Hagedorn Jonathan M, Lam Christopher M, D'Souza Ryan S, Sayed Dawood, Bendel Markus A, Ha Chris Thuc, Romero Joshua, Hall Morgan, Freeman Eric, Richardson Brian F, Hoelzer Bryan C
Mayo Clinic, Rochester, MN, USA.
University of Kansas Medical Center, Kansas City, KS, USA.
Neuromodulation. 2021 Apr;24(3):499-506. doi: 10.1111/ner.13359. Epub 2021 Jan 19.
High-frequency 10 kHz spinal cord stimulation (10 kHz-SCS) has achieved analgesia superior to traditional SCS in a number of studies. However, there is concern regarding long-term outcomes of 10 kHz-SCS. Prior work has suggested that explant rates are higher with 10 kHz-SCS. Our primary objective was to determine the explant rate of 10 kHz-SCS in a large patient cohort from multiple centers followed for at least 12 months after implant surgery.
We performed a retrospective chart review of all patients who received a 10 kHz-SCS implant before July 1, 2019. We abstracted patient demographics, implant date, primary site of pain, implant indication, explant date, and reason for explant. A total of 744 patients were included in the study analysis.
Average age of the overall cohort was 65.53 years and 407 (54.7%) were women. Average follow-up for all patients was 793 days. There were a total of 76 explants (10.2%). The most common reason for explant was loss of efficacy, which accounted for 39 explants (51.3% of total explants, 5.2% of overall cohort). Female sex and radiculopathy as the SCS indication were associated with statistically significant decreased risk of 10 kHz-SCS explant.
We found 10 kHz-SCS explant rates to be similar to prior reported explant rates for traditional SCS devices. Patient-related factors including female sex and radiculopathy as the primary SCS indication may be protective factors against explantation.
在多项研究中，高频10kHz脊髓刺激（10kHz-SCS）已实现优于传统脊髓刺激的镇痛效果。然而，人们对10kHz-SCS的长期效果存在担忧。先前的研究表明，10kHz-SCS的取出率更高。我们的主要目的是确定来自多个中心的大型患者队列中10kHz-SCS的取出率，这些患者在植入手术后至少随访12个月。
我们对2019年7月1日前接受10kHz-SCS植入的所有患者进行了回顾性病历审查。我们提取了患者的人口统计学信息、植入日期、疼痛的主要部位、植入指征、取出日期和取出原因。共有744名患者纳入研究分析。
整个队列的平均年龄为65.53岁，女性有407名（54.7%）。所有患者的平均随访时间为793天。总共有76例取出（10.2%）。取出的最常见原因是疗效丧失，这占了39例取出（占取出总数的51.3%，占整个队列的5.2%）。女性以及神经根病作为脊髓刺激的指征与10kHz-SCS取出风险的统计学显著降低相关。
我们发现10kHz-SCS的取出率与先前报道的传统脊髓刺激装置的取出率相似。与患者相关的因素，包括女性以及神经根病作为主要的脊髓刺激指征，可能是防止取出的保护因素。
