Evidence map›Paper›PMID 30341735›Full record

ArticleAnnals of biomedical engineering2019

Novel In Vitro Test Systems and Insights for Transcatheter Mitral Valve Design, Part I: Paravalvular Leakage.

Eric L Pierce, Vahid Sadri, Beatrice Ncho, Keshav Kohli, Siddhi Shah, Ajit P Yoganathan

Abstract read
PubMed Full text at PMC Publisher
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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. 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

6 authors.

Eric L PierceWallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, 387 Technology Circle NW, Suite 200, Atlanta, GA, 30313, USA.
Vahid SadriWallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, 387 Technology Circle NW, Suite 200, Atlanta, GA, 30313, USA.
Beatrice NchoWallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, 387 Technology Circle NW, Suite 200, Atlanta, GA, 30313, USA.
Keshav KohliWallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, 387 Technology Circle NW, Suite 200, Atlanta, GA, 30313, USA.
Siddhi ShahWallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, 387 Technology Circle NW, Suite 200, Atlanta, GA, 30313, USA.
Ajit P YoganathanWallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, 387 Technology Circle NW, Suite 200, Atlanta, GA, 30313, USA. ajit.yoganathan@bme.gatech.edu.ORCID http://orcid.org/0000-0001-5818-1316

Funding

Echocardiography to Predict Recurrent IMR After Surgical Mitral Valve ReplacementR01HL103723 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI GORMAN, ROBERT C, HUNG, JUDY W · 2011 to 2020
$5.3M
Optimized Mitral AnnuloplastyR01HL147256 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI DASI, LAKSHMI PRASAD, GORMAN, ROBERT C · 2019 to 2022
$3.1M
Quantitative Force Measurements to Optimize Valve Repair for Ischemic MRR01HL113216 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI GORMAN, JOSEPH H, YOGANATHAN, AJIT P · 2013 to 2016
$2.9M
NHLBI NIH HHS R01 HL103723NHLBI NIH HHS R01 HL113216NHLBI NIH HHS R01HL113216NHLBI NIH HHS R01 HL147256
6 · The paper itself

Abstract

While transcatheter mitral valve (TMV) replacement technology has great clinical potential for surgically inoperable patients suffering from mitral regurgitation, no TMV has yet achieved regulatory approval. The diversity of devices currently under development reflects a lack of consensus regarding optimal design approaches. In Part I of this two-part study, a test system was developed for the quantification of paravalvular leakage (PVL) following deployment of a TMV or TMV-like device in pressurized, explanted porcine hearts (N = 7). Using this system, PVL rate was investigated as a function of steady trans-mitral pressure (ΔP), TMV shape, and TMV-annular oversizing, using a series of "mock TMV plug" devices. Across all devices, PVL was found to approximately trend with the square of ΔP. PVL rates were approximately 0-15 mL/s under hypotensive pressure, 10-40 mL/s under normotension, and 30-85 mL/s under severe hypertension. D-shaped devices significantly reduced PVL vs. circular devices; however, this effect was diminished upon oversizing to the annulus by 6 mm inter-trigonal distance. In conclusion, this steady pressure, in vitro test system was effective to compare PVL performance across TMV-like designs. PVL exhibited complex dynamics in terms of its response to transvalvular pressure and TMV profile.

Indexed as

Heart Valve ProsthesisMitral ValvePostoperative ComplicationsTranscatheter Aortic Valve ReplacementAnimalsSwineDevice–tissue interactionFlow rateIn VitroMedical deviceMitral valveParavalvular leakageTest methodTranscatheterTranscatheter mitral valve implantationTranscatheter mitral valve replacement

Identifiers

PMID30341735
PMCPMC6344268

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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.