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

The DOI matches its Crossref record; 25 of the 25 references it cites were found in a registry or an index.

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

Open access
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
DOI 10.1093/eurheartj/eht197PMC PMC3717311
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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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Crossref · 10.1093/eurheartj/eht197

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Figure 1 Study flowchart.
Figure 1 Study flowchart.CC BY-NC · PubMed Central
Figure 2 Mean office blood pressure reduction (P-value < 0.001).
Figure 2 Mean office blood pressure reduction (P-value < 0.001).CC BY-NC · PubMed Central
Figure 3 Graphic display of the office systolic BP results for each of the patients enrolled at baseline and 6 months.
Figure 3 Graphic display of the office systolic BP results for each of the patients enrolled at baseline and 6 months.CC BY-NC · PubMed Central
Figure 4 Mean ambulatory blood pressure reduction (P-value < 0.001).
Figure 4 Mean ambulatory blood pressure reduction (P-value < 0.001).CC BY-NC · PubMed Central

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

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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.
ORCID
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
DOI
10.1093/eurheartj/eht197
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
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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