Marco Reining1, Dirk Winkler2, Joachim Boettcher3, Juergen Meixensberger2, Michael Kretzschmar1,4. 1. Department of Pain Medicine and Palliative Care, SRH Wald-Klinikum Gera, Gera, Germany. 2. Clinic of Neurosurgery, University Hospital Leipzig, Leipzig, Germany. 3. Friedrich-Schiller University of Jena, Jena, Germany. 4. SRH University of Applied Health Sciences, Campus Gera, Gera, Germany.
Abstract
OBJECTIVE: Patients fitted with a neurostimulator face a greater need to undergo magnetic resonance imaging (MRI) scans. Given the lack of literature in this regard, this study aims to review our experience with MRI examinations on patients implanted with a dorsal root ganglion stimulation (DRG-S) system and their potential adverse events. MATERIALS AND METHODS: We conducted a retrospective analysis of the prospective treatment documentation gathered from November 2011 to October 2020. We identified 259 MRI registrations for patients with an implanted neurostimulation system; the MRI examinations were performed using a 1.5 Tesla MRI system in accordance with a structured scheme. RESULTS: Among the 259 MRI registrations identified in this study, 28 corresponded to patients with an implanted DRG-S system. In 2 cases, no MRI scan was performed, and thus, only 26 MRI examinations were evaluated in detail. The DRG-S device was approved for the requested MRI scans in only 2 of these 26 cases (7.7%). In addition, 2 minor adverse events (syncopal episode and connection problem) were identified, and only the second problem (3.8%) was related to neurostimulator operation. CONCLUSIONS: Necessary MRI examinations in patients with DRG-S systems are rarely covered by the European CE/US Food and Drug Administration (CE/FDA) approval. Although the manufacturer recommendations are against the use of MRI in patients with implanted DRG-S in certain conditions, we performed these scans without causing injury to the patient or damaging the device. Given that data on safety are limited, MRIs should be conducted study related. We provide recommendations for the procedure that should be followed when an MRI is needed urgently.
OBJECTIVE: Patients fitted with a neurostimulator face a greater need to undergo magnetic resonance imaging (MRI) scans. Given the lack of literature in this regard, this study aims to review our experience with MRI examinations on patients implanted with a dorsal root ganglion stimulation (DRG-S) system and their potential adverse events. MATERIALS AND METHODS: We conducted a retrospective analysis of the prospective treatment documentation gathered from November 2011 to October 2020. We identified 259 MRI registrations for patients with an implanted neurostimulation system; the MRI examinations were performed using a 1.5 Tesla MRI system in accordance with a structured scheme. RESULTS: Among the 259 MRI registrations identified in this study, 28 corresponded to patients with an implanted DRG-S system. In 2 cases, no MRI scan was performed, and thus, only 26 MRI examinations were evaluated in detail. The DRG-S device was approved for the requested MRI scans in only 2 of these 26 cases (7.7%). In addition, 2 minor adverse events (syncopal episode and connection problem) were identified, and only the second problem (3.8%) was related to neurostimulator operation. CONCLUSIONS: Necessary MRI examinations in patients with DRG-S systems are rarely covered by the European CE/US Food and Drug Administration (CE/FDA) approval. Although the manufacturer recommendations are against the use of MRI in patients with implanted DRG-S in certain conditions, we performed these scans without causing injury to the patient or damaging the device. Given that data on safety are limited, MRIs should be conducted study related. We provide recommendations for the procedure that should be followed when an MRI is needed urgently.
Authors: Marco Reining; Dirk Winkler; Joachim Böttcher; Jürgen Meixensberger; Michael Kretzschmar Journal: Schmerz Date: 2021-11-03 Impact factor: 1.629