Department of Anesthesiology, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
Pain Med. 2019 Jul 1;20(7):1355-1361. doi: 10.1093/pm/pny245.
The aims of this study were to identify the reasons for explanation of spinal cord stimulator (SCS) devices and to further quantify the proportions and time lines of these causes of explantation in order to determine improvement opportunities for the development of best practices.
Retrospective, single academic center.
Patients who were implanted with percutaneous SCS devices from 2002 to 2015 and with follow-up available until the end of September 2017 were included in this retrospective chart analysis.
Of the 356 patients trialed, 252 underwent implantation of an SCS device with a permanent to trial ratio of 71%. Of the patients who had a permanent implant, 50% had failed back surgery syndrome, 25% had complex regional pain syndrome, and 25% had other diagnoses. At the end of the study period, the explantation rate was 30%. The causes for explantation included biological complications (26.6%), paresthesia limitations or side effects (26.6%), hardware complications (13.3%), ineffective pain control (28%), and no further need for stimulation therapy (5.3%).
Device removal is not uncommon, and opportunities to enhance the long-term success of SCS devices do exist. These include modification of trialing methods, achieving better paresthesia overlay, using magnetic resonance imaging (MRI) conditional equipment, development of robust technologies and hardware to reduce equipment malfunction, and improving efficacy with new innovative wave forms.
本研究旨在确定脊髓刺激器(SCS)设备的解释原因,并进一步量化这些原因导致设备移除的比例和时间线,以确定为制定最佳实践而改进的机会。
回顾性、单一学术中心研究。
纳入了 2002 年至 2015 年接受经皮 SCS 设备植入且随访至 2017 年 9 月结束的患者进行回顾性图表分析。
在接受试验的 356 例患者中,有 252 例患者植入了永久性 SCS 设备,临时至永久性设备的比例为 71%。在永久性植入患者中,50%为失败性脊柱手术后综合征,25%为复杂性区域疼痛综合征,25%为其他诊断。在研究期末,设备移除率为 30%。移除的原因包括生物并发症(26.6%)、感觉异常限制或副作用(26.6%)、硬件并发症(13.3%)、疼痛控制无效(28%)和不再需要刺激治疗(5.3%)。
设备移除并不罕见,提高 SCS 设备长期成功率的机会确实存在。这些机会包括改进试验方法、实现更好的感觉异常覆盖、使用磁共振成像(MRI)条件设备、开发稳健的技术和硬件以减少设备故障以及使用新的创新波形提高疗效。