Dataset Information

The Efficacy, Safety, and Outcomes of Brain-responsive Neurostimulation (RNS® System) therapy in older adults.

ABSTRACT:

Objectives

The gold standard for the management of drug-resistant focal epilepsy (DRE) is resection of epileptogenic zone. However, some patients may not be candidates for resection. Responsive neurostimulation is approved in patients above 18 years of age for such patients. We aimed to investigate whether RNS outcomes and safety varied based on age.

Methods

We performed a single-center retrospective cohort study of patients with DRE who were treated with RNS between May 2008 and February 2020. We included patients who had been implanted with RNS for >6 months (N = 55), dividing them into older (N = 11) and younger adults (N = 44) depending on implantation age (≥50 and <50 years, respectively).

Results

Mean age at implantation in older adults was 54.9 ± 3.5 years. Seizure onset age, epilepsy duration, and comorbidities were significantly higher in older adults ( P < .01). Stimulation parameters, treatment duration, and median seizure frequency reduction (76% in older vs 50% in younger adults) were statistically comparable between the two cohorts. Posttreatment, antiseizure medication burden was significantly decreased in older compared with younger adults (P = .048). Postoperative and delayed adverse events among older adults were mild. Compared with three younger adults, none of the older adults required device explantation due to surgical site infection.

Conclusion

Our study suggests that older adults treated with the RNS System achieve seizure outcomes comparable to younger adults with the additional benefit of a significant postimplantation medication reduction. With efficacy and safety similar to younger adults, brain-responsive neurostimulation was well-tolerated in older adults.

SUBMITTER: Zawar I

PROVIDER: S-EPMC8633477 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:OBJECTIVE:Brain-responsive neurostimulation (RNS System, NeuroPace) is used to treat medically refractory focal epilepsy and also provides long-term ambulatory neurophysiologic data. We sought to determine whether these data could predict the clinical response to antiseizure drugs (ASDs). METHODS:First, newly added medications were identified in RNS System patients followed at a single epilepsy center. Daily detection rates including "episode starts" (predominantly interictal activity) and "long episodes" (often electrographic seizures) were compared before and after ASD initiation. Efficacy was determined from documentation of clinical improvement and medication retention. Next, the analysis was repeated on an independent sample of patients from a multicenter long-term treatment trial, using an efficacy measure of ?50% reduction in diary-recorded seizure frequency after 3 months. RESULTS:In the single center cohort, long episodes, but not episode starts, had a significantly greater reduction in the first week for clinically efficacious compared to inefficacious medications. In this cohort, having no long episodes in the first week was highly predictive of ASD efficacy. In the multicenter cohort, both long episodes and episode starts had a significantly greater reduction for effective medications starting in the first 1-2 weeks. In this larger dataset, a ?50% decrease in episode starts was 90% specific for efficacy with a positive predictive value (PPV) of 67%, and a ?84% decrease in long episodes was 80% specific with a PPV of 48%. Conversely, a <25% decrease in long episodes (including any increase) or a <20% decrease in episode starts had a predictive value for inefficacy of >80%. SIGNIFICANCE:In RNS System patients with stable detection settings, when new ASDs are started, detection rates within the first 1-2 weeks may provide an early, objective indication of efficacy. These data could be used to identify responses to medication trials early to allow more rapid medication adjustments than conventionally possible.