Feasibility and safety of robotic PCI in China: first in man experience in Asia
Feasibility and safety of robotic PCI in China: first in man experience in Asia
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DOI：
10.11909/j.issn.1671-5411.2019.05.004
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发表时间：
2019-01-01
影响因子：
2.5
通讯作者：
Xu, Bo
中科院分区：
文献类型：
--
作者：
Dou, Ke-Fei;Song, Chen-Xi;Xu, Bo
目的评价第二代机器人经皮冠状动脉介入治疗（R-PCI）系统在中国的可行性和安全性。背景：机器人PCI已被证明是进行冠状动脉介入治疗的有效方法。它还具有更准确的病变测量、改善支架展开、降低地理遗漏发生率和减少操作者辐射暴露的其他受益。方法本单中心评价纳入了10例连续入选的PCI患者。临床成功定义为残余狭窄< 30%且无院内主要不良心血管事件。通过比较早期与晚期病例的效率指标来评估学习曲线效应。结果11个病灶均成功治疗，无人工干预或MACE发生。大多数病变（63%）为ACC/AHA B2和C级。平均手术时间为57.7 ± 26.4分钟，但有两个手术是现场演示的一部分。排除2例存活病例，平均手术时间为51.8 +/- 23.7 min。根据PCI时间，手术效率从早期病例到晚期病例趋于改善（48.3 +/- 32.9 vs. 25.5 +/- 13.0 min，P = 0.27），透视时间（20.3 +/- 8.2 vs. 12.5 +/- 4.6 min，P = 0.16），造影剂体积（145.0 ± 28.9 vs. 102.5 ± 17.1 mL，P = 0.05）和空气比释动能剂量（1932 ± 978 vs. 1007 ± 70 mGy，P = 0.31）。结论第二代机器人PCI安全、有效，在中国的早期经验中，手术效率有提高的趋势。
Objectives To evaluate the feasibility and safety of a second generation robotic percutaneous coronary intervention (R-PCI) system in China. Background Robotic PCI has been shown to be an effective method for conducting coronary interventions. It has further benefits of more accurate lesion measurement, improved stent deployment, reduced incidence of geographic miss and reduction of operator radiation exposure. Methods This single center evaluation enrolled 10 consecutive patients who had been selected for PCI. Clinical success was defined as residual stenosis < 30% and no in-hospital major adverse cardiovascular events. Learning curve effect was assessed by comparing efficiency metrics of early vs. later cases. Results Eleven lesions were treated all successfully without manual interruption or MACE events. Most lesions (63%) were ACC/AHA class B2 and C. Mean procedure time was 57.7 +/- 26.4 min, however two procedures were part of live demonstrations. Excluding the two live cases, the mean procedure time was 51.8 +/- 23.7 min. Procedural efficiency tended to improve from early cases to later cases based on PCI time (48.3 +/- 32.9 vs. 25.5 +/- 13.0 min, P = 0.27), fluoroscopy time (20.3 +/- 8.2 vs. 12.5 +/- 4.6 min, P = 0.16), contrast volume (145.0 +/- 28.9 vs. 102.5 +/- 17.1 mL, P = 0.05) and Air Kerma dose (1932 +/- 978 vs. 1007 +/- 70 mGy, P = 0.31). Conclusions Second generation robotic PCI was safe, effective and there were trends toward improvements in procedural efficiency during this early experience in China.