Automatic Registration and Error Color Maps to Improve Accuracy for Navigated Bone Tumor Surgery Using Intraoperative Cone-Beam CT.

Computer-assisted surgery (CAS) can improve surgical precision in orthopaedic oncology. Accurate alignment of the patient's imaging coordinates with the anatomy, known as registration, is one of the most challenging aspects of CAS and can be associated with substantial error. Using intraoperative, on-the-table, cone-beam computed tomography (CBCT), we performed a pilot clinical study to validate a method for automatic intraoperative registration. Methods: Patients who were ≥18 years of age, had benign bone tumors, and underwent resection were prospectively enrolled. In addition to inserting a navigation tracking tool into the exposed bone adjacent to the surgical field, 2 custom plastic ULTEM tracking tools (UTTs) were attached to each patient's skin adjacent to the tumor using an adhesive. These were automatically localized within the 3-dimensional CBCT volume to be used as image landmarks for registration, and the corresponding tracker landmarks were captured using an infrared camera. The main outcomes were the fiducial registration error (FRE) and the target registration error (TRE). The navigation time was recorded. Results: Thirteen patients with benign tumors in the femur (n = 10), tibia (n = 2), and humerus (n = 1) underwent navigation-assisted resections. The mean values were 0.67 ± 0.15 mm (range, 0.47 to 0.97 mm) for FRE and 0.83 ± 0.51 mm (range, 0.42 to 2.28 mm) for TRE. Registration was successful in all cases. The mean time for CBCT imaging and tracker registration was 7.5 minutes. Conclusions: We present a novel automatic registration method for CAS exploiting intraoperative CBCT capabilities, which provided improved accuracy and reduced operative times compared with more traditional methods. Clinical Relevance: This proof-of-principle study validated a novel process for automatic registration to improve the accuracy of resecting bone tumors using a surgical navigation system.

Navigation-Guided Transnasal Endoscopic Delineation of the Posterior Margin for Maxillary Sinus Cancers: A Preclinical Study.

BACKGROUND: The resection of advanced maxillary sinus cancers can be challenging due to the anatomical proximity to surrounding critical anatomical structures. Transnasal endoscopy can effectively aid the delineation of the posterior margin of resection. Implementation with 3D-rendered surgical navigation with virtual endoscopy (3D-SNVE) may represent a step forward. This study aimed to demonstrate and quantify the benefits of this technology. MATERIAL AND METHOD: Four maxillary tumor models with critical posterior extension were created in four artificial skulls (Sawbones®). Images were acquired with cone-beam computed tomography and the tumor and carotid were contoured. Eight head and neck surgeons were recruited for the simulations. Surgeons delineated the posterior margin of resection through a transnasal approach and avoided the carotid while establishing an adequate resection margin with respect to tumor extirpation. Three simulations were performed: 1) unguided: based on a pre-simulation study of cross-sectional imaging; 2) tumor-guided: guided by real-time tool tracking with 3D tumor and carotid rendering; 3) carotid-guided: tumor-guided with a 2-mm alert cloud surrounding the carotid. Distances of the planes from the carotid and tumor were classified as follows and the points of the plane were classified accordingly: "red": through the carotid artery; "orange": <2 mm from the carotid; "yellow": >2 mm from the carotid and within the tumor or <5 mm from the tumor; "green": >2 mm from the carotid and 5-10 mm from the tumor; and "blue": >2 mm from the carotid and >10 mm from the tumor. The three techniques (unguided, tumor-guided, and carotid-guided) were compared. RESULTS: 3D-SNVE for the transnasal delineation of the posterior margin in maxillary tumor models significantly improved the rate of margin-negative clearance around the tumor and reduced damage to the carotid artery. "Green" cuts occurred in 52.4% in the unguided setting versus 62.1% and 64.9% in the tumor- and carotid-guided settings, respectively (p < 0.0001). "Red" cuts occurred 6.7% of the time in the unguided setting versus 0.9% and 1.0% in the tumor- and carotid-guided settings, respectively (p < 0.0001). CONCLUSIONS: This preclinical study has demonstrated that 3D-SNVE provides a substantial improvement of the posterior margin delineation in terms of safety and oncological adequacy. Translation into the clinical setting, with a meticulous assessment of the oncological outcomes, will be the proposed next step.

In situ tissue pathology from spatially encoded mass spectrometry classifiers visualized in real time through augmented reality.

Integration between a hand-held mass spectrometry desorption probe based on picosecond infrared laser technology (PIRL-MS) and an optical surgical tracking system demonstrates in situ tissue pathology from point-sampled mass spectrometry data. Spatially encoded pathology classifications are displayed at the site of laser sampling as color-coded pixels in an augmented reality video feed of the surgical field of view. This is enabled by two-way communication between surgical navigation and mass spectrometry data analysis platforms through a custom-built interface. Performance of the system was evaluated using murine models of human cancers sampled in situ in the presence of body fluids with a technical pixel error of 1.0 ± 0.2 mm, suggesting a 84% or 92% (excluding one outlier) cancer type classification rate across different molecular models that distinguish cell-lines of each class of breast, brain, head and neck murine models. Further, through end-point immunohistochemical staining for DNA damage, cell death and neuronal viability, spatially encoded PIRL-MS sampling is shown to produce classifiable mass spectral data from living murine brain tissue, with levels of neuronal damage that are comparable to those induced by a surgical scalpel. This highlights the potential of spatially encoded PIRL-MS analysis for in vivo use during neurosurgical applications of cancer type determination or point-sampling in vivo tissue during tumor bed examination to assess cancer removal. The interface developed herein for the analysis and the display of spatially encoded PIRL-MS data can be adapted to other hand-held mass spectrometry analysis probes currently available.

Feasibility study of navigated endoscopy for the placement of high dose rate brachytherapy applicators in the esophagus and lung.

PURPOSE: To evaluate the electromagnetic (EM) tracking of endoscopes and applicators as a method of positioning a high dose rate (HDR) luminal applicator. METHOD: An anatomical phantom consisting of a rigid trachea and flexible esophagus was used to compare applicator placement measurements using EM tracking vs the traditional method using two-dimensional (2D) fluoroscopy and surface skin markers. The phantom included a tumor in the esophagus and several pairs of optically visible points inside the lumen that were used to simulate proximal and distal ends of tumors of varying lengths. The esophagus tumor and lung points were visible on a computed tomography (CT) image of the phantom, which was used as ground truth for the measurements. The EM tracking system was registered to the CT image using fiducial markers. A flexible endoscope was tracked using the EM system and the locations of the proximal and distal ends of the tumor identified and this position recorded. An EM-tracked applicator was then inserted and positioned relative to the tumor markings. The applicator path was mapped using the EM tracking. The gross tumor length (GTL) and the distance between the first dwell position and distal edge of tumor (offset) were measured using the EM tracking and 2D fluoroscopy methods and compared to the same measurements on the CT image. RESULTS: The errors in GTL using EM tracking were on average -0.5 ± 1.7 mm and 0.7 ± 3.6 mm for esophagus and lung measurements, similar to errors measured using the 2D fluoroscopy method of -0.9 ± 1.2 mm and 3.4 ± 4.4 mm. Offset measurements were slightly larger while using EM tracking relative to the fluoroscopy method but these were not statistically significant. CONCLUSIONS: Electromagnetic tracking for placement of lumen applicators is feasible and accurate. Tracking of the endoscope that is used to identify the proximal and distal ends of the tumor and of the applicator during insertion generates accurate three-dimensional measurements of the applicator path, GTL and offset. Guiding the placement of intraluminal applicators using EM navigation is potentially attractive for cases with complex insertions, such as those with nonlinear paths or multiple applicator insertions.

Intraoperative cone-beam CT-guided osteotomy navigation in mandible and maxilla surgery.

OBJECTIVES: Surgical navigation systems based on preoperative imaging are now increasingly used for guidance of head and neck resection and reconstruction. The primary aim of this study was to quantify osteotomy cutting accuracy using an image-guidance system for intraoperative cone-beam computed tomography (CBCT) imaging and surgical saw navigation. To enable clinical translation of this CBCT-guided navigation system, a secondary aim of the study was to design and fabricate a patient reference tracker suitable for clinical use on a mobile mandible. METHODS: First, a preclinical cadaveric study was performed to quantify navigation accuracy with the use of clinically suitable patient reference trackers. Second, a proof-of-principle patient study was conducted to evaluate this technique under clinical conditions. RESULTS: In both preclinical (5 cadavers) and clinical (5 patients) experiments, the mean cutting accuracy was less than 2 mm. In all preclinical specimens, bilateral mandibulectomies and bilateral maxillectomies were performed, for a total of 20 cut planes for analysis. The mean (standard deviation [SD]) values for distance, pitch, and roll were 1.4 mm (1.1 mm), 4.2° (3.5°), and 2.9° (2.5°) mm, respectively. Five mandibulectomies were performed on five patients, for a total of 10 cut planes for analysis. The mean (SD) values for distance, pitch, and roll were 1.7 mm (0.8 mm), 5.4° (1.5°), and 6.7° (4.6°) mm, respectively. CONCLUSIONS: The overall performance in comparison to alternative approaches warrants further consideration. In terms of accuracy, the results presented here are comparable to recent systematic reviews assessing CAD-CAM cutting guides that cite accuracies of ~2 to 2.5 mm. LEVEL OF EVIDENCE: 2 Laryngoscope, 130:1122-1127, 2020.

Quantitative anatomical comparison of transnasal and transcranial approaches to the clivus.

BACKGROUND AND OBJECTIVE: The clivus was defined as "no man's land" in the early 1990s, but since then, multiple approaches have been described to access it. This study is aimed at quantitatively comparing endoscopic transnasal and microsurgical transcranial approaches to the clivus in a preclinical setting, using a recently developed research method. METHODS: Multiple approaches were performed in 5 head and neck specimens that underwent high-resolution computed tomography (CT): endoscopic transnasal (transclival, with hypophysiopexy and with far-medial extension), microsurgical anterolateral (supraorbital, mini-pterional, pterional, pterional transzygomatic, fronto-temporal-orbito-zygomatic), lateral (subtemporal and subtemporal transzygomatic), and posterolateral (retrosigmoid, far-lateral, retrolabyrinthine, translabyrinthine, and transcochlear). An optic neuronavigation system and dedicated software were used to quantify the working volume of each approach and calculate the exposure of different clival regions. Mixed linear models with random intersections were used for statistical analyses. RESULTS: Endoscopic transnasal approaches showed higher working volume and larger exposure compared with microsurgical transcranial approaches. Increased exposure of the upper clivus was achieved by the transnasal endoscopic transclival approach with intradural hypophysiopexy. Anterolateral microsurgical transcranial approaches provided a direct route to the anterior surface of the posterior clinoid process. The transnasal endoscopic approach with far-medial extension ensured a statistically larger exposure of jugular tubercles as compared with other approaches. Presigmoid approaches provided a relatively limited exposure of the ipsilateral clivus, which increased in proportion to their invasiveness. CONCLUSIONS: This is the first anatomical study that quantitatively compares in a holistic way exposure and working volumes offered by the most used modern approaches to the clivus.

Navigation-guided osteotomies improve margin delineation in tumors involving the sinonasal area: A preclinical study.

OBJECTIVES: To demonstrate and quantify, in a preclinical setting, the benefit of three-dimensional (3D) navigation guidance for margin delineation during ablative open surgery for advanced sinonasal cancer. MATERIALS AND METHODS: Seven tumor models were created. 3D images were acquired with cone beam computed tomography, and 3D tumor segmentations were contoured. Eight surgeons with variable experience were recruited for the simulation of osteotomies. Three simulations were performed: 1) Unguided, 2) Guided using real-time tool tracking with 3D tumor segmentation (tumor-guided), and 3) Guided by 3D visualization of both the tumor and 1-cm margin segmentations (margin-guided). Analysis of cutting planes was performed and distance from the tumor surface was classified as follows: "intratumoral" when 0 mm or negative, "close" when greater than 0 mm and less than or equal to 5 mm, "adequate" when greater than 5 mm and less than or equal to 15 mm, and "excessive" over 15 mm. The three techniques (unguided, tumor-guided, margin-guided) were statistically compared. RESULTS: The use of 3D navigation for margin delineation significantly improved control of margins: unguided cuts had 18.1% intratumoral cuts compared to 0% intratumoral cuts with 3D navigation (p < 0.0001). CONCLUSION: This preclinical study has demonstrated the significant benefit of navigation-guided osteotomies for sinonasal tumors. Translation into the clinical setting - with rigorous assessment of oncological outcomes - would be the proposed next step.

The image-guided operating room-Utility and impact on surgeon's performance in the head and neck surgery.

BACKGROUND: The image-guided operating room (OR) is an emerging standard for dealing with complex cases in many surgical disciplines including neurosurgery, thoracic surgery, maxillofacial trauma, and orthopedic surgery. Its use in head and neck oncological surgery is not well established. The primary aim of this study was to assess the image quality of cone-beam CT (CBCT) under real clinical conditions. The secondary aim was to assess the effect on surgical performance and decision making. METHODS: Intraoperative 3D imaging was performed using a CBCT capable C-Arm mounted on a multi-axis robot (Siemens Zeego) in the image-guided OR. All patients had immediate preoperative imaging taken with further intraoperative imaging performed as required. Ten initial patients, comprising 28 intraoperative scans, were used for questionnaire-based image reviews conducted with experienced head and neck clinicians. Scans were assessed for aspects of both image quality and clinical utility, on separate 5-point Likert scales (1-5). RESULTS: The median rating for bony detail was 4 out of 5. Vascular detail was increased (P < 10-8 ) from 1 to 3 with the use of IV contrast (region of interest CT# was 284 HU [SD, 47 HU]). Images were rated as 4 for freedom from artifact. Soft tissue definition was 2, with no significant improvement (P = .2) with the addition of IV iodinated contrast. Surgeons rated the greatest clinical utility (4) for the CBCT when assessing postreconstruction imaging of a complex case. CONCLUSIONS: The image quality of CBCT in the image-guided OR is good for bony detail and complex oncological reconstructions in the head and neck setting but probably has limited benefit for intraoperative soft tissue delineation. Future studies must also focus on clinical outcomes to help demonstrate the value of the image-guided OR.

Endonasal and Transoral Approaches to the Craniovertebral Junction: A Quantitative Anatomical Study.

BACKGROUND: The endoscopic endonasal approach has recently been added to the surgical armamentarium to access the anterior craniovertebral junction (CVJ). Comparative analyses with the transoral approach are scarce. The aim of this study was to provide a quantitative anatomical analysis of both approaches. METHODS: In four specimens the endoscopic endonasal approach (before and after sphenoidectomy) and the transoral approach (without and with a soft palate split) were performed. ApproachViewer-part of GTx-UHN (Guided Therapeutics software, developed at University Health Network, Toronto, ON, Canada)-was used to quantify and visualize the working volume, as well as the exposed area, of each surgical approach. Different modalities (crossing and non-crossing) were used to quantify the exposure of the deep surface, providing an indirect quantitative value of the 'surgical freedom'. The lowest point exposed by the endonasal approaches was compared with that predicted by preoperative radiological lines. Non-parametric Welch analysis of variance (ANOVA) was used for statistical analyses. RESULTS: The working volume was significantly larger and the distance to the target was shorter with the transoral approaches than with the endonasal approaches. Clival exposure was better with the endonasal approaches than with the non-crossing transoral approach without a soft palate split; areas below C1 were better exposed with the transoral routes. The nasoaxial line best predicted surgical exposure with the endonasal approaches. CONCLUSION: Endoscopic endonasal and transoral approaches to the anterior CVJ provide optimal exposure of different areas that overlap at the level of C1 when no anatomical anomalies are present. A split of the soft palate is not necessary during the transoral approach if it is combined with an endoscopic endonasal approach.

Volumetric Analysis of Endoscopic and Maxillary Swing Surgical Approaches for Nasopharyngectomy.

Objectives/Hypothesis The endoscopic endonasal approach (EEA) for nasopharyngectomy is an alternative to the maxillary swing approach (MSA) for selected recurrent nasopharyngeal carcinomas (NPC). We compare the access between these approaches. Methods Three cadaver specimens were used to compare access volumes of the EEA and MSA. Exposure volumes were calculated using image guidance registration to cone beam computed tomography and tracking of accessible tissue with volumetric quantification. The area of exposure to the carotid artery was measured. Results The MSA provided higher volumes for access volume compared with the EEA (66.6 vs 39.1 cm 3 , p = 0.009). The working area was larger in the MSA (80.2 vs 56.9 cm 2 , p = 0.06). The exposure to the carotid artery was higher in the MSA (1.88 vs 1.62 cm 2 , p = 0.04). The MSA provided larger volume of exposure for tumors of the parapharyngeal space with exposure below the palate. Conclusions This study suggests that the MSA for nasopharyngectomy provides a larger volume of exposure. However, much of the increased exposure relates to exposure of the parapharyngeal space below the palate. The EEA provides adequate access to superior anatomical structures.

Cone-Beam Computed Tomography-Guided Navigation in Complex Osteotomies Improves Accuracy at All Competence Levels: A Study Assessing Accuracy and Reproducibility of Joint-Sparing Bone Cuts.

BACKGROUND: The objective of this study was to assess the accuracy and reproducibility of a novel cone-beam computed tomography (CBCT)-guided navigation system designed for osteotomies with joint-sparing bone cuts. METHODS: Eighteen surgeons participated in this study. First, 3 expert tumor surgeons resected bone tumors in 3 Sawbones tumor models identical to actual patient scenarios. They first performed these osteotomies without navigation and then performed them using a navigation system and 3-dimensional (3D) planning tools based on CBCT imaging. The 2 sets of measurements were compared using image-based measurements from post-resection CBCT. Next, 15 residents, fellows, and orthopaedic staff surgeons were instructed on the use of the system, and their navigated resections were compared with navigated resections performed by the 3 expert tumor surgeons. RESULTS: One hundred and twenty-six navigated cuts done by the orthopaedic oncologists were compared with 126 non-navigated cuts by the same surgeons. The cuts violated the tumor in 22% (6) of the 27 non-navigated resections compared with none of the 27 navigated resections. The navigated cuts were significantly more accurate in terms of entry point, pitch, and roll (p < 0.001). The variation among the 3 surgeons when they used navigation was <0.6 mm for the entry cut and, on average, 1.5° for pitch and roll. All 18 surgeons then completed a total of 144 navigated cuts. The level of experience did not result in a significant difference among groups with regard to cut accuracy. Two cuts went into the tumor. The mean distance from the planned bone cuts to the actual entry points into bone was 1.5 mm (standard deviation [SD] = 1.4 mm) for all users. The mean difference in pitch and roll between the planned and actual cuts was 3.5° (SD = 2.8°) and 3.7° (SD = 3.2°) for all users. CONCLUSIONS: Even in expert hands, navigated cuts were significantly more accurate than non-navigated cuts. When the osteotomies were aided by navigation, their accuracy did not differ according to the level of professional experience. CBCT-based metrics enable intraoperative assessments of cut accuracy and reconstruction planning. CLINICAL RELEVANCE: CBCT-guided navigated osteotomies can improve accuracy regardless of surgeon experience and decrease the variability among different surgeons.

Intraoperative image guidance in transoral robotic surgery: A pilot study.

BACKGROUND: Intraoperative image guidance during transoral robotic surgery (TORS) is hampered by imaging-friendly instrumentation and intraoperative positioning. The purpose of this study was to develop and validate an accurate image-guidance system for TORS. METHODS: A custom radiolucent mouth retractor was fabricated from biocompatible material (Med-610; Stratasys, Minneapolis, MN). Teflon beads were placed in the oropharynx and carotid arteries of 3 cadavers. CT scans were obtained in the preoperative and intraoperative positions. Displacement of targets between preoperative and intraoperative scans was measured. Surgical navigation was based on the open-source Image-Guided Surgery Toolkit. Target registration error (TRE) was determined by measuring the distance between the tracker and bead registered to preoperative versus intraoperative scans. RESULTS: The inferior oropharyngeal targets demonstrated the greatest displacement between positions. A significant reduction in TRE was observed when registering the tracker to the intraoperative compared to the preoperative scan. CONCLUSION: This study describes an accurate intraoperative image-guidance system for TORS.

Two-Dimensional High Definition Versus Three-Dimensional Endoscopy in Endonasal Skull Base Surgery: A Comparative Preclinical Study.

BACKGROUND AND OBJECTIVE: Three-dimensional (3D) endoscopy has been recently introduced in endonasal skull base surgery. Only a relatively limited number of studies have compared it to 2-dimensional, high definition technology. The objective was to compare, in a preclinical setting for endonasal endoscopic surgery, the surgical maneuverability of 2-dimensional, high definition and 3D endoscopy. METHODS: A group of 68 volunteers, novice and experienced surgeons, were asked to perform 2 tasks, namely simulating grasping and dissection surgical maneuvers, in a model of the nasal cavities. Time to complete the tasks was recorded. A questionnaire to investigate subjective feelings during tasks was filled by each participant. In 25 subjects, the surgeons' movements were continuously tracked by a magnetic-based neuronavigator coupled with dedicated software (ApproachViewer, part of GTx-UHN) and the recorded trajectories were analyzed by comparing jitter, sum of square differences, and funnel index. RESULTS: Total execution time was significantly lower with 3D technology (P < 0.05) in beginners and experts. Questionnaires showed that beginners preferred 3D endoscopy more frequently than experts. A minority (14%) of beginners experienced discomfort with 3D endoscopy. Analysis of jitter showed a trend toward increased effectiveness of surgical maneuvers with 3D endoscopy. Sum of square differences and funnel index analyses documented better values with 3D endoscopy in experts. CONCLUSIONS: In a preclinical setting for endonasal skull base surgery, 3D technology appears to confer an advantage in terms of time of execution and precision of surgical maneuvers.

Quantification of Working Volumes, Exposure, and Target-Specific Maneuverability of the Pterional Craniotomy and Its Minimally Invasive Variants.

OBJECTIVE: Quantitative comparison of minimally invasive and standard cranial approaches remains a methodologic challenge. The aim of this study was to apply a new digital, navigation-based method to quantify multiple parameters of the pterional, supraorbital, lateral supraorbital and mini-pterional approaches and to describe a target-specific maneuverability score. METHODS: Supraorbital, lateral supraorbital, mini-pterional, and standard pterional craniotomies were performed on 8 sides in 4 cadaver heads. The limits of superficial and deep exposure and surgical target points were registered with image-guidance (Medtronic Stealth). A custom software (Guided Therapeutics Eyes II Software [GTxEyesII]) calculated superficial and deep surface areas, working volumes, and target distances. Volumes were reconstructed digitally and visualized with GTxEyesII. Finally, we defined for each approach a target-specific maneuverability score based on surface exposure, target distance, target position, and anatomical obstacles. RESULTS: Surface exposure and volumes were significantly smaller for keyhole approaches compared with standard pterional craniotomy (P < 0.01). Maneuverability index scores showed the greatest values for standard pterional craniotomies, but nearly equally high scores could be achieved by one or several of the less-invasive approaches for most of the targets. CONCLUSIONS: The combination of a navigation-based measurement method with custom software (GTxEyesII) provides a powerful tool for visualization and quantification of surgical approaches. Compared with standard pterional craniotomy, alternative keyhole craniotomies offer comparable deep exposure with smaller working volumes and relatively high maneuverability for specific targets.

Accuracy and reproducibility of virtual cutting guides and 3D-navigation for osteotomies of the mandible and maxilla.

BACKGROUND: We set out to determine the accuracy of 3D-navigated mandibular and maxillary osteotomies with the ultimate aim to integrate virtual cutting guides and 3D-navigation into ablative and reconstructive head and neck surgery. METHODS: Four surgeons (two attending, two clinical fellows) completed 224 unnavigated and 224 3D-navigated osteotomies on anatomical models according to preoperative 3D plans. The osteotomized bones were scanned and analyzed. RESULTS: Median distance from the virtual plan was 2.1 mm unnavigated (IQR 2.6 mm, ≥3 mm in 33%) and 1.2 mm 3D-navigated (IQR 1.1 mm, ≥3 mm in 6%) (P<0.0001); median pitch was 4.5° unnavigated (IQR 7.1°) and 3.5° 3D-navigated (IQR 4.0°) (P<0.0001); median roll was 7.4° unnavigated (IQR 8.5°) and 2.6° 3D-navigated (IQR 3.8°) (P<0.0001). CONCLUSION: 3D-rendering enables osteotomy navigation. 3 mm is an appropriate planning distance. The next steps are translating virtual cutting guides to free bone flap reconstruction and clinical use.

Real-time continuous image-guided surgery: Preclinical investigation in glossectomy.

OBJECTIVES/HYPOTHESIS: To develop, validate, and study the efficacy of an intraoperative real-time continuous image-guided surgery (RTC-IGS) system for glossectomy. STUDY DESIGN: Prospective study. METHODS: We created a RTC-IGS system and surgical simulator for glossectomy, enabling definition of a surgical target preoperatively, real-time cautery tracking, and display of a surgical plan intraoperatively. System performance was evaluated by a group of otolaryngology residents, fellows, medical students, and staff under a reproducible setting by using realistic tongue phantoms. Evaluators were grouped into a senior and a junior group based on surgical experience, and guided and unguided tumor resections were performed. National Aeronautics and Space Administration Task Load Index (NASA-TLX) scores and a Likert scale were used to measure workloads and impressions of the system, respectively. Efficacy was studied by comparing surgical accuracy, time, collateral damage, and workload between RTC-IGS and non-navigated resections. RESULTS: The senior group performed more accurately (80.9% ± 3.7% vs. 75.2% ± 5.5%, P = .28), required less time (5.0 ± 1.3 minutes vs. 7.3 ± 1.2 minutes, P = .17), and experienced lower workload (43 ± 2.0 vs. 64.4 ± 1.3 NASA-TLX score, P = .08), suggesting a trend of construct validity. Impressions were favorable, with participants reporting the system is a valuable practice tool (4.0/5 ± 0.3) and increases confidence (3.9/5 ± 0.4). Use of RTC-IGS improved both groups' accuracy, with the junior group improving from 64.4% ± 5.4% to 75.2% ± 5.5% (P = .01) and the senior group improving from 76.1% ± 4.5% to 80.9% ± 3.7% (P = .16). CONCLUSIONS: We created an RTC-IGS system and surgical simulator and demonstrated a trend of construct validity. Our navigated simulator allows junior trainees to practice glossectomies outside the operating room. In all evaluators, navigation assistance resulted in increased surgical accuracy. LEVEL OF EVIDENCE: NA Laryngoscope, 127:E347-E353, 2017.

Three-dimensional virtual navigation versus conventional image guidance: A randomized controlled trial.

OBJECTIVES/HYPOTHESIS: Providing image guidance in a 3-dimensional (3D) format, visually more in keeping with the operative field, could potentially reduce workload and lead to faster and more accurate navigation. We wished to assess a 3D virtual-view surgical navigation prototype in comparison to a traditional 2D system. METHODS: Thirty-seven otolaryngology surgeons and trainees completed a randomized crossover navigation exercise on a cadaver model. Each subject identified three sinonasal landmarks with 3D virtual (3DV) image guidance and three landmarks with conventional cross-sectional computed tomography (CT) image guidance. Subjects were randomized with regard to which side and display type was tested initially. Accuracy, task completion time, and task workload were recorded. RESULTS: Display type did not influence accuracy (P > 0.2) or efficiency (P > 0.3) for any of the six landmarks investigated. Pooled landmark data revealed a trend of improved accuracy in the 3DV group by 0.44 millimeters (95% confidence interval [0.00-0.88]). High-volume surgeons were significantly faster (P < 0.01) and had reduced workload scores in all domains (P < 0.01), but they were no more accurate (P > 0.28). CONCLUSION: Real-time 3D image guidance did not influence accuracy, efficiency, or task workload when compared to conventional triplanar image guidance. The subtle pooled accuracy advantage for the 3DV view is unlikely to be of clinical significance. Experience level was strongly correlated to task completion time and workload but did not influence accuracy. LEVEL OF EVIDENCE: N/A. Laryngoscope, 126:1510-1515, 2016.

Optically-tracked handheld fluorescence imaging platform for monitoring skin response in the management of soft tissue sarcoma.

Standard clinical management of extremity soft tissue sarcomas includes surgery with radiation therapy. Wound complications (WCs) arising from treatment may occur due to bacterial infection and tissue breakdown. The ability to detect changes in these parameters during treatment may lead to earlier interventions that mitigate WCs. We describe the use of a new system composed of an autofluorescence imaging device and an optical three-dimensional tracking system to detect and coregister the presence of bacteria with radiation doses. The imaging device visualized erythema using white light and detected bacterial autofluorescence using 405-nm excitation light. Its position was tracked relative to the patient using IR reflective spheres and registration to the computed tomography coordinates. Image coregistration software was developed to spatially overlay radiation treatment plans and dose distributions on the white light and autofluorescence images of the surgical site. We describe the technology, its use in the operating room, and standard operating procedures, as well as demonstrate technical feasibility and safety intraoperatively. This new clinical tool may help identify patients at greater risk of developing WCs and investigate correlations between radiation dose, skin response, and changes in bacterial load as biomarkers associated with WCs.

Minimally invasive electro-magnetic navigational bronchoscopy-integrated near-infrared-guided sentinel lymph node mapping in the porcine lung.

BACKGROUND: The use of near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) for sentinel lymph node (SN) mapping has been investigated in lung cancer; however, this has not been fully adapted for minimally invasive surgery (MIS). The aim of our study was to develop a minimally invasive SN mapping integrating pre-operative electro-magnetic navigational bronchoscopy (ENB)-guided transbronchial ICG injection and intraoperative NIR thoracoscopic imaging. METHODS: A NIR thoracoscope was used to visualize ICG fluorescence. ICG solutions in a 96-well plate and ex vivo porcine lungs were examined to optimize ICG concentrations and injection volumes. Transbronchial ICG injection (n=4) was assessed in comparison to a traditional transpleural approach (n=3), where after thoracotomy an ICG solution (100 µL at 100 µg/mL) was injected into the porcine right upper lobe for SN identification. For further translation into clinical use, transbronchial ICG injection prior to thoracotomy followed by NIR thoracoscopic imaging was validated (n=3). ENB was used for accurate targeting in two pigs with a pseudo-tumor. RESULTS: The ICG fluorescence at 10 µg/mL was the brightest among various concentrations, unchanged by the distance between the thoracoscope and ICG solutions. Injected ICG of no more than 500µ L showed a localized fluorescence area. All 7 pigs showed a bright paratracheal lymph node within 15 minutes post-injection, with persistent fluorescence for 60 minutes. The antecedent transbronchial ICG injection succeeded in SN identification in all 3 cases at the first thoracoscopic inspection within 20 minutes post-injection. The ENB system allowed accurate ICG injection surrounding the pseudo-tumors. CONCLUSIONS: ENB-guided ICG injection followed by NIR thoracoscopy was technically feasible for SN mapping in the porcine lung. This promising platform may be translated into human clinical trials and is suited for MIS.

Navigated pelvic osteotomy and tumor resection: a study assessing the accuracy and reproducibility of resection planes in Sawbones and cadavers.

BACKGROUND: This Sawbones and cadaver study was performed to assess the accuracy and reproducibility of pelvic bone cuts made with use of a novel navigation system with a navigated osteotome and oscillating saw. METHODS: Using a novel navigation system and a three-dimensional planning tool, we navigated pelvic bone cuts that were representative of typical cuts made in pelvic tumor resections. The system includes a prototype mobile C-arm for intraoperative cone-beam computed tomography, real-time optical tracking (Polaris), and three-dimensional visualization software. Three-dimensional virtual radiographs were utilized in addition to triplanar (axial, sagittal, and coronal) navigation. In part one of the study, we navigated twenty-four sacral bone cuts in Sawbones models and validated our results in sixteen similar cuts in cadavers. In part two, we developed three Sawbones models of pelvic tumors based on actual patient scenarios and compared three navigated resections with three non-navigated resections for each tumor model. Part three assessed the accuracy of the system with multiple users. RESULTS: There were ninety navigated cuts in Sawbones that were compared with fifty-four non-navigated cuts. In the navigated Sawbones cuts, the mean entry and exit cuts were 1.4 ± 1 mm and 1.9 ± 1.2 mm from the planned cuts, respectively. In comparison, the entry and exit cuts in Sawbones that were not navigated were 2.8 ± 4.9 mm and 3.5 ± 4.6 mm away from the planned osteotomy site. The navigated cuts were significantly more accurate (p ≤ 0.01). In the cadaver study, navigated entry and exit cuts were 1.5 ± 0.9 mm and 2.1 ± 1.5 mm from the planned cuts. The variation among three different users was 1 mm on both the entry and exit cuts. CONCLUSIONS: Navigation to guide pelvic bone cuts is accurate and feasible. Three-dimensional radiographs should be used for improved accuracy. Navigated cuts were significantly more accurate than non-navigated cuts were. A margin of 5 mm between the target tumor volume and the planned cut plane would result in a negative margin resection in more than 95% of the cuts. CLINICAL RELEVANCE: The accuracy of pelvic bone tumor resections and pelvic osteotomies can be improved with navigation to within 5 mm of the planned cut.