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 HEARTguideTM may reduce major TAVI complications.

AIMS: (1) To compare morphometric aortic root measurements by FEops HEARTguideTM and GE software; (2) to validate the accuracy of FEops HEARTguideTM 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 HEARTguideTM. FEops HEARTguideTM 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 HEARTguideTM 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 HEARTguideTM 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 HEARTguideTM is encountered at an individual patient level.