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DBS Adverse Events: Results from 1154 PD Patients
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Deep brain stimulation for Parkinson's disease: Prevalence of adverse events and need for standardized reporting A Videnovic, L Verhagen Metman Movement Disorders 2008;23:343-349 Adverse events related to deep brain stimulation are common, but their true prevalence cannot be accurately determined with current reporting methods, according to this study. The authors analyzed reports of adverse events from 47 studies of STN and GPi DBS in PD published from 1996 to 2007, representing 1,154 patients (928 STN, 226 GPi) and 2,205 electrode placements. They grouped AEs into three classes: procedure-related, hardware-related, and stimulation- or disease progression-related events. The most common events were: Procedure-related events: ÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂSTN (%)ÂGPi (%) Mental status/behavioralÂÂÂÂÂÂÂÂ18.4ÂÂÂÂÂÂÂÂÂÂÂÂ9.3 InfectionÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂ2ÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂ2.6 ICH-symptomaticÂÂÂÂÂÂÂÂÂ2ÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂ4 Misplaced electrodeÂÂÂÂÂÂÂÂÂÂÂÂÂ1.7ÂÂÂÂÂÂÂÂÂÂÂÂÂ2 Speech disturbanceÂÂÂÂÂÂÂÂÂÂÂÂÂÂ1.5ÂÂÂÂÂÂÂÂÂÂÂÂÂ3.9 InfarctionÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂ0.2ÂÂÂÂÂÂÂÂÂÂÂÂÂ2.2 Among mental status changes, confusion was by far the most common. Hardware-related events (combined GPi and STN, %): InfectionÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂ2.4 MalfunctioningÂÂ1 Lack of benefitÂ0.9 A total of 8.7% of patients experienced one or more hardware-related AE. Stimulation- or progression-related events, which did not disappear with adjustment (%): ÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂSTN (%)ÂGPi (%) Weight gainÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂ37.5ÂÂÂÂÂÂÂÂÂÂÂÂ17.6 DysarthriaÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂ12.8ÂÂÂÂÂÂÂÂÂÂÂÂ11.8 Eyelid opening apraxiaÂÂ11.3ÂÂÂÂÂÂÂÂÂÂÂÂ0 Gait ignition failureÂÂÂÂÂÂÂÂÂÂÂ0ÂÂÂÂÂÂÂÂÂÂÂÂÂÂÂ17.6 Because of the variation in classification of AE reporting among the included studies, the authors note that "a retrospective review of the available literature cannot provide accurate data on the prevalence of AEs associated with DBS in PD." They recommend the adoption of a standardized system for AE reporting in DBS trials, in which all AEs are classified along the lines they employed in this study, plus the temporal characteristics of the AE and its response to programming adjustments.