Assessing the safety of implantable cardioverter-defibrillator reuse-A retrospective case-control study

Pacing Clin Electrophysiol. 2019 Aug;42(8):1095-1098. doi: 10.1111/pace.13742. Epub 2019 Jun 30.

Abstract

Aims: The safety of pacemaker reuse has been proven by numerous studies in the last two decades. With the exception of one research paper, the safety of reuse of implantable cardioverter-defibrillators has not been properly investigated. Our aim was to establish whether resterilized implantable cardioverter-defibrillators are as safe as new devices in relation to functionality and infection rates.

Methods: All the patients (n = 271) implanted with a new or a donated, used implantable cardioverter-defibrillator (ICD) at the Institute of Cardiovascular Disease Timisoara Romania between January 2001 and December 2012 were included in the study. The patients had class I indication for ICD implantation. One hundred fifty-seven patients received reused ICDs and 114 patients received new ICDs. Complications were defined as infections that required reintervention, device malfunction, and replacements due to untimely or unexpected battery depletion.

Results: Complications occurred in 4.38% of the patients in the new ICD group and in 1.91% of the reused ICD group. The difference was not considered statistically significant (odds ratio 0.28, 95% confidence interval 0.04-1.82, P = .18).

Conclusion: According to our data, properly verified and resterilized ICDs are as safe as new devices, when risk of infection or malfunction rates are assessed. Due to the high costs of new ICDs, their safe reuse has profound humanitarian and financial implications.

Keywords: device infection; device malfunction; implantable cardioverter-defibrillator reuse; resterilization.

MeSH terms

  • Adult
  • Aged
  • Case-Control Studies
  • Defibrillators, Implantable* / adverse effects
  • Equipment Reuse*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Retrospective Studies