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Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial
Open accessAbstract
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.
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“In humans, the nerves pass from the sympathetic chain and ganglia to the kidneys via the outer adventitia of the renal arteries, or just beyond in perirenal adipose tissue and connective tissue, potentially within reach of radiofrequency energy delivered by a catheter in the artery lumen120–124.”
From The Sympathetic Nervous System Alterations in Human Hypertension (2015) · cites this paper as [122]
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“Efferent sympathetic renal denervation can be achieved with luminal delivery of radiofrequency and ultrasonic energy.”
From The Sympathetic Nervous System Alterations in Human Hypertension (2015) · cites this paper as [122]
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Metadata
- Authors
- Worthley, S. G., Tsioufis, C. P., Worthley, M. I., Sinhal, A., Chew, D. P., Meredith, I. T., Malaiapan, Y., & Papademetriou, V.
- Affiliations
- Royal Adelaide Hospital (AU)
- National and Kapodistrian University of Athens (GR)
- Flinders University (AU)
- Monash University (AU)
- Georgetown University (US)
- Corresponding author
- Worthley, Stephen G.
- Venue
- European Heart Journal
- Publisher
- Oxford University Press (OUP)
- Published
- 2013-06-19
- Volume
- 34
- Issue
- 28
- Pages
- 2132-2140
- ISSN
- 0195-668X (ISSN-L)
- 1522-9645
- PMC
- PMC3717311
- OpenAlex
- W2096346609
- Cited by
- 271
- References
- 25
- Citations by year
- 2025: 3 · 2024: 3 · 2023: 9 · 2022: 5 · 2021: 5 · 2020: 12 · 2019: 14 · 2018: 16 · 2017: 18 · 2016: 31 · 2015: 46 · 2014: 93 · 2013: 14
- FWCI
- 41.66
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- European Heart Journal (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion, cc-by-nc)
- HighWire Press Open Archive (submittedVersion)
- Funders
- St. Jude Medical
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Nephrology › Renal and Vascular Pathologies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
- Keywords
- renal denervation, resistant hypertension, multielectrode catheter, renal artery injury, glomerular filtration rate
- MeSH terms
- Adolescent, Adult, Aged, Antihypertensive Agents, Blood Pressure, Creatinine, Electrodes, Female, Glomerular Filtration Rate, Humans, Hypertension, Male, Middle Aged, Postoperative Complications, Prospective Studies, Renal Artery, Sympathectomy, Treatment Outcome, Catheter Ablation, Blood Pressure Monitoring, Ambulatory, Cystatin C, Young Adult
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