EARLY TAVR update: New data highlight economic benefits of treating asymptomatic aortic stenosis
Performing transcatheter aortic valve replacement (TAVR) on asymptomatic patients with severe aortic stenosis (AS) may be a cost-effective treatment option in the long run, according to new late-breaking data presented at TCT 2026 in San Diego.
Neel Butala, MD, MBA, an interventional cardiologist with University of Colorado Medicine, presented the data on Sunday, Nov. 1. The goal was to explore data from the landmark EARLY TAVR trial to learn more about how treating asymptomatic patients early instead of clinical surveillance may impact hospitals and health systems over time.
Looking back at the impact of EARLY TAVR
EARLY TAVR has been one of cardiology’s most closely watched clinical trials for years now. The randomized study examined data from 901 patients 65 years old or older with asymptomatic severe AS. Patients either underwent traditional clinical surveillance or they were treated with transfemoral TAVR with a Sapien 3 TAVR valve from Edwards Lifesciences.
Overall, as lead investigator Philippe Généreux, MD, first announced at TCT 2024, EARLY TAVR showed that performing TAVR on asymptomatic patients was both safe and effective. Those findings went on to make a major impact. The U.S. Food and Drug Administration (FDA) referenced EARLY TAVR when it approved multiple TAVR valves for treating asymptomatic patients, for example, and the U.S. Centers for Medicare and Medicaid Services (CMS) pointed to the trial as the primary reason it finalized Medicare coverage for asymptomatic TAVR.
Upfront costs vs. 5-year cumulative costs
This latest analysis examined the EARLY TAVR patients from an economic point of view. As one might expect, the upfront costs were much higher for patients treated with TAVR right away. However, nearly all clinical surveillance patients went on develop symptoms and then undergo TAVR, so it did not take long for their costs to increase as well. In fact, the mean five-year cumulative costs were $86,572 for TAVR patients and $85,044 for clinical surveillance patients.
Going beyond five years, the authors determined that asymptomatic TAVR was associated with an increase in lifetime costs of approximately $4,500 and an increase in quality-adjusted life years (QALY) of 0.3 QALYS. This broke down to an incremental cost-effectiveness ratio (ICER) of $14,698 per QALY gained. To help put that in context, Butala emphasized that $120,000 per QALY is commonly used to represent a cost-effective intervention.
Another key takeaway from this EARLY TAVR update was the fact that researchers performed an additional sensitivity analysis that included the cost of repeat aortic valve interventions for all surviving patients 10 years after their index procedure. Even going that extra step, the group still found asymptomatic TAVR to be a cost-effective intervention—approximately $25,000 per QALY gained.
New insights into the value of asymptomatic TAVR
Benjamin Galper, MD, chair of cardiology and director of the structural heart program at Mid-Atlantic Permanente Medical Group, joined Butala on the TCT stage as a panelist to share his own perspective on these data.
One of Galper’s biggest takeaways was the fact that this economic analysis may have actually undersold the value of treating these patients right away instead of waiting for symptoms. The clinical surveillance patients in EARLY TAVR were watched closely and referred for treatment as soon as they developed symptoms. Real-world clinical surveillance patients, however, would be waiting longer to undergo TAVR and likely develop worse symptoms that lead to more hospitalizations.
“It’s likely the true benefit of asymptomatic TAVR was underestimated in this study,” he said.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.