title: Efficacy of antibiotic prophylaxis before the implantation of pacemakers and cardioverter-defibrillators: results of a large, prospective, randomized, double-blinded, placebo-controlled trial.
abstract: BACKGROUND
  Although routinely administered, definitive evidence for the benefits of prophylactic antibiotics before the implantation of permanent pacemakers and implantable cardioverter-defibrillators from a large double-blinded placebo-controlled trial is lacking. The purpose of this study was to determine whether prophylactic antibiotic administration reduces the incidence of infection related to device implantation.
  
  
  RESULTS
  This double blinded study included 1000 consecutive patients who presented for primary device (Pacemaker and implantable cardioverter-defibrillators) implantation or generator replacement randomized in a 1:1 fashion to prophylactic antibiotics or placebo. Intravenous administration of 1 g of cefazolin (group I) or placebo (group 2) was done immediately before the procedure. Follow-up was performed 10 days, 1, 3, and 6 months after discharge. The primary end point was any evidence of infection at the surgical incision (pulse generator pocket), or systemic infection related to be procedure. The safety committee interrupted the trial after 649 patients were enrolled due to a significant difference in favor of the antibiotic arm (group I: 2 of 314 infected patients-0.63%; group II: 11 of 335 to 3.28%; RR=0.19; P=0.016). The following risk factors were positively correlated with infection by univariate analysis: nonuse of preventive antibiotic (P=0.016); implant procedures (versus generator replacement: P=0.02); presence of postoperative hematoma (P=0.03) and procedure duration (P=0.009). Multivariable analysis identified nonuse of antibiotic (P=0.037) and postoperative hematoma (P=0.023) as independent predictors of infection.
  
  
  CONCLUSIONS
  Antibiotic prophylaxis significantly reduces infectious complications in patients undergoing implantation of pacemakers or cardioverter-defibrillators.
authors.affiliation: Heart Institute University of São Paulo Medical School, São Paulo, Brazil.
authors.forename: Julio Cesar
authors.initials: JC
authors.lastname: de Oliveira
authors.forename: Martino
authors.initials: M
authors.lastname: Martinelli
authors.forename: Silvana Angelina D'Orio
authors.initials: SA
authors.lastname: Nishioka
authors.forename: Tânia
authors.initials: T
authors.lastname: Varejão
authors.forename: David
authors.initials: D
authors.lastname: Uipe
authors.forename: Anísio Alexandre Andrade
authors.initials: AA
authors.lastname: Pedrosa
authors.forename: Roberto
authors.initials: R
authors.lastname: Costa
authors.forename: Andre
authors.initials: A
authors.lastname: D'Avila
authors.forename: Stephan B
authors.initials: SB
authors.lastname: Danik
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis; D002437:Cefazolin / Q000008:administration & dosage*; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D011446:Prospective Studies; D016459:Prosthesis-Related Infections / Q000382:microbiology / Q000401:mortality / Q000517:prevention & control*; D012307:Risk Factors; D013530:Surgical Wound Infection / Q000382:microbiology / Q000401:mortality / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D002437:Cefazolin