Evidence map›Paper›PMID 41018913›Full record

ArticleAPL bioengineering2025

Credibility assessment of patient-specific modeling in transcatheter aortic valve implantation. I. A population-based validation of patient-specific modeling.

Chiara Catalano, Roberta Scuoppo, Tahir Turgut, Vincent Bouwman, Nils Götzen, Stefano Cannata, Giovanni Gentile, Caterina Gandolfo, Salvatore Pasta

Erratum issuedAbstract read
In one paragraph

Article in APL bioengineering, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Chiara CatalanoDepartment of Engineering, Università degli Studi di Palermo, Viale delle Scienze Ed. 8, Palermo, Italy.ORCID https://orcid.org/0000-0001-6567-061X
Roberta ScuoppoDepartment of Engineering, Università degli Studi di Palermo, Viale delle Scienze Ed. 8, Palermo, Italy.
Tahir Turgut4RealSim Services BV, Groene Dijk 2B, 3401 NJ IJsselstein, Netherlands.ORCID https://orcid.org/0009-0006-9472-4529
Vincent Bouwman4RealSim Services BV, Groene Dijk 2B, 3401 NJ IJsselstein, Netherlands.ORCID https://orcid.org/0009-0007-5142-5737
Nils Götzen4RealSim Services BV, Groene Dijk 2B, 3401 NJ IJsselstein, Netherlands.ORCID https://orcid.org/0009-0006-7132-0783
Stefano CannataDepartment for the Treatment and Study of Cardiothoracic Diseases and Cardiothoracic Transplantation, IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad alta Specializzazione), Palermo, Italy.
Giovanni GentileRadiology Unit, Department of Diagnostic and Therapeutic Services, IRCCS ISMETT, via Tricomi, 5, Palermo, Italy.ORCID https://orcid.org/0000-0003-3767-815X
Caterina GandolfoDepartment for the Treatment and Study of Cardiothoracic Diseases and Cardiothoracic Transplantation, IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad alta Specializzazione), Palermo, Italy.ORCID https://orcid.org/0000-0001-6049-8961

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Transcatheter aortic valve implantation (TAVI) has become a standardized treatment for aortic valve stenosis, supported by computational modeling to enhance procedural planning. However, the credibility of TAVI simulations requires rigorous validation following regulatory standards. This study aims to perform a population-based validation of the structural and hemodynamic simulation performance of the SAPIEN 3 (S3) Ultra device by comparing computational predictions with clinical post-TAVI data, following the ASME V&V 40 framework. A patient-specific structural model followed by fluid-structure interaction was developed to simulate S3 deployment and then assess post-TAVI hemodynamics in 20 patients. Structural parameters (device diameters) and hemodynamic indices (effective orifice area, EOA, and transmural pressure gradient, TPG) were extracted. Validation was performed using empirical cumulative distribution function (ECDF) analysis, with an acceptance threshold of 5% for model credibility. EOA and TPG predictions showed reasonable agreement with echocardiographic data (errors within 10%). ECDF-based comparison demonstrated a high level of accuracy for device diameters (≤5% area metric), whereas hemodynamic parameters exhibited slightly greater discrepancies, potentially due to clinical measurement variability. This study establishes a robust computational validation framework for patient-specific TAVI modeling, ensuring regulatory compliance and clinical applicability. These findings highlight the potential of

Identifiers

PMID41018913
PMCPMC12471802

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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.