Abstract
While paresthesia-based Spinal Cord Stimulation (SCS) has been proven effective as treatment for chronic neuropathic pain, its initial benefits may lead to the development of “Failed SCS Syndrome’ (FSCSS) defined as decrease over time related to Loss of Efficacy (LoE) with or without Loss of Coverage (LoC). Development of technologies associating new paresthesia-free stimulation waveforms and implanted pulse generator adapters provide opportunities to manage patients with LoE. The main goal of our study was to investigate salvage procedures, through neurostimulation adapters, in patients already implanted with SCS and experiencing LoE. We retrospectively analyzed a cohort of patients who were offered new SCS programs/waveforms through an implanted adapter between 2018 and 2021. Patients were evaluated before and at 1-, 3-, 6- and 12-month follow-ups. Outcomes included pain intensity rating with a Visual Analog Scale (VAS), pain/coverage mappings and stimulation preferences. Last follow-up evaluations (N = 27) showed significant improvement in VAS (p = 0.0001), ODI (p = 0.021) and quality of life (p = 0.023). In the 11/27 patients with LoC, SCS efficacy on pain intensity (36.89%) was accompanied via paresthesia coverage recovery (55.57%) and pain surface decrease (47.01%). At 12-month follow-up, 81.3% preferred to keep tonic stimulation in their waveform portfolio. SCS conversion using adapters appears promising as a salvage solution, with an emphasis on paresthesia recapturing enabled via spatial retargeting. In light of these results, adapters could be integrated in SCS rescue algorithms or should be considered in SCS rescue.
Highlights
Paresthesia-based Spinal Cord Stimulation (SCS) is a well-established therapy with robust clinical evidence aimed at treating patients suffering from refractory Failed BackSurgery Syndrome(FBSS)/Persistent Spinal Pain Syndrome after surgery (PSPS-T2) [1,2,3,4].In some cases, the initial benefits of the therapy may decrease over time, described as “Failed SCS Syndrome” (FSCSS), which may lead to explantation of the device [5,6,7]
Mean performance of the initial paresthesia coverage was 37.8 ± 39.5%
Characterized by Loss of Efficacy (LoE), this retrospective study highlights the clinically significant results observed with new SCS spatial and temporal modalities delivered through new systems, as a salvage therapy
Summary
Paresthesia-based Spinal Cord Stimulation (SCS) is a well-established therapy with robust clinical evidence aimed at treating patients suffering from refractory Failed BackSurgery Syndrome(FBSS)/Persistent Spinal Pain Syndrome after surgery (PSPS-T2) [1,2,3,4].In some cases, the initial benefits of the therapy may decrease over time, described as “Failed SCS Syndrome” (FSCSS), which may lead to explantation of the device [5,6,7]. Paresthesia-based Spinal Cord Stimulation (SCS) is a well-established therapy with robust clinical evidence aimed at treating patients suffering from refractory Failed Back. Documented and analyzed the reasons for which a small but substantial proportion of patients have been explanted over time (7.9% per year). Besides the explants related to complications (hardware dysfunction, cerebrospinal fluid leak, documented allergy to device components or infection), this study group reported that over half of explants (94/180) were performed because patients had lost the analgesic benefits of SCS therapy over time, described as Loss of Efficacy (LoE). For patients using paresthesia-based stimulation, therapy benefits may be reduced over time due to a Loss of pain Coverage (LoC) [10,11,12]
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