National Tunisian Multicenter Prospective Study on Cardiac Implantable Electronic Devices (Tunisian NATURE-CIED study): One-year complications and predictive factors

Background: The prevalence of cardiac implantable electronic devices (CIEDs) in Tunisia is rising because of increased life expectancy and broader indications. This has led to a higher incidence of complications related to vascular access, device pockets, leads, and patient characteristics. Objective: We aimed to evaluate the prevalence, types, and predictors of complications occurring within the first year after CIED implantation and to profile the demographic and epidemiologic characteristics of CIED recipients in Tunisia. Methods: The National Tunisian Multicenter Prospective Study on Cardiac Implantable Electronic Devices is a nationwide, prospective study. We enrolled consecutive patients, from January 2021 to February 2022, undergoing de novo implantation of pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy devices, generator replacements, and upgrading procedures. Patients attended 4 follow-up visits within the first year. Results: We enrolled 1500 patients with a mean age of 70.1 ± 15.2 years. Most (86.5%) received conventional pacemakers. The overall complication rate was 8.6%, with 129 complications in 80 patients. No significant associations were found between age or gender and complication rates. However, overweight and obesity were independent predictors of overall complications. Procedures performed in private health care settings were associated with a 56.2% reduction in complication rates. Generator replacements were linked to a 64.2% decrease in complication rates. Conversely, urgent or out-of-hours procedures increased the risk of complications by 62.7%. Procedures performed by non-electrophysiologist implanters were associated with an 89.5% increase in overall complication rates. Conclusion: Complications were more prevalent with cardiac resynchronization therapy devices. Identifying specific procedural predictors may pinpoint patients at higher risk, affecting personalized treatments and CIED implantation strategies.