Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/79963
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Type: | Journal article |
Title: | Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: The EnligHTN I trial |
Author: | Worthley, S. Tsioufis, C. Worthley, M. Sinhal, A. Chew, D. Meredith, I. Malaiapan, Y. Papademetriou, V. |
Citation: | European Heart Journal, 2013; 34(28):2132-2140 |
Publisher: | W B Saunders Co Ltd |
Issue Date: | 2013 |
ISSN: | 0195-668X 1522-9645 |
Statement of Responsibility: | Stephen G. Worthley, Costas P. Tsioufis, Matthew I. Worthley, Ajay Sinhal, Derek P. Chew, Ian T. Meredith, Yuvi Malaiapan, and Vasilios Papademetriou |
Abstract: | Aims: Catheter-based renal artery sympathetic denervation has emerged as a novel therapy for treatment of patients with drug-resistant hypertension. Initial studies were performed using a single electrode radiofrequency catheter, but recent advances in catheter design have allowed the development of multi-electrode systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and efficacy of the EnligHTN™ multi-electrode system. Methods and results: We conducted the first-in-human, prospective, multi-centre, non-randomized study in 46 patients (67% male, mean age 60 years, and mean baseline office blood pressure 176/96 mmHg) with drug-resistant hypertension. The primary efficacy objective was change in office blood pressure from baseline to 6 months. Safety measures included all adverse events with a focus on the renal artery and other vascular complications and changes in renal function. Renal artery denervation, using the EnligHTN™ system significantly reduced the office blood pressure from baseline to 1, 3, and 6 months by −28/10, −27/10 and −26/10 mmHg, respectively (P < 0.0001). No acute renal artery injury or other serious vascular complications occurred. Small, non-clinically relevant, changes in average estimated glomerular filtration rate were reported from baseline (87 ± 19 mL/min/1.73 m2) to 6 months post-procedure (82 ± 20 mL/min/1.73 m2). Conclusion: Renal sympathetic denervation, using the EnligHTN™ multi-electrode catheter results in a rapid and significant office blood pressure reduction that was sustained through 6 months. The EnligHTN™ system delivers a promising therapy for the treatment of drug-resistant hypertension. |
Keywords: | Hypertension Renal denervation Blood pressure Percutaneous |
Rights: | © The Author 2013.This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com. |
DOI: | 10.1093/eurheartj/eht197 |
Published version: | http://dx.doi.org/10.1093/eurheartj/eht197 |
Appears in Collections: | Aurora harvest 4 Medicine publications |
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hdl_79963.pdf | Published version | 424.6 kB | Adobe PDF | View/Open |
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