For decades, the standard management of asymptomatic severe aortic stenosis (AS) with preserved left ventricular function was watchful waiting, with surveillance every 6 to 12 months until symptoms emerged.1 That approach has been substantially challenged by recent trial data and a landmark regulatory decision.2-4
In May 2025, the FDA approved the Edwards SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform for patients with asymptomatic severe AS, based on results from the EARLY TAVR trial.3,4 The trial randomized 901 patients with a mean age of 75.8 years to early TAVR or clinical surveillance. At a median follow-up of 3.8 years, the composite primary endpoint of death, stroke, or unplanned cardiovascular hospitalization occurred in 26.8% of the TAVR group versus 45.3% of the surveillance group, a significant difference driven primarily by reduction in unplanned hospitalization.3,4 Notably, 87% of patients in the surveillance arm ultimately underwent aortic valve replacement during follow-up.3,4
The EARLY TAVR data reinforce a growing body of evidence indicating that untreated severe AS, even without classic symptoms, is associated with substantial long-term adverse outcomes, including increased mortality risk.2,3 The 2025 approval applies specifically to the SAPIEN 3 platform and to a population aged 65 and older with low surgical risk. It does not apply to younger patients or to patients with bicuspid aortic valves, who were not included in EARLY TAVR.
For clinicians, these developments underscore the importance of systematic symptom evaluation, early echocardiographic identification, and timely heart team referral, particularly given persistent evidence that severe AS remains undertreated across U.S. practice settings.
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