Evidence map›Paper›PMID 39909987›Full record

ArticleCardiovascular engineering and technology2025

A Novel Transcatheter Device to Treat Calcific Aortic Valve Stenosis: An Ex Vivo Study.

Francesca Perico, Eleonora Salurso, Fabio Pappalardo, Michal Jaworek, Enrico Fermi, Maria Chiara Palmieri, Flavius Constantin Apostu, Riccardo Vismara, Marco Vola

Abstract read
In one paragraph

Article in Cardiovascular engineering and technology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

9 authors.

Francesca PericoDepartment of Electronics, Information and Bioengineering, Politecnico di Milano, Via Golgi 39, 20133, Milan, Italy. francesca.perico@polimi.it.ORCID 0000-0003-0704-5108
Eleonora SalursoDepartment of Electronics, Information and Bioengineering, Politecnico di Milano, Via Golgi 39, 20133, Milan, Italy.
Fabio PappalardoDepartment of Electronics, Information and Bioengineering, Politecnico di Milano, Via Golgi 39, 20133, Milan, Italy.
Michal JaworekDepartment of Electronics, Information and Bioengineering, Politecnico di Milano, Via Golgi 39, 20133, Milan, Italy.
Enrico FermiAorticLab S.r.l., Bioindustry Park, Colleretto Giacosa, Turin, Italy.
Maria Chiara PalmieriAorticLab S.r.l., Bioindustry Park, Colleretto Giacosa, Turin, Italy.
Flavius Constantin ApostuAorticLab S.r.l., Bioindustry Park, Colleretto Giacosa, Turin, Italy.
Riccardo VismaraDepartment of Electronics, Information and Bioengineering, Politecnico di Milano, Via Golgi 39, 20133, Milan, Italy.
Marco VolaHôpital Cardiologique et Pneumologique Louis-Pradel, Hospices Civils de Lyon, Bron, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAortic valve stenosis (AVS) is the most common valvular disease in developed countries. Surgical or transcatheter bioprosthetic aortic valve (AV) replacement is the standard treatment for severe AVS. However, bioprostheses are prone to structural degeneration. Hence, in terms of lifetime management, there is a need for therapies that can postpone AV replacement. With the aim of fragmenting calcifications and restoring AV leaflets flexibility, a new transcatheter debridement device (TDD) exploiting ultrasound is under development. We performed an ex-vivo study on human hearts to quantify how TDD treatment affects stenotic AVs hemodynamic. Additionally, a qualitative histological analysis was performed to assess TDD's impact on AV leaflets.

methodsThree human hearts affected by AVS were characterized pre- and post-treatment in an ex-vivo beating heart simulator. To replicate physiological flowrates, a pulsatile pump was connected to the left ventricle, while a systemic impedance simulator connected to the aortic root and a reservoir connected to the left atrium closed the hydraulic circuit. Transvalvular pressure drop (ΔPsys), backflow volume, and effective orifice area (EOA) were evaluated. For histological analysis, AV leaflets sections were stained with Haematoxylin/Eosin and AlizarineRedS to highlight calcifications.

resultsThe treatment induced a reduction in ΔPsys in all tested samples, improving EOA, but caused an increase in backflow volume. Moreover, histology suggested AV leaflets integrity.

conclusionsThe TDD procedure improved AV fluid-dynamics during systole in all tested samples, without evidence of damage to tissues. This suggests TDD could be a promising option to postpone AV replacement for patients with AVS.

Indexed as

Aortic ValveAortic Valve StenosisCalcinosisHeart Valve ProsthesisHeart Valve Prosthesis ImplantationTranscatheter Aortic Valve ReplacementUltrasonic TherapyAgedBioprosthesisFemaleHemodynamicsHumansMaleProsthesis DesignAortic valve stenosisEx-vivo set upHuman heartTranscatheter debridement deviceUltrasound shockwave

Identifiers

PMID39909987
PMCPMC12130158

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.