Evidence map›Paper›PMID 30845067›Full record

ArticleASAIO journal (American Society for Artificial Internal Organs : 1992)2020

In Vitro Durability and Stability Testing of a Novel Polymeric Transcatheter Aortic Valve.

Oren M Rotman, Brandon Kovarovic, Matteo Bianchi, Marvin J Slepian, Danny Bluestein

Open access · greenAbstract read
In one paragraph

Article in ASAIO journal (American Society for Artificial Internal Organs : 1992), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
1.8field-weighted citation impact, top 14% 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

23 citing papers in PubMed, 28 citations in OpenAlex.

  1. Review
  2. Article
  3. Innovation and Challenges in Materials for Transcatheter Aortic Valves.Journal of cardiovascular translational research · 2026
    Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Bioinspired functional materials for biomedical applications.Frontiers in bioengineering and biotechnology · 2026
    Review
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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

5 authors at 2 institutions in 1 country.

Oren M RotmanFrom Department of Biomedical Engineering, Stony Brook University, Stony Brook, New York.
Brandon KovarovicFrom Department of Biomedical Engineering, Stony Brook University, Stony Brook, New York.
Matteo BianchiFrom Department of Biomedical Engineering, Stony Brook University, Stony Brook, New York.
Marvin J SlepianDepartment of Biomedical Engineering, University of Arizona, Tucson, Arizona.
Danny BluesteinFrom Department of Biomedical Engineering, Stony Brook University, Stony Brook, New York.
Stony Brook University · USUniversity of Arizona · US

Funding

Optimizing Cardiovascular Device Thromboresistance for Eliminating AnticoagulantsU01EB012487 · NIBIB · STATE UNIVERSITY NEW YORK STONY BROOK · PI BLUESTEIN, DANNY · 2010 to 2014
$6.9M
Biomechanical Approaches and Technologies for Enhancing TAVR OutcomesU01EB026414 · NIBIB · STATE UNIVERSITY NEW YORK STONY BROOK · PI BLUESTEIN, DANNY · 2018 to 2022
$3.8M
A Novel Polymeric Valve for Transcatheter Aortic Valve ReplacementR41HL134418 · NHLBI · POLYNOVA CARDIOVASCULAR, INC · PI BLUESTEIN, DANNY · 2017 to 2018
$225k
NHLBI NIH HHS R41 HL134418NIBIB NIH HHS U01 EB012487NIBIB NIH HHS U01 EB026414
6 · The paper itself

Abstract

Transcatheter aortic valve replacement (TAVR) has emerged as an effective therapy for the unmet clinical need of inoperable patients with severe aortic stenosis (AS). Current clinically used tissue TAVR valves suffer from limited durability that hampers TAVR's rapid expansion to younger, lower risk patients. Polymeric TAVR valves optimized for hemodynamic performance, hemocompatibility, extended durability, and resistance to calcific degeneration offer a viable solution to this challenge. We present extensive in vitro durability and stability testing of a novel polymeric TAVR valve (PolyNova valve) using 1) accelerated wear testing (AWT, ISO 5840); 2) calcification susceptibility (in the AWT)-compared with clinically used tissue valves; and 3) extended crimping stability (valves crimped to 16 Fr for 8 days). Hydrodynamic testing was performed every 50M cycles. The valves were also evaluated visually for structural integrity and by scanning electron microscopy for evaluation of surface damage in the micro-scale. Calcium and phosphorus deposition was evaluated using micro-computed tomography (μCT) and inductive coupled plasma spectroscopy. The valves passed 400M cycles in the AWT without failure. The effective orifice area kept stable at 1.8 cm with a desired gradual decrease in transvalvular pressure gradient and regurgitation (10.4 mm Hg and 6.9%, respectively). Calcium and phosphorus deposition was significantly lower in the polymeric valve: down by a factor of 85 and 16, respectively-as compared to a tissue valve. Following the extended crimping testing, no tears nor surface damage were evident. The results of this study demonstrate the potential of a polymeric TAVR valve to be a viable alternative to tissue-based TAVR valves.

Indexed as

Heart Valve ProsthesisMaterials TestingStyrenesAortic Valve StenosisCalcinosisHemodynamicsHumansIn Vitro TechniquesTranscatheter Aortic Valve Replacementpoly(styrene-b-isobutylene-b-styrene)Styrenes

Identifiers

PMID30845067
PMCPMC7136031
OpenAlexW2922184763

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.