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

OBJECTIVES

Recent advancements in spinal cord stimulation (SCS) technologies have focused on improving device performance and therapeutic effectiveness. However, SCS implant status and postimplant therapeutic utilization have historically been poorly monitored, with limited outcomes reported, primarily owing to inherent limitations of legacy technology and clinic-based data collection. The recent emergence of SCS remote monitoring enables daily, objective tracking of device use, establishing reliable longitudinal data integrity. This advancement supports a new standard for long-term surveillance of SCS implant status and therapy utilization and enables benchmarking against previously reported estimates.

MATERIALS AND

METHODS

After institutional review board exemption, deidentified data were extracted from a manufacturer database for the first 500 consecutive US patients implanted with a remote monitoring-capable SCS system to retrospectively analyze rates of real-world SCS therapy utilization, explant, and virtual explant.

RESULTS

In total, 493 patients met the eligibility criteria, with a median age of 67 years; 58.8% were female. At a median SCS implant duration of 364 days, 95.1% remained implanted, whereas 4.9% were explanted. The most common reason for explant was surgical complications, including infection and pocket-site pain. Among patients implanted, 96.8% were actively using SCS; 2.3% were not actively using SCS, and 0.9% were considered virtual explants owing to prolonged SCS inactivity.

CONCLUSIONS

Automated SCS remote monitoring offers targeted enhancements to therapeutic care and may support longitudinal accountability and data integrity through daily transmission of objective device data. Unlike traditional methods for assessing device explant, which underestimate SCS discontinuation rates, real-time monitoring enables first-of-its-kind detection of inactive users and virtual explants for a more comprehensive assessment of real-world outcomes. The high rate of SCS usage in these results indicates the potential value of remote care and provides support for the adoption of remote monitoring as a new standard for postimplant device management and long-term surveillance.