从皮下和静脉输入植入式心脏转换器-除器不适当的冲击:来自FDAMAUDE数据库的报告
Robert G Hauser1, Mariam Desouki1, Larissa I Stanberry1
1Joseph F. Novogratz Family Heart Rhythm Science Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota.
Heart rhythm O2
|February 25, 2026
概括
皮下植入式心脏转换器-除器 (S-ICDs) 在现实实践中可能比以前想象的更有不适当的冲击 (IAS). 大多数S-ICDIAS事件是由于过度传感,而非通过静脉输入的ICD主要是由心律失常引起的.
科学领域:
- 心脏病学 心脏病学
- 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:
- 皮下 implantable cardioverter-defibrillators (S-ICDs) 在预防心脏突然死亡方面非常有效.
- 现有的数据表明,S-ICD不适当冲击 (IAS) 率与静脉输入植入式心脏转换器-除器 (TV-VR ICD) 类似或高于.
- 在常规临床实践中,关于S-ICD IAS的现实数据有限.
研究的目的:
- 评估报告给FDA的IAS事件,用于波士顿科学公司的标志S-ICD和TV-VR ICD.
- 使用现实数据,比较S-ICD和TV-VR ICD之间IAS的发生率和原因.
- 评估S-ICD IAS的临床影响.
主要方法:
- 在FDA的MAUDE数据库中搜索了波士顿科学所提交的不良事件报告.
- 包括2020年至2024年的Emblem S-ICDs和TV-VR ICDs的报告.
- 分析了IAS事件,其原因和后果.
主要成果:
- 对于S-ICDs提交了超过22,000份MAUDE报告,对于TV-VR ICDs提交了近7,000份.
- 在S-ICD报告中,IAS占23.4%,而在TV-VR ICD中占11.7%.
- 过度感应是S-ICDIAS (91.1%) 的首要原因,而快速心房动/SVT导致了大多数TV-VR ICDIAS (69.5%).
结论:
- 现实数据表明,S-ICD IAS可能比以前报告的更频繁.
- 对S-ICD IAS的发生,原因和结果进行进一步调查是有必要的.
- 了解S-ICD患者的IAS对于优化设备治疗至关重要.
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