Reduced Risk of Reoperations With Modern Deep Brain Stimulator Systems: Big Data Analysis From a United States Claims Database

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 an...

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Autores principales: Chengyuan Wu, Sean J. Nagel, Rahul Agarwal, Monika Pötter-Nerger, Wolfgang Hamel, Ashwini D. Sharan, Allison T. Connolly, Binith Cheeran, Paul S. Larson
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Publicado: Frontiers Media S.A. 2021
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spelling oai:doaj.org-article:551150811a1947bd8086fdefcddaf82a2021-12-02T14:16:54ZReduced Risk of Reoperations With Modern Deep Brain Stimulator Systems: Big Data Analysis From a United States Claims Database1664-229510.3389/fneur.2021.785280https://doaj.org/article/551150811a1947bd8086fdefcddaf82a2021-12-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fneur.2021.785280/fullhttps://doaj.org/toc/1664-2295Objective: 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.Chengyuan WuSean J. NagelRahul AgarwalMonika Pötter-NergerWolfgang HamelAshwini D. SharanAllison T. ConnollyBinith CheeranPaul S. LarsonFrontiers Media S.A.articledeep brain stimulationParkinson's diseaseessential tremorMedicarebig data & analyticsneurosurgeryNeurology. Diseases of the nervous systemRC346-429ENFrontiers in Neurology, Vol 12 (2021)
institution DOAJ
collection DOAJ
language EN
topic deep brain stimulation
Parkinson's disease
essential tremor
Medicare
big data & analytics
neurosurgery
Neurology. Diseases of the nervous system
RC346-429
spellingShingle deep brain stimulation
Parkinson's disease
essential tremor
Medicare
big data & analytics
neurosurgery
Neurology. Diseases of the nervous system
RC346-429
Chengyuan Wu
Sean J. Nagel
Rahul Agarwal
Monika Pötter-Nerger
Wolfgang Hamel
Ashwini D. Sharan
Allison T. Connolly
Binith Cheeran
Paul S. Larson
Reduced Risk of Reoperations With Modern Deep Brain Stimulator Systems: Big Data Analysis From a United States Claims Database
description 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.
format article
author Chengyuan Wu
Sean J. Nagel
Rahul Agarwal
Monika Pötter-Nerger
Wolfgang Hamel
Ashwini D. Sharan
Allison T. Connolly
Binith Cheeran
Paul S. Larson
author_facet Chengyuan Wu
Sean J. Nagel
Rahul Agarwal
Monika Pötter-Nerger
Wolfgang Hamel
Ashwini D. Sharan
Allison T. Connolly
Binith Cheeran
Paul S. Larson
author_sort Chengyuan Wu
title Reduced Risk of Reoperations With Modern Deep Brain Stimulator Systems: Big Data Analysis From a United States Claims Database
title_short Reduced Risk of Reoperations With Modern Deep Brain Stimulator Systems: Big Data Analysis From a United States Claims Database
title_full Reduced Risk of Reoperations With Modern Deep Brain Stimulator Systems: Big Data Analysis From a United States Claims Database
title_fullStr Reduced Risk of Reoperations With Modern Deep Brain Stimulator Systems: Big Data Analysis From a United States Claims Database
title_full_unstemmed Reduced Risk of Reoperations With Modern Deep Brain Stimulator Systems: Big Data Analysis From a United States Claims Database
title_sort reduced risk of reoperations with modern deep brain stimulator systems: big data analysis from a united states claims database
publisher Frontiers Media S.A.
publishDate 2021
url https://doaj.org/article/551150811a1947bd8086fdefcddaf82a
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