Assessment of MRI issues for a new cerebral spinal fluid shunt, gravitational valve (GV)

A gravitational valve (GV) may be used to treat hydrocephalus, offering possible advantages that include avoidance of over drainage and long-term complications. Because a GV is made from metal, there are potential safety and other problems related to the use of MRI. The objective of this investigation was to evaluate MRI-related issues (i.e., magnetic field interactions, heating, and artifacts) for a newly developed, metallic GV.

Tests were performed on the GV (GAV 2.0) using well-accepted techniques to assess magnetic field interactions (translational attraction and torque, 3-Tesla), MRI-related heating (1.5-T/64-MH and 3-T/128-MHz, whole body averaged SAR, 2.7-W/kg and 2.9-W/kg, respectively), artifacts (3-Tesla; gradient echo and T1-weighted, spin echo sequences), and possible functional changes related to exposures to different MRI conditions (exposing six samples each to eight different pulse sequences at 1.5-T/64-MHz and 3-T/128-MHz).

Magnetic field interactions were not substantial (deflection angle 2°, no torque) and heating was minor (highest temperature rise, ≥1.9°C, highest background temperature rise, ≥1.7°C). Artifacts on the gradient echo pulse sequence extended approximately 10mm from the size and shape of the GV. The different exposures to 1.5-T/64-MHz and 3-T/128-MHz conditions did not alter or damage the operational aspects of the GV samples.

The findings demonstrated that MRI can be safely used in patients with this GV and, thus, this metallic implant is deemed acceptable or "MR Conditional" (i.e., using current labeling terminology), according to the conditions used in this study.