Evidence map›Paper›PMID 31231661›Full record

ReviewFrontiers in cardiovascular medicine2019

Preclinical Assessment of Cardiac Valve Substitutes: Current Status and Considerations for Engineered Tissue Heart Valves.

Benjamin L Zhang, Richard W Bianco, Frederick J Schoen

Abstract readReview
In one paragraph

Review in Frontiers in cardiovascular medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 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

31 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Preclinical Large AnimalCurrent cardiology reviews · 2023
    Pooled it
  2. Pooled it
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  7. Review
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  10. Review
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  12. Review
  13. Bicuspid Aortic Valve-Associated Regulatory Regions RevealArteriosclerosis, thrombosis, and vascular biology · 2023
    Article
  14. Article
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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

3 authors.

Benjamin L ZhangDepartment of Surgery, University of Minnesota, Minneapolis, MN, United States.
Richard W BiancoDepartment of Surgery, University of Minnesota, Minneapolis, MN, United States.
Frederick J SchoenDepartment of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tissue engineered heart valve (TEHV) technology may overcome deficiencies of existing available heart valve substitutes. The pathway by which TEHVs will undergo development and regulatory approval has several challenges. In this communication, we review: (1) the regulatory framework for regulation of medical devices in general and substitute heart valves in particular; (2) the special challenges of preclinical testing using animal models for TEHV, emphasizing the International Standards Organization (ISO) guidelines in document 5840; and (3) considerations that suggest a translational roadmap to move TEHV forward from pre-clinical to clinical studies and clinical implementation.

Indexed as

animal modelsheart valve substitutespreclinical studiesregulatory pathwaytissue engineered heart valvestranslation

Identifiers

PMID31231661
PMCPMC6566127

What OpenQuestion holds

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LicenceCC BY
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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.