Surgical Paddle Electrode Implantation as a Rescue Therapy to Failed Percutaneous Leads in Failed Back Surgery Syndrome Patients.

ABSTRACT

INTRODUCTION: Spinal cord stimulation (SCS) to treat failed back surgery syndrome (FBSS) can be provided with either percutaneously or surgically implanted electrodes. Percutaneous electrodes are considered the first choice in many pain practices, but surgical paddle electrodes can also be indicated if a percutaneous electrode fails to retain sufficient pain relief or if percutaneous implantation is considered unachievable. Although the current efficacy of surgical paddle electrodes has been based mainly upon pain intensity scores, the evidence on surgical paddle electrodes as a rescue to failed percutaneous electrodes remains even more scarce. OBJECTIVE: This study aimed to evaluate the safety and clinical effectiveness of rescue surgical paddle electrodes in FBSS patients, multidimensionally. MATERIALS AND METHODS: The occurrence of complications, pain intensity scores, psychosocial-related questionnaires, and medication intake were collected. Subsequently, a Quality-of-Life Index (QLI) was calculated. A clinically relevant effect was obtained if the minimal clinically important difference regarding pain intensity was reached. RESULTS: A total of 25 patients were included in the study. The pain intensity scores were significantly reduced (p < 0.001), and clinically relevant reductions occurred during short-term (0-6 months), mid-term (1-3 years), and long-term follow-up (≥4 years). The structural morphine usage and QLI were significantly decreased at short-term follow-up (p = 0.038 and p = 0.036, respectively). Six complications occurred in five patients, of which, four concerned hardware-related problems and two were of biological origin. CONCLUSION: SCS utilizing a surgical paddle electrode as a salvage treatment to failed conventional percutaneous cylindrical lead SCS can be practiced safely and effectively to treat FBSS. Because of potentially improved clinical effectiveness and cost-effectiveness resulting from fewer reoperations, a SCS treatment algorithm may benefit from expediting surgical paddle electrodes.