Development of a novel, concentric micro-ECoG array enabling simultaneous detection of a single location by multiple electrode sizes.

Objective.Detection of the epileptogenic zone is critical, especially for patients with drug-resistant epilepsy. Accurately mapping cortical regions exhibiting high activity during spontaneous seizure events while detecting neural activity up to 500 Hz can assist clinicians' surgical decisions and improve patient outcomes.Approach.We designed, fabricated, and tested a novel hybrid, multi-scale micro-electrocorticography (micro-ECoG) array with a unique embedded configuration. This array was compared to a commercially available microelectrode array (Neuronexus) for recording neural activity in rodent sensory cortex elicited by somatosensory evoked potentials and pilocarpine-induced seizures.Main results.Evoked potentials and spatial maps recorded by the multi-scale array ('micros', 'mesos', and 'macros' refering to the relative electrode sizes, 40 micron, 1 mm, and 4 mm respectively) were comparable to the Neuronexus array. The SSEPs recorded with the micros had higher peak amplitudes and greater signal power than those recorded by the larger mesos and macro. Seizure onset events and high-frequency oscillations (∼450 Hz) were detected on the multi-scale, similar to the commercially available array. The micros had greater SNR than the mesos and macro over the 5-1000 Hz frequency range during seizure monitoring. During cortical stimulation experimentation, the mesos successfully elicited motor effects.Significance.Previous studies have compared macro- and microelectrodes for localizing seizure activity in adjacent regions. The multi-scale design validated here is the first to simultaneously measure macro- and microelectrode signals from the same overlapping cortical area. This enables direct comparison of microelectrode recordings to the macroelectrode recordings used in standard neurosurgical practice. Previous studies have also shown that cortical regions generating high-frequency oscillations are at an increased risk for becoming epileptogenic zones. More accurate mapping of these micro seizures may improve surgical outcomes for epilepsy patients.

Minimally Invasive, Endoscopic-Assisted Device for Subdural Electrode Implantation in Epilepsy.

BACKGROUND: Subdural grids and strip electrodes provide wide coverage of the cerebral cortex, precise delineation of the extent of the seizure onset zone, and improved spatial sampling to perform functional mapping for eloquent cortex. OBJECTIVE: To describe a novel device that allows for a minimally invasive approach to implantation of subdural grid and strip electrodes. METHODS: A skull mounted device was created to allow for implantation of subdural electrodes through a keyhole craniotomy with direct visualization using the aid of a flexible neurovideoscope. The initial studies in preparation for grid development performed on cadaveric skulls were analyzed to determine the size of craniotomy required for deployment, maximal distance of strip electrode deployment from center of craniotomy, and visual inspection of the cortex was performed for any underlying damage. RESULTS: The device allowed for the placement of subdural electrodes through a 40-mm craniotomy. Subdural electrodes were deployed in multiple directions to a distance of a 70-mm radius from the center of the craniotomy. There was no visual damage to the underlying cortex after the procedures were completed. CONCLUSION: Large craniotomies are typically desired to provide direct visualization of the implantation of subdural electrodes, but can increase the risk of subdural hemorrhages and infections. This study describes a novel minimally invasive endoscopically assisted device for the implantation of subdural strip electrodes under direct visualization. With this device, we are able to limit the size of the craniotomy, avoid incision through the temporalis muscle, and implant subdural electrodes with visualization of the cortex.

Contact Forces Required to Record Monophasic Action Potentials: A Complement to Catheter Contact Force Measurement.

OBJECTIVE: The ability to monitor catheter contact force (CF) plays a major role in assessing radiofrequency ablation, impacting lesion size and arrhythmia recurrence, and dictating ablation duration and/or overall patient safety. Our study sought to determine the relative CFs required to elicit reproducible monophasic action potential (MAP) recordings. METHODS: The study utilized four swine in which: first, median sternotomies were performed and MAPs were collected from seven ventricular locations on the epicardial surface of each heart; and second, a subset of endocardial signals was recorded from a reanimated heart. In these studies, the initial elicitation and then loss of stable MAP waveforms were recorded, as were their associated catheter CFs (n = 371). RESULTS: Mean CF at the onset of stable MAP recordings was 14.2 ± 2.9 g for epicardial and 16.6 ± 2.5 g for endocardial locations. Across epicardial locations, no significant differences in CF were required to elicit MAPs. Additionally, endocardial and epicardial CFs for MAPs did not significantly differ for respective locations, i.e., right ventricular septum endocardial versus epicardial. In our study, the catheter CFs required to elicit MAPs were within optimal ranges previously reported for eliciting clinically viable radiofrequency ablations. CONCLUSION: We believe that MAP recordings could complement CF measurements with electrical data, providing additional clinical feedback for physicians performing cardiac ablation. SIGNIFICANCE: If applied clinically, MAP recordings could potentially improve ablation outcomes in patients with cardiac arrhythmias.

Visualization of catheter ablation for atrial fibrillation: Impact of devices and anatomy.

Endocardial access to the left atrium is commonly achieved to treat patients with atrial fibrillation, using different device delivery systems for cardiac ablation. But the large variation in human anatomy presses the limits of existing medical devices. In this unique study, we directly visualized the device-tissue interface in fresh reanimated human hearts using Visible Heart(®) methodologies. Our goal was to better understand any opportunities to improve therapeutic approaches. The visual images obtained in this study (also featured in this article) allow a more intimate grasp of the key steps required in various ablation procedures, as well as some limitations of current device designs. These images show the potential risks of conducting transseptal punctures and the difficulties of placing catheter tips in certain scenarios (e.g., when creating circumferential lesions); they also demonstrate potential problems that could occur while attempting to place catheter tips on such anatomies like the mitral isthmus. In our analysis of these images, we focus on where enhancements are needed to refine device functionality.

Tissue properties of the fossa ovalis as they relate to transseptal punctures: a translational approach.

OBJECTIVES: This study focused on how catheter size affects transseptal puncture, what transseptal indication means, and whether the swine model is predictive for humans. BACKGROUND: Transseptal puncture is a common procedure that gains access to the left atrium, allowing percutaneous mitral valve repair, left atrial appendage closure, and left-sided ablations. The basic approach has not changed in many years; however, the frequency of transseptal punctures and the size of devices are increasing with emerging treatments. METHODS: A broad range of devices (4 F to 18 F) were advanced through atrial septa of swine hearts; some devices were inserted in both swine and human hearts using 10 F catheters. RESULTS: Greater forces were required to puncture through the septa of human hearts compared to those of swine. Larger catheters used in swine hearts required greater force to advance them through the septa, causing greater dilation of tissue and sometimes tearing the floor of the fossa ovalis; analyses indicated an exponential increase in the size of the iatrogenic atrial septal defect. Specific tissue property testing of the septum primum showed that this tissue sheared at a lower exerted force in a superior to inferior direction. CONCLUSIONS: Results may provide physicians with important knowledge about what to expect when treating a possible iatrogenic atrial septal defect or help them understand the consequences of transseptal punctures. Comparative data between swine and human atrial septal tissue properties provide critical insights between the species and offer clinicians and device designers important information relative to differences in tissue behaviors.

Assessing the Relative Integrity of Formed Cardiac Linear Lesions by Recording Both Focal Monophasic Action Potentials and Contact Forces: A Technical Brief.

The use of therapeutic ablation in patients with atrial fibrillation has become a mainstay in the treatment of this disease, yet often these individuals require multiple procedures. In other words, successful first time treatments are impacted by challenges, including the generation of linear lesions in certain anatomies like the mitral isthmus of the left atrium. Hence, there is a need to find ways to address the presence of unwanted conduction gaps at the time of lesion creation. In this paper, we describe a novel approach to examine conduction gaps, by using a proof of concept device to examine local electrical activation within the cardiac areas of an applied lesion, i.e., to locate gaps in the lesion set. To accomplish this, both epicardial and endocardial linear ablation lines composed of spot lesions with conduction gaps were created in a porcine model. The forces necessary to elicit monophasic action potentials (MAP) were collected from >200 measurements on the epicardium of the right ventricle. Ablations were then performed on the ventricular epicardium and left atrial mitral isthmus endocardially, while recording MAPs. We were able to successfully demonstrate the use of a proof of concept device to identify conduction gaps in linear lesion sets; furthermore, we were able to determine required contact forces to appropriately determine focal electrical changes of the underlying tissues. New catheter designs that incorporate capabilities to record focal MAPs could be employed clinically to better assess a given lesion quality and/or to determine the existence of an undesired conduction gap.