心脏起器和ICD发生器故障:对美国食品和药物管理局年度报告的分析
William H Maisel1, Megan Moynahan, Bram D Zuckerman
1Cardiovascular Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass 02215, USA. wmaisel@bidmc.harvard.edu
JAMA
|April 28, 2006
概括
心脏起器和植入式心脏转换器-除器 (ICD) 的故障影响了数千人,心脏起器的可靠性得到了改善. 然而,在后来的几年里,ICD故障率显著增加,突出显示了持续监测设备性能的必要性.
科学领域:
- 心脏病学 心脏病学
- 生物医学工程 生物医学工程
- 医疗设备分析 医疗设备分析
背景情况:
- 心脏起器和植入式心脏转换器-除器 (ICD) 对于降低高风险患者的死亡率至关重要.
- 越来越复杂的心脏器件的可靠性仍然是一个研究领域.
研究的目的:
- 分析美国食品和药物管理局 (FDA) 对起器和ICD的批准后报告.
- 为了确定设备故障率的趋势,并评估整体性能.
主要方法:
- 对1990-2002年FDA关于心脏起器和ICD的年度报告的审查.
- 分析确认的发电机故障和探测数据.
- 计算每1000种植入物每年的故障更换率.
主要成果:
- 由于已确认的故障,超过1.7万台心脏起器和ICD设备被检查.
- 在研究期间,心脏起器故障率显著下降.
- 在最初的下降后,ICD功能障碍率在研究后半年显著增加,比起起动脉起器,其率明显高.
- 电池/电容器问题和电气问题是设备故障的主要原因.
结论:
- 成千上万的患者经历了心脏起器和ICD故障,需要仔细监测.
- 虽然心脏起器的可靠性有所改善,但ICD故障的上升趋势需要注意.
- 尽管它们具有拯救生命的好处,但对心脏器件性能进行持续监测是必不可少的.
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