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

2024

3D Heart Models Help Surgeons Plan Operations for Children with Heart Defects

Sample size: 19 publication 10 minutes Evidence: high

Author Information

Author(s): Shiraishi Isao, Yamagishi Masaaki, Hoashi Takaya, Kato Yoshiaki, Iwai Shigemitsu, Ichikawa Hajime, Nishii Tatsuya, Yamagishi Hiroyuki, Yasukochi Satoshi, Kawada Masaaki, Suzuki Takaaki, Shinkawa Takeshi, Yoshimura Naoki, Inuzuka Ryo, Hirata Yasutaka, Hirose Keiichi, Ikai Akio, Sakamoto Kisaburo, Kotani Yasuhiro, Kasahara Shingo, Hisada Toshiaki, Kurosaki Kenichi, Schweiger Martin

Primary Institution: National Cerebral and Cardiovascular Center, Japan

Hypothesis

Can super-flexible 3D heart models improve surgical planning and outcomes for pediatric patients with congenital heart disease?

Conclusion

The study found that super-flexible 3D heart models significantly aided surgeons in preoperative decision-making and surgical simulation.

Supporting Evidence

Thirteen patients (68.4%) were rated as 'essential' by surgeons after surgery.
The 3D heart models allowed detailed anatomical diagnosis and simulated surgery.
The accuracy of the models was validated by a non-destructive method using industrial CT.
The mean error of the 3D models was 0.58 ± 0.23 mm, which is acceptable for surgical use.
The study was conducted in compliance with the Declaration of Helsinki.
The 3D models were approved as a Class II medical device in Japan.
Surgeons rated the models as 'very useful' or 'essential' for preoperative planning.
The study included five pediatric cardiology institutes in Japan.

Takeaway

Doctors used special 3D-printed heart models to practice surgeries on kids with heart problems, which helped them do a better job during the real operations.

Methodology

The study was a single-arm, open-label, multicenter clinical trial involving pediatric patients with complex congenital heart disease, using 3D heart models for surgical simulation.