Commissural Alignment in SAPIEN 3 Valves: Impact on Gradient and Mortality at Follow‐Up

ABSTRACT Background Commissural misalignment (CMA) has demonstrated to difficult future coronary access in self‐expandable prosthesis and has been related with subclinical leaflet thrombosis and a potential increase in valve gradients and aortic regurgitation at follow‐up. Aims The aim of our study was to assess the commissural alignment of the balloon expandable SAPIEN 3 valve (Edwards Lifesciences) and to evaluate its impact on transvalvular gradient and mortality at 5 years of follow‐up. Methods Consecutive patients treated with SAPIEN 3 prosthesis guided with intraprocedural transesophageal echocardiogram (TEE) with a minimal follow‐up of 5 years were included. Commissural alignment between the prosthesis and the native valve was measured by TEE by two independent cardiologists using a standardized 3‐cusp view pre and post‐valve deployment. CMA was defined as a neocommissure deviation > 30° compared with native commissures. Echocardiographic gradients and clinical events were recorded during follow‐up and compared between groups. Results One hundred and five patients (54% male, mean age 80.4 years) were included; 63 (40%) were classified as “aligned” (CMA < 30°) and 42 (60%) as “misaligned” (CMA > 30°). Patients with CMA > 30° presented smaller aortic annulus (23.8 vs. 20.7, p < 0.01) and received smaller valves. There was a slight increase of mean transvalvular gradient during follow‐up (9.2−10.3 mmHg, p < 0.05), without significant differences between groups. Mortality rate was 16.2% at 1 year and 49.5% at 5 years; and not related to commissural alignment. Conclusions Significant CMA is present in 40% of patients treated with SAPIEN 3 valves, however, we didn't find a significant association between CMA and gradient increase or mortality during long‐term follow‐up.