Efficacy and Safety of an Extravascular ICD

Quick Takes

  • A novel extravascular ICD (single-lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation) can be safely implanted and is effective at terminating life-threatening sustained ventricular arrhythmias.
  • A novel extravascular ICD has a defibrillation success rate of 98.7%.

Study Questions:

What is the safety and efficacy of a novel extravascular ICD (implantable cardioverter-defibrillator; single-lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation)?

Methods:

This was a prospective, nonrandomized, premarket study. Patients with ICD indications received an extravascular ICD system. The primary efficacy endpoint was successful defibrillation at implantation. The primary safety endpoint was freedom from major system- or procedure-related complications at 6 months.

Results:

A total of 356 patients were enrolled, 316 of whom had an implantation attempt. Among the 302 patients in whom ventricular arrhythmia could be induced, the percentage of patients with successful defibrillation was 98.7%. A total of 299 of 316 patients (95%) were discharged with a working extravascular ICD system. The percentage of patients free from major complications at 6 months was 93%. No major intraprocedural complications were reported. At 6 months, 25 major complications were observed, in 23 of 316 patients (7%). The success rate of antitachycardia pacing was 51%. A total of 29 patients received 118 inappropriate shocks for 81 episodes. Eight systems were explanted without extravascular ICD replacement over the 10.6-month follow-up period.

Conclusions:

The authors concluded that extravascular ICDs were implanted safely and were able to detect and terminate induced ventricular arrhythmias at the time of implantation.

Perspective:

The current manuscript concerns a novel extravascular ICD, which is being considered for regulatory approval. Currently available ICDs are either the transvenous or totally subcutaneous devices. A totally subcutaneous ICD avoids the vascular and mechanical complications of a transvenous device, but due to its totally subcutaneous location, it cannot do antitachycardia pacing. It also has shorter battery longevity and larger size, both of which are the consequences of the extrathoracic location of the lead and the generator. The substernal location of the novel ICD described in this manuscript provides the benefit of a lower energy requirement for shocks and painless therapy with antitachycardia pacing. The inappropriate shock rate was mostly due to atrial oversensing, and the authors indicate they modified their approach during the study to reduce this risk. The novel extravascular ICD shows a promise of the best of two worlds, but it will require implanting cardiologists to learn how to safely and reliably enter a space heretofore off limits to them.

Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure

Keywords: Arrhythmias, Cardiac, Defibrillators, Defibrillators, Implantable, Heart Failure, Pacemaker, Artificial, Patient Discharge, Secondary Prevention, Shock, Tachycardia


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