Abstract
Introduction: Cardiac implantable electronic device (CIED) infections remain a significant clinical challenge, particularly in high-risk populations. In view of their severity, a re-evaluation of preventive strategies is warranted. Real-world evidence on the procedural safety and effectiveness of a gentamicin-containing hemostatic collagen sponge (GS) for pocket prophylaxis is limited.
Methods: We conducted a retrospective single-center analysis of consecutive CIED implantations between October 2022 and October 2024 (n=143). Peri-operative prophylaxis consisted of intravenous ceftriaxone 2 g (gentamicin 600 mg in patients with penicillin allergy). In addition, a gentamicin-containing hemostatic collagen sponge was placed in the device pocket. Outcomes included procedural success, local and systemic complications, inflammatory markers, transesophageal echocardiography (TEE) for endocarditis, and CIED-related infection during 12-month follow-up.
Results: Median age was 74.5 years with males comprising 58% of the study population. Comorbidities were frequent (hypertension 81%, coronary artery disease 56%, heart failure 33%, diabetes mellitus 27%, renal failure 11%, COPD 5.6%). Among the patients, 5.6% were immunocompromised. Devices included dual-chamber pacemakers 76%, single-chamber pacemakers 10.5%, implantable cardioverter-defibrillators 10.5%, and event recorders 4%; lead configuration was one lead 17%, two leads 74.5%, and three leads 8.5%. Indications were third-degree AV block 35%, secondary prevention in heart failure 19.58%, second-degree AV block Mobitz II 11.89%, tachycardia–bradycardia syndrome 11.89%, sick sinus syndrome 9.79%, second-degree AV block Mobitz I 4.20%, heart failure as primary indication 3.50%, pacemaker replacement 2.80%, and SA block 1.40%. Procedural success was 99.3% with only one lead dislodgement. Post-operative inflammatory markers remained within normal limits (CRP 1.93 ± 3.82 mg/L; median 0.51 mg/L; leukocytes 7.87 ± 2.49 × 10^9/L; procalcitonin 0.138 ± 0.11 ng/mL; n = 13)., and no pathological fevers occurred. No severe peri-operative infections were observed; over 12 months, no CIED-associated infections occurred. Clinical signs of pocket infection were absent in 142/143 (99.3%). One patient (0.7%) developed a pocket hematoma with localized tenderness while under intensive immunosuppression. Post-procedure TEE detected no endocarditis in any patient.
Conclusion: In this cohort, the addition of a gentamicin-containing hemostatic collagen sponge to standard peri-operative antibiotic prophylaxis was associated with very low infection and complication rates over 12 months. Prospective multicenter studies are required to define effectiveness and safety across broader settings.
