Medtronic Clinical Research, Medtronic plc, Mounds View, Minnesota, USA.
Cardiology/Electrophysiology, Inova Medical Group, Mclean, Virginia, USA.
J Cardiovasc Electrophysiol. 2022 Jun;33(6):1085-1095. doi: 10.1111/jce.15511. Epub 2022 May 8.
The extravascular implantable cardioverter-defibrillato (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.
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.
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.
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.
带胸骨下导联的血管外植入式心律转复除颤器（EV ICD）系统是一种新型的非经静脉植入式 ICD 系统，可替代目前市售的 ICD 系统。EV ICD 提供除颤和起搏治疗，而不会有血管内导联植入的潜在长期并发症，但需要新的植入程序，其安全性正在评估中。
本文总结了 EV ICD 的发展，包括对该系统有贡献的临床前和临床评估以及迄今为止的程序改进。
广泛的临床前研究评估和四项包含 >140 例急性和慢性植入的人体临床研究，促进了 EV ICD 系统的开发和完善，目前正在全球进行关键研究。
EV ICD 可能为保护患者免受心源性猝死提供一种有临床价值的解决方案，同时避免了经静脉硬件的长期后果。EV ICD 避免了在心脏和脉管系统中的放置，与经静脉系统相比具有优势；与皮下系统相比，EV ICD 除颤所需能量更少，可使设备更小，并在单个系统中提供抗心动过速和停搏起搏等起搏功能。
