TY - JOUR
T1 - Surgical and Hardware-Related Adverse Events of Deep Brain Stimulation
T2 - A Ten-Year Single-Center Experience
AU - Bouwens van der Vlis, Tim A M
AU - van de Veerdonk, Mégan M G H
AU - Ackermans, Linda
AU - Leentjens, Albert F G
AU - Janssen, Marcus L F
AU - Kuijf, Mark L
AU - Schruers, Koen R J
AU - Duits, Annelien
AU - Gubler, Felix
AU - Kubben, Pieter
AU - Temel, Yasin
N1 - Copyright © 2021. Published by Elsevier Inc.
PY - 2022/2
Y1 - 2022/2
N2 - 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.
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.
KW - Deep Brain Stimulation/adverse effects
KW - Electrodes, Implanted/adverse effects
KW - Humans
KW - Quality of Life
KW - Retrospective Studies
KW - Surgical Wound Infection/etiology
KW - SURGERY
KW - infection
KW - complications
KW - RISK
KW - PULSE-GENERATOR
KW - deep brain stimulation
KW - REPLACEMENT
KW - TRIAL
KW - Adverse events
KW - SUBTHALAMIC NUCLEUS
KW - THALAMIC-STIMULATION
KW - INFECTION
KW - COMPLICATIONS
KW - hardware failure
U2 - 10.1016/j.neurom.2021.12.011
DO - 10.1016/j.neurom.2021.12.011
M3 - Article
C2 - 35125149
SN - 1094-7159
VL - 25
SP - 296
EP - 304
JO - Neuromodulation
JF - Neuromodulation
IS - 2
ER -