召回的起器和植入式心脏调节器-除器的管理:一个决策分析模型
Mitesh S Amin1, David B Matchar, Mark A Wood
1Department of Internal Medicine, Virginia Commonwealth University Medical Center, Richmond, USA.
JAMA
|July 27, 2006
概括
在咨询下决定是否更换可植入器件取决于故障率和死亡风险. 当心脏起器的故障率超过0.3%或除器的1.0-3.0%时,通常会更换设备.
科学领域:
- 心脏病学 心脏病学
- 生物医学工程 生物医学工程
- 健康决策分析 分析健康决策
背景情况:
- 在咨询下植入可移植设备的临床管理指南有限.
- 对于临床医生来说,了解设备更换与持续监测的风险和好处至关重要.
研究的目的:
- 通过使用决策分析,根据咨询确定植入式设备的最佳管理策略.
- 立即更换设备与持续的临床随访进行比较.
主要方法:
- 开发了一个决策模型来评估立即替代与监测的风险和益处.
- 关键变量包括设备故障率 (每年0.0001%1.0%) 和替换死亡率 (0.10%1.00%).
主要成果:
- 设备更换的决定主要是由故障率和死亡率的影响驱动的.
- 如果失败率超过0.3%,依赖心脏起器的患者可能需要更换.
- 植入式心脏转换器-除器替换的决定因失败率 (1.0%3.0%),手术死亡率和心律失常风险而有所不同.
结论:
- 召回设备的更换决定取决于故障发生率和故障影响.
- 这一分析为管理被召回的设备提供了一个框架,考虑设备,患者和机构因素.
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