Doshi Shephal K, Knops Reinoud E, Ebner Adrian, Husby Michael, Marcovecchio Alan, Sanghera Rick, Scheck Don, Burke Martin C
Department of Electrophysiology, Pacific Heart Institute, Santa Monica, CA, USA.
Department of Clinical and Experimental Cardiology, Amsterdam UMC, Academic Medical Center, Meibergdreef 9, Amsterdam, The Netherlands.
Europace. 2025 Mar 5;27(3). doi: 10.1093/europace/euaf044.
Intercostal extravascular implantable cardioverter defibrillator (EV-ICD) leads may work better in contact with the pericardium thereby directing pacing and defibrillation energy towards excitable myocytes. We report 3-month safety and performance outcomes with a second-generation intercostal EV-ICD lead paired with standard, commercially available ICD pulse generators (PGs).
Subjects undergoing a transvenous ICD (TV-ICD) procedure received a concomitant intercostal EV-ICD lead system. The intercostal EV-ICD lead was connected sequentially to a PG in a left pectoral and then a left mid-axillary location. Extravascular ICD lead assessment included sensing and defibrillation of induced ventricular arrhythmias and pacing capture. The intercostal EV-ICD system was followed in a 'recording-only' mode and the control TV-ICD system in 'therapy delivery' mode to compare stored events. Devices were evaluated prior to hospital discharge, 2 weeks, 1 month, 2 months, and 3 months post-implant. Defibrillation testing was repeated prior to lead removal; 20/20 (100%) were successfully implanted (median implant time of 9 min). Two major lead complications were reported over a mean of 82 days: (i) lead movement and (ii) infection of both the TV-ICD and EV-ICD systems. Intraoperative pacing capture was achieved with the integrated bipolar configuration in 19 of 20 (95%) subjects. Pacing capture with the EV-ICD system was tolerated in all subjects, with over 90% feeling no pain after a 1-month recovery from the procedure. Induced VF episodes were sensed in all subjects and defibrillated successfully in 17 of 17 patients (100%) with a left mid-axillary PG and 19 of 20 patients (95%) with a left pectoral PG. Sensing and defibrillation were successful in 18 of 18 (100%) tested prior to lead removal.
In this pilot experience with a second-generation intercostal EV-ICD lead implantation, sensing and defibrillation of induced VF were successful when paired with a standard ICD PG from either a left mid-axillary or pectoral pocket.
NCT number: NCT05791032; URL: https://clinicaltrials.gov/study/NCT05791032.
肋间血管外植入式心律转复除颤器（EV-ICD）导线与心包接触时可能效果更好，从而将起搏和除颤能量导向可兴奋的心肌细胞。我们报告了第二代肋间EV-ICD导线与标准的市售ICD脉冲发生器（PG）配对使用3个月的安全性和性能结果。
接受经静脉ICD（TV-ICD）手术的受试者同时接受了肋间EV-ICD导线系统。肋间EV-ICD导线依次连接到左胸和左腋中线位置的PG。血管外ICD导线评估包括对诱发的室性心律失常的感知和除颤以及起搏夺获。肋间EV-ICD系统以“仅记录”模式进行随访，对照TV-ICD系统以“治疗递送”模式进行随访以比较存储的事件。在出院前、植入后2周、1个月、2个月和3个月对设备进行评估。在拔除导线前重复进行除颤测试；20例（100%）均成功植入（中位植入时间为9分钟）。在平均82天内报告了2例主要导线并发症：（i）导线移位和（ii）TV-ICD和EV-ICD系统均发生感染。20例受试者中有19例（95%）通过集成双极配置在术中实现了起搏夺获。所有受试者均耐受EV-ICD系统的起搏夺获，术后1个月恢复后，超过90%的人没有疼痛感觉。所有受试者均能感知诱发的室颤发作，17例患者中有17例（100%）使用左腋中线PG成功除颤，20例患者中有19例（95%）使用左胸PG成功除颤。在拔除导线前进行测试的18例（100%）中，感知和除颤均成功。
在这项第二代肋间EV-ICD导线植入的初步经验中，当与来自左腋中线或胸袋的标准ICD PG配对时，诱发室颤的感知和除颤均成功。
NCT编号：NCT05791032；网址：https://clinicaltrials.gov/study/NCT05791032 。
