Prevention of Arrhythmia Device Infection Trial - PADIT

Feb 04, 2019
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
CANNeCTIN Network
Date Published:
12/10/2018
Date Updated:
02/04/2019
Original Posted Date:
02/05/2019
References

Contribution To Literature:

A strategy of additional antibiotics among patients undergoing CIED implantation is not superior to a single dose of preoperative antibiotics in reducing device infections.

Description:

The goal of the trial was to assess the efficacy of additional antibiotic measures compared with conventional administration of a single dose of preoperative antibiotics among patients undergoing implantation of a cardiac implantable electronic device (CIED).

Study Design

Patients undergoing CIED implantation at 28 sites were randomized in a cluster, randomized four-period crossover design to conventional treatment (n = 9,627) or incremental antibiotics (n = 9,976). In the conventional arm, a single dose of cefazolin 1-2 g was administered intravenously (IV) 60 minutes before skin incision or vancomycin 1-1.5 g IV in penicillin-allergic patients. In the incremental antibiotic strategy, patients received IV cefazolin as well as preoperative vancomycin. Penicillin-allergic patients only received vancomycin. The incremental antibiotic strategy also included intraoperative wound pocket wash before skin closure and postoperative oral cephalexin 500 mg 4 times/day, or cephadroxil 1,000 mg twice daily for 2 days. Penicillin-allergic patients received clindamycin 150-300 mg at 3 times/day.

  • Total number of enrollees: 19,603
  • Duration of follow-up: 1 year
  • Mean patient age: 72 years
  • Percentage female: 34%

Inclusion criteria:

  • Implantation of CIED

Other salient features/characteristics:

  • Immunocompromised: 1.5%
  • New permanent pacemaker implantation or implantable cardioverter-defibrillator: 34%
  • At least 1 other procedure: 14%

Principal Findings:

The primary outcome, hospitalization due to device infection within 1 year, for conventional vs. incremental antibiotics, was 1.0% vs. 0.8%, p = 0.10.

Secondary outcomes, for conventional vs. incremental antibiotics:

  • Among high-risk patients (n = 12,842), hospitalization due to device infection within 1 year: 1.2% vs. 1.0%
  • Need for surgical intervention: 1.1% vs. 1.0%, p = 0.57

Interpretation:

The results of this trial indicate that a strategy of additional antibiotics among patients undergoing CIED implantation is not superior a single dose of preoperative antibiotics in reducing device infections. Overall infection rates were low, even among patients deemed to be high-risk (~1%).

References:

Krahn AD, Longtin Y, Philippon F, et al. Prevention of Arrhythmia Device Infection Trial: The PADIT Trial. J Am Coll Cardiol 2018;72:3098-109.

Editorial Comment: Baddour LM, DeSimone DC, Sohail MR. Interventions to Prevent CIED Infections: More or Less? J Am Coll Cardiol 2018;72:3110-1.

Keywords: Anti-Bacterial Agents, Arrhythmias, Cardiac, Cefadroxil, Cefazolin, Cephalexin, Clindamycin, Defibrillators, Implantable, Infections, Pacemaker, Artificial, Penicillin G, Penicillins, Secondary Prevention, Vancomycin


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