Crozier Ian, Murgatroyd Francis, Amin Anish, Clementy Nicolas, Duncker David, Kotschet Emily, Wiggenhorn Christopher, Boersma Lucas V A
Christchurch Hospital, Christchurch, New Zealand.
King's College Hospital, London, UK.
Heart Rhythm. 2025 Mar 17. doi: 10.1016/j.hrthm.2025.02.012.
Premarket clinical trials have shown the extravascular implantable cardioverter-defibrillator (EV-ICD) system to provide effective therapy with a low complication rate, but its performance in the real world is unknown.
We report on the periprocedural safety and performance of the EV-ICD system from the postmarket Enlighten (EV-ICD Post-Approval Registry) Study.
Enlighten is an ongoing, global, prospective, postmarket registry study, enrolling patients guideline indicated for an ICD with a planned implantation of the Aurora EV-ICD system (Medtronic, Mounds View, MN). Procedure characteristics and outcomes, defibrillation testing details, system- or procedure-related major complications, electrical measurements, and pacing therapy programming through discharge were analyzed. A meta-analysis of premarket EV-ICD studies is included in the Supplemental Material for comparison with postmarket Enlighten Study data.
In total, 228 Enlighten patients underwent an Aurora EV-ICD implant attempt (49.4 ± 15.4 years old; 27.9% female; 43.5 ± 16.1 mean left ventricular ejection fraction). Tunneling and substernal lead placement were successful in 227 of 228 (99.6%) patients. After electrical testing, 221 (96.9%) patients remained implanted with the EV-ICD and proceeded to follow-up. Defibrillation testing, if performed, was successful in 191 of 193 (99.0%) patients. The rate of system- or procedure-related major complications at discharge was 3.9%. Electrical measurements were stable at discharge.
In a global, real-world cohort, the EV-ICD system demonstrated a high success rate for terminating induced ventricular arrhythmia episodes at implant and a low rate of periprocedural major complications at discharge, comparable with the premarket experience.
NCT06048731 (Enlighten Study: The EV-ICD Post-Approval Registry).
上市前临床试验表明，血管外植入式心脏复律除颤器（EV-ICD）系统能提供有效治疗且并发症发生率低，但其在现实世界中的性能尚不清楚。
我们报告来自上市后Enlighten（EV-ICD批准后注册研究）研究中EV-ICD系统的围手术期安全性和性能。
Enlighten是一项正在进行的全球前瞻性上市后注册研究，纳入计划植入Aurora EV-ICD系统（美敦力公司，明尼苏达州芒兹维尤）且符合ICD植入指南指征的患者。分析手术特征和结果、除颤测试细节、系统或手术相关的主要并发症、电测量以及出院时的起搏治疗编程。补充材料中包含上市前EV-ICD研究的荟萃分析，用于与上市后Enlighten研究数据进行比较。
共有228例Enlighten患者尝试植入Aurora EV-ICD（年龄49.4±15.4岁；27.9%为女性；平均左心室射血分数43.5±16.1）。228例患者中有227例（99.6%）成功进行了隧道式和胸骨下导线植入。电测试后，221例（96.9%）患者仍植入EV-ICD并进入随访。如果进行除颤测试，193例患者中有191例（99.0%）成功。出院时系统或手术相关主要并发症的发生率为3.9%。出院时电测量稳定。
在全球现实世界队列中，EV-ICD系统在植入时终止诱发室性心律失常发作的成功率高，出院时围手术期主要并发症发生率低，与上市前经验相当。
NCT06048731（Enlighten研究：EV-ICD批准后注册研究）
