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  • iSYS1® Robotic Frameless Brain Biopsies for Intracranial Tumors: A Prospective, Single Center, Exploratory Pilot Study to Evaluate Feasibility, Accuracy and Safety

    Final Number:

    Federico G Legnani MD; Andrea Franzini; Luca Mattei; Andrea Saladino MD; Cecilia Casali MD; Alessandro Perin MD PhD; Francesco Prada MD; Vittoria Cojazzi; Claudia Fanizzi MD; Marco Saini; Gernot Kronreif; Francesco DiMeco MD

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2018 Annual Meeting

    Introduction: Needle biopsies are amongst the most common procedures in cranial neurosurgery and submillimetric precision is essential. Despite MRI and CT based stereotactic guidance, accurate alignment of the biopsy needle with the preplanned trajectory is still associated with inaccuracy. Frameless robotic surgery could increase accuracy and enhance the safety and efficacy of these procedures.

    Methods: We present a series of 36 consecutive patients harboring a cerebral neoplasm who underwent frameless image-guided stereotactic biopsy with the iSYS1® robotic system. Features, such as age, gender, type of tumor, tumor location, histopathology, surgical timing, target error (TE), duration of hospital stay and postoperative complications were collected.

    Results: Median patient age was 61 years (range 41-78). One patient required a reoperation due to inaccurate sampling not related to the robotic device. The median number of samples submitted to pathology for each lesion was 6 (range 4-8), diagnostic yield was 97,2%. Mean length of hospital stay was 1.6 days (median 1). The median operating time was 20 minutes (range 10- 45, mean 24). The mean length of trajectory from entry point to target point was 52 mm (range 34,4 – 74,9). The mean TE at entry was 2.1 mm (median 0.2, range 3.8) ; at target mean TE was 0.98 mm (median 0.8, range 0.1-4). Inaccuracy in the first biopsy, requiring reoperation, likely occurred from head holder displacement and resulted in a TE of 4 mm at entry and 3,7 mm at target. The second biopsy was accurate and diagnostic.

    Conclusions: In this preliminary patient series intraoperative frameless robotic iSYS1® assisted biopsy was safe and resulted in high target accuracy and diagnostic yield. Larger studies are necessary to further evaluate the full potential of this device.

    Patient Care: Our data suggests that intraoperative frameless robotic iSys1® biopsy appeared to be a feasible procedure, did not modify our OR routine workflow, was safe and effective, resulting in high target accuracy and diagnostic yield.

    Learning Objectives: To determine the role of robotic minimally invasive bioptic surgery in patients harbouring a brain tumor not amenable for surgical resection


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