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. 2024 Dec 3;11(12):387.
doi: 10.3390/jcdd11120387.

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  1 , Masaaki Yamagishi  2 , Takaya Hoashi  3   4 , Yoshiaki Kato  1 , Shigemitsu Iwai  3 , Hajime Ichikawa  3 , Tatsuya Nishii  5 , Hiroyuki Yamagishi  6 , Satoshi Yasukochi  7 , Masaaki Kawada  8 , Takaaki Suzuki  4 , Takeshi Shinkawa  9 , Naoki Yoshimura  10 , Ryo Inuzuka  11 , Yasutaka Hirata  12 , Keiichi Hirose  13 , Akio Ikai  13 , Kisaburo Sakamoto  13 , Yasuhiro Kotani  14 , Shingo Kasahara  14 , Toshiaki Hisada  15 , Kenichi Kurosaki  1
Affiliations

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 et al. J Cardiovasc Dev Dis. .

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 VSports手机版. 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. .

Keywords: 3D printing; clinical trial; congenital heart disease; heart surgery; simulation; stereolithography; vacuum casting V体育安卓版. .

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Conflict of interest statement

I. S. and K. K. received joint research funds from crossMedical Co. , Ltd V体育ios版. All other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Flowchart of the fabrication and evaluation of the super-flexible 3D heart models. The left side of the diagram shows the process used by the clinical institutes, and the right side shows the process used by the manufacturer.
Figure 2
Figure 2
Fabrication of full-scale and flexible 3D heart models. The (top panel) shows the image acquisition, segmentation, and stereolithography 3D printing process. The (bottom panel) shows the vacuum casting process using a silicone mold.
Figure 3
Figure 3
The measured stress–strain data points and the linear (blue) and the quadratic (orange) approximations.
Figure 4
Figure 4
Error validation of stereolithography and vacuum casting (Case #2). Errors in the external (A,B) and internal (C) surfaces are shown as a pseudocolor representation (arrows indicate the edge of the VSD). (D): Vector plot on the split surface of (C). (E): Histogram of the errors. (F): The deviation curve of the total surfaces. VSD: ventricular septal defect. *: identification mark.
Figure 5
Figure 5
Anatomical diagnosis using super-flexible 3D heart models. (A,B): Nine-month-old male infant with tetralogy of Fallot (Case #1). The white arrow indicates severe right ventricular outflow obstruction. (C,D): A 6-month-old female infant with DORV (non-committed VSD) and interrupted aortic arch (Case #8). (E,F): An 18-month-old female infant with right isomeric heart, large VSD, pulmonary stenosis, and total anomalous pulmonary venous drainage (Case #10). Arrowheads indicate small muscular VSDs, VSD: ventricular septal defect, TA: tricuspid annulus, RVAW: right ventricular anterior wall.
Figure 6
Figure 6
Simulated Norwood procedure (chimney reconstruction of the aortic arch [18,19] in a 3-month-old infant with hypoplastic left heart syndrome (Case #15)). Asterisks in (A–F) indicate the hypoplastic aortic arch. SVC: superior vena cava, aAo: ascending aorta, dAo: descending aorta, NAo: neoaorta, MPA: main pulmonary artery, LPA: left pulmonary artery, RPA: right pulmonary artery, RA: right atrium, RV: right ventricle.
Figure 7
Figure 7
(A–F) Simulated surgery of the half-turned truncal switch procedure [20,21] in a 15-month-old infant with transposition of the great arteries and severe pulmonary stenosis (Case #12). Abbreviations are shown in Figure 6. RAA: right atrial appendage, LAA: left atrial appendage, LA: left atrium, RCA: right coronary artery, LCA: left coronary artery, MPAT: main pulmonary arterial trunk, AoT: aortic trunk, VSD: ventricular septal defect.
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