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.

Epidemiologic features and management of hypertension in Tunisia, the results from the Hypertension National Registry (NaTuRe HTN).

BACKGROUND: Hypertension is the leading cause of morbi-mortality in our country. Thus, we conducted this national survey on hypertension to analyze the profile of the Tunisian hypertensive patient and to assess the level of blood pressure control. METHODS: Nature HTN is an observational multicentric survey, including hypertensive individuals and consulting their doctors during the period of the study. Blood pressure measurements were conducted during consultation, using a standardized auscultatory or oscillometric sphygmomanometer after at least 15 min of rest. The diagnosis of new hypertension is based on the 2018 ESC/ESH criteria. The primary endpoint of our study was uncontrolled hypertension defined by a systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. RESULTS: Three hundred twenty-one investigators participated in the study. We enrolled 25,890 patients with a female predominance (Sex ratio, 1.21) and an average age of 64.4 ± 12.2 years. Most individuals were treated in the public sector (74%), 39.4% of patients were diabetic, 25.8% were obese, 44.6% were overweight and 14% were smokers. Hypertension was controlled in 51.7% of cases if we consider 140/90 as a BP target, and only in 18.6% if we consider 130/80 as a target. The independent predictors of uncontrolled blood pressure were male sex (OR = 1.09, 95%CI [1.02-1.16]), age > 65 year-old (OR = 1.07, 95% CI[1.01-1.13], diabetes (OR = 1.18, 95% CI [1.11-1.25], Smoking (OR = 1.15, 95% CI [1.05-1.25]), Obesity (OR = 1.14, 95% CI[1.07-1.21]), management in public sector (OR = 1.25, 95% CI [1.16-1.34]), and Heart rate > 80 bpm (OR = 1.59, 95% CI [1.48-1.71]). Contrarily, high educational level (OR = 0.9, 95% CI [0.84-0.97], absence of history of coronary disease (OR = 0.86, 95% CI [0.8-0.93]), salt restriction (OR = 0.48, 95% CI [0.45-0.51]), drug compliance (OR = 0.57, 95% CI[0.52-0.61]), and regular physical activity (OR = 0.77, 95% CI[0.71-0.84]) are strong predictors of blood pressure control. CONCLUSION: NaTuRe HTN showed that blood pressure control was reached in more than half of the Tunisian people. The control remains low in patients with high cardiovascular profiles and in those treated in the public sector. A national health program based on therapeutic education, regular control and continuous support to the public institutions is needed to decrease the burden of hypertension incidence rate.

[Left ventricular hypertrophy in hemodialysis patient: Prevalence, electrocardiographic, echocardiographic study and associated risk factors]. / Hypertrophie ventriculaire gauche chez les hémodialysés : prévalence, étude électrique, échographique et facteurs de risque.

BACKGROUND: Left ventricular hypertrophy is the most prevalent cardiac abnormality in hemodialysis patients. The diagnosis of this abnormality is possible by electrocardiogram and/or echocardiography. Our study aimed to assess the prevalence of left ventricular hypertrophy in hemodialysis patients and the accuracy of different electrocardiographic criteria. METHODS: This was a cross-sectional retrospective study including 60 hemodialysis patients between 2017 and 2018. A left ventricular mass index higher than 115g/m2 and 95g/m2 respectively in men and women defines echocardiographic left ventricular hypertrophy. We assessed left ventricular hypertrophy prevalence, sensitivity, specificity, and area under the receiver-operating characteristics (ROC) curve of fourteen different electrocardiographic criteria for identification of left ventricular hypertrophy. RESULTS: This was a cohort of 60 patients composed of 27 men and 33 women with a mean age 52.6±15,8years. Hypertension was the most common cardiovascular risk factor (82 %). The prevalence of left ventricular hypertrophy at echography was 65 %. Prevalence of left ventricular hypertrophy at electrocardiographic varied across the different criteria ranging from 5 % (R wave in DI) to 32 % (Perugia score). The highest left ventricular hypertrophy prevalence at electrocardiographic was found with the five following criteria: Perugia score (32 %), Peguero-Lo Presti index (28 %), Sokolow-Lyon index, Cornell index, Framingham-adjusted Cornell voltage (17 %). Sensitivity was ranged from 5 % (R in DI, Gubner-Ungerleider index, and product) to 41 % (Perugia score). The specificity of most criteria was ≥90 % except for the Perugia score (85 %). The sensitivity, specificity, postitive and negative productive values and left ventricular hypertrophy prevalence using the five most accurate criteria combined were respectively 48, 90, 70.28, 77.85 and 33 %. Hypertension, duration of HD, arteriovenous fistula, interdialytic weight gain, systolic blood pressure, hemoglobin <9g/dL and hyperparathyroidism were significantly associated with left ventricular hypertrophy. CONCLUSION: The prevalence of left ventricular hypertrophy detected by echocardiography was high. All electrocardiographic criteria had a low sensibility and a high specificity in the diagnostic of echocardiographic left ventricular hypertrophy. To improve the accuracy of electrocardiographic criteria, it is necessary to combine several electrocardiographic criteria and not often focused on a single classic electrocardiographic index.

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.

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.

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.

Epidemiological characteristics, management, and outcomes of atrial fibrillation in TUNISIA: Results from the National Tunisian Registry of Atrial Fibrillation (NATURE-AF).

BACKGROUND: Contemporary registries on atrial fibrillation (AF) are scare in North African countries. HYPOTHESIS: In the context of the epidemiological transition, prevalence of valvular AF in Tunisia has decreased and the quality of management is still suboptimal. METHODS: NATURE-AF is a prospective Tunisian registry, involving consecutive patients with AF from March 1, 2017 to May 31, 2017, with a one-year follow-up period. All the patients with an Electrocardiogram-documented AF, confirmed in the year prior to enrolment were eligible. The epidemiological characteristics and outcomes were described. RESULTS: A total of 915 patients were included in this study, with a mean age of 64.3 ± 22 years and a male/female sex ratio of 0.93. Valvular AF was identified in 22.4% of the patients. The mean CHA2 DS2 VASC score in nonvalvular AF was 2.4 ± 1.6. Monotherapy with antiplatelet agents was prescribed for 13.8% of the patients. However, 21.7% of the subjects did not receive any antithrombotic agent. Oral anticoagulants were prescribed for half of the patients with a low embolic risk score. In 341 patients, the mean time in therapeutic range was 48.87 ± 28.69%. Amiodarone was the most common antiarrhythmic agent used (52.6%). During a 12-month follow-up period, 15 patients (1.64%) had thromboembolism, 53 patients (5.8%) had major hemorrhage, and 52 patients (5.7%) died. CONCLUSIONS: NATURE-AF has provided systematic collection of contemporary data regarding the epidemiological and clinical characteristics as well as the management of AF by cardiologists in Tunisia. Valvular AF is still prevalent and the quality of anticoagulation was suboptimal.

Tunisian Consensus document on magnetic resonance imaging in patients with intracardiac devices.

INTRODUCTION: Patients with ferromagnetic cardiac devices, particularly cardiac implantable electronic devices (CIED) such as pacemakers or implantable cardioverter defibrillators, are often inappropriately deprived of magnetic resonance imaging (MRI) for safety reasons. This consensus document is written by a multidisciplinary working group involving rhythmologists, interventional cardiologists, echocardiographists and radiologists. Its objective is to establish good practice recommendations to optimize the management of patients with cardiac devices requiring MRI examination, while ensuring their safety and facilitating their access to MRI.

Angioplasty of Anomalous Coronaries Arising from the Opposite Sinus with an Interarterial Course, is it Safe?

BACKGROUND: The coronary artery with an interarterial course CAIAC is the most threatening coronary anomaly, especially if it concerns the left coronary. Percutaneous coronary intervention PCI is scarcely described given its low prevalence and lack of long-term outcome data. Therefore, we assessed through this case series the feasibility and safety of PCI in this population. METHODS: This is an observational multicentric study including patients with CAIAC arising from the opposite sinus of Valsalva. The primary endpoints were immediate angiographic success and target lesion revascularization. RESULTS: During the period of the study, we performed 27235 PCI in six Cath labs, 26 procedures concerning abnormal coronaries including 12 with CAIAC. The median age was 57 years extremes: 43-78 with male predominance 1:11. Anomalous coronary artery was Right coronary artery RCA in eight patients, Left main LM in three patients, and left anterior descending LAD in one patient. The stenosis was located in all cases in proximal segments beyond the inter-arterial course proximal LAD, the superior genius of the RCA, or the proximal segment of mid-RCA. Five patients showed slit-like ostium and all have an angle take-off <45° on CT scan. After a median follow-up of 24 months, four subjects presented target lesion revascularization TLR, all were initially treated with either a bare-metal stent or with balloons. CONCLUSIONS: PCI of patients with CAIAC is feasible and appears safe. The operator should carefully analyze the angiogram before PCI to choose the appropriate guiding catheter and should be acquainted with the different techniques for improving backup.

Women leaders in Cardiology. Contemporary profile of the WHO European region.

Aims: Women's participation is steadily growing in medical schools, but they are still not sufficiently represented in cardiology, particularly in cardiology leadership positions. We present the contemporary distribution of women leaders in cardiology departments in the World Health Organization European region. Methods and results: Between August and December 2020, we applied purposive sampling to collect data and analyse gender distribution of heads of cardiology department in university/third level hospitals in 23 countries: Austria, Azerbaijan, Belgium, Bosnia-Herzegovina, Croatia, France, Germany, Greece, Italy, North Macedonia, Morocco, Poland, Portugal, Russia, Serbia, Slovakia, Slovenia, Spain, Switzerland, Tunisia, Turkey, Ukraine, and the UK. Age, cardiology subspecialty, and number of scientific publications were recorded for a subgroup of cardiology leaders for whom data were available. A total of 849 cardiology departments were analysed. Women leaders were only 30% (254/849) and were younger than their men counterpart (♀ 52.2 ± 7.7 years old vs. ♂ 58.1 ± 7.6 years old, P = 0.00001). Most women leaders were non-interventional experts (♀ 82% vs. ♂ 46%, P < 0.00001) and had significantly fewer scientific publications than men {♀ 16 [interquartile range (IQR) 2-41] publications vs. ♂ 44 (IQR 9-175) publications, P < 0.00001}. Conclusion: Across the World Health Organization European region, there is a significant gender disparity in cardiology leadership positions. Fostering a diverse and inclusive workplace is a priority to achieve the full potential and leverage the full talents of both women and men.

Assessement of stress induced by high-fidelity simulation sessions among medical students.

INTRODUCTION: Simulation is a growing pedagogical method in training health professionals. The use of high-fidelity simulators may be associated with significant stress. OBJECTIVE: to measure self-assessed intensity of stress before and after a planned simulation training session of a third degree atrio-ventricular block  among  medical students. METHODS: A sample of 30 students participating in a high-fidelity simulation training course (10 playing the role of team leader and 20 in the role of medical intern) was studied. Stress was evaluated by self-assessment using a numerical scale before and after the session. The peri-traumatic distress inventory was used to measure the level of distress experienced by the participants. RESULTS: The median stress score was 3, 5±2, 4 before and 6, 2±2, 4 after the simulation session (p<0.001). Stress intensity increased significantly after the session in students playing the role of the team leader than those playing the role of medical intern (8, 4±0, 8 versus 5, 2±2, 3 p<0.001).The average score for peri-traumatic distress inventory was also significantly higher in the team leaders (18, 8±10, 4 Vs 9, 2±3, 7 p=0,022). CONCLUSION: Simulation-induced stress, as measured by self-assessment, increased significantly after the session and was influenced by the role to be played during the scenario.  Stress should be taken into account before debriefing.

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.

General anesthesia is not superior to local anesthesia for remote magnetic ablation of atrial fibrillation.

BACKGROUND: Remote magnetic navigation is an emerging technology for atrial fibrillation (AF) ablation. General anesthesia (GA) has shown to be superior to local anesthesia (LA) for manual AF ablation in terms of catheter stability and lesion formation. We aimed at comparing GA with LA for remote magnetic AF ablation procedures. METHODS: All patients eligible for a remote magnetic ablation of AF were included in this study. Ninety patients (70% of the patients were male; age: 60 ± 10 years; CHA2 DS2 -VASC : 1.6 ± 1.2; paroxysmal AF: 60%, persistent AF: 40%), including 45 patients with GA, and 45 patients with LA were enrolled consecutively. RESULTS: There was no significant difference in total procedure time between the two groups (237 ± 50 minutes in the GA group vs 240 ± 61 minutes in the LA group; P = 0.84). Fluoroscopy time was significantly increased in the GA group (14.6 ± 6 minutes vs 11.6 ± 6 minutes, P = 0.018). Ablation time was not different between the two groups (2,320 ± 984 seconds in the GA group vs 2,055 ± 1,023 seconds in the LA group; P = 0.25). After a mean follow-up of 1 year (including repeat procedures), 39/45 patients (86.6%) within the GA group were free from recurrences versus 40/45 patients (88.8%) in the LA group (P = 0.74) without antiarrhythmic drugs. CONCLUSION: For remote magnetic AF ablation, procedures under LA have similar results to GA in terms of efficacy and safety after 1-year follow-up.

New oral anticoagulants in patients undergoing atrial flutter radiofrequency catheter ablation: an observational study.

AIM: Atrial flutter (AFL) ablation requires optimal periprocedural anticoagulation in order to minimize thromboembolic events/bleeding risk. This study describes the characteristics of patients receiving new oral anticoagulants before AFL ablation and assesses complications. METHODS: This multicenter, retrospective study reports ischemic and hemorrhagic predischarge, postprocedural complications. RESULTS: We evaluated 60 patients (62.3% male; mean age: 69.2 ± 9.7 years; CHA2DS2-VASc score: 2.44 ± 1.46, HAS-BLED score: 1.14 ± 0.7). Twenty-one (35.0%) and 23 patients (38.3%) received twice-daily dabigatran 110 or 150 mg; 16 patients (26.6%) received once-daily rivaroxaban (15 mg [n = 5] or 20 mg [n = 11]). Four cases of postprocedural minor bleeding were reported. CONCLUSION: This is the first study assessing new oral anticoagulants for periprocedural anticoagulation, specifically in patients undergoing AFL ablation. No major bleeding was reported. Further prospective investigation is warranted.