|Title||Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.|
|Publication Type||Journal Article|
|Year of Publication||2023|
|Authors||Rauck RL, Loudermilk E, Thomson SJ, Paz-Solis JFrancisco, 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 MA, 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, De Carolis G, Bhatia S, Green M, Villarreal A, Crooks MT, Gwinn RP, Pilitsis JG, Sato H, Vega SMaldonado, M Hillegass G, Carnes P, Scherer C, Brill S, Yu J, Brennan JJ, Gatzinsky K, Navani A, Snook LT, Bujedo BMugabure, Ares JDe Andrés, Murillo A, Trobridge AT, Assil K, Shah J, McLeod C, Buwembo J, De Coster O, Miller N, Sanapati M, Mikhael M, Przkora R, Sukenaga N, Raso LJ, Calodney AK, Jerez LElena Các, Uchiyama T, Kallewaard J-W, Chandler B, Piedimonte F, Candido KD, Weaver TE, Agari T, Holthouse D, Woon R, Patel N, Lechleiter K, Jain R|
|Date Published||2023 Feb|
|Keywords||Chronic Pain, Humans, Postoperative Complications, Prospective Studies, Registries, Spinal Cord, Spinal Cord Stimulation, Treatment Outcome|
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).
|Alternate Journal||Pain Manag|