Department of Neurosurgery, National Neuroscience Institute, Singapore.
Department of Neurosurgery, National Neuroscience Institute, Singapore.
Neuromodulation. 2024 Jun;27(4):781-788. doi: 10.1016/j.neurom.2023.04.474. Epub 2023 Jun 19.
Drug-resistant epilepsy (DRE) can have devastating consequences for patients and families. Vagal nerve stimulation (VNS) is used as a surgical adjunct for treating DRE not amenable to surgical resection. Although VNS is generally safe, it has its inherent complications. With the increasing number of implantations, adequate patient education with discussion of possible complications forms a critical aspect of informed consent and patient counseling. There is a lack of large-scale reviews of device malfunction, patient complaints, and surgically related complications available to date.
Complications associated with VNS implants performed between 2011 and 2021 were identified through a search of the United States Food and Drug Administration Manufacturer And User Facility Device Experience (MAUDE) data base. We found three models on the data base, CYBERONICS, INC pulse gen Demipulse 103, AspireSR 106, and SenTiva 1000. The reports were classified into three main groups, "Device malfunction," "Patient complaints," and "Surgically managed complications."
A total of 5888 complications were reported over the ten-year period, of which 501 reports were inconclusive, 610 were unrelated, and 449 were deaths. In summary, there were 2272 reports for VNS 103, 1526 reports for VNS 106, and 530 reports for VNS 1000. Within VNS 103, 33% of reports were related to device malfunction, 33% to patient complaints, and 34% to surgically managed complications. For VNS 106, 35% were related to device malfunction, 24% to patient complaints, and 41% to surgically managed complications. Lastly, for VNS 1000, 8% were device malfunction, 45% patient complaints, and 47% surgically managed complications.
We present an analysis of the MAUDE data base for adverse events and complications related to VNS. It is hoped that this description of complications and literature review will help promote further improvement in its safety profile, patient education, and management of both patient and clinician expectations.
耐药性癫痫（DRE）可能给患者及其家庭带来毁灭性的后果。迷走神经刺激（VNS）被用作治疗无法手术切除的 DRE 的手术辅助手段。尽管 VNS 通常是安全的，但它也有其固有并发症。随着植入数量的增加，充分的患者教育以及对可能并发症的讨论是知情同意和患者咨询的关键方面。迄今为止，尚无关于设备故障、患者投诉和手术相关并发症的大规模综述。
通过搜索美国食品和药物管理局制造商和用户设施设备体验（MAUDE）数据库，确定了 2011 年至 2021 年期间与 VNS 植入相关的并发症。我们在数据库中找到了三种型号，分别是 Cyberonics, INC 脉冲发生器 Demipulse 103、AspireSR 106 和 SenTiva 1000。报告分为三大类，“设备故障”、“患者投诉”和“手术管理并发症”。
在十年期间共报告了 5888 例并发症，其中 501 例报告结果不确定，610 例与研究无关，449 例为死亡。总的来说，VNS 103 有 2272 例报告，VNS 106 有 1526 例报告，VNS 1000 有 530 例报告。在 VNS 103 中，33%的报告与设备故障有关，33%与患者投诉有关，34%与手术管理并发症有关。对于 VNS 106，35%与设备故障有关，24%与患者投诉有关，41%与手术管理并发症有关。最后，对于 VNS 1000，8%与设备故障有关，45%与患者投诉有关，47%与手术管理并发症有关。
我们对 MAUDE 数据库中与 VNS 相关的不良事件和并发症进行了分析。希望对这些并发症的描述和文献综述能够有助于进一步提高其安全性、患者教育以及患者和临床医生期望的管理水平。
