Evidence map›Paper›PMID 39965045›Full record

ArticleCirculation. Cardiovascular interventions2025

Pathology of Self-Expanding Transcatheter Aortic Bioprostheses and Hypoattenuated Leaflet Thickening.

Yu Sato, Sho Torii, Kenji Kawai, Kazuyuki Yahagi, Matthew Kutyna, Rika Kawakami, Takao Konishi, Aimee E Vozenilek, Hiroyuki Jinnouchi, Atsushi Sakamoto and 13 more

Abstract readComparative Study
In one paragraph

Article in Circulation. Cardiovascular interventions, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Article
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  10. Review
  11. Can a CT scan characterise and predict HALT evolution?EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    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

23 authors.

Yu SatoCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).
Sho ToriiCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).ORCID 0000-0002-5934-0427
Kenji KawaiCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).ORCID 0000-0001-7160-9508
Kazuyuki YahagiCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).
Matthew KutynaCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).
Rika KawakamiCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).ORCID 0000-0002-8896-6971
Takao KonishiCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).
Aimee E VozenilekCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).ORCID 0000-0001-5928-8844
Hiroyuki JinnouchiCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).
Atsushi SakamotoCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).ORCID 0000-0002-6372-9224
Hiroyoshi MoriCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).ORCID 0000-0001-6060-3485
Anne CornelissenCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).ORCID 0000-0002-5452-4657
Masayuki MoriCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).ORCID 0000-0002-5224-8206
Takamasa TanakaCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).
Teruo SekimotoCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).ORCID 0000-0002-1054-9406
Robert KutysCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).
Saikat Kumar B GhoshCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).
John K ForrestYale University School of Medicine, New Haven, CT (J.K.F.).ORCID 0000-0003-4079-3482
Michael J ReardonHouston Methodist DeBakey Heart and Vascular Center, TX (M.J.R.).ORCID 0000-0002-2880-6132
Maria E RomeroCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).
Frank D KolodgieCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).
Renu VirmaniCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).ORCID 0000-0003-1879-0015
Aloke V FinnCVPath Institute Inc, Gaithersburg, MD (Y.S., S.T., K.K., K.Y., M.K., R. Kawakami, T.K., A.E.V., H.J., A.S., H.M., A.C., M.M., T.T., T.S., R. Kutys, S.K.B.G., M.E.R., F.D.K., R.V., A.V.F.).ORCID 0000-0003-0359-0184

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundHypoattenuated leaflet thickening (HALT) is believed to reflect leaflet thrombosis; however, no systematic histological examination of HALT has ever been performed. The aim of this study was to evaluate histological findings of explanted self-expanding transcatheter aortic bioprosthetic valves from clinical trials and to compare microCT findings of suspected HALT with histology findings of valve thrombosis and its characterization over time.

methodsA total of 123 self-expanding transcatheter aortic valves were collected through autopsy (n=89) or surgical explant (n=34) from 11 CoreValve/Evolut clinical trials. Histological findings in transcatheter aortic valve leaflets were evaluated. MicroCT imaging was used to evaluate HALT in histology. Cases with infective endocarditis (10/123) or transcatheter aortic valve-in-surgical aortic valve procedures (3/123) were excluded.

resultsA total of 110 cases were divided into 3 groups based on implant duration: <30 days (n=42), 30 to 365 days (n=35), and >365 days (n=33). Thrombus and inflammation scores were consistent across groups, while scores for pannus, calcification, and structural change increased over time. The analysis of leaflet thickening by histology was performed on 320 leaflets and any degree of leaflet thickening was observed in 46.5% (149/320) of leaflets. Histologically, leaflet thickening was confirmed as an acute, organizing, and organized thrombus (ie, pannus). In the <30 days group, all leaflet thickening was due to acute thrombus, while most thrombi were organized >30 days. The types of thrombi could not be differentiated by microCT imaging.

conclusionsHALT represents the presence of a thrombus and its progression. Our data suggest that treatment of HALT would likely be most effective in the early stages before the thrombus becomes organized and emphasizes the need for early detection.

Indexed as

Aortic ValveBioprosthesisHeart Valve ProsthesisThrombosisTranscatheter Aortic Valve ReplacementAgedAged, 80 and overAutopsyFemaleHumansMaleProsthesis DesignTime FactorsTreatment OutcomeX-Ray Microtomographyaortic valveendocarditishistologythrombosisX-ray microtomography

Identifiers

PMID39965045
PMCPMC11827688

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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.