What question did this study set out to answer?

To assess whether intravenous antibiotic prophylaxis prevents severe infective complications following permanent pacemaker implantation and to identify clinical risk factors associated with device infection.

October 1, 1994HeartOpen Access

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

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Why the study?

Does intravenous antibiotic prophylaxis reduce repeat operations for infective complications in patients undergoing first implantation of a permanent pacing system?

Population

473 patients undergoing first implantation of a permanent pacing system

Comparison

Intravenous flucloxacillin started at the time… vs No antibiotic

Design

RCT, Randomised, Open trial

Follow-up

mean 19 (SD 5) months

Authors

JMJ. P. D. MounseyUniversity of North Carolina at Chapel Hill MGMichael GriffithBaystate Medical Center MTM TynanNewcastle upon Tyne Hospitals NHS Foundation Trust

Discussion

Member takes

Implication

Supports routine antibiotic prophylaxis for first pacemaker implantation; confirms reduction in reoperations for infection.

Key Points

To assess whether intravenous antibiotic prophylaxis prevents severe infective complications following permanent pacemaker implantation and to identify clinical risk factors associated with device infection.
Prospective open randomized trial evaluating 473 patients undergoing first permanent pacemaker implantation over 17 months, alongside an observational cohort of 183 non-randomized patients followed for a mean (SD) of 19 (5) months.
Patients were randomized to receive either 48 hours of intravenous flucloxacillin (or clindamycin for penicillin-allergic patients) initiated at implantation (n=224) or no antibiotic prophylaxis (n=249).
The primary endpoint was a repeat surgical operation required to manage an infective complication.
Infective complications requiring repeat operation occurred in 3.6% of patients receiving no antibiotics (9/249) versus 0.0% of patients receiving antibiotic prophylaxis (0/224; P=0.003).
Across the entire cohort (n=656), 13 infections developed (12 in non-antibiotic patients, 1 in the antibiotic group; P=0.006), manifesting as pulse generator or electrode erosion (n=9), Staphylococcus aureus septicaemia (n=3), and pocket abscess caused by Staphylococcus epidermidis (n=1).
Infection risk was significantly greater when operators had performed 100 or fewer prior implants, when procedures were prolonged, or following reoperation for non-infective complications such as lead displacement.

Structured PICO

Does intravenous antibiotic prophylaxis reduce repeat operations for infective complications in patients undergoing first implantation of a permanent pacing system?

Population

473 patients undergoing first implantation of a permanent pacing system

Intervention

Intravenous flucloxacillin (or clindamycin if allergic to penicillin) started at the time of implantation and continued for 48 hours

Comparator

No antibiotic

Outcome

Repeat operation for an infective complicationhard clinical

Routine antibiotic prophylaxis significantly reduces the incidence of infective complications requiring reoperation after permanent pacemaker implantation.

Cite This Study

Mounsey et al. (1994) studied this question.

synapsesocial.com/papers/6a0ee1dbe29b511e9f2293eb https://doi.org/10.1136/hrt.72.4.339

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

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

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

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Also Consider

Also Consider