Medical Affairs Europe, Neuromodulation, LivaNova Deutschland GmbH, LivaNova PLC owned subsidiary, Lindberghstraße 25, 80939, Munich, Germany.
Department of Neurosurgery, Heinrich Heine University, Düsseldorf, Germany.
Neuroradiology. 2021 Sep;63(9):1407-1417. doi: 10.1007/s00234-021-02705-y. Epub 2021 Apr 12.
Vagus nerve stimulation (VNS) is an effective adjunctive treatment for drug-resistant epilepsy (DRE) and difficult-to-treat depression (DTD). More than 125.000 patients have been implanted with VNS Therapy® System (LivaNova PLC) since initial approval. Patients with DRE often require magnetic resonance imaging (MRI) of the brain during the course of their disease. VNS Therapy System devices are labeled to allow MRI under certain conditions; however, there are no published comprehensive articles about the real-world experience using MRI in patients with implanted VNS devices.
A systematic review in accordance with PRISMA statement was performed using PubMed database. Full-length articles reporting MRI (1.5 T or 3 T scanner) of patients with implanted VNS for DRE or DTD and published since 2000 were included. The primary endpoint was a positive outcome that was defined as a technically uneventful MRI scan performed in accordance with the VNS Therapy System manufacturer guidelines and completed according to the researchers' planned scanning protocol without harm to the patient.
Twenty-six articles were eligible with 25 articles referring to the VNS Therapy System, and 216 patients were included in the analysis. No serious adverse events or serious device-related adverse events were reported. MRI scan was prematurely terminated in one patient due to a panic attack.
This systematic review indicates that cranial MRI of patients with an implanted VNS Therapy System can be completed satisfactorily and is tolerable and safe using 1.5 T and 3 T MRI scanners when performed in adherence to the VNS manufacturer's guidelines.
迷走神经刺激（VNS）是治疗耐药性癫痫（DRE）和难治性抑郁症（DTD）的有效辅助治疗方法。自最初批准以来，已有超过 125,000 名患者植入了 VNS 治疗系统（LivaNova PLC）。患有 DRE 的患者在疾病过程中通常需要进行脑部磁共振成像（MRI）检查。VNS 治疗系统设备已贴上标签，允许在某些条件下进行 MRI；然而，目前尚无关于在植入 VNS 设备的患者中使用 MRI 的实际经验的综合文章。
根据 PRISMA 声明进行了系统评价，使用 PubMed 数据库。纳入了自 2000 年以来发表的报告了 DRE 或 DTD 患者植入 VNS 后进行 MRI（1.5 T 或 3 T 扫描仪）的全文文章，并符合 VNS 治疗系统制造商指南的技术上无并发症的 MRI 扫描，并且按照研究人员的计划扫描方案完成，而不会对患者造成伤害。
有 26 篇文章符合条件，其中 25 篇文章涉及 VNS 治疗系统，分析中纳入了 216 名患者。未报告严重不良事件或严重与设备相关的不良事件。由于恐慌症发作，一名患者的 MRI 扫描提前终止。
这项系统评价表明，当按照 VNS 制造商的指南进行时，使用 1.5 T 和 3 T MRI 扫描仪可以成功完成对植入 VNS 治疗系统的患者的颅脑 MRI 检查，并且耐受良好且安全。
