Longevity of the Subcutaneous Implantable Defibrillator: Long-Term Follow-Up of the European Regulatory Trial Cohort

Dominic A M J Theuns, Ian G. Crozier, Craig S. Barr, Margaret A. Hood, Riccardo Cappato, Reinoud E. Knops, Alexander H. Maass, Lucas V A Boersma, Luc Jordaens

Research output: Contribution to journalArticle

Abstract

Background - The recent advent of subcutaneous implantable cardioverter defibrillators (S-ICDs) has provided investigators with a safe and effective new therapy in patients at risk of sudden cardiac death. At present, no data are available with regard to the longevity of these new devices. This study evaluated the longevity of the S-ICD system. Methods and Results - All patients enrolled in the European Regulatory Trial were included in the analysis. During follow-up, time and causes of device replacement or explantation were assessed and categorized. Device longevity was estimated using Kaplan-Meier analysis. Fifty-five patients were followed for a median of 5.8 years. During follow-up, 26 (47%) patients underwent device replacement and 5 (9%) underwent device explantation. Median time to replacement was 5.0 years (Q1-Q3, 4.4-5.6 years). Replacement was caused by battery depletion in 25 patients (92%), of which 5 within 1.5 years because of premature battery depletion, and by infection in 1 patient (2%). Replacement for a transvenous ICD system was required in 4 patients (7%) because of ineffective defibrillation in 1 (0.003 per patient-year), need for resynchronization therapy in 2 (0.01 per patient-year), and for antibradycardia pacing in 1 (0.003 per patient-year). At 5 years follow-up, 71% of devices were still in service. Conclusions - This study provides the first estimate of S-ICD system longevity since its introduction in clinical practice. Median longevity of the first generation S-ICD system was 5.0 years. The majority of devices were replaced because of battery depletion.

Original languageEnglish
Pages (from-to)1159-1163
Number of pages5
JournalCirculation: Arrhythmia and Electrophysiology
Volume8
Issue number5
DOIs
Publication statusPublished - Oct 1 2015

Keywords

  • arrhythmias, cardiac
  • bradycardia
  • death, sudden, cardiac
  • defibrillators, implantable
  • longevity

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)
  • Medicine(all)

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  • Cite this

    Theuns, D. A. M. J., Crozier, I. G., Barr, C. S., Hood, M. A., Cappato, R., Knops, R. E., Maass, A. H., Boersma, L. V. A., & Jordaens, L. (2015). Longevity of the Subcutaneous Implantable Defibrillator: Long-Term Follow-Up of the European Regulatory Trial Cohort. Circulation: Arrhythmia and Electrophysiology, 8(5), 1159-1163. https://doi.org/10.1161/CIRCEP.115.002953