Long-term Safety of Spinal Cord Stimulation Systems in A Prospective, Global Registry of Patients With Chronic Pain

Abstract

Aim: The availability of long-term (>2years) 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 3yearsafter device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant(1776completed 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 >3years was 7.6% (n=98). Of these, 32subjects (2.5%) indicated inadequate pain relief as cause for removal. Implantsite 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).