Antibiotic selection and risk profiles in patients receiving antibacterial cardiovascular implantable electronic device envelopes – a real world sample and analysis

Abstract

Background The use of a cardiovascular implantable electronic device (CIED) envelope impregnated with antibiotics provides short-term local antibiotic delivery in the implant pocket and may lower infection risk. Biologic antibacterial (BIO) envelopes, such as the porcine extracellular matrix (ECM) device hydrated with antibiotics, facilitate active remodeling of the pocket into vital, vascularized tissue and provide short-term local antibiotic delivery. Limited clinical data is available on real-world clinician patient selection criteria, antibiotic choices, or clinical outcomes. Purpose To explore antibiotic hydration solution physician choices with respect to patient profiles, and to determine post-implant infection outcomes in patients receiving a CIED BIO envelope. Methods A post-hoc sub-analysis of a multicenter, non-randomized study of 1017 patients receiving a biologic envelope (hydrated with or without antibiotics) during CIED procedures (SECURE Study) assessed antibiotic hydration choices, patient risk profiles, and the type and timing of infection for days 0–90 post procedure. Patient selection and antibiotic hydration choice were at the discretion of the treating physician. Results 850 patients received BIO envelopes, with a mean age of 71.9 years, and 60.5% having ≥2 standard infection risk factors. High power devices accounted for 47.6% and reoperations for 44.0% of the procedures. Antibiotic choice for envelope hydration prior to implantation is described in Table 1 below. Also, antibiotic combinations with gentamicin were used in 18.1% and other antibiotic combinations in 9.2% of patients. Patients receiving gentamicin hydrated BIO envelopes (BIO+G) trended toward fewer pocket infections vs. those without gentamicin (BIO-G) (0.0% vs. 1.6%, p=0.070) but the overall pocket infection rate of 1.2% was not significantly different based upon antibiotic choice. In a multivariate logistic regression model designed to predict the total infection rate, the use of gentamicin was associated with a 3-fold reduction in likelihood of infection, OR 3.0 (1.0–10.0); AUC=0.70. No differences in overall infection rates among patients undergoing lead or pocket revision only procedures (0.0% vs. 0.0%) or other major adverse events were observed based upon antibiotic usage. Conclusions Real world clinical decision-making regarding antibiotic choice for biologic antibacterial envelopes varies among implanting clinicians and influences observed outcomes. The use of biologic antibacterial envelopes hydrated with gentamicin was associated with a lower likelihood of infection within 90 days when compared to biologic envelopes hydrated without gentamicin. Clinical trials to optimize patient selection processes and determine the best antibiotic choice when employing a CIED envelope merit further investigation. FUNDunding Acknowledgement Type of funding sources: Other. Main funding source(s): The work was supported by Aziyo Biologics, Inc. Table 1. BIO Envelope Hydration

Risk Profiles and Outcomes of Patients Receiving Cardiovascular Implantable Electronic Devices With and Without Antibacterial Envelopes

“…Taken together, the results of this analysis indicate that antibiotic-eluting CIED envelopes are preferred for patients and devices with a higher risk for infection, as also demonstrated by previous studies [ 13 , 16 , 20 - 24 ]. To aid clinical decision-making and potentially improve patient care, we combined our practice patterns, the results from this analysis, and results from previous studies to suggest a decision tree for CIED antibacterial envelope usage, as illustrated in Figure 1 [ 3 , 5 , 11 , 12 , 16 , 20 - 22 , 26 , 45 - 50 ].…”

Risk profiles and outcomes of patients receiving antibacterial cardiovascular implantable electronic device envelopes: A retrospective analysis

“…Interestingly, there was no statistical difference in observed infection rates between the envelope and no envelope groups, even though the envelope group contained significantly more patients with ≥ 2 infection risk factors. Our results and those of other studies[ 9 , 12 , 24 , 26 ], support that the utilization of antibacterial envelopes (biologic or non-biologic) may reduce the potential risk burden of patients with multiple concurrent infection risk factors who are undergoing CIED procedures. However, further studies are needed to determine if there are specific patient types that could benefit the most from receiving an antibacterial envelope.…”

“…Conversely, ECM (the material that the biologic envelope is made from) has been shown to promote constructive remodeling and healthy tissue restoration[ 20 - 23 ]. Both biologic and non-biologic envelopes have been reported to support clinical infection prevention strategies[ 12 , 24 - 26 ].…”