The entirely subcutaneous implantable cardioverter-defibrillator: initial clinical experience in a large Dutch cohort

J Am Coll Cardiol. 2012 Nov 6;60(19):1933-9. doi: 10.1016/j.jacc.2012.06.053. Epub 2012 Oct 10.

Abstract

Objectives: The purpose of the study was to evaluate the efficacy and safety of the entirely subcutaneous implantable cardioverter-defibrillator (S-ICD).

Background: A new entirely S-ICD has been introduced, that does not require lead placement in or on the heart. The authors report the largest multicenter experience to date with the S-ICD with a minimum of 1-year follow-up in the first 118 Dutch patients who were implanted with this device.

Methods: Patients were selected if they had a class I or IIa indication for primary or secondary prevention of sudden cardiac death. All consecutive patients from 4 high-volume centers in the Netherlands with an S-ICD implanted between December 2008 and April 2011 were included.

Results: A total of 118 patients (75% males, mean age 50 years) received the S-ICD. After 18 months of follow-up, 8 patients experienced 45 successful appropriate shocks (98% first shock conversion efficacy). No sudden deaths occurred. Fifteen patients (13%) received inappropriate shocks, mainly due to T-wave oversensing, which was mostly solved by a software upgrade and changing the sensing vector of the S-ICD. Sixteen patients (14%) experienced complications. Adverse events were more frequent in the first 15 implantations per center compared with subsequent implantations (inappropriate shocks 19% vs. 6.7%, p = 0.03; complications 17% vs. 10%, p = 0.10).

Conclusions: This study demonstrates that the S-ICD is effective in terminating ventricular arrhythmias. There is, however, a considerable percentage of ICD related adverse events, which decreases as the therapy evolves and experience increases.

Publication types

  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Arrhythmias, Cardiac / epidemiology*
  • Arrhythmias, Cardiac / physiopathology
  • Arrhythmias, Cardiac / therapy*
  • Child
  • Cohort Studies
  • Death, Sudden, Cardiac / epidemiology
  • Death, Sudden, Cardiac / prevention & control
  • Defibrillators, Implantable*
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Netherlands / epidemiology
  • Retrospective Studies
  • Subcutaneous Tissue* / physiology
  • Treatment Outcome
  • Young Adult