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Clinical Articles, News & Views

Safety and efficacy of totally subcutaneous ICDs

Subcutaneous implantable cardioverter-defibrillators (ICDs) show efficacy and safety in the treatment of life-threatening ventricular arrhythmias, according to a study1 published recently in Circulation.

The most frequent complications associated with ICDs involve the transvenous leads. A subcutaneous ICD has been developed as an alternative system. This study evaluated the safety and effectiveness of the system (Cameron Health/Boston Scientific) for the treatment of life-threatening ventricular arrhythmias.

The 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.

References

1. Weiss R, Knight BP, Gold MR, et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation 2013;128:944–53. http://dx.doi.org/10.1161/​CIRCULATIONAHA.113.003042

Published on: October 30, 2013

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ENDORSED BY

  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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