The Challenge of Converting “Failed Spinal Cord Stimulation Syndrome” Back to Clinical Success, Using SCS Reprogramming as Salvage Therapy, through Neurostimulation Adapters Combined with 3D-Computerized Pain Mapping Assessment: A Real Life Retrospective Study

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.

Combining Awake Anesthesia with Minimal Invasive Surgery Optimizes Intraoperative Surgical Spinal Cord Stimulation Lead Placement

“…In light of these results, awake surgery appears to achieve greater outcomes than general anesthesia, especially by means of the MAST approach [27,28], which facilitates intraoperative testing with objective pain mapping tools [16,[29][30][31][32].…”

“…A better option would probably consist in combining rather than opposing these two strategies [3]. Recent technological innovation offers new opportunities to shape and optimize the delivered electrical field by means of Multiple Independent Current Control (MICC TM ) technology [16,23]. Our vision is that when implanting SCS, neural spatial targeting, is of crucial importance, not only as it catalyzes spatial targeting by temporal resolution adjustments, but also in terms of electrical consumption, as it optimizes SCS lead implantation close to the target.…”

“…This also identifies new SCS mechanisms of action conveyed by different patterns from the classical gate control theory [19][20][21][22]. -SCS spatial resolution has been optimized through multiplication of contacts at the surface of implanted leads, generating more precise and complex electrical fields, in view of enhancing spatial neural targeting [16,23].…”

“…During the last decades, technological refinements have shown promising perspectives in two directions: -SCS temporal resolution has been the subject of intensive research, making new waveforms available for the last generation of internal pulse generators (IPG). This modulates temporal resolution of the electrical signal in view of obtaining better pain relief, less discomfort and more personalized therapy by selecting or even combining several signals at the same time [13][14][15][16][17][18]. This also identifies new SCS mechanisms of action conveyed by different patterns from the classical gate control theory [19][20][21][22].…”

Advances in Neuromodulation for Chronic Pain

“…The first step towards the holy grail is to walk the extra mile for every patient, even for those who do not respond anymore to the initial paradigm. Salvage strategies and algorithms are gaining interest from researchers and clinicians [8][9][10][11][12][13]. Salvage therapy should not only consist of converting patients towards new paradigms but also introducing extra tools to regain freedom and independence in terms of patient empowerment.…”