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Abstract：
Endovascular procedures are conventionally conducted using two dimensional fluoroscopy. A new technology platform, Fiber Optic RealShape (FORS), has recently been introduced allowing real time, three dimensional visualisation of endovascular devices using fiberoptic technology. It functions as an add on to conventional fluoroscopy and may facilitate endovascular procedures. This first in human study assessed the feasibility of FORS in clinical practice.
A prospective cohort feasibility study was performed between July and December 2018. Patients undergoing (regular or complex) endovascular aortic repair (EVAR) or endovascular peripheral lesion repair (EVPLR) were recruited. FORS guidance was used exclusively during navigational tasks such as target vessel catheterisation or crossing of stenotic lesions. Three types of FORS enabled devices were available: a flexible guidewire, a Cobra-2 catheter, and a Berenstein catheter. Devices were chosen at the physician\'s discretion and could comprise any combination of FORS and non-FORS devices. The primary study endpoint was technical success of the navigational tasks using FORS enabled devices. Secondary study endpoints were user experience and fluoroscopy time.
The study enrolled 22 patients: 14 EVAR and eight EVPLR patients. Owing to a technical issue during start up, the FORS system could not be used in one EVAR. The remaining 21 procedures proceeded without device or technology related complications and involved 66 navigational tasks. In 60 tasks (90.9%), technical success was achieved using at least one FORS enabled device. Users rated FORS based image guidance \"better than standard guidance\" in 16 of 21 and \"equal to standard guidance\" in five of 21 procedures. Fluoroscopy time ranged from 0.0 to 52.2 min. Several tasks were completed without or with only minimal X-ray use.
Real time navigation using FORS technology is safe and feasible in abdominal and peripheral endovascular procedures. FORS has the potential to improve intra-operative image guidance. Comparative studies are needed to assess these benefits and potential radiation reduction.
A prospective cohort feasibility study was performed between July and December 2018. Patients undergoing (regular or complex) endovascular aortic repair (EVAR) or endovascular peripheral lesion repair (EVPLR) were recruited. FORS guidance was used exclusively during navigational tasks such as target vessel catheterisation or crossing of stenotic lesions. Three types of FORS enabled devices were available: a flexible guidewire, a Cobra-2 catheter, and a Berenstein catheter. Devices were chosen at the physician\'s discretion and could comprise any combination of FORS and non-FORS devices. The primary study endpoint was technical success of the navigational tasks using FORS enabled devices. Secondary study endpoints were user experience and fluoroscopy time.
The study enrolled 22 patients: 14 EVAR and eight EVPLR patients. Owing to a technical issue during start up, the FORS system could not be used in one EVAR. The remaining 21 procedures proceeded without device or technology related complications and involved 66 navigational tasks. In 60 tasks (90.9%), technical success was achieved using at least one FORS enabled device. Users rated FORS based image guidance \"better than standard guidance\" in 16 of 21 and \"equal to standard guidance\" in five of 21 procedures. Fluoroscopy time ranged from 0.0 to 52.2 min. Several tasks were completed without or with only minimal X-ray use.
Real time navigation using FORS technology is safe and feasible in abdominal and peripheral endovascular procedures. FORS has the potential to improve intra-operative image guidance. Comparative studies are needed to assess these benefits and potential radiation reduction.
摘要：
血管内手术通常使用二维荧光透视进行。一个新的技术平台，光纤真实形状（FORS），最近推出了允许实时，使用光纤技术的血管内装置的三维可视化。它的功能是对传统透视的补充，并可能有助于血管内手术。这项首次在人类研究中评估了FORS在临床实践中的可行性。
2018年7月至12月进行了前瞻性队列可行性研究。招募接受（常规或复杂）血管内主动脉修复（EVAR）或血管内周围病变修复（EVPLR）的患者。FORS指导仅用于导航任务，例如目标血管导管插入术或狭窄病变的穿越。三种类型的FORS启用设备可用：柔性导丝，Cobra-2导管,还有一个Berenstein导管.器械由医师自行选择，可包括FORS和非FORS器械的任意组合。主要研究终点是使用启用FORS的设备进行导航任务的技术成功。次要研究终点是用户体验和透视时间。
该研究纳入了22名患者：14名EVAR患者和8名EVPLR患者。由于启动期间的技术问题，FORS系统不能在一个EVAR中使用。其余21个程序在没有设备或技术相关并发症的情况下进行，涉及66个导航任务。在60个任务（90.9%）中，使用至少一个支持FORS的设备取得了技术成功。用户在21个程序中的16个中将基于FORS的图像指导评为“优于标准指导”，并在21个程序中的5个中将其评为“等于标准指导”。透视时间为0.0至52.2分钟。在没有或仅使用最少X射线的情况下完成了几项任务。
使用FORS技术的实时导航在腹部和周围血管内手术中是安全可行的。FORS具有改善术中图像指导的潜力。需要进行比较研究来评估这些益处和潜在的辐射减少。
2018年7月至12月进行了前瞻性队列可行性研究。招募接受（常规或复杂）血管内主动脉修复（EVAR）或血管内周围病变修复（EVPLR）的患者。FORS指导仅用于导航任务，例如目标血管导管插入术或狭窄病变的穿越。三种类型的FORS启用设备可用：柔性导丝，Cobra-2导管,还有一个Berenstein导管.器械由医师自行选择，可包括FORS和非FORS器械的任意组合。主要研究终点是使用启用FORS的设备进行导航任务的技术成功。次要研究终点是用户体验和透视时间。
该研究纳入了22名患者：14名EVAR患者和8名EVPLR患者。由于启动期间的技术问题，FORS系统不能在一个EVAR中使用。其余21个程序在没有设备或技术相关并发症的情况下进行，涉及66个导航任务。在60个任务（90.9%）中，使用至少一个支持FORS的设备取得了技术成功。用户在21个程序中的16个中将基于FORS的图像指导评为“优于标准指导”，并在21个程序中的5个中将其评为“等于标准指导”。透视时间为0.0至52.2分钟。在没有或仅使用最少X射线的情况下完成了几项任务。
使用FORS技术的实时导航在腹部和周围血管内手术中是安全可行的。FORS具有改善术中图像指导的潜力。需要进行比较研究来评估这些益处和潜在的辐射减少。
