title: Cardiac implantable electronic device infections: incidence, risk factors, and the effect of the AigisRx antibacterial envelope.
abstract: BACKGROUND
  Cardiac implantable electronic device (CIED) infection is associated with morbidity and mortality.
  
  
  OBJECTIVE
  To determine the incidence and risk factors for CIED infection, to develop a scoring index for risk stratification, and to analyze the effect of the AIGISRx envelope on infection rates.
  
  
  METHODS
  Consecutive patients who underwent a CIED procedure were identified and surveyed for 6 months for the development of an infection necessitating removal of all implanted hardware.
  
  
  RESULTS
  In the pre-envelope era, an infection occurred in 25 (1.5%) of 1651 patients. After its availability, an envelope was used in 275 (22%) of 1240 patients; an infection occurred in 8 (0.6%) patients in this era (P = .029 vs pre-envelope). In the overall cohort of 2891 patients, the infection rate was 1.2% and 3.5% in patients with an implantable cardioverter-defibrillator device and those with a cardiac resynchronization therapy defibrillator device, respectively (P = .018); in these patients, 7 independent risk factors predicted infection: early pocket re-exploration, male sex, diabetes, upgrade procedure, heart failure, hypertension, and glomerular filtration rate < 60 mL/min. A composite risk score (0-25; C index 0.72; 95% confidence interval 0.61-0.83) was created by weight, adjusting these 7 factors: 3 groups emerged-low risk (score 0-7; 1% infection), medium risk (score 8-14; 3.4% infection), and high risk (score ≥15; 11.1% infection). The envelope reduced infections by 79% and 100% in the medium- and high-risk groups, respectively.
  
  
  CONCLUSIONS
  CIED infection most commonly occurred in patients with an implantable cardioverter-defibrillator device and those with a cardiac resynchronization therapy defibrillator device. A composite score based on clinical variables appeared feasible for infection risk stratification. The AIGISRx envelope significantly lowered the risk of CIED infection. Randomized clinical data are warranted.
authors: Arrhythmia Institute, Valley Health System, Ridgewood, New Jersey, New York, New York. Electronic address: mittsu@valleyhealth.com.
authors: Suneet
authors: S
authors: Mittal
authors: Arrhythmia Institute, Valley Health System, Ridgewood, New Jersey, New York, New York.
authors: Richard E
authors: RE
authors: Shaw
authors: Arrhythmia Institute, Valley Health System, Ridgewood, New Jersey, New York, New York.
authors: Kimberly
authors: K
authors: Michel
authors: Arrhythmia Institute, Valley Health System, Ridgewood, New Jersey, New York, New York.
authors: Rachel
authors: R
authors: Palekar
authors: Arrhythmia Institute, Valley Health System, Ridgewood, New Jersey, New York, New York.
authors: Aysha
authors: A
authors: Arshad
authors: Arrhythmia Institute, Valley Health System, Ridgewood, New Jersey, New York, New York.
authors: Dan
authors: D
authors: Musat
authors: Arrhythmia Institute, Valley Health System, Ridgewood, New Jersey, New York, New York.
authors: Mark
authors: M
authors: Preminger
authors: Arrhythmia Institute, Valley Health System, Ridgewood, New Jersey, New York, New York.
authors: Tina
authors: T
authors: Sichrovsky
authors: Arrhythmia Institute, Valley Health System, Ridgewood, New Jersey, New York, New York.
authors: Jonathan S
authors: JS
authors: Steinberg
mesh_terms: D000368:Aged; D001424:Bacterial Infections / Q000517:prevention & control*; D017147:Defibrillators, Implantable / Q000009:adverse effects; D004554:Electric Countershock / Q000009:adverse effects; D004581:Electronics; D005260:Female; D006801:Humans; D008297:Male; D019736:Prostheses and Implants / Q000009:adverse effects*; D016459:Prosthesis-Related Infections / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D012189:Retrospective Studies; D012307:Risk Factors; D012737:Sex Factors
keywords: Cardiac implantable electronic device; Infection