Shaikh Zohaib A, Eilenberg Michael F, Cohen Todd J
Department of Medicine, NYU Winthrop Hospital, Mineola, NY.
Vicarious Surgical, Inc., Cambridge, MA.
J Innov Card Rhythm Manag. 2017 Aug 15;8(8):2795-2802. doi: 10.19102/icrm.2017.080806. eCollection 2017 Aug.
Radiation exposure is a serious concern during fluoroscopic procedures, including electrophysiology (EP) studies and radiofrequency catheter ablation of arrhythmias. Operators typically don lead aprons to protect themselves from radiation, but wearing lead can result in greater fatigue and orthopedic injury during long procedures. To address this problem, two robotic catheter systems (RCS) have previously been introduced on the market, the Niobe (Stereotaxis Inc., St. Louis, MO, USA) and Sensei X (Hansen Medical, Inc., Mountain View, CA, USA) systems. However, the widespread adoption of these systems has been limited by both cost and ease of use. In contrast, the Amigo™ RCS (Catheter Precision, Inc., Mount Olive, NJ, USA) was developed to provide a simple, lower profile, and less expensive remote catheter manipulation solution. Approved by the United States Food and Drug Administration (FDA), this technology allows for operators to remotely manipulate electrophysiology (EP) catheters from outside the fluoroscopy field. Notably, the Amigo™ RCS (Catheter Precision, Inc., Mount Olive, NJ, USA) first underwent an early study in dogs in 2008 to demonstrate its safety and efficacy in an animal model. After a clinical trial evaluating its safety and mapping capabilities in humans was completed in 2010, the Amigo™ RCS (Catheter Precision, Inc., Mount Olive, NJ, USA) underwent several scientific studies to examine its ability to assist in the mapping and ablation of various arrhythmias in comparison with the conventional manual approach. The Amigo™ RCS (Catheter Precision, Inc., Mount Olive, NJ, USA) achieved mapping and ablation success rates that were similar to those achieved with manual catheter manipulation, and no complications due to its use were observed. It was approved by the FDA for use in diagnostic EP studies of the right atrium and ventricle in 2012, with this indication later expanded in 2014 to include radiofrequency ablations. The device is currently compatible with the Blazer™ (Boston Scientific, Natick, MA, USA) and EZ STEER™ (Biosense Webster, Inc., Diamond Bar, CA, USA) catheter handles. Here, we present a clinical report in which the Amigo™ RCS (Catheter Precision, Inc., Mount Olive, NJ, USA) was employed to map and ablate symptomatic supraventricular tachycardia. Dr. Cohen's clinical experience with this robotic system is also reviewed.
在包括电生理（EP）研究和心律失常的射频导管消融在内的透视检查过程中，辐射暴露是一个严重问题。操作人员通常会穿戴铅围裙来保护自己免受辐射，但在长时间操作过程中，穿戴铅制品会导致更大的疲劳和骨科损伤。为了解决这个问题，此前市场上已推出了两种机器人导管系统（RCS），即Niobe系统（美国密苏里州圣路易斯市的Stereotaxis公司）和Sensei X系统（美国加利福尼亚州山景城的Hansen Medical公司）。然而，这些系统的广泛应用受到成本和易用性的限制。相比之下，Amigo™ RCS（美国新泽西州橄榄山市的Catheter Precision公司）的开发目的是提供一种简单、外形更低、成本更低的远程导管操作解决方案。该技术获得了美国食品药品监督管理局（FDA）的批准，使操作人员能够在透视视野外远程操作电生理（EP）导管。值得注意的是，Amigo™ RCS（美国新泽西州橄榄山市的Catheter Precision公司）于2008年首先在犬类中进行了早期研究，以证明其在动物模型中的安全性和有效性。在2010年完成了一项评估其在人体中的安全性和标测能力的临床试验后，Amigo™ RCS（美国新泽西州橄榄山市的Catheter Precision公司）又进行了多项科学研究，以检验其与传统手动方法相比辅助各种心律失常标测和消融的能力。Amigo™ RCS（美国新泽西州橄榄山市的Catheter Precision公司）取得的标测和消融成功率与手动导管操作相似，且未观察到因使用该系统而导致的并发症。2012年，它获得FDA批准用于右心房和心室的诊断性EP研究，该适应证在2014年后来扩大到包括射频消融。该设备目前与Blazer™（美国马萨诸塞州纳蒂克市的波士顿科学公司）和EZ STEER™（美国加利福尼亚州钻石吧市的Biosense Webster公司）导管手柄兼容。在此，我们报告一例使用Amigo™ RCS（美国新泽西州橄榄山市的Catheter Precision公司）标测和消融症状性室上性心动过速的临床病例。同时也回顾了科恩医生使用该机器人系统的临床经验。
