Focus of the Report: This report focuses on the efficacy and safety of TYRX antibacterial envelopes (Medtronic Inc.) for the prevention of infection following implantation of cardiac implantable electronic devices (CIEDs).

Technology Description: The TYRX antibacterial envelope is a surgical mesh that contains minocycline and rifampin and is designed to hold a pacemaker, pulse generator, or defibrillator in place at the time of surgical implantation. The aim of the envelope is to stabilize a CIED to reduce device migration, erosion, or the incidence of twiddler syndrome, while the antibiotics eluted into the device pocket aim to reduce the rate of infection.

Controversy: Untreated CIEDI infections (CIEDIs) have a high mortality rate; even with appropriate treatment, the patient mortality rate can be as high as 20%. Costs associated with an episode of CIEDI care may reach more than $170,000. The addition of antibacterial envelopes to standard care infection prophylaxis techniques may represent a strategy to substantially reduce the risk of morbidity and mortality associated with CIEDIs.

Key Questions:

  • Do antibacterial envelopes for the prevention of CIEDIs as an adjunct to standard care infection control reduce the number of infections versus standard care with no antibacterial envelope or with alternative infection prophylaxis?

  • Are there any immediate or long-term safety complications associated with the use of antibacterial envelopes for CIEDI prevention?

  • Have definitive patient selection criteria been established for the use of antibacterial envelopes for CIEDI prevention?

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