EP142 12-month clinical outcomes and energy modeling from a prospective, multi-center study of a differential target multiplexed™ spinal cord stimulation derivative

• Published in: Regional anesthesia and pain medicine Vol. 48; no. Suppl 1; p. A119
• Main Authors: Provenzano, David, Amirdelfan, Kasra, Grewal, Prahbdeep, Rice, Calysta, Noel, Kate, Cleland, Andrew, LaRue, Maddie
• Format: Journal Article
• Language: English
• Published: Secaucus BMJ Publishing Group LTD 01.09.2023
• Subjects: Chronic pain; Energy; Pain; Spinal cord
• ISSN: 1098-7339; 1532-8651
• DOI: 10.1136/rapm-2023-ESRA.208

Background and AimsDifferential Target Multiplexed™ spinal cord stimulation (DTM™ SCS) is an established therapy that has shown superior back pain relief to traditional SCS [1]. Derivatives of DTM™ are being investigated to understand opportunities for therapy personalization. This prospective, multi-center, open- label, post-market study evaluated the efficacy and energy use of reduced-energy DTMTM derivative (DTM™ endurance).MethodsSCS candidates with an overall Visual Analog Score (VAS) of ≥6 with moderate to severe chronic, intractable back and/or leg pain were eligible. Eligible subjects underwent an SCS trial programmed with DTM™ endurance and proceeded in study if successful. Evaluation visits occurred at 1-, 3-, 6-, and 12-months post-activation. Programming data was used to calculate battery energy usage (Intellis™, Medtronic). 2 tailored specific and validated models utilizing real patient programming data were used for determining recharge interval and device longevity.Results57 subjects enrolled at 12 US sites from November 2020 – June 2021 (demographics in table 1). Post-laminectomy pain/PSPS was the main etiology (91.2%). 49 subjects underwent trial, 35 were implanted, and 27 completed the 12-Month visit. Changes in overall, back, and leg pain were clinically sustained through 12-months (figure 1). Outcomes including quality of life, disability, and safety will be presented. Therapy energy usage was consistent throughout the duration of the study, with a mean current usage of 55 µC/s at 12-months. Amplitude ranges, cycling parameters, recharge interval and duration, and longevity will be reported.Abstract EP142 Figure 1Visual analog sea le (VAS} scores for overall, back and leg pain. Values shown represent mean VAS scores (scale of 0 ta 10, with 10 being the most pain} tram per-protocol subjects at baseline, 3-month, 6-month and 12-month follow-up. Error bars represent Standard Error (SE}[Figure omitted. See PDF]Abstract EP142 Table 1Baseline demographics for enrolled and implanted subjectsSubject Character1istics Enrolled (N=57) lmplanted (N=35) Age (years)  Mean (SDJ 63.2 (11.93) 62.4 (12.70}  Me-dian 67 67  Min to Max 40.0to85.0 40.0to 85.0 Sex (n.%}  F 33 {57.9%) 21 {60.0%)  M 24 (42.1%) 14 (40.0%) Ethnicity (n,%)  Not Hiispanic Or latino 53 (93.0%) 33 (94.3%)  Hispanie Or latino 3 (5.3%) 1 (2.9%)  Not Reported 1 (1.8%) 1 (2.9%) Race(n,%)  White 54 (94.7%) 34 (97.1%)  Asi1an 1 (1.8%) 0(0.0%)  Black or Af,rican American 1 (1..8%) 1 (2.9%)  Not Reported 1 (1.8%) 0(0.0%) Time since pa,in o:nset (y,ears)  Mean (SD)  Median  Min toMax 13.4 (13.27) 7 1.0 to 60.0 13.7 (13.44} 8 1.0 to 60.0 Re!eva,nt• Surgi;cal History (n,%)  At LeastOne Relevanr Suirgery 50 (87.7%) 31 (88.6%)  No Surgical Hisfory 7 (12.3%) 4(11.4%) Niumber of Surgeries  Mean {SD) 1.7 (1.48) 1.8 (1.75)  Median 1 1  Min toMax O.Oto9.0 O.Oto 9.0 rel.:1œd lo tlle SCS cl!NÎce/pai11 ConclusionsThe use of a DTM™ endurance in this study resulted in clinically meaningful pain relief with reduced energy usage.IRB Approval – Initial IRB Approval – Initial