Real-World Spinal Cord Stimulation Utilization and Implant Status: An Analysis of a Novel, Real-Time, Remote Monitoring Database.
Remote monitoring of spinal cord stimulation devices shows a high rate of usage and may improve tracking of therapy utilization and implant status.
Where it sits
this study against the rest of the setmelanotide corpusSummary and findings
This study analyzed the utilization and implant status of spinal cord stimulation (SCS) devices in 493 patients using a remote monitoring database. At a median SCS implant duration of 364 days, 95.1% of patients remained implanted, and 96.8% were actively using the device. The findings highlight the potential of remote monitoring for better tracking of SCS therapy utilization.
Abstract
<h4>Objectives</h4>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.<h4>Materials and methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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.
Background
This paper addresses the clinical question of how spinal cord stimulation (SCS) devices are utilized in real-world settings, particularly focusing on implant status and therapy adherence. Previous studies have indicated that monitoring of SCS outcomes has been inadequate due to limitations in traditional data collection methods. The introduction of remote monitoring technologies offers a potential solution to improve tracking and reporting of SCS device utilization and patient outcomes.
Methods
This retrospective analysis utilized deidentified data from a manufacturer database, focusing on the first 500 consecutive US patients implanted with a remote monitoring-capable SCS system. The study included 493 patients who met eligibility criteria, with a median age of 67 years and 58.8% being female. The primary outcome measures included rates of SCS therapy utilization, explant, and virtual explant.
Results
At a median SCS implant duration of 364 days, 95.1% of patients remained implanted, and 4.9% were explanted. The most common reason for explant was surgical complications, including infection and pocket-site pain. Among the implanted patients, 96.8% were actively using the SCS, while 2.3% were not actively using it, and 0.9% were classified as virtual explants due to prolonged inactivity.
Interpretation
The findings suggest that remote monitoring may provide a more accurate assessment of SCS utilization compared to traditional methods, which often underestimate discontinuation rates. While the high usage rate of 96.8% is statistically significant, the clinical significance of this finding may vary based on individual patient contexts. Confounding factors include the retrospective nature of the study and reliance on a single manufacturer's database, which may limit generalizability.
Key findings
- 95.1% remained implanted at a median SCS implant duration of 364 days, n=493.
- 4.9% were explanted, with surgical complications being the most common reason.
- 96.8% were actively using SCS, while 2.3% were not actively using SCS.
- 0.9% were considered virtual explants due to prolonged inactivity.
Limitations
- retrospective analysis with potential selection bias
- data sourced from a single manufacturer database
- lack of long-term follow-up data on patient outcomes
- no assessment of clinical outcomes related to SCS therapy