Abstract

Introduction: Local antibiotic delivery using an antibacterial envelope (AE) was shown to reduce major cardiac implantable electronic devices (CIEDs) infections in a controlled trial. We sought to assess the effect of AE use on CIED infection rates in subsequent clinical practice in the U.S. Methods: Using the Nationwide Readmissions Database and ICD 9/10-PCS codes, we identified patients who had a CIED implanted between 2010 and 2018. Patients were stratified according to the use of an AE. Outcomes were CIED infection rates as well as trends and predictors of AE use. Results: A total of 866,245 patients underwent CIED implantation between 2010 and 2018, with 8489 (1.0%) having an AE implanted during the same index admission. AE use showed an increasing pattern from 0.2% in 2012 up to 3.3% in 2018, p<0.001. After excluding the last 6 months of each calendar year to allow for 6 months of follow-up data, a total 438,299 patients had a CIED implanted with 3938 (0.9%) receiving an AE. The rate of CIED related infection during 6-months post-implantation was lower among patients who had an AE (1.2% vs. 2.2, P<0.001), and this difference persisted after adjustment using a multivariable regression model (OR, 0.53; 95% CI: 0.39-0.71, P<0.001). Some patient factors (hypertension, heart failure, chronic kidney disease, atrial fibrillation and obesity), and hospital characteristics were independent predictors of increased likelihood of AE use during CIED placement (Table 1). Conclusions: There is an up-trending pattern of AE use during CIED implantation. The use of these envelopes is associated with a lower risk of CIED related infection.

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