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The Development of the Extravascular Defibrillator with Substernal Lead Placement: A New Frontier for Device-Based Treatment of Sudden Cardiac Arrest
  • +9
  • Amy Thompson,
  • Brett Atwater,
  • Lucas V.A. Boersma,
  • Ian Crozier,
  • Gregory Engel,
  • J Rod Gimbel,
  • Bradley Knight,
  • Jaimie Manlucu,
  • Francis Murgatroyd,
  • David O'Donnell,
  • Juergen Kuschyk,
  • Paul DeGroot
Amy Thompson
Medtronic plc
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Brett Atwater
Inova Medical Group
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Lucas V.A. Boersma
St. Antonius Hospital
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Ian Crozier
Christrchurch Hospital
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Gregory Engel
Palo Alto Medical Foundation
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J Rod Gimbel
Columbia Saint Mary’s Hospital
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Bradley Knight
Northwestern University
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Jaimie Manlucu
London Health Sciences Centre
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Francis Murgatroyd
Kings College Hospital
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David O'Donnell
Austin and Repatriation Medical Center
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Juergen Kuschyk
University Medical Center Mannheim
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Paul DeGroot
Medtronic
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Abstract

Introduction: The extravascular ICD (EV ICD) system with substernal lead placement is a novel non-transvenous alternative to current commercially available ICD systems. The EV ICD provides defibrillation and pacing therapies without the potential long-term complications of endovascular lead placement. Methods: This paper summarizes the development of the EV ICD, including the pre-clinical and clinical evaluations that have contributed to system and procedural refinements to date. Results: Extensive pre-clinical research evaluations and 4 human clinical studies with >140 combined acute and chronic implants have enabled the development and refinement of the EV ICD system, currently in worldwide pivotal study. Conclusion: The EV ICD may represent a clinically valuable solution in protecting patients from sudden cardiac death while avoiding the long-term consequences of transvenous hardware. The EV ICD offers advantages over transvenous and subcutaneous systems by avoiding placement in the heart and vasculature; relative to subcutaneous systems, EV ICD requires less energy for defibrillation, enabling a smaller device, and provides pacing features such as anti-tachycardia and asystole pacing in a single system.

Peer review status:IN REVISION

27 Nov 2021Submitted to Journal of Cardiovascular Electrophysiology
30 Nov 2021Assigned to Editor
30 Nov 2021Submission Checks Completed
06 Dec 2021Reviewer(s) Assigned
21 Dec 2021Review(s) Completed, Editorial Evaluation Pending
03 Jan 2022Editorial Decision: Revise Minor
07 Jan 20221st Revision Received