Division of Cardiovascular Medicine, Sulpizio Cardiovascular Center, University of California, San Diego, La Jolla, California.
Division of Interventional Radiology, Medical University, Graz, Austria.
JACC Cardiovasc Interv. 2016 Oct 10;9(19):2058-2064. doi: 10.1016/j.jcin.2016.07.002. Epub 2016 Sep 14.
The goal of this study was to evaluate the feasibility and safety of a robotic-assisted platform (CorPath 200, Corindus Vascular Robotics, Waltham, Massachusetts) for treating peripheral artery disease.
A robotic-assisted platform for percutaneous coronary intervention is available for treating coronary artery disease.
In this prospective single-arm trial, patients with symptomatic peripheral artery disease (Rutherford class 2 to 5) affecting the femoropoplital artery were enrolled. Endpoints evaluated were: 1) device technical success, defined as successful cannulation of the target vessel with the robotic system; 2) device safety, defined as absence of device related serious adverse event (hospitalization, prolonged hospitalization, life threatening, or resulted in death); and 3) clinical procedural success, defined as <50% residual stenosis without an unplanned switch to manual assistance or device-related serious adverse event in the periprocedural period.
The study enrolled 20 subjects (65.5 ± 9.3 years of age; 70% male) with primarily Rutherford class 2 to 3 (90%) symptoms. A total of 29 lesions (lesion length: 33.1 ± 15.5 mm) were treated with the majority (89.7%) being located in the superficial femoral artery. Device technical success, safety and clinical procedural success were all 100% with provisional stenting required in 34.5% of lesions. Fluoroscopy time (7.1 ± 3.2 min) and contrast use (73.3 ± 9.2 ml) compared favorably with studies in similar patient cohorts. There were no adverse events associated with the use of the robotic system.
These data demonstrate the feasibility and safety of using a robotic-assisted platform for performing peripheral arterial revascularization.
本研究旨在评估一种用于治疗外周动脉疾病的机器人辅助平台（CorPath 200，Corindus 血管机器人，马萨诸塞州沃尔瑟姆）的可行性和安全性。
一种用于经皮冠状动脉介入治疗的机器人辅助平台可用于治疗冠状动脉疾病。
在这项前瞻性单臂试验中，招募了患有症状性外周动脉疾病（Rutherford 分级 2 至 5 级）影响股腘动脉的患者。评估的终点包括：1）器械技术成功，定义为机器人系统成功穿刺目标血管；2）器械安全性，定义为无器械相关严重不良事件（住院、延长住院时间、危及生命或导致死亡）；3）临床程序成功，定义为<50%残余狭窄，无计划转为手动辅助或器械相关严重不良事件发生在围手术期。
该研究共纳入 20 名受试者（65.5 ± 9.3 岁；70%为男性），主要为 Rutherford 分级 2 至 3 级（90%）症状。共治疗 29 处病变（病变长度：33.1 ± 15.5 mm），其中大部分（89.7%）位于股浅动脉。器械技术成功率、安全性和临床程序成功率均为 100%，34.5%的病变需要临时支架置入。与类似患者队列的研究相比，透视时间（7.1 ± 3.2 min）和造影剂使用（73.3 ± 9.2 ml）均有明显改善。无与机器人系统使用相关的不良事件。
这些数据表明，使用机器人辅助平台进行外周动脉血运重建是可行和安全的。
