Three Dimensional Visualisation of Endovascular Guidewires and Catheters Based on Laser Light instead of Fluoroscopy with Fiber Optic RealShape Technology: Preclinical Results

Jansen, Marloes M.; Khandige, Anuradha; Kobeiter, Hicham; Vonken, Evert-Jan; Hazenberg, Constantijn E.V.B.; Herwaarden, Joost A. van

doi:10.1016/j.ejvs.2020.02.035

Cited by 29 publications

(13 citation statements)

References 13 publications

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Section: Discussionmentioning

confidence: 99%

“…New radiation reducing techniques that are efficient in reducing radiation doses but have not been evaluated in this study are image fusion, Fiber Optic RealShape navigation, and endovascular robotics. 16 Except for 3D image fusion, these techniques are not yet commercially available on a larger scale and still need to be proven to be safe and effective. Also, novel machine learning techniques and artificial intelligence may improve radiation dose prediction models in the hybrid operation room or perform radiation dose tracking more accurately.…”

Section: Figurementioning

confidence: 99%

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Radiation Awareness for Endovascular Abdominal Aortic Aneurysm Repair in the Hybrid Operating Room: An Instant Operator Risk Chart for Daily Practice

et al. 2021

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Introduction: While the operator radiation dose rates are correlated to patient radiation dose rates, discrepancies may exist in the effect size of each individual radiation dose predictors. An operator dose rate prediction model was developed, compared with the patient dose rate prediction model, and converted to an instant operator risk chart. Materials and Methods: The radiation dose rates (DRoperator for the operator and DRpatient for the patient) from 12,865 abdomen X-ray acquisitions were selected from 50 unique patients undergoing standard or complex endovascular aortic repair (EVAR) in the hybrid operating room with a fixed C-arm. The radiation dose rates were analyzed using a log-linear multivariable mixed model (with the patient as the random effect) and incorporated varying (patient and C-arm) radiation dose predictors combined with the vascular access site. The operator dose rate models were used to predict the expected radiation exposure duration until an operator may be at risk to reach the 20 mSv year dose limit. The dose rate prediction models were translated into an instant operator radiation risk chart. Results: In the multivariate patient and operator fluoroscopy dose rate models, lower DRoperator than DRpatient effect size was found for radiation protocol (2.06 for patient vs 1.4 for operator changing from low to medium protocol) and C-arm angulation. Comparable effect sizes for both DRoperator and DRpatient were found for body mass index (1.25 for patient and 1.27 for the operator) and irradiated field. A higher effect size for the DRoperator than DRpatient was found for C-arm rotation (1.24 for the patient vs 1.69 for the operator) and exchanging from femoral access site to brachial access (1.05 for patient vs 2.5 for the operator). Operators may reach their yearly 20 mSv year dose limit after 941 minutes from the femoral access vs 358 minutes of digital subtraction angiography radiation from the brachial access. Conclusion: The operator dose rates were correlated to patient dose rate; however, C-arm angulation and changing from femoral to brachial vascular access site may disproportionally increase the operator radiation risk compared with the patient radiation risk. An instant risk chart may improve operator dose awareness during EVAR.

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Section: Discussionmentioning

confidence: 99%

Section: Figurementioning

confidence: 99%

Radiation Awareness for Endovascular Abdominal Aortic Aneurysm Repair in the Hybrid Operating Room: An Instant Operator Risk Chart for Daily Practice

et al. 2021

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“…Preclinical study results indicate that the fiber can be incorporated in our guidewires without adversely affecting the mechanical properties (torquability, pushability) of the devices. 8 …”

Section: Methodsmentioning

confidence: 99%

“…That notwithstanding, the technology is obviously intended for clinical use. Results of a preclinical study have been published recently, 8 and first‐in‐human clinical study results have been presented. 37 , 38 , 39…”

Section: Methodsmentioning

confidence: 99%

“…For its initial intended use, aiding the positioning and navigation of a catheter or guidewire during endovascular procedures, creating of such a roadmap is accomplished most naturally with a digital subtraction angiogram (DSA) or coregistered preoperative computerized tomography angiography (CTA). 8 While FORS does not completely eliminate the use of radiation, it does offer great potential to reduce the cumulative radiation dose of endovascular procedures.…”

Section: Introductionmentioning

confidence: 99%

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Shape accuracy of fiber optic sensing for medical devices characterized in bench experiments

et al. 2021

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Purpose: Fiber Optic RealShape (FORS) is a new technology that visualizes the full threedimensional shape of medical devices, such as catheters and guidewires, using an optical fiber embedded in the device. This three-dimensional shape provides guidance to clinicians during minimally invasive procedures, and enables intuitive navigation. The objective of this paper is to assess the accuracy of the FORS technology, as implemented in the current state-of-the-art Philips FORS system. The FORS system provides the shape of the entire device, including tip location and orientation. We consider all three aspects. Methods: In bench experiments, we determined the accuracy of the location and orientation of the tip by displacing and rotating the fiber end, while allowing the rest of the fiber to change shape freely. To test the accuracy of the full shape, we have placed the fiber in a groove, which was accurately machined in a thick, stiff metal "path plate." We then compared the reconstructed shape with the known shape of the groove. Results: The tip location is found with submillimeter accuracy, and the orientation is sensed with milliradian accuracy. The shape of a fiber in the path plate faithfully follows the known shape of the groove, with typical deviation less than 0.5 mm in the plane of the plate. Out of plane accuracy, perhaps slightly less relevant clinically, is more challenging, due to the influence of twist; yet even out of the plane, the deviation is only submillimeter. Conclusion:The technology achieves submillimeter precision and provides full three-dimensional shape, surpassing the reported precision of other navigation and tracking technologies, and therefore may potentially alleviate the need for fluoroscopy.

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Multimodal Sensing Guidewire for C-Arm Navigation with Random UV Enhanced Optical Sensors Using Spatio-Temporal Networks

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Soulez

Monet

et al. 2021

Medical Image Computing and Computer Assisted Intervention – MICCAI 2021

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Three Dimensional Visualisation of Endovascular Guidewires and Catheters Based on Laser Light instead of Fluoroscopy with Fiber Optic RealShape Technology: Preclinical Results

Cited by 29 publications

References 13 publications

Radiation Awareness for Endovascular Abdominal Aortic Aneurysm Repair in the Hybrid Operating Room: An Instant Operator Risk Chart for Daily Practice

Radiation Awareness for Endovascular Abdominal Aortic Aneurysm Repair in the Hybrid Operating Room: An Instant Operator Risk Chart for Daily Practice

Shape accuracy of fiber optic sensing for medical devices characterized in bench experiments

Multimodal Sensing Guidewire for C-Arm Navigation with Random UV Enhanced Optical Sensors Using Spatio-Temporal Networks

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