-
Multicenter Study
Therapy-Related Explants After Spinal Cord Stimulation: Results of an International Retrospective Chart Review Study.
- Jean-Pierre Van Buyten, Frank Wille, Iris Smet, Carin Wensing, Jennifer Breel, Edward Karst, Marieke Devos, Katja Pöggel-Krämer, and Jan Vesper.
- Department of Anesthesia and Pain Management, AZ Nikolaas Hospital, Sint-Niklaas, Belgium.
- Neuromodulation. 2017 Oct 1; 20 (7): 642-649.
ObjectivesClinical trials of spinal cord stimulation (SCS) have largely focused on conversion from trial to permanent SCS and the first years after implant. This study evaluates the association of type of SCS and patient characteristics with longer-term therapy-related explants.Materials And MethodsImplanting centers in three European countries conducted a retrospective chart review of SCS systems implanted from 2010 to 2013. Ethics approval or waiver was obtained, and informed consent was not required. The chart review recorded implants, follow-up visits, and date and reasons for any explants through mid-2016. Results are presented using Cox regression to determine factors associated with explant for inadequate pain relief.ResultsFour implanting centers in three countries evaluated 955 implants, with 8720 visits over 2259 years of follow-up. Median age was 53 years; 558 (58%) were female. Explant rate was 7.9% per year. Over half (94 of 180) of explants were for inadequate pain relief, including 32/462 (6.9%) of implants with conventional nonrechargeable SCS, 37/329 (11.2%) with conventional rechargeable and 22/155 (14.2%) with high-frequency (10 kHz) rechargeable SCS. A higher explant rate was found in univariate regression for conventional rechargeable (HR 1.98, p = 0.005) and high-frequency stimulation (HR 1.79, p = 0.035) than nonrechargeable SCS. After covariate adjustment, the elevated explant rate persisted for conventional rechargeable SCS (HR 1.95, p = 0.011), but was not significant for high-frequency stimulation (HR 1.71, p = 0.069).ConclusionsThis international, real-world study found higher explant rates for conventional rechargeable and high-frequency SCS than nonrechargeable systems. The increased rate for conventional rechargeable stimulation persisted after covariate adjustment.© 2017 The Authors. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals, Inc. on behalf of International Neuromodulation Society.
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