Long-Term Real-World Outcomes and Device Management of Intrathecal Drug Delivery Systems: A 16-Year Single-Center Experience with a Primary Focus on Baclofen Therapy

Objective Intrathecal baclofen (ITB) therapy is an established treatment for refractory spasticity; however, long-term real-world data integrating both clinical outcomes and device-related factors remain limited. This study aimed to evaluate long-term outcomes and device-related management issues associated with intrathecal drug delivery systems, with a primary focus on intrathecal baclofen therapy for refractory spasticity. Methods We retrospectively reviewed 137 patients who underwent intrathecal pump implantation between 2008 and 2024 at a single tertiary center. Patients were categorized into six diagnostic groups. Clinical outcomes, drug dosing patterns, complications, and device-related parameters including refill frequency and pump longevity were analyzed. Results A total of 103 patients received ITB therapy and 34 received intrathecal morphine. During follow-up, 104 patients (75.9%) continued therapy with regular refills, and 29 patients required pump replacement. In the ITB group, 94.2% of patients showed improvement in Modified Ashworth Scale scores. Device-related complications occurred in 16 cases (9.47%), most of which required surgical revision. Deaths observed during follow-up were attributed to underlying disease progression and were not directly related to the device or therapy. Conclusion A total of 103 patients received ITB therapy and 34 received intrathecal morphine. During follow-up, 104 patients (75.9%) continued therapy with regular refills, and 29 patients required pump replacement. In the ITB group, 94.2% of patients showed improvement in Modified Ashworth Scale scores. Device-related complications occurred in 16 cases (9.47%), most of which required surgical revision. Deaths observed during follow-up were attributed to underlying disease progression and were not directly related to the device or therapy.