Anomalous aortic origin of a coronary artery (AAOCA) is a rare congenital heart condition with fixed and dynamic stenotic elements, potentially causing ischemia. Invasive coronary angiography under stress is the established method for assessing hemodynamics in AAOCA, yet it is costly, technically intricate, and uncomfortable. Computational fluid dynamics (CFD) simulations offer a noninvasive alternative for patient-specific hemodynamic analysis in AAOCA. This systematic review examines the role of CFD simulations in AAOCA, encompassing patient-specific modeling, noninvasive imaging-based boundary conditions, and flow characteristics. Screening articles using AAOCA and CFD-related terms prior to February 2023 yielded 19 publications, covering 370 patients. Over the past four years, 12 (63%) publications (259 patients) employed dedicated CFD models, whereas 7 (37%) publications (111 patients) used general-purpose CFD models. Dedicated CFD models were validated for fixed stenosis but lacked dynamic component representation. General-purpose CFD models exhibited variability and limitations, with fluid–solid interaction models showing promise. Interest in CFD modeling of AAOCA has surged recently, mainly utilizing dedicated models. However, these models inadequately replicate hemodynamics, necessitating novel CFD approaches to accurately simulate pathophysiological changes in AAOCA under stress conditions.

Advances in information technology, computational modeling, and engineering are enabling new approaches to disease prevention, diagnosis, and treatment. This chapter examines the evolving role of simulation as a medical device (SimMD), emphasizing its ability to complement, or, in some cases, replace traditional clinical methods. Within the broader context of personalized medicine and in silico approaches, the focus is on physics-based, patient-specific models of the human body, its functions, and its interaction with medical devices. The chapter introduces the concept of SimMD and reviews the state of the art, showing how simulation is becoming part of clinical practice. It then presents a framework for physics-based modeling workflows, addressing the core elements. Key challenges such as reproducibility, reliability, and clinical usability are highlighted. A regulatory perspective follows, comparing current approval pathways in the European Union and the United States, and outlining the importance of verification, validation, and uncertainty quantification (VVUQ) for clinical adoption. The chapter concludes with current challenges and prospects for standardization, automation, and broader healthcare integration. By combining workflow and regulatory insights, it provides a comprehensive view of simulation’s transformative role in medicine.

Higher-translucency zirconia grades (4Y- and 5Y-PSZ) offer esthetic advantages over conventional 3Y-TZP but exhibit reduced flexural strength, raising concerns for restorations with reduced connector dimensions. It is unclear whether biaxial flexural strength, as determined by standardized specimen testing, translates to the fracture resistance of geometrically complex multi-unit bridges. This study compared the biaxial flexural strength (DIN EN ISO 6872:2015, n = 45) of three zirconia grades (3Y-TZP, 4Y-PSZ, and 5Y-PSZ) with the fracture behavior of monolithic five-unit fixed dental prostheses (FDPs) with deliberately undersized connectors (n = 24, teeth 33–37) made from the same three zirconia grades. Finite element (FE) analysis was used to compare the simulated elastic stress distribution with the experimentally observed fracture location. Biaxial flexural strength differed significantly among all groups (3Y-TZP: 1406.5 ± 133.3 MPa, 4Y-PSZ: 1146.9 ± 215.9 MPa, and 5Y-PSZ: 657.0 ± 137.5 MPa; p < 0.001). In contrast, bridge fracture loads differed less between the zirconia grades (3Y-TZP: 542.1 ± 44.9 N, 4Y-PSZ: 466.6 ± 116.6 N, and 5Y-PSZ: 372.1 ± 32.1 N). Only 5Y-PSZ showed significantly lower fracture loads than 3Y-TZP (p < 0.001), whereas 4Y-PSZ did not differ significantly from either 3Y-TZP (p = 0.253) or 5Y-PSZ (p = 0.129). All bridges initially fractured at the undersized connector, matching the site of the highest predicted tensile stress in den FE analysis. With this deliberately undersized connector, the differences in biaxial flexural strength between 3Y-TZP and 4Y-PSZ did not translate proportionally in a significant difference in fracture load. The FE analysis correctly identified the fracture-critical connector. The fracture load was not predicted, since the simulations were calibrated to the experimental fracture load values.