Evidence map›Paper›PMID 21796327›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2011

Catheter-based renal sympathetic denervation: chronic preclinical evidence for renal artery safety.

Marian K Rippy, Denise Zarins, Neil C Barman, Andrew Wu, Keith L Duncan, Christopher K Zarins

Abstract read
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Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed
18.9field-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

49 citing papers in PubMed, 174 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Renal denervation in patients with chronic kidney disease: current evidence and future perspectives.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023
    Review
  6. 2022 Renal denervation therapy for the treatment of hypertension: a statement from the Thai Hypertension Society.Hypertension research : official journal of the Japanese Society of Hypertension · 2023
    Article
  7. Article
  8. Renal Sympathetic Denervation for Hypertension.Kidney international reports · 2022
    Review
  9. Review
  10. Renal Denervation to Treat Heart Failure.Annual review of physiology · 2021
    Review
  11. Article
  12. Review
  13. Article
  14. Safety of catheter-based radiofrequency renal denervation on branch renal arteries in a porcine model.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2019
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Renal artery sympathetic denervation: observations from the UK experience.Clinical research in cardiology : official journal of the German Cardiac Society · 2016
    Article
  20. Observational
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

6 authors at 3 institutions in 1 country.

Marian K RippyRippy Pathology Solutions, Woodbury, MN, USA. marian.rippy@comcast.net
Denise Zarins
Neil C Barman
Andrew Wu
Keith L Duncan
Christopher K Zarins
Medtronic (United States) · USPhipps Houses · USStanford University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRenal sympathetic hyperactivity is associated with hypertension, a leading cause of mortality worldwide. Renal sympathetic denervation via the Symplicity Catheter System has been shown to decrease blood pressure by 33/11 mmHg by 6 months, with no radiofrequency (RF)-related adverse sequelae visible by CT/MR angiography or renal duplex ultrasound 6 months after the procedure. Here, we present preclinical work predating those clinical results. We performed therapeutic renal sympathetic denervation in a swine animal model to characterize the vascular safety and healing response 6 months after renal denervation therapy.

methodsIn December 2007, seven domestic swine received a total of 32 radiofrequency ablations via the Symplicity Catheter System and were euthanatized 6 months later. Renal angiography was done before, immediately after, and 6 months after procedure. The renal vessels were examined histologically with H&E and Movat pentachrome stains to identify evidence of vascular and neural injury. The kidneys and urinary system were also examined for evidence of gross and microscopic abnormalities.

resultsRenal nerve injury involved primarily nerve fibrosis, replacement of nerve fascicles with fibrous connective tissue, and thickening of the epineurium and perineurium. Renal arterial findings included fibrosis of 10-25% of the total media and underlying adventitia, with mild disruption of the external elastic lamina. No significant smooth muscle hyperplasia or inflammatory components were observed. There was no renal arterial stenosis or thrombosis observed by angiography or histology. No gross or microscopic device-related abnormalities were noted in the kidney, surrounding stroma, or urinary bladder.

conclusionsIn a swine model, renal denervation via the Symplicity Catheter System resulted in no clinically significant adverse renal artery or renal findings 6 months after the procedure. This is corroborated by the vascular safety profile demonstrated in subsequent human clinical studies.

Indexed as

Catheter AblationAnimalsCathetersEquipment DesignKidneyModels, AnimalRadiographyRenal ArterySus scrofaSympathectomySympathetic Nervous SystemTime FactorsVascular System Injuries

Identifiers

PMID21796327
OpenAlexW2060989550

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Registered trials

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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.