Aortic roadmapping during EVAR: a combined FEM-EM tracking feasibility study.

PURPOSE: Currently, the intra-operative visualization of vessels during endovascular aneurysm repair (EVAR) relies on contrast-based imaging modalities. Moreover, traditional image fusion techniques lack a continuous and automatic update of the vessel configuration, which changes due to the insertion of stiff guidewires. The purpose of this work is to develop and evaluate a novel approach to improve image fusion, that takes into account the deformations, combining electromagnetic (EM) tracking technology and finite element modeling (FEM). METHODS: To assess whether EM tracking can improve the prediction of the numerical simulations, a patient-specific model of abdominal aorta was segmented and manufactured. A database of simulations with different insertion angles was created. Then, an ad hoc sensorized tool with three embedded EM sensors was designed, enabling tracking of the sensors' positions during the insertion phase. Finally, the corresponding cone beam computed tomography (CBCT) images were acquired and processed to obtain the ground truth aortic deformations of the manufactured model. RESULTS: Among the simulations in the database, the one minimizing the in silico versus in vitro discrepancy in terms of sensors' positions gave the most accurate aortic displacement results. CONCLUSIONS: The proposed approach suggests that the EM tracking technology could be used not only to follow the tool, but also to minimize the error in the predicted aortic roadmap, thus paving the way for a safer EVAR navigation.

Early and mid-term results after endovascular repair of thoracoabdominal aortic aneurysms using the off-the-shelf multibranched t-Branch device: a national multi-center study.

Objective: The multibranched off-the-shelf Zenith® t-Branch (Cook Medical, Bloomington, IN) device is commonly chosen for endovascular repair of thoracoabdominal aortic aneurysms. The aim of this study was to report early and mid-term outcomes in all patients treated with the t-Branch in Norway; Design and Methods: A retrospective multicenter study with Norwegian centers performing complex endovascular aortic repair was undertaken. T-Branch patients from 2014 to 2020 were included. All postoperative computed tomography angiography images were reviewed, and demographic, anatomical, perioperative and follow-up data were analyzed; Results: Seventy patients were treated in a single-step (n = 55) or staged (n = 15) procedure. Symptomatic presentation was seen in 20 patients, six of which had a contained rupture. Technical success was 87% (n = 59), with failures caused by unsuccessful bridging of target vessels (n = 4), target vessel bleeding (n = 3), persisting type 1c endoleak (n = 1) and t-Branch malrotation (n = 1). 30-day mortality was 9% (n = 6) and was associated with high BMI (p = .038). The spinal cord ischemia rate was 21% (n = 15) and was associated with type II aneurysms (OR 5.4, 95% CI 1.1-26.7, p = .04), smoking (OR 6.0, 95% CI 1.3-27.6, p = .02) and intraoperative blood loss (OR 1.1, 95% CI 1.0-1.3, p = .01). Survival at one, two and three years was 84 ± 4%, 70 ± 6% and 67 ± 6%, respectively. Freedom from aortic-related reinterventions at one, two and three years was 80 ± 5%, 65 ± 7% and 50 ± 8%, respectively; Conclusion: The study showed low early mortality (9%) and satisfactory mid-term survival. Technical success was achieved in acceptable 87% of procedures. The rate of spinal cord ischemia was high, occurring in 21% of patients.

This paper provides a national experience of all TAAA patients treated with the multibranched t-Branch stent graft in Norway in a multi-center study. As we aimed at including all Norwegian patients operated with the device, the paper adds real-world data on t-Branch outcomes from four regional smaller-volume vascular centers.The paper provides technical and clinical mid-term results with several patients being followed up for >3 years.Technical success was achieved in 87% of procedures.The 30-day mortality rate was 9% and survival at one, two and three years was 85 ± 4%, 70 ± 6% and 67 ± 6%, respectively.Spinal cord ischemia was associated with Crawford type II aneurysms, smoking and intraoperative blood loss.

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.

A Retrospective Evaluation of Intra-Prosthetic Thrombus Formation After Endovascular Aortic Repair in Cook Zenith Alpha and Medtronic Endurant II Patients.

OBJECTIVE: To investigate the occurrence of limb graft occlusion (LGO) and intra-prosthetic thrombus (IPT) formation in Zenith Alpha and Endurant II stent graft limbs. METHODS: A single centre retrospective study was conducted on patients treated with the Zenith Alpha and Endurant II stent grafts between 2017 and 2019. All post-operative computed tomography angiography images were re-investigated for thrombus formation. Demographic, aneurysm, and stent graft data were collected and compared. LGO was defined as complete occlusion or significant stenosis (≥ 50% lumen diameter reduction). Logistic regression on pro-thrombotic risk factors was conducted. Freedom from LGO and overall limb IPT were compared using Kaplan-Meier analyses. RESULTS: Seventy-eight Zenith Alpha and eighty-six Endurant II patients were studied. The median follow up was 33 (IQR 25, 44) months for Zenith Alpha patients and 36 (IQR 22, 46) months for Endurant II patients (p = .53). LGO was seen in 15% (n = 12) of Zenith Alpha patients and 5% (n = 4) of Endurant II patients (p = .032), and freedom from LGO was significantly higher among Endurant II patients (p = .024). The Zenith Alpha stent graft was an independent risk factor for LGO (OR 3.9, 95% CI 1.1 - 13.4; p = .032). Among Zenith Alpha patients, limb flare compression within the main body gate was over represented in LGO patients (p = .011). There was no difference in freedom from overall limb IPT between the stent graft systems. For Endurant II limbs, IPT was significantly less common in the integrated ipsilateral limbs (without ETLW/ETEW stent graft limbs) (p = .044). Main endograft body IPT was correlated with overall limb IPT (p = .035). CONCLUSION: LGO was significantly more common among Zenith Alpha than Endurant II patients. Zenith Alpha limbs was an independent risk factor for LGO. There was no difference between stent grafts in overall limb IPT formation.

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.

Midterm Outcomes for Endovascular Repair of Thoraco-Abdominal Aortic Aneurysms.

Objective: To investigate technical and clinical outcomes in patients with thoraco-abdominal aortic aneurysms treated with the multibranched off the shelf Zenith t-Branch stent graft or a custom made device (CMD). Methods: A retrospective study was conducted of patients operated on at a single tertiary vascular centre in Norway. Twenty eight t-Branch and 17 CMD patients were identified. Demographic, aneurysm, and peri-operative data were summarised and compared. Results: Thirty day mortality was 4% (2/45), with mortality rates of 7% (2/28) and 0 in t-Branch and CMD patients, respectively (p = .52). Technical success was 87% (39/45), with a non-significant difference between t-Branch and CMD procedures of 89% (25/28) and 82% (14/17), respectively (p = .63). Stent graft coverage was significantly longer in t-Branch patients (p = .020). Paraparesis or paraplegia developed in 18% (5/28) of t-Branch patients and 12% (2/17) of CMD patients (p = .69), and spinal cord ischaemia was associated with Crawford type II aneurysms (p = .010) and aortic coverage >400 mm (p = .050). The estimated survival at one and two years for t-Branch patients was 93% and 88%, and 100% and 92% for CMD patients. Freedom from re-intervention was estimated at 70% and 43% at one and two years for t-Branch patients, and 58% and 50% for CMD patients. Conclusion: The study showed low 30 day mortality rates, acceptable technical success rates, high medium term survival, and no statistically significant differences in clinically relevant outcomes between t-Branch and CMD patients.

Influence of patient-specific rehearsal on operative metrics and technical success for endovascular aneurysm repair.

INTRODUCTION: Patient-specific rehearsal (PsR) is a recent technology within virtual reality (VR) simulation that lets the operators train on patient-specific data in a simulated environment prior to the procedure. Endovascular aneurysm repair (EVAR) is a complex procedure where operative metrics and technical success might improve after PsR. MATERIAL AND METHODS: We compared technical success and operative metrics (endovascular procedure time, contralateral gate cannulation time, fluoroscopy time, total radiation dose, number of angiograms and contrast medium use) between 30 patients, where the operators performed PsR (the PsR group), and 30 patients without PsR (the control group). RESULTS: The endovascular procedure time was significantly shorter in the PsR group than in the control group (median 44 versus 55 min, p = .017). The other operative metrics were similar. Technical success rates were higher in the PsR group, 96.7% primary and assisted primary outcome versus 90.0% in the control group. The differences were not significant (p = .076). CONCLUSIONS: PsR before EVAR reduced endovascular procedure time, and our results indicate that it might improve technical success, but further studies are needed to confirm those results.

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.

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.

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.

A new removable airway stent.

BACKGROUND: Malignant airway obstruction is a feared complication and will most probably occur more frequently in the future because of increasing cancer incidence and increased life expectancy in cancer patients. Minimal invasive treatment using airway stents represents a meaningful and life-saving palliation. We present a new removable airway stent for improved individualised treatment. METHODS: To our knowledge, the new airway stent is the world's first knitted and uncovered self-expanding metal stent, which can unravel and be completely removed. In an in vivo model using two anaesthetised and spontaneously breathing pigs, we deployed and subsequently removed the stents by unravelling the device. The procedures were executed by flexible bronchoscopy in an acute and a chronic setting - a 'proof-of-principle' study. RESULTS: The new stent was easily and accurately deployed in the central airways, and it remained fixed in its original position. It was easy to unravel and completely remove from the airways without clinically significant complications. During the presence of the stent in the chronic study, granulation tissue was induced. This tissue disappeared spontaneously with the removal. CONCLUSIONS: The new removable stent functioned according to its purpose and unravelled easily, and it was completely removed without significant technical or medical complications. Induced granulation tissue disappeared spontaneously. Further studies on animals and humans are needed to define its optimal indications and future use.

Disocclusion-based 2D-3D registration for aortic interventions.

Occlusions introduced by medical instruments affect the accuracy and robustness of existing intensity-based medical image registration algorithms. In this paper, we present disocclusion-based 2D-3D registration handling occlusion and dissimilarity during registration. Therefore, we introduce two disocclusion techniques, Spline Interpolation and Stent-editing, and two robust similarity measures, Huber and Tukey Gradient Correlation. Our techniques are validated on synthetic and real interventional data and compared with well-known approaches. Results prove that an integration of disocclusion into the registration procedure yield higher accuracy and robustness. It is also shown that the robust measures have different effects depending on the type of occluding structure.

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.

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.

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.