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

Preprocedural virtual planning of transcatheter aortic valve implantation (TAVI) using FEops HEARTguide^TM may reduce major TAVI complications.

(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.

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.

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.

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.