Safety and performance of the second generation EnligHTN™ Renal Denervation System in patients with drug-resistant, uncontrolled hypertension. (July 2017)

• Record Type: Journal Article
• Authors: Worthley, Stephen G.; Wilkins, Gerard T.; Webster, Mark W.; Montarello, Joseph K.; Delacroix, Sinny; Whitbourn, Robert J.; Warren, Roderic J.
• Is Part Of: Atherosclerosis. Volume 262(2017)
• Page Start: 94
• Page End: 100
• Publication Date: 2017-07
• Subjects: Renal denervation -- Resistant hypertension -- Ablation catheter; Arteriosclerosis -- Periodicals; Electronic journals; 616.136
• DOI: 10.1016/j.atherosclerosis.2017.04.022
• Languages: English
• ISSNs: 0021-9150

Abstract

Abstract: Background and aims: 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. Methods: 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. Results: 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. Conclusions: 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. Highlights: The second generation EnligHTN™ System permitted simultaneous delivery of radiofrequency therapy. There were no major safety concerns out to 24 months with the second generation EnligHTN™ System. Renal denervation with the second generation EnligHTN™ System was efficacious at reducing blood pressure 24 months post renal denervation.