Introduction

Dorsal root ganglion (DRG) stimulation is a form of neuromodulation used to treat neuropathic pain due to a myriad of etiologies. Though this relatively new therapy has been shown to be quite effective, complications associated with the implantation of this therapy have not been well documented.

Objectives

The primary objective of this study was to describe the device-related complications associated with DRG stimulator implantations.

Materials and Methods

This was a single-center retrospective analysis of 31 patients who underwent full implantation of neuromodulation hardware marketed for DRG stimulation. The predefined endpoints included device-related complications associated with DRG implantations, such as hardware failure, explantation procedures, and revision surgery. Additional endpoints included percentage of patients receiving therapy and pain as measured using the visual analog scale (VAS) pain scale at initial, six-month, and 12-month follow-up after hardware implantation.

Results

Thirty-one patients were included out of 42 patients trialed. Baseline VAS in patients was 7.7 (31 patients). At initial follow-up, six-month follow-up, and one-year follow-up, VAS scores were 4.7 (31 patients), 5.3 (20 patients), and 5.5 (13 patients), respectively. Paired t-test between preoperative VAS (mean 7.3) and one-year follow-up VAS (5.5) demonstrated statistical significance (p = 0.027). At initial, six-month, and one-year follow-up, 30/31 (97%), 19/24 (79%), and 18/23 (78%) patients were confirmed to be receiving DRG stimulation therapy after permanent implant. Of the 31 patients who were implanted with a permanent system, 8 (26%) were explanted and an additional 10 (29%) required revision surgery.

Conclusion

In this study, we examine the various device-related complications associated with DRG stimulation requiring repeat surgery. High rates of hardware failure, revision surgery, and explantation of stimulators illustrate the need for hardware optimization to improve patient outcomes.

中文翻译：

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31例患者背根神经节刺激止痛装置相关并发症的单中心回顾性分析

介绍

背根神经节 (DRG) 刺激是一种神经调节形式，用于治疗由多种病因引起的神经性疼痛。尽管这种相对较新的疗法已被证明非常有效，但与植入该疗法相关的并发症尚未得到充分证明。

目标

本研究的主要目的是描述与背根神经节刺激器植入相关的设备相关并发症。

材料和方法

这是一项单中心回顾性分析，对 31 名接受完全植入神经调节硬件的患者进行了 DRG 刺激。预定义的终点包括与背根神经节植入相关的设备相关并发症，例如硬件故障、外植程序和翻修手术。其他终点包括接受治疗的患者百分比和在硬件植入后的初始、6 个月和 12 个月的随访中使用视觉模拟量表 (VAS) 疼痛量表测量的疼痛。

结果

42 名受试患者中包括 31 名患者。患者的基线 VAS 为 7.7（31 名患者）。在初始随访、6 个月随访和 1 年随访时，VAS 评分分别为 4.7（31 名患者）、5.3（20 名患者）和 5.5（13 名患者）。术前VAS（平均7.3）和一年随访VAS（5.5）之间的配对t检验显示出统计学意义（ p  = 0.027）。在最初、6 个月和 1 年的随访中，30/31 (97%)、19/24 (79%) 和 18/23 (78%) 的患者被证实在永久后接受 DRG 刺激治疗注入。在植入永久性系统的 31 名患者中，有 8 名 (26%) 进行了移植，另外 10 名 (29%) 需要进行翻修手术。

结论

在这项研究中，我们检查了与需要重复手术的 DRG 刺激相关的各种设备相关并发症。硬件故障、翻修手术和刺激器移植的高发生率表明需要对硬件进行优化以改善患者的治疗效果。