Evidence map›Paper›PMID 37934316›Full record

ArticleAnnals of biomedical engineering2024

A Novel Transcatheter Device for the Edge-to-Edge Treatment of Tricuspid Regurgitation: A Preliminary Evaluation.

Eleonora Salurso, Francesca Perico, Fabio Pappalardo, Marco Gard, Matteo Antoniotti, Eugenio Passanante, Daniele Zanotti, Michele De Bonis, Ottavio Alfieri, Riccardo Vismara

Open access · hybridAbstract read
In one paragraph

Article in Annals of biomedical engineering, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 26% 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

3 citing papers in PubMed, 3 citations in OpenAlex.

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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

10 authors at 2 institutions in 1 country.

Eleonora SalursoDepartment of Electronics, Information and Bioengineering, Politecnico di Milano, Via Golgi 39, 20133, Milan, Italy. eleonora.salurso@polimi.it.ORCID http://orcid.org/0000-0002-7704-3282
Francesca PericoDepartment 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.
Marco GardGard Consulting, Ivrea, Turin, Italy.
Matteo AntoniottiGard Consulting, Ivrea, Turin, Italy.
Eugenio PassananteStarTric s.r.l., Milan, Italy.
Daniele ZanottiStarTric s.r.l., Milan, Italy.
Michele De BonisStarTric s.r.l., Milan, Italy.
Ottavio AlfieriDepartment of Cardiac Surgery, San Raffaele University Hospital, Milan, Italy.
Riccardo VismaraDepartment of Electronics, Information and Bioengineering, Politecnico di Milano, Via Golgi 39, 20133, Milan, Italy.
Politecnico di Milano · ITSan Raffaele University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tricuspid regurgitation (TR) is the most common pathology of the tricuspid valve (TV), with significant mortality in severe cases. A well-established strategy to treat TR is represented by the clover surgical technique, which consists of stitching together the free edges of TV leaflets, producing a clover-shaped valvular orifice. Transcatheter treatments for TR constitute a valuable alternative for high-risk patients. In this work we investigated haemodynamic performances and safety of a novel device (StarTric device (STD)) aiming to perform the clover technique via percutaneous access. To assess haemodynamic performances, STD and clover were applied on porcine pathological TVs and tested. Fluid dynamic indexes of both strategies were compared to the pathological model. To evaluate device safety, forces exchanged between device and leaflets were compared to the extraction force (EF) required to STD to completely pass through the leaflet. Clover technique and STD induced a comparable TV backflow reduction (48% and 47%, respectively), with associated increase of TV flow in all tested conditions. Diastolic transvalvular pressure similarly increased indicating a reduction, though not significant, of the valvular orifice. Forces ranged from 1N to 1.71N, compared to an EF of 22.16 ± 8.6N. Force varied significantly amongst different working conditions (normotensive, mild, and severe hypertensive) for each leaflet, whilst no significative variation was found on different leaflets in the same working condition. In the adopted experimental scenario, STD demonstrated comparable efficacy to the surgical strategy in restoring TV haemodynamic. The forces acting on the leaflets following STD implantation were far lower when compared to EFs.

Indexed as

Heart Valve Prosthesis ImplantationTricuspid Valve InsufficiencyAnimalsCathetersHemodynamicsHumansSwineTreatment OutcomeTricuspid ValveClover techniquePercutaneous treatmentsTricuspid regurgitation

Identifiers

PMID37934316
PMCPMC10859327
OpenAlexW4388453690

What OpenQuestion holds

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LicenceCC BY
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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.