In silico simulations can be used to evaluate and optimize the safety, quality, efficacy and applicability of medical devices. Furthermore, in silico modeling is a powerful tool in therapy planning to optimally tailor treatment for each patient. For this purpose, a workflow to perform fast preoperative risk assessment of paravalvular leakage (PVL) after transcatheter aortic valve replacement (TAVR) is presented in this paper. To this end, a novel, efficient method is introduced to calculate the regurgitant volume in a simplified, but sufficiently accurate manner. A proof of concept of the method is obtained by comparison of the calculated results with results obtained from in vitro experiments. Furthermore, computational fluid dynamics (CFD) simulations are used to validate more complex stenosis scenarios. Comparing the simplified leakage model to CFD simulations reveals its potential for procedure planning and qualitative preoperative risk assessment of PVL. Finally, a 3D device deployment model and the efficient leakage model are combined to showcase the application of the presented leakage model, by studying the effect of stent size and the degree of stenosis on the regurgitant volume. The presented leakage model is also used to visualize the leakage path. To generalize the leakage model to a wide range of clinical applications, further validation on a large cohort of patients is needed to validate the accuracy of the model’s prediction under various patient-specific conditions.

计算机模拟可用于评估和优化医疗设备的安全性、质量、功效和适用性。此外，计算机建模是治疗规划的强大工具，可以为每位患者提供最佳的治疗方案。为此，本文提出了一种对经导管主动脉瓣置换术 (TAVR) 后瓣周漏 (PVL) 进行快速术前风险评估的工作流程。为此，引入了一种新颖、有效的方法，以简化但足够准确的方式计算反流量。通过将计算结果与体外实验获得的结果进行比较，获得了该方法的概念证明。此外，计算流体动力学（CFD）模拟用于验证更复杂的狭窄场景。将简化的渗漏模型与 CFD 模拟进行比较，揭示了其在 PVL 手术规划和定性术前风险评估方面的潜力。最后，通过研究支架尺寸和狭窄程度对反流量的影响，将 3D 装置部署模型和高效渗漏模型结合起来，展示所提出的渗漏模型的应用。所提出的泄漏模型还用于可视化泄漏路径。为了将泄漏模型推广到广泛的临床应用，需要对大量患者进行进一步验证，以验证模型在各种患者特定条件下预测的准确性。