Neuromodulation : journal of the International Neuromodulation Society
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The evolution of neuromodulation devices in order to enter magnetic resonance imaging (MRI) scanners has been one of understanding limitations, engineering modifications, and the development of a consensus within the community in which the FDA could safely administer labeling for the devices. In the initial decades of neuromodulation, it has been contraindicated for MRI use with implanted devices. In this review, we take a comprehensive approach to address all the major products currently on the market in order to provide physicians with the ability to determine when an MRI can be performed for each type of device implant. ⋯ This is the first comprehensive guideline with regards to various devices in the market and MRI compatibility from the American Society of Pain and Neuroscience.
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Case Reports Multicenter Study
Intrathecal Baclofen for Severe Spasticity: Longitudinal Data From the Product Surveillance Registry.
To assist in the assessment of intrathecal baclofen (ITB) therapy risks and benefits by providing surgical intervention rate, safety, and elective device replacement rate data. ⋯ ITB therapy for the treatment of severe spasticity requires surgical implantation of a programmable infusion system for chronic drug delivery. If complications arise, many necessitate surgical intervention for correction. For spinal and cerebral spasticity in pediatric and adult patients, discontinuation rates due to an adverse event were low (0.3%), and there was high acceptance (99.1%) of surgical intervention for therapy continuation. Patient/caregiver willingness to accept surgical and other risks for therapy continuation was extremely high.
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Neuromodulation is a growing therapeutic modality for the treatment of chronic pain. Determining whether a patient is an appropriate candidate for implantation of a neuromodulatory device and whether the device requires an MRI conditional feature necessitates understanding the patient's likelihood of requiring an MRI. Active treatment of cancer represents known high-risk clinical scenarios for MRI. However, the growth of MRI as a tool for diagnosis of cancer also warrants consideration by implanting physicians when assessing high-risk patients. ⋯ High likelihood of MRI within the oncologic context represents important distinction criteria for neuromodulation as patients may benefit from implantation of an MR conditional system.
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Randomized Controlled Trial Comparative Study
A Comparison of Refill Procedures and Patient Outcomes Following Ultrasound-Guided and Template-Guided Intrathecal Drug Delivery Systems With Recessed Ports.
Intrathecal drug delivery systems (IDDS) are refilled using templates and palpation. The 2017 Polyanalgesic Consensus Conference recommends ultrasound only when reservoir ports are difficult to identify. The purpose of this study was to compare procedural outcomes and patient's preference for refill method of IDDS. ⋯ Patients preferred ultrasound even though it lengthened the duration of refills compared to template-guided procedures. Fewer patients experienced procedural pain with ultrasound compared with template-guided refills. No safety issues were observed in either group.
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Case Reports Observational Study
Catheter Access Port (Computed Tomography) Myelography in Intrathecal Drug Delivery Troubleshooting: A Case Series of 70 Procedures.
Intrathecal drug delivery is used for the treatment of intractable spasticity, dystonia, and pain. When the symptomatology fails to respond to therapy, the cause could be failure of the medication infusion. The purpose of this study is to assess pump catheter access port (CAP)-myelography and CAP-CT-myelography as advanced imaging methods in treatment failure. ⋯ CAP-CT myelography with 2D/3D reconstructions is an essential step in the diagnostic algorithm for cases involving ITDD failure.