Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.
Condition: Sick Sinus Syndrome; Complete Heart Block; Syncope; Chronic Systolic Heart Failure
MeSH terms: Infections; Syncope; Heart Failure, Systolic; Heart Block; Sick Sinus Syndrome
Intervention: polymixin/bacitracin; cephalexin, or levofloxacin, or clindamycin; Saline
Intervention description: Antibacterial irrigation; Post operative oral antibiotics; Saline irrigation
Intervention MeSH terms: Levofloxacin; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cephalexin; Polymyxins; Bacitracin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1010.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CIED infection

Summary:

      The number of cardiac implantable electronic devices (CIEDs) implanted each year has grown
      rapidly over the past two decades. CIED infections, defined as infections involving the
      generator implant site (pocket) and/or intravascular leads, have become increasingly
      prevalent, with the rate of growth in infections outpacing that of CIED procedures. The odds
      of both short term and long term mortality are at least doubled in patients who suffer CIED
      infections, and long term survival is particularly poor in women. Optimal strategies to
      prevent CIED infections in high-risk patients are largely unproven. However, recent
      observational studies of an antibiotic-coated envelope implanted at the time of CIED
      procedure have shown that this strategy is associated with a low incidence of CIED
      infections. Other interventions to prevent CIED infections, including the use of antibiotic
      irrigant used to wash the pocket during implantation and postoperative oral antibiotics, are
      commonly used but not supported by rigorous controlled studies. The Specific Aim of this
      study is to test the hypothesis that the use of the 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years old

          -  Able to give informed consent

          -  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

        Exclusion Criteria:

          -  Medical condition that is likely to be fatal in less than one year

          -  Emergent CIED procedure

          -  Allergy to rifampin or minocycline, Allergy to polymyxin-B or bacitracin

          -  Enrollment in WRAP-IT trial

          -  Current CIED pocket infection