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Original Articles

Efficacy of Antibiotic Prophylaxis Before the Implantation of Pacemakers and Cardioverter-Defibrillators

Results of a Large, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial

Julio Cesar de Oliveira, MD; Martino Martinelli, MD; Silvana Angelina D'Orio Nishioka, PhD; Tânia Varejão, PhD; David Uipe, MD; Anísio Alexandre Andrade Pedrosa, PhD; Roberto Costa, MD and Stephan B. Danik, MD

From the Heart Institute (InCor) University of São Paulo Medical School, São Paulo, Brazil.

Correspondence to Stephan Danik, MD, 55 Fruit Street, GRB 109, Massachusetts General Hospital, Boston, MA 0211. E-mail sdanik{at}partners.org

Received August 26, 2008; accepted November 28, 2008.

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.

Methods and 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.

Key Words: antibiotic prophylaxis • pacemaker • surgical procedures • infection

Related Article

Proof Positive: Efficacy of Antibiotic Prophylaxis in Device Implantation

Melanie Maytin and Laurence M. Epstein
Circ Arrhythm Electrophysiol 2009 2: 4-5. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

				J. N. Khan, N. Prasad, and J. Glancy Letter by Khan et al Regarding Article "Efficacy of Antibiotic Prophylaxis Before the Implantation of Pacemakers and Cardioverter-Defibrillators: Results of a Large, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial" Circ Arrhythm Electrophysiol, June 1, 2009; 2(3): e13 - e13. [Full Text] [PDF]

				M. Maytin and L. M. Epstein Proof Positive: Efficacy of Antibiotic Prophylaxis in Device Implantation Circ Arrhythm Electrophysiol, February 1, 2009; 2(1): 4 - 5. [Full Text] [PDF]