Single-Arm Study: Evaluation of transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation – The Lancet

This article discusses the ALIGN-AR study, a prospective, multicenter, single-arm trial conducted across 20 US sites. The study enrolled 180 high-risk patients suffering from moderate-to-severe or severe symptomatic aortic regurgitation, who were treated with the Trilogy transcatheter heart valve. The average age of participants was 75.5 years, with a roughly equal gender distribution among the 180 participants. The primary safety endpoint of the study was assessed against a prespecified performance goal of 40.5%, with results showing a 27% event rate, which was considered non-inferior (p<0.0001). Additionally, the primary efficacy endpoint, 1-year all-cause mortality, was 7.8%, significantly below the performance goal of 25%, also demonstrating non-inferiority (p<0.0001). The study reported a 95% technical success rate with adverse events such as new pacemaker implantation occurring in 24% of the patients. These findings suggest that the Trilogy transcatheter heart valve is a viable and effective option for high-risk patients, achieving favorable short-term clinical and hemodynamic outcomes. Further follow-up is necessary to determine long-term results and effects on left ventricular remodeling.

Reference (link to abstract – $ for full-text):

Torsten P Vahl et al. (2024). Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study. The Lancet, Volume (Issue), Pages. DOI: https://doi.org/10.1016/S0140-6736(23)02806-4