Clinical Impact of Rapid Prototyping 3D Models of Congenital Heart Disease on Surgical Management
Patient-specific, 3D printed models have been utilized in preoperative planning for many years. Among researchers and clinicians, there is a perception that preoperative exposure to 3D printed models, derived from patient images (CT or MRI), aid in procedural planning. 3D printed models for heart surgery have the potential to improve a clinician's preparedness and therefore may reduce surgically-related morbidity and mortality. This randomized clinical trial aims to evaluate whether pre-procedural planning of surgeons exposed to a patient-specific 3D printed heart model will decrease cardiopulmonary bypass time, morbidity, and mortality.
• Pediatric subjects undergoing primary complex two-ventricle repair of congenital heart defect, including but not limited to:
• double outlet right ventricle (DORV),
• transposition of the great arteries with ventricular septal defect and pulmonary stenosis (TGA/VSD/PS),
• truncus arteriosus with ventricular septal defect (TA/VSD)
• congenitally corrected transposition of the arteries with pulmonary stenosis (CCTGA/PS).
• Patient who will undergo preoperative cardiac MR or cardiac CT imaging
• a. Images will be validated by the IRC prior to inclusion
• Written informed consent (and assent when applicable) and HIPAA authorization obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.