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.

Prognostic value of highly-sensitive troponin in preeclampsia.

INTRODUCTION: Pre-eclampsia is a pregnancy complication leading to significant morbidity and mortality. High-sensitivity troponin (hs-cTnI ) is one of the most sensitive cardiac biomarkers, but its variation in preeclampsia remains poorly studied. AIM: To assess the prognostic value of hyper-sensitive troponin in preeclampsia. METHODS: It was a prospective study including patients with preeclampsia. The exclusion criteria included conditions that may cause an elevation of hs-cTnI. Preoperative laboratory assessment included the determination of the level of hs-cTnI. The discriminative value of the preoperative hs-cTnI allowing to predict the onset of complications was evaluated by the ROC curve. Group A included patients whose rate was above the calculated cutoff, and group B included the others. RESULTS: Seventy seven patients were included. Complications occurred in 22% of cases. The preoperative hs-cTnI cutoff of 6.3 ng/l predicted the onset of complications (sensitivity 70.6% / specificity 86.6% / p < 0.0001). There was a higher rate of severe pre-eclampsia and complications, a higher systolic and mean arterial blood pressure values in group A with significant differences. Both groups were comparable demographically, obstetrically, clinically and biologically. CONCLUSION: According to the results of our study, increased values of preoperative hs-cTnI may predict the onset of complications in pregnancies complicated by preeclampsia.

New-onset atrial fibrillation after acute coronary syndrome: prevalence and predictive factors.

INTRODUCTION: New-onset AF atrial fibrillation (NOAF) frequently complicates acute coronary syndromes (ACS) leading to adverse outcomes in the short and long term. The prevalence of NOAF in patients hospitalized for ACS is variably reported and ranges between 2 and 37%. Several predictor factors have been implicated in the literature but remain a subject of controversy. AIM: To determine the prevalence of NOAF in a population of patients admitted for ACS and to identify its predictive factors. METHODS: We carried out a prospective, descriptive and comparative observational study in hospitalized patients with ACS who did not have a previous diagnosis of AF. RESULTS: In our study, we included 404 patients hospitalized for ACS. The prevalence of NOAF was 10%. In the multivariate analytical study, we retained as independent predictors of NOAF: age greater than 62 years (p = 0.04; adjusted OR = 4.83; CI95%: 1.07-21.77), chronic renal failure (p = 0.043; adjusted OR = 6.61; CI95%: 1.06-35.80), history of stroke (p = 0.002; adjusted OR = 44.51; CI95%: 3.97- 498.10) and finally uricemia greater than or equal to 62 mg / l (p = 0.04; adjusted OR = 4.4; CI95%: 1.06-18.15). CONCLUSIONS: The prevalence of NOAF in patients with ACS was 10%. Its systematic screening in these patients appears to be a relevant approach because of the strong association between these two pathologies.

Silent stroke in patients with atrial fibrillation: Prevalence and predictive factors.

BACKGROUND: Silent strokes are damagesof brain not accompanied by symptoms suggestive of stroke. Currentepidemiological trends suggesttheirindependent association with atrial fibrillation (AF). However, this association is not yetwelldefined. AIM: To assess the prevalence of silent stroke in AF and determine itspredictivefactors. METHODS: We carried out a cross-sectional study enrolling 37 patients followed for non-valvular AF in the cardiologydepartment. All participants had a clinicalevaluation and brain MRI. RESULTS: The mean age was 66 ± 7 yearswith asex ratio (M / F) of 0.76. The mostcommon class of AF was the persistent form (70%). Oral anticoagulant therapywasprescribedin 32 patients (94.1%). Silent strokewerereported in 9 patients (24.3%). Age ≥72 years and CHA2DS2VASc score ≥ 4 weresignificantlyassociatedwith silent strokes in the univariate study withsensitivities of 77.8% and 62.5% respectively and specificities of 78.6% and 92.3% respectively. In the multivariate study, only CHA2DS2VASc score ≥ 4 wasconsidered to be an independentpredictor of silent stroke in AF (p = 0.004; adjusted OR = 20; CI95%: 2.6-152.6). CONCLUSIONS: Our resultsregarding the association between silent strokesand AF confirmedpreviousevidence. Screening for theselesions in AF patients at high thromboembolicriskappears to be a relevant approachgiventheirpoorprognosis.

Diagnostic accuracy of strain imaging in predicting myocardial viability after an ST-elevation myocardial infarction.

In the acute phase of ST-elevation myocardial infarction (STEMI) viability imaging techniques are not validated and/or not available.This study aimed to evaluate the ability of strain parameters assessed in the acute phase of STEMI, to predict myocardial viability after revascularization.Thirty-one STEMI patients whose culprit coronary artery was recanalized and in whom baseline echocardiogram showed an akinesia in the infarcted area, were prospectively included. Bidimensional left ventricular global longitudinal strain (GLS), and territorial longitudinal strain (TLS) in the territory of the infarct related artery were obtained within 24 hours from admission. Delayed enhancement (DE) cardiac magnetic resonance imaging (CMR) was used as a reference test to assess post-revascularization myocardial viability. DE-CMR was performed 3 months after percutaneous coronary intervention. According to myocardial viability, patients were divided into 2 groups; CMR viable myocardium patients with more than half of infarcted segments having a DE <50% (group V) and CMR nonviable myocardium patients with half or more of the infarcted segments having a DE >50% (group NV).GLS and TLS were lower in group V compared to group NV (respectively: -14.4% ±â€Š2.9% vs -10.9% ±â€Š2.4%, P = .002 and -11.0 ±â€Š4.1 vs -3.2 ±â€Š3.1, P = .001). GLS was correlated with DE-CMR (r = 0.54, P = .002) and a cut off value of -13.9% for GLS predicted viability with 86% sensitivity (Se) and 78% specificity (Sp). TLS showed the strongest correlation with DE-CMR (r = 0.69, P < .001). A cut off value of -9.4% for TLS yielded a Se of 78% and a Sp of 95% to predict myocardial viability.GLS and TLS measured in the acute phase of STEMI predicted myocardial viability assessed by 3 months DE-CMR. They are prognostic indicators and they can be used to guide the priority and usefulness of percutaneous coronary intervention in these patients.

Diagnostic and prognostic value of 2D-Strain in Non-ST Elevation Myocardial Infarction.

BACKGROUND: Strain has shown a promising diagnostic and prognostic value in acute coronary syndromes. With, however, less data in non-ST elevation myocardial infarction (NSEMI). AIM: to evaluate in NSTEMI patients, the ability of strain to predict the severity of the disease, by assessing correlations to established prognostic parameters, and to predict culprit and occluded coronary arteries (CA). Secondary, to determine factors associated to strain changes during follow-up. METHODS: The study was prospective, NSTEMI patients with significant coronary lesion and without significant non-ischaemic disease were included. Angiographic and echocardiographic investigation including global (GLS) and territorial (TLS) longitudinal strain were performed within 24h from admission. Syntax I score was calculated. Severe coronary artery disease (CAD) was defined by left main of three-vessel disease. RESULTS: Seventy NSTEMI patients aged 60.2±10.1 years were enrolled; 61% were smokers, 54% diabetics and 46% hypertensive. 34% had a severe CAD, 7% had an acute coronary occlusion (ACO) and 14% a chronic coronary total occlusion (CTO). GLS >-15.3% predicted a left ventricular ejection fraction (LVEF) <50% with 80% Sensitivity (Se) and 78% Specificity (Sp). GLS was associated to CAD complexity and severity. GLS > -14.1% detected severe CAD with 83% Se and 80%Sp. TLS determined the culprit artery in 74% of cases and TLS > -9.2% predicted ACO with 85% Se and 85% Sp. TLS was also associated to CTO. At a 10 months median follow-up [3-12months], GLS significantly improved, baseline LVEF, GLS, wall motion score index and revascularization were the predictors of this improvement. CONCLUSION: In NSTEMI patients, GLS detected severe CAD and poor myocardial function. TLS predicted the culprit vessel and its occlusion. GLS improvement at midterm was predicted by baseline systolic LV function parameters and myocardial revascularization.

Simulation training for continuing professional development of nurses in cardiology and cardiovascular surgery.

BACKGROUND:   Nurses play a key role in cardiac arrest management, especially those assigned to cardiac intensive care units, where they are often actively involved in cardiopulmonary resuscitation. AIM: To evaluate the effect of simulation training in in continuing professional development of nurses in this setting. METHODS: A comparative study using paired samples (where the candidate was his own control with repeated measures before and after intervention), was conducted among nurses working in the cardiology and cardiovascular surgery division of our institution. The primary endpoint was the change in skills judged on the basis of competency score of 20 assessed before and after simulation training. RESULTS: 32 nurses participated in the training session. Despite a median job seniority of 8.5 years [4.0 - 12.5], only 44% of nurses had already participated in a simulation session. Although most of the candidates (84%) had previously performed chest compressions, only 34% had delivered an electrical defibrillation during their exercise. We showed a significant increase in overall scores from 8.0 [5.0 - 9.8] to 17.5 [17.0 - 19.0] after the simulation training session (p<0.0001). All the criteria judged in the evaluation grid (basic life support, manual electrical defibrillation) were significantly improved and the most positive effect was observed in the manual defibrillation where the prior experience of the participants was limited. CONCLUSIONS: Simulation learning had a major positive impact on the development of nurses' skills in terms of cardiopulmonary resuscitation.

Left ventricular non compaction and septal defects.

We report the case of a 23-year-old woman with a not yet described (to the best of our knowledge) association of left ventricle non-compaction with both atrial and ventricular defects. Family genetic survey concluded to, a probably sporadic, E101K gene mutation.

Prevalence and predictors of Sleep Apnea in Atrial Fibrillation patients.

BACKGROUND: Obstructive Sleep Apnea Syndrome (OSAS) is a common but often under diagnosed condition that constitutes a real public health problem. The prevalence of OSAS in atrial fibrillation (AF) patients ranges from 32 to 85% according to recent studies. AIM: To determine the prevalence and severity of OSAS in a population followed for non-valvular AF (NVAF), and to identify OSAS's predictive factors in this population. METHODS: A cross-sectional study was conducted, including successive patients followed for NVAF. Patients with a known history of OSAS were not included. All patients had a clinical screening for symptoms suggestive of OSAS and underwent an ambulatory sleep study. RESULTS: We included 100 patients in this study. OSAS was detected in 90% of NVAF patients. The average apnea-hypopnea index (AHI) was 21.6 ± 13.6 e/h. OSAS was mild in 32%, moderate in 27% and severe in 31% of cases. Clinical characteristics were comparable between patients with and without OSAS. The multivariate analytical study concluded that independent predictive factors of OSAS in AF patients were an age greater than 61 years (p=0.029), AF duration more than 2 years (p=0.04) and snoring (p=0.01). CONCLUSIONS: OSAS was diagnosed in 90% of NVAF patients. Thus, a systematic screening for OSAS in AF patients may be a relevant approach given its high prevalence in this population and its therapeutic implications. Snoring, age greater than 61 years, and AF duration more than 2 years were independently associated with OSAS in our study.

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.

Outcome predictors of cardiogenic shock complicating ST-segment elevation myocardial infarction.

BACKGROUND: Cardiogenic shock complicating ST elevation myocardial infarction is burdened by a high mortality. There is only limited evidence for the management except for early revascularization and the relative ineffectiveness of intra-aortic balloon pump. AIM: Our objectives were to evaluate outcome and predictors of early all-cause 30-day mortality in the setting of cardiogenic shock complicating ST elevation myocardial infarction. METHODS: From January 2009 to August 2018, all patients who presented within the first 48 hours of ST elevation myocardial infarction complicated by cardiogenic shock and receiving invasive management were prospectively included. RESULTS: The study cohort comprised 122 consecutive patients. The mean age was 65±12 years and 74.5% of patients were males. Left ventricular failure was the most common etiology of cardiogenic shock (72.1%) and mechanical complications occurred in 8.2% of cases. Percutaneous coronary interventions were proposed for all patients and performed in a primary setting in 72.1%. A high prevalence of no reflow was noted (15.6%). Multivessel coronary artery disease was noted in 64.8% and multivessel percutaneous coronary interventions at the index procedure were performed in 22.1% of cases. Intra-aortic balloon pump was used in 17.2% of patients. The 30-day mortality was 58.2%. The only predictor of early mortality was the immediate multivessel percutaneous coronary intervention (OR=4.1, 95%CI 1.1-14.5; p=0.031). CONCLUSION: Despite invasive management strategies, 30-day mortality of cardiogenic shock complicating ST elevation myocardial infarction remained as high as 58.2%. Immediate multivessel percutaneous coronary intervention was the only predictor of early mortality.

Feasibility and safety of Same-Day Discharge after transradial percutaneous coronary intervention: a Tunisian monocentric study.

BACKGROUND: The continuing increase in care, needs and costs in cardiology with the advances in percutaneous coronary intervention (PCI) techniques represent the ideal scenario for considering same-day discharge (SDD) PCI program. AIM: The primary endpoints were to examine feasibility and safety of SDD-PCI. METHODS: We conducted a comparative observational study of a prospective cohort (April 2017 to September 2017) where patients benefited from SDD-PCI with a retrospective cohort (October 2016 to March 2017) where patients were conventionally managed. We established pre-procedural eligibility criteria and per and post-procedural exclusion criteria to estimate feasibility of SDD-PCI. Safety was assessed at 24 hours and 30 days comparatively in both groups. RESULTS: In the one-year study period, 709 PCI were performed. The eligibility for SDD-PCI was 17.2% (122 patients) and feasibility was 14.7% (104 patients). Ultimately, 50 out of 370 patients in the prospective cohort (SDD-group) and 54 out of 339 patients in the retrospective cohort (control-group) had or could have benefited from SDD-PCI. The transradial access was the most used (98.1%). 59.7% of treated lesions were B2 or C type, 53.8% interested the left anterior descending artery and 29.8% were bifurcations. In both groups, no complications were observed at 24 hours. At 30 days, one single non-fatal myocardial infarction related to subacute stent thrombosis occurred in the SDD-group and was attributed to antiplatelet therapy interruption. CONCLUSION: SDD-PCI is feasible and safe on the condition of strict stratification criteria of patients before judging their discharge the same day after PCI.

Oral anticoagulation therapy using acenocoumarol during the month of ramadan: a comparative study between fasting and non-fasting patients.

BACKGROUND AND OBJECTIVES: The effect of Ramadan fasting on anticoagulation by vitamin K antagonists has been previously investigated in small scale studies with controversial results. From this perspective, this study aimed to compare the fluctuations of anticoagulation in fasting and nonfasting patients taking Acenocoumarol and to identify the factors associated with such fluctuations. METHODS: The study, conducted between May and August 2018, was a comparative one. Three study periods were defined: before Ramadan (BR), Ramadan and after Ramadan (AR). Enrolment involved ambulatory patients aged over eighteen, without medical contraindications to fasting (for the fasting group) and whom international normalized ratio (INR) was within the therapeutic target range during the last three months BR. Anticoagulation monitoring consisted in five consecutive INR assays; INR0 (during the 14 days BR), INR1 (between the 1st and the 14th day of Ramadan), INR2 (between the 15th and the 28th day of Ramadan), INR3 (28 days after INR2) and INR4 (28 days after INR3). INR stability was assessed by calculating four percentages of time in therapeutic range (TTR); TTR0 (between INR0 and INR1), TTR1 (between INR0 and INR2), TTR2 (between INR2 and INR3) and TTR3 (between INR3 and INR4). The null hypothesis was the occurrence of an anticoagulation imbalance (evaluated by TTR) in fasting patients in comparison with non-fasting ones. RESULTS: One hundred and twenty-two patients (84 fasting patients), aged 60 ± 19 years, were included. In fasting patients, the average differences of INR1, 2, 3 and 4 compared with INR0 were statistically non-significant and accounted for +0.46, +0.34, +0.28 and +0.30 respectively. Among the three TTRs, only TTR2 significantly decreased in comparison with TTR0 in fasting group (50.3 ± 37.4 vs. 63.6 ± 39.3%, p=0.004). TTR1, 2 and 3 were comparable between fasting and non-fasting patients. CONCLUSIONS: The fluctuations of anticoagulation balance, assessed by TTR, were comparable between fasting and non-fasting patients taking Acenocoumarol.