Prophylactic antibiotics for cardiac pacemaker implantation. A prospective trail.

Abstract

SUMMARY A prospective trial was conducted to assess the value of prophylactic antibiotic treatment in preventing postoperative infection of permanent transvenous pacemaker systems. Four hundred and thirty-one patients were randomly allocated to treatment (234) or no-treatment (197) groups. Treated patients received systemic benzylpenicillin and flucloxacillin just before operation and one and six hours afterwards.Nine primary generator pocket infections occurred without evidence of wound dehiscence or skin erosion. Seven infections were in untreated patients and two in treated patients. Antibiotic prophylaxis diminishes the risk of infection after pacemaker implantations.Pacemaker generator pocket infection has remained a major complication of implantation since the first units were used 25 years ago. Sepsis rates in recent series have varied between 0-3%1 and 12-6%.2It is common practice to employ prophylactic antibiotic treatment at the time of implantation in the expectation that the number of infections will be reduced. Some retrospective analyses of uncontrolled series have supported this view3 but Siddons and Nowak4 have suggested that the protective effect is small. Furthermore there is no uniformity of practice in the use of antibiotics. In these circumstances there was clearly a need for a prospective trial to evaluate the effectiveness of prophylactic antibiotic treatment at the time of pacemaker implantation. SubjectsWe studied all patients who underwent elective permanent pacemaker implantation (new systems) non-elective reoperations, such as the repositioning of previously implanted electrodes, were studied separately.Four hundred and thirty-one patients were randomly allocated to treatment or no-treatment groups with the single exception of 13 patients who reported allergy to penicillin and who did not receive antibiotics. The patients were allocated according to the last digit of their hospital record number: odd numbers received treatment and even numbers did not.The antibiotic regimen was: flucloxacillin 1 g together with benzylpenicillin 600 mg intramuscularly, one hour before operation one hour and six hours after operation.All operations were carried out under local anaesthesia after premedication with either intravenous diazepam or morphine sulphate and droperidol. All procedures took place in the same operating theatre using standard instrument packs, and aseptic technique. This theatre was used on other occasions for minor surgical procedures. Chlorhexidine 4% was used for hand cleansing. Providoneiodine 10% aqueous solution was used for skin preparation on the night before the operation and on the morning of operation, and was followed by providone-iodine 7-5% with surfactants at the time of operation.5 All new systems consisted of standard intravenous electrodes attached to subcutaneous or subfascial generators. Cephalic, perctoral,6 539 on 9 May 2018 by guest. Protected by copyright.

Permanent Pacemaker and Implantable Cardioverter-Defibrillator Implantation

“…The use of antibiotics in a pacemaker procedure follows the principle of prophylaxis, in which the risk for infection is low but the monetary penalty or morbidity is high. [35][36][37] The selection of antibiotics is based on site-specific flora for wound infection and the spectrum, kinetics, and toxicity of the antimicrobial agent. The risk factors for infection have been well defined.…”

Prophylactic Use of Vancomycin in Adult Cardiology and Cardiac Surgery

“…However, on the basis of two cases of severe S. aureus bacteremia, Hartstein et al concluded that antibiotics might reduce the severity of infection (57,58). More recently, four of five placebo-controlled trials and one meta-analysis indicated that prophylactic antibiotic therapy reduces the incidence of infections related to pacemaker implantation (59)(60)(61)(62)(63)(64). On the basis of controlled trials and various observational studies, it seems that prophylactic antibiotics are widely used prior to permanent pacemaker implantation and also that definitive guidelines are needed since there is little or no standardization.…”

Prevention of Cardiac Implantable Electronic Device Infections: Update and Evaluation of the Potential Role for Capsulectomy or the Antibiotic Pouch

“…One of the first randomized trials of intravenous antibiotics, reported in 1981, randomized patients who were scheduled to have a transvenous pacemaker implanted, to both intravenous flucloxacillin and intramuscular benzylpenicillin or to no antibiotics. [6] Two hundred and thirty four patients received antibiotics and one hundred and ninety-seven did not. Infection rates were 0.8% for the antibiotic treated group and 3.6% in the group who did not receive antibiotics.…”

“…Prior to 1994, the data supporting the use of intravenous antibiotics was variable. [6], [16] In 1994, Drs. Mounsey and colleagues reported one of the first prospective randomized trials that demonstrated a benefit of pre-incision antibiotics.…”