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
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.
Authors
- Tatsuya Nishii (ORCID: https://orcid.org/0000-0001-8353-2181)
- Naoki Yoshimura (ORCID: https://orcid.org/0000-0002-4265-0947)
- Shigemitsu Iwai (ORCID: https://orcid.org/0000-0002-0031-5227)
- Toshiaki Hisada (ORCID: https://orcid.org/0000-0001-8091-9567)
- Yasutaka Hirata (ORCID: https://orcid.org/0000-0003-1673-6891)
- Yasuhiro Kotani (ORCID: https://orcid.org/0000-0002-7820-288X)
- Takaya Hoashi (ORCID: https://orcid.org/0000-0003-0320-3682)
- Akio Ikai (ORCID: https://orcid.org/0000-0002-5737-7293)
- Takeshi Shinkawa (ORCID: https://orcid.org/0000-0003-0656-4053)
- Shingo Kasahara (ORCID: https://orcid.org/0000-0002-3698-4836)
- Ryo Inuzuka (ORCID: https://orcid.org/0000-0001-7501-689X)
- Masaaki Yamagishi (ORCID: https://orcid.org/0000-0003-2846-9161)
- Isao Shiraishi (ORCID: https://orcid.org/0000-0003-4801-7955)
- Satoshi Yasukochi (ORCID: https://orcid.org/0000-0002-7283-5248)
- Kenichi Kurosaki (ORCID: https://orcid.org/0000-0001-7943-8221)
- Hiroyuki Yamagishi (ORCID: https://orcid.org/0000-0002-9756-3744)
- Hajime Ichikawa (ORCID: https://orcid.org/0000-0003-0858-1017)
- Kisaburo Sakamoto (ORCID: https://orcid.org/0000-0001-7859-7853)
- Keiichi Hirose
- Yoshiaki Kato (ORCID: https://orcid.org/0000-0002-9123-6363)
- Takaaki Suzuki (ORCID: https://orcid.org/0009-0006-5126-9474)
- Masaaki Kawada
Institutions
- Jichi Medical University (JP)
- Keio University (JP)
- Kyoto Prefectural University of Medicine (JP)
- Okayama University Hospital (JP)
- National Cerebral and Cardiovascular Center (JP)
- Tokyo Women's Medical University (JP)
- Nagano Children's Hospital (JP)
- Shizuoka Children's Hospital (JP)
- University of Toyama (JP)
- The University of Tokyo (JP)
- Saitama Medical University (JP)
Publication Details
- Journal
- Journal of Cardiovascular Development and Disease
- Published
- 2024-12-03
- DOI
- https://doi.org/10.3390/jcdd11120387
- Citations
- 1
- Primary Topic
- Anatomy and Medical Technology
- Type
- article
- Field-Weighted Citation Impact
- 0.18