Evidence map›Paper›PMID 23782649›Full record

ArticleEuropean heart journal2013

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

Stephen G Worthley, Costas P Tsioufis, Matthew I Worthley, Ajay Sinhal, Derek P Chew, Ian T Meredith, Yuvi Malaiapan, Vasilios Papademetriou

Open access · bronzeAbstract readEvaluation StudyMulticenter Study
In one paragraph

Article in European heart journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 106 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
106citing papers in PubMed, 4 pooled it
37.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

106 citing papers in PubMed, 4 syntheses or guidelines pooled it, 272 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Trial
  6. Review
  7. Device's design and clinical perspectives for resistant hypertension therapy.International journal of cardiology. Cardiovascular risk and prevention · 2024
    Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Device-based therapies for arterial hypertension.Nature reviews. Cardiology · 2020
    Review
  19. Review
  20. Italian Society of Arterial Hypertension (SIIA) Position Paper on the Role of Renal Denervation in the Management of the Difficult-to-Treat Hypertensive Patient.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2020
    Review

46 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 3 countries.

Stephen G WorthleyCardiovascular Research Centre, c/o The Cardiovascular Investigational Unit, Level 6 Theatre Block, University of Adelaide, Royal Adelaide Hospital, Adelaide 5000, Australia. stephen.worthley@adelaide.edu.au
Costas P Tsioufis
Matthew I Worthley
Ajay Sinhal
Derek P Chew
Ian T Meredith
Yuvi Malaiapan
Vasilios Papademetriou
Flinders University · AUMonash University · AUNational and Kapodistrian University of Athens · GRRoyal Adelaide Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsCatheter-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

resultsWe 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).

conclusionRenal 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.

Indexed as

AdolescentAdultAgedAntihypertensive AgentsBlood PressureBlood Pressure Monitoring, AmbulatoryCatheter AblationCreatinineCystatin CElectrodesFemaleGlomerular Filtration RateHumansHypertensionMaleMiddle AgedAntihypertensive AgentsCreatinineCystatin CBlood pressureHypertensionPercutaneousRenal denervation

Identifiers

PMID23782649
PMCPMC3717311
OpenAlexW2096346609

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.