The development of the extravascular defibrillator with substernal lead placement: A new Frontier for device‐based treatment of sudden cardiac arrest

<jats:title>Abstract</jats:title><jats:sec><jats:title>Introduction</jats:title><jats:p>The extravascular implantable cardioverter‐defibrillator (EV ICD) system with substernal lead placement is a novel nontransvenous 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 but requires a new procedure for implantation with a safety profile under evaluation.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>This paper summarizes the development of the EV ICD, including the preclinical and clinical evaluations that have contributed to the system and procedural refinements to date.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Extensive preclinical research evaluations and four 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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>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 antitachycardia and asystole pacing in a single system.</jats:p></jats:sec>