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

Abstract

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.

Assessing Potential Risks of Future Redo Transcatheter Aortic Valve Replacement in Asian Patients

“…Third, a larger valve with underfilling was frequently used in BE TAV implantation for border zone annulus in our study population to obtain a larger effective orifice area, as previously shown. 16 , 22 Generally, by adjusting the filling volume of BE TAVs with limited sizes, continuously distributed native annular areas are covered. However, because the BE TAV has the structural property of foreshortening with TAV expansion, a larger valve size with underfilling demonstrated a significantly greater TAV height than a smaller valve size with overfilling, albeit with comparable TAV areas.…”