Efficacy of antibiotic prophylaxis before the implantation of pacemakers and cardioverter-defibrillators: results of a large, prospective, randomized, double-blinded, placebo-controlled trial.
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.
de Oliveira
Julio Cesar
JC
Heart Institute University of São Paulo Medical School, São Paulo, Brazil.
Martinelli
Martino
M
Nishioka
Silvana Angelina D'Orio
SA
Varejão
Tânia
T
Uipe
David
D
Pedrosa
Anísio Alexandre Andrade
AA
Costa
Roberto
R
D'Avila
Andre
A
Danik
Stephan B
SB
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
D000900:Anti-Bacterial Agents; D002437:Cefazolin