Efficacy and safety of a modified ozone-mediated neurolysis in treatment for patients with resistant hypertension

The sympathetic ganglion was the initial target of renal denervation (RDN) for treating resistant hypertension (RH). In this pilot Phase II single-arm, open-label clinical trial, we developed a modified neurolysis technique based on one of the traditional pain-relieving techniques, CT-guided ozone-mediated neurolysis, to treat RH. A total of 45 patients were enrolled and underwent the operation, which involved the injection of an oxygen-ozone gas mixture around the lumbar/renal ganglia under CT guidance. Following the procedure, the antihypertensive medication burden (AHMB) decreased from 4.2 pre-procedure to 3.5 at 3 months and 3.2 at 6 months post-procedure. Additionally, at 3 months post-procedure follow-up, there was a significant decrease in the average 24-h mean systolic blood pressure (SBP) by -6.8 ± 2.1 mmHg, morning SBP/diastolic blood pressure (DBP) by -9.2 ± 2.3/-4.7 ± 1.3 mmHg, and daytime SBP/DBP by -8.0 ± 2.4/-2.9 ± 1.5 mmHg. By 6 months post-procedure follow-up, compared with pre-operation values, we observed a significant decrease in the average 24-h SBP by -5.53 ± 0.76 mmHg, morning SBP by -5.6 ± 2.1 mmHg, and daytime SBP/DBP by -7.2 ± 0.96/-2.3 ± 0.6 mmHg. We did not find significant reductions in the 24-h mean DBP, morning DBP, and nighttime SBP/DBP at the 6-month follow-up. No adverse events were observed during or after the procedure. We concluded that CT-guided ozone-mediated neurolysis targeting the renal-related lumbar ganglia is a promising alternative for treating RH, with advantages including being minimally invasive, contrast-free, non-invasive to the renal artery, and cost-effective.