Clinical outcomes of patients with bicuspid aortic valve undergoing a targeted transcatheter aortic valve replacement approach: the LIRA Method

Background: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) disease is still burdened by a non-negligible rate of stroke and permanent pacemaker implantation (PPI). These suboptimal results, possibly related to the unique BAV anatomy, might suggest the use of a different sizing method in this setting. The aim of our study is to evaluate whether the application of the supra-annular LIRA method might improve clinical outcomes in this population.

Methods: In this single center retrospective study, we enrolled consecutive patients with severe aortic stenosis and raphe-type BAV undergone TAVR with the implantation of supra-annular self-expanding prostheses sized according to the LIRA method. The primary endpoint was the device success. Secondary endpoints were in-hospital and 30-days safety outcomes and 1-year clinical efficacy. All study endpoints were adjudicated according to VARC 3 criteria.

Results: A total of 104 patients (mean age 79.8± 5.83) were enrolled in our study. Mean STS score was 4.96±4.73%. The use of the LIRA method led to prosthesis downsizing in 85.6% of patients. Device success was 94.2%. All cause death was 0%, conversion to surgery was 0% and an extremely low rate of stroke (1.9%) and PPI (9.6%) was observed. The intended performance of the valve was 96.1% and it was maintained at 1-year follow-up. Clinical efficacy at 1-year was reached in 90.6% of patients.

Conclusions: The LIRA method represents an alternative option for prosthesis sizing in patients with type 1 and type 2 BAV undergoing TAVR with promising early and mid-term outcomes.