National Tunisian Study of Cardiac Implantable Electronic Devices: Design and Protocol for a Nationwide Multicenter Prospective Observational Study
Authors: Chabrak Sonia , Haggui Abdeddayem , Allouche Emna , Ouali Sana , Ben Halima Afef , Kacem Slim , Krichen Salma , Marrakchi Sonia , Fehri Wafa , Mourali Mohamed Sami , Jabbari Zeineb , Ben Halima Manel , Neffati Elyes , Heraiech Aymen  , Slim Mehdi , Kachboura Salem , Gamra Habib , Hassine Majed , Kraiem Sondes , Kammoun Sofien , Bezdah Leila , Jridi Gouider , Bouraoui Hatem , Kammoun Samir , Hammami Rania , Chettaoui Rafik , Ben Ameur Youssef , Azaiez Fares , Tlili Rami , Battikh Kais , Ben Slima Hedi , Chrigui Rim , Fazaa Samia , Sanaa Islem , Ellouz Yassine , Mosrati Mohamed , Milouchi Sami , Jarmouni Soumaya , Ayadi Wacef , Akrout Malek , Razgallah Rabie , Neffati Wissal , Drissa Meriem , Charfeddine Selma , Abdessalem Salem , Abid Leila , Zakhama Lilia 
Published: October 2023

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