On the Evaluation and Validation of Off-the-shelf Statistical Shape Modeling Tools: A Clinical Application.

Statistical shape modeling (SSM) has proven useful in many areas of biology and medicine as a new generation of morphometric approaches for the quantitative analysis of anatomical shapes. Recently, the increased availability of high-resolution in vivo images of anatomy has led to the development and distribution of open-source computational tools to model anatomical shapes and their variability within populations with unprecedented detail and statistical power. Nonetheless, there is little work on the evaluation and validation of such tools as related to clinical applications that rely on morphometric quantifications for treatment planning. To address this lack of validation, we systematically assess the outcome of widely used off-the-shelf SSM tools, namely ShapeWorks, SPHARM-PDM, and Deformetrica, in the context of designing closure devices for left atrium appendage (LAA) in atrial fibrillation (AF) patients to prevent stroke, where an incomplete LAA closure may be worse than no closure. This study is motivated by the potential role of SSM in the geometric design of closure devices, which could be informed by population-level statistics, and patient-specific device selection, which is driven by anatomical measurements that could be automated by relating patient-level anatomy to population-level morphometrics. Hence, understanding the consequences of different SSM tools for the final analysis is critical for the careful choice of the tool to be deployed in real clinical scenarios. Results demonstrate that estimated measurements from ShapeWorks model are more consistent compared to models from Deformetrica and SPHARM-PDM. Furthermore, ShapeWorks and Deformetrica shape models capture clinically relevant population-level variability compared to SPHARM-PDM models.