Presented at the 2013 AAPM Annual Meeting « Back

Long-Term Outcomes of Spinal Cord Stimulation with Paddle Leads in the Treatment of Failed Back Surgery Syndrome: Technical and Psychosocial Considerations

Lara Tollapi, MD, meryparoli@hotmail.it¹, Mery Paroli, PsycD¹, Giuliano De Carolis, MD¹, Paolo Poli, MD², (1) Santa Chiara University Hospital, Pisa, Italy, (2) Pisa University, Pisa, Italy

Introduction: The objective of this study was to demonstrate the safety and efficacy of a percutaneous paddle lead for SCS. Percutaneous paddle lead (S8 seriesTM leads, St Jude Medical) was implanted using introduction system for percutaneous implantation (EpiducerTM lead delivery system, St. Jude Medical). Materials and Methods: Our case studies reports about 44 percutaneous leads in 42 patients. 4 patients suffered a negative trial and explanted the percutaneous paddle. Results: After 24 months from the implant VAS and all dimensions of IPQ decreased in significant way (p<. 001). At the last follow-up 65% stopped their pain medications. SCS improved quality of life the variation (?T) of all SF-36 dimensions is significant higher than the baseline (p<.001). Regarding the body area coverage, in the axial-lumbar area it was in a range of 90-100% and in the radicular and lower limbs was in a range of 80-90%. No perioperative complications occurred. The dislocation of the percutaneous paddle is a rare adverse event (1%). Our Cases reported only 1 dislocation after an accidental shock. In 3 cases we recorded a dislocation soon after the post operative period (3%). In all the cases has been possible to operate with positive outcome without explantation. Four patients explanted the paddle after 5 weeks with no adverse events. 1 patient explanted after 6 months without adverse events too. Conclusions: Our results confirmed that SCS continues to be a valuable tool in the treatment of chronic disabling pain. Paddle leads seemed to be an efficient alternative for patients with FBSS.

Funding: None