Worthley Stephen G, Wilkins Gerard T, Webster Mark W, Montarello Joseph K, Delacroix Sinny, Whitbourn Robert J, Warren Roderic J
St Andrew's Hospital, Adelaide, Australia.
Dunedin Hospital, Dunedin, New Zealand.
Atherosclerosis. 2017 Jul;262:94-100. doi: 10.1016/j.atherosclerosis.2017.04.022. Epub 2017 May 3.
Catheter-based renal denervation for the treatment of drug-resistant hypertension has been intensively investigated in recent years. To date, only limited data have been published using multi-electrode radiofrequency ablation systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and performance of the second generation EnligHTN™ Renal Denervation System.
This first-in-human, prospective, multi-center, non-randomized study included 39 patients (62% male, mean age 63 years, and mean baseline office blood pressure 174/93 mmHg) with drug-resistant hypertension. The primary safety and performance objectives were to characterize, from baseline to 6 months post procedure, the rate of serious procedural and device related adverse events, as adjudicated by an independent Clinical Events Committee, and the reduction of office systolic blood pressure.
Renal artery denervation, using the second generation EnligHTN multi-electrode system significantly reduced office blood pressure from baseline to 1, 3, 6, 12, 18 and 24 months by 19/7, 26/9, 25/7, 23/7, 25/8 and 27/9 mmHg, respectively (p ≤ 0.0005). No serious device or procedure related adverse events affecting the renal arteries or renal function occurred through 24 months of follow-up.
Renal sympathetic denervation using the second generation EnligHTN Renal Denervation System resulted in safe, rapid, and significant mean office blood pressure reduction that was sustained through 24 months. Future studies will need to address the utility of this system against an appropriate sham based comparator.
近年来，基于导管的肾去神经术治疗难治性高血压受到了深入研究。迄今为止，使用能够以预定模式形成损伤的多电极射频消融系统发表的数据有限。本研究旨在评估第二代EnligHTN™肾去神经术系统的安全性和性能。
这项首次人体、前瞻性、多中心、非随机研究纳入了39例难治性高血压患者（男性占62%，平均年龄63岁，平均基线诊室血压为174/93 mmHg）。主要安全性和性能目标是由独立的临床事件委员会判定，从基线到术后6个月，严重手术及器械相关不良事件的发生率，以及诊室收缩压的降低情况。
使用第二代EnligHTN多电极系统进行肾动脉去神经术，从基线到1、3、6、12、18和24个月，诊室血压显著降低，分别降低了19/7、26/9、25/7、23/7、25/8和27/9 mmHg（p≤0.0005）。在24个月的随访中，未发生影响肾动脉或肾功能的严重器械或手术相关不良事件。
使用第二代EnligHTN肾去神经术系统进行肾交感神经去神经术可安全、快速且显著降低平均诊室血压，且这种降低在24个月内持续存在。未来的研究需要针对合适的假手术对照来探讨该系统的效用。
