Safety and Efficacy of a New Renal Denervation Catheter in Hypertensive Patients in the Absent of Antihypertensive Medications: A Pilot Study

Abstract

Aim. The aim of present study was to determine the safety and efficacy of a new renal artery denervation system for treatment of hypertensive patients. Methods. Hypertensive patients with mean office systolic blood pressure ≥150mmHg and ≤180mmHg or an average of 24-hour ambulatory systolic blood pressure ≥145mmHg and ≤170mmHg after stopping hypertensive medications for 2 weeks or more were enrolled to undergo renal denervation (RDN) using a new RDN system. Changes in office blood pressure and mean 24-hour ambulatory blood pressure and safety were assessed after 6 months. Results. Fifteen patients underwent RDN and followed up for 6 months. At the 6-month follow-up, office systolic blood pressure decreased 11.5±9.9mmHg (P<0.01) and office diastolic blood pressure decreased 6.9±4.8mmHg (P<0.01); mean 24-hour ambulatory systolic blood pressure decreased 7.5±7.7mmHg (P<0.05) and mean 24-hour diastolic blood pressure decreased 3.3±4.7mmHg (P>0.05) compared to baseline values. There were no serious RDN-related adverse events during follow-up. Conclusion. Our results demonstrate that the new RDN system is safe and could significantly reduce blood pressure in hypertensive patients in the absence of antihypertensive medications. This trial is registered with ChiCTR1800017815.

Renal Denervation in Asia

“…Golden Leaf (Shanghai Golden Leaf Med-Tec Co, Shanghai, China) has also developed a 6-electrode basket design radiofrequency energy-based RDN catheter. 18 One study showed that office and ambulatory SBP significantly decreased by 11.5 and 7.5 mm Hg, respectively, at 3 months. A sham-controlled randomized trial is planned.…”

Percutaneous renal denervation in the management of hypertension: Chinese expert scientific statement

“…In China, the RDN ablation catheters that either have completed or are undergoing clinical trial (listed in order of study initiation) include SyMapCath ® /SymPioneer ® Renal Sympathetic Nerve Mapping and Ablation System from SyMap Medical (Suzhou) Technology Co. Ltd [24] ., Netrod ® Multi-electrode mesh basket-like Renal Sympathetic Nerve RFA system from Shanghai Golden Leaf MedTech Co.Ltd. [25] , Iberis ® (Bioheart) Multi-electrode Ablation Catheter from Shanghai Bioheart Biotechnology Co. Ltd., and the Cryofocus cryoablation system from Cryofocus Medtech (Shanghai) Co. Ltd. The characteristics of the various ablation catheter systems used and under clinical study in China are presented in Table 1.…”

Device-Based Sympathetic Nerve Regulation for Cardiovascular Diseases

“…In addition, some new RDN operating systems have been developed, such as the multipolar ablation catheter IberisBloom (Terumo, Tokyo, Japan) etc. ( 60 – 65 ) and the non-invasive stereotactic radiotherapy ( 66 ), whose clinical applications are expected.…”