Bradycardia: antibiotics decreased pacemaker infection.

Clinical bottom line (level 1b)

  1. Patients fitted with a new permanent pacemaker who were given antibiotics, were less likely to need a repeat operation due to infection than those not given antibiotics (NNT = 28 at 19 months) .
Mounsey et al: British Heart Journal 1994; 72: 339-343
Expires August 2003

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: general hospital, UK

473 patients (aged mean 74 years, 55% male) underwent elective implantation of a new permanent pacing system

Excluded if
  • undergoing pulse generator or electrode changes
  • overt sepsis in whom the operator thought antibiotics were clinically indicated
  • refusal of consent and those whom it was inappropriate to approach for informed consent (eg. those with dementia)


    • Control Group: (n = 249, 249 analysed): no antibiotics before implantation
    Experimental Group: (n = 224, 224 analysed): Flucloxacillin 1 g i.v. immediately before surgery, followed by 500 mg by mouth every 6 hours for 48 hours or clindamycin 600 mg i.v. followed by 300 mg every 6 hours for 48 hours if patient was allergic to penicillin.
    All implantations were performed under local anaesthesia after oral diazepam premedication. Standard transvenous electrodes were introduced either via the cephalic vein, the subclavian vein or occasionally via the internal jugular vein. Wound closure was with interrupted or continuous absorbable sutures to the subcutaneous tissue. All wounds were dressed in the theatre using an adhesive dressing.
    100% followed for 19 months
    Outcome notes:
    • infection rate : repeat operation for an infective complication defined as septicaemia, pocket abscess or erosion of the pulse generator or electrode through the skin

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    infection rate 19 months 9
    (3.60%)    		 0
    (0.00%)    		 100%
    (% to %)    		 3.61%
    (1.30% to 5.93%)    		 28
    (17 to 77)

    Comments

    1. 183 patients were not randomised but were included in the study analysis- 64 received antibiotics and 119 did not. Of these, 1 patient in the antibiotic group became infected and 3 more in the no antibiotic group. These were included in the study analysis but not this CAT.
    2. The most common cause of infection was erosion of either the pulse generator or the pacing device.

    Citation

    1. Mounsey JP, Griffith MJ, Tynan M, et al: Antibiotic prophylaxis in permanent pacemaker implantation: a prospective randomised trial. British Heart Journal 1994; 72: 339-343
    Contributor: Clare Wotton and Bob Phillips, August 1999
    Reviewer:

    Clinical Question.
    Patient permanent pacing system
    Intervention or Exposure antibiotics
    Comparison no antibiotics
    Outcome infection rates