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.

[Monocentric retrospective study on the prevalence and significance of incomplete right bundle branch block in young competitive athletes in Tunisia]. / Étude rétrospective monocentrique sur la prévalence et la signification du bloc de branche droit incomplet chez les jeunes sportifs de compétition en Tunisie.

AIMS: Few studies have assessed the prevalence and significance of right bundle branch block in athletes. Aims of this study were to evaluate the prevalence of incomplete right bundle branch block and its correlation with the nature of sports practice and to compare the athlete with right bundle branch block and the one with a normal electrocardiogram. METHODS: It was a retrospective study of the electrocardiogram and echocardiography of competitive athletes recruited in the medical-sports center of Sousse RESULTS: A total of 554 athletes were included. Mean age was 16.1 ± 2.9 years and 69 % were male. The mean training duration was 5.8 hours per week. The prevalence of incomplete right bundle branch block was 13.9 % (77 cases). Endurance sports were practiced in 71.4 % of cases among subjects with right bundle branch block versus 55.4 % in the rest of the population (p < 0.001). The basal diameter of the right ventricle was larger in athletes with right bundle branch block compared to athletes without right bundle branch block: 28 ± 3.6 mm versus 24 ± 2.4 mm (p < 0.001). CONCLUSIONS: The results of this study suggest that right bundle branch block is a marker of incomplete right ventricular remodeling. This remodeling represents a form of adaptation to sustained elevation of volumetric load observed mainly in endurance sports.

A retrospective study from a single center to compare outcomes in 79 patients with in-stent restenosis treated with paclitaxel-coated balloon angioplasty or drug-eluting stent implantation.

BACKGROUND: Despite the recent progress made in drug-eluting stents (DESs), in-stent restenosis (ISR) is still a common complication of percutaneous coronary interventions. This retrospective study from a single center aimed to compare outcomes in 79 patients with ISR treated with paclitaxel-coated balloon (PCB) angioplasty or DES implantation. RESULTS: From January 2017 to December 2021, 83 ISR lesions from 79 patients were included. Thirty-two were treated with PCB and 51 treated with available DES in the catheterization laboratory. Baseline characteristics were similar in both groups. Mean time between index angioplasty and restenosis was 27 months with a minimum of 4 months and a maximum of 70 months. Concerning Mehran ISR angiographic classification, classes II and III were more likely treated with DES. Stenosis diameter and minimal lumen diameter (MLD) were similar in both groups. PCB used was significantly shorter than DES: Mean length was 19.75 ± 5.7 versus 22.1 ± 16.5 (p < 0.001), respectively. Angiographic results immediately after intervention were similar in both groups: In-segment MLD after the procedure was 2.5 ± 0.4 in the DES group and 2.26 ± 0.55 in the PCB group. A median follow-up of 20 months was achieved for 68 patients, and 11 were lost to follow-up. There was also no difference in both groups regarding free from events survival. CONCLUSIONS: The findings from this study support recent international studies that have shown no significant differences between DES and PCB and in-stent restenosis. This suggests that PCB use is an option to consider in our local daily practice.

Combination Therapy With Nicardipine and Isosorbide Dinitrate to Prevent Spasm in Transradial Percutaneous Coronary Intervention (from the NISTRA Multicenter Double-Blind Randomized Controlled Trial).

Verapamil and nitroglycerin are widely used to prevent radial artery spasm (RAS) during percutaneous cardiovascular procedures. However, these agents are not typically available in most African countries and consequently, isosorbide dinitrate is often the only spasmolytic treatment. Our aim was to compare the efficacy of isosorbide dinitrate alone versus isosorbide dinitrate used together with nicardipine to prevent RAS during transradial coronary procedures. This was a randomized controlled double-blind multicenter trial. Patients (n = 1,523) were randomized to receive either a sole therapy of isosorbide dinitrate (n = 760) or the combination of isosorbide dinitrate and nicardipine (n = 763). Our primary end point was the occurrence of RAS; defined as considerable perceived hindrance of catheter advancement. Our secondary end points were severe RAS; defined as (1) severe arm pain, (2) the need for either morphine or midazolam treatment, and (3) necessity for crossover to the contralateral radial or femoral artery. RAS incidence was reduced with the combination therapy versus isosorbide dinitrate alone (15% vs 25%, p <0.001), with a number needed to treat of 10 patients. There was also a significant reduction in the incidence of the secondary end points with combination therapy (3.6% vs 8.2%, p <0.001), with a number needed to treat of 22 patients. This result was driven by reductions in both femoral crossover (0.5% vs 2.4%, p = 0.003) and the use of morphine or midazolam injections (1.6% vs 3.5%, p = 0.02) with combination therapy. In conclusion, we demonstrated the superiority of the combination therapy of isosorbide dinitrate and nicardipine over isosorbide dinitrate alone in reducing the incidence of RAS.

Prognostic impact of diabetes mellitus on patients managed by urgent percutaneous coronary intervention.

INTRODUCTION: Diabetes Mellitus (DM) is known to be associated with worse outcomes following percutaneous coronary intervention (PCI). AIM: To assess prognostic impact of DM on patients managed by urgent PCI following ST-segment elevation myocardial infarction (STEMI). METHODS: In a retrospective study, STEMI patients admitted to our department from January 2016 to December 2019 and treated with urgent PCI (primary or rescue PCI) were included. They were divided in two groups: Diabetic and non-diabetic patients. They were followed-up for a period of 12 months. Major cardiac adverse event (MACE) was a composite outcome of the following events: myocardial infarction, target vessel revascularization, target lesion revascularization or cardiovascular death. MACEs were collected during follow-up. RESULTS: Our population consisted of 225 patients. DM was observed in 104 STEMI patients (46.2%). Diabetic patients had higher frequency of hypertension (p 1.4mmol/l (p 75 years, hyperglycemia at admission (>10mmol/l), extensive anterior infarction and procedure failure were associated with in-hospital mortality in the non-diabetic group. Factors associated with 12-months mortality and MACEs among diabetic patients were age > 75 years, anemia, CKD and left ventricular systolic dysfunction. CONCLUSIONS: Despite modern era of STEMI treatment, diabetic patients still have a poor prognosis. These results highlight the need for coronary risk factors treatment among these patients.

Outcomes and prognostic factors of patients treated for in-stent restenosis: a retrospective single-center experience.

BACKGROUND: The incidence of in-stent restenosis (ISR) remains relatively common despite the use of drug-eluting stents. Outcomes and prognostic factors following ISR revascularization are still being investigated. We aimed to describe the outcomes following different ISR treatment strategies in order to identify prognostic factors associated with worse outcomes. RESULTS: In a retrospective cohort study, we included patients who were admitted to our department and treated for ISR, from January 2017 to December 2018. All patients were followed up for a median period of 24 months. Major cardiac adverse event (MACE) was a composite outcome of the following events: myocardial infarction, target vessel revascularization, target lesion revascularization or cardiovascular death. MACEs were collected during follow-up. Our population consisted of 116 patients. Mean age was 60 years old with a sex ratio of 2.8. During follow-up, 44 patients (37.9%) had at least one MACE. Independent factors identified by multivariate logistic regression were ISR of the proximal left anterior descending artery [Odds ratio (OR) = 1.29; 95% confidence interval (95% CI) 1.16-1.81; p = 0.05], diffuse ISR [OR = 2.16; 95% CI 1.1-3.47; p = 0.022], double or triple vessel disease [OR = 2.97; 95% CI 1.2-6.8; p = 0.008], two or more stents per lesion [OR = 1.82; 95% CI 1.14-2.21, p = 0.031] and absence of post-dilatation in the initial angioplasty [OR = 1.32; 95% CI 1-1.35; p = 0.04]. CONCLUSIONS: Our study suggested that ISR is related to poor outcomes. Identifying prognostic factors would play a key role in the refinement of interventional techniques.

Delay of Fibrinolysis in ST- Elevation Myocardial Infarction: Results of an Investigation Conducted in a Single Center in Sousse Tunisia.

BACKGROUND: The aim of our study was to assess the delay of fibrinolysis in ST elevation myocardial infarction (STEMI) in our region and to identify characteristics associated with prolonged delay. PATIENTS AND METHODS: We analyzed clinical characteristics of a prospective cohort of unselected patients admitted for (STEMI). The study was conducted over three years 2007-2009 and 250 patients were included in a single center without capability of percutaneous coronary intervention. RESULTS: The mean age of our patients was 58±13, 7 years. Ninety percent of our patients consult directly the emergency department and 61, (5%) of them were admitted within first 6 hours of onset of symptoms. Median time to reperfusion was 46 min. Predictor of this long delay to initiate fibrinolysis were inter-department decision OR 6; 95% CI 3,48-10,34, diabetes OR 2,25; 95% CI 1,28-3,96 age >58,4 years OR 1,97; 95% CI 1,19-3,25 and transfer from regional hospital to our center OR 1,78; 95% 1,03-3.07. CONCLUSION: These results suggest that improvement in organization health care system can shorten delay to fibrinolysis in a center without percutaneous coronary intervention capability.

[Permanent cardiac pacing: about 234 patients]. / La stimulation cardiaque permanente : à propos de 234 patients.

BACKGROUND: Permanent cardiac pacing remains the only effective treatment for chronic, symptomatic bradycardia. In recent years, the role of implantable pacing devices has expanded substantially. AIM: To compare the situation of patients with critical brady arrhythmias before and after pacing focusing on indication for pacemaker implantation, frequency of re intervention and early and late complications. METHODS: Retrospective study performed over 24 years between 1984 and 2007 at the department of cardiology of Farhat Hached hospital. A total of 234 patients were included, and the database was formed by the patients' files and the protocols of implantation. RESULTS: The mean age of patients was 69.5 years. The most frequently reported signs and symptoms before implantation of pace maker were dizzy spells and syncope respectively in 53% and 29.1% of patients. Among the electrocardiographic alterations leading to an indication of pacemaker implantation, atrio-ventricular blocks were the most numerous at 74.4% followed by sinus node disease at 17.1%. Early complications were represented essentially by haematoma and infection of the pocket of pacemaker respectively at 2.9% for each one. After a mean follow up of 6.8 years, 88 patients (45.3%) still free of symptoms. Late complications include lead dislodgement and pacemaker syndrome at 2% for each one. CONCLUSION: The results of our study demonstrates that even the rate of complications following pacemaker implantation is not high, the follow-up of patients should be fast, complete, safe, and clear, and should include sufficient documentation.

Reduction in coagulation factor VII plasma levels by R353Q but not the -323P0/10 promoter polymorphism in healthy Tunisians.

The association between the R353Q and -323P0/10 (10-bp insertion in the promoter region at position -323) factor VII mutations and plasma factor VII levels was investigated in a group of 214 healthy Tunisians. The frequency for the Q allele was 0.253 and that for the 10-bp allele was 0.206, and their distribution was variable, with a high prevalence of the 10-bp allele (0.306) seen in North Tunisia and a high prevalence of the Q allele (0.288) see in the Sahel region. No significant linkage disequilibrium was observed between the two mutations, and the most prevalent haplotype was -323P0/353R (0.589 +/- 0.054). Carriers of the R353Q (P < 0.001), but not -323P0/10 (P = 0.088), factor VII mutations had lower mean factor VII serum concentrations. This reduction in mean serum factor VII was more pronounced among homozygous (Q/Q) carriers and among males (49.9%) compared to females (32.7%). Adjusting for all other variables in the linear regression analysis (sex, age, region, smoking, and R353Q and -323P0/10 mutations), heterozygous carriers of the -323P0/10 and R353Q mutation had on average reductions of 10 units (P = 0.005) and 30 units (P < 0.001) in plasma factor VII, respectively, compared to noncarriers, while homozygote carriers of the R353Q (-43.3, P < 0.001), but not carriers of the -323P0/10 (-6.30, P = 0.356), had significantly lower levels of mean plasma factor VII. These data suggest that part of the previously described effects on FVIIc levels associated with the R/Q polymorphism may be explained by genetic variation in the promoter region of the FVII gene.

Echinococcosis of the heart: clinical and echocardiographic features in 12 patients.

UNLABELLED: We describe the clinical and echocardiographic features in 12 patients with hydatid cyst of the heart who were screened between 1985 and 2001. Presenting symptoms have a wide variability but the main symptom was precordial pain. The electrocardiogram was always abnormal and showed T wave inversion in 8 cases, ST depression in 5 cases, incomplete right bundle-branch block in one case and atrial fibrillation in one case. Transthoracic echocardiography and transoesophageal echocardiography constitute the imaging procedure of choice for the diagnosis of cardiac hydatid cyst with a high sensibility, specificity. Computed tomography (CT) was performed in all patients and confirmed the echocardiographic data. MRI was performed in one patient with right atrium hydatid cyst location and confirmed the echocardiographic data. CONCLUSION: In the presence of atypical symptomatology in a patient coming from an endemic area of hydatid cyst, the diagnosis of cardiac echinococcosis is possible.TTE and TEE are the imaging procedure of choice and sufficient for the diagnosis of cardiac hydatid cyst. CT and/or MRI provide more information about the extension of echinococcus disease in other intra- or extrathoracic locations.

[Epidemiologic features of myocardial infarction in young patients]. / Caractéristiques épidémiologiques de l'infarctus chez le sujet jeune.

Acute myocardial infarction (AMI) in persons under the age of 45 years is uncommon. To determine the clinical features in young patients presenting with AMI, we include 38 patients with mean age 35 years who survive from myocardial infarction. This disease is almost associated with cardiovascular risk factors, the most common of which are tobacco abuse (90%) and diabetes (20%). The coronary arteries are most often normal (40%) or single vessel (33%). In hospital complications are the same as in the older adult but the prognosis seems to be better.

[Surgically treated chronic aortic insufficiency: prognostic value of preoperative echocardiography]. / Insuffisance aortique chronique opérée: valeur pronostique des données échocardiographiques préopératoires.

Between March 1979 and December 1998, 38 patients with isolated chronic aortic insufficiency underwent aortic valve replacement. The aim of this study is to determine whether preoperative echocardiography parameters are useful in predicting operative results in patients with aortic valve replacement for chronic aortic insufficiency. The global survival is 92% in one year and 89% in ten years. We conclude that on end systolic left ventricle diameter < 55 mm has good prognosis (p = 0.019) and there is a strong correlation between preoperative end systolic and post operative end systolic diameter an end diastolic left ventricular diameter > 70 mm and a left ventricular fractional shortening < 25% weren't predictive of a poor prognosis.

The transesophageal echocardiographic diagnosis of left atrial myxoma simulating a left atrial thrombus in the setting of mitral stenosis.

We report the case of a 56-year-old woman with a history of rheumatic heart disease. The clinical, electrocardiographic, and radiologic findings suggested mitral stenosis. Left atrial obstructive myxoma simulating a thrombus was found by transthoracic echocardiography (TTE). The diagnosis was established by use of transesophageal echocardiography (TEE), confirmed after surgery and by anatomical investigation. Cardiac myxoma associated with mitral stenosis may be difficult to diagnose accurately using TTE. The advantage of TEE in this case and in patients with mitral stenosis is emphasized.

[Right atrium angiosarcoma disclosed by alveolar hemorrhage]. / Angiosarcome de l'oreillette droite révélé par une hemorragie alvéolaire.

UNLABELLED: Cardiac angiosarcoma represents a primary cardiac malignancy tumor whose early diagnosis is difficult because of its non specific clinical presentation. We present the case of a 57 years old patient with medium abundance hemoptysis. The chest X ray film and CT scan showed bilateral pulmonary infiltrate without cardiac anomaly. Abdominal echography showed disseminated hepatic tumoral lesions. A transthoracic echocardiography made after apparition of heart failure symptoms found a right atrium cardiac tumor. The hepatic lesion biopsy showed angiosarcoma. CONCLUSION: In presence of uncommon systemic symptoms like diffuse pulmonary lesions associated with cardiac anomaly, the diagnosis of angiosarcoma should be included.

[Feasibility of transesophageal echocardiography during balloon mitral valvulotomy]. / Echographie transoesophagienne multiplan durant la dilatation mitrale percutanée.

The purpose of this study was to demonstrate the utility and feasibility of transesophageal echocardiography during percutaneous balloon mitral valvuloplasty (PBMV). 40 patients were included with symptomatic rheumatic mitral valve stenosis with mean age of 31 years. Transoesophageal echocardiographic monitoring allowed an immediate detection of mitral insufficiency in 10 patients. This latter was moderate in eight cases and severe in two cases indicating to stop the procedure. The addition of on-line TEE during PBMV facilitate and confirm the success of the procedure and detect complications.

[Cardiac tamponade revealing systemic scleroderma]. / Une tamponnade cardiaque révélatrice d'une sclérodermie systémique.

The frequency of pericardial involvement in Systemic Sclerosis (SSc) is high but usually was asymptomatic and cardiac tamponnade was exceptional. We report a case of systemic sclerosis (scleroderma) revealed by cardiac tamponnade. This case illustrate the value of transthoracic echocardiography in the diagnosis of cardiac tamponnade in systémic sclerosis.

[Cardiopericardial echinococcosis]. / Echinococcose cardiopéricardique.

UNLABELLED: Cardiac hydatid cysts are rare and represent 0.5 to 2% off all hydatid cyst in human. We describe clinical and echographic features in 12 patients with cardiac echinococcosis, admitted between 1992 and 2001. Average age was 40 years (16-60 years). The cysts were located in the left ventricle wall (3 patients), right ventricle wall (3 patients) right atrium (3 patients) and pericardial cavity (3 patients). Cardiac Hydatid cyst diagnosis was established by transthoracic echocardiography (TTE) and transoesophageal echocardiography (TEE) in all cases. Computed tomography and magnetic resonance imaging confirmed echographic finding. All patients were operated. The operation finding confirmed the imaging data. Only one patient died in the post operative period. No recurrence or associated complication were reported in the late follow up. CONCLUSION: In presence of atypical symptomatology in a patient coming from an endemic area of hydatid cyst the diagnosis of cardiac echinococcosis is possible. TTE and TEE are the imaging procedure of choice and sufficient for the diagnosis of cardiac hydatid cyst. CT and/or MRI provide more information about the extension of echinococcosis diseases in other intra or extrathoracic location.

[Cardiovascular manifestations of Kawasaki syndrome. Value of echocardiography in diagnosis and progression]. / Manifestations cardiovasculaires du syndrome de Kawasaki. Apport de l'échocardiographie dans le diagnostic et l'évolution.

Seven children with suspected Kawasaki disease were studied by echocardiogram. Coronary abnormalities occurred in all patients, associated with: thrombosis (2 patients) small pericardial effusion (2 patients) poor ventricular function (2 patients), moderate mitral regurgitation (2 patients). Patients received treatment with intravenous gamma globulin, aspirin, and anticoagulant. Echocardiogram abnormalities disappeared between 1 and 26 months after the onset of the disease; only persist coronary hyperechogenecity in 6 patients.

[Candida albicans prosthetic valve endocarditis. Two cases]. / Endocardite infectieuse à Candida albicans sur prothèse. A propos de deux cas.

TWO CASES: Candida albicans prosthetic valve endocarditis (PVE) is a rare entity with serious complications. We report two cases of Candida albicans PVE, confirmed by culture of the prosthetic valve. The first patient died twenty days after surgery with cerebral bleeding secondary to multiple mycotic aneurysms, the second patient was still alive eight months following a Saint-Jude aortic valve replacement and prolonged antifungal therapy. The difficulty of diagnosis and management are discussed.