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 (μerror + 3σerror) 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 (μerror + 3σerror) 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 (μerror + 3σerror) 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.
Purpose A recent clinical trial has shown the feasibility of robotic cochlear implantation. The electrode was inserted through the robotically drilled tunnel and an additional access through the external auditory canal was created to provide for means of visualization and manipulation. To obviate the need for this additional access, the utilization of multiple robotically drilled tunnels targeting the round window has been proposed. The objective of this study was to assess the feasibility of electrode insertion through a robotic multiport approach. Methods In four ex vivo human head specimens (left side), four trajectories through the facial recess (2x) and the retrofacial and suprameatal region were planned and robotically drilled. Optimal three-port configurations were determined for each specimen by analyzing combinations of three of the four trajectories, where the three trajectories were used for the electrode, endoscopic visualization and manipulative assistance. Finally, electrode insertions were conducted through the optimal configurations. Results The electrodes could successfully be inserted, and the procedure sufficiently visualized through the facial recess drill tunnels in all specimens. Effective manipulative assistance for sealing the round window could be provided through the retrofacial tunnel. Conclusions Electrode insertion through a robotic three-port approach is feasible. Drill tunnels through the facial recess for the electrode and endoscope allow for optimized insertion angles and sufficient visualization. Through a retrofacial tunnel effective manipulation for sealing is possible.
Recombinant immunotoxins are composed of antibody-derived targeting entities fused to truncated toxins. Pseudomonas toxins inactivate eEF2 by ADPribosylation and are potent antitumoral agents in clinical development. The sensitivity of tumor cells towards such fusion proteins, and hence their therapeutic efficacy, is influenced by multiple factors: (i) access to tumor cells, (ii) target antigen binding and internalization, (iii) entry into the cytosol, (iv) enzymatic modification of the intracellular target eEF2, and (v) induction of apoptosis. Parameters that affect these steps and hence modulate sensitivity include: (i) protein stability and immunogenicity, (ii) presence, density and internalization of target antigen, (iii) cellular factors involved in processing, routing or translocation of the toxin, (iv) factors involved in diphthamide synthesis on eEF2, and (v) factors that influence cellular susceptibility towards apoptosis. This chapter describes sensitivity or resistance factors for Pseudomonas exotoxin -derived immunotoxins that were identified experimentally and/ or observed in clinical studies.
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