Incidence and Risk Factors for Spinal Cord Stimulator Lead Migration With or Without Loss of Efficacy: A Retrospective Review of 91 Consecutive Thoracic Lead Implants.

OBJECTIVE: Lead migration after spinal cord stimulator (SCS) implant is a commonly reported complication and the most common reason for revision surgery in cases of loss of efficacy. The primary aims of this study are to describe the incidence and degree of lead migration in the subacute postoperative period after SCS implant and to report potential risk factors for lead migration. MATERIALS AND METHODS: We performed a retrospective chart review of all patients at a single academic center who received an SCS implant from January 1, 2020, to December 31, 2020. Information on patient (age, sex, weight, and height) and operative factors (device manufacturer, epidural access level and method, and implantable pulse generator location) were extracted from medical records. Intraoperative imaging was compared to subacute follow-up imaging obtained less than 20 days postimplant to measure lead migration distance. Regression models were fitted to determine associations between lead migration distance and potential clinical risk factors. RESULTS: A total of 91 cases (182 leads) were included in the study. Within 20 days of implantation, 88.5% of leads had migrated (86.3% caudal and 2.2% cephalad). Mean migration distance for leads with caudal migration only was 12.34 ± 12.19 mm based on anteroposterior radiographs and 16.95 ± 15.68 mm on lateral radiographs. There was an association of greater caudal lead migration as patient body mass index increased (ß-coefficient 0.07 [95% confidence interval 0.01-0.13], p = 0.031). Within the entire cohort, one patient (1.1%) required lead revision for loss of efficacy. CONCLUSIONS: In the subacute postoperative period after SCS implant, the majority of SCS leads migrated caudally with an average of two lead contacts. Knowledge of this expected migration and risk factors can better inform implanting physicians intraoperatively when deciding final lead placement location. The finding of high likelihood of caudal lead migration in the subacute postoperative period brings the need for a well-designed prospective study to the forefront of our field. This will allow implanting providers to make well-informed decisions for intraoperative lead placement.

Patient Satisfaction With Spinal Cord Stimulation and Dorsal Root Ganglion Stimulation for Chronic Intractable Pain: A Systematic Review and Meta-Analysis.

OBJECTIVES: In the spinal cord stimulation (SCS) and dorsal root ganglion stimulation (DRG-S) literature, the typical primary outcome measure includes pain relief, whether numeric rating scale changes or percentage pain relief, and functional outcomes and patient satisfaction are included as secondary outcomes. This systematic review and meta-analysis aims to determine the rate of patient satisfaction with the use of SCS and DRG-S in the treatment of chronic intractable pain. MATERIALS AND METHODS: The study protocol was registered in the PROSPERO International prospective register of systematic reviews. We queried articles from multiple electronic data bases, including MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials data bases, and hand-searched reference lists of identified publications. All periods were included. Inclusion criteria encompassed randomized controlled trials (RCTs) and prospective observational studies that reported patient satisfaction in patients who underwent SCS or DRG-S. Bias evaluation for the included studies involved appropriate guidelines for each study design (Cochrane risk of bias tool for RCTs and Newcastle-Ottawa scale for observational studies). RESULTS: Our search strategy identified 242 unique citations, of which nine RCTs and 23 observational studies were included for analysis. Overall, 25 studies comprising 1355 participants were pooled in our quantitative analysis. The pooled proportion of patients who reported satisfaction from all studies was 82.2% (95% CI, 77.8%-86.2%). This finding had high statistical heterogeneity (I2 = 74.0%). Subgroup analysis did not reveal differences in satisfaction when studies were stratified based on study design (RCT or observational study) or follow-up period (six, 12, 24, and 36 months). CONCLUSIONS: Our results show high levels of patient satisfaction across the SCS and DRG-S literature when these treatment modalities are used for chronic intractable pain, regardless of SCS programming algorithm. However, there is a scarcity of unbiased and/or non-industry-funded prospective studies in the neuromodulation field, and future efforts to expand this area of the SCS and DRG-S literature are greatly needed.

Explantation of 10 kHz Spinal Cord Stimulation Devices: A Retrospective Review of 744 Patients Followed for at Least 12 Months.

OBJECTIVES: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.