@Article{info:doi/10.2196/47525,
author="Chabrak, Sonia
and Haggui, Abdeddayem
and Allouche, Emna
and Ouali, Sana
and Ben Halima, Afef
and Kacem, Slim
and Krichen, Salma
and Marrakchi, Sonia
and Fehri, Wafa
and Mourali, Mohamed Sami
and Jabbari, Zeineb
and Ben Halima, Manel
and Neffati, Elyes
and Heraiech, Aymen 
and Slim, Mehdi
and Kachboura, Salem
and Gamra, Habib
and Hassine, Majed
and Kraiem, Sondes
and Kammoun, Sofien
and Bezdah, Leila
and Jridi, Gouider
and Bouraoui, Hatem
and Kammoun, Samir
and Hammami, Rania
and Chettaoui, Rafik
and Ben Ameur, Youssef
and Azaiez, Fares
and Tlili, Rami
and Battikh, Kais
and Ben Slima, Hedi
and Chrigui, Rim
and Fazaa, Samia
and Sanaa, Islem
and Ellouz, Yassine
and Mosrati, Mohamed
and Milouchi, Sami
and Jarmouni, Soumaya
and Ayadi, Wacef
and Akrout, Malek
and Razgallah, Rabie
and Neffati, Wissal
and Drissa, Meriem
and Charfeddine, Selma
and Abdessalem, Salem
and Abid, Leila
and Zakhama, Lilia",
title="National Tunisian Study of Cardiac Implantable Electronic Devices: Design and Protocol for a Nationwide Multicenter Prospective Observational Study",
journal="JMIR Res Protoc",
year="2024",
month="Apr",
day="8",
volume="13",
pages="e47525",
keywords="Tunisia; study; pacemaker; implantable cardioverter defibrillator; cardiac resynchronization therapy; design; complication",
abstract="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 ",
issn="1929-0748",
doi="10.2196/47525",
url="https://www.researchprotocols.org/2024/1/e47525",
url="https://doi.org/10.2196/47525",
url="http://www.ncbi.nlm.nih.gov/pubmed/38588529"
}