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Single-site access robot-assisted epicardial mapping with a snake robot: Preparation and first clinical experience

机译:使用蛇形机器人的单站点访问机器人辅助心外膜测绘:准备和首次临床经验

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CardioARM, a highly flexible "snakelike" medical robotic system (Medrobotics, Raynham, MA), has been developed to allow physicians to view, access, and perform complex procedures intrapericardially on the beating heart through a single-access port. Transthoracic epicardial catheter mapping and ablation has emerged as a strategy to treat arrhythmias, particularly ventricular arrhythmias, originating from the epicardial surface. The aim of our investigation was to determine whether the CardioARM could be used to diagnose and treat ventricular tachycardia (VT) of epicardial origin. Animal and clinical studies of the CardioARM flexible robot were performed in hybrid surgical-electrophysiology settings. In a porcine model study, single-port pericardial access, navigation, mapping, and ablation were performed in nine animals. The device was then used in a small, single-center feasibility clinical study. Three patients, all with drug-refractory VT and multiple failed endocardial ablation attempts, underwent epicardial mapping with the flexible robot. In all nine animals, navigation, mapping, and ablation were successful without hemodynamic compromise. In the human study, all three patients demonstrated a favorable safety profile, with no major adverse events through a 30-day follow-up. Two cases achieved technical success, in which an electroanatomic map of the epicardial ventricle surface was created; in the third case, blood obscured visualization. These results, although based on a limited number of experimental animals and patients, show promise and suggest that further clinical investigation on the use of the flexible robot in patients requiring epicardial mapping of VT is warranted.
机译:CardioARM是一种高度灵活的“蛇状”医疗机器人系统(Medrobotics,Raynham,MA),已开发出来,可让医生通过一个单一的端口在搏动的心脏上进行心包内查看,访问和执行复杂的操作。经胸心外膜导管标测和消融已成为一种治疗心律失常的策略,尤其是心外膜表面的心律失常。我们的研究目的是确定CardioARM是否可用于诊断和治疗心外膜源性室性心动过速(VT)。 CardioARM柔性机器人的动物和临床研究是在混合外科电生理环境中进行的。在一项猪模型研究中,对9只动物进行了单端口心包进入,导航,标测和消融。然后将该设备用于小型,单中心的可行性临床研究。 3名均患有药物难治性VT且多次心内膜消融尝试均失败的患者,使用柔性机器人进行了心外膜定位。在所有九只动物中,导航,标测和消融均成功,且无血流动力学损害。在人体研究中,所有三名患者均表现出良好的安全性,经过30天的随访,未出现重大不良事件。有两个案例获得了技术上的成功,其中创建了心外膜心室表面的电解剖图。在第三种情况下,血液模糊了可视化。尽管基于有限数量的实验动物和患者,这些结果显示出希望,并表明需要对需要心外膜测绘VT的患者使用柔性机器人进行进一步的临床研究。

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