August 5, 2020New England Journal of Medicine478 citationsOpen Access

Subcutaneous or Transvenous Defibrillator Therapy

RKReinoud E. Knops LNLouise R.A. Olde Nordkamp PDPeter-Paul Delnoy

Key Result

The subcutaneous ICD was noninferior to the transvenous ICD regarding device-related complications and inappropriate shocks in patients needing ICD therapy.

Structured PICO

Does a subcutaneous ICD reduce device-related complications and inappropriate shocks compared to a transvenous ICD in patients with an indication for an ICD but no indication for pacing?

Population

849 adults (≥18 years of age) with a class I or IIa indication for implantable cardioverter-defibrillator (ICD) therapy for primary or secondary prevention, but no indication for pacing. Median age 63 years, 19.7% female, 69.1% ischemic cardiomyopathy, median left ventricular ejection fraction 30%.

Intervention

Subcutaneous implantable cardioverter-defibrillator (ICD)

Comparator

Transvenous implantable cardioverter-defibrillator (ICD)

Outcome

Composite of device-related complications and inappropriate shockscomposite

In patients requiring an ICD without a pacing indication, the subcutaneous ICD is noninferior to the transvenous ICD regarding the composite of device-related complications and inappropriate shocks.

Limitations

Trial was not powered to compare the individual components of the primary outcome (device-related complications and inappropriate shocks)
Need for longer-term follow-up to assess late lead-related complications and battery longevity

Abstract

In patients with an indication for an ICD but no indication for pacing, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks. (Funded by Boston Scientific; PRAETORIAN ClinicalTrials.gov number, NCT01296022.).

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