Vanloon Maarten, Van Broeckhoven Tim, Raymaekers Vincent, De Ridder Dirk, Billet Bart, Meeuws Sacha, Menovsky Tomas, Plazier Mark
Faculty of Health, Medicine and Life Sciences, University Maastricht, Maastricht, The Netherlands; Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium; Faculty of Medicine and Life Science, Hasselt University, Hasselt, Belgium.
Faculty of Health, Medicine and Life Sciences, University Maastricht, Maastricht, The Netherlands.
Neuromodulation. 2025 Feb;28(2):234-248. doi: 10.1016/j.neurom.2024.10.010. Epub 2024 Nov 25.
Dorsal root ganglion stimulation (DRGS) has emerged as a promising treatment for chronic neuropathic pain. However, its safety and complications are not fully understood, with existing literature primarily based on case reports, observational studies, and data base analyses. This systematic review and meta-analysis aims to assess the prevalence of noninfectious complications associated with DRGS, focusing on the trial phase, postimplantation period, and revisions, while identifying risk factors for these outcomes.
This systematic review adhered to Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines and was registered in the International Prospective Register of Systematic Reviews database. A comprehensive search was conducted across multiple data bases in June 2023. Studies included randomized and nonrandomized trials, and cohort studies involving ≥20 patients with DRGS. The exclusion criteria were studies that did not differentiate DRGS-specific complications, focused solely on infections, lacked sufficient data for prevalence estimation, or presented only subanalyses from larger studies. A meta-analysis of proportions was performed to estimate the overall prevalence of complications.
Thirteen studies with 634 participants were included. The pooled prevalence of all complications was 37% (95% CI: 19%-57%), with device-related complications being the most common at 27% (95% CI: 15%-42%). Lead fractures and migrations were the most frequently reported device-related complications with, respectively, 6% (95% CI: 2%-12%) and 6% (95% CI: 2%-10%). Procedure-related complications had a pooled prevalence of 1% (95% CI: 0%-5%), with dural puncture being the most common. The prevalence of DRGS explantations was 12%, primarily due to insufficient pain relief.
DRGS shows a safety profile comparable to that of spinal cord stimulation, with similar rates of lead migrations and fractures. Improvements in surgical techniques, technology, and clinician expertise are expected to reduce complications. Future research should standardize reporting practices and detail implantation techniques to better understand and refine best practices in DRGS implantation.
背根神经节刺激术(DRGS)已成为治疗慢性神经性疼痛的一种有前景的方法。然而,其安全性和并发症尚未完全明确,现有文献主要基于病例报告、观察性研究和数据库分析。本系统评价和荟萃分析旨在评估与DRGS相关的非感染性并发症的发生率,重点关注试验阶段、植入后期和翻修情况,同时确定这些结果的危险因素。
本系统评价遵循系统评价和荟萃分析的首选报告项目指南,并在国际前瞻性系统评价注册数据库中注册。2023年6月对多个数据库进行了全面检索。纳入的研究包括随机和非随机试验以及涉及≥20例接受DRGS治疗患者的队列研究。排除标准为未区分DRGS特异性并发症、仅关注感染、缺乏足够数据进行发生率估计或仅呈现大型研究的亚分析的研究。进行了比例荟萃分析以估计并发症的总体发生率。
纳入了13项研究,共634名参与者。所有并发症的合并发生率为37%(95%CI:19%-57%),其中与设备相关的并发症最为常见,为27%(95%CI:15%-42%)。导线断裂和移位是最常报告的与设备相关的并发症,分别为6%(95%CI:2%-12%)和6%(95%CI:2%-10%)。与手术相关的并发症合并发生率为1%(95%CI:0%-5%),最常见的是硬膜穿刺。DRGS取出术的发生率为12%,主要原因是疼痛缓解不足。
DRGS显示出与脊髓刺激术相当的安全性,导线移位和断裂的发生率相似。手术技术、技术和临床医生专业知识的改进有望减少并发症。未来的研究应规范报告方法并详细说明植入技术,以更好地理解和完善DRGS植入的最佳实践。