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Related Experiment Video

Updated: Jan 28, 2026

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Therapy From a Novel Substernal Lead: The ASD2 Study.

Lucas V A Boersma1, Béla Merkely2, Petr Neuzil3

  • 1Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands; Academic Medical Center (AMC), University of Amsterdam, Amsterdam, the Netherlands.

JACC. Clinical Electrophysiology
|February 21, 2019
PubMed
Summary

The ASD2 study shows a novel substernal lead effectively senses, paces, and defibrillates patients. This extravascular implantable cardioverter-defibrillator (ICD) system offers a promising alternative for cardiac rhythm management.

Keywords:
anterior mediastinumdefibrillation leadextravascularimplantable cardioverter-defibrillatorsubsternaltachyarrhythmia

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Area of Science:

  • Cardiology
  • Biomedical Engineering
  • Electrophysiology

Background:

  • Subcutaneous implantable cardioverter-defibrillators (ICDs) offer an alternative to transvenous systems when traditional implantation is not feasible.
  • Extravascular systems, particularly those placed substernally, may reduce defibrillation energy requirements and enhance pacing capabilities.

Purpose of the Study:

  • To evaluate the efficacy and safety of a novel implantable cardioverter-defibrillator (ICD) lead designed for substernal implantation.
  • To assess the ability of the substernal lead to adequately sense cardiac electrical activity, deliver pacing, and defibrillate the heart.

Main Methods:

  • An investigational lead was implanted in the substernal space via minimally invasive subxiphoid access.
  • Pacing thresholds and extracardiac stimulation were assessed, and defibrillation efficacy was tested by inducing ventricular fibrillation in up to two episodes.

Main Results:

  • The substernal lead was successfully implanted in 79 patients with a median implantation time of 12.0 ± 9.0 minutes.
  • Ventricular pacing and capture were achieved in 97.4% and 92.3% of patients, respectively, without extracardiac stimulation.
  • A 30-J shock successfully terminated 81.3% of induced ventricular fibrillation episodes, with 7 procedure-related adverse events in 6 patients.

Conclusions:

  • The ASD2 study successfully demonstrated the feasibility of pacing, sensing, and defibrillating using a lead specifically designed for the substernal space.
  • This extravascular ICD approach shows potential as a viable alternative to transvenous systems, particularly in challenging implantation scenarios.