Explant rates of electrical neuromodulation devices in 1177 patients in a single center over an 11-year period

Abstract

IntroductionThe publication of explant rates has established risk factors and a definitive objective outcome of failure for spinal cord stimulation (SCS) treating neuropathic pain. We present a UK study analyzing explants of electrical neuromodulation devices for different conditions over 11 years in a single center specializing in neuromodulation.MethodsA retrospective analysis was performed using a departmental database between 2008 and 2019. Explants were analyzed according to condition, mode of stimulation and other demographics using logistic regression and Kaplan-Meier graphs with log-rank (Mantel-Cox) test.ResultsOut of a total of 1177 patients, the explant rate was 17.8% at 5 years and 25.2% at 10 years. Loss of efficacy was the most frequent reason for explant 119/181 (65%). Multivariant regression analysis indicated patients with back pain without prior surgery had a reduced risk of explant (p=0.03). Patients with SCS systems that had 10 kHz, options of multiple waveforms, and rechargeable batteries also had a decreased risk of explant (p<0.001). None of these findings were confirmed when comparing Kaplan-Meier graphs, however. Contrary to other studies, we found gender and age were not independent variables for explant.ConclusionThese data contribute to a growing list of explant data in the scientific literature and give indications of what factors contribute to long-term utilization of electrical neuromodulation devices.

<p>Ten kilohertz SCS for Treatment of Chronic Upper Extremity Pain (UEP): Results from Prospective Observational Study</p>

“…However, because 10 kHz SCS is paresthesia-free, most cases of lead migration manifesting as decreased efficacy can be managed through reprogramming and very few cases require revision surgery or explant. 21 Indeed, the rate of explant due to loss of efficacy is comparatively low with 10 kHz SCS 29 , 30 and only one out of over 200 patients from six prospective and retrospective studies (including the current study) required an explant for loss of efficacy. 15 , 16 , 21–23 …”

Pain Relief and Safety Outcomes with Cervical 10 kHz Spinal Cord Stimulation: Systematic Literature Review and Meta-analysis

“…Of these, 144 were duplicate publications; therefore, 196 citations were reviewed during title and abstract screening. The full-text publications of 47 studies were then screened for eligibility, and 15 were included in this review [15][16][17][28][29][30][31][32][33][34][35][36][37][38][39]. Reasons for exclusion of articles during abstract screening and full-text screening included not meeting criteria for patient population, study design articles, nonclinical studies, and conference presentations.…”

“…Eight studies were retrospective observational studies [ 15 , 17 , 28 , 29 , 33 , 35 – 37 ], four were prospective single-arm studies [ 16 , 30 , 31 , 38 ], two were case reports [ 32 , 34 ], and one study was a post-hoc sub-analysis that combined the data from two of the prospective observational studies [ 39 ]. Four studies were conducted in the United States (US) [ 16 , 33 , 34 , 39 ], three in the United Kingdom [ 15 , 28 , 35 ], three in Australia [ 36 – 38 ], two in Italy [ 31 , 32 ], one in Germany [ 17 ], one was conducted in both Australia and the US [ 29 ], and one study was conducted both the UK and US [ 30 ]. The sample sizes analyzed in these studies, excluding the case reports, ranged from seven to 1177 patients.…”

“…No patients reported a neurological event or paresthesia following 10 kHz SCS in the studies included in this review (see Table 3) [16,17,[28][29][30][31][32][33][34][35][36][37][38].…”

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 Cohort Analysis

“…Tolerance could correspond either to local neurochemical adaptation to the electrical field delivered by the SCS lead [47] or to neurochemical "desensitization" at the level of spinal pathways/supra-spinal projections, even at the cortical integration level [48,49] or local architectural plasticity, including fibrotic developments, or else neural plasticity observed at the level of the central nervous system pathways/cortex. It is interesting to note that SCS tolerance has been reported in both sub-categories of stimulation: tonic stimulation and novel sub-perception waveforms [50,51]. The reasons for this phenomenon are not completely understood, but neural plasticity and fibrosis around the electrodes have been postulated as contributing factors [14].…”