OBJECTIVES: The aims of this study were to identify the reasons for explanation of spinal cord stimulator (SCS) devices and to further quantify the proportions and time lines of these causes of explantation in order to determine improvement opportunities for the development of best practices. DESIGN: Retrospective, single academic center. MATERIALS AND METHODS: Patients who were implanted with percutaneous SCS devices from 2002 to 2015 and with follow-up available until the end of September 2017 were included in this retrospective chart analysis. RESULTS: Of the 356 patients trialed, 252 underwent implantation of an SCS device with a permanent to trial ratio of 71%. Of the patients who had a permanent implant, 50% had failed back surgery syndrome, 25% had complex regional pain syndrome, and 25% had other diagnoses. At the end of the study period, the explantation rate was 30%. The causes for explantation included biological complications (26.6%), paresthesia limitations or side effects (26.6%), hardware complications (13.3%), ineffective pain control (28%), and no further need for stimulation therapy (5.3%). CONCLUSIONS: Device removal is not uncommon, and opportunities to enhance the long-term success of SCS devices do exist. These include modification of trialing methods, achieving better paresthesia overlay, using magnetic resonance imaging (MRI) conditional equipment, development of robust technologies and hardware to reduce equipment malfunction, and improving efficacy with new innovative wave forms.
OBJECTIVES: The aims of this study were to identify the reasons for explanation of spinal cord stimulator (SCS) devices and to further quantify the proportions and time lines of these causes of explantation in order to determine improvement opportunities for the development of best practices. DESIGN: Retrospective, single academic center. MATERIALS AND METHODS:Patients who were implanted with percutaneous SCS devices from 2002 to 2015 and with follow-up available until the end of September 2017 were included in this retrospective chart analysis. RESULTS: Of the 356 patients trialed, 252 underwent implantation of an SCS device with a permanent to trial ratio of 71%. Of the patients who had a permanent implant, 50% had failed back surgery syndrome, 25% had complex regional pain syndrome, and 25% had other diagnoses. At the end of the study period, the explantation rate was 30%. The causes for explantation included biological complications (26.6%), paresthesia limitations or side effects (26.6%), hardware complications (13.3%), ineffective pain control (28%), and no further need for stimulation therapy (5.3%). CONCLUSIONS: Device removal is not uncommon, and opportunities to enhance the long-term success of SCS devices do exist. These include modification of trialing methods, achieving better paresthesia overlay, using magnetic resonance imaging (MRI) conditional equipment, development of robust technologies and hardware to reduce equipment malfunction, and improving efficacy with new innovative wave forms.