Adjunctive use of a gentamicin-collagen sponge during CIED implantation demonstrated procedural feasibility with 0% clinically adjudicated CIED infections over a 12-month follow-up.
Cohort (n=143)
No
Does adjunctive gentamicin-collagen sponge use in the implant pocket prevent CIED infections in patients undergoing CIED implantation?
The adjunctive use of a gentamicin-collagen sponge in CIED implant pockets is procedurally feasible and showed no early safety signals or infections in a small retrospective cohort, though the lack of a control group limits causal conclusions.
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 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). Perioperative prophylaxis consisted of intravenous ceftriaxone 2 g; in patients with documented β ‐lactam allergy, intravenous clindamycin was administered. 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 the 12‐month follow‐up. Results The mean age was 74. 5 years (SD ± 12), with males comprising 58% of the study population. Comorbidities were frequent (hypertension 81. 1%, coronary artery disease 56%, heart failure 33%, diabetes mellitus 27%, renal failure 11%, and COPD 5. 6%). Among patients, 5. 6% were immunocompromised. Devices included dual‐chamber pacemakers (74. 8%), single‐chamber pacemakers (10. 5%), implantable cardioverter‐defibrillators (10. 5%), and event recorders (4. 2%). Lead configuration was one lead in 17%, two leads in 74. 5%, and three leads in 8. 5%. Procedural success was 99. 3%, with one lead dislodgement. Postoperative inflammatory markers remained within normal limits (CRP: 1. 93 ± 3. 82 mg/L; median: 0. 51 mg/L; leukocytes: 7. 87 ± 2. 49 × 10⁹/L; procalcitonin: 0. 138 ± 0. 11 ng/mL; n = 13), and no pathological fevers occurred. No clinically adjudicated CIED infections (major or minor) were observed during the 12‐month follow‐up. Clinical signs of pocket infection were absent in 142/143 patients (99. 3%). One patient (0. 7%) developed a pocket hematoma with localized tenderness while under intensive immunosuppression. Postprocedure TEE detected no endocarditis. Conclusion In this exploratory cohort, adjunctive gentamicin–collagen sponge use demonstrated procedural feasibility without early safety signals. These findings are descriptive and hypothesis‐generating. Given the retrospective design, absence of a control group, limited sample size, and zero‐event outcome, causal effectiveness cannot be established. Prospective multicenter studies with larger cohorts and longer follow‐up are warranted to define effectiveness, durability, and appropriate patient selection.
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Azizy et al. (Thu,) conducted a cohort in Cardiac implantable electronic device (CIED) implantations (n=143). Gentamicin-containing hemostatic collagen sponge was evaluated on CIED-related infection during 12-month follow-up. Adjunctive use of a gentamicin-collagen sponge during CIED implantation demonstrated procedural feasibility with 0% clinically adjudicated CIED infections over a 12-month follow-up.
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Journal of Interventional Cardiology
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