Clinical Validation of Predictive Procedural Planning Software in a Real‐World TAVI Population

Background Preprocedural virtual planning of transcatheter aortic valve implantation (TAVI) using FEops HEARTguide TM may reduce major TAVI complications. Aims (1) To compare morphometric aortic root measurements by FEops HEARTguide TM and GE software; (2) to validate the accuracy of FEops HEARTguide TM in predicting post‐TAVI paravalvular aortic regurgitation (AR) and new conduction abnormalities. Methods In 106 consecutive TAVI patients, aortic root dimensions essential for prosthesis sizing were measured using both GE software and FEops HEARTguide TM . FEops HEARTguide TM predictions were compared with the severity of post‐TAVI AR assessed by echocardiography, angiography, invasive hemodynamics, and the development of conduction abnormalities assessed by serial electrocardiography. Results Bland‐Altman analysis revealed smaller annulus perimeter, area and coronary artery ostia heights with FEops HEARTguide TM compared with GE software, leading to differences in prosthesis sizing in 23% of cases. Predicted AR was significantly higher in patients with moderate versus none/trace AR on echocardiography (14.3 vs. 2.8 mL/s, p = 0.006) and angiography (23.6 vs. 4.0 mL/s, p = 0.009), though overlap between adjacent AR grades was observed. Predicted AR did not significantly differ between patients with AR index < 25 and ≥ 25 (10.2 vs. 5.7 mL/s, p = 0.079). Contact pressure index was significantly higher in patients with new conduction abnormalities (17.5 vs. 10.0%, p = 0.006), despite overlap at patient level. Conclusions FEops HEARTguide TM generally underestimates aortic root dimensions compared with GE software, affecting prosthesis sizing in a substantial proportion of patients. While predictive at a population level, overlap in parameters predicted by FEops HEARTguide TM is encountered at an individual patient level.