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, may 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 may 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-day safety outcomes and 1-year clinical efficacy. All study endpoints were adjudicated according to Valve Academic Research Consortium 3 criteria.

Results: A total of 104 patients (mean age, 79.8 ± 5.83 years) were enrolled in our study. The mean Society of Thoracic Surgeons score was 4.96 ± 4.73%. 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 midterm outcomes.