PURPOSE: To assess safety of clinical MRI of the head in patients with implanted model 100, 102, and 103 vagus nerve stimulation (VNS) Therapy Systems (Cyberonics, Inc., Houston, TX) in 3.0 Tesla MRI (GE Healthcare, Milwaukee, WI). MATERIALS AND METHODS: The distributions of the radiofrequency B(1) (+)-field produced by the clinically used transmit/receive (T/R) head coil (Advanced Imaging Research Incorporated, Cleveland, OH) and body coil were measured in a head and shoulders phantom. These measurements were supplemented by temperature measurements on the lead tips and the implantable pulse generator (IPG) of the VNS devices in a head and torso phantom with the same two coils. Clinical 3T MRI head scans were then acquired under highly controlled conditions in a series of 17 patients implanted with VNS. RESULTS: Phantom studies showed only weak B(1) (+) fields at the location of the VNS IPG and leads for MRI scans using the T/R head coil. The MRI-related heating on a VNS scanned in vitro at 3T was also found to be minimal (0.4-0.8 degrees C at the leads, negligible at the IPG). The patient MRI examinations were completed successfully without any adverse incidents. No patient reported any heating, discomfort, or any other unusual sensation. CONCLUSION: Safe clinical MRI head scanning of patients with implanted VNS is shown to be feasible on a GE Signa Excite 3T MRI system using one specific T/R head coil. These results apply to this particular MRI system configuration. Extrapolation or generalization of these results to more general or less controlled imaging situations without supporting data of safety is highly discouraged.
PURPOSE: To assess safety of clinical MRI of the head in patients with implanted model 100, 102, and 103 vagus nerve stimulation (VNS) Therapy Systems (Cyberonics, Inc., Houston, TX) in 3.0 Tesla MRI (GE Healthcare, Milwaukee, WI). MATERIALS AND METHODS: The distributions of the radiofrequency B(1) (+)-field produced by the clinically used transmit/receive (T/R) head coil (Advanced Imaging Research Incorporated, Cleveland, OH) and body coil were measured in a head and shoulders phantom. These measurements were supplemented by temperature measurements on the lead tips and the implantable pulse generator (IPG) of the VNS devices in a head and torso phantom with the same two coils. Clinical 3T MRI head scans were then acquired under highly controlled conditions in a series of 17 patients implanted with VNS. RESULTS: Phantom studies showed only weak B(1) (+) fields at the location of the VNS IPG and leads for MRI scans using the T/R head coil. The MRI-related heating on a VNS scanned in vitro at 3T was also found to be minimal (0.4-0.8 degrees C at the leads, negligible at the IPG). The patient MRI examinations were completed successfully without any adverse incidents. No patient reported any heating, discomfort, or any other unusual sensation. CONCLUSION: Safe clinical MRI head scanning of patients with implanted VNS is shown to be feasible on a GE Signa Excite 3T MRI system using one specific T/R head coil. These results apply to this particular MRI system configuration. Extrapolation or generalization of these results to more general or less controlled imaging situations without supporting data of safety is highly discouraged.
Authors: Hongbae Jeong; Georgios Ntolkeras; Michel Alhilani; Seyed Reza Atefi; Lilla Zöllei; Kyoko Fujimoto; Ali Pourvaziri; Michael H Lev; P Ellen Grant; Giorgio Bonmassar Journal: PLoS One Date: 2021-01-13 Impact factor: 3.240
Authors: Christopher P Favazza; Deirdre M King; Heidi A Edmonson; Joel P Felmlee; Phillip J Rossman; Nicholas J Hangiandreou; Robert E Watson; Krzysztof R Gorny Journal: Med Devices (Auckl) Date: 2014-10-29