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 mm² , 23 vs. 20 mm; Zone 2: 400-430 mm² , 26 vs. 23 mm; Zone 3: 500-546 mm² , 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 cm² , p < 0.001; Zone 2: 1.83 ± 0.05 vs. 1.41 ± 0.05 cm² , p < 0.001; Zone 3: 1.93 ± 0.07 vs. 1.69 ± 0.07 cm² , 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.