Findings from three randomized trials of ultrasound renal denervation revealed a significant reduction in daytime ambulatory systolic blood pressure in patients with varying levels of hypertension.
A newly published study suggests ultrasound renal denervation offers consistent reduction of blood pressure regardless of hypertension severity.
For the study, recently published in JAMA Cardiology, researchers assessed the efficacy of ultrasound renal denervation (uRDN) via a pooled analysis of data from three prospective, randomized, sham-controlled studies. The study included patients taking up to two medications for mild to moderate hypertension that was either controlled or uncontrolled, as well as patients with resistant hypertension despite taking three or more prescribed medications. In the total of 506 patients (mean age of 54.1), 34 percent (173 patients) had hyperlipidemia and 12 percent (59 patients) had diabetes, according to the study.
While the researchers saw no differences in mean daytime ambulatory systolic blood pressure between the uRDN (Paradise Ultrasound Denervation System, ReCor Medical) group and the sham group after a one-month medication stabilization period, they noted significant reductions in the uRDN group across the three studies at two months. The study authors found a mean 8.5 mm Hg decrease in daytime ambulatory systolic blood pressure to 141.8 (13.8) mm Hg in comparison to a 2.9 mm Hg decrease to 147.9 (14.6) mm Hg with a sham treatment.
The researchers also found that 46.3 percent of patients treated with uRDN had blood pressure reductions of 10 mm Hg or more in comparison to 19.9 percent of patients who had the sham treatment.
“Not only was the overall magnitude of (blood pressure) reduction greater among uRDN compared with patients in the sham group, but a greater proportion of patients achieved large reductions, of 10 mm Hg or greater, with uRDN compared with sham,” wrote lead study author Ajay J. Kirtane, M.D., SM, a professor of medicine at Columbia University Irving Medical Center and director of the Cardiac Catheterization Laboratories at New York-Presbyterian/Columbia University Irving Medical Center, and colleagues.
In regard to a targeted threshold of less than 135/85 mm Hg for daytime ambulatory blood pressure, the researchers noted that 24.2 percent of patients treated with uRDN achieved this control threshold in comparison to 12.3 percent of patients who had the sham treatment. Kirtane and colleagues added the 98.6 percent of patients treated with uRDN were discharged the day of the procedure or the day after.
The study authors acknowledged there is no current procedural marker that constitutes a successful uRDN procedure. In order to isolate the impact of uRDN on blood pressure reduction, the study authors noted the follow-up was restricted to a two-month period in which there were no changes to patient medications other than for escape purposes. Kirtane and colleagues maintained that additional follow-up evaluation from these studies is required in order to gauge the durability and long-term safety of the uRDN treatment.