22-LB: 24-Month Results for 10-kHz Spinal Cord Stimulation (SCS) in Treating Painful Diabetic Neuropathy (PDN)
Authors: PETERSEN ERIKA , STAUSS THOMAS G. , SCOWCROFT JAMES A. , BROOKS ELIZABETH , WHITE JUDITH L. , SILLS SHAWN M. , AMIRDELFAN KASRA , GUIRGUIS MAGED , XU JIJUN , YU CONG , NAIRIZI ALI , PATTERSON DENIS G. , GALAN VINCENT , BUNDSCHU RICHARD , MEHTA NEEL , SAYED DAWOOD , DIBENEDETTO DAVID , SETHI KHALID A. , WU PAUL W. , ARGOFF CHARLES , NASR CHRISTIAN E. , TAYLOR ROD , CARAWAY DAVID L. 
Published: May 2022

Background and aims: PDN can lead to severe deterioration in quality of life. While published data demonstrate 10kHz SCS provides substantial refractory pain relief and neurologic improvement for PDN patients1, here we report durability of these outcomes.

Methods: Prospective, multicenter, RCT to document the impact of 10kHz SCS on PDN. Participants had PDN symptoms ≥12 months (M) , refractory to medications, lower limb pain intensity ≥5cm (0-10cm visual analog scale [VAS]) , and hemoglobin A1c ≤10%. Patients (N=216) were allocated 1:1 to 10kHz SCS (Nevro Corp.) plus conventional medical management (CMM) or CMM alone with optional crossover at 6 M.

Results: The 10kHz SCS patients maintained substantial pain relief from 3 M, averaging 81.9% (95%CI 77.3 - 86.5) decrease at 24 M. At 6 M follow up, 0% of 10kHz SCS participants but 93% of eligible CMM patients elected to crossover. After SCS, both groups reported similar significant improvements in pain, sleep disturbance, and in pain interference with mood and daily activities (see Figure 1) . There were no stimulation-related neurological deficits and 6 total explants (3.9%) , 5 due to procedure-related infections and 1 as a precaution for endocarditis.

Conclusions: The largest RCT to date of SCS management of PDN demonstrates safety, durable pain relief and neurologic improvement over 24 months with 10 kHz SCS.

Disclosure

E. Petersen: Consultant; Abbott, Biotronik, Boston Scientific Corporation, Medtronic, Nalu, Neuros Medical, Nevro Corp., Presidio, Saluda Medical, Vertos Medical Inc., Research Support; Medtronic, Neuros Medical, Nevro Corp., ReNeuron, Saluda Medical, SPR, Stock/Shareholder; neuro42, SynerFuse. C. Yu: Consultant; Boston Scientific Corporation, Nevro Corp., Research Support; Nevro Corp. A. Nairizi: Consultant; Nevro Corp. D. G. Patterson: Advisory Panel; AIS, Consultant; Pajunk Medical, Other Relationship; Abbott, CornerLoc, Flowonix, Saluda Medical, Vertiflex, Vertos, Vivex Biologics, Research Support; Nevro Corp., Speaker’s Bureau; AbbVie Inc., Lundbeck. V. Galan: None. R. Bundschu: None. N. Mehta: Consultant; Nevro Corp. D. Sayed: Consultant; Nevro Corp. D. Dibenedetto: None. K. A. Sethi: None. P. W. Wu: None. T. G. Stauss: None. C. Argoff: Consultant; Nevro Corp. C. E. Nasr: Advisory Panel; Exelixis, Horizon Therapeutics plc, Neurogastrx, Nevro Corp., Research Support; Siemens. R. Taylor: Consultant; Nevro Corp. D. L. Caraway: Employee; Nevro Corp. J. A. Scowcroft: Research Support; Boston Scientific Corporation, Nevro Corp., Saluda Medical. E. Brooks: Employee; Nevro Corp., Presidio Medical, Stock/Shareholder; Nevro Corp., Presidio Medical. J. L. White: Advisory Panel; Nevro Corp. S. M. Sills: None. K. Amirdelfan: Consultant; Nevro Corp. M. Guirguis: Advisory Panel; Averitas Pharma, Inc., Boston Scientific Corporation, Pacira BioSciences, Inc., Consultant; Avanos Medical, Inc., Nevro Corp., OmniaMed, Saluda Medical. J. Xu: None.

Funding

Nevro Corp.