Efficacy of larger valve sizing with underfilling in balloon‐expandable transcatheter aortic valve replacement

Objectives To investigate the efficacy and safety of larger valve sizing beyond the commercially recommended annular range in transcatheter aortic valve replacement (TAVR) with balloon‐expandable transcatheter heart valve (THVs). Background The clinical implications of larger balloon‐expandable THV implantation with underfilling are poorly evaluated. Methods This retrospective study included 692 consecutive patients who underwent TAVR with SAPIEN3. A total of 271 patients who underwent SAPIEN 3 implantation were analyzed based on three border zones (Zone 1: 300–345 mm 2 , 23 vs. 20 mm; Zone 2: 400–430 mm 2 , 26 vs. 23 mm; Zone 3: 500–546 mm 2 , 29 vs. 26 mm). The primary endpoint was the effective orifice area (EOA) assessed by echocardiography at 1 year, and secondary endpoints were a 30‐day mortality rate, procedural complications during TAVR, and a composite of death from any cause and heart failure requiring rehospitalization at 1 year. Results At 1‐year follow‐up, the EOA in the larger valve groups was greater than that in the recommended valve group in each zone (Zone 1: 1.45 ± 0.03 vs. 1.06 ± 0.06 cm 2 , p < 0.001; Zone 2: 1.83 ± 0.05 vs. 1.41 ± 0.05 cm 2 , p < 0.001; Zone 3: 1.93 ± 0.07 vs. 1.69 ± 0.07 cm 2 , p = 0.02). No significant difference in the secondary endpoint was observed in any of the zones. Conclusions Implantation of the out‐of‐range larger SAPIEN 3 THVs with underfilling was associated with greater EOA at the 1‐year follow‐up and feasible in the selected patients.