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成功将机器人辅助经皮冠状动脉介入系统引入日本临床实践:单中心首年调查。

Successful introduction of robotic-assisted percutaneous coronary intervention system into Japanese clinical practice: a first-year survey at single center.

机构信息

Division of Cardiovascular Medicine, Kurume University School of Medicine, 67 Asahi-machi, Kurume, 830-0011, Japan.

Fukuoka Memorial Hospital, Fukuoka, Japan.

出版信息

Heart Vessels. 2021 Jul;36(7):955-964. doi: 10.1007/s00380-021-01782-6. Epub 2021 Jan 27.

Abstract

In Japan, a robotic-assisted PCI (R-PCI) system, the CorPath GRX System (Corindus Inc.), has been approved for clinical use in 2018, which is the first introduction of R-PCI into Japan. In this study, the clinical performance of the R-PCI system in the initial year at Kurume University Hospital was evaluated comparing with conventional manual PCI (M-PCI). A total of 30 R-PCI and 77 M-PCI procedures performed between April 2019 and March 2020, were retrospectively included. The primary outcome was the rate of clinical success defined as < 30% residual stenosis without in-hospital major adverse cardiovascular events (MACE). The secondary outcomes were fluoroscopy time, dose area product (DAP), amount of radiation exposure to operators and assistants, procedural time, and contrast volume. Propensity-matching technique was used to match each R-PCI lesion to the nearest M-PCI lesion without replacement. After propensity score matching, 30 R-PCI procedures in 28 patients and 37 M-PCI procedures in 35 patients were analyzed. Clinical success rate with R-PCI was favorable and comparable to M-PCI (93.3 vs. 94.6%, p = 0.97), without any in-hospital MACE. The operator radiation exposure was significantly lower in R-PCI (0 vs. 24.5 µSV, p < 0.0001). Radiation exposure to the patients was tended to be reduced by R-PCI (DAP: 77.6 vs. 100.2 Gycm, p = 0.07). There were no statistically significant differences in radiation exposure to the assistant, fluoroscopy time, procedural time and contrast volume between the two groups (radiation exposure to the assistant: 10.5 vs. 10.0 µSV, p = 0.64, fluoroscopy time: 27.5 vs. 30.1 min, p = 0.55, procedural time: 72.4 vs. 61.6 min, p = 0.23, and contrast volume: 93.2 vs. 102.0 ml, p = 0.36). R-PCI in selected patients demonstrated favorable clinical outcomes with dramatical reduction of radiation exposure to operators.

摘要

在日本,一种名为 CorPath GRX 系统(Corindus Inc.)的机器人辅助经皮冠状动脉介入治疗(R-PCI)系统于 2018 年获准临床使用,这是 R-PCI 在日本的首次引入。在这项研究中,评估了久留米大学医院在初始年度使用 R-PCI 系统的临床性能,并与传统的手动经皮冠状动脉介入治疗(M-PCI)进行了比较。共纳入了 2019 年 4 月至 2020 年 3 月期间进行的 30 例 R-PCI 和 77 例 M-PCI 手术。主要结局是临床成功率,定义为 < 30%残余狭窄且院内无主要不良心血管事件(MACE)。次要结局是透视时间、剂量面积乘积(DAP)、操作人员和助手的辐射暴露量、手术时间和造影剂用量。采用倾向评分匹配技术将每个 R-PCI 病变与最近的 M-PCI 病变匹配,不进行替换。在倾向评分匹配后,对 28 名患者的 30 例 R-PCI 手术和 35 名患者的 37 例 M-PCI 手术进行了分析。R-PCI 的临床成功率良好,与 M-PCI 相当(93.3% vs. 94.6%,p = 0.97),且院内无任何 MACE。R-PCI 中操作人员的辐射暴露明显更低(0 与 24.5 μSV,p < 0.0001)。R-PCI 使患者的辐射暴露趋于减少(DAP:77.6 与 100.2 Gycm,p = 0.07)。两组间助手的辐射暴露、透视时间、手术时间和造影剂用量均无统计学差异(助手的辐射暴露:10.5 与 10.0 μSV,p = 0.64,透视时间:27.5 与 30.1 分钟,p = 0.55,手术时间:72.4 与 61.6 分钟,p = 0.23,造影剂用量:93.2 与 102.0 毫升,p = 0.36)。在选择的患者中,R-PCI 显示出良好的临床结果,并显著降低了操作人员的辐射暴露。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/69b8/7839282/afe077a46467/380_2021_1782_Fig1_HTML.jpg

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