Cited by 271Blood Pressure and Hypertension StudiesRenal and Vascular PathologiesCardiovascular Health and Disease Prevention

Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial

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Worthley, Stephen G., Tsioufis, Costas P., Worthley, Matthew I., Sinhal, Ajay, Chew, Derek P., Meredith, Ian T., Malaiapan, Yuvi, Papademetriou, Vasilios·2013·European Heart Journal

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.

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  • In humans, the renal 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 lumen.

    “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.”
  • Efferent sympathetic renal denervation can be achieved with luminal delivery of radiofrequency and ultrasonic energy.

    “Efferent sympathetic renal denervation can be achieved with luminal delivery of radiofrequency and ultrasonic energy.”

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Research works printed but not linked: 1

  1. [14]Guyton AC Hall JE Guyton and Hall Textbook of Medical Physiology with Student Consult Online Access 2006 11th ed Philadelphia Elsevier Saunders

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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
Published
2013-06-19
Volume
34
Issue
28
Pages
2132-2140
ISSN
  • 0195-668X (ISSN-L)
  • 1522-9645
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 · 2012: 1
FWCI
41.66
Type
journal article
Language
en
Open access
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 › Pulmonary and Respiratory Medicine › 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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