The Development of the Extravascular Defibrillator with Substernal Lead
Placement: A New Frontier for Device-Based Treatment of Sudden Cardiac
Arrest
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.