Complications of Responsive Neurostimulation System Implantation for Drug-resistant Epilepsy: An Analysis of the Federal MAUDE Database
Abstract number :
2.467
Submission category :
9. Surgery / 9C. All Ages
Year :
2024
Submission ID :
213
Source :
www.aesnet.org
Presentation date :
12/8/2024 12:00:00 AM
Published date :
Authors :
Presenting Author: Benjamin Cusick, MS2 – University of Louisville School of Medicine
Ian Mutchnick, MD, MS – University of Louisville School of Medicine
Zulfi Haneef, MBBS, MD – Baylor College of Medicine
Irfan Ali, MD – Baylor College of Medicine
Cemal Karakas, MD – University of Louisville School of Medicine/Norton Children's Hospital
Rationale: Rationale: Responsive Neurostimulation (RNS) is an emerging treatment for patients with drug-resistant epilepsy (DRE) who are unsuitable for surgical focal resection. The United States Food and Drug Administration (FDA) approved RNS therapy for adults in 2013 but has yet to be approved in the pediatric population. Data on adverse events, treatments, and outcomes remain scarce. This study will report on implant related RNS complications that have been submitted to the FDA.
Methods: Methods: Adverse event data were extracted from the Manufacturer and User Facility Device Experience (MAUDE) database for the manufacturer, Neuropace, spanning July 30, 2015, to March 3, 2024. Data on complication types, patient complaints, treatments, and outcomes were systematically extracted and categorized.
Results: Results: In the study period, a total of 500 adverse events were reported. After excluding duplicates (n=9), 491 unique reports were analyzed. Demographics were inconsistently reported, only 156 reports specified sex (76 males, 80 females). Age was reported in all reports, with 428 adults (≥21 years, range 21-77 years) and 63 pediatric patients (≤20 years, range 3-20 years). Primary complications were infections (44.1%), device-related issues (31.4%), and hemorrhages (9.8%). The most common detailed complication sub-types were deep infections (15.7%), lead breaks (11.6%), and intraparenchymal hemorrhages (3.5%). Common patient complaints included drainage (15.7%) and wound dehiscence (11.6%). Treatments predominantly involved antibiotics (40.1%) and wound care (20.4%). A significant proportion of complications necessitated device and lead explantation (37.3%). Device related complications were more common among all reported complications in adults compared to children (33.1% vs 19%, p=0.024). See Table 1 and Table 2 for details.
Conclusions:
Conclusion: The majority of FDA-reported RNS complications involve infections and device-related issues, with a higher prevalence of device-related complications in adults compared to children. The significant rate of infections leading to device and lead explantations highlights the urgent need for improved infection control measures. Future efforts should focus on developing strategies to mitigate infection risks and enhance device reliability to improve patient outcomes and reduce the necessity for device removal.
Funding: None
Surgery