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 52.2min. 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.
Highlights
In recent decades, an enormous shift has occurred from open operations to fluoroscopically guided endovascular interventions
While guidewires and catheters are being manipulated in a 3D space, these movements are presented to the physician in a 2D projection
This reduces the ability to differentiate between visible structures on the image, especially if these have similar radiopaque characteristics
Summary
An enormous shift has occurred from open operations to fluoroscopically guided endovascular interventions. While guidewires and catheters are being manipulated in a 3D space, these movements are presented to the physician in a 2D projection. This limits the ability to estimate the spatial relationship between the endovascular device and the vascular anatomy or to identify the shape and pointing direction of the device. These factors complicate conceptually basic tasks such as navigation through tortuous arteries and target vessel catheterisation. Fluoroscopy projections are shown as grayscale images This reduces the ability to differentiate between visible structures on the image, especially if these have similar radiopaque characteristics
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