Evidence map›Paper›PMID 39624936›Full record

ArticleEchocardiography (Mount Kisco, N.Y.)2024

Core Laboratory Versus Center-Reported Echocardiographic Assessment of the Native and Bioprosthetic Aortic Valve.

Bart J J Velders, Michiel D Vriesendorp, Neil J Weissman, Joseph F Sabik, Michael J Reardon, Francois Dagenais, Michael G Moront, Vivek Rao, Shinichi Fukuhara, Ralf Günzinger and 5 more

Registry-linked trialAbstract readMulticenter StudyComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Echocardiography (Mount Kisco, N.Y.), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02088554 (Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT02088554 naactive not recruitingnot on this map

Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease

TypeinterventionalSponsorMedtronic Cardiac SurgeryRan2014 to 2035Enrolled1,312ConditionsAortic StenosisArmsModel 400 aortic valve bioprosthesis
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

15 authors.

Bart J J VeldersCardiothoracic Surgery, Leiden University Medical Centre, Leiden, the Netherlands.ORCID 0000-0002-3999-4220
Michiel D VriesendorpCardiothoracic Surgery, Leiden University Medical Centre, Leiden, the Netherlands.
Neil J WeissmanCardiovascular Core Laboratories, MedStar Health Research Institute, and Georgetown University, Washington, District of Columbia, USA.
Joseph F SabikSurgery, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Michael J ReardonDepartment of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA.
Francois DagenaisDivision of Cardiac Surgery, Quebec Heart and Lung Institute, Quebec, Quebec, Canada.
Michael G MorontCardiothoracic Surgery, ProMedica Toledo Hospital, Toledo, Ohio, USA.
Vivek RaoDepartment of Cardiovascular Surgery, Peter Munk Cardiac Centre, Toronto General Hospital, Toronto, Ontario, Canada.
Shinichi FukuharaDepartment of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan, USA.
Ralf GünzingerDepartment of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany.
Wouter J van LeeuwenCardiothoracic Surgery, Erasmus Medical Center, Rotterdam, the Netherlands.
W Morris BrownCardiovascular Surgery, Piedmont Heart Institute, Atlanta, Georgia, USA.
Rolf H H GroenwoldClinical Epidemiology & Biomedical Data Science, Leiden University Medical Center, Leiden, the Netherlands.
Robert J M KlautzCardiothoracic Surgery, Leiden University Medical Centre, Leiden, the Netherlands.
Federico M AschCardiovascular Core Laboratories, MedStar Health Research Institute, and Georgetown University, Washington, District of Columbia, USA.

Funding

Medtronic
6 · The paper itself

Abstract

backgroundInsights into quantitative differences between core laboratory and center-reported echocardiographic assessment of the native and bioprosthetic aortic valve are lacking. We aimed to explore clinically relevant differences between these evaluations.

methodsData were used from the PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Pivotal Trial for the Avalus valve. In this trial, patients with an indication for surgical aortic valve replacement (SAVR) due to aortic stenosis or regurgitation (AR) were enrolled. Serial echocardiographic examinations were performed at each center and blindly reanalyzed by an independent echocardiographic core laboratory (ECL). For the bioprosthetic valve analysis, postoperative data throughout the 5-year follow-up were pooled. Differences between the ECL and the centers in continuous parameters were quantified in mean differences and intraclass correlation coefficients (ICCs). Agreement on AR, paravalvular leak (PVL), and prosthesis-patient mismatch (PPM) classification was investigated using Cohen's kappa coefficients.

resultsThe analysis on the native aortic valve was performed on 1118 echocardiograms. The relative mean difference was largest for the left ventricular outflow tract (LVOT) area, followed by stroke volume and effective orifice area (index), with center-reported values being 11%-7% higher. High ICCs of around 0.90 were observed for the parameters peak aortic jet velocity, mean pressure gradient, and the velocity-time integral across the aortic valve. Over 5000 echocardiograms were available for the bioprosthetic valve analysis. Therein, comparable results were observed. The kappa coefficient was 0.59 (95% confidence interval [CI] 0.56, 0.63) for agreement on native AR, 0.28 (95% CI 0.18, 0.37) for PVL, and 0.42 (95% CI 0.40, 0.44) for PPM.

conclusionsThere is high agreement between the ECL and clinical centers on continuous-wave Doppler-related measurements. In contrast, agreement is low for parameters that involve measurement of the LVOT diameter. These results provide important context for the interpretation of aortic valve performance in studies that lack central ECL evaluation.

trial registrationClinicalTrials.gov identifier: NCT02088554.

Indexed as

Aortic ValveBioprosthesisEchocardiographyHeart Valve ProsthesisAgedAortic Valve InsufficiencyAortic Valve StenosisFemaleHumansMaleReproducibility of ResultsTreatment Outcomebioprosthetic aortic valvecore laboratoryechocardiographyinterobserver variabilitynative aortic valve

Identifiers

PMID39624936
PMCPMC11613124

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Registered trials

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.