A novel miniature robotic device for frameless implantation of depth electrodes in refractory epilepsy

J Neurosurg 126:1622–1628, 2017

The authors’ group recently published a novel technique for a navigation-guided frameless stereotactic approach for the placement of depth electrodes in epilepsy patients. To improve the accuracy of the trajectory and enhance the procedural workflow, the authors implemented the iSys1 miniature robotic device in the present study into this routine.

METHODS As a first step, a preclinical phantom study was performed using a human skull model, and the accuracy and timing between 5 electrodes implanted with the manual technique and 5 with the aid of the robot were compared. After this phantom study showed an increased accuracy with robot-assisted electrode placement and confirmed the robot’s ability to maintain stability despite the rotational forces and the leverage effect from drilling and screwing, patients were enrolled and analyzed for robot-assisted depth electrode placement at the authors’ institution from January 2014 to December 2015. All procedures were performed with the S7 Surgical Navigation System with Synergy Cranial software and the iSys1 miniature robotic device.

RESULTS Ninety-three electrodes were implanted in 16 patients (median age 33 years, range 3–55 years; 9 females, 7 males). The authors saw a significant increase in accuracy compared with their manual technique, with a median deviation from the planned entry and target points of 1.3 mm (range 0.1–3.4 mm) and 1.5 mm (range 0.3–6.7 mm), respectively. For the last 5 patients (31 electrodes) of this series the authors modified their technique in placing a guide for implantation of depth electrodes (GIDE) on the bone and saw a significant further increase in the accuracy at the entry point to 1.18 ± 0.5 mm (mean ± SD) compared with 1.54 ± 0.8 mm for the first 11 patients (p = 0.021). The median length of the trajectories was 45.4 mm (range 19–102.6 mm). The mean duration of depth electrode placement from the start of trajectory alignment to fixation of the electrode was 15.7 minutes (range 8.5–26.6 minutes), which was significantly faster than with the manual technique. In 12 patients, depth electrode placement was combined with subdural electrode placement. The procedure was well tolerated in all patients. The authors did not encounter any case of hemorrhage or neurological deficit related to the electrode placement. In 1 patient with a psoriasis vulgaris, a superficial wound infection was encountered. Adequate physiological recordings were obtained from all electrodes. No additional electrodes had to be implanted because of misplacement.

CONCLUSIONS The iSys1 robotic device is a versatile and easy to use tool for frameless implantation of depth electrodes for the treatment of epilepsy. It increased the accuracy of the authors’ manual technique by 60% at the entry point and over 30% at the target. It further enhanced and expedited the authors’ procedural workflow.

Contemporary frameless intracranial biopsy techniques: Might variation in safety and efficacy be expected?

trajectory-stem-base

Acta Neurochir (2015) 157:2011–2016

Frameless stereotactic neuronavigation has proven to be a feasible technology to acquire brain biopsies with good accuracy and little morbidity and mortality. New systems are constantly introduced into the neurosurgical armamentarium, although few studies have actually evaluated and compared the diagnostic yield, morbidity, and mortality of various manufacturer’s frameless neuronavigation systems. The present study reports our experience with brain biopsy procedures performed using both the Medtronic Stealth TreonTM Vertek® and BrainLAB® Varioguide frameless stereotactic brain biopsy systems.

Patients and methods All 247 consecutive biopsies from January 2008 until May 2013 were evaluated retrospectively. One hundred two biopsies each were performed using the Medtronic (2008–2009) and BrainLAB® system (2011– 2013), respectively. The year 2010 was considered a transition year, in which 43 biopsies were performed with either system. Patient demographics, perioperative characteristics, and histological diagnosis were reviewed, and a comparison was made between the two brain biopsy systems.

Results The overall diagnostic yield was 94.6 %, i.e., 11 biopsies were nondiagnostic, 5 (4.9 %) with the Medtronic and 6 (5.9 %) with the BrainLAB® system. No differences besides the operating time (108 vs 120 min) were found between the two biopsy methods. On average, 6.6 tissue samples were taken with either technique. Peri- and postoperative complications were seen in 5.3 % and 12.9 %, consisting of three symptomatic hemorrhages (1.2 %). Biopsy-related mortality occurred in 0.8 % of all biopsies.

Conclusions Regarding diagnostic yield, complication rate, and biopsy-related mortality, there seems to be no difference between the frameless biopsy technique from Medtronic and BrainLAB®. In contemporary time, the neurosurgeon has many tools to choose from, all with a relatively fast learning curve and ever improving feasibility. Thus, the issue of choice involves not the results, but the familiarity, end-user friendliness, and overall comfort when operating the system.

The Silent Loss of Neuronavigation Accuracy

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Neurosurgery 72:796–807, 2013

Neuronavigation has become an intrinsic part of preoperative surgical planning and surgical procedures. However, many surgeons have the impression that accuracy decreases during surgery.

OBJECTIVE: To quantify the decrease of neuronavigation accuracy and identify possible origins, we performed a retrospective quality-control study.

METHODS: Between April and July 2011, a neuronavigation system was used in conjunction with a specially prepared head holder in 55 consecutive patients. Two different neuronavigation systems were investigated separately. Coregistration was performed with laser-surface matching, paired-point matching using skin fiducials, anatomic landmarks, or bone screws. The initial target registration error (TRE1) was measured using the nasion as the anatomic landmark. Then, after draping and during surgery, the accuracy was checked at predefined procedural landmark steps (Mayfield measurement point and bone measurement point), and deviations were recorded.

RESULTS: After initial coregistration, the mean (SD) TRE1 was 2.9 (3.3) mm. The TRE1 was significantly dependent on patient positioning, lesion localization, type of neuroimaging, and coregistration method. The following procedures decreased neuronavigation accuracy: attachment of surgical drapes (DTRE2 = 2.7 [1.7] mm), skin retractor attachment (DTRE3 = 1.2 [1.0] mm), craniotomy (DTRE3 = 1.0 [1.4] mm), and Halo ring installation (DTRE3 = 0.5 [0.5] mm). Surgery duration was a significant factor also; the overall DTRE was 1.3 [1.5] mm after 30 minutes and increased to 4.4 [1.8] mm after 5.5 hours of surgery.

CONCLUSION: After registration, there is an ongoing loss of neuronavigation accuracy. The major factors were draping, attachment of skin retractors, and duration of surgery. Surgeons should be aware of this silent loss of accuracy when using neuronavigation.

Frameless image-guided stereotaxy with real-time visual feedback for brain biopsy

Acta Neurochir (2012) 154:1663–1667 DOI 10.1007/s00701-012-1425-y

Frame-based stereotaxy remains the “gold standard” for cerebral biopsies and functional neurosurgery though new frameless stereotactic systems are evolving continually. As the technique of frameless stereotaxy gains increasing acceptance among neurosurgeons, this study assesses the feasibility of a system for frameless imageguided stereotaxy.

Methods All patients biopsied for intracranial lesions between February 2007 and August 2010 using the BrainLAB VarioGuide frameless stereotactic system were evaluated prospectively. Prior to surgery, patients underwent magnetic resonance (MR) imaging; additionally, fluoroethyl-tyrosine (FET)-positron emission tomography (PET) images were acquired and fused to MR images in selected cases. Biopsy trajectory length, lesion volume, procedure duration, and diagnostic yield were assessed.

Results Ninety-six diagnostic biopsies in 91 patients were evaluated. Lesion volume ranged from 0.17 to 121.8 cm3; trajectory length from 25.3 to 101.9 mm. Diagnostic yield was 93.8%. Mean operation time from skin incision to wound closure was 42 min; in the operating room, it was 99 min.

Conclusions Clinical experience indicates VarioGuide to be safe and accurate. Reachable range of lesion localisation appears to be comparable to a frame-based stereotaxy system. Operation times are brief. The unique design of this frameless stereotactic system allows real-time visual feedback of needle positioning.

Stereotactic Brain Biopsy With a Low-Field Intraoperative Magnetic Resonance Imager

Neurosurgery 68[ONS Suppl 1]:ons217–ons224, 2011 DOI: 10.1227/NEU.0b013e31820826c2

Techniques for stereotactic brain biopsy have evolved in parallel with the imaging modalities used to visualize the brain.

OBJECTIVE: To describe our technique for performing stereotactic brain biopsy using a compact, low-field, intraoperative magnetic resonance imager (iMRI).

METHODS: Thirty-three patients underwent stereotactic brain biopsies with the PoleStar N-20 iMRI system (Medtronic Navigation, Louisville, Colorado). Preoperative iMRI scans were obtained for biopsy target identification and trajectory planning. A skull-mounted device (Navigus, Medtronic Navigation) was used to guide an MRI-compatible cannula to the target. An intraoperative image was acquired to confirm accurate cannula placement within the lesion. Serial images were obtained to track cannula movement and to rule out hemorrhage. Frozen sections were obtained in all but 1 patient with a brain abscess.

RESULTS: Diagnostic tissue was obtained in 32 of 33 patients. In all cases, imaging demonstrated cannula placement within the lesion. Histological diagnoses included 22 primary brain tumors and 10 nonneoplastic lesions. In 61% of the cases, initial trajectory was corrected on the basis of the intraoperative scans. In 1 patient, biopsy was nondiagnostic despite accurate cannula placement. No patient suffered a clinically or radiographically significant hemorrhage during or after surgery. There were no intraoperative complications.

CONCLUSION: Stereotactic biopsy with a low-field iMRI is an accurate way to obtain specimens with a high diagnostic yield. This accuracy, combined with the acceptable additional procedural time, may obviate the need for frozen section. The ability to correct biopsy cannula placement during surgery eliminates the chance of misdiagnosis because of faulty targeting, as well as the risks associated with inconclusive frozen sections and ‘‘blind’’ replacement of the cannula.

Clinical Motor Outcome of Bilateral Subthalamic Nucleus Deep-Brain Stimulation for Parkinson’s Disease Using Image-Guided Frameless Stereotaxy

Neurosurgery 67:1088–1093, 2010 DOI: 10.1227/NEU.0b013e3181ecc887

Image-guided neuronavigation has largely replaced stereotactic frames when precise, real-time anatomic localization is required during neurosurgical procedures. However, some procedures, including placement of deep-brain stimulation (DBS) leads for the treatment of movement disorders, are still performed using frame-based stereotaxy. Despite the demonstration of comparable accuracy between frame-based and ‘‘frameless’’ image-guided approaches, the clinical efficacy of frameless DBS placement has never been reported.

OBJECTIVE: To analyze the outcomes of subthalamic nucleus (STN) DBS using the frameless technique for the treatment of Parkinson’s disease (PD).

METHODS: Of 31 subjects (20 men) with PD for 10 6 4 years, 28 had bilateral STN DBS and 3 had unilateral STN DBS. The Unified Parkinson’s Disease Rating Scale (UPDRS) motor scale (III) and total medication doses were assessed before surgery on and off medication and off medication/ON DBS (off/ON) after 6 to 12 months of STN DBS.

RESULTS: There was a 58% improvement from bilateral STN DBS in the UPDRS III (40 6 16 preoperatively off, 17 6 11 off/ON) 9.6 6 1.9 months after surgery (P , .001). This compared favorably with the published outcomes using the frame-based technique. All motor subscores improved significantly (P , .01). The mean reduction in medication was 50%. No intraoperative complications occurred, but one subject with hypertension died of a delayed hemorrhage postoperatively. Two subjects developed postoperative infections that required lead removal and antibiotics.

CONCLUSIONS: Bilateral STN DBS for PD performed by an experienced team using a frameless approach results in outcomes comparable to those reported with the use of the frame-based technique.