Infection Rates in Adult Patients Implanted with the RNS® System
Abstract number :
2.247
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2024
Submission ID :
1244
Source :
www.aesnet.org
Presentation date :
12/8/2024 12:00:00 AM
Published date :
Authors :
Presenting Author: Natalie Schmidt, FNP-BC – NeuroPace, Inc.
Cairn Seale, MS – NeuroPace
Merit Vick, – NeuroPace, Inc.
Ramona Gonis, BS – NeuroPace, Inc.
Martha Morrell, MD – NeuroPace
Rationale: The NeuroPace® RNS® System was approved by the FDA in November 2013 to treat medically refractory focal epilepsy in individuals 18 years of age and older. A 2017 report by Weber et al. (2017, Stereotact Funct Neurosurg, 95(5):325-329) described an infection rate in patients in the investigational trials of 3.7% per procedure to implant or replace the neurostimulator and/or leads. Here we provide updated information related to infection risk in adult patients with drug-resistant focal epilepsy treated with the RNS System.
Methods: All serious adverse events (SAEs) reports for the RNS System submitted to NeuroPace between 1/4/2018 and 1/4/2024 for patients 18 and older at initial implant were retrospectively reviewed for reports of infection. These cut-off dates were chosen due to the initiation of a new data collection system. SAEs were voluntarily reported to NeuroPace as part of post-market surveillance by the treating facility. “Serious adverse events” were classified per the FDA definition (ISO 14155 Second Edition 2011-02-01) and were reported to the FDA in compliance with MDR reporting obligations.
Results: A total of 5667 neurostimulator procedures occurred across 4961patients. This included 3650 initial neurostimulator implants, 118 lead-only procedures, 209 explants, 93 re-implants, and 1448 neurostimulator replacements. There were 47 procedures classified as “other adjustment.” Neurostimulator replacements occurred largely for expected end of battery service. A total of 136 infections were reported in 130 patients, resulting in an infection rate of 2.4% per procedure. Of these, 108 led to partial or total explant of the device. Culture results were reported for 67 SAEs and were most commonly unspecified staph (n=36).
Conclusions: Infection rates in adults implanted with the RNS System neurostimulator and leads are similar to, but slightly lower than, previously reported rates. One limitation of this analysis is that not all infections are reported to NeuroPace or to FDA, although infections leading to device explant or replacement are known to NeuroPace field personnel and reported accordingly. Future work will examine factors that could influence the risk for infection, including surgical practices that could mitigate that risk.
Funding: n/a
Clinical Epilepsy