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.

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?

Current and new imaging techniques in risk stratification of asymptomatic severe aortic stenosis.

Aortic stenosis (AS) is one of the most common valvular diseases in clinical practice. The prevalence of calcified AS with moderate or severe stenosis exceeds 2% after 75 years. The optimal timing of intervention for asymptomatic severe AS is uncertain and controversial. Identification of high-risk patients is based on echocardiographic parameters (left ventricular dysfunction, AS severity and progression), hemodynamic response to exercise, pulmonary hypertension, and elevated brain natriuretic peptides. However, early surgical aortic valve replacement (AVR), when compared to the watchful waiting approach, was associated with survival advantage. Moreover, new insights into pathophysiology of AS and advances in imaging modalities were helpful in the management of asymptomatic AS. In this report, we detail the potential role of echocardiography to guide timing of surgery and we discussed the use of early risk features based on recent imaging modalities.

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.

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.

Management of patients with cardiac implantable electronic devices (CIED) undergoing radiotherapy: A consensus document from the Tunisian Society of Oncology Radiotherapy and the Tunisian Society of Cardiology and Cardiovascular Surgery.

In patients with cardiac implantable electronic devices CIEDs, including cardiac pacemakers (PM) and implantable cardioverter-defibrillators (ICD), radiotherapy (RT) could compromise CIED function. Managing radiotherapy patients with CIED, has been a great practical and procedural challenge in radiotherapy and requires a structured multidisciplinary approach. A consensus document is presented as a result of a multidisciplinary working group involving cardiac electrophysiologists, Radiation Oncologists and Medical physicists. It aims to propose recommendations on risk stratification, management approach before, during and after radiation treatment/course of patients with CIED.

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.

Assessment of premature ventricular beats in athletes.

INTRODUCTION: Premature ventricular complexes (PVC) are generally considered as a benign electrocardiographic abnormality in the athleticpopulation. However it may be indicative of underlying heart disease which may increase the risk of sudden death. This implies the need forcardiological evaluation before indicating the ability to practice competitive sports. AIM: The aim of this study was to evaluate an athlete population with PVC and establish underlying etiologies in order to take a decisionregarding practicing sports. METHODS: This is a prospective study which included athletes examined in the Tunisian National Centre of Sports Medicine and Sports Science (TNCSM) from January 2013 to June 2015 who presented PVC on an electrocardiogram RESULTS: 5798 athletes were referred to the TNCSM . We identified 42 athletes having PVC with a prevalence of 1.8%. The average age of thestudy population was 21.6 ± 5.99 years. 83% were men. 88% were asymptomatic the electrocardiogram was considered normal in 62% ofthe athletes according to the Seattle criteria, At the Holter monitoring, the average number of PVC was 920 PVC / 24 hours. Thirteen athleteshad doublets and 11 had triplets. One patient had polymorphic PVC and an R/T phenomenon. The transthoracic echocardiography (TTE) wasnormal in 71 % of cases. Three athletes had hypertrophic cardiomyopathy (HCM). All patients underwent a stress test. The PVC disappearedin 12% of athletes. MRI was performed in 10 athletes confirming the three cases of HCM and revealing a case of arrhythmogenic rightventricular dysplasia and a case of compression of the right ventricle by pectusexacavatum. CONCLUSION: After this assessment, five athletes were not allowed to practice sport. This study shows the necessity of a thorough cardiological assessment of athletes with ventricular arrhythmia in order to detect underlying heart disease and prevent sudden death in this young apparentlyhealthy population.

Design and Rationale of the National Tunisian Registry of Atrial Fibrillation: Protocol for a Prospective, Multicenter Trial.

BACKGROUND: Atrial fibrillation (AF) is an important health problem in Tunisia. A significant change in the epidemiological pattern of heart disease has been seen in the last 3 decades; however, no large prospective multicenter trial reflecting national data has been published so far. Robust data on the contemporary epidemiological profile and management of AF patients in Tunisia are limited. OBJECTIVE: The aim of this study is to analyze, follow, and evaluate patients with AF in a large multicenter nationwide trial. METHODS: A total of 1800 consecutive patients with AF by electrocardiogram, reflecting all populations of all geographical regions of Tunisia, will be included in the study, with the objective of describing the epidemiological pattern of AF. Patients will be officially enrolled in the National Tunisian Registry of Atrial Fibrillation (NATURE-AF) only if an electrocardiogram diagnosis (12-lead, 24-hour Holter, or other electrocardiographic documentation) confirming AF is made. The qualifying episode of AF should have occurred within the last year, and patients do not need to be in AF at the time of enrollment. Patients will be followed for 1 year. Incidence of stroke or transient ischemic attack, thromboembolic events, and cardiovascular death will be recorded as the primary end point, and hemorrhagic accidents, measurement of international normalized ratio, and time in therapeutic range will be recorded as secondary end points. RESULTS: Results will be available at the end of the study; the demographic profile and general risk profile of Tunisian AF patients, frequency of anticoagulation, frequency of effective treatment, and risks of thromboembolism and bleeding will be evaluated according to the current guidelines. Major adverse events will be determined. NATURE-AF will be the largest registry for North African AF patients. CONCLUSIONS: This study would add data and provide a valuable opportunity for real-world clinical epidemiology in North African AF patients with insights into the uptake of contemporary AF management in this developing region. TRIAL REGISTRATION: ClinicalTrials.gov NCT03085576; https://clinicaltrials.gov/ct2/show/NCT03085576 (Archived by WebCite at http://www.webcitation.org/6zN2DN2QX). REGISTERED REPORT IDENTIFIER: RR1-10.2196/8523.

Hypertension and Atrial Fibrillation: What is the prevalence of obstructive sleep apnea syndrome?

INTRODUCTION: Obstructive sleep apnea-hypopnea syndrome (OSAS) and cardiovascular disease are public health problems. The objective of our study was to evaluate the frequency of OSAS in patients with hypertension and atrial fibrillation (AF) and to investigate the factors associated with OSAS in this population. METHODS: It's a cross-sectional study including 73patients with hypertension and AF. All patients underwent a respiratory polygraphy. RESULTS: Seventy-Threepatients were included (57 women). The mean age was 66.6±10.7 years. Obesity was found in 75% of patients. The mean duration of hypertension and AF evolution was respectively 8.7±7.3 years and 4.5±5.6 years.A resistant hypertension was found in 16% of patients. AF was paroxysmal in 34% of patients, persistent in 33% and permanent in 33% of patients.The mean Epworth score was 6.7±6.1 with excessive diurnal somnolence found in 30% of patients. According to the Berlin questionnaire, OSAS was "very likely" in 84% of patients. The prevalence of OSAS in patients with hypertension and AF was 77% with an average HAI of 23.26±19.57 per hour of sleep. OSAS was severe in 44% of patients, moderate in 15% of patients, and mild in 18% of patients. Factors associated with OSAS in our population were cognitive disorders (21% vs 0%, p=0.03), diurnal excessive sleepiness (21% vs. 0%, p=0.05), antiarrythmic therapy (63% vs 29%, p=0.016, OR=4.13, 95% CI 1.25-13.64) and nocturnal desaturation (25.86±17.68 vs 9.15±14.3 / H, p<0.0001). Our study did not find any significant difference between the groups regarding demographic characteristics, anthropometric, ultrasound data of patients and characteristics of hypertension and AF. CONCLUSION: OSAS is common among patients followed for hypertension and atrial fibrillation. Its screening is necessary to improve the management and prognosis of these two diseases. However, in the absence of predictive factors for OSA, a polygraph could be recommended for this population.

Value of Cine-MRI sequences before and after injection in the diagnosis of acute myocarditis.

BACKGROUND: Cardiovascular magnetic resonance (CMR) has become the examination of choice in case of suspicion of acute myocarditis. Late gadolinium enhancement (LGE) imaging is very important to establish this diagnosis. Cine MRI sequences are useful for the study of the myocardial contractility. AIMS:   The purpose is to estimate the value of cine MRI sequences before and after injection for the diagnosis of acute myocarditis compared with late gadolinium enhanced sequences. METHODS: We prospectively included 40 patients having a high suspicion of acute myocarditis and examined using a 1.5 Tesla CMR. Cine MRI sequences before and after injection were performed. The protocol also include  T2-weighted  short- tau-inversion-recovery (STIR T2) fast spin echo MRI and LGE imaging eight minutes after injection with visual adjustment of inversion time. RESULTS: Delayed enhancement was found among 23 patients. Fifteen patients (65 %) presented a spontaneous hyper signal detected visually on Cine MRI sequences before injection and 11 patients (48 %) on STIR T2. The hyper signal on Cine MRI sequences after injection of gadolinium was the same topography that the late raising at 23 patients. In addition, we highlighted a significant difference between this hyper signal before injection and the left ventricle ejection fraction (p=0.022) as well as with the telesystolic volume of the left ventricle (LV) indexed by the body mass (p=0.039). CONCLUSION: Our study suggests that Cine MRI sequences after injection are of equal performance in the diagnosis of acute myocarditis as the LGE sequences and its contibution is important when we want to shorten the examination or when inversion time isn't optimal.

Clinical and genetic investigation of atrial septal defect with atrioventricular conduction defect in a large consanguineous Tunisian family.

BACKGROUND: Atrial septal defect (ASD) is an autosomal dominant disease characterized by left-to-right shunting and increased right ventricular output. Approximately 5-10% of congenital heart diseases (CHD) are due to ASD, which is one of the most frequent CHD found in adults. The gene responsible for ASD was mapped to chromosome 5q35 encoding the transcription factor NKX2-5 that plays an important role for the regulation of septation during cardiac morphogenesis. METHODS: A Tunisian family including four affected members was investigated. Individuals were genotyped using the polymorphic microsatellite markers D5S394 and D5S2069 overlapping the NKX2-5 gene. RESULTS: We report here clinical and molecular investigation of a Tunisian consanguineous family with four affected members. Two presented with ASD associated with prolonged PR interval, whereas the other two presented only a prolonged PR interval. We also identified five asymptomatic individuals in the same family with ventricular preexcitation. Although the patients were products of a consanguineous marriage, no other abnormalities were observed in this family. Genotyping and linkage analysis showed exclusion of linkage between the gene responsible for ASD in this family and NKX2.5 gene. CONCLUSIONS: Our results further confirm the genetic heterogeneity of ASD.

[Hydatic pulmonary embolism complicating a cardiac hydatic cyst. A case report]. / Embolie pulmonaire hydatique compliquant un kyste hydatique du coeur. A propos d'un cas.

Hydatic pulmonary embolism: complication of a cardiac hydatic cyst:a case report hydatic cardiac cyst is a rare condition and represents only 0.5 to 2% of all visceral localisations of the hydatid disease. We reported a 28 year old patient with a multiple hydatic pulmonary embolism caused by the rupture of a hydatic cyst of the interventricular septum. The diagnosis was established by transthoracic echocardiography and CT Scan. Surgery was performed without delay and the outcome was good after a five month follow-up. This case illustrates the diagnostic value of the non invasive imaging means in hydatic cyst of the heart and underlines the importance of surgery realized before complications occur.