title: An unexpectedly high rate of revisions and removals in deep brain stimulation surgery: Analysis of multiple databases.
abstract: Deep brain stimulation (DBS) is an established therapy for movement disorders, and is under active investigation for other neurologic and psychiatric indications. While many studies describe outcomes and complications related to stimulation therapies, the majority of these are from large academic centers, and results may differ from those in general neurosurgical practice.
  
  
  
  Using data from both the Centers for Medicare and Medicaid Services (CMS) and the National Surgical Quality Improvement Program (NSQIP), we identified all DBS procedures related to primary placement, revision, or removal of intracranial electrodes. Cases of cortical stimulation and stimulation for epilepsy were excluded.
  
  
  
  Over 28,000 cases of DBS electrode placement, revision, and removal were identified during the years 2004-2013. In the Medicare dataset, 15.2% and of these procedures were for intracranial electrode revision or removal, compared to 34.0% in the NSQIP dataset. In NSQIP, significant predictors of revision and removal were decreased age (odds ratio (OR) of 0.96; 95% CI: 0.94, 0.98) and higher ASA classification (OR 2.41; 95% CI: 1.22, 4.75). Up to 48.5% of revisions may have been due to improper targeting or lack of therapeutic effect.
  
  
  
  Data from multiple North American databases suggest that intracranial neurostimulation therapies have a rate of revision and removal higher than previously reported, between 15.2 and 34.0%. While there are many limitations to registry-based studies, there is a clear need to better track and understand the true prevalence and nature of such failures as they occur in the wider surgical community.
authors.affiliation: Department of Neurological Surgery, University of California, San Francisco, United States. Electronic address: john.rolston@ucsf.edu.
authors.forename: John D
authors.initials: JD
authors.lastname: Rolston
authors.affiliation: Department of Neurological Surgery, University of California, San Francisco, United States.
authors.forename: Dario J
authors.initials: DJ
authors.lastname: Englot
authors.affiliation: Department of Neurological Surgery, University of California, San Francisco, United States.
authors.forename: Philip A
authors.initials: PA
authors.lastname: Starr
authors.affiliation: Department of Neurological Surgery, University of California, San Francisco, United States.
authors.forename: Paul S
authors.initials: PS
authors.lastname: Larson
mesh_terms: D000368:Aged; D016208:Databases, Factual / Q000706:statistics & numerical data; D046690:Deep Brain Stimulation / Q000009:adverse effects* / Q000706:statistics & numerical data; D004567:Electrodes, Implanted; D005260:Female; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000628:therapy*; D008875:Middle Aged; D009069:Movement Disorders / Q000628:therapy*; D009656:North America; D011183:Postoperative Complications / Q000601:surgery*; D012044:Regression Analysis; D012086:Reoperation / Q000379:methods* / Q000706:statistics & numerical data; D012189:Retrospective Studies
keywords: Adverse events; Complications; Deep brain stimulation; Movement disorders; Quality improvement