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ECAP‐Controlled Closed‐Loop Spinal Cord Stimulation Efficacy and Opioid Reduction Over 24‐Months: Final Results of the Prospective, Multicenter, Open‐Label Avalon Study
Author(s) -
Brooker Charles,
Russo Marc,
Cousins Michael J.,
Taylor Nathan,
Holford Lewis,
Martin Rebecca,
Boesel Tillman,
Sullivan Richard,
Hanson Erin,
Gmel Gerrit Eduard,
Shariati Nastaran Hesam,
Poree Lawrence,
Parker John
Publication year - 2021
Publication title -
pain practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.899
H-Index - 58
eISSN - 1533-2500
pISSN - 1530-7085
DOI - 10.1111/papr.13008
Subject(s) - medicine , opioid , chronic pain , anesthesia , spinal cord stimulation , stimulation , spinal cord , neurostimulation , implant , surgery , physical therapy , receptor , psychiatry
Chronic 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. Methods Fifty 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. Results At 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. Conclusion Over 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.