Ozone-mediated lumbar-renal sympathetic denervation is generally safe, well-tolerated, and showed efficacy in reducing blood pressure (BP) and antihypertensive medication burden, new trial data suggest. Findings were presented by Li Li, MD, from the Guangzhou Red Cross Hospital and Jinan University, China, on Tuesday at Cardiovascular Revascularization Technologies (CRT) 2024 in Washington, D.C. Speaking at CRT 2024, Li noted that while it is well established that renal denervation (RDN) reduces BP, it has also been reported that a computed tomography (CT)-guided intra-foremen or ganglionic injection of an oxygen-ozone mixture, as is widely used in the treatment of sympathetically driven pain conditions, commonly results in post-procedure hypotension – which has been considered a result of sympathetic blocking during anesthesia. “As we know that spinal nerve and ganglia are important components of the sympathetic system, we previously conducted a retrospective study including 140 patents undergoing CT-guided intra-foremen or lumbar peri-ganglia ozone injection for pain,” said Li. “We observed a magnitude BP reduction after the procedure.” “Notably, this decrease in blood pressure was independent of pain alleviation,” she added, noting that analysis revealed that post procedure BP reduction was associated with level of ozone injection at the lower thoracic vertebra and the upper lumbar vertebra, which strongly indicated that the renal sympathetic system was involved in BP reduction. As a result, Li and colleagues developed a modified approach to renal sympathetic denervation, CT-guided lumbar/renal denervation(L-RDN), which consists of injecting ozone around the lumbar ganglions and the proximal segment of renal artery at the level of the vertebra where the renal artery originated from the abdomen aorta. Study details To validate the safety and effectiveness of the novel CT-guided ozone mediated L-RDN in treating patients with resistant hypertension (RH), Li and her colleagues performed a single-arm open-label study in 17 patients with an average age of 65 years and an average anti-hypertensive burden of 4.12 medications. Li explained that the procedure began with a CT scan to determine the vertebral level where the left renal artery originated from abdomen aorta. After local anesthetic, a 21G needle was then delivered and confirmed by another CT scan to reach the target point, she said. “After confirming nothing can be abstracted from the needle, 8 ml gas mixture which contained 30% ozone and 70% oxygen was injected. The gas distribution was visualized by a repeat CT scan 5 minutes after the injection,” she said. The endpoints for effectiveness were changes in BP during 4 hours ambulatory BP monitor (ABPM), the anti-hypertensive medication burden, and the home BP control rate at 3 months follow-up. Key findings After the procedure, seven patients (46.7%) matched the drug-reduction criteria of two consecutive BP points measurement per day during the follow-up, while antihypertensive burden decreased to 3.87 medications after the procedure. On top of the lessened medication burden, L-RDN further reduced morning systolic blood pressure (SBP) by -8.56 mm Hg (p = 0.034) and diastolic blood pressure (DBP) by -4.62 mm Hg (p = 0.032) from baseline to week 12, as assessed by ABPM, said Li. “For 11 patients with normal baseline renal function, morning SBP reduced by -13.24 mm Hg (p < 0.001), morning DBP[diastolic blood pressure] reduced by -6.18 mm Hg (p = 0.011), and daytime SBP reduced by -4.07 mm Hg (p = 0.009) at 12 weeks of follow-up,” she added. Furthermore, no adverse events were reported intra- and post-operation. “CT-guided ozone-mediated lumbar-renal sympathetic denervation might be an alternative and novel approach of sympathetic denervation for treating RH,” said Li, adding that confirmatory studies are now warranted. Photo Credit: Jason Wermers/CRTonline.org Photo Caption: Li Li, MD, presents results from a study of ozone-mediated lumbar-renal sympathetic denervation Tuesday at CRT 2024 in Washington, D.C.