Evidence map›Paper›PMID 25240550›Full record

ReviewJACC. Cardiovascular interventions2014

Methodological standardization for the pre-clinical evaluation of renal sympathetic denervation.

Kenichi Sakakura, Elena Ladich, Elazer R Edelman, Peter Markham, James R L Stanley, John Keating, Frank D Kolodgie, Renu Virmani, Michael Joner

Open access · greenAbstract readReview
In one paragraph

Review in JACC. Cardiovascular interventions, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
4.9field-weighted citation impact, top 4% 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

35 citing papers in PubMed, 76 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Preclinical Evaluation of a Novel Cryo Renal Denervation System.JACC. Basic to translational science · 2025
    Article
  6. Article
  7. Article
  8. Frontiers in physiology · 2025
    Article
  9. Article
  10. Article
  11. Article
  12. Translational value of preclinical models for renal denervation: a histological comparison of human versus porcine renal nerve anatomy.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
    Article
  13. A drug-induced hypotensive challenge to verify catheter-based radiofrequency renal denervation in an obese hypertensive swine model.Clinical research in cardiology : official journal of the German Cardiac Society · 2022
    Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Kenichi SakakuraCVPath Institute, Inc., Gaithersburg, Maryland.
Elena LadichCVPath Institute, Inc., Gaithersburg, Maryland.
Elazer R EdelmanCBSET, Inc., Lexington, Massachusetts.
Peter MarkhamCBSET, Inc., Lexington, Massachusetts.
James R L StanleyCBSET, Inc., Lexington, Massachusetts.
John KeatingCBSET, Inc., Lexington, Massachusetts.
Frank D KolodgieCVPath Institute, Inc., Gaithersburg, Maryland.
Renu VirmaniCVPath Institute, Inc., Gaithersburg, Maryland.
Michael JonerCVPath Institute, Inc., Gaithersburg, Maryland. Electronic address: mjoner@cvpath.org.
CVPath Institute · US

Funding

Vascular Drug Delivery - Supplement for EquipmentR01GM049039 · NIGMS · MASSACHUSETTS INSTITUTE OF TECHNOLOGY · PI EDELMAN, ELAZER R · 1994 to 2019
$8.9M
NIGMS NIH HHS R01 GM049039NIGMS NIH HHS R01 GM49039
6 · The paper itself

Abstract

Transcatheter ablation of renal autonomic nerves is a viable option for the treatment of resistant arterial hypertension; however, structured pre-clinical evaluation with standardization of analytical procedures remains a clear gap in this field. Here we discuss the topics relevant to the pre-clinical model for the evaluation of renal denervation (RDN) devices and report methodologies and criteria toward standardization of the safety and efficacy assessment, including histopathological evaluations of the renal artery, periarterial nerves, and associated periadventitial tissues. The pre-clinical swine renal artery model can be used effectively to assess both the safety and efficacy of RDN technologies. Assessment of the efficacy of RDN modalities primarily focuses on the determination of the depth of penetration of treatment-related injury (e.g., necrosis) of the periarterial tissues and its relationship (i.e., location and distance) and the effect on the associated renal nerves and the correlation thereof with proxy biomarkers including renal norepinephrine concentrations and nerve-specific immunohistochemical stains (e.g., tyrosine hydroxylase). The safety evaluation of RDN technologies involves assessing for adverse effects on tissues local to the site of treatment (i.e., on the arterial wall) as well as tissues at a distance (e.g., soft tissue, veins, arterial branches, skeletal muscle, adrenal gland, ureters). Increasing experience will help to create a standardized means of examining all arterial beds subject to ablative energy and in doing so enable us to proceed to optimize the development and assessment of these emerging technologies.

Indexed as

AnimalsBiomarkersBlood PressureCatheter AblationHypertensionImmunohistochemistryKidneyModels, AnimalNorepinephrineRenal ArteryRisk FactorsStaining and LabelingSwineSympathectomyBiomarkersNorepinephrineimmunohistochemical stainspathologypre-clinicalrenal denervationrenal norepinephrine concentration

Identifiers

PMID25240550
PMCPMC4625553
OpenAlexW2010632161

What OpenQuestion holds

Textmetadata
LicenceTDM
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.