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脊髓刺激器取出的风险因素和生存分析。

Risk Factors and Survival Analysis of Spinal Cord Stimulator Explantation.

机构信息

Department of Neurosurgery, University of Iowa Carver College of Medicine, Iowa City, IA, USA.

Department of Mechanical and Aerospace Engineering, University of Virginia, Charlottesville, VA, USA.

出版信息

Neuromodulation. 2021 Jan;24(1):61-67. doi: 10.1111/ner.13173. Epub 2020 Jun 3.

Abstract

OBJECTIVE

The treatment failure rate for spinal cord stimulators (SCS) remains unacceptably high, with reports of removal in up to 30% of patients. The purpose of this study is to perform survival and multivariate regression analyses of patients who have undergone SCS explantation in order to identify patient characteristics that may predict treatment failure.

MATERIALS AND METHODS

We identified 253 patients who underwent SCS placement using current procedural terminology codes in a private health insurance data base spanning 2003-2016. Patient demographics, opioid use, surgical indications, as well as comorbidities were noted. At least 6 months of continuous claims data before and after implantation were required for inclusion. Patients who underwent explantation were defined as those who underwent removal without replacement within 90 days and had at least 90 days of continuous insurance eligibility following removal. Those who underwent removal for infectious reasons were identified with corresponding diagnosis codes.

RESULTS

Of the 252 patients who met the inclusion criteria, 17 (6.7%) underwent SCS explantation. Median follow-up time was 2.0 years. Of those who had their system explanted, six patients (2.8%) had their systems removed for infection and 11 (4.3%) for noninfectious reasons. Bivariate analysis revealed that younger age and tobacco use were associated with an increased likelihood of explantation. The Cox proportional hazards analysis demonstrated that younger age, tobacco use, and the presence of "other" mental health disorders were predictive of explantation.

CONCLUSIONS

In a cohort of SCS patients from multiple institutions, this study demonstrates that explantation for noninfectious reasons is more likely in younger patients, tobacco users, and those with certain psychiatric conditions. With an estimated 10% of patients opting to have their devices removed within 5 years of implantation, refining the ability of clinicians to predict who will see benefit from SCS treatment remains necessary.

摘要

目的

脊髓刺激器(SCS)的治疗失败率仍然高得令人无法接受,据报道,多达 30%的患者需要将其移除。本研究的目的是对接受 SCS 取出术的患者进行生存和多变量回归分析,以确定可能预测治疗失败的患者特征。

材料和方法

我们在一个私人健康保险数据库中使用当前程序术语代码确定了 253 名接受 SCS 植入术的患者,该数据库涵盖了 2003-2016 年的数据。记录了患者的人口统计学、阿片类药物使用、手术指征以及合并症。纳入研究的患者需要至少有植入前和植入后 90 天的连续索赔数据。将在 90 天内无更换且移除后至少有 90 天连续保险资格的患者定义为接受了移除而没有更换的患者。通过相应的诊断代码确定了因感染原因而接受移除的患者。

结果

在符合纳入标准的 252 名患者中,有 17 名(6.7%)接受了 SCS 取出术。中位随访时间为 2.0 年。在接受系统移除的患者中,有 6 名(2.8%)因感染而移除系统,有 11 名(4.3%)因非感染性原因而移除。单变量分析显示,年龄较小和吸烟与移除的可能性增加相关。Cox 比例风险分析表明,年龄较小、吸烟以及存在“其他”心理健康障碍是移除的预测因素。

结论

在来自多个机构的 SCS 患者队列中,本研究表明,非感染性原因导致的移除更可能发生在年龄较小、吸烟以及有某些精神疾病的患者中。预计有 10%的患者在植入后 5 年内选择移除其设备,因此,完善临床医生预测谁将从 SCS 治疗中受益的能力仍然是必要的。

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