Olatoye, Oludare

Background: High-frequency (10-kHz) spinal cord stimulation (SCS) continues to be an emerging therapy in chronic pain management. The same complications that plagued earlier SCS systems may affect newer stimulation technologies, although there is limited data on the type of complications and surgical management of these complications. Objective: The aim of this study was to systematically examine real-world complications associated with 10-kHz SCS reported on the Manufacturer and User Facility Device Experience (MAUDE) database. Materials and Methods: The MAUDE database was queried for entries reported between January 1, 2016 and December 31, 2020. Entries were classified into procedural complications, device-related complications, patient complaints, surgically managed complications, serious adverse events, and/or other complications. Primary outcomes included type and frequency of complications, and surgical management of complications. Results: A total of 1651 entries were analyzed. Most entries were categorized as procedural complications (72.6%), followed by serious adverse events (10.5%), device-related complications (10.5%), and patient complaints (9.9%). Most complications were managed surgically with explant (50.9%) rather than revision (5.0%) or incision/drainage (6.6%). Of procedural complications, the most common entries included non-neuraxial infection (52.9%), new neurological symptoms (14.7%), and dural puncture (9.5%). Of device-related complications, the most common entries included lead damage (41.6%), erosion (18.5%), and difficult insertion (11.5%). Conclusion: This retrospective 5-year analysis of complications from10-kHz SCS provides a real-world assessment of safety data unique for this stimulation modality. This analysis may help inform future clinical decisions, lead to device enhancement and optimization, and improve mitigation of risks to provide safe and efficacious use of 10-kHz SCS.

AbstractBackgroundChronic headaches are the second most prevalent disease and second most common cause for years lived with disability worldwide. Occipital neuralgia can cause headaches or be present in addition to other more prevalent causes of headache. If these headaches fail to respond to conservative and pharmacological therapy, physicians proceed to more invasive treatments, starting with infiltration of the greater occipital nerve with local anesthetic with or without corticosteroids, followed by nerve ablation or stimulation. Occipital nerve stimulation gained more popularity as the technology improved and more pain physicians received training on interventional procedures.MethodsIn this manuscript, we are presenting our experience with ultrasound-guided implant of occipital nerve stimulators using peripheral nerve stimulator systems. After confirming appropriateness of treatment by a successful occipital nerve block (i.e., resulting in >50% relief in patients’ pain intensity), we implanted five stimulator systems in three patients (two bilateral).ResultsWe followed these patients for an average of eight months, and the average pain reduction was ∼50%. We did not observe any adverse events during or immediately after surgery. One patient developed an adverse reaction to the adhesive of the battery transmitter, but it was not severe enough to stop her from using the stimulator.ConclusionsConsidering the ease of implant and minimal side effects, implant of peripheral nerve stimulators to stimulate the occipital nerve is a promising treatment modality for patients with chronic headache who present with features of occipital neuralgia. However, wider use of this treatment modality is subject to further studies.