title: Retrospective comparative analysis of cardiovascular implantable electronic device infections with and without the use of antibacterial envelopes.
abstract: BACKGROUND
  Cardiovascular implantable electronic device (CIED) infections are associated with morbidity and mortality. Peri-operative systemic intravenous antibiotic prophylaxis reduces the rate of CIED infections. AIGISRx, a polymer envelope implanted with the CIED, releases minocycline and rifampin, and has been introduced to reduce infections.
  
  
  METHODS
  Retrospective review of 184 patients who underwent CIED implantation was conducted. Ninety-two patients were implanted with an AIGISRxenvelope (AIGISRxgroup) and 92 patients were not implanted with an AIGISRxenvelope (control group). Data were collected on demographics and risk factors for CIED infections (i.e. congestive heart failure, renal insufficiency, chronic kidney disease, oral anticoagulant use, chronic steroid use, need for lead replacement or revision, temporary pacing, early re-intervention, and having more than two leads in place). Rates of implantation success, major infections and mortality were compared between the AIGISRxgroup and the control group.
  
  
  RESULTS
  The AIGISRxgroup had longer hospitalizations (6.8±10.7 days vs 3.1±5.2 days; P=0.001), higher chronic corticosteroid use, higher rates of replacement or revision (51.1% vs 8.7%; P=0.001), and a greater proportion of devices with more than two intracardiac leads (42.4% vs 29.3%; P=0.03) than the control group. Successful implantation occurred in 97% of patients in both groups. Major infection was seen in 5.4% of cases in the AIGISRxgroup and 1.1% of cases in the control group (P=0.048). Device removal was conducted in 3.3% of cases in the AIGISRxgroup compared with 1.1% of cases in the control group (P=0.16). There were two deaths in the AIGISRxgroup. Organisms cultured were meticillin-resistant Staphylococcus aureus, meticillin-susceptible S. aureus and Enterococcus faecalis.
  
  
  CONCLUSIONS
  The AIGISRxgroup had higher rates of major infection but also higher risk factors compared with the control group. The rate of device extraction and CIED-related mortality was higher in the AIGISRxgroup than in the control group.
authors.affiliation: Department of Infectious Disease, Alabama Infectious Diseases Center, Huntsville, AL, USA. Electronic address: ali_hasoun@yahoo.com.
authors.forename: A
authors.initials: A
authors.lastname: Hassoun
authors.affiliation: Department of Infectious Disease, Alabama Infectious Diseases Center, Huntsville, AL, USA.
authors.forename: E D
authors.initials: ED
authors.lastname: Thottacherry
authors.affiliation: Department of Infectious Disease, Alabama Infectious Diseases Center, Huntsville, AL, USA.
authors.forename: M
authors.initials: M
authors.lastname: Raja
authors.affiliation: Department of Infectious Disease, Alabama Infectious Diseases Center, Huntsville, AL, USA.
authors.forename: M
authors.initials: M
authors.lastname: Scully
authors.affiliation: Department of Infectious Disease, Alabama Infectious Diseases Center, Huntsville, AL, USA.
authors.forename: A
authors.initials: A
authors.lastname: Azarbal
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis / Q000379:methods*; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D020878:Device Removal; D005260:Female; D006801:Humans; D008297:Male; D008911:Minocycline / Q000008:administration & dosage*; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D016459:Prosthesis-Related Infections / Q000453:epidemiology* / Q000401:mortality*; D012189:Retrospective Studies; D016019:Survival Analysis
chemical_list: D000900:Anti-Bacterial Agents; D008911:Minocycline
keywords: Cardiac implantable device; Complications; Infection