Complications of Deep Brain Stimulator Implantation for Drug-resistant Epilepsy: Findings from the Federal MAUDE Database
Abstract number :
2.263
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2024
Submission ID :
607
Source :
www.aesnet.org
Presentation date :
12/8/2024 12:00:00 AM
Published date :
Authors :
Presenting Author: Sydney Speed, MS1 – University of Louisville School of Medicine
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: Deep brain stimulation (DBS) has emerged as a viable treatment option for drug-resistant epilepsy (DRE), gaining approval from the United States Food and Drug Administration (FDA) in 2018. Despite its promise, comprehensive data on patient-reported complications, their management, and outcomes remain sparse. This study aims to elucidate the nature and frequency of DBS-related complications reported to the FDA.
Methods: We analyzed adverse event reports related to DBS devices from multiple manufacturers, submitted to the Manufacturer and User Facility Device Experience (MAUDE) database between July 2013 and March 2024. Reports were included if they pertained to epilepsy treatment, excluding non-epilepsy indications, duplicate entries, multi-patient trials lacking specific treatment or outcome details, and events later deemed non-reportable.
Results: Of 209 reports, 151 were related to epilepsy treatment. Demographic details were inconsistently provided (43 males, 42 females, 66 unspecified). The cohort included 93 adult patients (≥ 21 years, range 22-86), 6 pediatric patients (≤ 20 years, range 16-20), and 52 patients of unspecified age. Predominant complications were device-related issues (n=95, 62.9%) and patient complaints (n=66, 43.7%). Notable but less frequent complications included infection (n=12, 7.9%) and hemorrhage (n=4, 2.6%). Key specific complications encompassed impedance issues (n=34, 22.5%), device failure (n=32, 21.2%), and inadequate stimulation (n=14, 9.3%). Patient complaints largely involved increased seizure activity (n=20, 13.2%) and psychiatric alterations (n=9, 6%). Common outcomes involved battery, hardware, or lead replacement (n=37, 24%), battery and/or lead removal (n=23, 15.2%), and device reprogramming (n=12, 7.9%). Surgical intervention was the most frequent treatment (13.2%).
Conclusions: The analysis reveals that device-related issues and patient complaints, particularly regarding seizure exacerbation and psychological effects, are prevalent complications of DBS therapy for DRE. The significant rate of surgical interventions for device replacement underscores an urgent need to enhance device reliability. Future efforts should concentrate on elucidating the causes of device failures and developing robust strategies to mitigate these issues, thereby optimizing treatment outcomes for patients with DRE.
Funding: This research was not funded.
Clinical Epilepsy