Hussain Nasir, Boulos Racha, Malik Tarik M, Abd-Elsayed Alaa, Essandoh Michael K, Khan Safdar, Nguyen Anthony, Weaver Tristan E
Department of Anesthesiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.
Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.
Neuromodulation. 2023 Jan;26(1):124-130. doi: 10.1016/j.neurom.2022.01.021. Epub 2022 Mar 31.
Placement of percutaneous spinal cord stimulator (SCS) implant has become a therapeutic option for various chronic pain conditions; however, early surgical explant still occurs. Unfortunately, evidence regarding the incidence of early surgical explant, and patient-specific factors and comorbidities associated with such, is limited and mixed. The objective of this retrospective analysis was to elucidate the incidence and predictors of percutaneous SCS explant within the first two years of device placement.
The PearlDiver-Mariner Patient Record Database of all payer claims was used to identify patients who underwent percutaneous lead SCS implant (leads and generator) with subsequent explant within two years of initial device implant. The primary outcome was to determine the incidence of SCS explant within the first two years of device placement. Secondary outcomes included evaluating the effects of several patient-specific comorbidities on explant rates using univariate regression analysis.
Across the database, a total of 52,070 patients who underwent percutaneous lead SCS implant were included, of whom 3104 (5.96%) had SCS explant within the first two years. Most explants occurred within the first-year time interval at 72.8% (2260 patients), whereas only 27.2% (844 patients) had SCS explant between years one and two. At the one-year time interval, covariates associated with an increased odds ratio (OR) (95% CI) of SCS explant were 1) depression (1.39 [1.26, 1.52]), 2) chronic preoperative (1.27 [1.16, 1.39]) or postoperative (1.23 [1,13, 1.36]) opioid use, 3) cannabis abuse (1.58 [1.20, 2.02]), 4) tobacco use (1.13 [1.04, 1.23]), and 5) coagulopathy (1.22 [1.07, 1.38]). In contrast, the OR of explant was lower in patients who were older, men, or had diabetes (complicated or uncomplicated). All associated covariates became nonsignificant after the first year of SCS implant (ie, between the first and second years), and only depression and tobacco use remained as associated factors for device explant.
Our retrospective analysis highlights that the rate of percutaneous SCS explant appears to considerably decrease after the first year of device implant. Furthermore, this analysis sheds additional insights into patients who may be at risk of early percutaneous SCS explant, especially within the first year of device placement, and underscores the importance of a continued multidimensional/biopsychologic assessment in patients with chronic pain.
经皮脊髓刺激器（SCS）植入已成为各种慢性疼痛疾病的一种治疗选择；然而，早期手术取出仍会发生。遗憾的是，关于早期手术取出的发生率以及与之相关的患者特异性因素和合并症的证据有限且存在矛盾。本回顾性分析的目的是阐明经皮SCS在植入后两年内取出的发生率及预测因素。
使用包含所有支付方索赔信息的PearlDiver - Mariner患者记录数据库，识别接受经皮导联SCS植入（导联和发生器）且在初始设备植入后两年内进行取出的患者。主要结局是确定设备植入后两年内SCS取出的发生率。次要结局包括使用单因素回归分析评估几种患者特异性合并症对取出率的影响。
在整个数据库中，共有52070例接受经皮导联SCS植入的患者，其中3104例（5.96%）在植入后两年内进行了SCS取出。大多数取出发生在第一年时间间隔内，占72.8%（2260例患者），而只有27.2%（844例患者）在第一年和第二年之间进行了SCS取出。在一年时间间隔内，与SCS取出的优势比（OR）（95%CI）增加相关的协变量为：1）抑郁症（1.39[1.26,1.52]），2）术前（1.27[1.16,1.39]）或术后（1.23[1.13,1.36]）长期使用阿片类药物，3）大麻滥用（1.58[1.20,2.02]），4）吸烟（1.13[1.04,1.23]），以及5）凝血功能障碍（1.22[1.07,1.38]）。相比之下，年龄较大、男性或患有糖尿病（无论是否伴有并发症）的患者取出的OR较低。在SCS植入第一年之后（即第一年和第二年之间），所有相关协变量均无统计学意义，只有抑郁症和吸烟仍然是设备取出的相关因素。
我们的回顾性分析强调，在设备植入第一年之后，经皮SCS取出率似乎大幅下降。此外，该分析为可能有早期经皮SCS取出风险的患者提供了更多见解，尤其是在设备植入的第一年内，并强调了对慢性疼痛患者持续进行多维度/生物心理评估的重要性。
