Long-term Safety of Spinal Cord Stimulation Systems in A Prospective, Global Registry of Patients With Chronic Pain
Richard Rauck, Eric Loudermilk, Simon Thomson, J. Paz, Louis Bojrab, John Noles, Jan Vesper, Joseph Atallah, Daniel Roth, Joseph Hegarty, Michel Prudhomme, Gregory M Phillips, Stephen G. Smith, Mohab Ibrahim, Channing D Willoughby, Jon B. Obray, Mayank Gupta, Julio Paez, Anthony Berg, Nathan J. Harrison, Paolo Maino, Praveen Mambalam, Matthew McCarty, Glyn Towlerton, Sarah Love‐Jones, Shakil Ahmed, Albert Lee, Binit Shah, Itay Goor‐Aryeh, Marc Russo, Nicolás Díaz Varela, Jeffrey B Phelps, J. Cid, Tacson Fernandez, Concepción Pérez, Douglas Keehn, Joshua M. Rosenow, Nameer Haider, Andrew G. Parrent, Melinda M. Lawrence, Peter Georgius, Laura Demartini, Agustin Mendiola, Vivek Mehta, R. 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 Brennan, Kliment Gatzinsky, Annu Navani, Lee T Snook, Borja Mugabure Bujedo, Javier De Andrés Ares, Abel Murillo, Andrew Trobridge, Kamyar Assil, Jawad Ali Shah, Carroll McLeod, Joseph Buwembo, Olivier De Coster, Nathan Miller, Mehendra Sanapati, Medhat Mikhael, Rene Przkora, Norihiko Sukenaga, Louis J. Raso, Aaron Calodney, Luz Elena Cáceres Jerez, Takuya Uchiyama, Jan Willem Kallewaard, Brett Chandler, Fabián Piedimonte, Kenneth D. Candido, Tristan Weaver, Takashi Agari, David Holthouse, Rex Woon, Nileshkumar Patel, Kristen Lechleiter, Roshini Jain
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)