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.