A Randomized Noninferiority Study of the TYRX-A Antibacterial Envelope Alone Versus Envelope Plus Intraoperative Antibacterial Irrigant and Postoperative Oral Antibiotics to Prevent Cardiac Implantable Electronic Device Infections in High-Risk Patients


To test the hypothesis that the use of the TYRX antibacterial envelope alone is noninferior to a strategy using the antibacterial envelope and intraoperative antibacterial irrigant and postoperative oral antibiotics for the reduction of cardiac implantable device infections in patients with ≥2 risk factors for infection.


At least 2 of the following risk factors for infection:

  • Diabetes mellitus
  • Chronic kidney disease (estimated creatinine clearance <30 ml/min)
  • Therapeutic anticoagulation
  • Chronic heart failure
  • Chronic use of corticosteroids
  • Fever ≥38° C or leukocytois (≥11,000 cells/mm3) within 24 hrs of implant
  • Device revision (including generator change, or extraction)
  • ≥3 leads in situ (CRT system or abandoned leads)
  • Early reoperation (pocket re-entry <2 weeks)
  • Previous CIED infection