Abstract

Background: Antibacterial cardiovascular implantable electronic device (CIED) envelopes provide short-term local antibiotic delivery and can reduce implant site infection risk. Available antibacterial CIED envelopes are either fabricated from biologic material (extracellular matrix hydrated with antibiotics by the user) or from non-biologic material (synthetic mesh coated with antibiotics by the manufacturer). Objective: To compare the risk profiles and outcomes of CIED procedure patients receiving no envelope vs an antibacterial envelope. Methods: Records of consecutive CIED procedure patients at one center were reviewed through 12 months follow-up. Procedures used either no envelope, a biologic envelope pre-hydrated with vancomycin and gentamicin (BIO) [CanGaroo®, Aziyo Biologics], or a non-biologic envelope coated with minocycline and rifampin (Non-BIO) [TYRX™, Medtronic]. Results: CIED procedures were performed on 248 patients (191 with envelope, 89 BIO, 102 Non-BIO). Patients receiving envelopes were younger, had significantly more comorbid risk factors (p<0.001), and received high powered devices and reoperative procedures more often (p<0.001)(Table 1). BIO envelopes were used more often in higher risk patients (84% vs 78%) and reoperative patients (62% vs 38%) compared to Non-BIO envelopes. CIED implant site pocket infection rates were low (envelope 0.5%, no envelope 0%, p=0.584), with no significant difference between BIO and Non-BIO envelopes. Conclusion: Antibacterial envelopes were used more often to treat patients with multiple comorbid risk factors. Biologic envelopes were used more often in higher risk patients. There was no significant difference in CIED implant site pocket infection rates for patients receiving biologic or non-biologic antibacterial envelopes.

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