Efficacy of a gentamycin-collagen sponge to prevent infections in patients with an implantable cardioverter defibrillator undergoing device replacement or lead revision: Results of a monocentric ICD registry observational study

Abstract

Background: Despite the obvious benefits, the use of implantable cardioverter defibrillators (ICDs) is associated with serious complications, including infections. In particular, device replacement or revision procedures are associated with an increased risk of infection.

Objective: The aim of the study was to compare the cardiac device infection rate with and without the use of a gentamycin-collagen sponge (GCS) in patients undergoing device replacement or revision procedures of implanted ICDs.

Methods: A total of 507 consecutive ICD patients from a prospective single-center ICD registry who underwent elective device replacement, system upgrade, or lead revision between 2017 and April 2024 were analyzed. From September 2020 onwards a GCS was inserted into the device pocket (GCS group, n = 277). These patients were compared with patients who underwent surgery between 2017 and August 2020 (control group, n = 230).

Results: The baseline characteristics were similar between both groups. The GCS was well tolerated, and no complications were associated with the GCS. The Kaplan-Meier estimated infection rate after 1 year was 0.7% in the GCS group and 3.9% in the control group (P = .005). The use of the GCS was an independent predictor for a lower device infection rate during follow-up (hazard ratio [HR], 0.23, 95% confidence interval [CI], 0.07-0.84).

Conclusion: The additional use of a GCS was associated with a lower incidence of device infections than standard-of-care infection prevention strategies alone.

Keywords: Antibiotic prophylaxis; Device infection; Device replacement; Gentamycin sponge; Implantable cardioverter-defibrillator; Lead revision.