Advancements in MRI Conditionality of Spinal Cord Stimulation Systems: A Narrative Review of Recent SCS Systems and...

Spinal cord stimulation (SCS) has become a vital therapy for managing intractable chronic pain, especially in patients unresponsive to conventional treatments. However, integrating SCS devices with magnetic resonance imaging (MRI) poses significant clinical challenges. The strong magnetic and radio frequency (RF) fields generated by MRI can interact with the implanted SCS devices, leading to potential risks such as device malfunction, heating, and image distortion, which complicate both the safety and efficacy of this essential diagnostic tool. New-generation SCS devices are now designed with modern materials and circuitry, which renders them relatively safe. The plethora of devices and leads available in medical industry market requires practitioners and technicians to develop a comprehensive overview of MRI-conditional technologies and remain aware of the challenges, failures, and safety concerns that still exist, albeit to a much lesser extent.

This review aims to thoroughly evaluate the current advancements and challenges in MRI-conditional SCS devices. The study focuses on the technological innovations that have enhanced the safety of such devices, the specific operational conditions under which these devices are deemed safe, and the clinical implications of these developments. By summarizing pertinent information from manufacturer specifications and coverage of commonly encountered malfunctions and adverse events for devices used in mainstream clinical practice, this review seeks to offer valuable insights for clinicians navigating the complexities of SCS device management in patients requiring MRI diagnostics.

This review was conducted through a comprehensive analysis of device manufacturers' manuals and guidelines; recent literature, including peer-reviewed articles; case studies; and safety data obtained from regulatory bodies and authentic publicly available information. The analysis focused on identifying technological advancements and reported adverse events as well as the clinical implications of using SCS devices in MRI environments. By synthesizing findings from various sources, the review presented an integrated perspective on MRI safety in SCS therapy.

The review identified several key advancements in MRI-compatible and conditional SCS devices, with significant improvements in lead design, shielding techniques, and device programming that have enhanced the devices' safety in MRI environments. However, despite these advancements, multiple instances of device malfunction, particularly those related to high lead impedance, heating under MRI exposure, inability to enter or exit MRI modes, and more, were reported across various manufacturers; in some cases, these issues have led to FDA recalls, manufacturers' advisories, and warnings. Additionally, observations were made regarding the prevalence of certain types of operational failures in devices made by specific manufacturers.

The evolution of MRI-compatible SCS devices has markedly improved the safety and efficacy of combining SCS therapy with essential diagnostic imaging. Ongoing technological advancements and rigorous safety validations continue to enhance patient outcomes, allowing individuals with chronic pain to receive comprehensive care without compromising on diagnostic accuracy or therapeutic efficacy. Knowledge of operational guidelines and device specifications combined with guarding against commonly encountered safety challenges should protect patients from serious adverse events. Future developments must tackle the remaining challenges and refine MRI compatibility to further integrate these critical aspects of patient care.