Evidence map›Paper›PMID 30194551›Full record

ArticleAnnals of biomedical engineering2019

Novel Polymeric Valve for Transcatheter Aortic Valve Replacement Applications: In Vitro Hemodynamic Study.

Oren M Rotman, Brandon Kovarovic, Wei-Che Chiu, Matteo Bianchi, Gil Marom, Marvin J Slepian, Danny Bluestein

Abstract read
In one paragraph

Article in Annals of biomedical engineering, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
–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

33 citing papers in PubMed.

  1. Article
  2. Innovation and Challenges in Materials for Transcatheter Aortic Valves.Journal of cardiovascular translational research · 2026
    Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Early Feasibility Study of a Hybrid Tissue-Engineered Mitral Valve in an Ovine Model.Journal of cardiovascular development and disease · 2024
    Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Review
  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.

Oren M RotmanDepartment of Biomedical Engineering, Stony Brook University, Stony Brook, NY, 11794-8151, USA.
Brandon KovarovicDepartment of Biomedical Engineering, Stony Brook University, Stony Brook, NY, 11794-8151, USA.
Wei-Che ChiuDepartment of Biomedical Engineering, Stony Brook University, Stony Brook, NY, 11794-8151, USA.
Matteo BianchiDepartment of Biomedical Engineering, Stony Brook University, Stony Brook, NY, 11794-8151, USA.
Gil MaromDepartment of Biomedical Engineering, Stony Brook University, Stony Brook, NY, 11794-8151, USA.
Marvin J SlepianDepartment of Biomedical Engineering, University of Arizona, Tucson, AZ, 85721, USA.
Danny BluesteinDepartment of Biomedical Engineering, Stony Brook University, Stony Brook, NY, 11794-8151, USA. danny.bluestein@stonybrook.edu.

Funding

Optimizing Cardiovascular Device Thromboresistance for Eliminating AnticoagulantsU01EB012487 · NIBIB · STATE UNIVERSITY NEW YORK STONY BROOK · PI BLUESTEIN, DANNY · 2010 to 2014
$6.9M
A Novel Polymeric Valve for Transcatheter Aortic Valve ReplacementR41HL134418 · NHLBI · POLYNOVA CARDIOVASCULAR, INC · PI BLUESTEIN, DANNY · 2017 to 2018
$225k
National Heart, Lung, and Blood Institute R41-HL134418National Institute of Biomedical Imaging and Bioengineering U01EB012487NHLBI NIH HHS R41 HL134418NIBIB NIH HHS U01 EB012487
6 · The paper itself

Abstract

Transcatheter aortic valve replacement (TAVR) is a minimally-invasive approach for treating severe aortic stenosis. All clinically-used TAVR valves to date utilize chemically-fixed xenograft as the leaflet material. Inherent limitation of the tissue (e.g., calcific degeneration) motivates the search for alternative leaflet material. Here we introduce a novel polymeric TAVR valve that was designed to address the limitations of tissue-valves. In this study, we experimentally evaluated the hemodynamic performance of the valve and compared its performance to clinically-used valves: a gold standard surgical tissue valve, and a TAVR valve. Our comparative testing protocols included: (i) baseline hydrodynamics (ISO:5840-3), (ii) complementary patient-specific hydrodynamics in a dedicated system, and (iii) thrombogenicity. The patient-specific testing system facilitated comparing TAVR valves performance under more realistic conditions. Baseline hydrodynamics results at CO 4-7 L/min showed superior effective orifice area (EOA) for the polymer valve, most-notably as compared to the reference TAVR valve. Regurgitation fraction was higher in the polymeric valve, but within the ISO minimum requirements. Thrombogenicity trends followed the EOA results with the polymeric valve being the least thrombogenic, and clinical TAVR being the most. Hemodynamic-wise, the results strongly indicate that our polymeric TAVR valve can outperform tissue valves.

Indexed as

Aortic ValveAortic Valve StenosisBioprosthesisHeart Valve ProsthesisHemodynamicsModels, CardiovascularTranscatheter Aortic Valve ReplacementHumansThrombosisAortic stenosisHeart valveMedical deviceProsthetic heart valveTAVITAVRThrombogenicityValve hydrodynamics

Identifiers

PMID30194551
PMCPMC6475193

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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.