Pain management · 2023

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.

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Rauck Richard L, Loudermilk Eric, Thomson Simon J, Paz-Solis Jose Francisco, Bojrab Louis, Noles John, Vesper Jan, Atallah Joseph, Roth Daniel, Hegarty Joseph, Prud'Homme Michel, Phillips Gregory M, Smith Stephen G, Ibrahim Mohab, Willoughby Channing D, Obray Jon B, Gupta Mayank, Paez Julio, Berg Anthony P, Harrison Nathan J, Maino Paolo, Mambalam Praveen, McCarty Matthew, Towlerton Glyn, Love-Jones Sarah, Ahmed Shakil, Lee Albert, Shah Binit, Goor-Aryeh Itay, Russo Marc A, Varela Nicolas, Phelps Jeffrey B, Cid José, Fernandez Tacson, Pérez-Hernández Concepción, Keehn Douglas, Rosenow Joshua M, Haider Nameer, Parrent Andrew G, Lawrence Melinda M, Georgius Peter, Demartini Laura, Mendiola Agustin, Mehta Vivek, Thoma Reinhard, Israel Atef F, Carolis Giuliano De, Bhatia Sanjay, Green Matthew, Villarreal Armando, Crooks Matthew T, Gwinn Ryder P, Pilitsis Julie G, Sato Hitoaki, Vega Sergio Maldonado, Hillegass M Gabriel, Carnes Paul, Scherer Christian, Brill Silviu, Yu James, Brennan James J, Gatzinsky Kliment, Navani Annu, Snook Lee T, Bujedo Borja Mugabure, Andrés Ares Javier De, Murillo Abel, Trobridge Andrew T, Assil Kamyar, Shah Jawad, McLeod Carroll, Buwembo Joseph, Coster Olivier De, Miller Nathan, Sanapati Mehendra, Mikhael Medhat, Przkora Rene, Sukenaga Norihiko, Raso Louis J, Calodney Aaron K, Cáceres Jerez Luz Elena, Uchiyama Takuya, Kallewaard Jan-Willem, Chandler Brett, Piedimonte Fabián, Candido Kenneth D, Weaver Tristan E, Agari Takashi, Holthouse David, Woon Rex, Patel Nileshkumar, Lechleiter Kristen, Jain Roshini

Аннотация

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).

Предметные рубрики MeSH

Humans Spinal Cord Stimulation Prospective Studies Chronic Pain Postoperative Complications Registries Spinal Cord Treatment Outcome

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.

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Аннотация

Предметные рубрики MeSH