Division of Cardiovascular Medicine, University of California, San Diego, Sulpizio Cardiovascular Center, La Jolla, California.
Division of Cardiovascular Medicine, University of California, San Diego, Sulpizio Cardiovascular Center, La Jolla, California.
JACC Cardiovasc Interv. 2017 Jul 10;10(13):1320-1327. doi: 10.1016/j.jcin.2017.03.050.
The aims of this study were to evaluate the feasibility and technical success of robotically assisted percutaneous coronary intervention (R-PCI) for the treatment of coronary artery disease (CAD) in clinical practice, especially in complex lesions, and to determine the safety and clinical success of R-PCI compared with manual percutaneous coronary intervention (M-PCI).
R-PCI is safe and feasible for simple coronary lesions. The utility of R-PCI for complex coronary lesions is unknown.
All consecutive PCI procedures performed robotically (study group) or manually (control group) over 18 months were included. R-PCI technical success, defined as the completion of the procedure robotically or with partial manual assistance and without a major adverse cardiovascular event, was determined. Procedures ineligible for R-PCI (i.e., atherectomy, planned 2-stent strategy for bifurcation lesion, chronic total occlusion requiring hybrid approach) were excluded for analysis from the M-PCI group. Clinical success, defined as completion of the PCI procedure without a major adverse cardiovascular event, procedure time, stent use, and fluoroscopy time were compared between groups.
A total of 315 patients (mean age 67.7 ± 11.8 years; 78% men) underwent 334 PCI procedures (108 R-PCIs, 157 lesions, 78.3% type B2/C; 226 M-PCIs, 336 lesions, 68.8% type B2/C). Technical success with R-PCI was 91.7% (rate of manual assistance 11.1%, rate of manual conversion 7.4%, rate of major adverse cardiovascular events 0.93%). Clinical success (99.1% with R-PCI vs. 99.1% with M-PCI; p = 1.00), stent use (stents per procedure 1.59 ± 0.79 with R-PCI vs. 1.54 ± 0.75 with M-PCI; p = 0.73), and fluoroscopy time (18.2 ± 10.4 min with R-PCI vs. 19.2 ± 11.4 min with M-PCI; p = 0.39) were similar between the groups, although procedure time was longer in the R-PCI group (44:30 ± 26:04 min:s vs. 36:34 ± 23:03 min:s; p = 0.002). Propensity-matched analysis confirmed that procedure time was longer in the robotic group (42:59 ± 26:14 min:s with R-PCI vs. 34:01 ± 17:14 min:s with M-PCI; p = 0.007), although clinical success remained similar (98.8% with R-PCI vs. 100% with M-PCI; p = 1.00).
This study demonstrates the feasibility, safety, and high technical success of R-PCI for the treatment of complex coronary disease. Furthermore, comparable clinical outcomes, without an adverse effect on stent use or fluoroscopy time, were observed with R-PCI and M-PCI.
本研究旨在评估机器人辅助经皮冠状动脉介入治疗(R-PCI)治疗冠状动脉疾病(CAD)的可行性和技术成功率,特别是在复杂病变中的应用,并比较 R-PCI 与手动经皮冠状动脉介入治疗(M-PCI)的安全性和临床成功率。
R-PCI 治疗简单冠状动脉病变是安全可行的。机器人辅助治疗复杂冠状动脉病变的效果尚不清楚。
纳入了 18 个月内连续进行的所有机器人辅助(研究组)或手动(对照组)PCI 手术。确定 R-PCI 技术成功率,定义为成功完成手术,无论是机器人辅助还是部分手动辅助,且无重大心血管不良事件。不适合 R-PCI 的手术(即旋磨术、分叉病变的计划双支架策略、需要杂交技术的慢性完全闭塞病变)被排除在 M-PCI 组的分析之外。比较两组之间的临床成功率(定义为无重大心血管不良事件的 PCI 手术完成情况)、手术时间、支架使用和透视时间。
共 315 例患者(平均年龄 67.7 ± 11.8 岁,78%为男性)接受了 334 例 PCI 手术(108 例 R-PCI,157 处病变,78.3%为 B2/C 型;226 例 M-PCI,336 处病变,68.8%为 B2/C 型)。R-PCI 的技术成功率为 91.7%(手动辅助率 11.1%,手动转换率 7.4%,重大心血管不良事件率 0.93%)。临床成功率(R-PCI 为 99.1%,M-PCI 为 99.1%;p=1.00)、支架使用(R-PCI 每例手术使用 1.59 ± 0.79 个支架,M-PCI 为 1.54 ± 0.75 个支架;p=0.73)和透视时间(R-PCI 为 18.2 ± 10.4 分钟,M-PCI 为 19.2 ± 11.4 分钟;p=0.39)在两组间相似,尽管 R-PCI 组的手术时间较长(44:30 ± 26:04 分钟:秒 vs. 36:34 ± 23:03 分钟:秒;p=0.002)。倾向评分匹配分析证实,机器人组的手术时间较长(R-PCI 为 42:59 ± 26:14 分钟:秒,M-PCI 为 34:01 ± 17:14 分钟:秒;p=0.007),尽管临床成功率相似(R-PCI 为 98.8%,M-PCI 为 100%;p=1.00)。
本研究表明 R-PCI 治疗复杂冠状动脉疾病具有可行性、安全性和较高的技术成功率。此外,与 M-PCI 相比,R-PCI 与 M-PCI 具有相似的临床效果,且不影响支架使用或透视时间。