Multicentre experience with the second-generation subcutaneous implantable cardioverter defibrillator and the intermuscular two-incision implantation technique

J Cardiovasc Electrophysiol. 2019 Jun;30(6):854-864. doi: 10.1111/jce.13894. Epub 2019 Mar 13.

Abstract

Introduction: The recently developed second-generation subcutaneous implantable cardioverter defibrillator (S-ICD) and the intermuscular two-incision implantation technique demonstrate potential favorable features that reduce inappropriate shocks and complications. However, data concerning large patient populations are lacking. The aim of this multicentre prospective study was to evaluate the safety and outcome of second-generation S-ICD using the intermuscular two-incision technique in a large population study.

Methods and results: The study population included 101 consecutive patients (75% male; mean age, 45 ± 13 years) who received second-generation S-ICD (EMBLEM; Boston Scientific, Marlborough, MA) implantation using the intermuscular two-incision technique as an alternative to the standard implantation technique. Twenty nine (29%) patients were implanted for secondary prevention. Twenty four (24%) patients had a previously implanted transvenous ICD. All patients were implanted without any procedure-related complications. Defibrillation testing was performed in 80 (79%) patients, and ventricular tachycardia was successfully converted at less than or equal to 65 J in 98.75% (79/80) of patients without pulse generator adjustments. During a median follow-up of 21 ± 10 months, no complications requiring surgical revision or local or systemic device-related infections were observed. Ten patients (9.9%) received appropriate and successful shocks for ventricular arrhythmias. Three (2.9%) patients experienced inappropriate shocks due to oversensing the cardiac signal (n = 1), noncardiac signal (n = 1), and a combination of both cardiac and noncardiac signals (n = 1), with one patient requiring device explantation. No patients required device explantation due to antitachycardia pacing indications.

Conclusions: According to our multicentre study, second-generation S-ICD implanted with the intermuscular two-incision technique is an available safe combination and appears to be associated with a low risk of complications, such as inappropriate shocks.

Keywords: implantable cardioverter defibrillator; intermuscular technique; subcutaneous implantable cardioverter defibrillator; two-incision technique.

Publication types

  • Multicenter Study

MeSH terms

  • Action Potentials
  • Adolescent
  • Adult
  • Aged
  • Arrhythmias, Cardiac / diagnosis
  • Arrhythmias, Cardiac / physiopathology
  • Arrhythmias, Cardiac / therapy*
  • Defibrillators, Implantable*
  • Device Removal
  • Electric Countershock / adverse effects
  • Electric Countershock / instrumentation*
  • Female
  • Heart Conduction System / physiopathology*
  • Heart Rate*
  • Humans
  • Italy
  • Male
  • Middle Aged
  • Prosthesis Failure
  • Prosthesis Implantation / adverse effects
  • Prosthesis Implantation / instrumentation*
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Secondary Prevention / instrumentation*
  • Time Factors
  • Treatment Outcome
  • Young Adult