Real-World Spinal Cord Stimulation Utilization and Implant Status: An Analysis of a Novel, Real-Time, Remote...

Area of Science:

• Neuromodulation
• Medical Device Technology
• Health Informatics

Background:

• Spinal cord stimulation (SCS) advancements focus on device performance but lack robust monitoring of implant status and therapeutic use.
• Traditional methods for tracking SCS outcomes are limited by legacy technology and clinic-based data collection.
• Emerging SCS remote monitoring enables objective, daily tracking of device usage and implant status.

Purpose of the Study:

• To evaluate real-world SCS therapy utilization, explant rates, and virtual explant rates using remote monitoring data.
• To establish a new standard for long-term surveillance of SCS implant status and therapy utilization.
• To compare outcomes from remote monitoring with historical estimates.

Main Methods:

• Retrospective analysis of deidentified data from the first 500 US patients with remote monitoring-capable SCS systems.
• Data extraction from a manufacturer database following institutional review board exemption.
• Analysis of therapy utilization, explant, and virtual explant rates in 493 eligible patients.

Main Results:

• At a median implant duration of 364 days, 95.1% of patients remained implanted, with surgical complications being the primary explant reason.
• 96.8% of implanted patients actively used SCS; 2.3% were inactive, and 0.9% were virtual explants.
• Remote monitoring identified a high rate of SCS usage and provided comprehensive data on device status.

Conclusions:

• Automated SCS remote monitoring enhances therapeutic care, accountability, and data integrity.
• Real-time monitoring offers a more accurate assessment of SCS discontinuation rates than traditional methods.
• The high SCS usage observed supports remote monitoring as a new standard for postimplant device management and surveillance.