Antibiotic prophylaxis in permanent pacemaker implantation: a prospective randomised trial.

Mounsey, J. P. D.; Griffith, Michael; Tynan, M.; Gould, F.K.; MacDermott, Aidan; Gold, Ronald G.; Bexton, R. S.

doi:10.1136/hrt.72.4.339

Cited by 74 publications

(57 citation statements)

References 8 publications

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“…No cases of superficial infection occurred among the patients who received antibiotic prophylaxis. This finding is consistent with the results published by Monsey et al 18 in which skin erosion was the most common presentation.…”

Section: Discussionsupporting

confidence: 83%

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

Oliveira

Filho

Nishioka

et al. 2009

Circ: Arrhythmia and Electrophysiology

323

148

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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.

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Section: Discussionsupporting

confidence: 83%

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

Oliveira

Filho

Nishioka

et al. 2009

Circ: Arrhythmia and Electrophysiology

323

148

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“…The occurrence of these 3 fatal events, as well as another 2 severe and 1 mild event, emphasizes that postoperative infections causing sepsis or endocarditis are not uncommon and carry an ominous prognosis in a defibrillator population; every effort should be undertaken to provide adequate preventive measures. Mounsey et al 13 showed a significant beneficial effect in patients receiving antibiotic prophylaxis before pacemaker implantation.…”

Section: Patient Deathsmentioning

confidence: 98%

Adverse Events With Transvenous Implantable Cardioverter-Defibrillators

et al. 1998

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on behalf of the European 7219 Jewel ICD InvestigatorsBackground-A newly developed classification system relates adverse events to the surgical procedure or the function of the implantable defibrillator. Methods and Results-Adverse events were monitored during prospective clinical evaluation of the Medtronic model 7219Jewel ICD and were classified according to the definitions of the ISO 14155 standard for device clinical trials into 3 groups: severe and mild device-related and severe non-device-related adverse events. In addition, events were related to the surgical procedure, treatment with the device, or cardiac function. Seven hundred seventy-eight patients were followed up for an average of 4.0 months after ICD implantation. In total, 356 adverse events were observed in 259 patients. At 1, 3, and 12 months after ICD implantation, 99%, 98%, and 97% of the patients, respectively, survived; 95%, 93%, and 92%, respectively, were free of surgical reintervention; and 79%, 68%, and 51%, respectively, were free of any adverse event. Twenty patients died: 6 deaths were related to the surgical procedure, 12 deaths were considered unrelated to ICD treatment, and 2 patients died of an unknown cause. Of 111 nonlethal severe adverse device effects, 47 required surgical intervention, 19 times for correction of a dislodged lead. Inappropriate delivery of therapy was observed 128 times in 111 patients, and the events were typically resolved by reprogramming or drug adjustment. Nine of these required rehospitalization. Conclusions-Approximately 50% of patients experience an adverse event within the first year after ICD implantation.The observed adverse event rate depends on the definitions and the prospective monitoring. The incidence of inappropriate therapy emphasizes the need for improved detection algorithms and for quality-of-life evaluations, especially when considering ICD treatment in high-risk but arrhythmia-free patients. (Circulation. 1998;98:663-670.)

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“…Rates of wound infection were 3.2% and 6.5% for the clindamycin and cephalothin groups, respectively (not significant), with no cases of endocarditis. For pacemaker implantation, 48 h of flucloxacillin (or clindamycin in those who were allergic) was compared with placebo in a randomized trial of 473 patients undergoing first-ever permanent pacemaker placement (21). All nine serious infections occurred among those in the placebo group.…”

Section: Preoperative Prophylaxismentioning

confidence: 99%

Current Indications for the Use of Clindamycin: A Critical Review

Śmieja

1998

Canadian Journal of Infectious Diseases and Medical Microbiolog

110

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OBJECTIVES:To review the literature and develop evidence-based guidelines for the use of the antibiotic clindamycin. DATA SOURCES: A search of the MEDLINE database for randomized clinical trials, cohort studies and review articles that examine the therapeutic use or potential adverse effects of clindamycin was undertaken for the years 1966 to 1996. In addition, relevant citations obtained from the references cited in the identified reviews, book chapters and antibiotic guidelines were included. DATA EXTRACTION: Selected articles examining the indications for or adverse effects from the prophylactic or therapeutic use of clindamycin were selected. A level of evidence was assigned to the indication according to published criteria. DATA SYNTHESIS AND CONCLUSIONS: Randomized clinical trials (level 1 evidence) support the use of clindamycin in a number of common conditions, including preoperative prophylaxis, intra-abdominal infections, recurrent group A streptococcal pharyngitis, Chlamydia trachomatis cervicitis and anaerobic lung infections. Cohort studies (level 2 evidence) support the use of clindamycin for bone and soft tissue infections. Expert opinion (level 3 evidence) supports the use of clindamycin for invasive group A streptococcal infection and the treatment of diabetic foot infections. Clindamycin's disadvantages are its high cost, the common occurrence of rash and the predisposition of patients taking clindamycin to Clostridium difficile-associated colitis. Based on cohort studies, the risk of severe diarrhea in out-patients is as low as one per 1000, but the risk of in-patients acquiring C difficile colonization may be as high as 30%.

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Antibiotic prophylaxis in permanent pacemaker implantation: a prospective randomised trial.

Cited by 74 publications

References 8 publications

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

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

Adverse Events With Transvenous Implantable Cardioverter-Defibrillators

Current Indications for the Use of Clindamycin: A Critical Review

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