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.

[Immediate, medium- and long-term outcomes of percutaneous coronary intervention with very long drug eluting stent : An observational multicentric study]. / Les résultats immédiats, à moyen et à long terme de l'angioplastie coronaire par stent actif très long : à propos d'une étude multicentrique observationnelle.

INTRODUCTION: Very long coronary lesions account for 20% of coronary stenoses in the real world. There are few data on the effectiveness of angioplasty of these lesions with very long active stents (DES) in the literature. We conducted this study to assess the long-term outcomes of angioplasty with DES length ≥ 40 mm in a population with multiple cardiovascular risk factors. PATIENTS AND METHODS: This is a retrospective, multicenter, descriptive, and prognostic study, conducted between January 2015 and January 2020, in four Tunisian centers, including all patients who underwent angioplasty with a DES of length ≥ 40 mm with a follow-up of at least one year. The primary outcome was a combined criteria (major cardiovascular and Cerebral events: MACCE) (stroke, acute coronary syndrome, revascularization of the target lesion: TLR, cardiovascular death: CVD). RESULTS: We included 480 procedures. More than half of the patients had at least three risk factors. The prevalence of high blood pressure, diabetes and smoking were 61.1%, 56.6% and 60.4%, respectively. The treated lesions were complex: 23.54% calcified lesions, 8.75% chronic occlusions, 25% bifurcation lesions and 12.08% ostial lesions. The average length of the stents was 47.72 mm. We noted 17 cases of per-procedural complications (3.55%). The median follow-up was 35 months (extremes 1-60 months). The rate of stent thrombosis was 0.83%. The incidence of MACCE, TLR and CVD were respectively 16.25%, 8.12% and 5.2%. In multivariate analysis, diabetes (HR = 1.7, 95% CI [1.01-2.9]), dyslipidemia (HR = 2.08, 95% CI [1.3-3.3]), familial coronary artery disease (HR = 1.9, 95% CI [1.01-3.6]), left ventricle dysfunction (HR = 2.07, 95% CI [1.1-3.6]) and bifurcation lesions (HR = 1.9, 95% CI [1.2-3.14]) were the independent predictors of MACCE, while statin intake (HR = 0.38, 95% CI [0.19-0.78]) was a protective factor. CONCLUSION: Angioplasty with very long DES is associated with low levels of MACCE, TLR, stent thrombosis and CVD in our population. Therefore, it could be an interesting alternative to cardiac surgery. Randomized comparative studies of the two treatment options are needed.

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.

Design and Rationale of the National Observational Multicentric Tunisian Registry of Hypertension: Protocol for Evaluating Hypertensive Patient Care in Clinical Practice.

BACKGROUND: This study was designed to evaluate the care of hypertensive patients in daily clinical practice in public and private centers in all Tunisian regions. OBJECTIVE: This study will provide us an overview of hypertension (HTN) management in Tunisia and the degree of adherence of practitioners to international recommendations. METHODS: This is a national observational cross-sectional multicenter study that will include patients older than 18 years with HTN for a duration of 4 weeks, managed in the public sector from primary and secondary care centers as well as patients managed in the private sector. Every participating patient signed a consent form. The study will exclude patients undergoing dialysis. The parameters that will be evaluated are demographic and anthropometric data, lifestyle habits, blood pressure levels, lipid profiles, treatment, and adherence to treatment. The data are collected via the web interface in the Dacima Clinical Suite. RESULTS: The study began on April 15, 2019 and ended on May 15, 2019. During this period, we included 25,890 patients with HTN. Data collection involved 321 investigators from 24 Tunisian districts. The investigators were doctors working in the private and public sectors. CONCLUSIONS: Observational studies are extremely useful in improving the management of HTN in developing countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT04013503; https://clinicaltrials.gov/ct2/show/NCT04013503. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21878.

Epidemiologic features and management of hypertension in Tunisia, the results from the Hypertension National Registry (NaTuRe HTN).

BACKGROUND: Hypertension is the leading cause of morbi-mortality in our country. Thus, we conducted this national survey on hypertension to analyze the profile of the Tunisian hypertensive patient and to assess the level of blood pressure control. METHODS: Nature HTN is an observational multicentric survey, including hypertensive individuals and consulting their doctors during the period of the study. Blood pressure measurements were conducted during consultation, using a standardized auscultatory or oscillometric sphygmomanometer after at least 15 min of rest. The diagnosis of new hypertension is based on the 2018 ESC/ESH criteria. The primary endpoint of our study was uncontrolled hypertension defined by a systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. RESULTS: Three hundred twenty-one investigators participated in the study. We enrolled 25,890 patients with a female predominance (Sex ratio, 1.21) and an average age of 64.4 ± 12.2 years. Most individuals were treated in the public sector (74%), 39.4% of patients were diabetic, 25.8% were obese, 44.6% were overweight and 14% were smokers. Hypertension was controlled in 51.7% of cases if we consider 140/90 as a BP target, and only in 18.6% if we consider 130/80 as a target. The independent predictors of uncontrolled blood pressure were male sex (OR = 1.09, 95%CI [1.02-1.16]), age > 65 year-old (OR = 1.07, 95% CI[1.01-1.13], diabetes (OR = 1.18, 95% CI [1.11-1.25], Smoking (OR = 1.15, 95% CI [1.05-1.25]), Obesity (OR = 1.14, 95% CI[1.07-1.21]), management in public sector (OR = 1.25, 95% CI [1.16-1.34]), and Heart rate > 80 bpm (OR = 1.59, 95% CI [1.48-1.71]). Contrarily, high educational level (OR = 0.9, 95% CI [0.84-0.97], absence of history of coronary disease (OR = 0.86, 95% CI [0.8-0.93]), salt restriction (OR = 0.48, 95% CI [0.45-0.51]), drug compliance (OR = 0.57, 95% CI[0.52-0.61]), and regular physical activity (OR = 0.77, 95% CI[0.71-0.84]) are strong predictors of blood pressure control. CONCLUSION: NaTuRe HTN showed that blood pressure control was reached in more than half of the Tunisian people. The control remains low in patients with high cardiovascular profiles and in those treated in the public sector. A national health program based on therapeutic education, regular control and continuous support to the public institutions is needed to decrease the burden of hypertension incidence rate.

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.

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.

Epidemiology of heart failure and long-term follow-up outcomes in a north-African population: Results from the NAtional TUnisian REgistry of Heart Failure (NATURE-HF).

The NATURE-HF registry was aimed to describe clinical epidemiology and 1-year outcomes of outpatients and inpatients with heart failure (HF). This is a prospective, multicenter, observational survey conducted in Tunisian Cardiology centers. A total of 2040 patients were included in the study. Of these, 1632 (80%) were outpatients with chronic HF (CHF). The mean hospital stay was 8.7 ± 8.2 days. The mortality rate during the initial hospitalization event for AHF was 7.4%. The all-cause 1-year mortality rate was 22.8% among AHF patients and 10.6% among CHF patients. Among CHF patients, the older age, diabetes, anemia, reduced EF, ischemic etiology, residual congestion and the absence of ACEI/ ARBs treatment were independent predictors of 1-year cumulative rates of rehospitalization and mortality. The female sex and the functional status were independent predictors of 1-year all-cause mortality and rehospitalization in AHF patients. This study confirmed that acute HF is still associated with a poor prognosis, while the mid-term outcomes in patients with chronic HF seems to be improved. Some differences across countries may be due to different clinical characteristics and differences in healthcare systems.

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.

Angioplasty of Anomalous Coronaries Arising from the Opposite Sinus with an Interarterial Course, is it Safe?

BACKGROUND: The coronary artery with an interarterial course CAIAC is the most threatening coronary anomaly, especially if it concerns the left coronary. Percutaneous coronary intervention PCI is scarcely described given its low prevalence and lack of long-term outcome data. Therefore, we assessed through this case series the feasibility and safety of PCI in this population. METHODS: This is an observational multicentric study including patients with CAIAC arising from the opposite sinus of Valsalva. The primary endpoints were immediate angiographic success and target lesion revascularization. RESULTS: During the period of the study, we performed 27235 PCI in six Cath labs, 26 procedures concerning abnormal coronaries including 12 with CAIAC. The median age was 57 years extremes: 43-78 with male predominance 1:11. Anomalous coronary artery was Right coronary artery RCA in eight patients, Left main LM in three patients, and left anterior descending LAD in one patient. The stenosis was located in all cases in proximal segments beyond the inter-arterial course proximal LAD, the superior genius of the RCA, or the proximal segment of mid-RCA. Five patients showed slit-like ostium and all have an angle take-off <45° on CT scan. After a median follow-up of 24 months, four subjects presented target lesion revascularization TLR, all were initially treated with either a bare-metal stent or with balloons. CONCLUSIONS: PCI of patients with CAIAC is feasible and appears safe. The operator should carefully analyze the angiogram before PCI to choose the appropriate guiding catheter and should be acquainted with the different techniques for improving backup.

Thrombolysis for pulmonary embolism during pregnancy . About four cases.

Pregnancy is correlated with a significant increase in the risk of pulmonary embolism (PE) given the physiological changes in fibrinolysis and mechanical stress induced by the pregnant uterus. Our goal is to demonstrate through four cases of massive bilateral PE occurred during pregnancy, the possibility of thrombolysis in pregnant women. We report the observation of four pregnant patients, between 28 and 38 years old and whose term varies between nine and 36 last menstrual period, hospitalized for serious PE complicated by cardiorespiratory arrest in one case and haemodynamic instability in other cases. Pulmonary angioscan was performed in three cases and transesophageal echocardiography in a patient with cardiogenic shock. Thrombolysis based on rtPA was performed in all cases, with a favorable evolution in 3 cases. No maternal or fetal complication has been observed during pregnancy or on follow-up that ranges from two to seven years. These findings underscore the safety and efficacy of thrombolysis, which remains the only life-saving therapeutic method immediately available in these severe forms of PE during pregnancy. The risk of bleeding induced by pregnancy should not be a contraindication.