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现代脑深部电刺激系统降低再次手术风险:来自美国索赔数据库的大数据分析

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

作者信息

Wu Chengyuan, Nagel Sean J, Agarwal Rahul, Pötter-Nerger Monika, Hamel Wolfgang, Sharan Ashwini D, Connolly Allison T, Cheeran Binith, Larson Paul S

机构信息

Department of Neurological Surgery, Vickie and Jack Farber Institute for Neuroscience, Thomas Jefferson University, Philadelphia, PA, United States.

Department of Neurological Surgery, Center for Neuro-Restoration, Cleveland Clinic, Cleveland, OH, United States.

出版信息

Front Neurol. 2021 Dec 2;12:785280. doi: 10.3389/fneur.2021.785280. eCollection 2021.

Abstract

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 implantation of modern and traditional DBS systems in patients with Parkinson's disease (PD) or essential tremor (ET) in the United States. Retrospective, contemporaneous cohort study. Multicenter data from the United States Centers for Medicare and Medicaid Services administrative claims database between 2016 and 2018. This population-based sample consisted of 5,998 patients implanted with a DBS system, of which 3,869 patients had a 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. Implantation of a modern directional (MD) or traditional omnidirectional (TO) DBS system. 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. 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. 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.

摘要

深部脑刺激(DBS)系统的设计和制造有了显著改进,但尚无研究考虑现代系统对并发症的影响。我们试图比较美国帕金森病(PD)或特发性震颤(ET)患者植入现代和传统DBS系统后再次手术的相对发生率。回顾性同期队列研究。来自美国医疗保险和医疗补助服务中心管理索赔数据库2016年至2018年的多中心数据。这个基于人群的样本包括5998例植入DBS系统的患者,其中3869例患者植入了该系统并被初步诊断为PD或ET。3810例患者有3个月的随访数据,3561例患者有12个月的随访数据,1812例患者有24个月的随访数据。植入现代定向(MD)或传统全向(TO)DBS系统。我们假设MD系统会影响并发症发生率。再次手术率是主要结局。相关诊断、患者特征和植入中心细节作为协变量。进行Kaplan-Meier分析以比较无事件生存率,使用回归模型确定协变量的影响。植入现代系统的患者再次手术的可能性降低了36%,这主要是由于急性再次手术和颅内电极再次手术的差异。在考虑实践差异和植入中心经验的情况下,风险降低仍然存在。在PD患者中,风险降低更为明显。在首次包括现代DBS系统的多中心器械相关并发症分析中,我们发现现代系统与较低的再次手术率相关。在为PD或ET患者选择DBS器械时,应仔细考虑这种风险情况。需要进行前瞻性研究以进一步调查潜在原因。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/489b/8675885/576e49cf5b42/fneur-12-785280-g0001.jpg

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