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.

Management of patients with cardiovascular diseases during Ramadan.

During the month of Ramadan, over one billion Muslims observe a water and food fast from sunrise to sunset. The practice of this religious duty causes marked changes in eating and sleeping habits. With the increasing incidence of cardiovascular (CV) risk factors, the number of patients with CV pathologies who wish to fast is increasing worldwide, and in Tunisia, which is ranked as a high CV risk country. If fasting has been shown to be beneficial for the improvement of some metabolic parameters, its practice in patients with CV pathology remains debated. The Tunisian Society of Cardiology and Cardiovascular Surgery (STCCCV) in consultation with the National Instance of Evaluation and Accreditation in Health (INEAS) has established this document in the form of a consensus after having analysed the literature with the aim of addressing these questions: -What is the impact of fasting in patients with CV pathologies? -How to stratify the risk of fasting according to CV pathology and comorbidities? -How to plan fasting in patients with CV diseases? -What are the hygienic and dietary measures to be recommended during fasting in patients with CV pathologies? -How to manage medication during the month of Ramadan in patients with CV diseases?

Impact of Carotid atheroma on cardiovascular risk in Mauritanian hypertensive patients.

AIM: To determine the prevalence of carotid atheroma in hypertensive patients and assess the levels of cardiovascular risk. METHODS: This is a prospective study that took place in the outpatient department of the National Cardiology Center of Nouakchott over a period of 6 months (October 2019 to March 2020). Patients with hypertension without complications were included. Patients lost to followup and those whose records were incomplete were excluded from the study. RESULTS: Out of a total of 171 patients, a total of 93 patients (54.38%) was collected, of which 54.8% were women, 55.9% of the patients in the series were over 50 years old.The associated cardiovascular risk factors were dominated by dyslipidemia (27.9%), diabetes (20.4%), smoking (26.8%). hypertension was grade 2 in 47.3% of patients and grade 3 in 52.7% of patients. Left ventricular hypertrophy was noted in 77.4% of patients. Echo-Doppler of the supra-aortic trunks revealed atherosclerotic plaques in 63.4% of patients. CONCLUSION: The prevalence of carotid atheroma in hypertensive patients at high cardiovascular risk level was frequent in our series, it follows from this to recommend early detection for optimal management.

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.

Contribution of the ACE (rs1799752) and CYP11B2 (rs1799998) Gene Polymorphisms to Atrial Fibrillation in the Tunisian Population.

BACKGROUND: This study investigated the association of angiotensin-converting enzyme (ACE I/D) and aldosterone synthase (CYP11B2-344C/T) gene polymorphisms in the renin-angiotensin-aldosterone system (RAAS) with atrial fibrillation (AF) in the Tunisian population. MATERIALS AND METHODS: The study population included 120 patients with AF and 123 age-matched controls. Genotyping of the I/D polymorphism in the ACE gene and the -344C/T polymorphism in the CYP11B2 gene was performed by polymerase chain reaction (PCR) and PCR-RFLP methods, respectively. RESULTS: The genotype distribution of the ACE I/D and CYP11B2-344C/T polymorphisms was significantly different between AF patients and control participants (p < 0.01 and p < 0.006 respectively). In addition, ACE I/D increased the risk of AF significantly by 3.41-fold for the DD genotype (OR = 3.41; 95% CI [1.39-8.34]; p < 0.007), and after adjusting for confounding factors (age, diabetes, hypertension, and dyslipidemia), the risk was higher (OR = 5.71; 95% CI [1.48-21.98]; p < 0.01). Likewise, the CYP11B2-344C/T polymorphism increased the incidence of AF for the TT genotype (OR = 3.66; 95% CI [1.62-8.27]; p < 0.002) and the CT genotype (OR = 2.68; 95% CI [1.22-5.86]; p < 0.01). After adjusting for confounding factors (age, diabetes, hypertension and dyslipidemia), the risk remained higher for the TT genotype (OR = 3.58; 95% CI [1.08-11.77]; p < 0.03). Furthermore, the haplotype-based association of the ACE I/D and CYP11B2-344C/T polymorphisms showed that the D-T haplotype increased the risk for AF. CONCLUSION: Our study suggests a significant association of the ACE (I/D) and CYP11B2-344C/T polymorphisms with AF in the Tunisian population.

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.

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.

Epidemiological characteristics, management, and outcomes of atrial fibrillation in TUNISIA: Results from the National Tunisian Registry of Atrial Fibrillation (NATURE-AF).

BACKGROUND: Contemporary registries on atrial fibrillation (AF) are scare in North African countries. HYPOTHESIS: In the context of the epidemiological transition, prevalence of valvular AF in Tunisia has decreased and the quality of management is still suboptimal. METHODS: NATURE-AF is a prospective Tunisian registry, involving consecutive patients with AF from March 1, 2017 to May 31, 2017, with a one-year follow-up period. All the patients with an Electrocardiogram-documented AF, confirmed in the year prior to enrolment were eligible. The epidemiological characteristics and outcomes were described. RESULTS: A total of 915 patients were included in this study, with a mean age of 64.3 ± 22 years and a male/female sex ratio of 0.93. Valvular AF was identified in 22.4% of the patients. The mean CHA2 DS2 VASC score in nonvalvular AF was 2.4 ± 1.6. Monotherapy with antiplatelet agents was prescribed for 13.8% of the patients. However, 21.7% of the subjects did not receive any antithrombotic agent. Oral anticoagulants were prescribed for half of the patients with a low embolic risk score. In 341 patients, the mean time in therapeutic range was 48.87 ± 28.69%. Amiodarone was the most common antiarrhythmic agent used (52.6%). During a 12-month follow-up period, 15 patients (1.64%) had thromboembolism, 53 patients (5.8%) had major hemorrhage, and 52 patients (5.7%) died. CONCLUSIONS: NATURE-AF has provided systematic collection of contemporary data regarding the epidemiological and clinical characteristics as well as the management of AF by cardiologists in Tunisia. Valvular AF is still prevalent and the quality of anticoagulation was suboptimal.

Management of patients with cardiac implantable electronic devices (CIED) undergoing radiotherapy: A consensus document from the Tunisian Society of Oncology Radiotherapy and the Tunisian Society of Cardiology and Cardiovascular Surgery.

In patients with cardiac implantable electronic devices CIEDs, including cardiac pacemakers (PM) and implantable cardioverter-defibrillators (ICD), radiotherapy (RT) could compromise CIED function. Managing radiotherapy patients with CIED, has been a great practical and procedural challenge in radiotherapy and requires a structured multidisciplinary approach. A consensus document is presented as a result of a multidisciplinary working group involving cardiac electrophysiologists, Radiation Oncologists and Medical physicists. It aims to propose recommendations on risk stratification, management approach before, during and after radiation treatment/course of patients with CIED.

Tunisian Consensus document on magnetic resonance imaging in patients with intracardiac devices.

INTRODUCTION: Patients with ferromagnetic cardiac devices, particularly cardiac implantable electronic devices (CIED) such as pacemakers or implantable cardioverter defibrillators, are often inappropriately deprived of magnetic resonance imaging (MRI) for safety reasons. This consensus document is written by a multidisciplinary working group involving rhythmologists, interventional cardiologists, echocardiographists and radiologists. Its objective is to establish good practice recommendations to optimize the management of patients with cardiac devices requiring MRI examination, while ensuring their safety and facilitating their access to MRI.

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 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.

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.

Evaluation of students' motivation during the gamification of electrocardiogram interpretation learning.

INTRODUCTION: The quality of the training of medical students is one of the guarantors of the proper functioning of our health system. Gamification is an innovative educational pedagogical method that stimulates the pleasure of learning and encourages learner motivation. AIM: To evaluate the subjective and external motivations and academic self-efficacy of DCEM1 students by playing with TD sessions designed to learn the systematic interpretation of rhythm disorders on surface ECGs using playing cards. METHODS: It was a descriptive, cross-sectional study. Three successive groups of 25 students each took part in this study which took place at the Faculty of Medicine of Tunis. Each group was subdivided into 5 subgroups. During the TD session, the same 18 playing cards are distributed to each subgroup, and various wide and thin QRS tachycardia ECG plots are projected successively. Each subgroup should collect playing cards related to the methodical interpretation of each ECG trace and establish the final diagnosis of rhythm disorder. At the end of the pedagogical training, an anonymous self-assessment questionnaire to measure the types of motivation and academic self-efficacy was submitted to the students. RESULTS: Seventy-five students participated in our study. They were mostly female (sex ratio = 4). Gamification learning using playing cards has generated learners' intrinsic motivation (5.89 ± 0.97), allowing them to feel more confident in themselves, capable of acquiring new skills. Regarding extrinsic motivation, having good results on the exam was not their main concern (4.34 ± 1.23). This learning method has created a feeling of self-efficacy among our learners (5,004 ± 0,98). Indeed, they proved to be able to assimilate the fundamental notions of the course (5.86 ± 1.26), to understand the most complex material of the course (5 ± 1.55) and to acquire the competences targeted by this course (5.41 ± 0.5 ). Finally, all learners were satisfied with the method of gamification learning using playing cards. They recommended that this method be generalized throughout all ECG sessions. CONCLUSION: Gamification learning seems to be an effective and appropriate approach to teaching in the medical field since it allows to associate the notion of pleasure and the act of learning and stimulating motivation and self-efficacy learners.

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.

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.