CONGRESS ABSTRACT

Background Leadless intracardiac pacemakers have been developed to reduce complications associated with conventional cardiac implantable electronic devices (CIEDs), particularly pocket- and lead-related complications, including infections, lead dislodgement, fracture, and system-related septicemia Methods From September 2022 to December 2025, 63 leadless pacemakers were implanted in our center: 30 single-chamber devices, 32 VDD dual-chamber devices, and one dual-chamber system. Patients were predominantly male (49/63), with a mean age of 80.5 years and a mean follow-up of 528 days. Comorbidities included diabetes (25%), hypertension (73%), anticoagulant therapy (59%), and renal insufficiency (41%), including 8 patients with severe renal failure (predialysis or dialysis). Seventeen patients had a history of congestive heart failure; mean left ventricular ejection fraction at implantation was 55.4%. High-risk clinical features included prior CIED infection (n=3), limited vascular access (n=18), valvular prostheses (n=6), immunosuppression (n=25), recurrent sepsis (n=23), and active competitive endurance sports (n=2) Results Between 2024 and 2025, 668 conventional CIED procedures were performed at our center, with an overall acute complication rate of 10.8%, including pneumothorax (5.1%), pocket hematoma (5.7%), late lead dislodgement (5.4%), pocket revision for skin erosion (1.2%), and device-related infection (1.8%), with systemic involvement in three cases. Among the 63 leadless pacemaker implantations, only one mild vascular complication occurred (arteriovenous fistula with inguinal hematoma), successfully treated surgically without impact on survival. No acute pericardial effusion, device dislodgement, or loss of capture was observed during follow-up. No hospitalizations for device-related sepsis were reported Conclusions In a real-world population characterized by advanced age and high clinical risk, leadless pacemakers demonstrated an excellent safety profile, with a markedly lower rate of complications and infections compared with conventional CIED implantation. The absence of transvenous leads eliminates lead-related complications, while standardized implantation techniques enhance procedural safety. Despite higher upfront costs, leadless pacing represents a valuable option in selected patients at high septic risk or with limited vascular access, where reduced hospitalizations and avoidance of prolonged antibiotic therapy may offset initial expenses