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

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 degrees 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 degrees) and 42 (60%) as "misaligned" (CMA > 30 degrees). Patients with CMA > 30 degrees 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.