PMID- 25313847
OWN - NLM
STAT- MEDLINE
DCOM- 20160223
LR  - 20220210
IS  - 1525-1403 (Electronic)
IS  - 1094-7159 (Linking)
VI  - 18
IP  - 4
DP  - 2015 Jun
TI  - Analysis of adverse events in the management of chronic migraine by peripheral 
      nerve stimulation.
PG  - 305-12; discussion 312
LID - 10.1111/ner.12243 [doi]
AB  - 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). CONCLUSION: 
      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.
CI  - (c) 2014 International Neuromodulation Society.
FAU - Sharan, Ashwini
AU  - Sharan A
AD  - Thomas Jefferson University Hospital, Philadelphia, PA, USA.
FAU - Huh, Billy
AU  - Huh B
AD  - The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
FAU - Narouze, Samer
AU  - Narouze S
AD  - Summa Western Reserve Hospital, Cuyahoga Falls, OH, USA.
FAU - Trentman, Terrence
AU  - Trentman T
AD  - Mayo Clinic, Phoenix, AZ, USA.
FAU - Mogilner, Alon
AU  - Mogilner A
AD  - NYU Langone Medical Center, New York, NY, USA.
FAU - Vaisman, Julien
AU  - Vaisman J
AD  - Pain and Wellness Center, Peabody, MA, USA.
FAU - Ordia, Joe
AU  - Ordia J
AD  - The Center for Pain Relief, Charleston, WV, USA.
FAU - Deer, Timothy
AU  - Deer T
AD  - The Center for Pain Relief, Charleston, WV, USA.
FAU - Venkatesan, Lalit
AU  - Venkatesan L
AD  - St. Jude Medical, Plano, TX, USA.
FAU - Slavin, Konstantin
AU  - Slavin K
AUID- ORCID: 0000-0002-7946-8639
AD  - University of Illinois-Chicago, Chicago, IL, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00267371
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20141014
PL  - United States
TA  - Neuromodulation
JT  - Neuromodulation : journal of the International Neuromodulation Society
JID - 9804159
SB  - IM
MH  - Analysis of Variance
MH  - Chronic Disease
MH  - Cranial Nerves/*physiology
MH  - Double-Blind Method
MH  - Electrodes, Implanted/*adverse effects
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Migraine Disorders/*therapy
MH  - Pain Measurement
MH  - *Transcutaneous Electric Nerve Stimulation/adverse 
      effects/instrumentation/methods
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Adverse events
OT  - device characteristics
OT  - migraine
OT  - peripheral nerve stimulation
OT  - surgeon experience
EDAT- 2014/10/15 06:00
MHDA- 2016/02/26 06:00
CRDT- 2014/10/15 06:00
PHST- 2014/05/02 00:00 [received]
PHST- 2014/07/21 00:00 [revised]
PHST- 2014/08/06 00:00 [accepted]
PHST- 2014/10/15 06:00 [entrez]
PHST- 2014/10/15 06:00 [pubmed]
PHST- 2016/02/26 06:00 [medline]
AID - S1094-7159(21)01696-2 [pii]
AID - 10.1111/ner.12243 [doi]
PST - ppublish
SO  - Neuromodulation. 2015 Jun;18(4):305-12; discussion 312. doi: 10.1111/ner.12243. 
      Epub 2014 Oct 14.