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.
(©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, Lilia Zakhama. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 08.04.2024.)