title: Efficacy of a Bio-Absorbable Antibacterial Envelope to Prevent Cardiac Implantable Electronic Device Infections in High-Risk Subjects.
abstract: BACKGROUND
  Cardiac implantable electronic device (CIED) infections are potentially preventable complications associated with high morbidity, mortality, and cost. A recently developed bio-absorbable antibacterial envelope (TYRX™-A) might prevent CIED infections in high-risk subjects. However, data regarding safety and efficacy have not been published.
  
  
  RESULTS
  In a single-center retrospective cohort study, we compared the prevalence of CIED infections among subjects with ≥2 risk factors treated with the TYRX™-A envelope (N = 135), the nonabsorbable TYRX™ envelope (N = 353), and controls who did not receive an envelope (N = 636). Infection was ascertained by individual chart review. The mean (95% confidence interval) number of risk factors was 3.08 (2.84-3.32) for TYRX™-A, 3.20 (3.07-3.34) for TYRX™, and 3.09 (2.99-3.20) for controls, P = 0.3. After a minimum 300 days follow-up, the prevalence of CIED infection was 0 (0%) for TYRX™-A, 1 (0.3%) for TYRX™, and 20 (3.1%) for controls (P = 1 for TYRX™-A vs. TYRX™, P = 0.03 for TYRX™-A vs. controls, and P = 0.002 for TYRX™ vs. controls). In a propensity score-matched cohort of 316 recipients of either envelope and 316 controls, the prevalence of infection was 0 (0%) and 9 (2.8%), respectively, P = 0.004. When limited to 122 TYRX™-A recipients and 122 propensity-matched controls, the prevalence of CIED infections was 0 (0%) and 5 (4.1%), respectively, P = 0.024.
  
  
  CONCLUSIONS
  Among high-risk subjects, the TYRX™-A bio-absorbable envelope was associated with a very low prevalence of CIED related infections that was comparable to that seen with the nonabsorbable envelope.
authors.affiliation: Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Kolek
authors.affiliation: Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
authors.forename: Neel J
authors.initials: NJ
authors.lastname: Patel
authors.affiliation: Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
authors.forename: Walter K
authors.initials: WK
authors.lastname: Clair
authors.affiliation: Department of Medicine, Cardiology Division, Wake Forest University, Winston-Salem, North Carolina, USA.
authors.forename: S Patrick
authors.initials: SP
authors.lastname: Whalen
authors.affiliation: Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
authors.forename: Jeffrey N
authors.initials: JN
authors.lastname: Rottman
authors.affiliation: Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
authors.forename: Arvindh
authors.initials: A
authors.lastname: Kanagasundram
authors.affiliation: Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
authors.forename: Sharon T
authors.initials: ST
authors.lastname: Shen
authors.affiliation: Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
authors.forename: Pablo J
authors.initials: PJ
authors.lastname: Saavedra
authors.affiliation: Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
authors.forename: Juan C
authors.initials: JC
authors.lastname: Estrada
authors.affiliation: Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Abraham
authors.affiliation: Department of Medicine, Cardiology Division, Vanderbilt University, Nashville, Tennessee, USA.
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Ellis
mesh_terms: D020341:Absorbable Implants / Q000706:statistics & numerical data; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D015984:Causality; D015331:Cohort Studies; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004343:Drug Implants / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000706:statistics & numerical data*; D015995:Prevalence; D016459:Prosthesis-Related Infections / Q000175:diagnosis / Q000453:epidemiology* / Q000517:prevention & control*; D012189:Retrospective Studies; D012307:Risk Factors; D017678:Sex Distribution; D015996:Survival Rate; D013714:Tennessee / Q000453:epidemiology; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D003692:Delayed-Action Preparations; D004343:Drug Implants
keywords: antibacterial envelope; cardiac implantable electronic device; infection