Role of depression in blood pressure control. A cross-sectional multicentric study.

RESEARCH PROBLEM: Hypertension is a multifactorial disease that affects approximately one third of the Tunisian adult population. It is a major risk factor for stroke and cardiovascular disease. Environmental and psychosocial factors play an important role in hypertension onset and control. The prevalence of depression among hypertensive patients is 26, 8% and its presence is associated with increased risk of cardiovascular related morbi-mortality. Our study aims to evaluate the role of depression in blood pressure control among ambulatory hypertensive patients. Investigative process: This study is a cross-sectional, multicentric and descriptive study. We intend to include three hundred and two patients. A 24-hour ambulatory blood pressure monitor will be used to evaluate blood pressure control. Depression will be assessed by the 9-item Patient Health Questionnaire (PHQ-9) in Tunisian dialect. Clinical, socio-environmental, psychosocial and therapeutic and prognosis data will be collected from medical records. Patients will be classified into two groups: Controlled versus non-controlled hypertension. PHQ-9 scores will be then compared between the two cohorts. RESEARCH PLAN: Ethical considerations will be undertaken and respected. All patients should express an informed oral consent before enrollment. This trial will run for three months from the 15th August 2022. TRIAL REGISTRATION: NCT05516173.

Simulation versus theoretical learning for the transradial approach: a randomized controlled trial in interventional cardiology.

INTRODUCTION: Simulation-based education (SE) in interventional cardiology improves knowledge acquisition and mastery of procedures including the conventional radial access (CRA). AIM: To evaluate the contribution of SE in CRA compared with theoretical learning alone. METHODS: This is a prospective randomized controlled study including cardiology residents and patients with normal radial pulses. Experienced residents as well as patients with contraindications to CRA, requiring urgent intervention, or with hemodynamic instability were not included. Missing the teaching sessions was the exclusion criteria. Residents were randomized into two groups: simulation versus control. They attended a theory lecture explaining CRA and were evaluated Only the simulation group attended an SE session with measurement of heart rate (HR) and stress level. A real application was then performed with measurement of HR and stress level. The primary outcome was success puncture rate. RESULTS: The success of the puncture was similar between the two groups (p=0.651). In the practical application, the stress level was significantly different before the procedure but similar after the end of the procedure. The stress level varied significantly within the same group before and after the procedure The simulation group was significantly less tachycardic both before and during the procedure with a significant difference between the two groups (p <10-3). CONCLUSION: This study demonstrated the interest of SE in novice residents for CRA as a complement to theoretical learning upstream of the real-life procedure.

[The curious case of a cardiac mass : A case report]. / Un curieux cas de masse cardiaque : à propos d'un cas.

BACKGROUND: Retained foreign bodies are dreadful events associated with invasive procedures. Their occurrence implicate physical complications as well as serious professional and medico-legal consequences. Cases of retained surgical items, in the pericardial space, following cardiothoracic surgery are rare and their management is delicate as the risks of their removal must be thoroughly weighed against the complications of leaving them inside the chest. CASE PRESENTATION: We report the case of a retained foreign body, discovered in an asymptomatic patient, on a routine medical check-up, 4 years after cardiac surgery. CONCLUSIONS: Clinical and paraclinical manifestations of retained surgical foreign bodies are nonspecific. The progress of cardiac imaging means makes it possible to identify these rare foreign bodies with greater precision, and allows, with extreme caution, to monitor patients who are perfectly asymptomatic and who are reluctant to undergo surgery.

Evaluation of the distal radial approach in percutaneous coronary interventions. A controlled, randomized non-inferiority trial.

INTRODUCTION: The conventional radial approach (CRA), the gold standard approach for percutaneous coronary interventions (PCI), is associated with the risk of radial artery occlusion (RAO). The distal radial approach (DRA) is an effective alternative with fewer complications. AIM: To evaluate the efficacy in terms of puncture success and safety by RAO rate of the DRA in elective PCI in Tunisian patients. METHODS: It was a randomized controlled non-inferiority trial including patients hospitalized for elective PCI. The protocol was previously published (Tunis Med 2022; 100(3): 192-202). The primary endpoints were puncture success and RAO rate at 30 days. RESULTS: Overall, 250 patients were included and the groups were comparable. The preprocedural examination of the radial pulse and the Barbeau test were similar. The majority of PCIs were coronary angiography (82%). In ITT, respectively in CRA versus DRA, puncture success rates were similar (97.6% versus 96.8%; p≤0.500). RAO rates were similar (2.4% versus 3.2%; p≤0.500). Crossovers were similar. PCI through DRA lasted longer but was not more irradiating, however it required more contrast. Overall bleeding and vascular complications were similar. CONCLUSION: This study demonstrated the non-inferiority of DRA compared to CRA for elective PCIs in a Tunisian population regarding puncture success and RAO rate at 30 days. Multicenter trials including urgent PCI with systematic ultrasound screening for RAO are needed.

Evaluation of the Distal Radial Approach in percutaneous coronary interventions. Controlled, randomized non-inferiority trial.

RESEARCH PROBLEM: The conventional radial approach is the recommended vascular access for percutaneous coronary interventions. It is effective and feasible but associated with a risk of occlusion of the radial artery. The distal radial approach is proposed as a new approach to reduce complications and preserve the radial artery. However, few clinical trials in real life were conducted in North African patients. This trial aims to evaluate the efficacy and safety of the distal radial approach versus the conventional radial approach. Investigative process : This trial is a non-inferiority, randomized controlled trial with two parallel arms: distal radial approach and conventional radial approach. Two hundred fifty patients scheduled for percutaneous coronary intervention will be included. The two main endpoints are the puncture success rate with a non-inferiority margin of 10% and the occlusion rate of the punctured radial artery attributed to the end of hemostasis and to 30 days. Secondary Endpoints : catheterization success, crossover rate, procedure time, radial artery spasm, bleeding complications, QuickDASH pain score, Operator satisfaction. A single blind analysis will be led according to the per-protocol and intention-to-treat methods. RESEARCH PLAN: Ethical considerations will be undertaken and respected. This trial will run for four months from February 2022. The results will provide parameters related to the efficacy and safety of the distal radial approach, improving clinical practice. TRIAL REGISTRATION: NCT05311111.

Drug-Eluting-Balloon Angioplasty in Tunisian population versus Everolimus-platinum-chrome-stent for de-novo coronary lesion.

RESEARCH PROBLEM: Drug-eluting balloon (DEB) angioplasty is a well-established treatment modality for in-stent restenosis, however its safety and efficacy in de-novo lesion especially in large vessel remains undetermined. Theoretically, DEB sight to eliminate stent thrombosis and reduce restenosis rates by leaving no metal behind. AIM: To compare the results of angioplasty of de novo lesions by DEB (SEQUENT PLEASE) versus DES (Promus Premier and Promus Elite) in a Tunisian population. THE ENDPOINTS will be primarily the Late Lumen Loss at 12 months and secondarily the Major Cardiovascular Event rate (MACE) at 12 months. INVESTIGATIVE PROCESS: This is a randomized controlled non-inferiority trial including 290 patients with chronic coronary disease or non-ST elevation myocardial infarction with de novo lesions. After coronarography, angiographic parameters concerning lesion location and quantitative analysis will be collected. Patients will be treated with DEB or DES according to their allocation group. Before removal of the guide, post-procedural angiographic parameters will be evaluated. Follow-up will be performed for 12 months and an angiographic examination will be performed either as an emergency or at 12 months. The significance level will be 5%. A univariate analysis will be performed to search for predictive factors of MACE. RESEARCH PLAN: Ethical considerations will be undertaken and respected. The study will run for 15 months starting August 25, 2021 Trial registration: NCT05516446.

Evaluation of left ventricular systolic function in children with sickle cell anemia: contribution of 2D strain.

BACKGROUND: Cardiovascular involvement is not well studied in children with sickle cell disease. The aim of this study was to evaluate the echocardiographic parameters and to investigate speckle tracking echocardiography (STE) interest in detecting subclinical myocardial impairment of children with sickle cell disease. METHODS: The study was directed in the echocardiographic laboratory in the military hospital of Tunis between July 2018 and December 2018. 30 patients with sickle cell anemia (SCA) and 30 controls were compared. The echocardiographic measurements were indexed according to body surface. Cardiac output, left ventricular ejection fraction, wall thickness, as well as LV 2-D longitudinal systolic strain were assessed. RESULTS: The SCA Group included 30 patients (11.8 ± 2yrs, sex ratio: 1.31) with homozygous SCA and the C Group included 30 healthy controls (12.7 ± 1,2yrs, sex ratio: 1.27). According to the findings, SCA Group showed significantly larger LV diameter (36.2±2.5mm/m2 vs 29.3±1.3mm/m2, p=0.005). SCA Group also showed lower LV ejection fraction (62%±0.5 vs 65%±5, p=0.001). No significant difference was observed for cardiac output (p=0.4). Otherwise, two-dimensional longitudinal strain of LV was higher in SCA group (-21%±3.07 vs -25%±2.98; p<0.01). CONCLUSIONS: Our study highlights several cardiac abnormalities in children with SCA, which could represent a marker of disease severity and point out the importance of the cardiologic screening of these patients.

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.

Clinical Outcomes of Patients Treated With the Bioresorbable Scaffold.

INTRODUCTION: Bioresorbable scaffold (BRS) is a novel device to treat coronary lesions. It may induce a revolution in percutaneous coronary intervention (PCI) and a novel treatment termed vascular restoration therapy. These devices provide short-term scaffolding of the vessel and then dissolve, which would treat the plaque and coronary lumen without inflicting a permanent foreign body in the coronary artery. AIM: This study sought to describe scaffolding in a cohort of Tunisian coronary diseased patients and assess its immediate and mid-term outcomes. METHODS: Twenty nine patients with 42 lesions were enrolled. Mean age was 51.4 years. Mean number of scaffolds per patient was 1.57. RESULTS: Our population was at high cardiovascular risk cumulating at least 3 risk factors. Most of them presented with an acute coronary syndrome (66.6%). In 76.1% there were type A/B1 lesions. Moderate calcification was present in 42.2%. Bifurcation lesions were present in 21.3% and just one chronic total occlusion was treated. Clinical device success and clinical procedural success were respectively 93.1% and 90.3%.Using Kaplan-Meier methods. At 18 months : - The major adverse cardiac events (MACE) rate was 44.8%. - The probability of survival without target lesion revascularization (TLR) was 59.5%. - Definite or Possible scaffold thrombosis rate was 6.9%. In our study, BRS implantation was associated with a high rate of adverse events in the longer term except in case of IVUS guidance with respect of Predilatation + Sizing + Postdilatation (PSP) protocol. CONCLUSION: The theoretical concept of Scaffolding is attractive. One must put into perspective that it is still significantly evolving and improving.

Stent implantation for ostial left anterior descending coronary artery stenosis: clinical particularities, therapeutic strategies, and medium-term outcomes.

BACKGROUND: The stenosis of the ostial left anterior descending artery represents one of the challenges for the interventional cardiologist. The aim of our study was to define the characteristics of this population and to analyze their results in medium term. METHODS: We had undertaken a retrospective study of 76 patients treated in the Cardiology Department of the Military Hospital of Tunis, between January 2014 and March 2017. Percutaneous coronary revascularizations of de novo ostial lesions of the left anterior descending artery were included. RESULTS: The mean age was 59.8 years with a male predominance. Two dilation strategies were adopted: 39% of patients had a "provisional-T-stenting" of the left main coronary artery versus 61% of patients who had a floating stent technic. The main immediate complication was acute occlusion of the circumflex artery ostium. After 12 months, the thrombosis and restenosis rates were 5,2% and 6,5%. Predictors of MACE were: Insulin-requiring diabetes(p=0.05), chronic renal failure(p=0.02), a low-pressure stent deployment(p=0.01), or the presence of signs of left ventricular failure (p<10-3). The predictive factors for stent thrombosis were the alteration of the left ventricular ejection fraction (p<0.01) and the eccentricity of the lesion (p<10-3). Finally, the predictive factors of restenosis were: acute per procedural occlusion of the ostial circumflex artery (p=0.01) or the presence of an associated lesion of distal IVA (p<0,001). CONCLUSION: Ostial lesions of the interventricular artery can be re-vascularized by percutaneous angioplasty with acceptable rates of major cardiovascular events. However, the risk of iterative revascularization remains significant.