001). Late complications were related to the valvular heart disease (p = 0.007), the ischemic etiology (p = 0.05), the oral antivitamine K treatment (p = 0.04) and the occurrence of early complication (p = 0.002). CONCLUSION: Our hospital, which is considered as a small Center of cardiac pacing (less than 80 procedures/year) had a low complication rate as well as big centers.

[Management of non small cell lung cancer]. / Implications thérapeutiques des récentes études sur la stratégie de prise en charge des cancers bronchiques non àpetite cellule.

BACKGROUND: The broncopulmonary cancer is a major problem of public health whose diagnosis is most of the time unfavorable. For a long time, strategies of management of cancer have not taken into consideration much the histological type and few authors have studied the implication of histological type of cancer on the future of patients having cancer. AIM: Taking into account the results of recent studies, we propose to review the recent epidemiological and biological aspects of bronchial cancers and then to study the impact on the therapeutic strategy. METHODS: Review of literature RESULTS: The scientific progress and the discovery of new mechanisms of carcinogenesis considerably enlarge the therapeutic potential targets and enable to adopt a more specific approach of the cancer cell. CONCLUSION: Despite the progress observed in thoracic cancerology, the benefits concerning survival remain modest. The oncoming of new molecules specifically targeting a stage of oncogenesis enables a better therapeutic selectivity and a lesser toxicity.