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.

Therapeutic targets achievement in secondary prevention after myocardial infarction in a North African tertiary center.

INTRODUCTION: Despite the demonstrated efficacy of cardiovascular (CV) preventive measures, data from international literature indicate that control of CV risk factors (RF) remains insufficient in very high-risk patients. AIM: This study aimed to assess prevalence of achievement of recommended therapeutic targets for the major and modifiable CVRF 12 months after myocardial infarction (MI). METHODS: From 1st January to 30th April 2023, we collected consecutive patients with type 1 MI who had completed 12 months follow-up. Primary endpoint was prevalence of achievement of all recommended therapeutic targets of low-density lipoprotein cholesterol (LDL-C), diabetes mellitus (DM), arterial hypertension (HTN), and smoking. Targets and treatment goals were defined according to the 2021 European Society of Cardiology guidelines on CV disease prevention. RESULTS: 107 patients, mean age 58.8 ± 8.8 years, 74.8% male, were included. 42 (39.3%) patients had HTN, 50 (46.7%) were diabetics, 77 (72.0%) were smokers and eight (7.5%) had hypercholesterolemia. At 12 months, primary endpoint was achieved in 20 (18.7%) patients. 55 (71.4%) of 77 smoker patients were weaned. Blood pressure was at target in 26 (61.9%) among hypertensive patients. In DM patients, HbA1c target was achieved in 23 (46.0%) of them. 32 patients (29.9%) achieved the goal of LDL-C < 0.55 g/L. CONCLUSIONS: Secondary prevention of CV disease was suboptimal. Less than a fifth of patients achieved treatment target for most major and modifiable risk factors. Improvement in follow-up care and treatment after MI is needed.

Management of patients with cardiovascular diseases during Ramadan.

During the month of Ramadan, over one billion Muslims observe a water and food fast from sunrise to sunset. The practice of this religious duty causes marked changes in eating and sleeping habits. With the increasing incidence of cardiovascular (CV) risk factors, the number of patients with CV pathologies who wish to fast is increasing worldwide, and in Tunisia, which is ranked as a high CV risk country. If fasting has been shown to be beneficial for the improvement of some metabolic parameters, its practice in patients with CV pathology remains debated. The Tunisian Society of Cardiology and Cardiovascular Surgery (STCCCV) in consultation with the National Instance of Evaluation and Accreditation in Health (INEAS) has established this document in the form of a consensus after having analysed the literature with the aim of addressing these questions: -What is the impact of fasting in patients with CV pathologies? -How to stratify the risk of fasting according to CV pathology and comorbidities? -How to plan fasting in patients with CV diseases? -What are the hygienic and dietary measures to be recommended during fasting in patients with CV pathologies? -How to manage medication during the month of Ramadan in patients with CV diseases?

Impact of Ramadan fasting on lipid profile and cardiovascular risk factors in patients with stable coronary artery disease.

BACKGROUND: The effects of Ramadan fasting (RF) on cardiometabolic risk factors in patients with stable ischemic heart disease are not well known. AIM: The aim of this study was to evaluate the impact of RF on lipid profile and cardiovascular risk factors in patients with a stable coronary heart disease. METHODS: A prospective observational study carried out in the Cardiology department of Charles Nicolle Hospital (Tunisia). Eighty-four patients with a stable ischemic heart disease who intended to fast were enrolled during May 2020. Detailed clinical and biochemical assessments were performed before and after the holy month. Parameters of glycemic control, lipid profile, ultrasensitive C-reactive protein concentration (us-CRP) and homocysteine were performed before- and after- Ramadan (BR and AR, respectively). RESULTS: Eighty-four patients including 79 males and 5 females, with a mean age of 57±7 years completed the study. Levels of cholesterol, triglycerides, low-density lipoprotein-cholesterol and apoprotein A were significantly improved AR fasting in comparison with their BR values. There was a significant decrease in blood fasting glucose, insulin level, Homeostasis model assessment of insulin resistance index and in us-CRP level. CONCLUSION: In patients with stable ischemic heart disease, RF may be accompanied by an improvement of lipid profile and glycemic parameters without increase in coronary events.

Subacute right ventricle perforation: a pacemaker lead complication.

Myocardial perforation is an uncommon but potentially life-threatening complication of pacemaker and implantable cardioverter-defibrillator. Myocardial perforation may be acute, subacute or chronic when it occurs within 24 hours of the device insertion; between 1 day and 30 days; and more than 30 days after implantation. This complication may occur in 1.7%-7% of patients. However, subacute myocardial perforation is rare and affects 0.5%-1.2% of patients. We report the case of an 85-year-old patient with a pacemaker failure 10 days after implantation due to a subacute myocardial perforation caused by an active fixation ventricular lead. Transthoracic echocardiography showed penetration of the ventricular lead through the right ventricular apex into the pericardium without any pericardial effusion. We confirmed myocardial perforation by a CT scan. We referred her to the surgery ward where she was successfully managed.

Relationship between Galectin-3 levels and severity of coronary artery disease in ST elevation myocardial infarction.

BACKGROUND: Galectin-3 is a new biomarker assumed to reflect fibrogenesis and inflammation. We aimed to investigate the relation of Gal-3 with the severity of coronary artery disease in patients with ST elevation myocardial infarction. METHODS: The prospective study enrolled 62 patients with ST elevation myocardial infarction who underwent coronary angiography. The burden of atherosclerosis was assessed by the number of involved vessels, the number of coronary lesions with a stenosis diameter more than 50% and the Gensini score. Gal-3 levels were measured on admission on miniVIDAS (BioMérieux). RESULTS: The mean age of the patients was 56±11 years old; 93.5% were males. Diabetes, hypertension and hyperlipidemia were respectively 29%, 35.5% and 24.2%. Among patients, 80.6% were active smokers. Mean level of Gal-3was 17±11 ng/ml and didn't differ significantly from the number of involved coronary vessels (p=0.82) and the Gensini score (p=0.4). There was a positive correlation between the number of coronary lesions with a stenosis diameter greater than 50% and Gal-3 (p=0.04). CONCLUSION: In patient with ST elevation myocardial infarction we found a positive correlation between the number of coronary stenosis and Gal-3 level.

[Echocardiographic factors determining immediate result of percutaneous mitral balloon commissurotomy]. / Paramètres échocardiographiques prédictifs du résultat immédiat de la commissurotomie mitrale percutanée.

AIM: Define echocardiographic predictors of the result after percutaneous mitral balloon commissurotomy (PMC). METHODS: PMC by the Inoue balloon was attempted in 247 patients (77% female) with severe mitral valve stenosis. The mean age was 35 years. All the patients had undergone echocardiographic examination before PMC to assess mitral anatomy, commissural calcification, and to determine the Wilkins score. RESULTS: The mean value of Wilkins score was 7,98 +/- 1,61 (range 5-13) and the mean mitral valve area (MVA) before PMC was 1 +/- 0,19 cm2 (range 0,5- 1,4 cm2). 29 patients (11,7%) had one-commissural calcification and 2 patients (0,8%) had bi-commissural calcifications. After PMC, the mean MVA increased to 1,79 +/- 0,34 cm2 (p <0,001) resulting in a success rate of 83%. Severe mitral regurgitation (> or =grade 3) occurred in five patients (2%). Wilkins score was an independent predictor of the immediate result of PMC but, if > 8, this score had a weak predictive value. Commissural morphology was another independent predictor of the immediate result of PMC. CONCLUSION: Echocardiography is now the cornerstone for the assessment of mitral anatomy before PMC and should integrate Wilkins score and commissural morphology for the selection of patients to PMC.

[In-hospital prognosis of right ventricular myocardial infarction]. / Pronostic a la phase hospitalière de l'infarctus du ventricule droit.

AIM: To identify prognostic risk factors for in-hospital outcome of right ventricular myocardial infarction (RVI). METHODS: A retrospective study of 20 patients admitted with acute myocardial infarction with a RVI defined by ST segment elevation > or = 1 mm in V3R and V4R leads. RESULTS: The mean age was 62 years. RVI was associated with an inferior myocardial infarction in 18 patients. Half of the patients had hemodynamic complication on admission (cardiogenic shock in 4 cases, right ventricular failure in 6 cases) and third degree atrio-ventricular block was present in 5 patients. Sixteen patients (80%) received thrombolysis and 3 went to an emergency angioplasty. The in-hospital mortality was 25% caused by a cardiogenic shock in 4 patients and a ventricular fibrillation in 1 patient. Statistic analysis showed that cardiogenic shock on admission, the absence of thrombolytic therapy and the low ejection fraction of the left ventricle were associated with a high in-hospital mortality (p = 0.004, p = 0.03, p = 0.03 respectively). CONCLUSION: In-hospital outcome of RVI is characterized by hemodynamic complications leading to a high incidence of mortality. Thus RVI must be diagnosed quickly and maximal therapeutic efforts must be done to procure the opening of the occluded coronary artery.

[Value of ambulatory blood pressure monitoring in blood pressure profile determination in type 2 diabetes]. / Apport de la MAPA dans l'étude du profil tensionnel du diabétique type 2.

Risk assessment in the type 2 diabetic patients must take into account the major risk factors, particularly arterial hypertension which is commonly associated, increasing the risk for macrovascular and microvascular complications. The aim of this study is to determine whether ambulatory blood pressure monitoring provides additional information to clinical (office) blood pressure measurement for the detection and control of hypertension in type 2 diabetic patients. Ambulatory blood pressure monitoring is more helpful than office blood pressure measurement for the evaluation of blood pressure levels. It is very valuable in type 2 diabetic patients for detecting autonomic dysfunction and elevated blood pressure load, which are associated with cardiovascular complications.