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https://hdl.handle.net/11055/1264| Title: | Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain | Authors: | Rauck RL Loudermilk E Thomson SJ Paz-Solis JF Bojrab L Noles J Vesper J Atallah J Roth D Hegarty J Prud'Homme M Phillips GM Smith SG Ibrahim M Willoughby CD Obray JB Gupta M Paez J Berg AP Harrison NJ Maino P Mambalam P McCarty M Towlerton G Love-Jones S Ahmed S Lee A Shah B Goor-Aryeh I Russo M Varela N Phelps JB Cid J Fernandez T Pérez-Hernández C Keehn D Rosenow JM Haider N Parrent AG Lawrence MM Georgius P Demartini L Mendiola A Mehta V Thoma R Israel AF Carolis G Bhatia S Green M Villarreal A Crooks MT Gwinn RP Pilitsis JG Sato H Vega SM Hillegass MG Carnes P Scherer C Brill S Yu J Brennan JJ Gatzinsky K Navani A Snook LT Jr Bujedo BM Andrés Ares J Murillo A Trobridge AT Assil K Shah J McLeod C Buwembo J Coster O Miller N Sanapati M Mikhael M Przkora R Sukenaga N Raso LJ Calodney AK Cáceres Jerez LE Uchiyama T Kallewaard JW Chandler B Piedimonte F Candido KD Weaver TE Agari T Holthouse D Woon R Patel N Lechleiter K Jain R |
Keywords: | SCS real-world evidence registry safety spinal cord stimulation |
Issue Date: | Feb-2023 | Source: | 13(2):115-127. | Abstract: | Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov). | URI: | https://hdl.handle.net/11055/1264 | ISSN: | 1758-1869 |
| Appears in Collections: | Scholarly and Clinical |
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