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.

Prevention of radial artery occlusion with rivaroxaban after trans-radial access coronary procedures: The RIVARAD multicentric randomized trial.

Background: Radial artery occlusion (RAO) remains the most frequent complication of trans-radial access. Once the radial artery is occluded, its future use as an access site for coronary procedures, or as a conduit for coronary bypass grafting or fistula for hemodialysis, will be precluded. Therefore, we aimed to assess the value of the short-term use of Rivaroxaban to prevent RAO after a trans-radial coronary procedure. Methods: This was a prospective, open-label, randomized study. The patients were randomly assigned (1:1) to one of two groups: those who received Rivaroxaban 10 mg for 7 days following the trans-radial coronary procedure (the Rivaroxaban Group) and those who received the standard treatment (the Control Group). The primary outcome was an occurrence of RAO evaluated by Doppler ultrasound at 30 days, and the secondary outcomes were hemorrhagic complications according to BARC classification. Results: We included 521 patients randomized into two Groups: the Control Group (N = 262) and the Rivaroxaban Group (N = 259). The 1-month RAO was significantly reduced in the Rivaroxaban Group as compared to the Control Group [6.9% vs. 13%; p = 0.011, OR = 0.5, (95% CI, 0.27-0.91)]. We noted no cases of severe bleeding events (BARC3-5). The overall incidence of minor bleeding (BARC1) was 2.3%, with no significant difference between the two groups [Rivaroxaban Group = 2.7%, Control Group = 1.9%, p = 0.54, OR= 1.4, (95%CI 0.44-4.5)]. Conclusions: Short-term postoperative anticoagulation with Rivaroxaban 10 mg for seven days reduces the rate of 1-month RAO.

The spiked helmet sign in a patient with erysipelas: an alarming electrocardiogram sign (a case report).

Early diagnosis of the spiked helmet sign is challenging. This ST-elevation myocardial infarction mimic was first described in 2011 by Littmann and colleagues and was linked to severe non-coronary pathologies, with a high risk of mortality. We present a case of a 60-year-old female patient who developed severe erysipelas with sepsis associated with severe hypokalemia. She had a spiked helmet sign on her routine electrocardiogram at hospital admission. We performed a coronary angiogram that showed no culprit artery. She developed afterward an ischemic stroke. Through intensive management of the patient's sepsis and electrolyte disturbance, she had a favorable outcome.

Transcatheter closure of congenital ventricular septal defects using the Amplatzer Duct Occluder II device: preliminary data from a Tunisian monocentric study.

INTRODUCTION: Percutaneous closure of congenital ventricular septal defects (VSDs) represents a promising alternative to surgery with lower rate of complications and shorter hospital stay. Its main limitation is the choice of the appropriate device for each type of defect. AIM: To report the experience of the service of cardiology (Sahloul hospital, Sousse, Tunisia) in percutaneous closure of congenital VSDs with Amplatzer Duct Occluder II (ADOII). METHODS: This was a retrospective, monocentric study, conducted from January 2013 to December 2017. The study included patients treated by percutaneous closure of congenital VSDs with the ADOII device. RESULTS: Twelve patients (6 boys; 6 girls) were included. The mean±SD of patients' age and weight were 65±41 months and 23±10 kg, respectively. VSDs were peri-membranous (n=9) and muscular (n=3), and defects were restrictive (n=11) and non-restrictive (n=1). The mean (minimum-maximum) size of VSDs was 4.72 (3-6) mm. Eleven ADOII prostheses were successfully implanted. One failure procedure was noted with migration of the device into the pulmonary artery. A second child with perimembranous defect developed transient atrioventricular block. No deaths occurred. CONCLUSION: The present early experience shows that percutaneous closure with ADOII device of perimembranous and trabecular VSDs is safe and effective.

Transcatheter closure of residual Gerbode defect after aortic valve replacement surgery.

A 42-year-old man with a history of surgically repaired coarctation of the aorta presented with a refractory right heart failure. Echocardiography revealed a calcified bicuspid aortic valve both regurgitant and stenotic and a defect within the membranous septum with left to right shunt from the left ventricle (LV) to the right atrium. The patient was referred to surgery for an aortic valve replacement and closure with patch repair of the Gerbode type defect. Post-operative course was complicated by refractory heart failure with a persistent left to right shunt through the defect due to loose sutures. Taking into account the high surgical risk, percutaneous closure of the defect was decided. An Amplatzer Duct Occluder (St Jude Medical, USA) I device was successfully released within the defect. The patient was completely asymptomatic on follow-up.

Neonatal cardiogenic shock revealing obstructive cardiac Hibernoma: case report.

BACKGROUND: Cardiac Hibernomas are very rare benign tumors and usually remain asymptomatic. Neonatal cardiogenic shock due to cardiac tumors is extremely very rare. Until this date a few cases of cardiac hibernoma have been reported in the literature. Transthoracic echocardiography help in the differential diagnosis, but the definitive diagnosis is histological. The management strategy is not clearly codified. The Aim is to report and discuss the clinical features of a cardiac Hibernoma and review the relevant literature. CASE PRESENTATION: We describe a case of a 2-day-old Caucasian full-term male neonate admitted in neonate intensive care with cardiogenic shock, having fluid resuscitation and inotropic drugs. Ventilatory support was started immediately with the subsequent reestablishment of normal blood pressure. Then he was transferred to the echocardiography laboratory. Transthoracic echocardiography showed two echogenic masses in the right atrium and right ventricle. The masses were extended to the pulmonary trunk. Pulmonary artery flow measurements showed the presence of pulmonary and tricuspid obstruction. Surgery was rapidly considered since the baby was hemodynamically unstable. Intraoperative evaluation showed a mass embedded in the interventricular septum that occupy the right ventricular cavity and the right atrium. The tumor involved also the chordae of the tricuspid. Partial resection was done. Tricuspid valve repair was performed by construction of new chordae from the autologous pericardium. The specimen was sent for histopathological analysis. The baby died immediately after surgery. Histological examination of the surgical specimen revealed clear multivacuolated cells filled with lipid droplets and granular intense eosinophilic cytoplasm which confirms the diagnosis of Hibernoma. CONCLUSION: Cardiac Hibernomas are rare benign tumors. The prognosis and treatment strategy is closely dependent on the location, initial clinical presentation and possible complications. The prognosis can be unfavorable if the tumor was obstructive and infiltrate the myocardium.

Trans-Catheter Closure of Patent Ductus Arteriosus, which device should we use?

Despite the operational experience in the percutaneous closure of Patent ductus arteriosus (PDA), complications can arise during the procedure. To overcome these complications the choice of the device must be adapted to each patient. AIM: To report the experience of the cardiology department in the transcatheter device closure of PDA and to determine the influencing factors of choice of the device. METHODS: Our study included patients with patent ductus arteriosus that are admitted for transcatheter closure, between September 2003 and June 2016. RESULT: One hundred and fifty-three patients were included in our study. Transcatheter closure was not done in 9 cases. The transcatheter closure was successful in 140 patients. The complications were observed in 11 patients that includes device embolization in 3 cases, aortic protrusion in four cases pulmonary protrusion in three cases and inguinal hematoma in one another. Three predictive factors of complications were: age < 2 years, tubular PDA type C and ratio duct diameter/weight > 0.95. A mild residual shunt was observed at the end of the procedure in 22.85 % of the patients. The risk of residual shunt was significantly increased when the age < 2 years, the large PDA, the presence of pulmonary hypertension and the tubular C PDA. CONCLUSION: The choice of the device depends essentially on age, the weight and the duct anatomy.

A coronary artery aneurysm revealing a Behçet's disease: a case report.

Behçet's disease (BD) is a multisystemic chronic vasculitis characterized by its clinical polymorphism. It concerns mainly young men and generally appears between the third and the fourth decades. Cardiac involvement in Behçet's disease is rare but represents a major prognostic factor. We report the case of a young man admitted in our department for the management of an acute coronary syndrome revealing a Behçet's disease. Coronary angiography had shown a giant thrombosed aneurysm of the left coronary artery. Surgical treatment was successfully performed and the patient had a left anterior descending coronary artery bypass using the left internal mammary artery graft.

Prevalence and factors associated with spontaneous closure of congenital ventricular septal defects.

BACKGROUND: Most of congenital ventricular septal defects evolve towards spontaneous closure of different mechanisms depending on their location. AIM: To determine the prevalence and factors associated with spontaneous closure of congenital ventricular septal defects. METHODS: We conducted a retrospective study of 1000 patients diagnosed with congenital ventricular septal defects in our department from January 2000 to December 2017. RESULTS: After an average follow-up of 52.65 months (± 76.93 months), 183 (18.88%) of ventricular septal defects closed spontaneously. The average time for spontaneous closure was 45.78 months (76.34 months). 30.77% of trabecular ventricular septal defects (p<0.05) and 16.93% of perimembranous defects closed spontaneously (p=0.17). 28.5% of perimembranous defects associated with aneurysm formation versus 17.4% of those without associated aneurysm evolved to spontaneous closure (p<0.05). 65.6% of spontaneous closure occured during the first 3 years of life. In multivariate analysis, trabecular site [OR=2.85; CI (2.05-3.97)] and aneurysms of membranous septum [OR=1.9; CI (1.41-2.8)] were independent factors associated with spontaneous closure of defects. CONCLUSION: The highest VSD closure rate was observed during the first three years of life. Trabecular site and aneurysms tissue of membranous septum were found as independent factors associated with spontaneous closure.

A comparative study of bypass versus percutaneous intervention for left main disease.

INTRODUCTION: Left main coronary artery disease is known as the highest risk lesion subset of ischemic heart disease. Several studies have shown a significant benefit following treatment with coronary artery bypass grafting compared with medical treatment. As a result, surgery has been the standard of care for the revascularization of left main disease for a long time. However, with the remarkable improvements in interventional cardiology, percutaneous coronary intervention has become technically feasible and showed favorable clinical outcomes. AIM: We sought to evaluate trends in treatment strategies of left main coronary artery disease over time in Sahloul University Hospital and to compare patient's characteristics as well as early, mid-term and long-term adverse outcomes of each therapeutic option. METHODS: From 2005 to 2016, 260 patients with unprotected left main disease (defined as stenosis of at least 50%) were included. 109 patients underwent PCI (group 1), 102 patients underwent Surgery (group 2) and 49 patients were medically treated (group 3). Major cardiac and cerebrovascular events were defined as the composite of: mortality, nonfatal myocardial infarction, stroke, and need for repeat revascularization. Event rates were estimated with Kaplan-Meier analyses. RESULTS: Over time, the proportion of patients treated with percutaneous coronary intervention rather than coronary artery bypass grafting increased substantially, whereas the proportion of patients who received medical therapy remained steady. Group 1 patients had more cardiogenic shock (6.4% vs 0%, p=0,01) at presentation compared to group 2. More patients treated with surgery had multivessel disease (73% vs 40%; p <0.001), more distal left main bifurcation lesions (52.3% vs 73.5%; p=0.001) and higher SYNTAX scores (23.3±9.96 vs 32.5±8.7; p <0.001). All the other baseline variables were similar. At follow up, there were no differences, at the adjusted analysis, in the rate of myocardial infarction, cerebrovascular accidents, and the composite endpoint of major cardiovascular and cerebrovascular events (HR: 1, 04; 95% CI: 0.59 to 1.83; p=0.88). Compared to percutaneous coronary intervention group, group 2 has a higher all-cause mortality (p=0.017) driven exclusively by an elevated incidence of operative mortality (13.7% vs. 6.4%; HR: 0.08; 95% CI: 0.017 to 0.43; p=0.003). Nevertheless, long-term advantage of coronary artery bypass grafting over percutaneous coronary intervention was the less need for repeat revascularization (HR: 3.1; 95% CI: 1.26 to 8.12; p=0.014). CONCLUSION: Our data show that revascularization therapy have evolved remarkably in the favor of percutaneous coronary intervention over the last decade. Angioplasty and coronary artery bypass graft show comparable safety. However, the need for revascularization is more common after percutaneous treatment.

The implantable cardioverter defibrillator: Indications and follow-up.

INTRODUCTION: Sudden cardiac death (SCD) is a public health problem. In most cases, it is the consequence of ventricular arrhythmias. The only treatment of proven effectiveness is the implantable cardioverter defibrillator (ICD). AIM: To describe indications for ICD implantation according to the underlying heart disease and report it's short and long-term results. METHODS: We report a retrospective and descriptive study involving 90 patients implanted with an ICD in our facility collected between January 2003 and December 2014. RESULTS: The average age of our population was 49 ± 15 years (14-76). A male predominance was noted (sex ratio: 6). Ischemic heart disease was the most common underlying heart disease found in 37% of cases. The average left ventricular ejection fraction was 43.5 ± 17.7%. A slight predominance of primary prevention was noted in our series (52%). Single, dual and triple chamber ICD were used in respectively 34%, 36% and 30% of cases. The use of triple chamber ICD was more frequent in cardiomyopathies and ischemic heart disease. Early complications were observed in 9 patients (10%). No deaths directly related to the ICD implantation procedure was observed in our series. The mean follow-up was 39.7 months (3-136). We recorded 14 deaths. The main cause of death was refractory heart failure. During follow-up, 16 patients (18%) received appropriate ICD shocks. The only predictor of appropriate therapies was the indication of ICD for secondary prevention (p=0,002). Twenty one patients (23%) had complications inherent to the implantation of ICD. The main complication was inappropriate shocks found in 11 patients (12%). The main cause of these shocks was supraventricular arrhythmias 68%). Ischemic heart disease (p = 0.001) and secondary prevention (p = 0.048) were significantly associated with the occurrence of inappropriate ICD shocks. The ICD was explanted after varying delays in 4 patients (4.4%). CONCLUSION: The results of our study were comparable to major ICD studies and registries particularly in terms of procedural, late complications and the occurrence of appropriate ICD therapies.

[Acute pulmonic valve endocarditis]. / Endocardite aiguë isolée de la valve pulmonaire.

Right heart endocarditis mainly affects tricuspid valve, especially in drug users. Isolated pulmonary valve infection is rare. We here report the case of a 32-year old young woman whose diagnosis of community-acquired pulmonary valve endocarditis was confirmed. This study is even more interesting because pulmonary valve endocarditis has occurred in a patient without a history of drug addiction; nevertheless, it wasn't associated with restrictive interventricular communication. The patient underwent emergency surgery due to the visualization of large and mobile vegetation on transthoracic heart ultrasound. Surgery was carried out under extracorporeal circulation and pulmonary valve has been replaced with a bioprosthesis. Bloodcultures and valve culture showed methicillin-sensitive staphylococcus aureus. Postoperative evolution was favorable, with a follow-up of 06 months without recurring infections.

[Right ventricular myxoma in a child: an uncommon presentation]. / Myxome du ventricule droit chez un enfant: une présentation très rare.

The right ventricle is an uncommon location for cardiac myxoma. Its most common complications are pulmonary embolism and obstruction due to pulmonary valve tumor. We report the case of a 11-year old child with repetitive syncopes admitted to Cardiology ward. Echocardiography showed a right ventricular myxoma of 2cm obstructing the pulmonary orifice. Emergency surgical excision was performed under cardiopulmonary bypasss with favorable postoperative course. Anatomo-pathological examination of the surgical specimen confirmed the diagnosis of myxoma. At 18 months follow-up, there was no evidence of tumor recurrence.

Conservative Management of Cardiac Hemangioma for 11 Years.

Cardiac hemangiomas are benign tumors with an unpredictable natural history. Surgical resection is the treatment of choice; however, conservative management can be an alternative in some patients. We report a case of a left-sided cardiac hemangioma that we managed conservatively for 11 years without obvious major complications in the patient, an adult woman.

Short, midterm and late results of percutaneous coronary interventions for left main coronary artery disease.

BACKGROUND: Left main coronary artery disease is found in 4-6% of patients undergoing diagnostic coronary angiography. Coronary artery bypass graft is the gold standard. However, percutaneous coronary intervention is a continuously evolving substitution for surgery in such patients. METHODS: We report a retrospective study of 32 patients with relevant left main coronary artery disease treated by angioplasty in our faculty, between January 2005 and March 2011. RESULTS: The mean age of the population on the study was 59.7±10.9 years. The sex-ratio was 3.57. The rate of angiographic success was 97%. The in-hospital stay was uneventful in 94%¨of our patients. Only one patient died of cardiogenic shock complicating an acute anterior myocardial infarction. After a mean follow up of 18.5 ± 15.4 months, the in-stent restenosis rate was 16.12%. The rate of major adverse cardiac events (MACE) was 29%. Independent predictive factors of MACE were: cardiogenic shock on admission (p=0.022), emergency procedures (p=0.033), Euroscore > 6 (p=0.001), Parsonnet score > 20 (p=0.036), High C réactive protein levels on admission (p=0.007),le taux de créatinine (p=0.008), un diamètre de référence du TCCG < 3.5 mm (p =0.036) et l'utilisation de stents  (p=0.036) and the use of bare metal stents (p=0.036). Independent predictive factors of in-stent restenosis were: use of bare metal stents (p=0.004) and Paclitaxel drug eluting stents (p=0.037). CONCLUSION: Percutaneous coronary intervention is safe and a validated alternative to coronary artery bypass graft for left main coronary artery disease. However, it should be reserved to selected patients and limited to experienced centers.

Transcatheter closure of a congenital coronary artery to right ventricle fistula: a case report.

INTRODUCTION: Congenital coronary artery fistula is a rare anomaly that may cause angina, atrial fibrillation, endocarditis, aneurysmal dilation and myocardial infarction. Both spontaneous regression and life-threatening complications have been described. Treatment can be conservative, surgical or more recently through transcatheter closure. CASE PRESENTATION: We report the case of a 27-year-old Tunisian man with a large coronary artery fistula from the left anterior descending artery to the right ventricle associated with pulmonary stenosis. This patient underwent a successful transcatheter closure of his coronary artery fistula followed by pulmonary dilatation and had an uneventful recovery after treatment. CONCLUSIONS: Transcatheter closure of a congenital coronary artery fistula is feasible and should be considered in carefully selected patients. Recanalization of the treated coronary fistula can occur, so follow-up angiography or other imaging modality should be performed in these patients.