With maximum operator shielding during femoral access, relative occupational radiation risk can be minimized. However, digital subtraction angiography image acquisition, recanalization of TVs, recanalization of superior mesenteric artery or celiac artery, and recanalization of branched TVs are predictors for increased occupational radiation dose risks caused by increased radiation doses to the patient and reduced options for shielding of the operator.

WHAT THIS PAPER ADDS Fiber Optic RealShape (FORS) technology is a new method to visualise endovascular guidewires and catheters inside the body in 3D, in real time. FORS functions as an add on to conventional fluoroscopy and uses integrated multicore optical fibres to track and visualise the entire devices based on light rather than X-ray. This paper contains the first in human use of FORS technology in (regular and complex) endovascular aortic repair and peripheral lesion repair. This exploratory study demonstrates the feasibility and potential of this technology in clinical practice and forms a foundation for future clinical research. Objective: 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. Methods: 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. Results: 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. Conclusion: 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.

WHAT THIS STUDY ADDSThis study is the first to describe the use of Fiber Optic RealShape (FORS) technology in a preclinical environment. FORS technology allows continuous, real time, three dimensional visualisation of the full length of endovascular guidewires and catheters, based on fibre optic technology.Objective: Fiber Optic RealShape (FORS) is a new technology platform that enables real time three dimensional (3D) visualisation of endovascular guidewires and catheters, based on the concepts of fibre optic technology instead of fluoroscopy. Anatomical context is provided by means of co-registered prior anatomical imaging, such as digital subtraction angiography or computed tomography. This preclinical study assesses the safety and feasibility of FORS technology. Methods: Six physicians performed endovascular tasks in a phantom model and a porcine model using FORS enabled floppy guidewires, Cobra-2 catheters and Berenstein catheters. Each physician performed a set of predefined tasks in both models, including setup of the FORS system, device registration, and 12 aortic and peripheral target vessel cannulation tasks. The evaluation of the FORS system was based on (i) target vessel cannulation success; (ii) safety assessment; (iii) the accuracy of the FORS based device visualisation; and (iv) user experience. Results: Successful cannulation was achieved in 72 of the 72 tasks (100%) in the phantom model and in 70 of the 72 tasks (97%) in the porcine model. No safety issues were reported. The FORS based device visualisation had a median offset at the tip of 2.2 mm (interquartile range 1.2e3.8 mm). The users judged the FORS based device visualisation to be superior to conventional fluoroscopic imaging, while not affecting the mechanical properties (torquability, pushability) of the FORS enabled guidewire and catheters. Conclusion:The combined outcomes of high cannulation success, positive user experience, adequate accuracy, and absence of safety issues demonstrate the safety and feasibility of the FORS system in a preclinical environment. FORS technology has great potential to improve device visualisation in endovascular interventions.

Preliminary results indicate that selective CTM is superior to MG in the evaluation of severe obscure overt intestinal bleeding.

Objective To describe the feasibility of a fresh frozen human cadaver model for research and training of endovascular image guided procedures in the aorta and lower extremity. Methods The cadaver model was constructed in fresh frozen human cadaver torsos and lower extremities. Endovascular access was acquired by inserting a sheath in the femoral artery. The arterial segment of the specimen was restricted by ligation of collateral arteries and, in the torsos, clamping of the contralateral femoral artery and balloon occlusion of the supratruncal aorta. Tap water was administered through the sheath to create sufficient intraluminal pressure to manipulate devices and acquire digital subtraction angiography (DSA). Endovascular cannulation tasks of the visceral arteries (torso) or the peripheral arteries (lower extremities) were performed to assess the vascular patency of the model. Feasibility of this model is based on our institute’s experiences throughout the use of six fresh frozen human cadaver torsos and 22 lower extremities. Results Endovascular simulation in the aortic and peripheral vasculature was achieved using this human cadaver model. Acquisition of DSA images was feasible in both the torsos and the lower extremities. Approximately 84 of the 90 target vessels (93.3%) were patent, the remaining six vessels showed signs of calcified steno-occlusive disease. Conclusions Fresh frozen human cadavers provide a feasible simulation model for aortic and peripheral endovascular interventions, and can potentially reduce the need for animal experimentation. This model is suitable for the evaluation of new endovascular devices and techniques or to master endovascular skills.