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

## TL;DR

A new minimally invasive treatment using ozone to target nerve clusters in the kidney area shows promise in reducing high blood pressure in patients who don't respond to traditional treatments.

## Contribution

A modified ozone-mediated neurolysis technique targeting renal-related lumbar ganglia is introduced as a novel treatment for resistant hypertension.

## Key findings

- Antihypertensive medication burden decreased significantly at 3 and 6 months post-procedure.
- Significant reductions in systolic blood pressure were observed at both 3 and 6 months.
- No adverse events were reported, indicating the procedure's safety.

## Abstract

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.