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

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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)115-127
Number of pages13
JournalPain management
Volume13
Issue number2
DOIs
StatePublished - Feb 1 2023

Keywords

  • SCS
  • real-world evidence
  • registry
  • safety
  • spinal cord stimulation

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine

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