Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors' Network.

The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship- emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.

Contribution of cardiac magnetic resonance imaging in the diagnosis of acute coronary syndrome with normal coronary angiography.

Background - Acute coronary syndrome with high level of troponin is a common pattern for emergency consultation. In 10% of cases, coronary angiography concluded that there were no significant coronary lesions. The contribution of cardiac magnetic resonance imaging (MRI) in the etiological investigation is increasing in these conditions. Aim - We analyzed the diagnostic value of cardiac MRI in case of acute coronary syndromes with elevated troponin and normal coronary angiography. Methods - It's a retrospective analytical study including 31 patients presenting with acute coronary syndrome with positive troponins and normal coronary angiography. All these patients underwent cardiac MRI. Results - The average age was 44.94 years. Cardiovascular risk factors were present in 38.70%. The average level of troponin was 4.85 ng/ml. Modification in the ST segment was noted in 87.1% of which 51.6% had ST elevated segment. Cardiac MRI was performed in the average of 8 days. MRI has contributed to the diagnosis in 77.4%: a myocardial infarction (MI) with no significant coronary lesions in 38.7% of cases, myocarditis in 29% of cases, Tako-Tsubo syndrome in 6.5% of cases and apical HCM in 3.2% of cases. MRI was normal in 22.6% of cases. Conclusions - The contribution of cardiac MRI is growing in the diagnostic management of patients with chest pain, elevated level of troponin and normal coronary angiography. The differential diagnoses have discriminating characteristics in MRI, allowing their identification with excellent diagnostic accuracy. The two main etiologies are myocardial necrosis and myocarditis.

[Acute myocardial infarction in elderly patients]. / Infarctus du myocarde chez le sujet âgé.

BACKGROUND: Age is the most important determinant of outcome for patients with acute coronary syndromes (ACS) and ischemic heart disease is the leading cause of death among elderly patients. AIM: To determine the epidemiologic particularities, the clinical presentation, and the treatment of Acute Myocardial Infarction (AMI) in patients over 65 years. METHODS: One hundred patients >65 years of age with myocardial infarction were hospitalized in intensive care of cardiologic unit of Military Hospital of Tunis between 2000 and 2008. Clinical characteristics, reperfusion therapy and outcomes of in-hospital period and for one year follow-up were seen for every patient. RESULTS: The mean age of our population was 77 years. Sex-ratio was 3/1.Our population was divided into tow groups; patients aged between 65 and 75 years (48 patients) and those aged more than 75 years (52 patients). Only 44 % of our patients had arrived at the hospital within the first 12 hours. STEMI was found in 65 % of our patients. At admission, 40 % had congestive heart failure (³ Killip II), 10 % were in cardiogenic shock. Urgent reperfusion therapy was given to 58 % of our patients; 33% received a thrombolytic therapy and 25 % were allocated to primary PCI. During in-hospital period, 40 % have developed congestive heart failure, 20 % have had a cardiogenic shock and 12 % were died. All these events were more frequent in patients aged over 75 years and reperfusion therapy was associated with best outcome. CONCLUSION: In our study invasive treatment such as fibrinolysis and PCI was associated to better outcome in acute period and at 12 months of follow up in elderly patients treated for AMI.

Clinical and electrophysiological profile of Brugada syndrome in the Tunisian population.

BACKGROUND: Most clinical studies of the clinical profile of Brugada syndrome (BS) have been conducted in either Asia, Europe, or America and their applicability to North African populations is largely unknown. The aim of the study was to analyze the clinical profile of BS in Tunisian patients. METHODS: The clinical and follow-up data of 24 patients (22 men, mean age: 40.8 ± 13.7 years) were collected since 2002. Baseline characteristics, morbidity, and mortality data were obtained from medical records. RESULTS: One patient (4.16%) survived sudden cardiac death (SCD), four patients (16.3%) had syncope, and 19 patients (79.1%) were asymptomatic. Eleven patients (45.8%) had a family history of SCD. Twenty patients showed a spontaneous coved-type ST-segment elevation on electrocardiogram and after medical challenge on the four remnants. An electrophysiological study was performed in 15 of 24 patients (62.5%), during which ventricular fibrillation was induced in six patients (40%); three of the six patients were previously asymptomatic. An implantable cardioverter defibrillator (ICD) was implanted in 14 patients (58.3%). After a mean follow-up of 26 ± 21 months, one patient died from a noncardiac cause and one patient (with a history of aborted SCD) received an appropriate shock from his ICD. None of the asymptomatic and noninducible patients experienced a cardiac event. CONCLUSIONS: BS is present in the North African population and is probably under-recognized. Tunisian patients with BS share with their western and Asiatic counterparts similar clinical profile.

[Cardiac conduction disorders in athletes: diagnosis and management]. / Troubles de la conduction cardiaque chez le sportif : diagnostic et prise en charge.

BACKGROUND: The sino-atrial or atrio-ventricular conduction disturbances are commonly seen in athletes. They are due to predominant effect of the parasympathetic tone. AIM: To describe the physiological cardiac adaptation to physical exercises and to specify the limits of this activity in front of persons with conduction abnormalities. METHODS: Review of literature and lecture of recommendations. RESULTS: conduction disturbances in athletes disappear during physical activities. Their frequency is variously reported in literature. These disorders should be well considered particularly when they are priors to sport practice and need definitive implantable devices. Such decision must be taken after a detailed evaluation of the nature of the physical activity wished and the conduction disturbance type. CONCLUSION: The decision to allow competition should be take after a careful evaluation of the conduction disorder and the type of sport.

[Sirolimus-eluting stent in the prevention of restenosis in small coronary arteries]. / Le Stent A Elution De Sirolimus Dans La Prevention De La Restenose Des Arteres Coronaires De Petit Calibre.

BACKGROUND: Angioplasty of coronary arteries with a small diameter (commonly defined as diameter inferior than 2.75 mm) is associated with a high rate of restenosis and revascularization. Since the use of Drug Eluting Stents (DES) and considering their good results on simple lesions compared to other techniques (balloon dilation and bare metal stents), many studies have also demonstrated the superiority of DES in reducing restenosis and revascularization of complex lesions in particular lesions on coronary arteries with small diameter. AIM: Assessment of this revascularization procedure. METHODS: Our study is a prospective one carried on between june 2002 and august 2006, involving a cohort of 299 patients. Patients are divided into 2 groups: group I: 175 patients with 220 lesions on coronary arteries with small diameter treated by 233 sirolimus DES (Cypher) and group II: 124 patients treated by 136 angioplasty of coronary arteries with diameter superior than 2.75 mm using 179 DES. RESULTS: During hospitalisation, there was no significant difference in MACE between the 2 groups. Nevertheless, 2 patients among the first group had no angioplasty because of unsuccessful progression of the balloon through the lesion and the absence of atherectomy in our center. All patients having acute thrombosis during hospitalization and presenting with ST elevated acute coronary syndrome had successful urgent revascularization with TIMI 3 flow. The mid-term follow-up (12 months) concerned 157/174 patients in group I and 113/123 patients in group II. We observed a higher mortality and non fatal myocardial infarction in group I without statistically significant difference. CONCLUSION: despite the complexity of the lesions on coronary arteries with small diameter and despite the association with several risk factors in particular diabetes, the use of DES reduces the MACE specially secondary revascularisations thus improving early and midterm prognosis.

[Infective endocarditis on probe of pacemaker]. / L'endocardite infectieuse sur sonde de stimulateur cardiaque.

Infective endocarditis is an uncommon but potentially lethal complication of permanent cardiac pacing. Infection is mainly caused by local contamination during the implantation procedure. The most frequently detected causative microorganisms were staphylococci. The clinical presentation is often atypical causing prolonged diagnostic delay. Bacteriological data and visualisation of neostructures consistent with vegetations on transoesophageal echocardiography, strongly suggest pacemaker lead infection. Management is based on a combined approach using both prolonged antibiotic treatment and early complete device explantation. Percutaneous techniques are currently the method of choice for lead extraction but it is not without possible complications. Antibiotic prophylaxis in order to reduce infection risk related to pacemaker implantation is widely recommended.

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.

The Effect of ACE I/D Polymorphisms Alone and With Concomitant Risk Factors on Coronary Artery Disease.

BACKGROUND: Coronary artery disease (CAD), also known as atherosclerotic heart disease, is a leading cause of mortality and morbidity throughout the world. The role of insertion/deletion (I/D) polymorphisms of the angiotensin-converting enzyme (ACE) gene in the etiology of CAD remains to be more completely clarified. The aim of this study was to determine the role of the ACE I/D polymorphism in patients with CAD and to study the association together with traditional risk factors in assessing the risk of CAD. METHODS: Our study population included 145 Tunisian patients with symptomatic CAD and a control group of 300 people matched for age and sex. All participants in the study were genotyped for the ACE I/D polymorphisms obtained by polymerase chain reaction amplification on genomic DNA. RESULTS: Our analysis showed that the ACE D allele frequency ( P < 10-3; odds ratio [OR] = 5.2; 95% confidence interval [CI] = 3.6-7.6) and DD genotype ( P < 10-3; OR = 6.8; 95% CI = 4.4-10) are significantly more prevalent among patients with CAD than in controls and may be predisposing to CAD. We further found that the risk of CAD is greatly potentiated by several concomitant risk factors (smoking, diabetes, hypertension, dyslipidemia, and a family history of CAD). CONCLUSION: The ACE D allele may be predictive in individuals who may be at risk of developing CAD. Further investigations of these polymorphisms and their possible synergisms with traditional risk factors for CAD could help to ascertain better predictability for CAD susceptibility.

Association of FV G1691A Polymorphism but not A4070G With Coronary Artery Disease.

Coronary artery disease (CAD) is one of the chief causes of death in the world. Several hypotheses have been promoted as for the origin of the disease, among which are genetic predispositions and/or environmental factors. The aim of this study was to determine the effect of factor V (FV) gene polymorphisms (Leiden, G1691A [FVL] and HR2 A4070G) and to analyze their association with traditional risk factors in assessing the risk of CAD. Our study population included 200 Tunisian patients with symptomatic CAD and a control group of 300 participants matched for age and sex. All participants were genotyped for the FVL and HR2 polymorphisms. Multivariate logistic regression was applied to analyze independent factors associated with the risk of CAD. Our analysis showed that the FVL A allele frequency ( P < 10-3, odds ratio [OR] = 2.81, 95% confidence interval [CI] = 1.6-4.9) and GA genotype ( P < 10-3, OR = 4.03, 95% CI = 2.1-7.6) are significantly more prevalent among patients with CAD compared to those controls and may be predisposing to CAD. We further found that the FVL mutation is an independent risk factor whose effect is not modified by other factors (smoking, diabetes, hypertension, dyslipidemia, and a family history of CAD) in increasing the risk of the disease. However, analysis of FV HR2 variation does not show any statistically significant association with CAD. The FVL polymorphism may be an independent risk factor for CAD. However, further investigations on these polymorphisms and their possible synergisms with traditional risk factors for CAD could help to ascertain better predictability for CAD susceptibility.

Multimodality imaging assessment of a caseous calcification of the mitral valve annulus.

Caseous calcification of the mitral annulus (CCMA) is a rare echocardiographic finding. It is commonly misdiagnosed as an abscess, tumor or infective vegetation on the mitral valve. Since it is a benign process, differentiating it from malignant intra-cardiac mass is primordial to avoid unnecessary surgery. Various imaging modalities can be complimentary for definitive diagnosis. We present a case of CCMA in a 71-year-old female patient. Her medical history revealed hypertension, diabetes mellitus, hyperlipidaemia and coronary artery disease. She was referred to our department for coronary catheterization because of angina symptoms upon minimal exertion. The lesion was detected during echocardiography and was defined as a mass of heterogeneous content with calcification points, located at the posterior side of the mitral valve annulus. Restricted motion of the posterior leaflet and the mass effect caused only minimal mitral regurgitation. To establish the correct diagnosis, we performed the full spectrum of noninvasive cardiac imaging modalities. Transesophageal echocardiography identified well-organized, composite lesion with regular edges, markedly calcified margins and more echolucent central portion. A computed tomography (CT) was performed, showing a hyperdense mass with hypodense center and a calcified peripheral rim located at the posterior mitral ring. Cardiac magnetic resonance imaging (MRI) showed that the mass was hypointense with respect to the myocardium in the T1 and T2-weighted sequences and only presented late-phase enhancement in the surrounding capsule. Based on the CT and MRI findings, the diagnosis of CCMA was established. The patient was managed conservatively.

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.

[Overview on the management of vasovagal syncope]. / Mise au point sur la prise en charge de la syncope vasovagale.

BACKGROUND: Vasovagal syncope (VVS) is the most common type of syncope. Despite its benignity, quality of life may be severely affected in a significant proportion of highly symptomatic patients. AIM: To review achral knowledgement concerning vasovagal syncope, to assess the utility of diagnostic investigation and report the updat therapeutic management. METHODS: An electronic search of the relevant literature was carried out using medline. Key words used for the final search were "Vasovagal syncope" "pathophysiology" "diagnosis" "tilt-table testing", "imlantableloop recoder", "treatment", "tilt training", isometric muscle tensing", "cardic pacing". RESULTS: A typical history of VVS is usually sufficient to make the diagnosis without any additional testing. Further testing is required when the diagnosis remains uncertain. Approaches to treatment are largely empirical and this is due to our lack of understanding of the pathophysiology. The management of VVS is often limited to reassuring and advising how to avoid predisposing factors with behaviour modification. For patients with recurrent episodes of syncope and premonitory symptoms, a conservative nondrug approach such as isometric muscle tensing should be considered. Tilt training can also be considered first-line therapy in motivated patients. Nevertheless, if patients still experience sudden recurrent and unpredictable episodes of syncope, a more aggressive treatment strategy is required with need of a prophylactic pharmacologic therapy. Various forms of medical treatment have been proposed but there are limited data from randomized controlled trials to support their effectiveness. The role of cardiac pacing is controversial and its indication should be restricted to patients over the age of 40 with severe recurrent syncope that is refractory to other therapies and in whom episodes include a substantial bradycardic component.

[Chronic heart failure: role of Doppler echocardiography in the evaluation of mortality risk]. / Insuffisance cardiaque chronique: place de l'échocardiographie-doppler dans l'évaluation du risque de mortalité.

BACKGROUND: Chronic heart failure (CHF) is a major cause of morbidity and mortality. Despite recent improvements in the management of this condition, the overall prognosis remains poor. Echocardiography is the most useful test in the evaluation of systolic and diastolic function and has also a prognostic value. AIM: The aim of this study is to determine echocardiographic predictors of mortality in patients with CHF. METHODS: We followed 100 patients with a diagnosis of CHF over an average period of 44+/-40.5 months. We compared echocardiographic parameters in survivors and non survivors. RESULTS: Four variables predicted death: LVEF <35% (p=0.001), TDE <150ms (p=0.001), E/A ratio >2 (p=0.05) and E/Ea ratio >10 (p=0.008). CONCLUSION: Doppler echocardiography has a central role in the evaluation of patients with CHF. It provides valuable prognostic information by combination of several parameters.

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors' Network.

The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability - have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors' Network.

The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship -emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors' Network.

The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability -, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors´ Network.

The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship -emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors´ Network of the European Society of Cardiology.