国产冠状动脉介入手术机器人在分叉病变中的临床应用与探讨The safety and effectiveness of robotically-assisted percutaneous coronary intervention on coronary bifurcation disease
王鸣,关韶峰,干倩,翟馨蓉,谢晓亮,刘市祺,侯增广,方唯一,曲新凯,韩文正
摘要(Abstract):
目的 评估自主研发的冠状动脉介入手术机器人多器械协同工作的安全性及有效性。方法 在离体模型血管通路中标记右冠状动脉近段至左心室后侧支及后降支计时点,比较人工操作(人工组)与介入手术机器人多器械递送操作(机器人组)通过分叉部位的器械到位率、器械装配时间、总时间;在动物实验中对冠状动脉造影图像标记左主干开口至左前降支远段及左回旋支远段计时点,比较人工组与机器人组通过分叉部位的器械到位率、器械装配时间、总时间、手术并发症发生情况。结果 人工组与机器人组在体外模型的器械到位率均为100%。在体外模型中,人工组导丝通过分叉时间、导丝装配时间、器械装配时间、器械到位时间、操作总时间均显著优于机器人组,差异均有统计学意义(均P<0.05)。而两组导丝操控时间[(21.90±3.19)s比(27.50±14.89)s,P=0.276]差异无统计学意义。在动物实验中,两组小型猪术中均无器械操作相关并发症发生。人工组在导丝操控时间[(27.90±13.73)s比(51.00±22.86)s,P=0.014]、导丝通过分叉时间[(16.80±7.01)s比(89.80±48.08)s,P <0.001]、导丝装配时间[(12.10±6.54)s比(85.20±46.95)s,P <0.001]、器械装配时间[(38.50±5.33)s比(114.50±40.12)s,P<0.001]、器械到位时间[(49.90±6.97)s比(121.30±39.43)s,P<0.001]、操作总时间[(133.20±19.06)s比(376.60±101.85)s,P <0.001]均显著优于机器人组,差异均有统计学意义。结论 本研究首次应用多器械协同冠状动脉介入机器人在体外模型及在体动物实验中与人工操作进行比较,证实了国产冠状动脉介入机器人在多器械协同递送中的可靠性及安全性,对未来应用冠状动脉介入机器人开展复杂病变介入操作具有重要的指导意义。
关键词(KeyWords): 介入手术机器人;分叉病变;多器械协同递送
基金项目(Foundation): 国家科技部重点研发计划项目(2019YFB1311700);; 上海市临床重点专科建设项目(shslczdzk02801)
作者(Author): 王鸣,关韶峰,干倩,翟馨蓉,谢晓亮,刘市祺,侯增广,方唯一,曲新凯,韩文正
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