Explantation of 10 kHz Spinal Cord Stimulation Devices: A Retrospective Review of 744 Patients Followed for at Least 12 Months

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Abstract

<p class="first" id="d2716554e148">High-frequency 10 kHz spinal cord stimulation (10 kHz-SCS) has achieved analgesia superior to traditional SCS in a number of studies. However, there is concern regarding long-term outcomes of 10 kHz-SCS. Prior work has suggested that explant rates are higher with 10 kHz-SCS. Our primary objective was to determine the explant rate of 10 kHz-SCS in a large patient cohort from multiple centers followed for at least 12 months after implant surgery. </p>

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Most cited references 12

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Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial.

Leonardo Kapural, Cong Yu, Matthew Doust … (2015)

Current treatments for chronic pain have limited effectiveness and commonly known side effects. Given the prevalence and burden of intractable pain, additional therapeutic approaches are desired. Spinal cord stimulation (SCS) delivered at 10 kHz (as in HF10 therapy) may provide pain relief without the paresthesias typical of traditional low-frequency SCS. The objective of this randomized, parallel-arm, noninferiority study was to compare long-term safety and efficacy of SCS therapies in patients with back and leg pain.

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Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform

Ed Tavel, Thomas Yearwood, Allen Burton … (2018)

The purpose of the multicenter, randomized, unblinded, crossover Success Using Neuromodulation with BURST (SUNBURST) study was to determine the safety and efficacy of a device delivering both traditional tonic stimulation and burst stimulation to patients with chronic pain of the trunk and/or limbs.

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Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial

Nagy Mekhail, Robert Levy, Timothy R Deer … (2019)

Spinal cord stimulation has been an established treatment for chronic back and leg pain for more than 50 years; however, outcomes are variable and unpredictable, and objective evidence of the mechanism of action is needed. A novel spinal cord stimulation system provides the first in vivo, real-time, continuous objective measure of spinal cord activation in response to therapy via recorded evoked compound action potentials (ECAPs) in patients during daily use. These ECAPs are also used to optimise programming and deliver closed-loop spinal cord stimulation by adjusting the stimulation current to maintain activation within patients' therapeutic window. We aimed to examine pain relief and the extent of spinal cord activation with ECAP-controlled closed-loop versus fixed-output, open-loop spinal cord stimulation for the treatment of chronic back and leg pain.