Jason E Pope1, Timothy R Deer2, Steven Falowski3, David Provenzano4, Michael Hanes5, Salim M Hayek5, Jacob Amrani6, Jonathan Carlson6, Ioannis Skaribas7, Kris Parchuri8, W Porter McRoberts9, Robert Bolash10, Nameer Haider11, Maged Hamza12, Kasra Amirdelfan13, Sean Graham14, Corey Hunter15, Eric Lee1, Sean Li16, Michael Yang1, Lucas Campos1, Shrif Costandi10, Robert Levy17, Nagy Mekhail10. 1. Summit Pain Alliance, Santa Rosa, CA, USA. 2. Center for Pain Relief, Charleston, WV, USA. 3. St. Luke's University Health Network, Bethlehem, PA, USA. 4. Pain Diagnostics and Interventional Care, Sewickley, PA, USA. 5. University Hospitals, Cleveland, OH, USA. 6. Arizona Pain, Chandler, AZ, USA. 7. Pain Doctor, Houston, TX, USA. 8. Spine & Orthopedic Specialists, Tulsa, OK, USA. 9. Holy Cross Hospital, Fort Lauderdale, FL, USA. 10. Cleveland Clinic, Cleveland, OH, USA. 11. Spinal & Skeletal Pain Medicine, Utica, NY, USA. 12. Midatlantic Spine Specialists, Richmond, VA, USA. 13. IPM Medical Group, Walnut Creek, CA, USA. 14. Spine Diagnostic and Treatment, Baton Rouge, LA, USA. 15. Ainsworth Institute of Pain Management, New York, NY, USA. 16. Premier Pain Centers, East Brunswick, NJ, USA. 17. Boca Raton Regional Hospital, Boca Raton, FL, USA.
Abstract
INTRODUCTION: Spinal cord stimulation (SCS) devices are cost effective and improve function as well as quality of life. Despite the demonstrated benefits of SCS, some patients have the device explanted. We are interested in exploring the patient characteristics of those explanted. METHODS: This is a retrospective chart review of neurostimulation patients who underwent explantation at 18 centers across the United States within the previous five years. RESULTS: Data from 352 patients were collected and compiled. Failed Back Surgery syndrome was the most common diagnosis (38.9%; n = 136/350) and over half of the patients reported numerical rating scale (NRS) scores ≥8 prior to implant (64.3%; n = 207/322). All patients reported changes in NRS scores across time, with an initial decrease after implant followed by a pre-explant increase (F (2, 961) = 121.7, p < 0.001). The most common reason for device explant was lack or loss of efficacy (43.9%; 152/346) followed by complications (20.2%; 70/346). Eighteen percent (18%; 62/343) of patients were explanted by a different physician than the implanting one. Rechargeable devices were explanted at a median of 15 months, whereas primary cell device explants occurred at a median of 36 months (CI 01.434, 2.373; median endpoint time ratio = 2.40). DISCUSSION: Loss or lack of efficacy and complications with therapy represent the most frequent reasons for neurostimulation explantation. Of the devices that were explanted, therapy was terminated earlier when devices were rechargeable, when complications occurred, or when pain relief was not achieved or maintained. Furthermore, in nearly 20% of the cases, a different provider than the implanting physician performed device removal. CONCLUSIONS: SCS is largely a safe and efficacious strategy for treating select chronic refractory pain syndromes. Further prospective data and innovation are needed to improve patient selection, maintain SCS therapeutic efficacy and reduce the reasons that lead to device explant.
INTRODUCTION: Spinal cord stimulation (SCS) devices are cost effective and improve function as well as quality of life. Despite the demonstrated benefits of SCS, some patients have the device explanted. We are interested in exploring the patient characteristics of those explanted. METHODS: This is a retrospective chart review of neurostimulation patients who underwent explantation at 18 centers across the United States within the previous five years. RESULTS: Data from 352 patients were collected and compiled. Failed Back Surgery syndrome was the most common diagnosis (38.9%; n = 136/350) and over half of the patients reported numerical rating scale (NRS) scores ≥8 prior to implant (64.3%; n = 207/322). All patients reported changes in NRS scores across time, with an initial decrease after implant followed by a pre-explant increase (F (2, 961) = 121.7, p < 0.001). The most common reason for device explant was lack or loss of efficacy (43.9%; 152/346) followed by complications (20.2%; 70/346). Eighteen percent (18%; 62/343) of patients were explanted by a different physician than the implanting one. Rechargeable devices were explanted at a median of 15 months, whereas primary cell device explants occurred at a median of 36 months (CI 01.434, 2.373; median endpoint time ratio = 2.40). DISCUSSION: Loss or lack of efficacy and complications with therapy represent the most frequent reasons for neurostimulation explantation. Of the devices that were explanted, therapy was terminated earlier when devices were rechargeable, when complications occurred, or when pain relief was not achieved or maintained. Furthermore, in nearly 20% of the cases, a different provider than the implanting physician performed device removal. CONCLUSIONS: SCS is largely a safe and efficacious strategy for treating select chronic refractory pain syndromes. Further prospective data and innovation are needed to improve patient selection, maintain SCS therapeutic efficacy and reduce the reasons that lead to device explant.
Authors: Marc Russo; Charles Brooker; Michael J Cousins; Nathan Taylor; Tillman Boesel; Richard Sullivan; Lewis Holford; Erin Hanson; Gerrit Eduard Gmel; Nastaran Hesam Shariati; Lawrence Poree; John Parker Journal: Neurosurgery Date: 2020-09-15 Impact factor: 4.654
Authors: Richard B North; Aaron Calodney; Robert Bolash; Konstantin V Slavin; Michael Creamer; Richard Rauck; Payam Vahedifar; Ira Fox; Cuneyt Özaktay; Sunil Panchal; Niek Vanquathem Journal: Neuromodulation Date: 2019-06-03
Authors: Timothy R Deer; Dawood Sayed; Mark N Malinowski; Jeffery J Rowe; Jessica B Jameson; Kevin Liang; Joseph A Sclafani Journal: Pain Med Date: 2019-12-01 Impact factor: 3.750
Authors: Michael Fishman; Harold Cordner; Rafael Justiz; David Provenzano; Christopher Merrell; Binit Shah; Julian Naranjo; Philip Kim; Aaron Calodney; Jonathan Carlson; Richard Bundschu; Mahendra Sanapati; Vipul Mangal; Ricardo Vallejo Journal: Pain Pract Date: 2021-08-27 Impact factor: 3.079