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.

New onset heart failure with reduced ejection fraction management: single center, real-life Tunisian experience.

BACKGROUND: Heart failure (HF) is a serious and frequent pathology. It represents a major public health problem. We have few data about this pathology in our country. The aim of our study is to determine the epidemiological, clinical, therapeutic, and prognostic characteristics of new-onset HF with reduced left ventricular ejection fraction (HFrEF) and to study the degree of conformity of the management of HF with international recommendations. RESULTS: Our study population includes 210 patients hospitalized for HFrEF newly diagnosed. The average age of our patients was 64 ± 12 years. A male predominance was noted with a sex ratio of 2.8. The main etiology of HF was ischemic heart disease noted in 97 patients (46.2%). The average LVEF is 33 ± 6%. The triple combination (angiotensin-converting enzyme inhibitors + beta blockers + Mineralocorticoid Receptor Antagonists) was prescribed in 75 patients (35.7%). The quadruple combination (angiotensin-converting enzyme inhibitors + beta blockers + Mineralocorticoid Receptor Antagonists + Sodium-Glucose Co-Transporter 2 inhibitors) was prescribed in 17 patients (8.1%). Myocardial revascularization was indicated in 97 patients (46.6%) and valve surgery was indicated in 49 patients (23.3%). Hospital mortality was 3.8% and at 1 year 18.1%. Among the 192 patients followed during the first year after discharge from hospital, 81 patients had to be re-hospitalized, i.e., a 1-year rehospitalization rate of 42.2%. CONCLUSIONS: Our study highlighted the epidemiological and clinical features of HF in a Tunisian care center, revealing our patient management deficiency. This pushes us to have a new Tunisian register to enable a better statistical analysis and lead to more relevant conclusions.

A rare case of concurrent left ventricular aneurysm and ventricular septal rupture complicating an inferior myocardial infarction: a case report.

Complications following acute myocardial infarction (MI) such as ventricular septal rupture (VSR) and left ventricular (LV) aneurysm are rare and can be dreadful. Their simultaneous presence in the same patient is extremely rare. We aimed to present a rare case of concomitant association of ventricular aneurysm and VSR complicating an inferior myocardial infarction. We report the unusual case of Mr. A. D, a 63-year-old, active smoker, with a history of diabetes mellitus and hypertension, admitted for the management of inferior MI within 6 days. The MI was complicated by an LV aneurysm in the inferoposterior and the inferoseptal walls associated with a VSR in the inferoseptal wall. The patient had only signs of right heart failure on admission. This observation illustrates on the one hand the rarity of the association of VSR and LV aneurysm after an inferior myocardial infarction, and on the other hand the possibility of founding them at an early stage of MI without any signs of cardiogenic shock.

Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study.

BACKGROUND: Coronary artery diseases remain the leading cause of death in the world. The management of this condition has improved remarkably in the recent years owing to the development of new technical tools and multicentric registries. OBJECTIVE: The aim of this study is to investigate the in-hospital and 1-year clinical outcomes of patients treated with percutaneous coronary intervention (PCI) in Tunisia. METHODS: We will conduct a prospective multicentric observational study with patients older than 18 years who underwent PCI between January 31, 2020 and June 30, 2020. The primary end point is the occurrence of a major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction, cerebrovascular accident, or target vessel revascularization with either repeat PCI or coronary artery bypass grafting (CABG). The secondary end points are procedural success rate, stent thrombosis, and the rate of redo PCI/CABG for in-stent restenosis. RESULTS: In this study, the demographic profile and the general risk profile of Tunisian patients who underwent PCI and their end points will be analyzed. The complexity level of the procedures and the left main occlusion, bifurcation occlusion, and chronic total occlusion PCI will be analyzed, and immediate as well as long-term results will be determined. The National Tunisian Registry of PCI (NATURE-PCI) will be the first national multicentric registry of angioplasty in Africa. For this study, the institutional ethical committee approval was obtained (0223/2020). This trial consists of 97 cardiologists and 2498 patients who have undergone PCI with a 1-year follow-up period. Twenty-eight catheterization laboratories from both public (15 laboratories) and private (13 laboratories) sectors will enroll patients after receiving informed consent. Of the 2498 patients, 1897 (75.9%) are managed in the public sector and 601 (24.1%) are managed in the private sector. The COVID-19 pandemic started in Tunisia in March 2020; 719 patients (31.9%) were included before the COVID-19 pandemic and 1779 (60.1%) during the pandemic. The inclusion of patients has been finished, and we expect to publish the results by the end of 2022. CONCLUSIONS: This study would add data and provide a valuable opportunity for real-world clinical epidemiology and practice in the field of interventional cardiology in Tunisia with insights into the uptake of PCI in this limited-income region. TRIAL REGISTRATION: Clinicaltrials.gov NCT04219761; https://clinicaltrials.gov/ct2/show/NCT04219761. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/24595.

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.

Thrombosed left ventricular pseudoaneurysm following myocardial infarction: a case report.

BACKGROUND: Pseudoaneurysm of inferior wall of the left ventricle is an uncommon complication of myocardial infarction with high mortality. CASE PRESENTATION: We report the case of a 63-year-old Tunisian man, diagnosed with a thrombosed left ventricular pseudoaneurysm and a pericardial effusion after 1 week of angina. CONCLUSIONS: Left ventricular pseudoaneurysm is a serious complication of myocardial infarction that has atypical presentations. Diagnosis is generally established by transthoracic echocardiography but confirmed by magnetic resonance imaging. Urgent surgery is the treatment choice given the risk of embolization and rupture.

Respiratory distress in a patient with Klinefelter syndrome: a suspicion of COVID-19 hiding severe pulmonary embolism.

Klinefelter syndrome is the most common congenital abnormality causing primary hypogonadism and predisposing to a state of hypercoagulability. We report the case of a 37-year-old man, of Algerian nationality, diagnosed with Klinefelter syndrome admitted to the hospital via the emergency room for acute chest pain and dyspnea. The patient arrived in Tunisia 36 hours ago. On admission, body temperature was 38.2°C, blood pressure, pulse and respiratory rate were 130/70 mmHg, 120/minute and 26/minute, respectively. He had an oxygen saturation of 87% in room air. His electrocardiography revealed a complete right bundle-branch block, chest X-Ray was normal. In front of the clinical presentation and the origin of the patient coming from an endemic country, COVID-19 infection was suspected but ruled out by pharyngeal swabs testing negative by real-time reverse-transcription polymerase chain reaction test and massive pulmonary embolism was diagnosed from his chest computed tomography images. The symptoms improved with anticoagulation treatment.

Unprotected left main percutaneous coronary intervention: prognostic value of SYNTAX score II.

BACKGROUND: Unprotected left main (LM) coronary artery disease (CAD) represents a challenging lesion with a major prognostic impact. AIM: Evaluate the clinical outcome and major adverse cardiac events (MACE) predictors of unprotected LM percutaneous coronary intervention (PCI) in an "all-comers" population. METHODS: We performed a prospective observational study of patients with unprotected LM stenosis treated by PCI. MACE were defined as the composite endpoint of all-cause death, myocardial infarction and target lesion revascularization. RESULTS: From January 2012 to December 2017, 150 consecutive patients who underwent unprotected LM PCI were included. The mean age was 64±12 years and 75.3% were males. Diabetes was noted in 50.7%. Emergent revascularization was performed in 20.7% of cases, including 3.3% patients with cardiogenic shock. Distal LM was involved in 76.7% of cases. A majority of patients (94.0%) had low or intermediate SYNTAX Score I (≤32). The median SYNTAX score II was 31.1. Drug-eluting stents were used in 78.7% and bare metal stents in 21.3% of patients, mainly in emergent setting where the former were unavailable. In distal LM PCI, provisional approach was mostly used (81.7%). The median follow-up was 13.4 months. MACE occurred in 23.3% with an estimate of 37.9% at 5 years. Significant predictors of MACE were cardiogenic shock, bare metal stents use, previous PCI, and SYNTAX score II ≥30. CONCLUSION: Unprotected LM PCI presents encouraging short and long term outcomes. SYNTAX score II might represent a predictor for long-term outcome in this particular lesion subset.

Adverse cardiovascular effects of doping in athletes.

The use of doping substances and methods is prevalent not only among elite athletes, but also among amateur athletes and other athletes. However, the abuse of substances and methods of doping has been associated with the occurrence of numerous adverse health effects. Cardiovascular effects are the most deleterious. The objective of this manuscript is to study through a review the literature, adverse cardiovascular effects after the abuse of substances and doping methods in athletes. Three major classes of products have more cardiovascular side effects; they are anabolic, stimulants and narcotics. It is possible to predict their use according to the desired objectives. Anabolic doping is used by sportsmen who practice strength sports, stimulants are used by those who practice speed sports, while endurance sportsmen prefer products that improve the transport of oxygen. Cases of myocardial infarction, hyperlipidemia, hypertension, venous thrombosis, arrhythmogenesis, heart failure and sudden cardiac death have been observed. The doping substances of varied nature seem to have adverse cardiovascular effects whose physiopathology remains a research and investigation track. Further randomized trials are needed to better understand the interaction of these doping substances taken in a combined way in athletes.

Predictors of the effectiveness of acupuncture in smoking cessation in coronary patients: a prospective study of 25 patients.

BACKGROUND: Smoking cessation should be a priority for smokers, especially coronary patients. AIM: To study the place and effectiveness of acupuncture in smoking cessation in coronary patients. METHODS: We conducted a prospective open-label study of 25 coronary smokers treated by acupuncture over a 10-month period, from June 2017 to March 2018. A 2-session protocol acupuncture weekly for three to five weeks, with a positive response. In order to evaluate the effectiveness of acupuncture, a questionnaire was completed by the doctor during the treatment, at three and six months after the end of the sessions. Positive response was defined by total cessation of smoking. RESULTS: The average age of our patients was 55.5 years (33 to 77 years). The sex ratio of our population was 1.5 with a male predominance. All our patients had a coronary history. The average cigarette consumption was 22.7 pack-years on average. The results of our study showed that acupuncture allows the withdrawal of 5 smokers (20%) from the first session. After the fifth session, 60% of our patients stopped smoking. At the end of the treatment, 17 smokers (70%) stopped smoking completely. At 3 and 6 months of treatment, we observed a stabilization of smoking cessation and decrease rates. CONCLUSION: Smoking cessation is difficult to obtain whatever the therapeutic method used, which encourages us to strengthen preventive measures.

Echocardiographic parameters of the right ventricle in chronic hemodialysis.

INTRODUCTION: Right ventricular (RV) dysfunction is one of the leading predictors of mortality and heart failure in chronic hemodialysis (HD) patients. AIM: To describe the different echocardiographic abnormalities of the RV in subjects with HD. METHODS: We performed a descriptive cross-sectional study covering the period from July to October 2018; involving 42 patients treated with chronic HD. Patients underwent a conventional transthoracic echocardiographic (TTE) study supplemented with tissue Doppler between two hemodialysis sessions. RESULTS: We included 42 patients. The sex ratio of our population was 1.6 with a male predominance, the average age of patients was 62.7 ± 12.4 years. The most important cardiovascular risk factor was arterial hypertension (78.6%). The most important causative nephropathy was nephroangisclerosis (31% of cases). The average age of dialysis was 34.5±30 months. Forty-two percent of our patients had RV dilation, 38% had right atrium dilatation, 7% had Right ventricular outflow tract dilatation, and 59.5% had RV hypertrophy. We noted RV systolic dysfunction in 66.7% of cases, a predominant normalized tricuspid profile with an average E / A ratio of 1.11 ± 0.5. CONCLUSION: Our study is consistent with the various echocardiographic data already raised in the literature, showing a high prevalence of RV dilatation and systolic dysfunction. It is one of the leading predictors of mortality and heart failure in chronic hemodialysis patients.