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Purpose: To evaluate the feasibility and accuracy of a radiation-free implantation of a thoracic aortic stent graft employing fiberoptic and electromagnetic tracking in an anthropomorphic phantom., Materials and Methods: An anthropomorphic phantom was manufactured based on computed tomography (CT) angiography data from a patient. An aortic stent graft application system was equipped with a fiber Bragg gratings and 3 electromagnetic sensors. The stent graft was navigated in the phantom by 3 interventionalists using the tracking data generated by both technologies. One implantation procedure was performed. The technical success of the procedure was evaluated using digital subtraction angiography and CT angiography (before and after the intervention). Tracking accuracy was determined at various anatomical landmarks based on separately acquired fluoroscopic images. The mean/maximum errors were measured for the stent graft application system and the tip/end of the stent graft., Results: The procedure resulted in technical success with a mean error below 3 mm for the entire application system and <2 mm for the position of the tip of the stent graft. Navigation/implantation and handling of the device were rated sufficiently accurate and on par with comparable, routinely used stent graft application systems., Conclusions: The study demonstrates successful stent graft implantation during a thoracic endovascular aortic repair procedure employing advanced guidance techniques and avoiding fluoroscopic imaging. This is an essential step in facilitating the implantation of stent grafts and reducing the health risks associated with ionizing radiation during endovascular procedures., (Copyright © 2022 SIR. Published by Elsevier Inc. All rights reserved.)

Background: In endovascular aneuysm repair (EVAR) procedures, medical instruments are currently navigated with a two-dimensional imaging based guidance requiring X-rays and contrast agent., Methods: Novel approaches for obtaining the three-dimensional instrument positions are introduced. Firstly, a method based on fibre optical shape sensing, one electromagnetic sensor and a preoperative computed tomography (CT) scan is described. Secondly, an approach based on image processing using one 2D fluoroscopic image and a preoperative CT scan is introduced., Results: For the tracking based method, average errors from 1.81 to 3.13 mm and maximum errors from 3.21 to 5.46 mm were measured. For the image-based approach, average errors from 3.07 to 6.02 mm and maximum errors from 8.05 to 15.75 mm were measured., Conclusion: The tracking based method is promising for usage in EVAR procedures. For the image-based approach are applications in smaller vessels more suitable, since its errors increase with the vessel diameter., (© 2021 The Authors. The International Journal of Medical Robotics and Computer Assisted Surgery published by John Wiley & Sons Ltd.)

Background: This study aimed to assess the error of different registration techniques and imaging modalities for fusion imaging of the aorta in a standardized setting using a anthropomorphic body phantom., Materials and Methods: A phantom with the 3D printed vasculature of a patient suffering from an infrarenal aortic aneurysm was constructed. Pulsatile flow was generated via an external pump. CTA/MRA of the phantom was performed, and a virtual 3D vascular model was computed. Subsequently, fusion imaging was performed employing 3D-3D and 2D-3D registration techniques. Accuracy of the registration was evaluated from 7 right/left anterior oblique c-arm angulations using the agreement of centerlines and landmarks between the phantom vessels and the virtual 3D virtual vascular model. Differences between imaging modalities were assessed in a head-to-head comparison based on centerline deviation. Statistics included the comparison of means ± standard deviations, student's t-test, Bland-Altman analysis, and intraclass correlation coefficient for intra- and inter-reader analysis., Results: 3D-3D registration was superior to 2D-3D registration, with the highest mean centerline deviation being 1.67 ± 0.24 mm compared to 4.47 ± 0.92 mm. The highest absolute deviation was 3.25 mm for 3D-3D and 6.25 mm for 2D-3D registration. Differences for all angulations between registration techniques reached statistical significance. A decrease in registration accuracy was observed for c-arm angulations beyond 30° right anterior oblique/left anterior oblique. All landmarks (100%) were correctly positioned using 3D-3D registration compared to 81% using 2D-3D registration. Differences in accuracy between CT and MRI were acceptably small. Intra- and inter-reader reliability was excellent., Conclusion: In the realm of registration techniques, the 3D-3D method proved more accurate than did the 2D-3D method. Based on our data, the use of 2D-3D registration for interventions with high registration quality requirements (e.g., fenestrated aortic repair procedures) cannot be fully recommended. Regarding imaging modalities, CTA and MRA can be used equivalently.

Introduction: 3D printing has a wide range of applications in medicine. In surgery, this technique can be used for preoperative planning of complex procedures, production of patient specific implants, as well as training. However, accuracy evaluations of 3D vascular models are rare., Objectives: Aim of this study was to investigate the accuracy of patient-specific 3D-printed aortic anatomies., Methods: Patients suffering from aorto-iliac aneurysms and with indication for treatment were selected on the basis of different anatomy and localization of the aneurysm in the period from January 1st 2014 to May 27th 2016. Six patients with aorto-iliac aneurysms were selected out of the database for 3D-printing. Subsequently, computed tomography (CT) images of the printed 3D-models were compared with the original CT data sets., Results: The mean deviation of the six 3D-vascular models ranged between -0.73 mm and 0.14 mm compared to the original CT-data. The relative deviation of the measured values showed no significant difference between the 3D-vascular and the original patient CT-data., Conclusion: Our results showed that 3D printing has the potential to produce patient-specific 3D vascular models with reliable accuracy. This enables the use of such models for the development of new endovascular procedures and devices., (Copyright © 2020 Elsevier GmbH. All rights reserved.)

Purpose: Today, ultrasound-guided peripheral endovascular interventions have the potential to be an alternative to conventional interventions that are still X-ray and contrast agent based. For the further development of this approach, a research environment is needed that represents the individual patient-specific endovascular properties as realistically as possible. Aim of the project was the construction of a phantom that combines ultrasound capabilities and the possibility to simulate peripheral endovascular interventions., Material and Methods: We designed a modular ultrasound-capable phantom with exchangeable patient specific vascular anatomy. For the manufacturing of the vascular pathologies, we used 3D printing technology. Subsequently, we evaluated the constructed simulator with regards to its application for endovascular development projects., Results: We developed an ultrasound-capable phantom with an exchangeable 3D-printed segment of the femoral artery. This modality allows the study of several patient-specific 3D-printed pathologies. Compared to the flow properties of a human artery (male; age 28) the phantom shows realistic flow properties in the duplex ultrasound image. We proved the feasibility of the simulator by performing an ultrasound-guided endovascular procedure. Overall, the simulator showed realistic intervention conditions., Conclusions: With the help of the constructed simulator, new endovascular procedures and navigation systems, such as ultrasound-guided peripheral vascular interventions, can be further developed. Additionally, in our opinion, the use of such simulators can also reduce the need for animal experiments., (Copyright © 2020 Elsevier GmbH. All rights reserved.)

Purpose: Endovascular interventions have become standard procedures for the therapy of abdominal aortic aneurysms. Therefore, endovascular surgeons need special skills which have to be learned and trained. Additionally, authentic simulators are needed for further development of new endovascular devices and procedures. The aim of this project was to develop an authentic and modular endovascular simulation environment with patient-specific vascular anatomy for training and research purposes., Material and Methods: We first designed a prototype with exchangeable 3D-printed patient-specific vascular anatomy. Then, the feasibility of the prototype was validated by a simulation of an EVAR procedure in a clinical setting., Results: We developed an authentic endovascular simulator with an exchangeable patient-specific vascular anatomy and performed an EVAR procedure under realistic conditions. The evaluation of the accuracy of the vascular models showed little deviation when compared with the original CT data., Conclusion: Endovascular simulators based on patient-specific 3D-printed vascular models can realistically mimic endovascular procedures and have the potential to be used for further development of new devices and grafts as well as for training purposes. Furthermore, in our opinion they can reduce the use of animals during developmental processes., (Copyright © 2020 Elsevier GmbH. All rights reserved.)

Purpose: During endovascular aneurysm repair (EVAR) procedures, medical instruments are guided with two-dimensional (2D) fluoroscopy and conventional digital subtraction angiography. However, this requires X-ray exposure and contrast agent is used, and the depth information is missing. To overcome these drawbacks, a three-dimensional (3D) guidance approach based on tracking systems is introduced and evaluated., Methods: A multicore fiber with fiber Bragg gratings for shape sensing and three electromagnetic (EM) sensors for locating the shape were integrated into a stentgraft system. A model for obtaining the located shape of the first 38 cm of the stentgraft system with two EM sensors is introduced and compared with a method based on three EM sensors. Both methods were evaluated with a vessel phantom containing a 3D-printed vessel made of silicone and agar-agar simulating the surrounding tissue., Results: The evaluation of the guidance methods resulted in average errors from 1.35 to 2.43 mm and maximum errors from 3.04 to 6.30 mm using three EM sensors, and average errors from 1.57 to 2.64 mm and maximum errors from 2.79 to 6.27 mm using two EM sensors. Moreover, the videos made from the continuous measurements showed that a real-time guidance is possible with both approaches., Conclusion: The results showed that an accurate real-time guidance with two and three EM sensors is possible and that two EM sensors are already sufficient. Thus, the introduced 3D guidance method is promising to use it as navigation tool in EVAR procedures. Future work will focus on developing a method with less EM sensors and a detailed latency evaluation of the guidance method.

Introduction: Endovascular aortic repair (EVAR) is a minimal-invasive technique that prevents life-threatening rupture in patients with aortic pathologies by implantation of an endoluminal stent graft. During the endovascular procedure, device navigation is currently performed by fluoroscopy in combination with digital subtraction angiography. This study presents the current iterative process of biomedical engineering within the disruptive interdisciplinary project Nav EVAR , which includes advanced navigation, image techniques and augmented reality with the aim of reducing side effects (namely radiation exposure and contrast agent administration) and optimising visualisation during EVAR procedures. This article describes the current prototype developed in this project and the experiments conducted to evaluate it., Methods: The current approach of the Nav EVAR project is guiding EVAR interventions in real-time with an electromagnetic tracking system after attaching a sensor on the catheter tip and displaying this information on Microsoft HoloLens glasses. This augmented reality technology enables the visualisation of virtual objects superimposed on the real environment. These virtual objects include three-dimensional (3D) objects (namely 3D models of the skin and vascular structures) and two-dimensional (2D) objects [namely orthogonal views of computed tomography (CT) angiograms, 2D images of 3D vascular models, and 2D images of a new virtual angioscopy whose appearance of the vessel wall follows that shown in ex vivo and in vivo angioscopies]. Specific external markers were designed to be used as landmarks in the registration process to map the tracking data and radiological data into a common space. In addition, the use of real-time 3D ultrasound (US) is also under evaluation in the Nav EVAR project for guiding endovascular tools and updating navigation with intraoperative imaging. US volumes are streamed from the US system to HoloLens and visualised at a certain distance from the probe by tracking augmented reality markers. A human model torso that includes a 3D printed patient-specific aortic model was built to provide a realistic test environment for evaluation of technical components in the Nav EVAR project. The solutions presented in this study were tested by using an US training model and the aortic-aneurysm phantom., Results: During the navigation of the catheter tip in the US training model, the 3D models of the phantom surface and vessels were visualised on HoloLens. In addition, a virtual angioscopy was also built from a CT scan of the aortic-aneurysm phantom. The external markers designed for this study were visible in the CT scan and the electromagnetically tracked pointer fitted in each marker hole. US volumes of the US training model were sent from the US system to HoloLens in order to display them, showing a latency of 259±86 ms (mean±standard deviation)., Conclusion: The Nav EVAR project tackles the problem of radiation exposure and contrast agent administration during EVAR interventions by using a multidisciplinary approach to guide the endovascular tools. Its current state presents several limitations such as the rigid alignment between preoperative data and the simulated patient. Nevertheless, the techniques shown in this study in combination with fibre Bragg gratings and optical coherence tomography are a promising approach to overcome the problems of EVAR interventions., (©2018 García-Vázquez V., et al., published by De Gruyter, Berlin/Boston.)