Therapy-Related Explants After Spinal Cord Stimulation: Results of an International Retrospective Chart Review Study

Abstract

ObjectivesClinical trials of spinal cord stimulation (SCS) have largely focused on conversion from trial to permanent SCS and the first years after implant. This study evaluates the association of type of SCS and patient characteristics with longer‐term therapy‐related explants.Materials and MethodsImplanting centers in three European countries conducted a retrospective chart review of SCS systems implanted from 2010 to 2013. Ethics approval or waiver was obtained, and informed consent was not required. The chart review recorded implants, follow‐up visits, and date and reasons for any explants through mid‐2016. Results are presented using Cox regression to determine factors associated with explant for inadequate pain relief.ResultsFour implanting centers in three countries evaluated 955 implants, with 8720 visits over 2259 years of follow‐up. Median age was 53 years; 558 (58%) were female. Explant rate was 7.9% per year. Over half (94 of 180) of explants were for inadequate pain relief, including 32/462 (6.9%) of implants with conventional nonrechargeable SCS, 37/329 (11.2%) with conventional rechargeable and 22/155 (14.2%) with high‐frequency (10 kHz) rechargeable SCS. A higher explant rate was found in univariate regression for conventional rechargeable (HR 1.98, p = 0.005) and high‐frequency stimulation (HR 1.79, p = 0.035) than nonrechargeable SCS. After covariate adjustment, the elevated explant rate persisted for conventional rechargeable SCS (HR 1.95, p = 0.011), but was not significant for high‐frequency stimulation (HR 1.71, p = 0.069).ConclusionsThis international, real‐world study found higher explant rates for conventional rechargeable and high‐frequency SCS than nonrechargeable systems. The increased rate for conventional rechargeable stimulation persisted after covariate adjustment.

Opioid‐sparing effects of 10 kHz spinal cord stimulation: a review of clinical evidence

“…Two studies have reported explant rates of 10 kHz SCS. The first study was a European multicenter, retrospective analysis that used data from 946 implanted subjects to derive annualized rates of explants defined as those that resulted in the termination of SCS therapy . The authors reported that the explant rate for inadequate pain relief was 5.0% per year of follow‐up for 10 kHz SCS, 5.5% for conventional rechargeable SCS, and 2.8% for nonrechargeable SCS.…”

“…The first study was a European multicenter, retrospective analysis that used data from 946 implanted subjects to derive annualized rates of explants defined as those that resulted in the termination of SCS therapy. 45 The authors reported that the explant rate for inadequate pain relief was 5.0% per year of follow-up for 10 kHz SCS, 5.5% for conventional rechargeable SCS, and 2.8% for nonrechargeable SCS. It is important to understand that 37.4% of the nonrechargeable devices were explanted and replaced due to battery depletion and , "real-world" analysis of satisfaction and explant rates in 10 kHz SCS commercial cases for any etiology.…”

The Neuromodulation Appropriateness Consensus Committee on Best Practices for Dorsal Root Ganglion Stimulation

“…The goal of neuromodulation therapy in the setting of chronic pain is to improve function and quality of life, decreasing the cost of the health care burden on society and reducing the opioid burden on the world population. Despite the successful use of SCS to treat many chronic pain syndromes, there are cases where SCS fails to produce initial or lasting relief . Dorsal root ganglion (DRG) stimulation is an option to improve outcomes in certain conditions that have challenged the efficacy of other forms of spinal stimulation and may, in fact, be the first choice of neuromodulation therapies for certain disorders.…”

“…Recent reviews of explant data also examined the potential reasons for device explantation. Pope and colleagues in their retrospective review of 352 SCS cases found that 43.9% (152/346) of explants occurred due to failure or lack of efficacy , and Van Buyten et al in a study of more than 900 patients, found that 50% of the devices were explanted due to therapeutic failure . These failures of device may suggest the need for different approaches, specifically with traditionally difficult pain patterns and regions.…”

Conventional versus High‐Frequency Neuromodulation in the Treatment of Low Back Pain Following Spine Surgery

“…Even in studies comparing battery life and explants, Drs. Sclafani and Leong states that HF10 therapy is commonly used for the most difficult LBP patients in Belgium 9 and HF10 was the lowest explant rate among rechargeable systems. This translates to a more convenient and comfortable experience and potentially less surgery for the patient with HF10.…”