用于保护患者的起器模式的安全性
Robert G Hauser1, Melanie Kapphahn-Bergs1, Ali Bahbah1
1Joseph F. Novogratz Family Heart Rhythm Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota.
Heart rhythm O2
|September 8, 2025
概括
波士顿科学 波士顿科学
科学领域:
- 心血管器械是指心血管器械.
- 生物医学工程 生物医学工程
- 医疗器械安全 医疗器械安全
背景情况:
- 波士顿科学公司的Ingenio心脏起器 (PMs) 可以进入安全模式 (SM) 由于高内部电池阻抗 (HIBIs).
- 旨在保持节奏的SM与节奏暂停和不良事件 (AE),包括死亡有关.
- 最近的警告强调了阿科拉德PM中HIBI和SM的发生.
研究的目的:
- 量化与心脏起器安全模式 (SM) 相关的不良事件 (AE).
- 将SM的AE与Abbott的备份 (BU),Medtronic的重置 (RE) 和Biotronik的备份模式进行比较.
主要方法:
- 搜索了FDA制造商和用户设施设备体验数据库 (2021-2024).
- 分析了涉及SM,BU,RE和Biotronik的备份模式的AE.
- 在不同的节拍器模式中比较事件类型和频率.
主要成果:
- 确定了1379个AE;525个 (91.5%) 涉及SM,相比之下,BU的31个 (5.4%) 和RE的18个 (3.1%) (P < .001).
- SM与349个同步事件有关,其中包括45个头部受伤/跌倒,而BU/RE的1个头部受伤 (P < .001).
- 节奏抑制发生在58%的SM相关的同步事件中,但不是BU或RE.
结论:
- 心脏起器安全模式 (SM) 与其他备用模式相比,与明显更多和严重的不良事件有关.
- 由于SM的高灵敏度 (0.25mV),可能会导致与之相关的风险.
- 对于依赖心脏起器的患者来说,MS可能会构成安全风险.
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