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Aortic regurgitation is a condition in which the aortic valve does not close properly, allowing blood to flow backward into the left ventricle. This results in decreased blood flow from the heart to the rest of the body. If untreated, aortic regurgitation can lead to an enlarged left ventricle and eventually heart failure. This condition is as common as aortic stenosis, a valvular disease where the aortic valve becomes narrowed. Transcatheter aortic valve replacement (TAVR) is frequently used for patients with aortic stenosis, but the artificial valves designed for aortic stenosis are not as effective in patients with aortic regurgitation. Consequently, treatment options for aortic regurgitation, particularly for patients too ill for open-heart surgery, have been limited. Now, a new study presented at the American College of Cardiology’s Annual Scientific Session (ACC.25) demonstrates that patients who underwent TAVR with a valve specifically designed for aortic regurgitation had an overall mortality rate of just 8.1% at one year, significantly lower than the trial's goal of 25%, which aimed to show non-inferiority.

The findings from 500 patients, by researchers at Cedars-Sinai (Los Angeles, CA, USA), build upon results previously reported for the trial’s first 180 patients. These results provide additional evidence that the Trilogy system, a new platform for treating aortic regurgitation, is both safe and effective. The Trilogy valve, developed by JenaValve (Irvine, CA, USA), is the first device specifically designed for transcatheter aortic valve replacement in patients with aortic regurgitation. The valve uses anchors to attach to the three leaflets of the aortic valve. The ALIGN-AR trial, which enrolled 500 patients between 2018 and 2024, included 180 patients in a premarket approval cohort and 320 patients in a continued access cohort. All patients had moderate to severe symptomatic aortic regurgitation and underwent TAVR with the Trilogy valve. As of now, 360 patients have at least one year of follow-up, and 200 have about two years of follow-up. The trial's primary endpoint was one-year mortality, with a prespecified goal of 75% survival, indicating that the valve was not inferior to expected outcomes without valve replacement. With a one-year survival rate of 91.9%, the trial exceeded this target.

The study also reported a device success rate of 96.4% and low rates of residual regurgitation, with only 1.5% of patients experiencing more than mild regurgitation at 30 days. Valve embolization occurred in just 1.6% of cases. Mortality rates at 30 days were lower in the continued access cohort (0.9%) compared to the premarket approval cohort (2.2%), likely due to better patient selection and procedural improvements over time. Evidence of left ventricular reverse remodeling was observed, with reduced ventricular volumes, improved ejection fraction, and decreased left ventricular mass—all known indicators of better long-term clinical outcomes. Although nearly one-quarter of patients required a pacemaker following TAVR, the researchers are looking into ways to modify the procedure or device to reduce the need for a pacemaker. Additionally, they plan to conduct a randomized controlled trial to compare TAVR with the Trilogy device to open-heart surgery in patients eligible for either procedure.

“These findings represent significant progress in overcoming the historical limitations associated with using off-label TAVR devices for aortic regurgitation,” said Raj Makkar, MD, vice president of Cardiovascular Innovation and Intervention at Cedars-Sinai. “It’s important to diagnose this disease and intervene in good time so that we can improve survival in these patients. Having a technology that is less invasive than open heart surgery will hopefully put more focus on this disease.” 

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