Objectives: Advances in Spinal cord stimulation (SCS) device technology in recent years have led to the development of SCS systems that are magnetic resonance imaging (MRI)-conditional, most of which are dependent on normal lead impedances. The objective of this study was to retrospectively analyze the rate of elevated lead impedance in these devices to determine the rate of failure of MR-conditional modes.
Materials and methods: This was a single-center, retrospective, chart-based review conducted during a five-year period. Patients were included if they had been implanted with an impedance-dependent MR-conditional SCS and had a documented impedance check at least 6 months after implantation. A Kaplan-Meier survival analysis was performed to map the survival of MR-conditionality over time.
Results: There were 363 cases included between 2015 and 2020, which corresponded to a total of 602 SCS leads. Nevro was the most common manufacturer (67.8%), followed by Boston Scientific (22.3%) and Abbott (9.9%). The average overall follow-up time was 2.25 years. Overall, 67 (18.5%) of patients had lead impedances over 10,000 Ω at follow-up with a total of 186 electrode contacts (3.9%). Leads most commonly had either one (40%), two (22%) or three (12%) electrode contacts out of range. Risk of failure of lead impedances increased by 35.4% with each successive year to a peak of 43% of all leads by year 5. Mean overall survival time of normal lead impedances was 4.77 years (CI 4.40-5.13). There was no statistically significant difference in mean overall survival time between Abbott (M = 4.0 years, SD = 1.25), Boston Scientific (M = 4.64 years, SD = 1.75) and Nevro (M = 4.80 years, SD = 3.28), χ2 (2, N = 358) = 1.511, p = 0.47; however, Abbott leads had a greater total number of failed impedance contacts (50/568, 8.8%), in comparison to Nevro (124/3064, 4.0%), χ2 (1, N = 3630) = 23.76, p < 0.00001, at a similar follow-up time.
Conclusion: This retrospective study identified elevated impedances in 18.5% of MR-conditional SCS devices at an average of 2.25 years follow-up resulting in loss of MR-conditionality and a mean overall lead survival time of 4.77 years for normal lead impedance.
Keywords: hardware complications; lead impedances; magnetic resonance conditionality; magnetic resonance imaging; patient safety; spinal cord stimulation.
© 2023 The Authors. Pain Practice published by Wiley Periodicals LLC on behalf of World Institute of Pain.