• Charles Brooker, Marc Russo, Michael J Cousins, Nathan Taylor, Lewis Holford, Rebecca Martin, Tillman Boesel, Richard Sullivan, Erin Hanson, Gerrit Eduard Gmel, Nastaran Hesam Shariati, Lawrence Poree, and John Parker.
• MJC Pain Management and Research Centre, St. Leonards, New South Wales, Australia.
• Pain Pract. 2021 Jul 1; 21 (6): 680-691.

IntroductionChronic pain is a major public health concern, as is the associated use of opioid medications, highlighting the importance of alternative treatments, such as spinal cord stimulation (SCS). Here, we present the final 24-month results of the Avalon study, which investigated the use of the first closed-loop SCS system in patients with chronic pain. The system measures the evoked compound action potentials (ECAPs) elicited by each stimulus pulse and drives a feedback loop to maintain the ECAP amplitude near constant.MethodsFifty patients were implanted with the Evoke system (Saluda Medical) and followed over 24-months. Pain, quality of life (QOL), function, sleep, and medication use were collected at baseline and each scheduled visit. ECAP amplitudes and programming adjustments were also monitored.ResultsAt 24 months, responder rates (≥ 50% pain reduction) and high responder rates (≥ 80% pain reduction) for overall pain were 89.5% and 68.4%, respectively, the latter up from 42.2% at 3 months. Significant improvements from baseline were observed in QOL, function, and sleep over the 24 months, including ≥ 80% experiencing a minimally important difference in QOL and > 50% experiencing a clinically significant improvement in sleep. At 24 months, 82.8% of patients with baseline opioid use eliminated or reduced their opioid intake. Over the course of the study, reprogramming need fell to an average of less than once a year.ConclusionOver a 24-month period, the Evoke closed-loop SCS maintained its therapeutic efficacy despite a marked reduction in opioid use and steady decrease in the need for reprogramming.© 2021 The Authors. Pain Practice published by Wiley Periodicals LLC on behalf of World Institute of Pain.

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