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1. National Tunisian Study of Cardiac Implantable Electronic Devices: Design and Protocol for a Nationwide Multicenter Prospective Observational Study

Author

Sonia Chabrak, Abdeddayem Haggui, Emna Allouche, Sana Ouali, Afef Ben Halima, Slim Kacem, Salma Krichen, Sonia Marrakchi, Wafa Fehri, Mohamed Sami Mourali, Zeineb Jabbari, Manel Ben Halima, Elyes Neffati, Aymen Heraiech, Mehdi Slim, Salem Kachboura, Habib Gamra, Majed Hassine, Sondes Kraiem, Sofien Kammoun, Leila Bezdah, Gouider Jridi, Hatem Bouraoui, Samir Kammoun, Rania Hammami, Rafik Chettaoui, Youssef Ben Ameur, Fares Azaiez, Rami Tlili, Kais Battikh, Hedi Ben Slima, Rim Chrigui, Samia Fazaa, Islem Sanaa, Yassine Ellouz, Mohamed Mosrati, Sami Milouchi, Soumaya Jarmouni, Wacef Ayadi, Malek Akrout, Rabie Razgallah, Wissal Neffati, Meriem Drissa, Selma Charfeddine, Salem Abdessalem, Leila Abid, and Lilia Zakhama

Subjects
Medicine, Computer applications to medicine. Medical informatics, R858-859.7
Abstract

BackgroundIn 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. ObjectiveThe 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. MethodsThe 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). ResultsThe 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. ConclusionsThis 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 RegistrationClinicalTrials.gov NCT05361759; https://classic.clinicaltrials.gov/ct2/show/NCT05361759 International Registered Report Identifier (IRRID)RR1-10.2196/47525

Published
2024
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2. Epidemiological characteristics, management, and outcomes of atrial fibrillation in <scp>TUNISIA</scp> : Results from the National Tunisian Registry of Atrial Fibrillation ( <scp>NATURE‐AF</scp> )

Author

Wejdene Wechtati, Wafa Fehri, Oussema Ben Rejab, Leila Riahi, Ali Neji, Feriel Baraket, Majed Hassine, Wacef Ayadi, Foued Azzouzi, Jawher Zemni, Rachid Mechmeche, Sofiene Kammoun, Monia Jammali, Emna Allouche, Khaled Sayahi, Mahmoud Cheikh Bouhlel, Habib Gamra, Rym Jemli, Rim Chrigui, Sanaa Islem, Mohamed Ali Meghaieth, Rawdha Othmani, Med Ali Azaiez, Kais Battikh, Hajer Rekik, Saoussen Antit, Tarek Najar, Sondes Kraiem, Iheb Chahbani, Riadh Garbaa, Manel Ben Halima, Salem Kachboura, Faouzi Addad, Rafik Chettaoui, Ikram Kammoun, Wissem Sdiri, Dorra Mbarek, Syrine Abid, Ali Ben Khalfallah, Mohamed Hmem, Sonia Chabrak, Khadija Mzoughi, Samir Kammoun, Slim Kacem, Soraya Ben Youssef, Khaled Ben Jemaa, Afef Ben Halima, Meriem Drissa, Mbarek Mohamed Ben, Hanene Charfeddine, Sami Braham, Wajih Smati, Habiba Drissa, Sami Milouchi, Amel Ouerghi, Zeynab Jebbari, Essia Boughzela, Sandrine Haidar, Salem Abdesselem, Mehdi Ben Miled, Sana Ouali, Hassen Ajmi, Malek Mezri, Rami Tlili, Leila Abid, Anissa Gharbi, Ridha Ennouri, Sonia Marrakchi, Faouzi Maatouk, Lilia Zakhama, Ali Guesmi, Mourad Jarrar, Mokdad Ayari, Sihem Heraiech, Habib Bousadia, Mariem Ben Romdhane, Hamda Zaghdoudi, Karim Ben Brahim, Leila Bezdah, Taha Ounissi, Hela Naanea, Wided Nasraoui, Basma Trimech, Gouider Jridi, Salma Krichane, Selma Charfeddine, Anissa Joulak, Larbi Noureddine, Abdeddayem Haggui, Moufid Hadrich, Karim Zoughi, Wassim Brahim, Fehmi Abbes Mohamed, Mohamed Sami Mourali, Leila Hached, Samir Tlili, Samira Kaabachi, and Nabil Hamrouni

Subjects
Male, medicine.medical_specialty, Tunisia, Antithrombotic Agent, medicine.medical_treatment, Clinical Investigations, Context (language use), 030204 cardiovascular system & hematology, Antiarrhythmic agent, outcomes, Amiodarone, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, Atrial Fibrillation, Epidemiology, medicine, Humans, Prospective Studies, Registries, 030212 general & internal medicine, anticoagulation, risk scores, Framingham Risk Score, business.industry, Anticoagulants, Atrial fibrillation, General Medicine, North Africa, medicine.disease, Stroke, Epidemiological transition, Female, Cardiology and Cardiovascular Medicine, business, management, medicine.drug
Abstract

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 CHA2DS2VASC 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.

Published
2021

3. Design and Rationale of the National Tunisian Registry of Atrial Fibrillation: Protocol for a Prospective, Multicenter Trial

Author

Sonia Marrakchi, Manel Ben Halima, Mohamed Ben Mbarek, Leila Abid, Rafik Chettaoui, H. Drissa, L. Zakhama, A. Haggui, Wajih Smati, Nadia Baraket, Sana Ouali, Soraya Ben Youssef, Gouider Jeridi, S. Chabrak, Salem Kachboura, Helmi Kammoun, Hedi Baccar, Samir Kammoun, Skander Ben Omrane, Habib Gamra, Najeh Ben Halima, Salem Abdesselem, Wided Nasraoui, Faouzi Maatouk, Ali Gasmi, Salma Krichène, Afef Ben Halima, Ali Neji, K. Sayahi, Sondes Kraiem, Rim Chrigui, Mohamed Fahmi Abbes, N. Larbi, Habib Haouala, W. Sdiri, F. Addad, Ines Issa, Slim Kacem, S. Milouchi, Youssef Harrath, Mohamed Rachid Boujnah, Samir Tlili, Essia Boughzala, Ali Ben Khalfallah, Mohamed Sami Mourali, and Abdallah Mahdhaoui

Subjects
medicine.medical_specialty, Heart disease, business.industry, Incidence (epidemiology), Atrial fibrillation, General Medicine, Demographic profile, 030204 cardiovascular system & hematology, registry, medicine.disease, North African, 03 medical and health sciences, 0302 clinical medicine, Multicenter trial, Emergency medicine, Epidemiology, NATURE-AF, Clinical endpoint, Protocol, Medicine, atrial fibrillation, 030212 general & internal medicine, business, Stroke
Abstract

Background Atrial fibrillation (AF) is an important health problem in Tunisia. A significant change in the epidemiological pattern of heart disease has been seen in the last 3 decades; however, no large prospective multicenter trial reflecting national data has been published so far. Robust data on the contemporary epidemiological profile and management of AF patients in Tunisia are limited. Objective The aim of this study is to analyze, follow, and evaluate patients with AF in a large multicenter nationwide trial. Methods A total of 1800 consecutive patients with AF by electrocardiogram, reflecting all populations of all geographical regions of Tunisia, will be included in the study, with the objective of describing the epidemiological pattern of AF. Patients will be officially enrolled in the National Tunisian Registry of Atrial Fibrillation (NATURE-AF) only if an electrocardiogram diagnosis (12-lead, 24-hour Holter, or other electrocardiographic documentation) confirming AF is made. The qualifying episode of AF should have occurred within the last year, and patients do not need to be in AF at the time of enrollment. Patients will be followed for 1 year. Incidence of stroke or transient ischemic attack, thromboembolic events, and cardiovascular death will be recorded as the primary end point, and hemorrhagic accidents, measurement of international normalized ratio, and time in therapeutic range will be recorded as secondary end points. Results Results will be available at the end of the study; the demographic profile and general risk profile of Tunisian AF patients, frequency of anticoagulation, frequency of effective treatment, and risks of thromboembolism and bleeding will be evaluated according to the current guidelines. Major adverse events will be determined. NATURE-AF will be the largest registry for North African AF patients. Conclusions This study would add data and provide a valuable opportunity for real-world clinical epidemiology in North African AF patients with insights into the uptake of contemporary AF management in this developing region. Trial registration ClinicalTrials.gov NCT03085576; https://clinicaltrials.gov/ct2/show/NCT03085576 (Archived by WebCite at http://www.webcitation.org/6zN2DN2QX). Registered report identifier RR1-10.2196/8523.

Published
2017

4. National Tunisian Registry of Atrial Fibrillation (NATURE-AF): Protocol for the Design and Rationale (Preprint)

Author

Afef Ben Halima, Sana Ouali, Mohamed Sami Mourali, Sonia Chabrak, Rafik Chettaoui, Manel Ben Halima, Abdeddayem Haggui, Noureddine Larbi, Salma Krichène, Sonia Marrakchi, Slim Kacem, Rim Chrigui, Mohamed Fahmi Abbes, Hédi Baccar, Nadia Baraket, Najeh Ben Halima, Ali Ben Khalfallah, Mohamed Ben Mbarek, Soraya Ben Youssef, Essia Boughzala, Mohamed Rachid Boujnah, Habiba Drissa, Habib Gamra, Ali Gasmi, Habib Haouala, Youssef Harrath, Ines Issa, Gouider Jeridi, Salem Kachboura, Samir Kammoun, Sondes Kraiem, Faouzi Maatouk, Sami Milouchi, Wided Nasraoui, Ali Neji, Khaled Sayahi, Wissem Sdiri, Wajih Smati, Samir Tlili, Leila Abid, Salem Abdesselem, Lilia Zakhama, Abdallah Mahdhaoui, Helmi Kammoun, Skander Ben Omrane, and Faouzi Addad

Abstract

BACKGROUND Atrial fibrillation (AF) is an important health problem in Tunisia. A significant change in the epidemiologic pattern of heart disease has been seen in the last 3 decades; however, no large prospective multicenter trial reflecting national data has been published so far. Robust data on the contemporary epidemiologic profile and management of atrial fibrillation (AF) patients in Tunisia are limited. OBJECTIVE The aim of this study was to analyze, follow, and evaluate patients with AF in a large multicenter nationwide trial. METHODS A total of 1800 consecutive patients with AF by electrocardiogram, reflecting all populations of all geographical regions of Tunisia, will be included in the study, with the objective to describe the epidemiologic pattern of AF. Patients will be officially enrolled in the NATURE-AF only if an electrocardiogram diagnosis (12-lead, 24-hour Holter, or other electrocardiographic documentation) confirming AF is made. The qualifying episode of AF should have occurred within the last year, and patients do not need to be in AF at the time of enrollment. Patients will be followed for 1 year. Incidence of stroke or transient ischemic attack, thromboembolic events, and cardiovascular death will be recorded as the primary end point and hemorrhagic accidents, measurement of international normalized ratio, and time in therapeutic range will be recorded as secondary end points. RESULTS Results w be available at the end of the study; the demographic profile and general risk profile of Tunisian AF patients, frequency of anticoagulation, frequency of effective treatment, and risks of thromboembolism and bleeding will be evaluated according to the current guidelines. Major adverse events will be determined. NATURE-AF will be the largest registry for North African AF patients. CONCLUSIONS This study would add data and provide a valuable opportunity for real-world clinical epidemiology in North African AF patients with insights into the uptake of contemporary AF management in this developing region. CLINICALTRIAL ClinicalTrials.gov NCT03085576; https://clinicaltrials.gov/ct2/show/NCT03085576 (Archived by WebCite at http://www.webcitation.org/6zN2DN2QX)

Published
2017

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