FDA Approves Sapien 3 TAVR for Asymptomatic Severe Aortic Stenosis

The FDA has approved Edwards Lifesciences' Sapien 3 transcatheter aortic valve replacement (TAVR) platform for treating patients with severe asymptomatic aortic stenosis (AS), marking the first such approval for this population. This decision is based on data from the EARLY TAVR trial, which demonstrated that patients receiving early TAVR intervention experienced significantly fewer combined events of death, stroke, or unplanned cardiovascular hospitalization compared with those managed by watchful waiting. Over nearly four years of follow-up, 26.8% of TAVR patients experienced these events versus 45.3% in the surveillance group. The trial also found that patients initially asymptomatic could develop symptoms suddenly and unpredictably, emphasizing the importance of early evaluation by a heart team. The findings suggest a potential shift in clinical guidelines, which have traditionally recommended monitoring until symptoms appear. Safety outcomes for early intervention were comparable to standard care, with no increase in short-term cardiovascular mortality.