Risk Factors for Infections Involving Cardiac Implanted Electronic Devices

J Am Coll Cardiol. 2019 Dec 10;74(23):2845-2854. doi: 10.1016/j.jacc.2019.09.060.

Abstract

Background: Cardiac implantable electronic device infection is a major complication that usually requires device removal. PADIT (Prevention of Arrhythmia Device Infection Trial) was a large cluster crossover trial of conventional versus incremental antibiotics.

Objectives: This study sought to investigate independent predictors of device infection in PADIT and develop a novel infection risk score.

Methods: In brief, over 4 6-month periods, 28 centers used either conventional or incremental prophylactic antibiotic treatment in all patients. The primary outcome was hospitalization for device infection within 1 year (blinded endpoint adjudication). Multivariable logistic prediction modeling was used to identify the independent predictors and develop a risk score for device infection. The prediction models were internally validated with bootstrap methods.

Results: Device procedures were performed in 19,603 patients, and hospitalization for infection occurred in 177 (0.90%) within 1 year of follow-up. The final prediction model identified 5 independent predictors of device infection (prior procedures [P], age [A], depressed renal function [D], immunocompromised [I], and procedure type [T]) with an optimism-corrected C-statistic of 0.704 (95% confidence interval: 0.660 to 0.744). A PADIT risk score ranging from 0 to 15 points classified patients into low (0 to 4), intermediate (5 to 6) and high (≥7) risk groups with rates of hospitalization for infection of 0.51%, 1.42%, and 3.41%, respectively.

Conclusions: This study identified 5 independent predictors of device infection and developed a novel infection risk score in the largest cardiac implantable electronic device trial to date, warranting validation in an independent cohort. The 5 independent predictors in the PADIT score are readily adopted into clinical practice. (Prevention of Arrhythmia Device Infection Trial [PADIT Pilot]; NCT01002911).

Keywords: antibiotics; cardiac implantable electronic device; implantable cardioverter defibrillator; infection; pacemaker.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antibiotic Prophylaxis / methods*
  • Arrhythmias, Cardiac / therapy
  • Canada / epidemiology
  • Cross-Over Studies
  • Defibrillators, Implantable / adverse effects*
  • Female
  • Hospitalization / statistics & numerical data*
  • Humans
  • Incidence
  • Male
  • Pacemaker, Artificial / adverse effects*
  • Prosthesis-Related Infections / epidemiology*
  • Prosthesis-Related Infections / prevention & control
  • Risk Assessment / methods*
  • Risk Factors

Associated data

  • ClinicalTrials.gov/NCT01002911