Analysis of Adverse Events in the Management of Chronic Migraine by Peripheral Nerve Stimulation

作者：Sharan Ashwini^*; Huh Billy; Narouze Samer; Trentman Terrence; Mogilner Alon; Vaisman Julien; Ordia Joe; Deer Timothy; Venkatesan Lalit; Slavin Konstantin

来源：Neuromodulation, 2015, 18(4): 305-312.

DOI：10.1111/ner.12243

• Adverse events
• device characteristics
• migraine
• peripheral nerve stimulation
• surgeon experience

ObjectiveIn this study, we analyze device- and procedure-related adverse events (AEs) from a recent prospective, multicenter, double-blinded controlled study that utilized peripheral nerve stimulation (PNS) of occipital nerves for management of chronic migraine.
MethodsPNS device characteristics (lead length and spacing), surgical techniques including lead orientation (parallel or perpendicular to the nerve), and implantable pulse generator (IPG) placement (upper buttock, abdomen, infraclavicular, or lower axilla) in 157 patients were analyzed to identify any relationship with the AE incidence rate. Number of prior PNS implants performed (NPPIP) by the implanter and its relationship with different AE categories (hardware-related, biological, and stimulation-related events) and frequently observed device/procedure-related AEs (lead migration/fracture/breakage, persistent pain at the lead/IPG location, unintended/undesirable changes in stimulation, infection) were also evaluated. Three-way ANOVA tests were utilized to evaluate the dependence of AE occurrence on the variables described above.
ResultsIPG pocket locations closer to the lead (e.g. infraclavicular region) were associated with a lower AE incidence rate (p < 0.05). Higher NPPIP was related to lower stimulation- and hardware-related AEs (p < 0.05), frequently observed AEs like lead migration, pain, and infection (p < 0.05), and procedure-related additional surgeries (p < 0.05).
ConclusionImplantation of the IPG closer to the lead location was associated with reduced AEs. PNS is a relatively new procedure, and the skill and precision in performing these procedures improves with experience. Our results demonstrate that as the implanter gains more experience with these procedures, a significant reduction in device- and procedure-related AEs may be expected.

• 出版日期2015-6