Intraosseous Basivertebral Nerve Ablation 3-Year Effectiveness and Safety Results: A Pooled Cohort Study of Two Prospective Clinical Trials

Monday, March 6, 2023

4:03 PM – 4:12 PM

Location: Phoenix Convention Center, 222C

Presenting Author(s)

Islam Fayed, DO

Clinical Fellow
Clinical Radiology of Oklahoma

Disclosure(s): No financial relationships to disclose

Author/Co-author(s)

Douglas Beall, MD

Chief of Radiology Services
Clinical Radiology of Oklahoma
KM

Kevin Macadaeg, MD

Physician
Indiana Spine Group

Disclosure(s):

Islam Fayed, DO: No financial relationships to disclose

Purpose: Vertebrogenic pain is a source of anterior column chronic low back pain, which is associated disc degeneration and endplate changes seen as Modic changes on MRI (Type I and II). The pain signal transmission by the basivertebral nerve (BVN) located within the vertebral body. Radiofrequency ablation (RFA) of the BVN was shown to be superior to sham-control and non-surgical standard care in randomized controlled trials of patients with primary vertebrogenic CLBP. We report 3-year aggregated results of two prospective, single arm, open-label, multi-center, follow-up studies of BVN ablation-treated patients.

Materials and Methods:

Results at 3-year post BVN ablation are reported for two studies:
A prospective, open label, single-arm follow-up study of the treatment arm of the randomized controlled trial of BVN ablation versus standard care conducted in 20 U.S. sites with follow-up at 3, 6, 9, 12, 24, 36, 48, and 60 months.
A prospective, open label, single-arm cohort follow-up study of BVN ablation treated patients in two US sites with follow-up at 3, 6, 9, 12, 36, 48, and 60 months. Patient-reported Oswestry disability index (ODI) and numeric pain scores (NPS) were compared using a two-sided paired t-test with a 0.05 level of significance.

Results:

95 patients who received BVN ablation and completed a 3-year visit were included in the aggregated analysis for an 84% retention rate. Patients reported severe pain and disability at baseline with a mean NSP of 6.7±1.2 and mean ODI of 46.1±10.8. Pain and functional improvements were significant at 3-years with a reduction in mean NPS of 4.3 points and a reduction in mean ODI of 31.2 points from baseline. Responder rates, using minimal clinically important differences of ≥ 15-points for ODI and ≥ 50% reduction in NPS from baseline, were 85.3% and 72.6%, respectively, and 26.3% of patients reported they were pain-free at 3 years. The combined ODI and NPS response rate was 69.5%. In patients taking opioids at baseline 74% had stopped, and in patients with prior steroid injections 77% had no injections through 3-years post BVN ablation. Only 4% of patients had steroid injection(s) through 3 years post BVN ablation that were adjudicated for the same vertebral level and pain etiology per independent physician reviewer. There were no serious device or device-procedure related adverse events reported through 3 years.

Conclusion:

Intraosseous basivertebral nerve ablation demonstrates excellent safety results as well as significant, durable improvements in pain and function through 3 years in patients with chronic vertebrogenic low back pain.