In a population of symptomatic patients with severe aortic regurgitation (AR) at high surgical risk, TAVR using the Trilogy transcatheter heart valve (THV) achieved prespecified safety outcomes at 30 days, based on findings from the ALIGN-AR trial presented Oct. 24 during TCT 2023.

The multicenter, nonblinded, single arm trial assessed 30-day primary safety outcomes in 180 patients with symptomatic AR (≥3+) at risk for surgical aortic valve replacement (SAVR). Similarly, the one-year primary efficacy outcome for all-cause mortality was assessed in a separate group of 180 patients.

Overall results found TAVR using the Trilogy THV met the 30-day performance goal for safety outcomes (26.7%, p for noninferiority<0.0001), as well as the 12-month performance goal for the efficacy outcome of all-cause mortality (7.8%, p for noninferiority<0.0001).

In presenting the findings, Vinod H. Thourani, MD, FACC, and Torsten P. Vahl, MD, noted that among safety endpoints, the rate of new pacemaker implantation was 24.0% and this declined to 14% in the last roughly one-third of patients enrolled. They also noted "excellent" echocardiographic performance and sustained improvement in quality of life and heart failure functional status at one year. They said that additional analysis will occur annually up through five years.