Physician antibiotic hydration preferences for biologic antibacterial envelopes during cardiac implantable device procedures

Abstract

BackgroundCardiac implantable electronic device (CIED) infection is a potentially serious complication of CIED procedures. Infection risk mitigation includes using guideline-recommended pre-operative intravenous antibacterial prophylaxis (IV ABX). The use of antibiotic-eluting CIED envelopes has also been shown to reduce infection risk. The relationship between and potential benefits associated with guideline-recommended IV ABX in combination with antibacterial envelopes have not been characterized.MethodsBiologic envelopes made from non-crosslinked extracellular matrix (ECM) were implanted into 1,102 patients receiving CIEDs. The implanting physician decided patient selection for using a biologic envelope and envelope hydration solution. Observational data was analyzed on IV ABX utilization rates, antibacterial envelope usage, and infection outcomes.ResultsOverall compliance with IV ABX was 96.6%, and most patients received a biologic envelope hydrated in antibiotics (77.1%). After a mean follow-up of 223 days, infection rates were higher for sites using IV ABX <80% of the time vs. sites using ≥80% (5.6% vs. 0.8%, p = 0.008). Physicians demonstrated preference for hydration solutions containing gentamicin in higher-risk patients, which was found by multivariate analysis to be associated with a threefold reduction in infection risk (OR 3.0, 95% CI, 1.0–10.0).ConclusionThese findings suggest that use of antibiotics, particularly gentamicin, in biologic envelope hydration solution may reduce infection risk, and use of antibacterial envelopes without adjunct IV ABX may not be sufficient to reduce CIED infections.Clinical trial registration[https://clinicaltrials.gov/], identifier [NCT02530970].

Infections of cardiac implantable electronic devices: Epidemiology, mechanisms, and preventive measures

“…Another available absorbable CIED envelope is made of a decellularized and non-crosslinked extracellular matrix produced from porcine intestinal submucosa [90]. This envelope does not possess antibiotic-eluting properties per se but can be impregnated with gentamycin before implantation [90,91]. Before recommending this envelope for routine clinical use, results from ongoing randomized trials are awaited.…”