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.

Design and Rationale of the National Tunisian Registry of Heart Failure (NATURE-HF): Protocol for a Multicenter Registry Study.

BACKGROUND: The frequency of heart failure (HF) in Tunisia is on the rise and has now become a public health concern. This is mainly due to an aging Tunisian population (Tunisia has one of the oldest populations in Africa as well as the highest life expectancy in the continent) and an increase in coronary artery disease and hypertension. However, no extensive data are available on demographic characteristics, prognosis, and quality of care of patients with HF in Tunisia (nor in North Africa). OBJECTIVE: The aim of this study was to analyze, follow, and evaluate patients with HF in a large nation-wide multicenter trial. METHODS: A total of 1700 patients with HF diagnosed by the investigator will be included in the National Tunisian Registry of Heart Failure study (NATURE-HF). Patients must visit the cardiology clinic 1, 3, and 12 months after study inclusion. This follow-up is provided by the investigator. All data are collected via the DACIMA Clinical Suite web interface. RESULTS: At the end of the study, we will note the occurrence of cardiovascular death (sudden death, coronary artery disease, refractory HF, stroke), death from any cause (cardiovascular and noncardiovascular), and the occurrence of a rehospitalization episode for an HF relapse during the follow-up period. Based on these data, we will evaluate the demographic characteristics of the study patients, the characteristics of pathological antecedents, and symptomatic and clinical features of HF. In addition, we will report the paraclinical examination findings such as the laboratory standard parameters and brain natriuretic peptides, electrocardiogram or 24-hour Holter monitoring, echocardiography, and coronarography. We will also provide a description of the therapeutic environment and therapeutic changes that occur during the 1-year follow-up of patients, adverse events following medical treatment and intervention during the 3- and 12-month follow-up, the evaluation of left ventricular ejection fraction during the 3- and 12-month follow-up, the overall rate of rehospitalization over the 1-year follow-up for an HF relapse, and the rate of rehospitalization during the first 3 months after inclusion into the study. CONCLUSIONS: The NATURE-HF study will fill a significant gap in the dynamic landscape of HF care and research. It will provide unique and necessary data on the management and outcomes of patients with HF. This study will yield the largest contemporary longitudinal cohort of patients with HF in Tunisia. TRIAL REGISTRATION: ClinicalTrials.gov NCT03262675; https://clinicaltrials.gov/ct2/show/NCT03262675. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12262.

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.