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Incidence of Neuraxial and Non-neuraxial Hematoma Complications From Spinal Cord Stimulator Surgery: Systematic Review and Proportional Meta-Analysis

      Abstract

      Objective

      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).

      Materials and Methods

      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.

      Results

      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%).

      Conclusion

      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.

      Keywords

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