JMIR Publications

ABSTRACT

Background:

In Tunisia, the number of cardiac implantable electronic devices (CIED) 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. The study also aims to describe the demographic and epidemiological characteristics of a nationwide sample of CIED patients 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/or system upgrade. 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 one-year follow-up period with four consecutive visits at 1, 3, 6, and 12 months after CIED implantation. The collected data is recorded electronically on the clinical suite platform: DACIMA Clinical Suite®.

Results:

The study started on January 18, 2021 and concluded on February 18, 2023. Twenty-seven cardiologists actively participated in data collection. Over this period, 1,500 patients were enrolled in the study consecutively. The mean age of the patients was 70.1+/- 15.2 years. The sex ratio was 1.15. Sixty percent of the patients were from the public sector, while 40% were from the private sector. A total of 1298 patients (86.3%) received a conventional PM and 75 patients (5%) received a biventricular pacemaker (CRT-P). ICDs 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. Clinical Trial: CLINICALTRIAL ClinicalTrials.gov Identifier: NCT05361759