Evidence map›Paper›PMID 26409002›Full record

ArticleBiomaterials2015

6-month aortic valve implantation of an off-the-shelf tissue-engineered valve in sheep.

Zeeshan Syedain, Jay Reimer, Jillian Schmidt, Matthew Lahti, James Berry, Richard Bianco, Robert T Tranquillo

Abstract read
In one paragraph

Article in Biomaterials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

53 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Growing Heart Valve Implants for Children.Journal of cardiovascular development and disease · 2023
    Review
  11. Article
  12. Review
  13. Article
  14. Tissue engineering: Relevance to neonatal congenital heart disease.Seminars in fetal & neonatal medicine · 2022
    Review
  15. Review
  16. Review
  17. Endothelial Progenitor Cell-BasedFrontiers in bioengineering and biotechnology · 2022
    Article
  18. Chronic haemodynamic performance of a biorestorative transcatheter heart valve in an ovine model.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2021
    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

7 authors.

Zeeshan SyedainDepartments of Biomedical Engineering, University of Minnesota, United States.
Jay ReimerDepartments of Biomedical Engineering, University of Minnesota, United States.
Jillian SchmidtDepartments of Biomedical Engineering, University of Minnesota, United States.
Matthew LahtiExperimental Surgical Services, University of Minnesota, United States.
James BerryExperimental Surgical Services, University of Minnesota, United States.
Richard BiancoExperimental Surgical Services, University of Minnesota, United States.
Robert T TranquilloDepartments of Biomedical Engineering, University of Minnesota, United States; Department of Chemical Engineering & Material Science, University of Minnesota, United States. Electronic address: tranquil@umn.edu.

Funding

University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR000114 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2012 to 2015
$35.0M
Tissue-engineered pulmonic valve grown from human cells for pediatric patientsR01HL107572 · NHLBI · UNIVERSITY OF MINNESOTA · PI TRANQUILLO, ROBERT T · 2011 to 2021
$6.2M
NCATS NIH HHS UL1 TR000114NCATS NIH HHS UL1TR000114NHLBI NIH HHS HL107572NHLBI NIH HHS R01 HL107572
6 · The paper itself

Abstract

Diseased aortic valves often require replacement, with over 30% of the current aortic valve surgeries performed in patients who will outlive a bioprosthetic valve. While many promising tissue-engineered valves have been created in the lab using the cell-seeded polymeric scaffold paradigm, none have been successfully tested long-term in the aortic position of a pre-clinical model. The high pressure gradients and dynamic flow across the aortic valve leaflets require engineering a tissue that has the strength and compliance to withstand high mechanical demand without compromising normal hemodynamics. A long-term preclinical evaluation of an off-the-shelf tissue-engineered aortic valve in the sheep model is presented here. The valves were made from a tube of decellularized cell-produced matrix mounted on a frame. The engineered matrix is primarily composed of collagen, with strength and organization comparable to native valve leaflets. In vitro testing showed excellent hemodynamic performance with low regurgitation, low systolic pressure gradient, and large orifice area. The implanted valves showed large-scale leaflet motion and maintained effective orifice area throughout the duration of the 6-month implant, with no calcification. After 24 weeks implantation (over 17 million cycles), the valves showed no change in tensile mechanical properties. In addition, histology and DNA quantitation showed repopulation of the engineered matrix with interstitial-like cells and endothelialization. New extracellular matrix deposition, including elastin, further demonstrates positive tissue remodeling in addition to recellularization and valve function. Long-term implantation in the sheep model resulted in functionality, matrix remodeling, and recellularization, unprecedented results for a tissue-engineered aortic valve.

Indexed as

Heart Valve ProsthesisAnimalsAortic ValveBiocompatible MaterialsBioprosthesisCollagenExtracellular MatrixFibrinFibroblastsHeart Valve DiseasesHemodynamicsHumansPolymersProsthesis DesignSheepSkinBiocompatible MaterialsCollagenFibrinPolymersAortic valve diseaseDecellualrized biomaterialHeart valveMatrix remodelingTissue engineering

Identifiers

PMID26409002
PMCPMC5520964

What OpenQuestion holds

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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.