心脏起器和ICD发电机的可靠性:对设备注册表的元分析
1Cardiovascular Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass 02215, USA. wmaisel@bidmc.harvard.edu
JAMA
|April 28, 2006
概括
心脏起器的可靠性显著提高. 植入式心脏转换器-除器 (ICD) 的故障率最初下降,但随后在最近的下降之前增加,需要持续监测.
科学领域:
- 心血管医学 心血管医学
- 生物医学工程 生物医学工程
- 医疗器械技术 医疗器械技术
背景情况:
- 数以百万计的起器和植入式心脏转换器-除器 (ICD) 设备已在全球植入.
- 关于这些心脏器械的长期可靠性和故障率的数据有限.
研究的目的:
- 对心脏起器和ICD的潜在注册表进行元分析.
- 确定年度故障率,并确定设备可靠性的趋势.
- 为了比较心脏起器与ICD的可靠性.
主要方法:
- 在多个数据库 (MEDLINE,Cochrane) 中进行了全面的文献搜索.
- 确定了符合特定纳入标准的三个潜在注册表,涵盖超过210万个心脏起器和14821个ICD人年.
- 提取了1983-2004年发电机故障 (不包括电线) 的数据,用于心脏起器和1988-2004年用于ICD.
主要成果:
- 20世纪80年代,心脏起器的可靠性显著改善,此后故障率一直很低.
- 植入式心脏转换器-除器 (ICD) 的可靠性最初有所改善,但故障率从1998年至2002年显著增加,然后下降.
- 每年的ICD故障率大约是心脏起器率的20倍,电池故障是最常见的原因.
结论:
- 随着时间的推移,心脏起器的可靠性大大提高了.
- 植入式心脏转换器-除器 (ICD) 的可靠性在最近的改善之前经历了故障率的暂时增加.
- 持续监测心脏起器和ICD性能对于了解设备可靠性趋势至关重要.
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