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

Yang Li,Naifeng Liu,Abdul Qadir Nawabi,Yi Feng,Qiming Dai,Genshan Ma

doi:10.1155/2019/7929706

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.

Highlights

Hyperactivity of the sympathetic nervous system contributes an important role in the pathophysiology of hypertension
Office systolic blood pressure decreased 11.5± 9.9mmHg (P
RDN is an interventional method used for the treatment of refractory hypertension, but the real world and clinical trial efficacy remains controversial

Summary

Introduction

Hyperactivity of the sympathetic nervous system contributes an important role in the pathophysiology of hypertension. Renal denervation (RDN) is a new interventional treatment for resistant hypertension in recent years [1,2,3,4]. Recent clinical studies have shown that there are some controversies about the efficacy of RDN in the treatment of hypertension [5,6,7]. Improvements in ablation catheters may further improve the quality of the procedure and reduce the operator’s operational difficulty, potentially ensuring the efficacy of the procedure. This prospective, single-center, selfcontrolled study was designed to evaluate the efficacy and safety of a new RDN system [(ablator no.: GL-06E15WA, ablation catheter no: GL-6w (12mm), Shanghai Golden. Leaf Medtech Company, Shanghai, China] in hypertensive patients without antihypertensive medication

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Discussion