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Deep Brain Stimulation Lead Implantation Using a Customized Rapidly Manufactured Stereotactic Fixture with Submillimetric Euclidean Accuracy

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Deep Brain Stimulation Lead Implantation Using a Customized Rapidly Manufactured Stereotactic Fixture with Submillimetric Euclidean Accuracy Clinical Study Stereotact Funct Neurosurg Received: June 25, 2019 DOI: 10.1159/000506959 Accepted: February 27, 2020 Published online: June 2, 2020 Deep Brain Stimulation Lead Implantation Using a Customized Rapidly Manufactured Stereotactic Fixture with Submillimetric Euclidean Accuracy a b b a Tyler J. Ball Kevin D. John Andrew M. Donovan Joseph S. Neimat a b Department of Neurosurgery, University of Louisville School of Medicine, Louisville, KY, USA; University of Louisville School of Medicine, Louisville, KY, USA Keywords no surgical complications. Conclusion: The MicrotableTM Deep brain stimulation · Stereotaxis · Deep brain platform is capable of submillimetric accuracy in patients stimulation accuracy · Frameless stereotaxis · Functional undergoing stereotactic surgery. It has achieved clinical ef- neurosurgery · Movement disorder surgery · Stereotactic ficacy in our patients without surgical complications and has surgery demonstrated the potential for superior accuracy compared to both traditional stereotactic frames and other common frameless systems. © 2020 S. Karger AG, Basel Abstract Background: The microTargetingTM MicrotableTM Platform is a novel stereotactic system that can be more rapidly fabri- cated than currently available 3D-printed alternatives. We Introduction present the first case series of patients who underwent deep brain stimulation (DBS) surgery guided by this platform and Technological advances have enabled significant im- demonstrate its in vivo accuracy. Methods: Ten patients un- provements in the area of stereotactic neurosurgery. New derwent DBS at a single institution by the senior author and technology and refinements of existing technology are 15 leads were placed. The mean age was 69.1 years; four enabling more effective ablation and modulation of dis- were female. The ventralis intermedius nucleus was targeted crete areas of the central nervous system than was possi- for patients with essential tremor and the subthalamic nu- ble in the past. Stereotactic neurosurgery relies on the ac- cleus was targeted for patients with Parkinson’s disease. Re- curacy and precision of targeting systems, whether they sults: Nine DBS leads in 6 patients were appropriately im- are frame-based or frameless. Additionally, given the va- aged to enable measurement of accuracy. The mean Euclid- riety of options now available for stereotaxis and the out- ean electrode placement error (EPE) was 0.97 ± 0.37 mm, and standing accuracy of many systems, the distinction be- the mean radial error was 0.80 ± 0.41 mm (n = 9). In the sub- tween traditional “frame-based and frameless” systems set of CT scans performed greater than 1 month postopera- has been blurred rendering these terms less relevant than tively (n = 3), the mean Euclidean EPE was 0.75 ± 0.17 mm they were in the past. In addition to concerns of accuracy and the mean radial error was 0.69 ± 0.17 mm. There were and precision, clinicians also need to consider patient © 2020 S. Karger AG, Basel Joseph S. Neimat, MD University of Louisville Department of Neurosurgery, Frazier Rehabilitation Institute [email protected] 220 Abraham Flexner Way, 15th Floor, Louisville, KY 40202 (USA) www.karger.com/sfn joseph.neimat @ ulp.org Downloaded by: East Carolina University - Laupus Library 150.216.132.43 - 6/3/2020 7:30:23 AM comfort, price, and workflow considerations in their hos- pital when choosing a targeting system. The earliest attempt at cranial stereotaxis may have been the encephalometer designed by Dimitrii Zernov in 1889. This rudimentary stereotactic instrument likened the cranial vault to a globe and referenced cerebral struc- Color version available online tures based off of lines of longitude and latitude, and was modified by Grigorii Rossolimo in 1907 [1]. However, these devices may have been ahead of their time and were not commonly used clinically. The first stereotactic frames to gain widespread clinical acceptance were pio- neered in 1947 by Ernst Spiegel and Henry Wycis, who translated the animal model constructed by Victor Hors- ley and Robert Clarke in the early 20th century. Their frames used pneumoencephalography as guidance for lo- Fig. 1. The microTargetingTM MicrotableTM Platform, as received calizing the basal ganglia utilizing Cartesian coordinates from the manufacturer. [2]. Then, in 1949, Lars Leksell produced a more refined stereotactic frame known as the Leksell frame, which uti- lized angle, depth, and anterior-posterior coordinates to gineers at Vanderbilt University pioneered a novel device target structures within the brain and allowed greater formally referred to as the microTargetingTM MicrotableTM control of trajectory [3]. Another leap forward came Platform. The device is manufactured by milling a plat- when Brown designed a stereotactic head frame to be form from a planar polycarbonate blank via a computer used in conjunction with a body CT scanner, which in- numerical control (CNC) router. The stereotactic trajec- corporated a localizer we now refer to as the N-bar [4]. tory is achieved by creating precisely recessed holes of Together, these technological advances provided unpar- variable depth and attaching metal legs of appropriate alleled guidance for neurosurgical procedures and helped length based on the stereotactic plan. In the OR, the legs to catalyze the development of radiosurgery and stereo- attach to four bone fiducials that have been previously tactic surgery [5]. placed and used as reference points in the stereotactic Over the past 15 years the increasing availability of vol- plan. The build time for the MicrotableTM Platform is sig- umetric imaging and additive manufacturing (3D print- nificantly reduced compared to the StarFixTM microTar- ing) has enabled the creation of customized stereotactic getingTM Platform such that the bone fiducials can be platforms that can be used for deep brain stimulation placed on the same day as the DBS leads if the mobile (DBS), stereo-EEG, and other stereotactic procedures [6– CNC unit is on-site. The CNC milling requires less than 8]. The application of these technologies has enabled 15 min, and the entire process from receipt of the sur- “frameless” stereotaxis with accuracy comparable to tra- geon’s plan to delivery of the MicrotableTM to sterile pro- ditional rigid frames, increased patient comfort, less “as- cessing requires less than 45 min (including time for mea- sembly” time in the OR and the novel ability to surements to be verified by a third party). The steriliza- simultaneously provide targeting for multiple trajectories tion protocol (for a pre-vacuum wrapped microTableTM) [6–11]. The StarFixTM microTargertingTM Platform is an consists of three preconditioning pulses, an exposure example of a 3D-printed stereotactic system that can pro- time of 4 min at 132 ° C, and, unless immediate use is re- vide these advantages with comparable accuracy to frame- quired, a 25-min drying time. Use of a ONE TRAY® based systems such as the Leksell G frame [12]. A current sealed sterilization container obviates the need for the ad- drawback of additive manufacturing, however, has been ditional drying time. The total sterilization time at our the extended production time required to produce and hospital is around 60 min. prepare the platforms. This has necessitated an addition- As a basis for comparison, construction of the Star- al visit for patients who sometime must travel long dis- FixTM Platform typically requires a 2-day process of man- tances for pre-procedural placement of bone fiducial ufacture, cooling, and preparation and must be done at markers. This has created a desire to explore other manu- remote sites with specialized 3D printers [13]. With the facturing methods to produce a fixture with similar cus- additional shipping time to get the platform to the hospi- tomized stereotactic accuracy. To address this need, en- tal where it will be used, a week between fiducial place- 2 Stereotact Funct Neurosurg Ball/John/Donovan/Neimat DOI: 10.1159/000506959 Downloaded by: East Carolina University - Laupus Library 150.216.132.43 - 6/3/2020 7:30:23 AM Table 1. Patient characteristics Patient Diagnosis Target Complications 1 ET VIM (bilateral) None 2 PD STN (right) None 3 ET VIM (bilateral) None Color version available online 4 ET VIM (bilateral) None 5 ET VIM (bilateral) None 6 PD STN (right) None 7 ET VIM (left) None 8 ET VIM (left) None 9 ET VIM (bilateral) None 10 PD STN (left) None ET, essential tremor; PD, Parkinson’s disease; VIM, ventralis intermedius nucleus; STN, subthalamic nucleus. Fig. 2. The microTargetingTM MicrotableTM Platform, as received from sterile processing. Patients There were 10 patients in this series. The mean age was 69.1 years (range 45–77); 6 were male and 4 were female. Seven were ment and the ultimate stereotactic surgery is recom- treated for essential tremor (ET) and 3 for Parkinson’s disease mended. (PD). The ventralis intermedius nucleus (VIM) was targeted for ET and the subthalamic nucleus (STN) for PD. Of these patients, Here we present a series of patients for whom we used there were eight VIM leads and one STN lead that had adequate this MicrotableTM Platform (Fig. 1, 2) for stereotaxis in thin-cut postoperative CT scans to enable accuracy calculations. DBS. The MicrotableTM Platform has been rigorously test- See Table 1 for a summary of patient diagnoses and targets. All ed for accuracy and was recently FDA approved. It is a patients also had the StarFixTM microTargetingTM Platform avail- cost-effective and lightweight system that has been shown able for the operation in case of perceived inaccuracy of the Mi- crotableTM system. One additional patient underwent laser inter- to have high accuracy in a series of cochlear implants and stitial thermal therapy (LITT) for mesial temporal lobe ablation comparable accuracy to the StarFixTM Platform in a phan- using the MicrotableTM for stereotaxis. This patient had a good tom model [13–16]. clinical outcome with no complications, but the patient is not in- cluded in this series because there was not a reliable way to deter- mine the accuracy of ablation probe placement with the available Methods imaging.
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