Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.

Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov).

Pain relief outcomes using an SCS device capable of delivering combination therapy with advanced waveforms and field shapes.

BACKGROUND: Given the range of subjective experiences reported by patients with chronic pain, Spinal Cord Stimulation (SCS) systems designed for tailored delivery of analgesic therapy may help improve treatment effectiveness and satisfaction. RESEARCH DESIGN AND METHODS: This case-series evaluated 420 patients with chronic back and/or leg pain implanted with an SCS device capable of sequential or simultaneous delivery of neurostimulation (i.e. combination therapy) as well as multiple waveforms and/or field shapes. Following implantation, an array of standard programs (e.g. paresthesia-based SCS), and a custom set of sub-perception programs were provided per patient feedback. Pain scores (Numeric Rating Scale, NRS) were collected at baseline and during follow-up. RESULTS: In this multicenter, observational series (n = 420, 53.1% female; Age: 64.2 ± 13.4 years), a mean overall pain score of 7.2 ± 1.8 (SD) was reported pre-trial (Baseline). At a mean follow-up duration of 208 ± 200 (SD) days, the mean overall pain score reduced to 2.4 (p < 0.0001). Overall pain was reduced by 5.1 ± 2.4 and 4.5 ± 2.4 points (NRS) at 3-months (N = 256) and at 12-months post-implant (N = 122) respectively (p < 0.0001). CONCLUSIONS: These results suggest that highly 'customizable' SCS approaches may allow for highly effective pain relief within the real-world clinical setting.

Utilization of multiple spinal cord stimulation (SCS) waveforms in chronic pain patients.

BACKGROUND: Advances in spinal cord stimulation (SCS) have improved patient outcomes, leading to its increased utilization for chronic pain. Chronic pain is dynamic showing exacerbations, variable severity, and evolving pain patterns. Given this complexity, SCS systems that provide a broad range of stimulation waveforms may be valuable. METHODS: The aim of this research was to characterize the usage pattern of stimulation waveforms and field shapes in chronic pain patients implanted with the Spectra System. A review of daily device usage in a cohort of 250 patients implanted for a minimum duration of one month was conducted. RESULTS: With follow-ups ranging between 1 month and 1 year post-implant, 72.8% of patients used Standard Rate, 34.8% Anode Intensification, 23.2% Higher Rate, and 8.4% Burst stimulation waveforms. Collectively, 60% used 1 or more advanced waveforms, either exclusively or along with Standard Rate. A trend showed patients continuing to use up to 3 programs one year post-implant. CONCLUSION: When given a choice, SCS patients often utilize a variety of waveforms, suggesting that patients may benefit from a single system that provides multiple waveforms and field shapes to customize therapy and improve efficacy.

Spinal Cord Stimulation (SCS) with Anatomically Guided (3D) Neural Targeting Shows Superior Chronic Axial Low Back Pain Relief Compared to Traditional SCS-LUMINA Study.

BACKGROUND: The aim of this study was to determine whether spinal cord stimulation (SCS) using 3D neural targeting provided sustained overall and low back pain relief in a broad routine clinical practice population. STUDY DESIGN AND METHODS: This was a multicenter, open-label observational study with an observational arm and retrospective analysis of a matched cohort. After IPG implantation, programming was done using a patient-specific, model-based algorithm to adjust for lead position (3D neural targeting) or previous generation software (traditional). Demographics, medical histories, SCS parameters, pain locations, pain intensities, disabilities, and safety data were collected for all patients. RESULTS: A total of 213 patients using 3D neural targeting were included, with a trial-to-implant ratio of 86%. Patients used seven different lead configurations, with 62% receiving 24 to 32 contacts, and a broad range of stimulation parameters utilizing a mean of 14.3 (±6.1) contacts. At 24 months postimplant, pain intensity decreased significantly from baseline (ΔNRS = 4.2, N = 169, P < 0.0001) and even more in in the severe pain subgroup (ΔNRS = 5.3, N = 91, P < 0.0001). Axial low back pain also decreased significantly from baseline to 24 months (ΔNRS = 4.1, N = 70, P < 0.0001, on the overall cohort and ΔNRS = 5.6, N = 38, on the severe subgroup). Matched cohort comparison with 213 patients treated with traditional SCS at the same centers showed overall pain responder rates of 51% (traditional SCS) and 74% (neural targeting SCS) and axial low back pain responder rates of 41% and 71% in the traditional SCS and neural targeting SCS cohorts, respectively. Lastly, complications occurred in a total of 33 of the 213 patients, with a 1.6% lead replacement rate and a 1.6% explant rate. CONCLUSIONS: Our results suggest that 3D neural targeting SCS and its associated hardware flexibility provide effective treatment for both chronic leg and chronic axial low back pain that is significantly superior to traditional SCS.