Pope Jason E, Deer Timothy R, Falowski Steven, Provenzano David, Hanes Michael, Hayek Salim M, Amrani Jacob, Carlson Jonathan, Skaribas Ioannis, Parchuri Kris, McRoberts W Porter, Bolash Robert, Haider Nameer, Hamza Maged, Amirdelfan Kasra, Graham Sean, Hunter Corey, Lee Eric, Li Sean, Yang Michael, Campos Lucas, Costandi Shrif, Levy Robert, Mekhail Nagy
Summit Pain Alliance, Santa Rosa, CA, USA.
Center for Pain Relief, Charleston, WV, USA.
Neuromodulation. 2017 Aug;20(6):543-552. doi: 10.1111/ner.12634. Epub 2017 Jul 17.
Spinal cord stimulation (SCS) devices are cost effective and improve function as well as quality of life. Despite the demonstrated benefits of SCS, some patients have the device explanted. We are interested in exploring the patient characteristics of those explanted.
This is a retrospective chart review of neurostimulation patients who underwent explantation at 18 centers across the United States within the previous five years.
Data from 352 patients were collected and compiled. Failed Back Surgery syndrome was the most common diagnosis (38.9%; n = 136/350) and over half of the patients reported numerical rating scale (NRS) scores ≥8 prior to implant (64.3%; n = 207/322). All patients reported changes in NRS scores across time, with an initial decrease after implant followed by a pre-explant increase (F (2, 961) = 121.7, p < 0.001). The most common reason for device explant was lack or loss of efficacy (43.9%; 152/346) followed by complications (20.2%; 70/346). Eighteen percent (18%; 62/343) of patients were explanted by a different physician than the implanting one. Rechargeable devices were explanted at a median of 15 months, whereas primary cell device explants occurred at a median of 36 months (CI 01.434, 2.373; median endpoint time ratio = 2.40).
Loss or lack of efficacy and complications with therapy represent the most frequent reasons for neurostimulation explantation. Of the devices that were explanted, therapy was terminated earlier when devices were rechargeable, when complications occurred, or when pain relief was not achieved or maintained. Furthermore, in nearly 20% of the cases, a different provider than the implanting physician performed device removal.
SCS is largely a safe and efficacious strategy for treating select chronic refractory pain syndromes. Further prospective data and innovation are needed to improve patient selection, maintain SCS therapeutic efficacy and reduce the reasons that lead to device explant.
脊髓刺激（SCS）设备具有成本效益，可改善功能及生活质量。尽管SCS已证实有诸多益处，但仍有部分患者将该设备取出。我们感兴趣的是探究那些取出设备的患者特征。
这是一项对过去五年内在美国18个中心接受设备取出手术的神经刺激患者的回顾性病历审查。
收集并整理了352例患者的数据。失败的脊柱手术综合征是最常见的诊断（38.9%；n = 136/350），超过半数患者在植入前报告数字评分量表（NRS）得分≥8（64.3%；n = 207/322）。所有患者均报告NRS评分随时间变化，植入后最初下降，然后在取出前上升（F(2, 961) = 121.7，p < 0.001）。设备取出的最常见原因是疗效缺失或丧失（43.9%；152/346），其次是并发症（20.2%；70/346）。18%（62/343）的患者由与植入医生不同的医生取出设备。可充电设备取出的中位时间为15个月，而原电池设备取出的中位时间为36个月（CI 01.434, 2.373；中位终点时间比 = 2.40）。
疗效缺失或丧失以及治疗并发症是神经刺激设备取出最常见的原因。在取出的设备中，当设备为可充电式、出现并发症或未实现或未维持疼痛缓解时，治疗更早终止。此外，在近20%的病例中，取出设备的是与植入医生不同的医疗人员。
SCS在很大程度上是治疗某些慢性难治性疼痛综合征的安全有效策略。需要进一步的前瞻性数据和创新，以改善患者选择、维持SCS治疗效果并减少导致设备取出的原因。
