Dataset Information

Evolution and Stagnation of Image Guidance for Surgery in the Lateral Skull: A Systematic Review 1989-2020.

ABSTRACT: Objective: Despite three decades of pre-clinical and clinical research into image guidance solutions as a more accurate and less invasive alternative for instrument and anatomy localization, translation into routine clinical practice for surgery in the lateral skull has not yet happened. The aim of this review is to identify challenges that need to be solved in order to provide image guidance solutions that are safe and beneficial for use during lateral skull surgery and to synthesize factors that facilitate the development of such solutions. Methods: Literature search was conducted via PubMed using terms relating to image guidance and the lateral skull. Data extraction included the following variables: image guidance error, imaging resolution, image guidance system, tracking technology, registration method, study endpoints, clinical target application, and publication year. A subsequent search of FDA 510(k) database for identified image guidance systems and extraction of the year of approval, intended use, and indications for use was performed. The study objectives and endpoints were subdivided in three time phases and summarized. Furthermore, it was analyzed which factors correlated with the image guidance error. Factor values for which an error ?0.5 mm (?_error + 3?_error) was measured in more than one study were identified and inspected for time trends. Results: A descriptive statistics-based summary of study objectives and findings separated in three time intervals is provided. The literature provides qualitative and quantitative evidence that image guidance systems must provide an accuracy ?0.5 mm (?_error + 3?_error) for their safe and beneficial application during surgery in the lateral skull. Spatial tracking accuracy and precision and medical image resolution both correlate with the image guidance accuracy, and all of them improved over the years. Tracking technology with accuracy ?0.05 mm, computed tomography imaging with slice thickness ?0.2 mm, and registration based on bone-anchored titanium fiducials are components that provide a sufficient setting for the development of sufficiently accurate image guidance. Conclusion: Image guidance systems must reliably provide an accuracy ?0.5 mm (?_error + 3?_error) for their safe and beneficial use during surgery in the lateral skull. Advances in tracking and imaging technology contribute to the improvement of accuracy, eventually enabling the development and wide-scale adoption of image guidance solutions that can be used safely and beneficially during lateral skull surgery.

SUBMITTER: Schneider D

PROVIDER: S-EPMC7831154 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Evolution and Stagnation of Image Guidance for Surgery in the Lateral Skull: A Systematic Review 1989-2020.

Schneider Daniel D Hermann Jan J Mueller Fabian F Braga Gabriela O'Toole Bom GOB Anschuetz Lukas L Caversaccio Marco M Nolte Lutz L Weber Stefan S Klenzner Thomas T

Frontiers in surgery 20210111

<b>Objective:</b> Despite three decades of pre-clinical and clinical research into image guidance solutions as a more accurate and less invasive alternative for instrument and anatomy localization, translation into routine clinical practice for surgery in the lateral skull has not yet happened. The aim of this review is to identify challenges that need to be solved in order to provide image guidance solutions that are safe and beneficial for use during lateral skull surgery and to synthesize fac ...[more]

PMID: 33505986

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Project description:Hypothesis: The use of freehand stereotactic image-guidance with a target registration error (TRE) of μTRE + 3σTRE < 0.5 mm for navigating surgical instruments during neurotologic surgery is safe and useful. Background: Neurotologic microsurgery requires work at the limits of human visual and tactile capabilities. Anatomy localization comes at the expense of invasiveness caused by exposing structures and using them as orientation landmarks. In the absence of more-precise and less-invasive anatomy localization alternatives, surgery poses considerable risks of iatrogenic injury and sub-optimal treatment. There exists an unmet clinical need for an accurate, precise, and minimally-invasive means for anatomy localization and instrument navigation during neurotologic surgery. Freehand stereotactic image-guidance constitutes a solution to this. While the technology is routinely used in medical fields such as neurosurgery and rhinology, to date, it is not used for neurotologic surgery due to insufficient accuracy of clinically available systems. Materials and Methods: A freehand stereotactic image-guidance system tailored to the needs of neurotologic surgery-most importantly sub-half-millimeter accuracy-was developed. Its TRE was assessed preclinically using a task-specific phantom. A pilot clinical trial targeting N = 20 study participants was conducted (ClinicalTrials.gov ID: NCT03852329) to validate the accuracy and usefulness of the developed system. Clinically, objective assessment of the TRE is impossible because establishing a sufficiently accurate ground-truth is impossible. A method was used to validate accuracy and usefulness based on intersubjectivity assessment of surgeon ratings of corresponding image-pairs from the microscope/endoscope and the image-guidance system. Results: During the preclinical accuracy assessment the TRE was measured as 0.120 ± 0.05 mm (max: 0.27 mm, μTRE + 3σTRE = 0.27 mm, N = 310). Due to the COVID-19 pandemic, the study was terminated early after N = 3 participants. During an endoscopic cholesteatoma removal, a microscopic facial nerve schwannoma removal, and a microscopic revision cochlear implantation, N = 75 accuracy and usefulness ratings were collected from five surgeons each grading 15 image-pairs. On a scale from 1 (worst rating) to 5 (best rating), the median (interquartile range) accuracy and usefulness ratings were assessed as 5 (4-5) and 4 (4-5) respectively. Conclusion: Navigating surgery in the tympanomastoid compartment and potentially in the lateral skull base with sufficiently accurate freehand stereotactic image-guidance (μTRE + 3σTRE < 0.5 mm) is feasible, safe, and useful. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03852329.

Project description:PurposesSurgical reduction of pelvic fracture is a challenging procedure, and accurate restoration of natural morphology is essential to obtaining positive functional outcome. The procedure often requires extensive preoperative planning, long fluoroscopic exposure time, and trial-and-error to achieve accurate reduction. We report a multi-body registration framework for reduction planning using preoperative CT and intraoperative guidance using routine 2D fluoroscopy that could help address such challenges.MethodThe framework starts with semi-automatic segmentation of fractured bone fragments in preoperative CT using continuous max-flow. For reduction planning, a multi-to-one registration is performed to register bone fragments to an adaptive template that adjusts to patient-specific bone shapes and poses. The framework further registers bone fragments to intraoperative fluoroscopy to provide 2D fluoroscopy guidance and/or 3D navigation relative to the reduction plan. The framework was investigated in three studies: (1) a simulation study of 40 CT images simulating three fracture categories (unilateral two-body, unilateral three-body, and bilateral two-body); (2) a proof-of-concept cadaver study to mimic clinical scenario; and (3) a retrospective clinical study investigating feasibility in three cases of increasing severity and accuracy requirement.ResultsSegmentation of simulated pelvic fracture demonstrated Dice coefficient of 0.92±0.06. Reduction planning using the adaptive template achieved 2-3 mm and 2-3° error for the three fracture categories, significantly better than planning based on mirroring of contralateral anatomy. 3D-2D registration yielded ~2 mm and 0.5° accuracy, providing accurate guidance with respect to the preoperative reduction plan. The cadaver study and retrospective clinical study demonstrated comparable accuracy: ~0.90 Dice coefficient in segmentation, ~3 mm accuracy in reduction planning, and ~2 mm accuracy in 3D-2D registration.ConclusionThe registration framework demonstrated planning and guidance accuracy within clinical requirements in both simulation and clinical feasibility studies for a broad range of fracture-dislocation patterns. Using routinely acquired preoperative CT and intraoperative fluoroscopy, the framework could improve the accuracy of pelvic fracture reduction, reduce radiation dose, and could integrate well with common clinical workflow without the need for additional navigation systems.

Project description:Intraoperative image guidance is a useful modality for transsphenoidal pituitary surgery. However, the outcomes associated with this technology have not been systematically evaluated.The purpose of the study was to quantify complication rates with and without the use of image guidance during transsphenoidal pituitary surgery using a nationwide database with broadly applicable results.A retrospective analysis of the Nationwide Inpatient Sample was performed from 2007 to 2011. Transsphenoidal pituitary resections for adenomas were identified by International Classification of Diseases-9th Revision, Clinical Modification code. The effect of image guidance on cerebrospinal fluid (CSF) leak complications and cost-benefit was analyzed.A total of 48,848 transsphenoidal pituitary resections were identified, of which 77.5% were partial resections and 22.5% were complete. Pathologic indications included benign (89.3%), malignant primary (0.6%), and malignant secondary (0.4%). Complications included same-stay death (0.4%), CSF leak (8.8%), postoperative CSF rhinorrhea (1.9%), diabetes insipidus (12.4%), and meningitis (0.4%). Image guidance was employed in 7% (n = 3401) of all cases. When analyzed by modality, computed tomography (CT)-assisted procedures had lower CSF rhinorrhea rates (1.1%) compared with cases with no image guidance (1.9%), whereas magnetic resonance (MR)-assisted procedures had the highest rates (2.7%, χ2 p < 0.001). Rates of CSF leak demonstrated a similar pattern (CT 6.4%, no image guidance 8.9%, MR 9.2%, χ2 p < 0.001). CT-assisted surgery had significantly shorter length of stay (2.9 days) versus no image guidance (3.7 days, p < 0.001), lower total charges ($47,589 versus $62,629, p < 0.001), and lower total cost ($16,748 versus $20,530, p < 0.001).CT-assisted surgery is associated with a lower rate of CSF leak, shorter length of stay, and lower cost compared with patients without image guidance. Further studies that control for severity and extent of disease are warranted to confirm this finding.

Dataset Information

Evolution and Stagnation of Image Guidance for Surgery in the Lateral Skull: A Systematic Review 1989-2020.

Publications

Evolution and Stagnation of Image Guidance for Surgery in the Lateral Skull: A Systematic Review 1989-2020.

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