Development and Validation of a High-Fidelity Cardiac Presurgical Planning Platform for Congenital Heart Defects Using 3D Printing Technology

Development and Validation of a High-Fidelity Cardiac Presurgical Planning Platform for Congenital Heart Defects Using 3D Printing Technology Background: Congenital heart defects (CHD) affect 1% of infants annually, with greater risk to children born into low socioeconomic status. Many CHD are associated with high infant mortality rates such as hypoplastic left heart syndrome (HLHS), a CHD which is fatal unless treated with complex surgical interventions. By creating Pre-Sure-CHD, a patient-specific preoperative surgical rehearsal and planning platform, Lazarus 3D will facilitate rehearsal of these complex cases, improving survival rates for infants born with CHD - particularly those with low socioeconomic status. Objective: To develop and validate Pre-Sure-CHD, enhancing surgical planning and rehearsal for CHD by providing surgeons with operable, high-fidelity, patient-specific models. Methods: The study comprises three specific aims: Aim 1 involves optimizing synthetic materials to replicate the mechanical properties of cardiac tissues, ensuring realism in the Pre-Sure-CHD models. Aim 2 utilizes proprietary 3D printing technology to create patient-specific prototypes for real CHD cases, informed by CT and MRI imaging data. Aim 3 assesses the content and construct validity of Pre-Sure-CHD through surgical planning refinement, recording changes, and collecting metrics for analysis. Results: The study aims to achieve milestones, including tuning polymers to mimic cardiac tissue properties, completing Pre-Sure-CHD prototypes, and obtaining a Likert scale survey score >3.5 and a 10% improvement in surgical metrics. Conclusion: Successful completion of this project will provide the first cardiothoracic surgical rehearsal platform for CHD, empowering surgeons to optimize their approaches in a risk-free environment. Implications: Pre-Sure-CHD holds the potential to revolutionize surgical planning for critical congenital heart defects, reducing mortality rates associated with these conditions. The project's success will pave the way for a future Phase II clinical study and collaborations with medical institutions, ultimately contributing to improved patient outcomes and healthcare advancement. Project Number: 1R43HL182462-01 | Fiscal Year: 2025 | NIH Institute/Center: National Heart Lung and Blood Institute (NHLBI) | Principal Investigator: Tyler Kelly | Institution: LAZARUS 3D, INC., Philomath, OR | Award Amount: $400,016 | Activity Code: R43 | Study Section: Special Emphasis Panel[ZMD1 JT (M1)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R43HL18246201