Initial Clinical Experience with the First FDA-Approved sEEG-Guided Radiofrequency Ablation System Featuring Real-Time Temperature Monitoring: A Case Series

Abstract

Abstract – Introduction: Stereoelectroencephalography-guided radiofrequency ablation (sEEG-RFA) has been used to create stereotactic lesions in epileptic networks. The method has been applied as a diagnostic (and at times, palliative) intervention, primarily in European epilepsy programs. To date, the technique has not been widely popularized in the USA given the lack of FDA-approved technology permitting safe usage of in situ sEEG electrodes for this purpose. Recently, the FDA approved a new hollow sEEG electrode and OneRF generator (NeuroOne) featuring real-time thermal monitoring. Case Presentations: The authors present four illustrative, consecutive cases of refractory epilepsy patients undergoing sEEG, who underwent subsequent sEEG-RFA using the new technology. The procedure was diagnostic in all cases, with no adverse events. Importantly, all 4 patients reported decreased seizure burden following the procedure, with observed improvements informing subsequent surgical decision-making in 3 patients. Conclusion: A new FDA-approved, hollow sEEG electrode technology permits safe sEEG-RFA lesioning, with a positive experience for both the patient and clinical team. The authors reaffirm use of this strategic technique as a diagnostic and prognostic tool, with possibility of secondary therapeutic, ablative effects. This development represents a significant advancement in the work-up of patients with intractable epilepsy, who are undergoing sEEG for invasive evaluation.