Schneider Daniel, Hermann Jan, Mueller Fabian, Braga Gabriela O'Toole Bom, Anschuetz Lukas, Caversaccio Marco, Nolte Lutz, Weber Stefan, Klenzner Thomas
ARTORG Center for Biomedical Engineering, University of Bern, Bern, Switzerland.
Department of Otorhinolaryngology, Head and Neck Surgery, Inselspital, University Hospital Bern, Bern, Switzerland.
Front Surg. 2021 Jan 11;7:604362. doi: 10.3389/fsurg.2020.604362. eCollection 2020.
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. Literature search was conducted 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 (μ + 3σ) was measured in more than one study were identified and inspected for time trends. 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 (μ + 3σ) 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. Image guidance systems must reliably provide an accuracy ≤0.5 mm (μ + 3σ) 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.
尽管针对图像引导解决方案进行了三十年的临床前和临床研究,将其作为器械和解剖定位的一种更准确、侵入性更小的替代方法,但在侧颅手术中尚未转化为常规临床实践。本综述的目的是确定为了提供在侧颅手术中安全且有益使用的图像引导解决方案而需要解决的挑战,并综合促进此类解决方案开发的因素。使用与图像引导和侧颅相关的术语在PubMed上进行文献检索。数据提取包括以下变量:图像引导误差、成像分辨率、图像引导系统、跟踪技术、配准方法、研究终点、临床目标应用和出版年份。随后在FDA 510(k)数据库中搜索已识别的图像引导系统,并提取批准年份、预期用途和使用适应症。研究目标和终点被细分为三个时间阶段并进行总结。此外,分析了哪些因素与图像引导误差相关。确定在不止一项研究中测量到误差≤0.5毫米(μ + 3σ)的因素值,并检查其时间趋势。提供了基于描述性统计的研究目标和结果的总结,分为三个时间间隔。文献提供了定性和定量证据,表明图像引导系统在侧颅手术中安全且有益应用时必须提供≤0.5毫米(μ + 3σ)的精度。空间跟踪精度和医学图像分辨率都与图像引导精度相关,并且多年来它们都有所提高。精度≤0.05毫米的跟踪技术、切片厚度≤0.2毫米的计算机断层扫描成像以及基于骨锚定钛基准点的配准是为开发足够精确的图像引导提供充分条件的组成部分。图像引导系统在侧颅手术中安全且有益使用时必须可靠地提供≤0.5毫米(μ + 3σ)的精度。跟踪和成像技术的进步有助于提高精度,最终能够开发并广泛采用可在侧颅手术中安全且有益使用的图像引导解决方案。