Neuromodulation : journal of the International Neuromodulation Society
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Observational Study
Sonication in Patients With Spinal Cord Stimulation: A New Approach for Infection Diagnostics.
Spinal cord stimulation (SCS) offers improvement in pain and function for several chronic pain conditions. There are concerns regarding bacterial colonization of the temporary lead extensions and subsequent infection risk in a two-session implantation procedure. Although there is no standardized evaluation of SCS lead contamination, this study evaluates the infection rate and microbial colonization of SCS lead extensions with sonication, a method that is established in implant-related infection diagnostics. ⋯ There is a discrepancy between the presence of microbial colonization and the occurrence of clinically relevant infections. Although the rate of microbial colonization of the lead extensions is high (21.9%), the surgical-site infection rate remained low (3.1%). Therefore, we can conclude that the two-session procedure is a safe approach that is not associated with a higher incidence of infection. Although the sonication method cannot be used as the sole tool for detecting infections in patients with SCS, it can provide additional value in microbial diagnostics in combination with clinical and laboratory parameters and conventional microbiological methods.
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High-frequency spinal cord stimulation (10-kHz SCS) has been shown to be an effective treatment for refractory low back pain and neck pain with and without limb pain in clinical trial and real-world studies. However, limited information is available in the literature on the type and frequency of programming parameters required to optimize pain relief. ⋯ In the study, 10-kHz SCS was an effective therapy for treating chronic pain, whereby a high responder rate (≥50% pain relief) was achieved with short time to pain relief in trial and maintained with limited device programming after permanent implant. The data presented here provide insight into the programming required during the trial and implant stages to obtain and maintain therapeutic efficacy.
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The overall awareness and potential of real-world data have drastically increased in the medical field, with potential implications for postmarket medical device surveillance. The goal of this study was to evaluate real-world data on incidence of infections, explantations, and displacements/mechanical complications of spinal cord stimulation (SCS) during the past eight years and to forecast point estimates for the upcoming three years on the basis of the identified patterns. ⋯ Based on real world data, device explantation was the most frequent event of interest, with negative peaks in the time series in 2016 and 2020, presumably due to the introduction of rechargeable pulse generators and to the COVID-19 pandemic, respectively.
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After a successful percutaneous cylindrical electrode five-to-seven-day trial of spinal cord stimulation, subsequent permanent surgical paddle lead (SPL) placement can be impeded by epidural scar induced by the trial leads (TLs). Our goal was to determine whether a delay between TL and subsequent SPL placement provokes enhanced epidural scarring with an increased need for laminotomy extension required for scar removal for optimal SPL placement. ⋯ TL placement leads to scarring in the epidural space that appears to mature after ten days of its placement. In approximately 34% of patients, this leads to prolonged operative time owing to the need for extension of laminotomy and subsequent clearing of epidural scar for optimal SPL placement.
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Review Historical Article
A Visual and Narrative Timeline Review of Spinal Cord Stimulation Technology and US Food and Drug Administration Milestones.
The aim of this study was to present key technologic and regulatory milestones in spinal cord stimulation (SCS) for managing chronic pain on a narrative timeline with visual representation, relying on original sources to the extent possible. ⋯ This timeline represents the evolution of SCS technology alongside expanding FDA-approved indications for use.