A retrospective review of elevated lead impedances in impedance-dependent magnetic resonance-conditional spinal cord stimulation devices.

IF 2.5 3区医学 Q2 ANESTHESIOLOGY Pain Practice Pub Date : 2024-02-01 Epub Date: 2023-10-14 DOI:10.1111/papr.13301

Cormac Francis Mullins, Stephany Harris, David Pang

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Abstract

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.

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阻抗依赖性磁共振条件脊髓刺激装置中导线阻抗升高的回顾性研究。

目的：近年来脊髓刺激（SCS）设备技术的进步导致了磁共振成像（MRI）条件下脊髓刺激系统的发展，其中大多数依赖于正常的导线阻抗。本研究的目的是回顾性分析这些设备中导线阻抗升高的比率，以确定MR条件模式的故障率。材料和方法：这是一项单中心、回顾性、基于图表的审查，为期五年。如果患者植入了阻抗依赖性MR条件脊髓刺激系统，并进行了至少6次阻抗检查，则将其包括在内植入后数月。Kaplan-Meier生存率分析用于绘制MR条件性随时间变化的生存率。结果：2015年至2020年间共有363例病例，相当于602条脊髓刺激导联。Nevro是最常见的制造商（67.8%），其次是Boston Scientific（22.3%）和Abbott（9.9%）。平均总体随访时间为2.25 年。总体而言，67名（18.5%）患者的导线阻抗超过10000 Ω，共有186个电极触点（3.9%）。导线最常见的是一个（40%）、两个（22%）或三个（12%）电极触点超出范围。引线阻抗失效的风险每年增加35.4%，到第5年达到43%的峰值。正常导线阻抗的平均总生存时间为4.77 年（CI 4.40-5.13）。Abbott（M = 4 年，SD = 1.25），波士顿科学（M = 4.64 年，SD = 1.75）和Nevro（M = 4.80 年，SD = 3.28），χ2（2，N = 358） = 1.511，p = 0.47；然而，与Nevro（124/3064，4.0%）相比，Abbott导线的失败阻抗接触总数更多（50/568，8.8%），χ2（1，N = 3630） = 23.76，p 结论：这项回顾性研究发现，18.5%的MR条件SCS设备的阻抗升高，平均为2.25 年随访导致MR条件性丧失，平均总铅生存时间为4.77 正常引线阻抗为年。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pain Practice ANESTHESIOLOGY-CLINICAL NEUROLOGY

CiteScore

5.60

自引率

3.80%

发文量

审稿时长

6-12 weeks

期刊介绍： Pain Practice, the official journal of the World Institute of Pain, publishes international multidisciplinary articles on pain and analgesia that provide its readership with up-to-date research, evaluation methods, and techniques for pain management. Special sections including the Consultant’s Corner, Images in Pain Practice, Case Studies from Mayo, Tutorials, and the Evidence-Based Medicine combine to give pain researchers, pain clinicians and pain fellows in training a systematic approach to continuing education in pain medicine. Prior to publication, all articles and reviews undergo peer review by at least two experts in the field.

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