title: Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation.
abstract: OBJECTIVE
  In 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.
  
  
  METHODS
  PNS 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.
  
  
  RESULTS
  IPG 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).
  
  
  CONCLUSIONS
  Implantation 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.
authors.affiliation: Thomas Jefferson University Hospital, Philadelphia, PA, USA.
authors.forename: Ashwini
authors.initials: A
authors.lastname: Sharan
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: Billy
authors.initials: B
authors.lastname: Huh
authors.affiliation: Summa Western Reserve Hospital, Cuyahoga Falls, OH, USA.
authors.forename: Samer
authors.initials: S
authors.lastname: Narouze
authors.affiliation: Mayo Clinic, Phoenix, AZ, USA.
authors.forename: Terrence
authors.initials: T
authors.lastname: Trentman
authors.affiliation: NYU Langone Medical Center, New York, NY, USA.
authors.forename: Alon
authors.initials: A
authors.lastname: Mogilner
authors.affiliation: Pain and Wellness Center, Peabody, MA, USA.
authors.forename: Julien
authors.initials: J
authors.lastname: Vaisman
authors.affiliation: The Center for Pain Relief, Charleston, WV, USA.
authors.forename: Joe
authors.initials: J
authors.lastname: Ordia
authors.affiliation: The Center for Pain Relief, Charleston, WV, USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Deer
authors.affiliation: St. Jude Medical, Plano, TX, USA.
authors.forename: Lalit
authors.initials: L
authors.lastname: Venkatesan
authors.affiliation: University of Illinois-Chicago, Chicago, IL, USA.
authors.forename: Konstantin
authors.identifier: http://orcid.org/0000-0002-7946-8639
authors.initials: K
authors.lastname: Slavin
mesh_terms: D000704:Analysis of Variance; D002908:Chronic Disease; D003391:Cranial Nerves / Q000502:physiology*; D004311:Double-Blind Method; D004567:Electrodes, Implanted / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000628:therapy*; D010147:Pain Measurement; D004561:Transcutaneous Electric Nerve Stimulation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D016896:Treatment Outcome
keywords: Adverse events; device characteristics; migraine; peripheral nerve stimulation; surgeon experience