Abstract
Objective: There have been significant improvements in the design and manufacturing of deep brain stimulation (DBS) systems, but no study has considered the impact of modern systems on complications. We sought to compare the relative occurrence of reoperations after de novo implantation of modern and traditional DBS systems in patients with Parkinson's disease (PD) or essential tremor (ET) in the United States.Design: Retrospective, contemporaneous cohort study.Setting: Multicenter data from the United States Centers for Medicare and Medicaid Services administrative claims database between 2016 and 2018.Participants: This population-based sample consisted of 5,998 patients implanted with a DBS system, of which 3,869 patients had a de novo implant and primary diagnosis of PD or ET. Follow-up of 3 months was available for 3,810 patients, 12 months for 3,561 patients, and 24 months for 1,812 patients.Intervention: Implantation of a modern directional (MD) or traditional omnidirectional (TO) DBS system.Primary and Secondary Outcome Measures: We hypothesized that MD systems would impact complication rates. Reoperation rate was the primary outcome. Associated diagnoses, patient characteristics, and implanting center details served as covariates. Kaplan–Meier analysis was performed to compare rates of event-free survival and regression models were used to determine covariate influences.Results: Patients implanted with modern systems were 36% less likely to require reoperation, largely due to differences in acute reoperations and intracranial lead reoperations. Risk reduction persisted while accounting for practice differences and implanting center experience. Risk reduction was more pronounced in patients with PD.Conclusions: In the first multicenter analysis of device-related complications including modern DBS systems, we found that modern systems are associated with lower reoperation rates. This risk profile should be carefully considered during device selection for patients undergoing DBS for PD or ET. Prospective studies are needed to further investigate underlying causes.
Highlights
Deep brain stimulation (DBS) is a highly effective treatment for movement disorders like essential tremor (ET) and Parkinson’s disease (PD)
Data from the Centers for Medicare and Medicaid Services (CMS) administrative claims database were analyzed to identify DBS implantations performed in patients with PD and ET
Using US insurance claims linked with patient device tracking data, we found that DBS reoperations occurred 36% less frequently within 2 years of follow-up with modern directional (MD) systems than with traditional omnidirectional (TO) systems
Summary
Deep brain stimulation (DBS) is a highly effective treatment for movement disorders like essential tremor (ET) and Parkinson’s disease (PD). While multiple randomized controlled trials have demonstrated the superiority of DBS over best medical therapy in PD, it is associated with approximately twice as many complications [1]. This risk–benefit ratio plays a significant role in willingness to consider DBS implantation and may contribute to its current underutilization [2]. Studies have been limited to traditional omnidirectional (TO) DBS systems. No study has considered the impact of modern DBS systems, which include a number of innovations. While much attention has been paid to segmented lead design allowing for stimulation field shaping [4, 5], modern systems differ in design and construction of its other components. Sought to compare the relative occurrence of complications necessitating
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