PMID- 35125149
OWN - NLM
STAT- MEDLINE
DCOM- 20220208
LR  - 20220208
IS  - 1525-1403 (Electronic)
IS  - 1094-7159 (Linking)
VI  - 25
IP  - 2
DP  - 2022 Feb
TI  - Surgical and Hardware-Related Adverse Events of Deep Brain Stimulation: A 
      Ten-Year Single-Center Experience.
PG  - 296-304
LID - S1094-7159(21)06989-0 [pii]
LID - 10.1016/j.neurom.2021.12.011 [doi]
AB  - INTRODUCTION: Although deep brain stimulation (DBS) is effective for treating a 
      number of neurological and psychiatric indications, surgical and hardware-related 
      adverse events (AEs) can occur that affect quality of life. This study aimed to 
      give an overview of the nature and frequency of those AEs in our center and to 
      describe the way they were managed. Furthermore, an attempt was made at 
      identifying possible risk factors for AEs to inform possible future preventive 
      measures. MATERIALS AND METHODS: Patients undergoing DBS-related procedures 
      between January 2011 and July 2020 were retrospectively analyzed to inventory 
      AEs. The mean follow-up time was 43 +/- 31 months. Univariate logistic regression 
      analysis was used to assess the predictive value of selected demographic and 
      clinical variables. RESULTS: From January 2011 to July 2020, 508 DBS-related 
      procedures were performed including 201 implantations of brain electrodes in 200 
      patients and 307 implantable pulse generator (IPG) replacements in 142 patients. 
      Surgical or hardware-related AEs following initial implantation affected 40 of 
      200 patients (20%) and resolved without permanent sequelae in all instances. The 
      most frequent AEs were surgical site infections (SSIs) (9.95%, 20/201) and wire 
      tethering (2.49%, 5/201), followed by hardware failure (1.99%, 4/201), skin 
      erosion (1.0%, 2/201), pain (0.5%, 1/201), lead migration (0.52%, 2/386 electrode 
      sites), and hematoma (0.52%, 2/386 electrode sites). The overall rate of AEs for 
      IPG replacement was 5.6% (17/305). No surgical, ie, staged or nonstaged, 
      electrode fixation, or patient-related risk factors were identified for SSI or 
      wire tethering. CONCLUSIONS: Major AEs including intracranial surgery-related AEs 
      or AEs requiring surgical removal or revision of hardware are rare. In 
      particular, aggressive treatment is required in SSIs involving multiple sites or 
      when Staphylococcus aureus is identified. For future benchmarking, the 
      development of a uniform reporting system for surgical and hardware-related AEs 
      in DBS surgery would be useful.
CI  - Copyright (c) 2021. Published by Elsevier Inc.
FAU - Bouwens van der Vlis, Tim A M
AU  - Bouwens van der Vlis TAM
AD  - Department of Neurosurgery, Maastricht University Medical Center, Maastricht, The 
      Netherlands. Electronic address: tim.bouwens@mumc.nl.
FAU - van de Veerdonk, Megan M G H
AU  - van de Veerdonk MMGH
AD  - Department of Neurosurgery, Maastricht University Medical Center, Maastricht, The 
      Netherlands.
FAU - Ackermans, Linda
AU  - Ackermans L
AD  - Department of Neurosurgery, Maastricht University Medical Center, Maastricht, The 
      Netherlands.
FAU - Leentjens, Albert F G
AU  - Leentjens AFG
AD  - Department of Psychiatry, Maastricht University Medical Center, Maastricht, The 
      Netherlands.
FAU - Janssen, Marcus L F
AU  - Janssen MLF
AD  - School for Mental Health and Neuroscience, Maastricht University, Maastricht, The 
      Netherlands; Department of Clinical Neurophysiology, Maastricht University 
      Medical Center, Maastricht, The Netherlands.
FAU - Kuijf, Mark L
AU  - Kuijf ML
AD  - Department of Neurology, Maastricht University Medical Center, Maastricht, The 
      Netherlands.
FAU - Schruers, Koen R J
AU  - Schruers KRJ
AD  - Department of Psychiatry, Maastricht University Medical Center, Maastricht, The 
      Netherlands; School for Mental Health and Neuroscience, Maastricht University, 
      Maastricht, The Netherlands; Mondriaan Mental Health Center, Maastricht, The 
      Netherlands.
FAU - Duits, Annelien
AU  - Duits A
AD  - School for Mental Health and Neuroscience, Maastricht University, Maastricht, The 
      Netherlands; Department of Psychology, Maastricht University Medical Center, 
      Maastricht, The Netherlands.
FAU - Gubler, Felix
AU  - Gubler F
AD  - Department of Neurosurgery, Maastricht University Medical Center, Maastricht, The 
      Netherlands.
FAU - Kubben, Pieter
AU  - Kubben P
AD  - Department of Neurosurgery, Maastricht University Medical Center, Maastricht, The 
      Netherlands.
FAU - Temel, Yasin
AU  - Temel Y
AD  - Department of Neurosurgery, Maastricht University Medical Center, Maastricht, The 
      Netherlands; School for Mental Health and Neuroscience, Maastricht University, 
      Maastricht, The Netherlands.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Neuromodulation
JT  - Neuromodulation : journal of the International Neuromodulation Society
JID - 9804159
SB  - IM
MH  - *Deep Brain Stimulation/adverse effects
MH  - Electrodes, Implanted/adverse effects
MH  - Humans
MH  - Quality of Life
MH  - Retrospective Studies
MH  - Surgical Wound Infection/etiology
OTO - NOTNLM
OT  - Adverse events
OT  - complications
OT  - deep brain stimulation
OT  - hardware failure
OT  - infection
EDAT- 2022/02/08 06:00
MHDA- 2022/02/09 06:00
CRDT- 2022/02/07 05:24
PHST- 2021/09/30 00:00 [received]
PHST- 2021/11/16 00:00 [revised]
PHST- 2021/12/08 00:00 [accepted]
PHST- 2022/02/07 05:24 [entrez]
PHST- 2022/02/08 06:00 [pubmed]
PHST- 2022/02/09 06:00 [medline]
AID - S1094-7159(21)06989-0 [pii]
AID - 10.1016/j.neurom.2021.12.011 [doi]
PST - ppublish
SO  - Neuromodulation. 2022 Feb;25(2):296-304. doi: 10.1016/j.neurom.2021.12.011.