复杂冠状动脉病变的ETcath200机器人PCI系统的可行性和安全性:一个前性的单中心研究
概括
ETcath200机器人系统对复杂的冠状动脉干预非常有希望,提供视觉反和高效的设备交换. 它在20名患者的试点研究中取得了很高的临床成功和安全性.
科学领域:
- 心血管干预 心血管干预
- 医疗机器人 医疗机器人
- 通过皮肤进行冠状动脉干预.
背景情况:
- 现有的机器人辅助PCI平台缺乏触觉反,并且具有繁的设备交换.
- 在中国开发的ETcath200系统包含导线力传感器,用于视觉阻力反.
- 它具有精简的设备交换和直观的操纵杆-滚筒接口.
研究的目的:
- 评估ETcath200机器人PCI系统的可行性,安全性和程序性能.
- 评估其在患有复杂冠状动脉病变的患者中的应用.
主要方法:
- 一个前性,单中心,单臂试验,涉及20名患有AHA/ACC型B2或C型复杂冠状动脉病变的患者.
- 使用ETcath200系统进行PCI,技术成功被定义为完全机器人完成.
- 临床成功被定义为残留狭窄<30%与TIMI 3流动和没有住院MACE;进行了30天的随访.
主要成果:
- 该研究包括20名冠状动脉复杂解剖 (79.2%为C型) 的患者 (平均年龄63.2岁,80%为男性).
- 在80%的案例中取得了技术上的成功;由于具有挑战性的解剖学或导线问题,20%需要手动转换.
- 所有患者在30天内都取得了临床成功,没有设备故障,MACE或严重不良事件. 平均手术时间为61.0分钟;辐射剂量为0.07mSv.
结论:
- 在复杂的冠状动脉病变中,ETcath200机器人PCI系统证明了可行性,安全性和可靠性.
- 观察到高临床成功和优秀的短期结果,只有在解剖学上具有挑战性的情况下才需要手动转换.
- 在复杂的冠状动脉干预中对ETcath200系统进行进一步的多中心评估得到了这些发现的支持.
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