Retrospective Assessment of Salvage to 10 kHz Spinal Cord Stimulation (SCS) in Patients Who Failed Traditional SCS Therapy: RESCUE Study.

BACKGROUND AND OBJECTIVES

A randomized clinical trial demonstrated that 10 kHz SCS (10kHz-SCS) therapy is superior to traditional low-frequency SCS (LF-SCS) at 12- and 24-month clinical follow-ups and led to Food and Drug Administration (FDA) approval of the therapy. The results of the study led our practices to trial 10kHz-SCS in patients who had not maintained pain relief with LF-SCS therapy. Here, we report a large set of data from two clinical sites to assess if 10kHz-SCS is an effective salvage modality when LF-SCS fails.

METHODS

We conducted a retrospective chart review of 120 patients across two clinical sites who had LF-SCS implants and were salvaged with 10kHz-SCS.

RESULTS

Data were analyzed from 105 patients between 28 and 90 years old (median 60) with chronic pain for 13.6 years. The mean duration of LF-SCS therapy was 4.66±3.9 years. The average Visual Analog Scale (VAS) decreased from 8.30±1.4 (median of 8) cm to 3.32±2.0 (median of 3) cm at 12 months and 3.36±2.0 (median of 3) cm at the most recent clinic visit (p<0.001) following salvage therapy. Pain relief of 50% or more was obtained in 85 out of 105 (81%) patients. Opioid usage decreased from 60.3±77.1 mg to 32.1±44.0 mg MSO4 equivalents (p = 0.001) at 12 months after salvage therapy.

CONCLUSION

Eighty-one percent of patient cases reviewed, where LF-SCS had failed, achieved >50% pain relief with 10kHz-SCS, and almost all exhibited some clinical improvement. Therefore, 10kHz-SCS should be considered an appropriate option to rescue failed LF-SCS.

Informations de copyright

© 2020 Kapural et al.

Déclaration de conflit d'intérêts

Drs Kapural and Sayed are paid consultants for Nevro Corp. This study was funded by an investigator initiated grant from Nevro to Drs Kapural and Sayed. Dr Leonardo Kapural reports research grants from Nevro, Biotronik, Saluda Medical, Gimer and Neuros, personal fees from Nalu, Abbott and Medtronic, during the conduct of the study;and personal fees from Nevro, outside the submitted work. Dr Dawood Sayed reports personal fees, consulting fees and sponsored research from Nevro, Abbott, Vertos,Medtronic, Flowonix, and Boston Scientific, and equity in SPR, PainTeq, and Vertos, outside the submitted work. The authors report no other potential conflicts of interest for this work.