title: Health and Economic Outcomes Associated with Use of an Antimicrobial Envelope as a Standard of Care for Cardiac Implantable Electronic Device Implantation.
abstract: BACKGROUND
  Infection of cardiac implanted electrical devices (CIED) is a problem. In selected patients, use of an "antibacterial envelope" (AIGISRx®) is associated with low CIED infection rates. The value of this device when used as a standard of care is unclear.
  
  
  RESULTS
  Retrospective analysis of all patients (N = 1,476) who underwent CIED implantation at a single hospital. During the study period, some implanters used the AIGISRx as a standard of care (Yes-AIGISRx Group, N = 365), whereas others did not use it at all (No-AIGISRx Group, N = 1,111). A risk score based on preoperative factors was calculated for each patient. Rates of CIED infection within 6 months were measured, and associated costs were estimated. The Yes-AIGISRx and No-AIGISRx groups had similar preoperative infection risk. In the No-AIGISRx group, 19 infections were observed (1.7%), versus 0 in the Yes-AIGISRx group (P = 0.006). The 6-month mortality rate among patients with infection was significantly greater than among those without infection (15.7% vs. 4.5%, P = 0.021). The average hospital duration for infection care was 13 days. By extrapolating the infection rate and costs observed in the No-AIGISRx group to the Yes-AIGISRx group, we estimated that there would have been 6.2 additional infections costing approximately $340,000. This cost was similar to the actual cost of the devices in the Yes-AIGISRx group, estimated at $320,000.
  
  
  CONCLUSIONS
  Standard of care use of an antibacterial envelope as a standard of care was associated with a significantly lower rate of CIED infection, and appeared to be economically reasonable. Prospective trials to address these findings may be worthwhile.
authors.affiliation: Heart, Lung and Vascular Medicine Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
authors.forename: Nasir
authors.initials: N
authors.lastname: Shariff
authors.affiliation: Medtronic Incorporated, Minneapolis, Minnesota, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Eby
authors.affiliation: Heart, Lung and Vascular Medicine Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
authors.forename: Evan
authors.initials: E
authors.lastname: Adelstein
authors.affiliation: Heart, Lung and Vascular Medicine Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Jain
authors.affiliation: Pittsburgh Veterans Administration Healthcare System, Pittsburgh, Pennsylvania, USA.
authors.forename: Alaa
authors.initials: A
authors.lastname: Shalaby
authors.affiliation: Heart, Lung and Vascular Medicine Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
authors.forename: Samir
authors.initials: S
authors.lastname: Saba
authors.affiliation: Heart, Lung and Vascular Medicine Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
authors.forename: Norman C
authors.initials: NC
authors.lastname: Wang
authors.affiliation: Heart, Lung and Vascular Medicine Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
authors.forename: David
authors.initials: D
authors.lastname: Schwartzman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D058409:Cardiac Resynchronization Therapy Devices / Q000009:adverse effects / Q000191:economics; D003362:Cost-Benefit Analysis; D017147:Defibrillators, Implantable / Q000009:adverse effects* / Q000191:economics; D004866:Equipment Contamination / Q000191:economics / Q000517:prevention & control*; D005260:Female; D017048:Health Care Costs; D006302:Health Services Research; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000009:adverse effects* / Q000191:economics; D010414:Pennsylvania; D017064:Process Assessment, Health Care / Q000191:economics; D011474:Prosthesis Design; D016459:Prosthesis-Related Infections / Q000175:diagnosis / Q000191:economics / Q000382:microbiology / Q000401:mortality / Q000517:prevention & control*; D012189:Retrospective Studies; D059039:Standard of Care; D062606:Tertiary Care Centers; D013997:Time Factors; D016896:Treatment Outcome
keywords: antibiotic; cardiac implantable electronic device; cardiac resynchronization therapy; defibrillator; infection; pacemaker