Explantation Rates of High Frequency Spinal Cord Stimulation in Two Outpatient Clinics

Area of Science:

• Neurology
• Pain Management
• Medical Devices

Background:

• High frequency 10 kHz spinal cord stimulation (SCS) shows promise for treating lower and leg pain.
• Previous studies, like the SENZA-RCT, demonstrated its efficacy over 12 months.
• Longer-term real-world data on SCS explantation rates are limited.

Purpose of the Study:

• To evaluate the explantation rates of high frequency 10 kHz SCS in a real-world clinical setting.
• To provide insights into the long-term performance and patient outcomes of this neuromodulation technology.

Main Methods:

• Retrospective review of patients implanted with high frequency SCS devices.
• Data collected from two outpatient private practice clinics over a 4-year period (July 2015 - June 2019).
• Kaplan-Meier method used to estimate implant survival probabilities over time.

Main Results:

• The estimated median time to explantation was 3.5 years.
• Implant survival probabilities at 1, 2, and 3 years were 88.4%, 76.5%, and 60.7%, respectively.
• Cumulative explantation rates by 1, 2, and 3 years were 11.1%, 22.2%, and 32.5%, with 65.9% of patients having prior neurostimulation.

Conclusions:

• The observed explantation rate for high frequency SCS was higher than expected based on prior efficacy studies.
• This highlights the need for more longitudinal data to understand the long-term effects and patient retention.
• Continued monitoring and data collection are essential as neuromodulation use expands.