Implanted Subdural Electrodes: Safety Issues and Complication Avoidance




Invasive electroencephalography via subdural implanted electrodes is essential for the identification and localization of the epileptogenic focus in a large percentage of cases of medically refractory epilepsy. The implantation of subdural electrodes constitutes a widely used method for the preoperative investigation of these patients. However, their implantation has been associated with the occurrence of some rare but potentially serious complications. This article systematically reviews the literature regarding safety issues, potential complications, and complication avoidance strategies associated with the implantation of subdural electrodes. Knowledge of all the reported complications may help in their early detection and their prompt management.


Epilepsy affects approximately 0.5% to 1% of the general population, and at some point approximately 20% of these patients develop medically intractable epilepsy despite adequate pharmaceutical treatment. It has been estimated that 2 to 3/1000 people suffer medically refractory epilepsy, which is equivalent to 17,000 new cases per year in the United States alone. More than 700,000 cases of medically refractory epilepsy exist in the United States that may be benefited from surgery. Approximately 20% to 50% of these patients may have localized epilepsy and may be good candidates for resective, disconnecting, or neuromodulation procedures. It has been shown that surgical management of these medically refractory cases significantly increases the possibility of seizure freedom, improves the postoperative quality of life, maximizes the patient’s social function, and may minimize the need for anticonvulsant medications and their associated side effects.


In most cases, consideration for surgical intervention requires identification and accurate localization of the epileptogenic focus or foci and any associated epileptogenic zones. Surface electroencephalography (EEG) cannot localize the epileptogenic foci in approximately 25% of the medically refractory cases. In these cases in which surface EEG can identify no epileptogenic foci, or in those cases in which electrophysiologic studies are disconcordant with imaging studies, invasive EEG is necessary for further investigation. Invasive EEG permits more accurate and sensitive information because it is closer to the source of cortical electrical activity; it is separated only by high electrical conductivity media (cerebrospinal fluid [CSF], brain parenchyma), and thus is characterized by a high signal/noise ratio. In addition, it can detect electrical activity from a significantly smaller cortical area than surface EEG, and has stable impedance throughout the whole recording period. Furthermore, invasive EEG may provide valuable information regarding the presence of eloquent cortical areas, and thus allow accurate cortical mapping.


The use of subdural electrodes was first described by Penfield and his coworkers in the late 1930s. The first documented case of epidural electrode recording was performed also by Penfield, Jasper, and Hebb in 1939. The use of invasive EEG monitoring started progressively increasing within the next few decades, and in the mid-1970s it became routine clinical practice for patients with medically refractory epilepsy. Epidural electrodes were initially more popular, whereas strip subdural electrodes inserted via burr holes later became more frequently used. The evolution of stereotactic surgery and the technological advancement of stereotactic hardware and software allowed the wide application of depth along with subdural electrodes for invasive EEG monitoring. Likewise, the development of more biocompatible and more flexible grid electrodes led to their wide application in the preoperative investigation of patients with medically intractable epilepsy. It has been estimated that invasive recording is nowadays used in 25% to 50% of surgical epilepsy series.


The wide clinical application of invasive monitoring in the preoperative evaluation of patients suffering from medically refractory epilepsy brings up the issue of safety of using invasive monitoring. It is generally accepted that subdural electrodes show higher complication rates than depth electrodes. Even though subdural electrode–associated complications are rare, they can occasionally become troublesome. Thorough knowledge of all the potential complications associated with the implantation of subdural electrodes, and all subdural-related safety issues, is of paramount importance for their early recognition and prompmanagement. Moreover, meticulous knowledge of all safety issues is mandatory for medicolegal purposes, and for appropriately informing all possible surgical candidates before obtaining their consent.


This article systematically reviews the pertinent literature and identifies all safety issues associated with the implantation of subdural electrodes. All the possible complications associated with their usage are reviewed, and any predisposing factors are identified, for developing efficient strategies and protocols for avoiding complications.


Material and methods


A systematic review of the English language literature was performed through the PubMed search engine. The search terms complication, depth, electrode, epidural, grid, intracranial, invasive, safety, strip, and subdural were used independently and in all possible combinations. Clinical series, miniseries, and case reports were included in our current study with no chronologic limitations. Adult, pediatric, and mixed population studies were all included in our analysis. All the recovered articles were reviewed for safety issues regarding the usage of invasive EEG monitoring, safety issues associated with the biocompatibility of the implanted electrodes, and/or the occurrence of any procedure-related or material-related complications. Special attention was paid to the study population overlap that existed in several articles, and every possible effort was made to avoid any recalculations of the reported subdural electrode–associated complications.


The type of study, the number of included patients, the type of implanted subdural electrodes, their manufacturing characteristics, the duration of invasive EEG monitoring, the perioperative management of these patients, and the observed major and/or minor complications were recorded and tabulated. Other parameters, such as the implantation surgical technique, the performing surgeon’s experience, and the type of underlying epilepsy, were also examined whenever available.


The role of imaging, intracranial pressure monitoring, or other developing strategies for the avoidance or early recognition of any subdural electrode-related complications is also examined in our current study. The applied strategies of various epilepsy surgery centers for preventing any subdural electrode complications described in the examined clinical series are also critically reviewed.




Results


The biocompatibility of the material of the commercially available, implantable subdural electrodes seems to raise no safety issues. There are no reported complications, as far as we know, caused by tissue reaction either to the electrodes’ contact material (platinum, silver, or stainless steel) or to the silastic material forming the matrix in which the contacts are embedded. In most of the reported cases, the contacts of the subdural electrodes are 3.97 to 5 mm in diameter, and 0.127 to 0.7 mm in thickness. The interdiskal distance varies between 5 and 10 mm. Histopathologic studies in patients undergoing invasive EEG monitoring via subdural electrodes have shown that there were no cortical changes but mild reactive leptomeningeal thickening, and mild mononuclear cell infiltration of the subarachnoid space. The recently developed hybrid electrodes ( Figs. 1 and 2 ), which are a combination of conventional subdural grid electrodes with microwire arrays, seem to be associated with no additional complications to the commonly occurring complications of the conventional electrodes. Likewise, the use of a newer microelectrode array (Neuroport, Cyberkinetics Neurotechnology Systems Inc, Boston, MA) ( Fig. 3 ), initially designed for human neuroprosthetic implantable systems, in invasive EEG recording, revealed no biocompatibility issues and no material-related brain tissue reactions. This microelectrode system is a 10 by 10 array of 96 platinum electrode disks (there are no contacts at the 4 corners), embedded on a 4 mm 2 silicon base, with 400-μm interdiskal spacing. Histopathologic examination of the resected cortex in these cases revealed minimal tissue reaction with mild regional microglial activation and limited scattered microhemorrhages.




Fig. 1


A 1×4 contact strip with 32 microwires ( A ), a hybrid 4×6 grid with 104 microwires ( B ), and a hybrid 4×4 grid with 112 microwires ( C ). Microwires are 40-μm diameter, platinum-iridium wire spaced 1 mm apart. Clinical macrocontacts are 4 mm diameter and spaced 10 mm center to center.

( From Van Gompel JJ, Stead SM, Giannini C, et al. Phase I trial: safety and feasibility of intracranial electroencephalography using hybrid subdural electrodes containing macro-and microelectrode arrays. Neurosurg Focus 2008;25:2; with permission.)



Fig. 2


The hybrid grid for intracranial monitoring. ( A ) Low-magnification view of hybrid 4×4 grid before implantation. ( B ) High-magnification view of the grid subunit. Note how 4 macroelectrodes surround a diamond-shaped and centered 4×4 grid of microwires. ( C ) Low-magnification view of implanted grid in a patient. ( D ) High-magnification view of grid subunit over human cortex. Note the improved spatial resolution of microwires compared with macroelectrodes.

( From Van Gompel JJ, Stead SM, Giannini C, et al. Phase I trial: safety and feasibility of intracranial electroencephalography using hybrid subdural electrodes containing macro-and microelectrode arrays. Neurosurg Focus 2008;25:3; with permission.)



Fig. 3


Representative intraoperative photographs showing elements of the microarray insertion procedure. ( A ) Setup of the surgical field after craniotomy, dural opening, and preliminary grid insertion. The positioning device for the impactor wand has been attached to a Greenberg retractor system. ( B ) Close-up view of the positioning device, showing multidimensional capability for fine-tuning of the impactor wand. ( C ) Close-up view of the impactor wand near the cortical target, in preparation for microarray implantation. ( D ) View of microarray after transpial insertion and stabilization with silk sutures to the dural edge. The device pedestal has been fixed to the cranium at the edge of the craniotomy. ( E ) Close-up view of the implanted microarray, showing mild subpial hemorrhage. ( F ) Final appearance of the device pedestal after wound closure. In this patient, the pedestal was brought through the scalp flap via a separate stab incision.

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Oct 13, 2017 | Posted by in NEUROSURGERY | Comments Off on Implanted Subdural Electrodes: Safety Issues and Complication Avoidance

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