Study Details Impact of Device-Related Infections After Cardiac Device Implantation

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Leveraging data from the PADIT trial, investigators provide an overview of the impact of extent and timing of infections following cardiac implantable electronic device implantation.

Using data from nearly 20,000 patients who underwent implantation of a cardiac implantable electronic device (CIED), a new study is offering clinicians an overview of the impact of infection extent and timing on associated risk of mortality.

Results of the study, which included patients from the Prevention of Arrhythmia Device Infection Trial (PADIT), suggest infections occurred in fewer than 1% of patients and the majority occurred with in the first 30 days, with further analysis offering a breakdown of all-cause risk associated with infections according to extent and timing.

“Findings suggest that early detection and treatment of cardiac implantable electronic device–related infections may be important in reducing associated mortality,” wrote investigators.

Led by PADIT prinicpal investigator Andrew Krahn, MD, professor and head of the Division of Cardiology at the University of British Columbia, and colleagues from institutions across North America, the current study was launched with the intent of developing a more detailed understanding of association of the extent and timing of CIED infection with all-cause mortality using data from PADIT. A prospective, cluster crossover randomized trial, PADIT was designed to assess the clinical effectiveness of incremental preoperative antibiotics for reducing device infection rates in patients receiving a CIED.

In total, the trial included 19,603 patients from 28 centers in Canada and the Netherlands. Results of the trial suggested there was no statistically significant benefit from incremental therapy with periprocedural antibiotics.

In the study 177 individuals developed a CIED infection requiring hospitalization, which was the cohort of interest in the current study by Krahn and colleagues. This cohort had a mean age of 68.7 (SD, 12.7) years and 74.6% were male.

The primary outcome interest for the current study was the risk of all-cause mortality associated with CIED infections, which were stratified by timing and extent using time-dependent analysis. For the purpose of analysis, timing was categorized as early and delayed, with early considered 3 months or fewer and delayed considered 3-12 months. Investigators classified extent as either localized or systemic.

Of the 177 infections, 62% (n=109) were considered localized infections and 38% (n=68) were considered systemic infections. When examining timing of infection, results indicated 67% (n=119) occurred within the first 3 months and 33% (n=58) occurred between 3-12 months. The cumulative incidence of infection was 0.6%, 0.7%, and 0.9% within 3, 6, and 12 months, respectively.

Compared to their counterparts who did not develop infection, those with early localized infections were not at an increased risk of all-cause mortality (adjusted hazard ratio [aHR], 0.64 [95% confidence interval [CI], 0.20-1.98]; P=.43), with investigators pointing out 0 deaths occurred at 30 days among the 74 patients with early localized infections. In contrast, patients with early systemic (aHR, 2.88 [95% CI, 1.48-5.61]; P=.002) . A more than 9-fold increase in risk of all-cause mortality was observed for those with delayed systemic infections (aHR, 9.30 [95% CI, 3.82-22.65]; P <.001) compared to their counterparts without CIED infection, with a 30-day mortality rate of 21.7%.

“Future studies should consider the potential relevance of infection timing and extent with respect to outcomes. The early detection and treatment of CIED infections is important in reducing mortality associated with this complication,” investigators added.


  1. Han H, Wang J, Birnie DH, et al. Association of the Timing and Extent of Cardiac Implantable Electronic Device Infections With Mortality. JAMA Cardiol. Published online April 05, 2023. doi:10.1001/jamacardio.2023.0467
  2. Krahn AD, Longtin Y, Philippon F, et al. Prevention of Arrhythmia Device Infection Trial: The PADIT Trial. J Am Coll Cardiol. 2018;72(24):3098-3109. doi:10.1016/j.jacc.2018.09.068