The Effect of 3D Heart Modelling on Family Quality of Life and Surgical Success

Summary

Introduction and Objective: In recent years, 3D (three-dimensional) modeling has been added to traditional and effective diagnostic methods such as Computed Tomography (CT), Magnetic Resonance Imaging (MRI), and Echocardiography. The purpose of this study is to determine the effectiveness of models created from patients' own radiological images using 3D printing technology in the clinical setting to simulate surgery in the preoperative period and provide preoperative parental education to improve family quality of life and positively influence patient outcomes.

Methods: The study is a two-group pretest-posttest randomized controlled study. The children who come to the outpatient clinic examination in a private hospital and who are subjected to Computed Tomography (CT) examination for diagnostic procedures will be modeled in the experimental group, pre-tests will be applied, and the model will be 3D printed after it is approved by the radiologist who is among the researchers. The sample size is 15 experimental group and 15 control group. After the radiologist's approval, surgical simulation and preoperative education will be applied to the experimental group. The control group will receive the same parent education as the standard model. Both groups will complete the Sociodemographic Information Form, Surgical Simulation Evaluation Form - Part I, and Pediatric Quality of Life Inventory (PedsQL) Family Impacts Module one week prior to hospitalization. Surgical simulation and preoperative education will be completed on the same day. On postoperative day 0, only the Surgical Simulation Evaluation Form - Part II will be applied and on postoperative day 15, the Surgical Simulation Evaluation Form - Part II and the Pediatric Quality of Life Inventory (PedsQL) Family Impacts Module will be applied to both groups as a posttest.

Pilot Study and Results: Modeling and 3D printing studies were conducted to carry out the study. A total of four diagnosed and treated patients were retrospectively analyzed. An intracardiac anomaly was detected in the patient data taken for the first model. It was decided to model the extracardiac structures since the inside of the heart was filled with blood, and the blood could not be ruled out as a solid structure. Finally, aortic coarctation was modeled clearly from the images taken and completed.

Conditions

• Congenital Heart Disease

Interventions

OTHER

Surgical Simulation with 3D Heart Model and Parental Education with "Congenital Heart Disease Parent Education Booklet" and tailored 3D Heart Modeling

The first step in the modeling process is masking. For this study, the average minimum value for masking ventricles and large vessels was set between 80 and 200 HU (Brüning et al., 2022). Threshold values of min 216 HU - max 1502 HU are used. At these HU values, the blood in the heart and great vessels is masked and the outline of the heart is revealed. Lowering the minimum HU value is necessary to make the heart walls more visible. However, this results in masking unwanted soft tissues other than the heart, such as muscle and fat. The masked unnecessary surrounding tissues are removed first with the cropping mask and then manually by marking along the contours of the heart and great vessels. Thus, a model containing only the heart and the desired large vessels will be created and cleaned from the surrounding tissues. With this mask, 3D reconstruction will be performed, and the model will be ready for printing.

Sponsors & Collaborators

• Yeditepe University

  lead OTHER

Principal Investigators

• AYLIN AKCA SUMENGEN, PhD · Yeditepe University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

0 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-01

Primary Completion

2023-12-01

Completion

2024-02-01

Countries

• Turkey (Türkiye)

Study Locations