Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA.
Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA.
Neuromodulation. 2023 Oct;26(7):1328-1338. doi: 10.1016/j.neurom.2022.07.005. Epub 2022 Aug 17.
The goal of this meta-analysis was to estimate the incidence of total hematomas, neuraxial hematomas, and non-neuraxial hematomas in patients who underwent temporary spinal cord stimulator (SCS) lead trial placement and permanent implantation of SCS leads and internal pulse generator (IPG).
A comprehensive search was conducted of databases of any publications before October 21, 2021. Eligible study designs included randomized control trials and prospective or retrospective observational studies with more than ten patients. The primary outcome variables were the incidences of total hematomas, neuraxial hematomas, and non-neuraxial hematomas in patients with SCS. These dichotomous categorical outcomes were abstracted from studies after Freeman-Tukey arcsine square root transformation using random-effects meta-analysis (DerSimonian and Laird method). Pooled incidence rates and 95% CIs were calculated for each outcome variable.
A total of 40 studies met the inclusion criteria. Included in the neuraxial and non-neuraxial hematoma analyses were 4751 patients and 3862 patients, respectively. The pooled incidence of any hematoma in patients with SCS was 0.81% (95% CI, 0.45%-1.27%). The pooled incidence of neuraxial hematoma in patients with SCS was 0.32% (95% CI, 0.18%-0.50%). This included primarily epidural hematomas (11/4751) but also comprised an intracranial hemorrhage in a patient on enoxaparin bridge therapy from warfarin and one patient not on anticoagulation with an intracranial subdural hematoma that resulted in death. The pooled incidence of non-neuraxial hematomas in patients with SCS was 0.59% (95% CI, 0.29%-1.00%).
The overall incidence of hematomas in patients with temporary SCS trial lead placement and permanent SCS/IPG implantations is less than 1%. Furthermore, the incidence of neuraxial hematomas is less than 0.5%, which is of particular interest given the potential devastating consequences of this complication. The results of this study can be used to inform patients and implanting physicians on hematoma complications from SCS and highlight that the benefits of SCS outweigh the hematoma risks if anticoagulation is appropriately managed perioperatively.
本荟萃分析旨在估计接受临时脊髓刺激器（SCS）导丝试验放置和永久性 SCS 导丝和内置脉冲发生器（IPG）植入的患者中总血肿、神经轴血肿和非神经轴血肿的发生率。
对 2021 年 10 月 21 日前的数据库进行了全面检索。合格的研究设计包括随机对照试验和前瞻性或回顾性观察性研究，每组患者超过 10 例。主要结局变量是 SCS 患者的总血肿、神经轴血肿和非神经轴血肿的发生率。使用随机效应荟萃分析（DerSimonian 和 Laird 法）对这些二项分类结局变量进行了从研究中提取的 Freeman-Tukey 反正弦平方根转换。计算了每个结局变量的汇总发生率和 95%置信区间（CI）。
共有 40 项研究符合纳入标准。纳入神经轴和非神经轴血肿分析的患者分别为 4751 例和 3862 例。SCS 患者任何血肿的汇总发生率为 0.81%（95%CI，0.45%-1.27%）。SCS 患者神经轴血肿的汇总发生率为 0.32%（95%CI，0.18%-0.50%）。这主要包括硬膜外血肿（11/4751），但也包括一名接受依诺肝素桥接治疗华法林的患者的颅内出血和一名未接受抗凝治疗的患者的颅内硬脑膜下血肿导致死亡。SCS 患者非神经轴血肿的汇总发生率为 0.59%（95%CI，0.29%-1.00%）。
接受临时 SCS 试验导丝放置和永久性 SCS/IPG 植入的患者血肿总发生率低于 1%。此外，神经轴血肿的发生率低于 0.5%，这尤其令人感兴趣，因为这种并发症可能会产生灾难性的后果。本研究的结果可用于告知患者和植入医生有关 SCS 血肿并发症的信息，并强调如果围手术期适当管理抗凝，SCS 的益处超过血肿风险。
