A systematic review of magnetic resonance imaging in patients with an implanted vagus nerve stimulation system. 2021

S Fetzer, and M Dibué, and A M Nagel, and R Trollmann
Medical Affairs Europe, Neuromodulation, LivaNova Deutschland GmbH, LivaNova PLC owned subsidiary, Lindberghstraße 25, 80939, Munich, Germany.

OBJECTIVE 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.

UI MeSH Term Description Entries
D008279 Magnetic Resonance Imaging Non-invasive method of demonstrating internal anatomy based on the principle that atomic nuclei in a strong magnetic field absorb pulses of radiofrequency energy and emit them as radiowaves which can be reconstructed into computerized images. The concept includes proton spin tomographic techniques. Chemical Shift Imaging,MR Tomography,MRI Scans,MRI, Functional,Magnetic Resonance Image,Magnetic Resonance Imaging, Functional,Magnetization Transfer Contrast Imaging,NMR Imaging,NMR Tomography,Tomography, NMR,Tomography, Proton Spin,fMRI,Functional Magnetic Resonance Imaging,Imaging, Chemical Shift,Proton Spin Tomography,Spin Echo Imaging,Steady-State Free Precession MRI,Tomography, MR,Zeugmatography,Chemical Shift Imagings,Echo Imaging, Spin,Echo Imagings, Spin,Functional MRI,Functional MRIs,Image, Magnetic Resonance,Imaging, Magnetic Resonance,Imaging, NMR,Imaging, Spin Echo,Imagings, Chemical Shift,Imagings, Spin Echo,MRI Scan,MRIs, Functional,Magnetic Resonance Images,Resonance Image, Magnetic,Scan, MRI,Scans, MRI,Shift Imaging, Chemical,Shift Imagings, Chemical,Spin Echo Imagings,Steady State Free Precession MRI
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000069279 Drug Resistant Epilepsy Epileptic condition in which adequate trials of two tolerated and appropriately chosen and used ANTIEPILEPTIC DRUGS schedules to achieve sustained seizure freedom failed. Drug Refractory Epilepsy,Epilepsy, Drug Refractory,Epilepsy, Drug Resistant,Epilepsy, Intractable,Intractable Epilepsy,Medication Resistant Epilepsy,Refractory Epilepsy,Drug Refractory Epilepsies,Drug Resistant Epilepsies,Epilepsies, Drug Refractory,Epilepsies, Drug Resistant,Epilepsies, Intractable,Epilepsies, Medication Resistant,Epilepsies, Refractory,Epilepsy, Medication Resistant,Epilepsy, Refractory,Intractable Epilepsies,Medication Resistant Epilepsies,Refractory Epilepsies,Refractory Epilepsies, Drug,Refractory Epilepsy, Drug,Resistant Epilepsies, Drug,Resistant Epilepsies, Medication,Resistant Epilepsy, Drug,Resistant Epilepsy, Medication
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes
D055536 Vagus Nerve Stimulation An adjunctive treatment for PARTIAL EPILEPSY and refractory DEPRESSION that delivers electrical impulses to the brain via the VAGUS NERVE. A battery implanted under the skin supplies the energy. Vagal Nerve Stimulation,Nerve Stimulation, Vagal,Nerve Stimulation, Vagus,Nerve Stimulations, Vagal,Nerve Stimulations, Vagus,Stimulation, Vagal Nerve,Stimulation, Vagus Nerve,Stimulations, Vagal Nerve,Stimulations, Vagus Nerve,Vagal Nerve Stimulations,Vagus Nerve Stimulations
D019736 Prostheses and Implants Artificial substitutes for body parts, and materials inserted into tissue for functional, cosmetic, or therapeutic purposes. Prostheses can be functional, as in the case of artificial arms and legs, or cosmetic, as in the case of an artificial eye. Implants, all surgically inserted or grafted into the body, tend to be used therapeutically. IMPLANTS, EXPERIMENTAL is available for those used experimentally. Implants, Artificial,Prostheses and Implant,Prosthesis,Prosthetic Implant,Endoprostheses,Endoprosthesis,Prostheses,Prosthetic Implants,Artificial Implant,Artificial Implants,Implant and Prostheses,Implant, Artificial,Implant, Prosthetic,Implants and Prostheses,Implants, Prosthetic

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