Abstract No. 372 Pooled Intraosseous Basivertebral Nerve Ablation: 4-Year Effectiveness and Safety Results from Two Long-Term Follow-Up Studies

The safety and efficacy of intraosseous basivertebral nerve ablation (BVNA) for the treatment of vertebrogenic pain has been demonstrated in two randomized controlled trials, two meta-analyses, and several single-arm studies and systematic reviews. The primary goal of this paper is to report the 4-year aggregate results of two prospective, single-arm, open-label, multi-center studies of patients treated with BVNA. Four-year aggregate results are reported for: 1) a prospective, open-label, single-arm sub-study of the treatment arm of the randomized controlled trial of basivertebral nerve ablation versus standard care conducted in 20 U.S. sites with follow-up at 3, 6, 9, 12, 24, 36, 48, and 60 months; and 2) a prospective, open-label, single-arm follow-up study of basivertebral nerve ablation-treated patients in two U.S. 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) at 4 years were compared to baseline using a two-sided paired t-test with a 0.05 level of significance. Secondary outcomes included responder rates and healthcare utilization. Ninety-four patients (N=94) received basivertebral nerve ablation and completed a 4-year visit (an 83% participation rate). At baseline, patients reported a mean NPS of 6.7 ± 1.2 and mean ODI of 46.2 ± 10.8, with 70% reporting back pain for ≥ 5 years. Pain and functional improvements were significant at four years with a reduction in mean NPS of 3.9 ± 2.6 points (95% CI 3.4, 4.5; p< 0.0001) and in mean ODI of 30.8 ± 15.9 (95% CI 27.5, 34.0; p< 0.0001) from baseline. Responder rates, using minimal clinically important differences of ≥ 15-points for ODI and ≥ 50% reduction in NPS from baseline, were 80.9% and 61.7%, respectively. 23.4% of patients reported being pain-free at four years. The combined ODI and NPS response rate was 59.6%. At four years there was a 70.4% decrease in the number of patients taking opioids compared to baseline, with only 9.6% of patients actively taking opioids. Only 4.3% of patients had therapeutic injections post-ablation that were adjudicated as treating the same pain etiology per independent physician reviewers. There were no serious device or procedure-related adverse events reported through 4 years. Intraosseous BVNA demonstrates clinically and statistically significant durable improvements in pain and function through four years post-ablation in patients with vertebrogenic chronic low back pain.