在心脏植入式电子设备患者的导管切除过程中发生的不良事件
Shiloh Sison1, Kenneth A Ellenbogen2, Charles D Swerdlow3
1Abbott Laboratories, Sunnyvale CA.
Heart rhythm
|February 14, 2026
概括
在心脏植入式电子设备 (CIED) 患者的导管切除过程中,不良事件 (AE) 是常见的,大多数与切除能量和设备相互作用有关. 许多AE是可以预防的,突出需要改进实践和设备设计.
科学领域:
- 心脏病学 心脏病学
- 电子生理学 电子生理学
- 医疗器械安全 医疗器械安全
背景情况:
- 目前对心脏植入式电子设备 (CIED) 患者进行导管切除的不良事件 (AE) 的审查并不反映当前的设备,程序或切除技术,如脉冲场 (PF) 和格子尖端射频 (RF).
- 现代的废除技术需要对CIED患者潜在并发症的最新理解.
研究的目的:
- 在当代CIED患者中进行导管切除的AE的特征.
- 确定改善患者安全和程序工作流程的影响.
主要方法:
- 对在FDA的MAUDE数据库和2020-2025年同行评审文献中报告的433个AE的分析.
- 专注于与较新的剥离技术相关的AE,包括PF和格子尖RF.
主要成果:
- 废除导管/能量导致97%的AE (RF89%,PF8%). 电磁相互作用 (68%) 包括心肌热损伤 (34%) 和发电机功能障碍 (20%).
- 机械相互作用 (32%) 包括脱位 (30%). 在56%的病例中,需要进行干预,包括更换/发电机.
- 大多数值升高发生在远离CIED尖端电极的剥离部位. 脉冲场移除导致所有6个确认的发电机故障;没有报告的冷移除副作用.
结论:
- 这项研究是对当代CIED患者的切除并发症的首次全面分析,揭示了旧技术的低估风险和新技术的新风险.
- 很大一部分AEs (超过40%) 似乎是可以预防的,这表明程序工作流程中的潜在差距和改善临床实践的机会.
- 研究结果表明,需要加强患者安全措施,优化程序技术,以及对CIED设计的潜在修改,以减轻在切除过程中的风险.
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