Van Buyten Jean-Pierre, Wille Frank, Smet Iris, Wensing Carin, Breel Jennifer, Karst Edward, Devos Marieke, Pöggel-Krämer Katja, Vesper Jan
Department of Anesthesia and Pain Management, AZ Nikolaas Hospital, Sint-Niklaas, Belgium.
Department of Anesthesiology and Pain Medicine, Academic Medical Center, Amsterdam, The Netherlands.
Neuromodulation. 2017 Oct;20(7):642-649. doi: 10.1111/ner.12642. Epub 2017 Aug 18.
Clinical trials of spinal cord stimulation (SCS) have largely focused on conversion from trial to permanent SCS and the first years after implant. This study evaluates the association of type of SCS and patient characteristics with longer-term therapy-related explants.
Implanting centers in three European countries conducted a retrospective chart review of SCS systems implanted from 2010 to 2013. Ethics approval or waiver was obtained, and informed consent was not required. The chart review recorded implants, follow-up visits, and date and reasons for any explants through mid-2016. Results are presented using Cox regression to determine factors associated with explant for inadequate pain relief.
Four implanting centers in three countries evaluated 955 implants, with 8720 visits over 2259 years of follow-up. Median age was 53 years; 558 (58%) were female. Explant rate was 7.9% per year. Over half (94 of 180) of explants were for inadequate pain relief, including 32/462 (6.9%) of implants with conventional nonrechargeable SCS, 37/329 (11.2%) with conventional rechargeable and 22/155 (14.2%) with high-frequency (10 kHz) rechargeable SCS. A higher explant rate was found in univariate regression for conventional rechargeable (HR 1.98, p = 0.005) and high-frequency stimulation (HR 1.79, p = 0.035) than nonrechargeable SCS. After covariate adjustment, the elevated explant rate persisted for conventional rechargeable SCS (HR 1.95, p = 0.011), but was not significant for high-frequency stimulation (HR 1.71, p = 0.069).
This international, real-world study found higher explant rates for conventional rechargeable and high-frequency SCS than nonrechargeable systems. The increased rate for conventional rechargeable stimulation persisted after covariate adjustment.
脊髓刺激（SCS）的临床试验主要集中在从试验性SCS转换为永久性SCS以及植入后的头几年。本研究评估了SCS类型和患者特征与长期治疗相关的移除装置之间的关联。
欧洲三个国家的植入中心对2010年至2013年植入的SCS系统进行了回顾性病历审查。获得了伦理批准或豁免，无需知情同意。病历审查记录了植入情况、随访情况以及截至2016年年中任何移除装置的日期和原因。使用Cox回归分析呈现结果，以确定与因疼痛缓解不足而移除装置相关的因素。
三个国家的四个植入中心评估了955例植入情况，在2259年的随访期间进行了8720次访视。中位年龄为53岁；558例（58%）为女性。每年的移除装置率为7.9%。超过一半（180例中的94例）的移除装置是由于疼痛缓解不足，其中包括462例传统非可充电SCS植入中的32例（6.9%）、329例传统可充电SCS植入中的37例（11.2%）以及155例高频（10 kHz）可充电SCS植入中的22例（14.2%）。在单因素回归分析中，发现传统可充电SCS（风险比[HR] 1.98，p = 0.005）和高频刺激（HR 1.79，p = 0.035）的移除装置率高于非可充电SCS。在进行协变量调整后，传统可充电SCS的移除装置率升高仍然存在（HR 1.95，p = 0.011），但高频刺激的移除装置率升高不显著（HR 1.71，p = 0.069）。
这项国际性的真实世界研究发现，传统可充电SCS和高频SCS的移除装置率高于非可充电系统。在进行协变量调整后，传统可充电刺激的移除装置率升高仍然存在。
