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Desmoid tumors are rare, benign, but locally aggressive fibromatoses that pose significant therapeutic challenges, particularly when located in the head and neck region. This report details the case of an extensive cervical desmoid tumor dependent on the levator scapulae muscle and involving the vertebral artery managed through surgical resection and intraoperative navigation. A 45-year-old male presented with a slowly growing cervical mass. Imaging revealed an 83x68x40 mm mass in the right lateral paravertebral space, dependent on the levator scapulae muscle and involving the vertebral artery. Biopsy confirmed a low-grade fusocellular myofibroblastic neoplasm consistent with a desmoid tumor. Given the poor prognosis associated with the symptomatic mass, surgical resection was performed using Brainlab intraoperative navigation (Brainlab, Munich, Germany). The procedure was successful, with preservation of vital structures and no evidence of recurrence postoperatively. Desmoid tumors in the head and neck region, though rare, require precise diagnostic and therapeutic approaches due to their aggressive nature and proximity to critical anatomical structures. The use of intraoperative navigation, in this case, facilitated accurate tumor resection, minimizing damage to surrounding tissues. Pathological analysis revealed a CTNNB1 gene mutation, specifically the S45P variant, which is associated with an increased risk of recurrence. This case highlights the importance of a multidisciplinary approach, incorporating advanced surgical techniques and genetic analysis, in the management of complex desmoid tumors. Intraoperative navigation proved invaluable in achieving successful surgical outcomes, underscoring its potential utility in similar cases. Continued follow-up is essential, given the potential for recurrence associated with desmoid tumors.
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OBJECTIVE: This article outlines a scalable system developed by the All of Us Research Program's Genetic Counseling Resource to vet a large database of healthcare resources for supporting participants with health-related DNA results. MATERIALS AND METHODS: After a literature review of established evaluation frameworks for health resources, we created SONAR, a 10-item framework and grading scale for health-related participant-facing resources. SONAR was used to review clinical resources that could be shared with participants during genetic counseling. RESULTS: Application of SONAR shortened resource approval time from 7 days to 1 day. About 256 resources were approved and 8 rejected through SONAR review. Most approved resources were relevant to participants nationwide (60.0%). The most common resource types were related to support groups (20%), cancer care (30.6%), and general educational resources (12.4%). All of Us genetic counselors provided 1161 approved resources during 3005 (38.6%) consults, mainly to local genetic counselors (29.9%), support groups (21.9%), and educational resources (21.0%). DISCUSSION: SONAR's systematic method simplifies resource vetting for healthcare providers, easing the burden of identifying and evaluating credible resources. Compiling these resources into a user-friendly database allows providers to share these resources efficiently, better equipping participants to complete follow up actions from health-related DNA results. CONCLUSION: The All of Us Genetic Counseling Resource connects participants receiving health-related DNA results with relevant follow-up resources on a high-volume, national level. This has been made possible by the creation of a novel resource database and validation system.
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The navigational accuracy of sea animals and trans-ocean birds provides inspiration in using geo-magnetic field (GMF) for realizing strategic truly autonomous underwater vehicles (AUV) capable of determining their absolute position on earth, without the aid of ship-referenced acoustic baseline systems. Supervised Machine Learning algorithms are applied on the GMF intensity data obtained from NOAA World Magnetic Model for a 900 km2 within the Indian mineral exploratory area in the Central Indian Ocean, with a resolution of 50 m, considering the sensitivity of commercially available magnetometers. It is identified that, for AUVs equipped with magnetometers with a detection sensitivity of 0.1 nT, the supervisory random forest regression and decision tree algorithm trained with priori GMF data, could provide trajectory guidance to AUVs with an absolute mean position accuracy in 2D plane, with reference to the last known position from Integrated Navigation system aided initially with GPS and with acoustic positioning in underwater. Circular Error Probable (CEP 50) of 53 m and 56 m, respectively. The scalar GMF anomaly navigation demonstrated to be a viable GPS-alternative navigation system could be extended to larger areas with inclination and declination vectors, as unique identifiers.
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Endodontic access preparation is one of the initial steps in root canal treatments and can be hindered by the obliteration of pulp canals and formation of tertiary dentin. Until now, methods for direct intraoperative visualization of the 3-dimensional anatomy of teeth have been missing. Here, we evaluate the use of shortwave infrared radiation (SWIR) for navigation during stepwise access preparation. Nine teeth (3 anteriors, 3 premolars, and 3 molars) were explanted en bloc with intact periodontium including alveolar bone and mucosa from the upper or lower jaw of human body donors. Analysis was performed at baseline as well as at preparation depths of 5 mm, 7 mm, and 9 mm, respectively. For reflection, SWIR was used at a wavelength of 1,550 nm from the occlusal direction, whereas for transillumination, SWIR was passed through each sample at the marginal gingiva from the buccal as well as oral side at a wavelength of 1,300 nm. Pulpal structures could be identified as darker areas approximately 2 mm before reaching the pulp chamber using SWIR transillumination, although they were indistinguishable under normal circumstances. Furcation areas in molars appeared with higher intensity than areas with canals. The location of pulpal structures was confirmed by superimposition of segmented micro-computed tomography (µCT) images. By radiomic analysis, significant differences between pulpal and parapulpal areas could be detected in image features. With hierarchical cluster analysis, both segments could be confirmed and associated with specific clusters. The local thickness of µCTs was calculated and correlated with SWIR transillumination images, by which a linear dependency of thickness and intensity could be demonstrated. Lastly, by in silico simulations of light propagation, dentin tubules were shown to be a crucial factor for understanding the visibility of the pulp. In conclusion, SWIR transillumination may allow direct clinical live navigation during endodontic access preparation.
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BACKGROUND: This study introduced an Augmented Reality (AR) navigation system to address limitations in conventional high tibial osteotomy (HTO). The objective was to enhance precision and efficiency in HTO procedures, overcoming challenges such as inconsistent postoperative alignment and potential neurovascular damage. METHODS: The AR-MR (Mixed Reality) navigation system, comprising HoloLens, Unity Engine, and Vuforia software, was employed for pre-clinical trials using tibial sawbone models. CT images generated 3D anatomical models, projected via HoloLens, allowing surgeons to interact through intuitive hand gestures. The critical procedure of target tracking, essential for aligning virtual and real objects, was facilitated by Vuforia's feature detection algorithm. RESULTS: In trials, the AR-MR system demonstrated significant reductions in both preoperative planning and intraoperative times compared to conventional navigation and metal 3D-printed surgical guides. The AR system, while exhibiting lower accuracy, exhibited efficiency, making it a promising option for HTO procedures. The preoperative planning time for the AR system was notably shorter (4 min) compared to conventional navigation (30.5 min) and metal guides (75.5 min). Intraoperative time for AR lasted 8.5 min, considerably faster than that of conventional navigation (31.5 min) and metal guides (10.5 min). CONCLUSIONS: The AR navigation system presents a transformative approach to HTO, offering a trade-off between accuracy and efficiency. Ongoing improvements, such as the incorporation of two-stage registration and pointing devices, could further enhance precision. While the system may be less accurate, its efficiency renders it a potential breakthrough in orthopedic surgery, particularly for reducing unnecessary harm and streamlining surgical procedures.
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The histologic definition of peripheral pulmonary lesion (PPL) is critical for a correct diagnosis and appropriate therapy. Non-invasive techniques for PPL biopsy are imaging-guided, using endobronchial ultrasound (EBUS), computed tomography (CT), and electromagnetic navigation bronchoscopy (ENB). To assess the diagnostic accuracy of PPL biopsy and provide a framework for reporting data for accuracy studies of PPL biopsy. A systematic review was conducted on PubMed, Scopus, and Web of Science to identify all the articles assessing the accuracy of EBUS, CT, and ENB between January 2000 and June 2023 basing search queries on keywords emerging from PICO question. Only studies investigating biopsy of PPL and reporting accuracy or necessary data to calculate it independently were included. Risk of bias was based on QUADAS-2 tool. In total, 81 studies were included. Median accuracy was 0.78 (range=0.51-0.94) in the EBUS group, 0.91 (range=0.73-0.97) in the CT group, 0.72 (range=0.59-0.97) in the ENB group, and 0.77 (range=0.61-0.92) in the combined group. Sensitivity and NPV ranges were 0.35-0.94 and 0.26-0.88 in the EBUS group, 0.71-0.97 and 0.46-1.00 in the CT group, 0.55-0.96 and 0.32-0.90 in the ENB group, and 0.70-0.90 and 0.28-0.79 in the combined group. Specificity and PPV were 1.00 in almost all studies. Overall complication rate was 3%, 30%, 8%, and 5% in the EBUS, CT, ENB, and combined groups. CT-guided biopsy was the most accurate technique, although with the highest complication rate. When calculating accuracy, indeterminate results must be considered false negatives according to the "intention-to-diagnose" principle.
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STUDY DESIGN: Retrospective Cohort Study. OBJECTIVE: The aim of this study was to compare the efficacy of CT-based computer assisted navigation (CAN) to conventional pedicle screw placement for patients with Adolescent Idiopathic Scoliosis (AIS). METHODS: This retrospective cohort study drew data from the National Readmissions Database, years 2016-2019. Patients undergoing posterior fusion for AIS, either via CAN or fluoroscopic-guided procedures, were identified via ICD-10 codes. Multivariate regression was performed to compare outcomes between operative techniques. Negative binomial regression was used to asses discharge disposition, while Gamma regression was performed to assess length of stay (LOS) and total charges. Patient demographics and comorbidities, measured via the Elixhauser comorbidity index, were both controlled for in our regression analysis. RESULTS: 28,868 patients, 2095 (7.3%) undergoing a CAN procedure, were included in our analysis. Patients undergoing CAN procedures had increased surgical complications (Odds Ratio (OR) 2.23; P < 0.001), namely, blood transfusions (OR 2.47; P < 0.001). Discharge disposition and LOS were similar, as were reoperation and readmission rates; however, total charges were significantly greater in the CAN group (OR 1.37; P < 0.001). Mean charges were 191,489.42 (119,302.30) USD for conventional surgery vs 268 589.86 (105,636.78) USD for the CAN cohort. CONCLUSION: CAN in posterior fusion for AIS does not appear to decrease postoperative complications and is associated with an increased need for blood transfusions. Given the much higher total cost of care that was also seen with CAN, this study calls into question whether the use of CAN is justified in this setting.
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In 1985, Professor KWOH first introduced robots into neurosurgery. Since then, advancements of stereotactic frames, radiographic imaging and neuronavigation have led to the dominance of classic stereotactic robots. A comprehensive retrieval was performed using academic databases and search agents to acquire professional information, with a cutoff date of June, 2024. This reveals a multitude of emerging technologies are coming to the forefront, including tremor filtering, motion scaling, obstacle avoidance, force sensing, which have made significant contributions to the high efficiency, high precision, minimally invasive, and exact efficacy of robot-assisted neurosurgery. Those technologies have been applied in innovative magnetic resonance-compatible neurosurgical robots, such as Neuroarm and Neurobot, with real-time image-guided surgery. Despite these advancements, the major challenge is considered as magnetic resonance compatibility in terms of space, materials, driving, and imaging. Future research directions are anticipated to focus on (1) robotic precise perception; (2) artificial intelligence; and (3) the advancement of telesurgery.
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Klippel-Feil syndrome (KFS) is a congenital deformity of the cervical spine. Clinical symptoms of KFS are reduced range of motion, short neck and low hairline. In adult KFS patients the deformity can lead to adjacent segmental instability with spinal canal stenosis, radiculopathy and myelopathy. This article reports about the diagnostics and treatment management of juvenile KFS patient with myelopathy due to instability of the C1/C2 segment, subsequent stenosis through the posterior arch of C1 and symptomatic myelopathy. This 7year-old boy could be successfully treated with C1 decompression and computer tomography (CT) guided C1/C2 stabilization with pedicle screws under intraoperative neuromonitoring.
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PURPOSE: We introduce a novel approach for bronchoscopic navigation that leverages neural radiance fields (NeRF) to passively locate the endoscope solely from bronchoscopic images. This approach aims to overcome the limitations and challenges of current bronchoscopic navigation tools that rely on external infrastructures or require active adjustment of the bronchoscope. METHODS: To address the challenges, we leverage NeRF for bronchoscopic navigation, enabling passive endoscope localization from bronchoscopic images. We develop a two-stage pipeline: offline training using preoperative data and online passive pose estimation during surgery. To enhance performance, we employ Anderson acceleration and incorporate semantic appearance transfer to deal with the sim-to-real gap between training and inference stages. RESULTS: We assessed the viability of our approach by conducting tests on virtual bronchscopic images and a physical phantom against the SLAM-based methods. The average rotation error in our virtual dataset is about 3.18 ∘ and the translation error is around 4.95 mm. On the physical phantom test, the average rotation and translation error are approximately 5.14 ∘ and 13.12 mm. CONCLUSION: Our NeRF-based bronchoscopic navigation method eliminates reliance on external infrastructures and active adjustments, offering promising advancements in bronchoscopic navigation. Experimental validation on simulation and real-world phantom models demonstrates its efficacy in addressing challenges like low texture and challenging lighting conditions.
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INTRODUCTION: As the volume of technology-assisted total hip arthroplasty (THA) increases, there is a need to characterise the outcomes of robotic-assisted (RA) and computer-navigated (CN) THA. The goal of this study was to assess outcomes and opioid consumption following CN-THA and RA-THA compared to conventionally-instrumented (CON) THA. METHODS: The Premier Database was queried for all patients who underwent primary, elective THA from 2015-2020. Patients were divided into 3 groups: CN, RA, or CON-THA. Yearly usage trends were assessed. Univariate and multivariate analyses were performed to assess the 90-day risk of postoperative complications. Opioid consumption was reported in morphine milligram equivalents (MME) for postoperative days (POD) 0 and 1. RESULTS: Overall, 474,707 elective THAs were identified (95.7% CON, 2.1% CN, 2.2% RA. After accounting for confounders, CN-THA patients were at decreased risk for periprosthetic joint infection (PJI) (aOR: 0.55, p < 0.001) and dislocation (aOR 0.45, p < 0.001), but increased risk for blood transfusion (aOR 1.97, <0.001) compared to CON-THA. RA-THA patients were at decreased risk of dislocation (aOR:0.66, p < 0.001) but increased risk for transfusion (aOR 1.20, p < 0.001), prosthesis breakage (aOR 3.88, p < 0.001), and periprosthetic fracture (aOR 1.72, p < 0.001). Opioid consumption for CN-THA patients was lower on POD1 and lower for RA-THA patients POD0 and 2 compared to CON-THA. DISCUSSION: CN-THA was associated with reduced rates of PJI and dislocation, but increased rates of blood transfusion while RA-THA was associated with decreased rates of dislocation, but increased rates of blood transfusion, prosthesis complications, and periprosthetic fracture compared to CON-THA. Technology-assisted THA was associated with lower postoperative opioid consumption.
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INTRODUCTION: Due to the complex anatomy of the spine and the intricate surgical procedures involved, spinal surgery demands a high level of technical expertise from surgeons. The clinical application of image-guided spinal surgery has significantly enhanced lesion visualization, reduced operation time, and improved surgical outcomes. AREAS COVERED: This article reviews the latest advancements in deep learning and artificial intelligence in image-guided spinal surgery, aiming to provide references and guidance for surgeons, engineers, and researchers involved in this field. EXPERT OPINION: Our analysis indicates that image-guided spinal surgery, augmented by artificial intelligence, outperforms traditional spinal surgery techniques. Moving forward, it is imperative to collect a more expansive dataset to further ensure the procedural safety of such surgeries. These insights carry significant implications for the integration of artificial intelligence in the medical field, ultimately poised to enhance the proficiency of surgeons and improve surgical outcomes.
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Background: Mandibular tumor surgery necessitates precise osteotomies based on tumor boundaries; however, conventional osteotomies often lack accuracy in predicting osteotomy positions and planes, potentially leading to excessive resection of normal bone tissues or residual tumors, thus compromising postoperative quality of life and clinical outcomes. Robotic-assisted surgery (RAS) augmented with artificial intelligence (AI) offers precise localization capabilities, aiding surgeons in achieving accurate osteotomy positioning. This study aimed to evaluate the feasibility and accuracy of a robotic magnetic navigation system for positioning and osteotomy in an intraoral surgical trial of a mandibular tumor model. Methods: Patient computed tomography (CT) imaging data of mandibular chin and body tumors were utilized to create 3D printed models, serving as study subjects for mandibular tumor resection. Ten pairs of models were printed for the experimental and control groups. The experimental group (EG) underwent osteotomy using a robot-assisted surgical navigation system, performing osteotomy under robotic navigation following alignment based on preoperative design. The control group (CG) underwent traditional surgery, estimating osteotomy position empirically according to preoperative design. Postoperative CT scans were conducted on both models, and actual postoperative results were compared to preoperative design. Osteotomy accuracy was evaluated by positional and angular errors between preoperatively designed and actual osteotomy planes. Results: For ten randomly selected spots on the left and right sides, respectively, the EG group had mean distance errors of 0.338 mm and 0.941 mm. These values were obtained from the EG group. In the EG group, on the left side, the mean angular errors were 14.741 degrees, while on the right side, they were 13.021 degrees. For the 10 randomly selected spots on the left and right sides, respectively, the CG had mean distance errors of 1.776 mm and 2.320 mm. This is in contrast to the results obtained by the EG. It was determined that the left side had a mean angle error of 16.841 degrees, while the right side had an error of 18.416 degrees in the CG group. The above results indicated significantly lower point errors of bilateral osteotomy planes in the experimental group compared to the control group. Conclusion: This study demonstrates the feasibility of electromagnetic navigation robot-assisted intraoral osteotomy for mandibular tumors and suggests that this approach can enhance the precision of clinical surgery.
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Neoplasias Mandibulares , Osteotomia , Procedimentos Cirúrgicos Robóticos , Humanos , Procedimentos Cirúrgicos Robóticos/métodos , Osteotomia/métodos , Osteotomia/instrumentação , Neoplasias Mandibulares/cirurgia , Neoplasias Mandibulares/diagnóstico por imagem , Tomografia Computadorizada por Raios X , Fenômenos Eletromagnéticos , Cirurgia Assistida por Computador/métodos , Inteligência Artificial , Mandíbula/cirurgia , Mandíbula/diagnóstico por imagem , Sistemas de Navegação Cirúrgica , Impressão TridimensionalRESUMO
Wayfinding systems using inertial data recorded from a smartphone carried by the walker have great potential for increasing mobility independence of blind pedestrians. Pedestrian dead-reckoning (PDR) algorithms for localization require estimation of the step length of the walker. Prior work has shown that step length can be reliably predicted by processing the inertial data recorded by the smartphone with a simple machine learning algorithm. However, this prior work only considered sighted walkers, whose gait may be different from that of blind walkers using a long cane or a dog guide. In this work, we show that a step length estimation network trained on data from sighted walkers performs poorly when tested on blind walkers, and that retraining with data from blind walkers can dramatically increase the accuracy of step length prediction.
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INTRODUCTION: Patient navigation, a complex health intervention meant to address widespread fragmentation across the healthcare landscape, has been widely adopted internationally. This rapid uptake in patient navigation has led to a broadening of the service's reach to include those of different social positions and different health conditions. Despite the popularity and prevalence of patient navigation programmes, the extent of patient involvement and/or partnership in their construction has yet to be articulated. This scoping review will explore and describe the extent to which patients have been engaged in the development and/or implementation of patient navigation programmes to date. METHODS AND ANALYSIS: This scoping review will adhere to the Arksey and O'Malley framework for conducting scoping reviews. The electronic databases MEDLINE, CINAHL, EMBASE, PsycINFO, SocINDEX and Scopus were searched in September 2023 using terms related to patient navigation and programme implementation. Inclusion criteria stipulate that the studies must: (1) include an intervention labelled as 'navigation' in a healthcare setting and (2) describe patient engagement in the design, development and/or implementation process of said patient navigation programme. To assess study eligibility, two reviewers will independently read through the titles and abstracts, followed by the full texts, of each study identified from the search strategy to determine whether they meet inclusion criteria. Reviewers will then extract data from the included studies, present descriptive study characteristics in tables, and perform qualitative content analysis. ETHICS AND DISSEMINATION: This review does not require ethics approval as data will be collated exclusively from peer-reviewed articles and thesis dissertations. A manuscript summarising the results of the review will be written and submitted to a peer-reviewed journal for publication. The review will map aspects of programme development that have repeatedly utilised patient perspectives and areas where engagement has lagged. This review will also depict how patient engagement varies across programme characteristics.
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Navegação de Pacientes , Participação do Paciente , Humanos , Navegação de Pacientes/organização & administração , Projetos de Pesquisa , Literatura de Revisão como AssuntoRESUMO
BACKGROUND: The diagnosis of peripheral pulmonary lesions (PPL) is still challenging. We describe a novel method for sampling PPL without bronchial signs by creating invisible tunnel under electromagnetic navigation without the transbronchial access tool (TABT). METHODS: During electromagnetic navigation, we adjust the angle of the edge extended working channel catheter based on the real-time position of the lesion in relation to the locating guide rather than preset route. A biopsy brush or biopsy forceps is used to punch a hole in the bronchial wall. A locating guide is then re-inserted to real-time navigate through the lung parenchyma to the lesion. Safety and feasibility of this method was analyzed. RESULTS: A total of 32 patients who underwent electromagnetic navigation bronchoscopy were retrieved. The mean size of the lesion is 23.1 mm. The mean operative time of all patients was 12.4 min. Ten of the patients did not have a direct airway to the lesion, thus creating an invisible tunnel. For them, the length of the tunnel from the bronchial wall POE to the lesion was 11-30 mm, with a mean length of 16.9 mm and a mean operation time of 14.1 min. Adequate samples were obtained from 32 patients (100%), and the diagnostic yield was 87.5% (28/32). Diagnostic yield of with create the invisible tunnel TBAT was 90% (9/10), and one patient undergone pneumothorax after operation. CONCLUSIONS: This method is feasible and safe as a novel approach sampling pulmonary lesions without bronchial signs, and it further improves current tunnel technique.
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Broncoscopia , Fenômenos Eletromagnéticos , Humanos , Broncoscopia/métodos , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Adulto , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/cirurgia , Brônquios/patologia , Brônquios/diagnóstico por imagem , Idoso de 80 Anos ou maisRESUMO
OBJECTIVES: To compare miniscrew versus bone tracing registration methods on dental implant placement accuracy and time efficiency in edentulous jaws using a dynamic computer-assisted implant surgery (d-CAIS) system. METHODS: Twelve fully edentulous maxillary models were allocated into two groups: miniscrew tracing (MST) group, where registration was performed by tracing four miniscrews; and bone tracing (BT) group, where registration was conducted by tracing maxillary bone fiducial landmarks. Six implants were placed on each model using the X-Guide® d-CAIS system. Pre- and postoperative cone-beam computed tomography (CBCT) scans were superimposed to evaluate implant placement accuracy. The time required for registration and the overall surgery time were also recorded. RESULTS: Thirty-six implants were placed in each group. The MST group showed significantly lower mean angulation deviations (mean difference (MD): -3.33°; 95% confidence interval (CI): -6.56 to -0.09); pâ¯=â¯0.044), 3D platform deviations (MD: -1.01 mm; 95%CI: -1.74 to -0.29; pâ¯=â¯0.006), 2D platform deviations (MD: -0.97 mm; 95%CI: -1.71 to -0.23; pâ¯=â¯0.010), and 3D apex deviations (MD: -1.18 mm; 95%CI: -1.92 to -0.44; pâ¯=â¯0.002) versus the BT group. The overall surgery time was similar for both groups (MD: 6.10 min.; 95%CI: -0.31 to 12.51; pâ¯=â¯0.06), though bone tracing required significantly more time compared with miniscrew registration (MD: 4.79 min.; 95%CI: 2.96 to 6.62; p < 0.05). CONCLUSIONS: Registration with MST increases the accuracy of implant placement with a d-CAIS system in edentulous jaws compared with the BT method, and slightly reduces the overall surgery time. CLINICAL SIGNIFICANCE: Miniscrew tracing registration improves implant placement accuracy in comparison with bone tracing registration.
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This study explores visuomotor control in athletes for collision avoidance using virtual reality. Thirty-nine athletes navigated dynamic scenarios, pursuing a virtual target while avoiding two to five virtual defenders. Confirmatory Factor Analysis validated a model that captured two features of scanning behavior based on head movements recorded during activity: the overall amount and temporal pattern. Linear mixed models showed that these features significantly differentiated successful from unsuccessful defender avoidance (pâ¯<â¯.05), suggesting that efficient environmental scanning is crucial for collision avoidance while highlighting the potential of visuomotor interventions to reduce collision-related sport injuries.
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BACKGROUND: Neuroendovascular procedures, especially those involving significant vessel tortuosity, giant intracranial aneurysms, or distally located lesions, frequently necessitate exchange methods. However, exchange maneuvers pose a risk of inadvertent vessel injury. To address these challenges, a Stabilizer device was developed and evaluated for its efficacy and safety. This clinical trial aimed to assess the efficacy and safety of the Stabilizer device in facilitating the navigation of neuroendovascular devices to target lesions in cases where the exchange technique was necessary. METHODS: This was a single-arm, prospective, open-label, multicenter clinical trial performed at nine different sites. It focused on investigating the use of the Stabilizer device for treating intracranial aneurysms and atherosclerosis. RESULTS: A total of 31 patients were enrolled across nine centers in Japan from July 21, 2022, to March 10, 2023. The study enrolled 24 (77.4%) patients with intracranial aneurysms and seven (22.6%) patients with intracranial artery stenosis. Majority of the target lesions were in the middle cerebral artery territory (83.9%). The Stabilizer device was used to exchange for 0.027-inch catheters, intermediate catheters, PTA balloons, and Wingspan stent system. The Stabilizer device demonstrated 100% technical success rate. While three complications related to the treatment were noted, there were no complications related to the device, including any vascular damage. CONCLUSIONS: This is the first multicenter clinical trial that investigated and demonstrated technical efficacy as well as overall safety profile of the Stabilizer device in neuroendovascular procedures where the use of an exchange method was necessary.
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INTRODUCTION: In the past two decades, bronchoscopy of peripheral pulmonary lesions (PPLs) has improved its diagnostic yield due to the combination of various instruments and devices. Meanwhile, the application is complex and intertwined. AREAS COVERED: This review article outlines strategies in diagnostic bronchoscopy for PPLs. We summarize the utility and evidence of key instruments and devices based on the results of clinical trials. Future perspectives of bronchoscopy for PPLs are also discussed. EXPERT OPINION: The accuracy of reaching PPLs by bronchoscopy has improved significantly with the introduction of combined instruments such as navigation, radial endobronchial ultrasound, digital tomosynthesis, and cone-beam computed tomography. It has been accelerated with the advent of approach tools such as newer ultrathin bronchoscopes and robotic-assisted bronchoscopy. In addition, needle aspiration and cryobiopsy provide further diagnostic opportunities beyond forceps biopsy. Rapid on-site evaluation may also play an important role in decision making during the procedures. As a result, the diagnostic yield of bronchoscopy for PPLs has improved to a level comparable to that of transthoracic needle biopsy. The techniques and technologies developed in the diagnosis will be carried over to the next step in the transbronchial treatment of PPLs in the future.