A Steerable and Electromagnetically Tracked Catheter: Navigation Performance Compared With Image Fusion in a Swine Model.

PURPOSE: Cannulation of visceral vessels is necessary during fenestrated and branched endovascular aortic repair. In an attempt to reduce the associated radiation and contrast dose, an electromagnetically (EM) trackable and manually steerable catheter has been developed. The purpose of this preclinical swine study was to evaluate the cannulation performance and compare the cannulation performance using either EM tracking or image fusion as navigation tools. MATERIALS AND METHODS: Both renal arteries, the superior mesenteric artery, and the celiac trunk were attempted to be cannulated using a 7F steerable, EM trackable catheter in 3 pigs. Seven operators attempted cannulation using first 3-dimensional (3D) image navigation with EM tracking and then conventional image fusion guidance. The rate of successful cannulation was recorded, as well as procedure time and radiation exposure. Due to the lack of an EM trackable guidewire, cannulations that required more than 1 attempt were attempted only with image fusion. The EM tracking position data were registered to preoperative 3D images using a vessel-based registration algorithm. RESULTS: A total of 72 cannulations were attempted with both methods, and 79% (57) were successful on the first attempt for both techniques. There was no difference in cannulation rate (p=1), and time-use was similar. Successful cannulation with image fusion was achieved in 97% of cases when multiple attempts were allowed. CONCLUSION: This study demonstrated the feasibility of a steerable and EM trackable catheter with 3D image navigation. Navigation performance with EM tracking was similar to image fusion, without statistically significant differences in cannulation rates and procedure times. Further studies are needed to demonstrate this utility in patients with aortic disease. CLINICAL IMPACT: Electromagnetic tracking in combination with a novel steerable catheter reduces radiation and contrast media doses while providing three-dimensional visualization and agile navigation during endovascular aortic procedures.

Vessel-based rigid registration for endovascular therapy of the abdominal aorta.

BACKGROUND: Combining electromagnetic tracking of instruments with preoperatively acquired images can provide detailed visualization for intraoperative guidance and reduce the need for fluoroscopy and contrast. In this study, we investigated the accuracy of a vessel-based registration method designed for matching preoperative image and electromagnetically tracked positions for endovascular therapy. MATERIAL AND METHODS: An open-source registration method was used to match the centerline extracted from computed tomography (CT) to electromagnetically tracked positions within a vascular phantom representing the abdominal aorta with bifurcations. The target registration error (TRE) was calculated for 11 fiducials distributed over the phantom. Median and intra-quartile range (IQR) for 30 registrations was reported. TRE < 5 mm was claimed sufficient for endovascular navigation, evaluated using the Wilcoxon signed-rank test. TRE was also compared to a 3D-3D registration method based on intraoperative cone-beam CT, using the Mann-Whitney U-test. RESULTS: The TRE was 3.75 (IQR: 3.48-3.99) mm for the centerline registration algorithm and 3.21 (IQR: 1.50-3.57) mm for the 3D-3D method (p < .001). For both methods, the TRE was significantly < 5 mm (p < .001). CONCLUSION: The centerline registration method was feasible, with an accuracy sufficient for navigation in endovascular therapy. The centerline method avoids additional image acquisition for registration purpose only.

Pulmonologist evaluation on new CT visualization for guidance to lung lesions during bronchoscopy.

OBJECTIVE: Endoluminal visualization in virtual and video bronchoscopy lacks information about the surrounding structures, and the traditional 2 D axial, coronal and sagittal CT views can be difficult to interpret. To address this challenge, we previously introduced a novel visualization technique, Anchored to Centerline Curved Surface, for navigated bronchoscopy. The current study compares the ACCuSurf to the standard ACS CT views as planning and guiding tools in a phantom study. MATERIAL AND METHODS: Bronchoscope operators navigated in physical phantom guided by virtual realistic image data constructed by fusion of CT dataset of phantom and anonymized patient CT data. We marked four different target positions within the virtual image data and gave 12 pulmonologists the task to navigate, with either ACCuSurf or ACS as guidance, to the corresponding targets in the physical phantom. RESULTS: Using ACCuSurf reduced the planning time and increased the grade of successful navigation significantly compared to ACS. CONCLUSION: The phantom setup with virtual patient image data proved realistic according to the pulmonologists. ACCuSurf proved superior to ACS regarding planning time and navigation success grading. Improvements on visualisation or display techniques may consequently improve both planning and navigated bronchoscopy and thus contribute to more precise lung diagnostics.

Endovascular navigation in patients: vessel-based registration of electromagnetic tracking to preoperative images.

Electromagnetic tracking of instruments combined with preoperative images can supplement fluoroscopy for guiding endovascular aortic repair (EVAR). The aim of this study was to evaluate the in-vivo accuracy of a vessel-based registration algorithm for matching electromagnetically tracked positions of an endovascular instrument to preoperative computed tomography angiography. Five patients undergoing elective EVAR were included, and a clinically available semi-automatic 3D-3D registration algorithm, based on similarity measures computed over the entire image, was used for reference. Accuracy was reported as target registration error (TRE) evaluated in manually selected anatomic landmarks on bony structures, placed close to the volume-of-interest. The median TRE was 8.2 mm (range: 7.1 mm to 16.1 mm) for the vessel-based registration algorithm, compared to 2.2 mm (range: 1.8 mm to 3.7 mm) for the reference algorithm. This illustrates that registration based on intraoperative electromagnetic tracking is feasible, but the accuracy must be improved before clinical use.

Vessel-based CTA-image to spatial anatomy registration using tracked catheter position data: preclinical evaluation of in vivo accuracy.

Electromagnetic tracking of endovascular instruments has the potential to substantially decrease radiation exposure of patients and personnel. In this study, we evaluated the in vivo accuracy of a vessel-based method to register preoperative computed tomography angiography (CTA) images to physical coordinates using an electromagnetically tracked guidewire. Centerlines of the aortoiliac arteries were extracted from preoperative CTA acquired from five swine. Intravascular positions were obtained from an electromagnetically tracked guidewire. An iterative-closest-point algorithm registered the position data to the preoperative image centerlines. To evaluate the registration accuracy, a guidewire was placed inside the superior mesenteric, left and right renal arteries under fluoroscopic guidance. Position data was acquired with electromagnetic tracking as the guidewire was pulled into the aorta. The resulting measured positions were compared to the corresponding ostia manually identified in the CTA images after applying the registration. The three-dimensional (3D) Euclidean distances were calculated between each corresponding ostial point, and the root mean square (RMS) was calculated for each registration. The median 3D RMS for all registrations was 4.82 mm, with an interquartile range of 3.53-6.14 mm. A vessel-based registration of CTA images to vascular anatomy is possible with acceptable accuracy and encourages further clinical testing. RELEVANCE STATEMENT: This study shows that the centerline algorithm can be used to register preoperative CTA images to vascular anatomy, with the potential to further reduce ionizing radiation exposure during vascular procedures. KEY POINTS: Preoperative images can be used to guide the procedure without ionizing intraoperative imaging. Preoperative imaging can be the only imaging modality used for guidance of vascular procedures. No need to use external fiducial markers to register/match images and spatial anatomy. Acceptable accuracy can be achieved for navigation in a preclinical setting.

Accuracy of instrument tip position using fiber optic shape sensing for navigated bronchoscopy.

The purpose of this study was to evaluate the accuracy of a method for estimating the tip position of a fiber optic shape-sensing (FOSS) integrated instrument being inserted through a bronchoscope. A modified guidewire with a multicore optical fiber was inserted into the working channel of a custom-made catheter with three electromagnetic (EM) sensors. The displacement between the instruments was manually set, and a point-based method was applied to match the position of the EM sensors to corresponding points on the shape. The accuracy was evaluated in a realistic bronchial model. An additional EM sensor was used to sample the tip of the guidewire, and the absolute deviation between this position and the estimated tip position was calculated. For small displacements between the tip of the FOSS integrated tool and the catheter, the median deviation in estimated tip position was ≤5 mm. For larger displacements, deviations exceeding 10 mm were observed. The deviations increased when the shape sensor had sharp curvatures relative to more straight shapes. The method works well for clinically relevant displacements of a biopsy tool from the bronchoscope tip, and when the path to the lesion has limited curvatures. However, improvements must be made to our configuration before pursuing further clinical testing.

Accuracy of electromagnetic tracking with a prototype field generator in an interventional OR setting.

PURPOSE: The authors have studied the accuracy and robustness of a prototype electromagnetic window field generator (WFG) in an interventional radiology suite with a robotic C-arm. The overall purpose is the development of guidance systems combining real-time imaging with tracking of flexible instruments for bronchoscopy, laparoscopic ultrasound, endoluminal surgery, endovascular therapy, and spinal surgery. METHODS: The WFG has a torus shape, which facilitates x-ray imaging through its centre. The authors compared the performance of the WFG to that of a standard field generator (SFG) under the influence of the C-arm. Both accuracy and robustness measurements were performed with the C-arm in different positions and poses. RESULTS: The system was deemed robust for both field generators, but the accuracy was notably influenced as the C-arm was moved into the electromagnetic field. The SFG provided a smaller root-mean-square position error but was more influenced by the C-arm than the WFG. The WFG also produced smaller maximum and variance of the error. CONCLUSIONS: Electromagnetic (EM) tracking with the new WFG during C-arm based fluoroscopy guidance seems to be a step forward, and with a correction scheme implemented it should be feasible.

Three-dimensional electromagnetic navigation vs. fluoroscopy for endovascular aneurysm repair: a prospective feasibility study in patients.

PURPOSE: To evaluate the in vivo feasibility of a 3-dimensional (3D) electromagnetic (EM) navigation system with electromagnetically-tracked catheters in endovascular aneurysm repair (EVAR). METHODS: The pilot study included 17 patients undergoing EVAR with a bifurcated stent-graft. Ten patients were assigned to the control group, in which a standard EVAR procedure was used. The remaining 7 patients (intervention group) underwent an EVAR procedure during which a cone-beam computed tomography image was acquired after implantation of the main stent-graft. The 3D image was presented on the navigation screen. From the contralateral side, the tip of an electromagnetically-tracked catheter was visualized in the 3D image and positioned in front of the contralateral cuff in the main stent-graft. A guidewire was inserted through the catheter and blindly placed into the stent-graft. The placement of the guidewire was verified by fluoroscopy before the catheter was pushed over the guidewire. If the guidewire was incorrectly placed outside the stent-graft, the procedure was repeated. Successful placement of the guidewire had to be achieved within a 15-minute time limit. RESULTS: Within 15 minutes, the guidewire was placed correctly inside the stent-graft in 6 of 7 patients in the intervention group and in 8 of 10 patients in the control group. In the intervention group, fewer attempts were needed to insert the guidewire correctly. CONCLUSION: A 3D EM navigation system, used in conjunction with fluoroscopy and angiography, has the potential to provide more spatial information and reduce the use of radiation and contrast during endovascular interventions. This pilot study showed that 3D EM navigation is feasible in patients undergoing EVAR. However, a larger study must be performed to determine if 3D EM navigation is better than the existing practice for these patients.

Three-dimensional endovascular navigation with electromagnetic tracking: ex vivo and in vivo accuracy.

PURPOSE: To evaluate the accuracy of a 3-dimensional (3D) navigation system using electromagnetically tracked tools to explore its potential in patients. METHODS: The 3D navigation accuracy was quantified on a phantom and in a porcine model using the same setup and vascular interventional suite. A box-shaped phantom with 16 markers was scanned in 5 different positions using computed tomography (CT). The 3D navigation system registered each CT volume in the magnetic field. A tracked needle was pointed at the physical markers, and the spatial distances between the tracked needle positions and the markers were calculated. Contrast-enhanced CT images were acquired from 6 swine. The 3D navigation system registered each CT volume in the magnetic field. An electromagnetically tracked guidewire and catheter were visualized in the 3D image and navigated to 4 specified targets. At each target, the spatial distance between the tracked guidewire tip position and the actual position, verified by a CT control, was calculated. RESULTS: The mean accuracy on the phantom was 1.28±0.53 mm, and 90% of the measured distances were ≤1.90 mm. The mean accuracy in swine was 4.18±1.76 mm, and 90% of the measured distances were ≤5.73 mm. CONCLUSION: This 3D navigation system demonstrates good ex vivo accuracy and is sufficiently accurate in vivo to explore its potential for improved endovascular navigation.

Endovascular image-guided navigation: validation of two volume-volume registration algorithms.

The limited volume covered by intraoperatively acquired CT scans makes the use of navigation systems difficult. Preoperative images cover a larger volume of interest. Hence, reliable registration of high quality preoperative to intraoperative CT will provide the necessary image information required for navigation. This study evaluates two algorithms (Siemens, CAMP) for volume-volume registration for usage during endovascular navigation. Twenty patients treated for abdominal aortic aneurysm were scanned with pre-, intra- and postoperative CT. Six data sets were excluded due to variations in image acquisition parameters and severe artifacts. Fourteen intra- and postoperative datasets were registered ten times with both algorithms, altogether 140 registrations for each program. In all data sets five specified landmarks placed by two radiologists were used to evaluate registration accuracy. The distance between the paired landmarks in the registered intra- and postoperative volumes was measured and the root mean square value calculated. Reference registrations were based on rigid body registration of the five landmarks in the intra- and postoperative volumes. Registration accuracy (mean ± SD) was for Siemens 5.05 ± 4.74 mm, for CAMP 4.02 ± 1.52 mm and for the reference registrations 2.72 ± 1.18 mm. The registration algorithms differed significantly, p < 0.001.

A novel research platform for electromagnetic navigated bronchoscopy using cone beam CT imaging and an animal model.

Electromagnetic guided bronchoscopy is a new field of research, essential for the development of advanced investigation of the airways and lung tissue. Consecutive problem-based solutions and refinements are urgent requisites to achieve improvements. For that purpose, our intention is to build a complete research platform for electromagnetic guided bronchoscopy. The experimental interventional electromagnetic field tracking system in conjunction with a C-arm cone beam CT unit is presented in this paper. The animal model and the navigation platform performed well and the aims were achieved; the 3D localization of foreign bodies and their navigated and tracked removal, assessment of tracking accuracy that showed a high level of precision, and assessment of image quality. The platform may prove to be a suitable platform for further research and development and a full-fledged electromagnetic guided bronchoscopy navigation system. The inclusion of the C-arm cone beam CT unit in the experimental setup adds a number of new possibilities for diagnostic procedures and accuracy measurements. Among other future challenges that need to be solved are the interaction between the C-arm and the electromagnetic navigation field, as we demonstrate in this feasibility study.

Efficiency of ultrasound training simulators: method for assessing image realism.

Although ultrasound has become an important imaging modality within several medical professions, the benefit of ultrasound depends to some degree on the skills of the person operating the probe and interpreting the image. For some applications, the possibility to educate operators in a clinical setting is limited, and the use of training simulators is considered an alternative approach for learning basic skills. To ensure the quality of simulator-based training, it is important to produce simulated ultrasound images that resemble true images to a sufficient degree. This article describes a method that allows corresponding true and simulated ultrasound images to be generated and displayed side by side in real time, thus facilitating an interactive evaluation of ultrasound simulators in terms of image resemblance, real-time characteristics and man-machine interaction. The proposed method could be used to study the realism of ultrasound simulators and how this realism affects the quality of training, as well as being a valuable tool in the development of simulation algorithms.

Using the CustusX toolkit to create an image guided bronchoscopy application: Fraxinus.

PURPOSE: The aim of this paper is to show how a specialized planning and guidance application called Fraxinus, can be built on top of the CustusX platform (www.custusx.org), which is an open source image-guided intervention software platform. Fraxinus has been customized to meet the clinical needs in navigated bronchoscopy. METHODS: The application requirements for Fraxinus were defined in close collaboration between research scientists, software developers and clinicians (pulmonologists), and built on top of CustusX. Its superbuild system downloads specific versions of the required libraries and builds them for the application in question, including the selected plugins. New functionality is easily added through the plugin framework. The build process enables the creation of specialized applications, adding additional documentation and custom configurations. The toolkit's libraries offer building blocks for image-guided applications. An iterative development process was applied, where the clinicians would test and provide feedback during the entire process. RESULTS: Fraxinus has been developed and is released as an open source planning and guidance application built on top of CustusX. It is highly specialized for bronchoscopy. The proposed workflow is adapted to the different steps in this procedure. The user interface of CustusX has been modified to enhance information, quality assurance and user friendliness with the intention to increase the overall yield for the patient. As the workflow of the procedure is relatively constant, some actions are predicted and automatically performed by the application, according to the requirements from the clinicians. CONCLUSIONS: The CustusX platform facilitates development of new and specialized applications. The toolkit supports the process and makes important extension and injection points available for customization.

Manually Steerable Catheter With Improved Agility.

PURPOSE: A prototype steerable catheter was designed for endovascular procedures. This technical pilot study reports the initial experience using the catheter for cannulation of visceral arteries. TECHNIQUE: The 7F catheter was manually steerable with operator control handle for bending and rotation of the tip. The maximum bending angle was approximately 90° and full 360° rotation of the tip was supported. The study involved 1 pig with 4 designated target arteries: the left and right renal arteries, the superior mesenteric artery, and the celiac trunk. Fluoroscopy with 3-dimensional (3D) overlay showing the ostia from preoperative computed tomography angiography was used for image guidance. The cannulation was considered successful if the guidewire was placed well inside the target artery. In addition to evaluating cannulation success, procedure time and associated radiation doses were recorded. The procedure was performed twice with 2 different operators. CONCLUSIONS: Both operators successfully reached all 4 target arteries, demonstrating the feasibility of the steerable catheter for endovascular cannulation of visceral arteries. No contrast medium was used, and median radiation dose was 4.5 mGy per cannulation. An average of approximately 2 minutes was used per cannulation. This study motivates further testing in a more comprehensive study to evaluate reproducibility in several animals and with inclusion of more operators. Further development by integrating the new catheter tool in a navigation system is also an interesting next step, combining fine control of catheter tip movements and 3D image guidance without ionizing radiation.

Laboratory test of Single Landmark registration method for ultrasound-based navigation in laparoscopy using an open-source platform.

PURPOSE: Test the feasibility of the novel Single Landmark image-to-patient registration method for use in the operating room for future clinical trials. The algorithm is implemented in the open-source platform CustusX, a computer-aided intervention research platform dedicated to intraoperative navigation and ultrasound, with an interface for laparoscopic ultrasound probes. METHODS: The Single Landmark method is compared to fiducial landmark on an IOUSFAN (Kyoto Kagaku Co., Ltd., Japan) soft tissue abdominal phantom and T2 magnetic resonance scans of it. RESULTS: The experiments show that the accuracy of the Single Landmark registration is good close to the registered point, increasing with the distance from this point (12.4 mm error at 60 mm away from the registered point). In this point, the registration accuracy is mainly dominated by the accuracy of the user when clicking on the ultrasound image. In the presented set-up, the time required to perform the Single Landmark registration is 40% less than for the FLRM. CONCLUSION: The Single Landmark registration is suitable for being integrated in a laparoscopic workflow. The statistical analysis shows robustness against translational displacements of the patient and improvements in terms of time. The proposed method allows the clinician to accurately register lesions intraoperatively by clicking on these in the ultrasound image provided by the ultrasound transducer. The Single Landmark registration method can be further combined with other more accurate registration approaches improving the registration at relevant points defined by the clinicians.

Electromagnetic navigation versus fluoroscopy in aortic endovascular procedures: a phantom study.

PURPOSE: To explore the possible benefits of electromagnetic (EM) navigation versus conventional fluoroscopy during abdominal aortic endovascular procedures. METHODS: The study was performed on a phantom representing the abdominal aorta. Intraoperative cone beam computed tomography (CBCT) of the phantom was acquired and merged with a preoperative multidetector CT (MDCT). The CBCT was performed with a reference plate fixed to the phantom that, after merging the CBCT with the MDCT, facilitated registration of the MDCT volume with the EM space. An EM field generator was stationed near the phantom. Navigation software was used to display EM-tracked instruments within the 3D image volume. Fluoroscopy was performed using a C-arm system. Five operators performed a series of renal artery cannulations using modified instruments, alternatingly using fluoroscopy or EM navigation as the sole guidance method. Cannulation durations and associated radiation dosages were noted along with the number of cannulations complicated by loss of guidewire insertion. RESULTS: A total of 120 cannulations were performed. The median cannulation durations were 41.5 and 34.5 s for the fluoroscopy- and EM-guided cannulations, respectively. No significant difference in cannulation duration was found between the two modalities (p = 0.736). Only EM navigation showed a significant reduction in cannulation duration in the latter half of its cannulation series compared with the first half (p = 0.004). The median dose area product for fluoroscopy was 0.0836 [Formula: see text]. EM-guided cannulations required a one-time CBCT dosage of 3.0278 [Formula: see text]. Three EM-guided and zero fluoroscopy-guided cannulations experienced loss of guidewire insertion. CONCLUSION: Our findings indicate that EM navigation is not inferior to fluoroscopy in terms of the ability to guide endovascular interventions. Its utilization may be of particular interest in complex interventions where adequate visualization or minimal use of contrast agents is critical. In vivo studies featuring an optimized implementation of EM navigation should be conducted.

Registration of Real-Time 3-D Ultrasound to Tomographic Images of the Abdominal Aorta.

The purpose of this study was to develop an image-based method for registration of real-time 3-D ultrasound to computed tomography (CT) of the abdominal aorta, targeting future use in ultrasound-guided endovascular intervention. We proposed a method in which a surface model of the aortic wall was segmented from CT, and the approximate initial location of this model relative to the ultrasound volume was manually indicated. The model was iteratively transformed to automatically optimize correspondence to the ultrasound data. Feasibility was studied using data from a silicon phantom and in vivo data from a volunteer with previously acquired CT. Through visual evaluation, the ultrasound and CT data were seen to correspond well after registration. Both aortic lumen and branching arteries were well aligned. The processing was done offline, and the registration took approximately 0.2 s per ultrasound volume. The results encourage further patient studies to investigate accuracy, robustness and clinical value of the approach.

CustusX: an open-source research platform for image-guided therapy.

PURPOSE: CustusX is an image-guided therapy (IGT) research platform dedicated to intraoperative navigation and ultrasound imaging. In this paper, we present CustusX as a robust, accurate, and extensible platform with full access to data and algorithms and show examples of application in technological and clinical IGT research. METHODS: CustusX has been developed continuously for more than 15 years based on requirements from clinical and technological researchers within the framework of a well-defined software quality process. The platform was designed as a layered architecture with plugins based on the CTK/OSGi framework, a superbuild that manages dependencies and features supporting the IGT workflow. We describe the use of the system in several different clinical settings and characterize major aspects of the system such as accuracy, frame rate, and latency. RESULTS: The validation experiments show a navigation system accuracy of [Formula: see text]1.1 mm, a frame rate of 20 fps, and latency of 285 ms for a typical setup. The current platform is extensible, user-friendly and has a streamlined architecture and quality process. CustusX has successfully been used for IGT research in neurosurgery, laparoscopic surgery, vascular surgery, and bronchoscopy. CONCLUSIONS: CustusX is now a mature research platform for intraoperative navigation and ultrasound imaging and is ready for use by the IGT research community. CustusX is open-source and freely available at http://www.custusx.org.

Probe calibration for freehand 3-D ultrasound.

Ultrasound (US) probe calibration establishes the rigid body transformation between the US image and a tracking device attached to the probe. This is an important requirement for correct 3-D reconstruction of freehand US images and, thus, for accurate surgical navigation based on US. In this study, we evaluated three methods for probe calibration, based on a single-point phantom, a wire-cross phantom requiring 2-D alignment and a wire phantom for freehand scanning. The processing of acquired data is fairly common to these methods and, to a great extent, based on automated procedures. The evaluation is based on quality measures in 2-D and 3-D reconstructed data. With each of the three methods, we calibrated a linear-array probe, a phased-array sector probe and an intraoperative probe. The freehand method performed best, with a 3-D navigation accuracy of 0.6 mm for one of the probes. This indicates that clinical accuracy in the order of 1 mm may be achieved in US-based surgical navigation.