Patients who underwent transcatheter aortic valve replacement (TAVR) with a valve designed to treat aortic regurgitation had an overall mortality rate of just 8.1% at one year, well below the trial's prespecified goal of 25% to show non-inferiority, according to a study presented at the American College of Cardiology's Annual Scientific Session (ACC.25).
These findings from 500 patients, expand upon results reported last year for the trial's first 180 patients. The results offer further confirmation that the new platform, called the Trilogy system, is safe and effective for treating aortic regurgitation, which occurs when the aortic valve doesn't close tightly enough, allowing blood to leak backward and reducing the flow of blood from the heart to the rest of the body.
Not only did we meet our prespecified safety and efficacy endpoint, we also saw excellent valve hemodynamics and valve function, and there was a very low rate of leakage across and around the valve. We also saw a significant improvement in quality of life."
Raj Makkar, MD, vice president of Cardiovascular Innovation and Intervention at Cedars-Sinai in Los Angeles, interventional cardiologist in the Smidt Heart Institute and the study's first author
While TAVR is now common in patients with aortic stenosis, a type of valvular disease in which the valve becomes narrowed, artificial valves designed for aortic stenosis do not work well for patients with aortic regurgitation. The Trilogy valve is the first device designed specifically for transcatheter replacement of the aortic valve in patients with aortic regurgitation; it uses anchors to attach to the three leaflets of the aortic valve.
The trial, called ALIGN-AR, enrolled 500 patients between 2018-2024, with 180 patients enrolled 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. To date, about 360 patients have at least one year of follow-up after their procedure and 200 have about two years of follow-up.
The trial's primary endpoint was mortality at one year, with a prespecified threshold of 75% survival or better indicating that the valve is not inferior to outcomes that would be expected in the absence of a valve replacement. With an overall survival rate of 91.9% at one year, the trial met and exceeded this endpoint. The study 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 and valve embolization noted in only 1.6%. The 30-day mortality rates were also lower in the continued access cohort (0.9%) compared to the initial premarket approval cohort (2.2%), likely due to a combination of improved patient selection and procedural improvements over time.
If left untreated, aortic regurgitation can cause the left ventricle to become enlarged and lead to heart failure.
"The key question was, if you put in a new aortic valve and prevent the leakage into the left ventricle, can you reverse this process? And the answer to that is actually yes. We've seen that there is favorable remodeling in terms of reversing the enlargement of the heart over a period of time," Makkar said.
Evidence of left ventricular reverse remodeling was demonstrated by reduced ventricular volumes, enhanced ejection fraction and decreased left ventricular mass—all known predictors of improved long-term clinical outcomes.
It is estimated that aortic regurgitation is about as common as aortic stenosis, but the treatment options have been more limited for aortic regurgitation, particularly in patients who are too ill to undergo open heart surgery.
"These findings represent significant progress in overcoming the historical limitations associated with using off-label TAVR devices for aortic regurgitation," Makkar said. "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."
Noting that almost one-quarter of patients required a pacemaker device after their TAVR procedure, the researchers are exploring potential opportunities to modify the procedure or device design to reduce the need for a pacemaker. Researchers are also planning a randomized controlled trial to compare TAVR with the Trilogy device versus open heart surgery in patients who are eligible for either procedure.
The study was funded by JenaValve, maker of the Trilogy valve.
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