Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator

Raul Weiss, Bradley Paul Knight, Michael R. Gold, Angel R. Leon, John M. Herre, Margaret Hood, Mayer Rashtian, Mark Kremers, Ian Crozier, Kerry L. Lee, Warren Smith, Martin C. Burke*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

319 Scopus citations

Abstract

BACKGROUND - The most frequent complications associated with implantable cardioverter-defibrillators (ICDs) involve the transvenous leads. A subcutaneous implantable cardioverter-defibrillator (S-ICD) has been developed as an alternative system. This study evaluated the safety and effectiveness of the S-ICD System (Cameron Health/Boston Scientific) for the treatment of life-threatening ventricular arrhythmias (ventricular tachycardia/ventricular fibrillation). METHODS AND RESULTS - This prospective, nonrandomized, multicenter trial included adult patients with a standard indication for an ICD, who neither required pacing nor had documented pace-terminable ventricular tachycardia. The primary safety end point was the 180-day S-ICD System complication-free rate compared with a prespecified performance goal of 79%. The primary effectiveness end point was the induced ventricular fibrillation conversion rate compared with a prespecified performance goal of 88%, with success defined as 2 consecutive ventricular fibrillation conversions of 4 attempts. Detection and conversion of spontaneous episodes were also evaluated. Device implantation was attempted in 321 of 330 enrolled patients, and 314 patients underwent successful implantation. The cohort was followed for a mean duration of 11 months. The study population was 74% male with a mean age of 52±16 years and mean left ventricular ejection fraction of 36±16%. A previous transvenous ICD had been implanted in 13%. Both primary end points were met: The 180-day system complication-free rate was 99%, and sensitivity analysis of the acute ventricular fibrillation conversion rate was >90% in the entire cohort. There were 38 discrete spontaneous episodes of ventricular tachycardia/ventricular fibrillation recorded in 21 patients (6.7%), all of which successfully converted. Forty-one patients (13.1%) received an inappropriate shock. CONCLUSIONS - The findings support the efficacy and safety of the S-ICD System for the treatment of life-threatening ventricular arrhythmias.

Original languageEnglish (US)
Pages (from-to)944-953
Number of pages10
JournalCirculation
Volume128
Issue number9
DOIs
StatePublished - Aug 29 2013

Keywords

  • Defibrillators
  • Heart arrest
  • Implantable
  • Tachycardia

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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