Systematic review of hardware-related complications of Deep Brain Stimulation: Do new indications pose an increased risk?

Jitkritsadakul, Onanong; Bhidayasiri, Roongroj; Kalia, Suneil K.; Hodaie, Mojgan; Lozano, Andrés M.; Fasano, Alfonso

doi:10.1016/j.brs.2017.07.003

Cited by 136 publications

(111 citation statements)

References 107 publications

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“…The most recent and closely related DBS review of hardware complications by Jitkritsadakul et al, investigated the differences in incidence rates across indications for DBS. They used this information to identify patients more at risk based on their indication in order to inform them prior to surgery . While we have similar rates of complications, our review did not focus on specific indications.…”

Section: Discussionmentioning

confidence: 99%

Estimating Risk for Future Intracranial, Fully Implanted, Modular Neuroprosthetic Systems: A Systematic Review of Hardware Complications in Clinical Deep Brain Stimulation and Experimental Human Intracortical Arrays

Bullard

Hutchison

Lee

et al. 2020

Neuromodulation: Technology at the Neural Interface

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Objective A new age of neuromodulation is emerging: one of restorative neuroengineering and neuroprosthetics. As novel device systems move toward regulatory evaluation and clinical trials, a critical need arises for evidence‐based identification of potential sources of hardware‐related complications to assist in clinical trial design and mitigation of potential risk. Materials and Methods The objective of this systematic review is to provide a detailed safety analysis for future intracranial, fully implanted, modular neuroprosthetic systems. To achieve this aim, we conducted an evidence‐based analysis of hardware complications for the most established clinical intracranial modular system, deep brain stimulation (DBS), as well as the most widely used intracranial human experimental system, the silicon‐based (Utah) array. Results Of 2328 publications identified, 240 articles met the inclusion criteria and were reviewed for DBS hardware complications. The most reported adverse events were infection (4.57%), internal pulse generator malfunction (3.25%), hemorrhage (2.86%), lead migration (2.58%), lead fracture (2.56%), skin erosion (2.22%), and extension cable malfunction (1.63%). Of 433 publications identified, 76 articles met the inclusion criteria and were reviewed for Utah array complications. Of 48 human subjects implanted with the Utah array, 18 have chronic implants. Few specific complications are described in the literature; hence, implant duration served as a lower bound for complication‐free operation. The longest reported duration of a person with a Utah array implant is 1975 days (~5.4 years). Conclusions Through systematic review of the clinical and human‐trial literature, our study provides the most comprehensive safety review to date of DBS hardware and human neuroprosthetic research using the Utah array. The evidence‐based analysis serves as an important reference for investigators seeking to identify hardware‐related safety data, a necessity to meet regulatory requirements and to design clinical trials for future intracranial, fully implanted, modular neuroprosthetic systems.

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Section: Discussionmentioning

confidence: 99%

Estimating Risk for Future Intracranial, Fully Implanted, Modular Neuroprosthetic Systems: A Systematic Review of Hardware Complications in Clinical Deep Brain Stimulation and Experimental Human Intracortical Arrays

Bullard

Hutchison

Lee

et al. 2020

Neuromodulation: Technology at the Neural Interface

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“…19 The risks of complication related to the intervention, however, continue to decrease with advances in surgical techniques. 5,29 Worsening of symptoms or unexplained new symptoms have been described. In one case described by Duits et al, 14 a 20-year-old female patient had hypertonia and dysphagia following DBS, which ultimately led to her death.…”

Section: Discussionmentioning

confidence: 99%

“…This methodology increases statistical power and is particularly helpful to investigate questions that were not originally addressed in the individual publications. 29 Our study protocol was developed, but not registered, by authors with content and methodological expertise (G.M.I., N.L., and N.M.A.) prior to conduct of the review.…”

Section: Search Strategy and Eligibility Criteriamentioning

confidence: 99%

Deep brain stimulation for Gilles de la Tourette syndrome in children and youth: a meta-analysis with individual participant data

Coulombe

Elkaim

Alotaibi

et al. 2019

Journal of Neurosurgery: Pediatrics

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OBJECTIVEGilles de la Tourette syndrome (GTS) is a disorder characterized by motor and vocal tics. Although by definition the onset of GTS is before age 18 years, clinical trials of deep brain stimulation (DBS) have been conducted only in adults. Using individual participant data (IPD) meta-analysis methodology, the current study investigated the safety and efficacy of DBS as a treatment for GTS in children and youth.METHODSA systematic review with no date or language restrictions was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. Three electronic databases were searched: PubMed, EMBASE, and Web of Science. From 843 articles screened, the IPD of 58 children and youth (ages 12–21 years) extracted from 21 articles were collected and analyzed. A mixed-effects univariable analysis followed by multivariable hierarchical regression was performed using change in the Yale Global Tic Severity Scale (YGTSS) score as the primary outcome and reported measures of comorbidities as secondary outcomes.RESULTSThe authors’ results showed an average improvement of 57.5% ± 24.6% across studies on the YGTSS. They also found that comorbid depression and stimulation pulse width each correlated negatively with outcome (p < 0.05). In patients with less severe GTS, greater improvements were evident following thalamic stimulation. More than one-quarter (n = 16, 27.6%) of participants experienced side effects, the majority of which were minor.CONCLUSIONSDBS in the pediatric population may be an effective option with a moderate safety profile for treatment of GTS in carefully selected children and youth. Large, prospective studies with long-term follow-up are necessary to understand how DBS influences tic symptoms and may alter the natural course of GTS in children.

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“…Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is an efficacious therapy for the treatment of the motor symptoms of Parkinson's disease (PD) [1][2][3]. However, implantation of hardware introduces the risk of suppurative skin erosion and subsequent infection (4.8-7.4% incidence of infection with or without erosion) [4,5]. When not adequately controlled with antibiotics, removal of the infected hardware is indicated [6][7][8].…”

Section: Introductionmentioning

confidence: 99%

Neuronal Activity and Synaptic Plasticity in a Reimplanted STN-DBS Patient with Parkinson’s Disease: Recordings from Two Surgeries

Milosevic

Vloo

Gramer

et al. 2020

Stereotact Funct Neurosurg

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The authors report the case of an elderly male in his 60s who, after 5 months of efficacious treatment with chronic deep brain stimulation of the subthalamic nucleus (STN-DBS), developed a hardware-related erosion necessitating removal of the complete DBS system. One and a half years following the first implantation, a new STN-DBS system was implanted along an immediately adjacent trajectory, and reproduction of clinical efficacy was reported. Additionally, 2 microstimulation protocols were compared between the 2 surgeries, i.e., one to assess the stimulation frequency response of STN neurons and another to assess inhibitory synaptic plasticity in the substantia nigra pars reticulata (SNr). The spontaneous neuronal firing rates of STN neurons in each hemisphere were also compared between the 2 surgeries. The results suggest that the frequency-sensitivity of STN neurons may have been reduced (i.e., more resistant to neuronal suppression), while the spontaneous baseline firing rates of STN neurons and the plasticity measured in the SNr remained unchanged (2 factors that may be indicative of neurodegenerative processes).

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Systematic review of hardware-related complications of Deep Brain Stimulation: Do new indications pose an increased risk?

Cited by 136 publications

References 107 publications

Estimating Risk for Future Intracranial, Fully Implanted, Modular Neuroprosthetic Systems: A Systematic Review of Hardware Complications in Clinical Deep Brain Stimulation and Experimental Human Intracortical Arrays

Estimating Risk for Future Intracranial, Fully Implanted, Modular Neuroprosthetic Systems: A Systematic Review of Hardware Complications in Clinical Deep Brain Stimulation and Experimental Human Intracortical Arrays

Deep brain stimulation for Gilles de la Tourette syndrome in children and youth: a meta-analysis with individual participant data

Neuronal Activity and Synaptic Plasticity in a Reimplanted STN-DBS Patient with Parkinson’s Disease: Recordings from Two Surgeries

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