Infections resulting from cardiac implantable electronic device (CIED) implantation are severely impacting on patients’ and on health care systems. The use of TYRX^TM absorbable antibiotic-eluting envelope has proven to decrease major CIED infections within 12 months of CIED surgery. The aim is to evaluate the impact of the envelope use on infection-related clinical events in a real-world contemporary patient population. Data on patients undergoing CIED surgery were collected prospectively by participating centers of the One Hospital ClinicalService project. Patients were divided into two groups according to whether TYRX^TM absorbable antibiotic-eluting envelope was used or not. Out of 1819 patients, 872 (47.9%) were implanted with an absorbable antibiotic-eluting envelope and included in the Envelope group and 947 (52.1%) patients who did not receive an envelope were included in the Control group. Compared to control, patients in the Envelope group had higher thrombo-embolic or hemorrhagic risk, higher BMI, lower LVEF and more comorbidities. During a mean follow-up of 1.4 years, the incidence of infection-related events was significantly higher in the control compared to the Envelope group (2.4% vs. 0.8%, P = 0.007). The five-year cumulative incidence of infection-related events was 8.1% in the control and 2.1% in the Envelope group (HR: 0.34, 95%CI: 0.14–0.80, P = 0.010). In our analysis, the use of an absorbable antibiotic-eluting envelope in the general CIED population was associated with a lower risk of systemic and pocket infection.

Objectives: Atrial fibrillation (AF) is the most common sustained arrhythmia associated with stroke, heart failure, and increased mortality. Due to its efficacy and safety, cryoballoon ablation (CBA) is widely accepted for rhythm control; however, long-term AF recurrence remains a challenge. Continuous monitoring with implantable loop recorders (ILRs) enhanced by artificial intelligence (AI) can detect both symptomatic and asymptomatic episodes, potentially optimizing patient management. This analysis assessed the long-term effectiveness of CBA in maintaining sinus rhythm and investigated the role of ILR-guided monitoring in enhancing therapeutic decisions. Methods: Data from 91 patients with paroxysmal or persistent atrial fibrillation (AF) who underwent pulmonary vein isolation using cryoballoon ablation at four Italian centers between April 2022 and April 2024 were analyzed. All patients received an insertable loop recorder (ILR) before or during hospitalization for ablation, allowing for the continuous remote monitoring of arrhythmias. Baseline demographics, procedural details, AF occurrence, AF burden (calculated as the total duration of all AF episodes occurring within a day and categorized by episode duration), therapeutic adjustments, and the effect of artificial intelligence (AI) on data processing were evaluated. Results: The cohort’s average age was 62.4 years, with 24.2% of participants being female. Physician-confirmed AF recurrence was noted in 26.7% of patients at 12 months and 49.5% at 24 months. The device data indicated a daily AF burden of ≥6 min in 47.2% at 12 months, with 25.9% surpassing 1 h. AI algorithms decreased false-positive alerts by 21%, resulting in an estimated saving of 19 clinician hours. In patients with pre-ablation ILR data, the median AF burden significantly decreased from 7% to 0.2% (p = 0.017). ILR-guided monitoring affected treatment adjustments, leading to the discontinuation of antiarrhythmic therapy in 36 patients and redo ablations in 8. Conclusions: Continuous ILR monitoring, combined with AI-driven analysis, enables the detection of AF recurrences and burden, thereby facilitating timely therapeutic adjustments.