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Performance and Safety of the Extravascular Implantable Cardioverter-Defibrillator in Patients With Hypertrophic

Konstantinos C Siontis1, Francis Murgatroyd2, Lucas V A Boersma3

  • 1Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA.

JACC. Clinical Electrophysiology
|March 12, 2026
PubMed

Insights

The extravascular implantable cardioverter-defibrillator (EV-ICD) is safe and effective for hypertrophic cardiomyopathy (HCM) patients. This novel device offers high defibrillation success and a comparable safety profile to non-HCM patients.

Area of Science:

  • Cardiology
  • Medical Devices
  • Electrophysiology

Background:

  • Implantable cardioverter-defibrillators (ICDs) are crucial for preventing sudden cardiac death in hypertrophic cardiomyopathy (HCM) patients.
  • Extravascular (EV) ICDs offer antitachycardia pacing and defibrillation without transvenous lead complications.

Purpose of the Study:

  • To assess the safety and performance of the novel EV-ICD system in patients diagnosed with HCM.
  • To compare EV-ICD outcomes in HCM patients versus non-HCM patients.

Main Methods:

  • Analysis from the international, multicenter Pivotal EV-ICD Study.
  • Patients categorized based on baseline HCM diagnosis.
  • Primary endpoints: defibrillation testing success and freedom from major complications over 3 years.

Main Results:

  • High implantation success rates for EV-ICD in both HCM (92.7%) and non-HCM (94.9%) patients.
  • 100% defibrillation testing success in HCM patients versus 98.5% in non-HCM patients.
  • Similar rates of appropriate/inappropriate therapies and major complications between HCM and non-HCM groups.

Conclusions:

  • The EV-ICD demonstrates excellent defibrillation efficacy in HCM patients.
  • The safety profile of EV-ICD in HCM patients is comparable to that in non-HCM populations.
  • EV-ICD is a viable alternative for ICD therapy in HCM patients.
Abstract

Keywords:
extravascularhypertrophic cardiomyopathyimplantable cardioverter-defibrillatorventricular tachycardia

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