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.

Can we achieve ESC 2019 guidelines LDL-cholesterol target in Tunisia?

INTRODUCTION: Dyslipidemias are a major cardiovascular risk factor. The control of LDLc level is one of the major targets in patients admitted for an acute coronary syndrome (ACS). AIM: To study the lipid profile after ACS and to assess the degree of applicability of the European guidelines in Tunisia. METHODS: This was a prospective, multicentric, non-randomized study involving consecutive patients admitted for ACS between October 2019 and March 2020; for whom a lipid assessment was carried out on admission and checked after four to six weeks under high dose of statin. RESULTS: One hundred patients were included. The mean age of our population was 58.7 years and the sex ratio was 5.7. Obesity was present in 15%, Diabetes in 35%, hypertension in 34% and smoking in 61% of cases. Our patients presented with ST segment elevation myocardial infraction in 51%. The mean total plasma LDLc level was 1.04±0.26g/L. A reduction in LDLc levels of more than 50% was noted in 33% of patients. A value less than 0.55g/L of LDLc was noted in 46% of patients. The therapeutic target (LDLc.

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.

Risk stratification for sudden cardiac death in patients with heart failure : Emerging role of imaging parameters.

BACKGROUND: Heart failure with reduced ejection fraction is a common condition that has a poor prognosis. Accurate selection of patients with ischemic heart disease and idiopathic dilated cardiomyopathy, who are at risk of sudden cardiac death (SCD), remains a challenge. In these cases, current indications for implantable cardioverter-defibrillators (ICD) rely almost entirely on left ventricular ejection fraction. However, this parameter is insufficient. Recently, noninvasive imaging has provided insight into the mechanism underlying SCD using myocardial deformation on echocardiography and magnetic resonance imaging. The aim of this review article was to underline the emerging role of these novel parameters in identifying high-risk patients. METHODS: A literature search was carried out for reports published with the following terms: "sudden cardiac death," "heart failure," "noninvasive imaging," "echocardiography," "deformation," "magnetic resonance imaging," and "ventricular arrhythmia." The search was restricted to reports published in English. RESULTS: The findings of this analysis suggest that cardiac magnetic resonance imaging and strain assessment by echocardiography, particularly longitudinal strain, can be promising techniques for cardiovascular risk stratification in patients with heart failure. CONCLUSION: In future, risk stratification of arrhythmia and patient selection for ICD placement may rely on a multiparametric approach using combinations of imaging modalities in addition to left ventricular ejection fraction.

ImpaCt of aspirin regimen on THrombin generation in diabEtic patients with acute coronary syndrome: CARTHaGE-ACS trial.

BACKGROUND: Diabetes is associated with a high rate of events after acute coronary syndrome. It was recently reported that once-daily aspirin might not provide stable biological efficacy in patients with diabetes. AIMS: We sought to compare the biological efficacy of aspirin given once a day versus aspirin divided twice per day in a population of diabetic patients with non-ST elevation acute coronary syndrome (NSTE-ACS) as assessed by the thrombin generation test. METHODS: We performed an open-label single-blind randomized study including 59 consecutive diabetic patients admitted for NSTE-ACS. Patients were randomly treated with aspirin 100 mg once a day (GA100; n = 20), aspirin 160 mg once a day (GA160; n = 19) or aspirin 100 mg twice a day (G2A100; n = 20). The primary endpoint was endogenous thrombin potential (ETP) at discharge and after 6 months. RESULTS: The mean age of our patients was 61.5 ± 9 years, and 73% were male. The baseline characteristics were comparable between the three groups. In the GA100 group, there was no significant effect on ETP variation at 6 months (1150.46 ± 504.84 vs. 1087.63 ± 454.18; p = 0.794). An increase in aspirin dose with a second daily administration of 100 mg was associated with a significant reduction in ETP at 6 months (1004.87 ± 196.2 vs. 1233.63 ± 333.5; p = 0.003). A nonsignificant decrease in ETP was seen in the GA160 group (from 1173.8 ± 388.07 to 1053.64 ± 269.93 at 6 months, p = 0.117). CONCLUSION: Only the twice-daily aspirin regimen led to better control of hypercoagulability in NSTE-ACS diabetic patients. However, no thrombin generation normalization was reported.

Coronary PCI revascularization novel treatment of bundle branch reentrant ventricular tachycardia.

Bundle branch reentrant ventricular tachycardia (VT) is a form of macroreentrant tachycardia. Although infrequent in occurrence, this arrhythmia presents with serious clinical manifestations and has potential for cure by catheter ablation. We report a case of bundle branch reentrant VT with ischemic source. Revascularization of culprit coronary artery was another means to treat VT. .

Management of patients with acute ST-elevation myocardial infarction: Results of the FAST-MI Tunisia Registry.

BACKGROUND: The FAST-MI Tunisia registry was set up by the Tunisian Society of Cardiology and Cardiovascular Surgery to assess the demographic and clinical characteristics, management and hospital outcome of patients with ST-elevation myocardial infarction (STEMI). METHODS: Data for 459 consecutive patients (mean age 60.8 years; 88.5% male) with STEMI, treated in 16 public hospitals (representing 72.2% of public hospitals in Tunisia treating STEMI patients), were collected prospectively.The most common risk factors were smoking (63.6%), hypertension (39.7%), diabetes (32%) and dyslipidaemia (18.2%). RESULTS: Among the 459 patients, 61.8% received reperfusion therapy: 30% with primary percutaneous coronary intervention (PPCI) and 31.8% with intravenous fibrinolysis (IF) (28.6% with pre-hospital thrombolysis). The median time from symptom onset to thrombolysis was 185 min and to PPCI was 358 min. In-hospital mortality was 5.3%. Compared with those managed at regional hospitals, patients managed at interventional university hospitals (n = 357) were more likely to receive reperfusion therapy (52.9% vs. 34.1%; p<0.001), with less IF (28.6% vs. 43.1%; p = 0.002) but more PPCI (37.8% vs. 3.9%; p<0.0001). However, in-hospital mortality in the two types of hospitals was similar (5.3% vs. 5.1%; p = 0.866). CONCLUSIONS: Data from the FAST-MI Tunisia registry show that a pharmaco-invasive strategy of management for STEMI should be promoted in non-interventional regional hospitals.

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.

Spectrum of Mutations in Hypertrophic Cardiomyopathy Genes Among Tunisian Patients.

BACKGROUND: Hypertrophic cardiomyopathy (HCM) is a common cardiac genetic disorder associated with heart failure and sudden death. Mutations in the cardiac sarcomere genes are found in approximately half of HCM patients and are more common among cases with a family history of the disease. Data about the mutational spectrum of the sarcomeric genes in HCM patients from Northern Africa are limited. The population of Tunisia is particularly interesting due to its Berber genetic background. As founder mutations have been reported in other disorders. METHODS: We performed semiconductor chip (Ion Torrent PGM) next generation sequencing of the nine main sarcomeric genes (MYH7, MYBPC3, TNNT2, TNNI3, ACTC1, TNNC1, MYL2, MYL3, TPM1) as well as the recently identified as an HCM gene, FLNC, in 45 Tunisian HCM patients. RESULTS: We found sarcomere gene polymorphisms in 12 patients (27%), with MYBPC3 and MYH7 representing 83% (10/12) of the mutations. One patient was homozygous for a new MYL3 mutation and two were double MYBPC3 + MYH7 mutation carriers. Screening of the FLNC gene identified three new mutations, which points to FLNC mutations as an important cause of HCM among Tunisians. CONCLUSION: The mutational background of HCM in Tunisia is heterogeneous. Unlike other Mendelian disorders, there were no highly prevalent mutations that could explain most of the cases. Our study also suggested that FLNC mutations may play a role on the risk for HCM among Tunisians.

Cardiac hydatid cyst revealed by ventricular tachycardia.

Hydatid disease is a human parasitic infestation caused by the larval stage of Echinococcus Granulosus. The liver and the lungs are the most common locations. Cardiac involvement is rare and accounts for 0.5-2% of all hydatid disease. We report an unusual presentation of cardiac hydatid cyst revealed by ventricular tachycardia in a patient with a history of cerebral hydatid cyst.

Clinical features of Candidiasis in patients with inherited interleukin 12 receptor ß1 deficiency.

BACKGROUND: Interleukin 12Rß1 (IL-12Rß1)-deficient patients are prone to clinical disease caused by mycobacteria, Salmonella, and other intramacrophagic pathogens, probably because of impaired interleukin 12-dependent interferon γ production. About 25% of patients also display mucocutaneous candidiasis, probably owing to impaired interleukin 23-dependent interleukin 17 immunity. The clinical features and outcome of candidiasis in these patients have not been described before, to our knowledge. We report here the clinical signs of candidiasis in 35 patients with IL-12Rß1 deficiency. RESULTS: Most (n = 71) of the 76 episodes of candidiasis were mucocutaneous. Isolated oropharyngeal candidiasis (OPC) was the most common presentation (59 episodes, 34 patients) and was recurrent or persistent in 26 patients. Esophageal candidiasis (n = 7) was associated with proven OPC in 2 episodes, and cutaneous candidiasis (n = 2) with OPC in 1 patient, whereas isolated vulvovaginal candidiasis (VVC; n = 3) was not. Five episodes of proven invasive candidiasis were documented in 4 patients; 1 of these episodes was community acquired in the absence of any other comorbid condition. The first episode of candidiasis occurred earlier in life (median age±standard deviation, 1.5 ± 7.87 years) than infections with environmental mycobacteria (4.29 ± 11.9 years), Mycobacterium tuberculosis (4 ± 3.12 years), or Salmonella species (4.58 ± 4.17 years) or other rare infections (3 ± 11.67 years). Candidiasis was the first documented infection in 19 of the 35 patients, despite the vaccination of 10 of these 19 patients with live bacille Calmette-Guérin. CONCLUSIONS: Patients who are deficient in IL-12Rß1 may have candidiasis, usually mucocutaneous, which is frequently recurrent or persistent. Candidiasis may be the first clinical manifestation in these patients.

[Evaluation of left ventricular function by systolic time intervals]. / Apport des intervalle de temps systoliques dans l'évaluation de la function ventriculaire gauche: etude bicentrique.

BACKGROUND: Evaluation of left ventricular systolic function, usually based on the assessment of the ejection fraction, is increasingly supplemented by other more sophisticated techniques such as 3D echocardiography and speckle tracking. However these methods require a high technicity and a good echogenicity. As heart failure leads to lengthening of aortic pre-ejectional time (PET) and shortening of left ventricular ejection time (ET), systolic time intervals (STI) were proposed for the evaluation of systolic myocardial performance. AIM: to establish a correlation between left ventricular ejection fraction (LVEF) and STI and determine a cut-off value of PET/ET ratio to diagnose a LVEF inferior to 35%. METHODS: 109 consecutive patients referred to two echocardiographic laboratories had measurements of STI and LVEF estimated by Simpson biplane method. Patients included were in sinus rhythm with a heart rate<100 beats per minute. Patients with atrial fibrillation, pacemaker or prosthetic valves were excluded. RESULTS: Feasibility of STI measurements was 100%. A significant negative correlation between PET and LVEF was found (r=-0.49, p<0.0001). LVEF was also significantly correlated to ET (r=0.44, p<0.0001). PET/ET ratio was significantly correlated to LVEF (r=-0.63, p<0.0001). Receiver operating curve analyses revealed a cut-off value of PET/ET ratio of 0.33 to diagnose a LVEF<35% with a sensitivity of 85% and a specificity of 78%. CONCLUSION: STI, easy to obtain and useful in case of poor quality echographic window, are an interesting alternative to evaluate systolic left ventricular function and may be used to detect alteration of LVEF.