Estimating the Risk of Deep Brain Stimulation in the Modern Era: 2008 to 2020

2021 ◽  
Author(s):  
Eun Jeong Koh ◽  
Joshua L Golubovsky ◽  
Richard Rammo ◽  
Arbaz Momin ◽  
Benjamin Walter ◽  
...  
Keyword(s):  
Deep Brain Stimulation ◽  
Brain Stimulation ◽  
Complication Rate ◽  
Surgical Complication ◽  
Neurological Complication ◽  
The United States ◽  
Complication Rates ◽  
Systemic Complication ◽  
United States Food ◽  
Deep Brain

Abstract BACKGROUND Deep brain stimulation (DBS) was first approved by the United States Food and Drug Administration in 1997. Although the fundamentals of DBS remain the same, hardware, software, and imaging have evolved significantly. OBJECTIVE To test our hypothesis that the aggregate complication rate in the medical literature in the past 12 years would be lower than what is often cited based on early experience with DBS surgery. METHODS PubMed, PsycINFO, and EMBASE were queried for studies from 2008 to 2020 that included patients treated with DBS from 2007 to 2019. This yielded 34 articles that evaluated all complications of DBS surgery, totaling 2249 patients. RESULTS The overall complication rate in this study was 16.7% per patient. There was found to be a systemic complication rate of 0.89%, intracranial complication rate of 2.7%, neurological complication rate of 4.6%, hardware complication rate of 2.2%, and surgical site complication rate of 3.4%. The infection and erosion rate was 3.0%. CONCLUSION This review suggests that surgical complication rates have decreased since the first decade after DBS was first FDA approved. Understanding how to minimize complications from the inception of a technique should receive more attention.

scholarly journals Electrocorticography During Deep Brain Stimulation Surgery: Safety Experience From 4 Centers Within the National Institute of Neurological Disorders and Stroke Research Opportunities in Human Consortium

Neurosurgery ◽  
2021 ◽  
Author(s):  
Nathaniel D Sisterson ◽  
April A Carlson ◽  
Ueli Rutishauser ◽  
Adam N Mamelak ◽  
Mitchell Flagg ◽  
...  
Keyword(s):  
Deep Brain Stimulation ◽  
Brain Stimulation ◽  
Complication Rate ◽  
Brain Research ◽  
Therapeutic Benefit ◽  
Complication Rates ◽  
Explanatory Variables ◽  
Stroke Research ◽  
Using Data ◽  
Deep Brain

Abstract BACKGROUND Intraoperative research during deep brain stimulation (DBS) surgery has enabled major advances in understanding movement disorders pathophysiology and potential mechanisms for therapeutic benefit. In particular, over the last decade, recording electrocorticography (ECoG) from the cortical surface, simultaneously with subcortical recordings, has become an important research tool for assessing basal ganglia-thalamocortical circuit physiology. OBJECTIVE To provide confirmation of the safety of performing ECoG during DBS surgery, using data from centers involved in 2 BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative-funded basic human neuroscience projects. METHODS Data were collected separately at 4 centers. The primary endpoint was complication rate, defined as any intraoperative event, infection, or postoperative magnetic resonance imaging abnormality requiring clinical follow-up. Complication rates for explanatory variables were compared using point biserial correlations and Fisher exact tests. RESULTS A total of 367 DBS surgeries involving ECoG were reviewed. No cortical hemorrhages were observed. Seven complications occurred: 4 intraparenchymal hemorrhages and 3 infections (complication rate of 1.91%; CI = 0.77%-3.89%). The placement of 2 separate ECoG research electrodes through a single burr hole (84 cases) did not result in a significantly different rate of complications, compared to placement of a single electrode (3.6% vs 1.5%; P = .4). Research data were obtained successfully in 350 surgeries (95.4%). CONCLUSION Combined with the single report previously available, which described no ECoG-related complications in a single-center cohort of 200 cases, these findings suggest that research ECOG during DBS surgery did not significantly alter complication rates.

Deep brain stimulation for obsessive-compulsive disorder

2019 ◽  
Vol 83 (1) ◽  
pp. 84-96 ◽  
Author(s):  
Sruja Arya ◽  
Megan M. Filkowski ◽  
Pranav Nanda ◽  
Sameer A. Sheth
Keyword(s):  
Deep Brain Stimulation ◽  
Obsessive Compulsive Disorder ◽  
Brain Stimulation ◽  
The United States ◽  
Outcome Data ◽  
Future Research ◽  
Obsessive Compulsive ◽  
Compulsive Disorder ◽  
United States Food ◽  
Deep Brain

Neurosurgical interventions have been used for decades to treat severe, refractory obsessive-compulsive disorder (OCD). Deep brain stimulation (DBS) is a neurosurgical procedure that is used routinely to treat movement disorders such as Parkinson's disease and essential tremor. Over the past two decades, DBS has been applied to OCD, building on earlier experience with lesional procedures. Promising results led to Humanitarian Device Exemption (HDE) approval of the therapy from the United States Food and Drug Administration in 2009. In this review, the authors describe the development of DBS for OCD, the most recent outcome data, and areas for future research.

scholarly journals A decade of emerging indications: deep brain stimulation in the United States

2016 ◽  
Vol 125 (2) ◽  
pp. 461-471 ◽  
Author(s):  
Brett E. Youngerman ◽  
Andrew K. Chan ◽  
Charles B. Mikell ◽  
Guy M. McKhann ◽  
Sameer A. Sheth
Keyword(s):  
Deep Brain Stimulation ◽  
Brain Stimulation ◽  
The United States ◽  
National Database ◽  
Hierarchical Regression ◽  
Complication Rates ◽  
Hospital Discharges ◽  
Lengths Of Stay ◽  
Comorbidity Scores ◽  
Deep Brain

OBJECTIVE Deep brain stimulation (DBS) is an emerging treatment option for an expanding set of neurological and psychiatric diseases. Despite growing enthusiasm, the patterns and implications of this rapid adoption are largely unknown. National trends in DBS surgery performed for all indications between 2002 and 2011 are reported. METHODS Using a national database of hospital discharges, admissions for DBS for 14 indications were identified and categorized as either FDA approved, humanitarian device exempt (HDE), or emerging. Trends over time were examined, differences were analyzed by univariate analyses, and outcomes were analyzed by hierarchical regression analyses. RESULTS Between 2002 and 2011, there were an estimated 30,490 discharges following DBS for approved indications, 1647 for HDE indications, and 2014 for emerging indications. The volume for HDE and emerging indications grew at 36.1% annually in comparison with 7.0% for approved indications. DBS for emerging indications occurred at hospitals with more neurosurgeons and neurologists locally, but not necessarily at those with the highest DBS caseloads. Patients treated for HDE and emerging indications were younger with lower comorbidity scores. HDE and emerging indications were associated with greater rates of reported complications, longer lengths of stay, and greater total costs. CONCLUSIONS DBS for HDE and emerging indications underwent rapid growth in the last decade, and it is not exclusively the most experienced DBS practitioners leading the charge to treat the newest indications. Surgeons may be selecting younger and healthier patients for their early experiences. Differences in reported complication rates warrant further attention and additional costs should be anticipated as surgeons gain experience with new patient populations and targets.

scholarly journals Deep brain stimulation treatment in dystonia: a bibliometric analysis

2020 ◽  
Vol 78 (9) ◽  
pp. 586-592
Author(s):  
Clarice LISTIK ◽  
Eduardo LISTIK ◽  
Rubens Gisbert CURY ◽  
Egberto Reis BARBOSA ◽  
Manoel Jacobsen TEIXEIRA ◽  
...  
Keyword(s):  
Deep Brain Stimulation ◽  
Bibliometric Analysis ◽  
Brain Stimulation ◽  
The United States ◽  
Scientific Journals ◽  
Long Term Outcomes ◽  
Generalized Dystonia ◽  
Research Domain ◽  
Deep Brain

ABSTRACT Background: Dystonia is a heterogeneous disorder that, when refractory to medical treatment, may have a favorable response to deep brain stimulation (DBS). A practical way to have an overview of a research domain is through a bibliometric analysis, as it makes it more accessible for researchers and others outside the field to have an idea of its directions and needs. Objective: To analyze the 100 most cited articles in the use of DBS for dystonia treatment in the last 30 years. Methods: The research protocol was performed in June 2019 in Elsevier’s Scopus database, by retrieving the most cited articles regarding DBS in dystonia. We analyzed authors, year of publication, country, affiliation, and targets of DBS. Results: Articles are mainly published in Movement Disorders (19%), Journal of Neurosurgery (9%), and Neurology (9%). European countries offer significant contributions (57% of our sample). France (192.5 citations/paper) and Germany (144.1 citations/paper) have the highest citation rates of all countries. The United States contributes with 31% of the articles, with 129.8 citations/paper. The publications are focused on General outcomes (46%), followed by Long-term outcomes (12.5%), and Complications (11%), and the leading type of dystonia researched is idiopathic or inherited, isolated, segmental or generalized dystonia, with 27% of articles and 204.3 citations/paper. Conclusions: DBS in dystonia research is mainly published in a handful of scientific journals and focused on the outcomes of the surgery in idiopathic or inherited, isolated, segmental or generalized dystonia, and with globus pallidus internus as the main DBS target.

Pediatric Deep Brain Stimulation for Dystonia: Current State and Ethical Considerations

2020 ◽  
Vol 29 (4) ◽  
pp. 557-573
Author(s):  
KATRINA A. MUÑOZ ◽  
JENNIFER BLUMENTHAL-BARBY ◽  
ERIC A. STORCH ◽  
LAURA TORGERSON ◽  
GABRIEL LÁZARO-MUÑOZ
Keyword(s):  
Quality Of Life ◽  
Deep Brain Stimulation ◽  
Brain Stimulation ◽  
The United States ◽  
Childhood Onset ◽  
Ethical Considerations ◽  
Current State ◽  
Limited Effectiveness ◽  
Deep Brain

AbstractDystonia is a movement disorder that can have a debilitating impact on motor functions and quality of life. There are 250,000 cases in the United States, most with childhood onset. Due to the limited effectiveness and side effects of available treatments, pediatric deep brain stimulation (pDBS) has emerged as an intervention for refractory dystonia. However, there is limited clinical and neuroethics research in this area of clinical practice. This paper examines whether it is ethically justified to offer pDBS to children with refractory dystonia. Given the favorable risk-benefit profile, it is concluded that offering pDBS is ethically justified for certain etiologies of dystonia, but it is less clear for others. In addition, various ethical and policy concerns are discussed, which need to be addressed to optimize the practice of offering pDBS for dystonia. Strategies are proposed to help address these concerns as pDBS continues to expand.

Unchanged safety outcomes in deep brain stimulation surgery for Parkinson disease despite a decentralization of care

2013 ◽  
Vol 119 (6) ◽  
pp. 1546-1555 ◽  
Author(s):  
Robert A. McGovern ◽  
John P. Sheehy ◽  
Brad E. Zacharia ◽  
Andrew K. Chan ◽  
Blair Ford ◽  
...  
Keyword(s):  
Deep Brain Stimulation ◽  
Parkinson Disease ◽  
Brain Stimulation ◽  
Length Of Hospital Stay ◽  
Critical Factor ◽  
High Volume ◽  
The United States ◽  
Primary Diagnosis ◽  
Low Volume ◽  
Deep Brain

Object Early work on deep brain stimulation (DBS) surgery, when procedures were mostly carried out in a small number of high-volume centers, demonstrated a relationship between surgical volume and procedural safety. However, over the past decade, DBS has become more widely available in the community rather than solely at academic medical centers. The authors examined the Nationwide Inpatient Sample (NIS) to study the safety of DBS surgery for Parkinson disease (PD) in association with this change in practice patterns. Methods The NIS is a stratified sample of 20% of all patient discharges from nonfederal hospitals in the United States. The authors identified patients with a primary diagnosis of PD (332.0) and a primary procedure code for implantation/replacement of intracranial neurostimulator leads (02.93) who underwent surgery between 2002 and 2009. They analyzed outcomes using univariate and hierarchical, logistic regression analyses. Results The total number of DBS cases remained stable from 2002 through 2009. Despite older and sicker patients undergoing DBS, procedural safety (rates of non-home discharges, complications) remained stable. Patients at low-volume hospitals were virtually indistinguishable from those at high-volume hospitals, except that patients at low-volume hospitals had slightly higher comorbidity scores (0.90 vs 0.75, p < 0.01). Complications, non-home discharges, length of hospital stay, and mortality rates did not significantly differ between low- and high-volume hospitals when accounting for hospital-related variables (caseload, teaching status, location). Conclusions Prior investigations have demonstrated a robust volume-outcome relationship for a variety of surgical procedures. However, the present study supports safety of DBS at smaller-volume centers. Prospective studies are required to determine whether low-volume centers and higher-volume centers have similar DBS efficacy, a critical factor in determining whether DBS is comparable between centers.

Awake versus asleep deep brain stimulation for Parkinson’s disease: a critical comparison and meta-analysis

2017 ◽  
Vol 89 (7) ◽  
pp. 687-691 ◽  
Author(s):  
Allen L Ho ◽  
Rohaid Ali ◽  
Ian D Connolly ◽  
Jaimie M Henderson ◽  
Rohit Dhall ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Deep Brain Stimulation ◽  
Side Effects ◽  
General Anaesthesia ◽  
Brain Stimulation ◽  
Meta Analysis ◽  
Complication Rates ◽  
Significant Difference ◽  
Deep Brain

ObjectiveNo definitive comparative studies of the efficacy of ‘awake’ deep brain stimulation (DBS) for Parkinson’s disease (PD) under local or general anaesthesia exist, and there remains significant debate within the field regarding differences in outcomes between these two techniques.MethodsWe conducted a literature review and meta-analysis of all published DBS for PD studies (n=2563) on PubMed from January 2004 to November 2015. Inclusion criteria included patient number >15, report of precision and/or clinical outcomes data, and at least 6 months of follow-up. There were 145 studies, 16 of which were under general anaesthesia. Data were pooled using an inverse-variance weighted, random effects meta-analytic model for observational data.ResultsThere was no significant difference in mean target error between local and general anaesthesia, but there was a significantly less mean number of DBS lead passes with general anaesthesia (p=0.006). There were also significant decreases in DBS complications, with fewer intracerebral haemorrhages and infections with general anaesthesia (p<0.001). There were no significant differences in Unified Parkinson’s Disease Rating Scale (UPDRS) Section II scores off medication, UPDRS III scores off and on medication or levodopa equivalent doses between the two techniques. Awake DBS cohorts had a significantly greater decrease in treatment-related side effects as measured by the UPDRS IV off medication score (78.4% awake vs 59.7% asleep, p=0.022).ConclusionsOur meta-analysis demonstrates that while DBS under general anaesthesia may lead to lower complication rates overall, awake DBS may lead to less treatment-induced side effects. Nevertheless, there were no significant differences in clinical motor outcomes between the two techniques. Thus, DBS under general anaesthesia can be considered at experienced centres in patients who are not candidates for traditional awake DBS or prefer the asleep alternative.

FDA Considers Classification of ECT

CNS Spectrums ◽  
2009 ◽  
Vol 14 (12) ◽  
pp. 668-670 ◽  
Author(s):  
S.H. Lisanby ◽  
Stefano Pallanti ◽  
Thomas E. Schlaepfer
Keyword(s):  
Brain Stimulation ◽  
The United States ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
United States Food ◽  
Recent Developments ◽  
States Food ◽  
Resistant Depression ◽  
Deep Brain

With the increasing number of new brain stimulation techniques now available and on the horizon, does electroconvulsive therapy (ECT) still have a role? As clinicians and researchers we say most definitely “yes”. ECT is the most effective and rapidly acting treatment for severe forms of depression and other disorders. Transcranial magnetic stimulation has shown promise but mainly for less severely ill and less treatment resistant patients. Deep brain stimulation (DBS) has shown promise for the more resistant cases but its invasiveness limits its use. Results from only ∼50 patients treated worldwide are available and at present it is not approved by the United States Food and Drug Administration for depression. Vagus nerve stimulation, less invasive than DBS but still a surgical procedure, is presently FDA approved for acute treatment resistant depression but published efficacy rates fall short of those seen with ECT. Therefore, there continues to be an important role for ECT in the treatment of severe psychiatric disorders. But will ECT always be there when our patients need it? Somewhat unexpected recent developments at the FDA may impact the future availability of ECT to severely depressed patients. Here we provide background on the classification of ECT devices, the FDA reclassification process, and the process for providing FDA input in these critical deliberations.

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