The U.S. Food and Drug Administration (FDA) has granted the first approval for transcatheter aortic valve replacement (TAVR) for asymptomatic, severe aortic stenosis. The license was granted to the SAPIEN 3 system from Edwards Lifesciences. As the company’s press release points out, without treatment, one in ten patients with symptoms of severe aortic stenosis dies within five weeks of their onset, and symptoms can develop unexpectedly and progress rapidly and unpredictably. However, TAVR has so far only been indicated in the presence of clinical manifestations of the disease.
The decision was prompted by the results of the multicenter randomized controlled clinical trials EARLY TAVR, which involved 901 patients with asymptomatic severe aortic stenosis. Of these, 455 underwent TAVR, the remaining 446 were left under dynamic observation according to current guidelines. During the median follow-up period of 3.8 years, death, stroke, or unplanned hospitalization for cardiovascular reasons occurred in 26.8 percent of participants in the main group versus 45.3 percent in the control group (p < 0.001).