<p>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.</p><p></p>

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

  • Lishuai Zhang,
  • Bin Huang,
  • Yizhi Zhang,
  • Fang Zeng,
  • PIngge Tian,
  • Biao Li,
  • Xiwei Chen,
  • Jiashuang Wang,
  • Yihui Huang,
  • Li Li

摘要

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.