The Effect of 3D Modeling on Family Quality of Life, Surgical Success and Patient Outcomes in Congenital Heart Diseases: A Randomized Controlled Trial Protocol

The most common congenital malformation of childhood is congenital heart disease (CHD). The degree to which the defect deviates from normal anatomy determines the severity of symptoms. Globally, between 0.8% and 1.2% of all live births are affected by CHD. While it occurs in 1% of 40,000 live births in the US, Asian countries have been reported to have the highest rate at 9.3 per 1000 live births. In Turkey, the rate has been reported to be between 0.6 and 1% per 100 live births. Between 25 % and 50 % of the children born with CHD have defects that will require open heart surgery. Reliable diagnostic methods provide much better treatment options, leading to a significant reduction in mortality. In addition to imaging methods such as Computed Tomography (CT), Magnetic Resonance Imaging (MRI), and Echocardiography (ECHO), 3D modeling and printing technologies have been added to these methods in recent years. There are differences and benefits among the different imaging methods. The most recent and rapidly developing method among them is 3D printing technologies.

It is predicted that 3D cardiac models obtained from patients' radiological images can be used for various purposes. It is stated that beneficial results can be obtained for multiple purposes, from planning and simulation before the definitive surgical procedure to patient-specific preoperative education. There are several techniques for modeling organs using 3D printing technology, which has developed rapidly in recent years. For the heart, two types of cardiac modeling are performed. These are filled solid models (blood pool) and hollow models. The hollow models are obtained from signals sent in a way that limits the perimeter of the area where the blood pool is located. These models are printed as a cross-section and show the intracardiac structure. However, technically, the peak heart rate of children is higher than that of adults, so the images may lose clarity, require more time and effort, and may not be as useful. Solid models have filled models of the atria and ventricles. They are typically modeled and printed from contrast-enhanced CT or MR images. Noncardiac structures can be added to these models (e.g., aorta, pulmonary artery, extracardiac vessels, trachea, and esophagus) with the goal of delineating large vessel abnormalities in the model. Extracardiac structures are very guiding in surgical simulation with easier and faster modeling than intracardiac structures. In particular, recurrent pulmonary artery stenosis and aortic coarctation can be successfully treated, and positive outcomes can be achieved with fast and patient-specific models. The operating time of surgically simulated patients is reduced, and procedures can be completed with less cost and fewer complications.

Targeted patient outcomes can be achieved by managing a multidisciplinary team that includes the patient and family and by using surgical simulation. In life-threatening diseases such as CHD, diagnosis, treatment, and surgical planning are long-term processes. This process causes serious psychological distress in parents, such as post-traumatic stress disorder. Parental/caregiver stress increases and the family's quality of life deteriorates, especially when the surgical procedure and interventions are not clearly understood. This situation negatively affects the postoperative recovery process of patients. A surgical procedure performed with good technique followed by poor postoperative management renders many interventions ineffective. Understanding the severity of the disease from the perspective of the parents can improve both the health-related quality of life of the child and the quality of life of the family, leading to more positive patient outcomes. Patient-specific modeling using 3D printing technology with images obtained through traditional methods is believed to eliminate all of these issues.