Rate of complications and infections among CIED patients with use of gentamicin-collagen sponge
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Abstract
Background: Cardiac implantable electronic device (CIED) infections and pocket haematoma formation are significant complications of CIED implantation procedures. Gentamicin-impregnated collagen sponges(GICS) have shown efficacy in reducing surgical site infections. Objectives: This retrospective observational study aimed to evaluate the incidence of pocket haematoma and infection in patients who underwent a CIED procedure with intra-pocket GICS use and to characterize the risk profile of the patient cohort. The study also compared the observed complication rates to those reported in the literature for similar high-risk populations. Methods: : The study reviewed the medical records of 204 patients at Edith Wolfson Medical Center who underwent a CIED procedure with GICS between April 2023 and July 2025. Patients were included if they had at least two risk factors for CIED infection or underwent a device replacement. Demographic data, procedure characteristics, and risk factors were collected, and PADIT, SHARIFF, and RI-AIAC scores were calculated. Results: : The study cohort consisted of 204 patients with a mean age of 79.1 years and an average follow-up of 333 days. The population had a high prevalence of comorbidities, with a mean of 3.62 risk factors per patient. The observed rates were a low 1.5% for pocket haematoma and 0.49% for pocket infection. All-cause mortality was 7.8%, with no deaths attributed to procedure-related complications. Conclusion: The use of GICS during CIED procedures in patients with a high risk of bleeding and infection may lead to improved outcomes. These findings suggest the potential for GICS to enhance safety in CIED implantations.
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