Evidence map›Paper›PMID 41087715›Full record

ArticleAnnals of biomedical engineering2025

Preclinical Validation of a Patient-Specific Patch-Planning Workflow for Congenital Cardiovascular Reconstruction.

Shannen B Kizilski, Dominic P Recco, Jocelyn M Davee, Ashley Masterson, Jiang Yao, Patrick D Earley, Nicholas E Kneier, Kenneth I Aycock, Brent A Craven, Pras Pathmanathan and 2 more

Abstract readValidation Study
In one paragraph

Article in Annals of biomedical engineering, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Shannen B Kizilski *Department of Cardiac Surgery, Boston Children's Hospital, 330 Longwood Avenue, Enders Building, 3rd Floor, Boston, MA, 02115, USA. Shannen.Kizilski@childrens.harvard.edu.
Dominic P Recco *Department of Cardiac Surgery, Boston Children's Hospital, 330 Longwood Avenue, Enders Building, 3rd Floor, Boston, MA, 02115, USA.ORCID http://orcid.org/0000-0003-2306-6443
Jocelyn M DaveeDepartment of Cardiac Surgery, Boston Children's Hospital, 330 Longwood Avenue, Enders Building, 3rd Floor, Boston, MA, 02115, USA.
Ashley MastersonDassault Systèmes, Wichita, KS, USA.
Jiang YaoDassault Systèmes, Johnston, RI, USA.
Patrick D EarleyDepartment of Cardiac Surgery, Boston Children's Hospital, 330 Longwood Avenue, Enders Building, 3rd Floor, Boston, MA, 02115, USA.
Nicholas E KneierDepartment of Cardiac Surgery, Boston Children's Hospital, 330 Longwood Avenue, Enders Building, 3rd Floor, Boston, MA, 02115, USA.
Kenneth I AycockOffice of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Brent A CravenOffice of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Pras PathmanathanOffice of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Peter E HammerDepartment of Cardiac Surgery, Boston Children's Hospital, 330 Longwood Avenue, Enders Building, 3rd Floor, Boston, MA, 02115, USA.
David M HogansonDepartment of Cardiac Surgery, Boston Children's Hospital, 330 Longwood Avenue, Enders Building, 3rd Floor, Boston, MA, 02115, USA.

Funding

Pediatric Surgeon-Scientist Training Program in Vascular DiseasesT32HD104582 · NICHD · BOSTON CHILDREN'S HOSPITAL · PI Joyce E. Bischoff, Arin K. Greene · 2022 to 2026
$1.1M
Eunice Kennedy Shriver National Institute of Child Health and Human Development T32HD104582NICHD NIH HHS T32 HD104582
6 · The paper itself

Abstract

purposeBranch pulmonary artery (BPA) reconstruction is associated with high reintervention rates. We present in vitro validation of a patch-planning workflow accounting for vessel prestretch, tissue properties, and suture uptake, to achieve targeted reconstructed dimensions.

methodsTwo physiologically compliant, centrally stenosed BPA silicone models were created to represent neonatal and child-age repairs. Preoperative CTs were segmented to create 3D models for virtual planning. Patches were designed to restore stenotic regions to target diameters under two physiological pressure extremes, accounting for model and patch material distensibility. Finite-element simulation determined the loaded flat patch configuration. Analytical transformation produced unloaded designs for patches planned at high pressure. Designs were laser projected onto patch surfaces, patches sutured, and postoperative CTs acquired (n ≥ 3 per model/pressure/material). Virtual model credibility was evaluated following a recent credibility assessment framework.

resultsPatches designed for low vs. high pressure differed in size by up to 25%. All samples were reconstructed to within 0.8 mm of the target diameter (n = 45), and all but three were within z-score ± 0.5. Through credibility assessment, we verified that simulations introduced < 3% error versus the analytical solution. Patch size was most sensitive to one standard deviation change in patch stiffness. From experiments, suture uptake exhibited highest variability from allocated offset.

conclusionPreclinical evaluation of a patch-planning workflow demonstrated accurate reconstruction of BPA stenosis. Incorporation of material properties is essential to achieve targeted reconstructed dimensions under physiological conditions. Model credibility assessment and in vitro validation of more complex patient-specific anatomy will precede prospective clinical trials.

Indexed as

Blood Vessel ProsthesisModels, CardiovascularPulmonary ArteryHumansInfant, NewbornWorkflowBiomechanicsCongenital heart diseasePulmonary artery stenosisSurgical planning

Identifiers

PMID41087715
PMCPMC12685992

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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.