Baptist Heart Specialists, 836 Prudential Drive, Suite 1700, Jacksonville, FL 32207 USA.
King's College Hospital, London, UK.
Europace. 2024 Aug 30;26(9). doi: 10.1093/europace/euae225.
The extravascular implantable cardioverter-defibrillator (EV ICD) has been shown to be safe and effective for patients at risk of sudden cardiac death, but little is known about EV ICD lead removal in humans. This analysis aimed to characterize the EV ICD lead removal experience thus far.
This was a retrospective analysis of lead removals from the EV ICD Pilot, Pivotal, and Continued Access Studies. Patients with a successful EV ICD implant who underwent lead removal were included. The main objective was lead removal success. Ancillary objectives included characterizing technique used, procedure complications, and reimplantation status. An EV ICD system was successfully implanted in 347 patients across the 3 studies (25.9% female; 53.4 ± 13.3 years; left ventricular ejection fraction: 39.7 ± 15.9). Of these patients, 29 (8.4%) underwent lead removal with a mean lead dwell time of 12.6 ± 14.3 months (0.2-58.4). The main reason for lead removal was lead dislodgement (n = 9, 31.0%). Lead removal was successful in 27/29 (93.1%) cases [100% (19/19) success rate <1 year and 80% (8/10) success rate >1 year post-implant]. Simple traction was used in 22/26 (84.6%) and extraction tools in 4/26 (15.4%) successful cases where technique was known. No complications were reported for any of the removal procedures. All 11 EV ICD reimplant attempts were successful.
Complete removal of the EV ICD lead was successful in 93.1% of cases, and simple traction was sufficient in most instances. Based on these results, lead removal from the substernal space was safe and achievable up to 3 years post-implant.
已经证明，血管外植入式心律转复除颤器（EV ICD）对于有心脏性猝死风险的患者是安全有效的，但对于人类 EV ICD 导联的移除知之甚少。本分析旨在描述迄今为止 EV ICD 导联移除的经验。
这是对 EV ICD 先导、关键和持续访问研究中导联移除的回顾性分析。纳入了成功植入 EV ICD 并接受导联移除的患者。主要目标是导联移除的成功率。辅助目标包括描述使用的技术、手术并发症和再植入状态。在 3 项研究中，共有 347 例患者成功植入 EV ICD 系统（25.9%为女性；53.4±13.3 岁；左心室射血分数：39.7±15.9）。其中 29 例（8.4%）患者因导联脱位而行导联移除，平均导联留置时间为 12.6±14.3 个月（0.2-58.4）。移除导联的主要原因是导联脱位（n=9，31.0%）。27/29（93.1%）例患者的导联移除成功[1 年内成功率 100%（19/19），植入后 1 年以上成功率 80%（8/10）]。已知技术时，22/26（84.6%）例成功病例采用单纯牵引，4/26（15.4%）例采用提取工具。任何移除手术均未报告并发症。所有 11 次 EV ICD 再植入尝试均成功。
在 93.1%的病例中，EV ICD 导联完全移除成功，大多数情况下单纯牵引即可。基于这些结果，在植入后 3 年内，从胸骨后空间安全且可实现导联移除。
