Wang Victor C, Bounkousohn Vickie, Fields Kara, Bernstein Clifford, Paicius Richard M, Gilligan Christopher
Department of Anesthesiology Perioperative and Pain Medicine, Newport Beach Headache and Pain, Coast Pain Management, Brigham and Women's Hospital, Boston, MA, USA.
Neuromodulation. 2021 Apr;24(3):507-511. doi: 10.1111/ner.13280. Epub 2020 Oct 5.
To report the explantation rates of high frequency 10 kHz spinal cord stimulation (SCS) in a real-world setting.
This is a retrospective review of patients implanted with high frequency spinal cord stimulators over a 4-year period in two outpatient private practice clinics, from July 2015 through June 2019, using the Kaplan-Meier product-limit method to estimate probabilities of implant survival over time.
The estimated median time to explantation was 3.5 years (95% confidence interval [CI] = 3.1-3.7) [Correction added on 15 October 2020, after first online publication: The preceeding sentence was amended to reflect the estimated median time.]. The estimated probabilities of implant survival beyond 1, 2, and 3 years postimplantation were 88.4% (95% CI = 81.3-93.0%), 76.5% (95% CI = 67.8-83.2%), and 60.7% (95% CI = 50.2-69.6%), respectively. The minimum (i.e., known) cumulative percentages of patients explanted by 1, 2, and 3 years postimplantation were 11.1% (14/126), 22.2% (28/126), and 32.5% (41/126), respectively. 65.9% of patients in this study had prior neurostimulation.
Recently, high frequency SCS technology has been demonstrated as more effective in treatment of lower- and leg-pain, compared to conventional low frequency SCS, in a 12-month randomized controlled trial (SENZA-RCT). Longer term results have yet to be published. In this study, we found that the explantation rate was much higher than expected, based on the prior studies demonstrating its efficacy. As the use of neuromodulation continues to grow, longitudinal data will be critical in understanding its long-term effects on treated patients.
报告在实际应用中高频10kHz脊髓刺激（SCS）的取出率。
这是一项对2015年7月至2019年6月期间在两家门诊私人诊所接受高频脊髓刺激器植入的患者进行的回顾性研究，为期4年，采用Kaplan-Meier乘积限法估计植入物随时间存活的概率。
估计取出的中位时间为3.5年（9５％置信区间[CI] = 3.1-3.7）[2020年10月15日首次在线发表后添加的更正：前一句进行了修改以反映估计的中位时间。]。植入后1年、2年和3年以上植入物存活的估计概率分别为88.4％（95％CI = 81.3-93.0％）、76.5％（95％CI = 67.8-83.2％）和60.7％（95％CI = 50.2-69.6％）。植入后1年、2年和3年取出患者的最小（即已知）累积百分比分别为11.1％（14/126）、22.2％（28/126）和32.5％（41/126）。本研究中65.9％的患者曾接受过神经刺激。
最近，在一项为期12个月的随机对照试验（SENZA-RCT）中，与传统低频SCS相比，高频SCS技术已被证明在治疗下肢疼痛方面更有效。长期结果尚未发表。在本研究中，我们发现基于先前证明其疗效的研究，取出率远高于预期。随着神经调节的使用持续增加，纵向数据对于了解其对治疗患者的长期影响至关重要。
