Evidence map›Paper›PMID 39728278›Full record

ArticleJournal of cardiovascular development and disease2024

Evaluation of the Efficacy and Accuracy of Super-Flexible Three-Dimensional Heart Models of Congenital Heart Disease Made via Stereolithography Printing and Vacuum Casting: A Multicenter Clinical Trial.

Isao Shiraishi, Masaaki Yamagishi, Takaya Hoashi, Yoshiaki Kato, Shigemitsu Iwai, Hajime Ichikawa, Tatsuya Nishii, Hiroyuki Yamagishi, Satoshi Yasukochi, Masaaki Kawada and 12 more

Abstract read
In one paragraph

Article in Journal of cardiovascular development and disease, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Review
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

22 authors.

Isao ShiraishiDepartment of Pediatric Cardiology, National Cerebral and Cardiovascular Center, Suita 564-8565, Japan.ORCID 0000-0003-4801-7955
Masaaki YamagishiDepartment of Pediatric Cardiovascular Surgery, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan.
Takaya HoashiDepartment of Pediatric Cardiac Surgery, National Cerebral and Cardiovascular Center, Suita 564-8565, Japan.
Yoshiaki KatoDepartment of Pediatric Cardiology, National Cerebral and Cardiovascular Center, Suita 564-8565, Japan.ORCID 0000-0002-9123-6363
Shigemitsu IwaiDepartment of Pediatric Cardiac Surgery, National Cerebral and Cardiovascular Center, Suita 564-8565, Japan.ORCID 0000-0002-0031-5227
Hajime IchikawaDepartment of Pediatric Cardiac Surgery, National Cerebral and Cardiovascular Center, Suita 564-8565, Japan.ORCID 0000-0003-0858-1017
Tatsuya NishiiDepartment of Radiology, National Cerebral and Cardiovascular Center, Suita 564-8565, Japan.ORCID 0000-0001-8353-2181
Hiroyuki YamagishiDepartment of Pediatrics, Keio University School of Medicine, Tokyo 160-8582, Japan.
Satoshi YasukochiHeart Center, Nagano Children' Hospital, Azumino 399-8288, Japan.ORCID 0000-0002-7283-5248
Masaaki KawadaDivision of Pediatric and Congenital Cardiovascular Surgery, Jichi Children's Medical Center Tochigi, Shimotsuke 329-0498, Japan.
Takaaki SuzukiDepartment of Pediatric Cardiac Surgery, Saitama Medical University International Medical Center, Hidaka 350-1298, Japan.ORCID 0009-0006-5126-9474
Takeshi ShinkawaDepartment of Cardiovascular Surgery, Tokyo Women's Medical University, Tokyo 162-8666, Japan.ORCID 0000-0003-0656-4053
Naoki YoshimuraDepartment of Thoracic and Cardiovascular Surgery, Graduate School of Medicine, University of Toyama, Toyama 930-0194, Japan.
Ryo InuzukaDepartment of Pediatrics, The University of Tokyo, Tokyo 113-8655, Japan.ORCID 0000-0001-7501-689X
Yasutaka HirataDepartment of Cardiovascular Surgery, The University of Tokyo, Tokyo 113-8655, Japan.ORCID 0000-0003-1673-6891
Keiichi HiroseDepartment of Cardiovascular Surgery, Mt. Fuji Shizuoka Children's Hospital, Shizuoka 420-8660, Japan.
Akio IkaiDepartment of Cardiovascular Surgery, Mt. Fuji Shizuoka Children's Hospital, Shizuoka 420-8660, Japan.
Kisaburo SakamotoDepartment of Cardiovascular Surgery, Mt. Fuji Shizuoka Children's Hospital, Shizuoka 420-8660, Japan.
Yasuhiro KotaniDepartment of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences and Okayama University Hospital, Okayama 700-8558, Japan.ORCID 0000-0002-7820-288X
Shingo KasaharaDepartment of Cardiovascular Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences and Okayama University Hospital, Okayama 700-8558, Japan.
Toshiaki HisadaGraduate School of Frontier Sciences, The University of Tokyo, Kashiwa 227-0871, Japan.
Kenichi KurosakiDepartment of Pediatric Cardiology, National Cerebral and Cardiovascular Center, Suita 564-8565, Japan.ORCID 0000-0001-7943-8221

Funding

Japan Agency for Medical Research and Development 16hk0102010h0003, 19he1302004j0003
6 · The paper itself

Abstract

Three-dimensional (3D) printing is an advanced technology for accurately understanding anatomy and supporting the successful surgical management of complex congenital heart disease (CHD). We aimed to evaluate whether our super-flexible 3D heart models could facilitate preoperative decision-making and surgical simulation for complex CHD. The super-flexible heart models were fabricated by stereolithography 3D printing of the internal and external contours of the heart from cardiac computed tomography (CT) data, followed by vacuum casting with a polyurethane material similar in elasticity to a child's heart. Nineteen pediatric patients with complex CHD were enrolled (median age, 10 months). The primary endpoint was defined as the percentage of patients rated as "essential" on the surgeons' postoperative 5-point Likert scale. The accuracy of the models was validated by a non-destructive method using industrial CT. The super-flexible heart models allowed detailed anatomical diagnosis and simulated surgery with incisions and sutures. Thirteen patients (68.4%) were classified as "essential" by the primary surgeons after surgery, with a 95% confidence interval of 43.4-87.4%, meeting the primary endpoint. The product error within 90% of the total external and internal surfaces was 0.54 ± 0.21 mm. The super-flexible 3D heart models are accurate, reliable, and useful tools to assist surgeons in decision-making and allow for preoperative simulation in CHD.

Indexed as

3D printingclinical trialcongenital heart diseaseheart surgerysimulationstereolithographyvacuum casting

Identifiers

PMID39728278
PMCPMC11677195

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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.