The U.S. Food and Drug Administration (FDA) has approved transcatheter aortic valve replacement (TAVR) for patients with severe symptomatic aortic stenosis who are at low risk for surgical mortality. Medtronic (Dublin, Ireland) announced the approval in a news release featuring its Evolut TAVR system. The FDA updated its overview webpage on the Edwards Sapien 3 and Edwards Sapien 3 Ultra Transcatheter Heart Valve System (Edwards Lifesciences, Irvine, California) to show that it was approved Friday.
“The majority of my patients want a replacement valve that’s going to minimize the risk of death, stroke, and other cardiovascular events during the procedure and allow them to leave the hospital faster and recover sooner. In patients appropriate for a biologic valve, that option is going to be TAVR,” said Michael Reardon, MD, cardiothoracic surgeon at Houston Methodist DeBakey Heart & Vascular Center, principal investigator and senior author of the Evolut Low Risk Trial. “With the low risk approval, risk stratification for TAVR treatment is becoming obsolete and heart teams will likely need to assess treatment options based on anatomical characteristics, concomitant risk factors, and also patient preference.”
The expansion of TAVR to low-risk patients was highly anticipated, especially after results of two randomized trials earlier this year. One compared the balloon-expandable Edwards Sapien 3 to surgical aortic valve replacement (SAVR) in low-risk patients; the other compared the self-expanding Medtronic Evolut valve to SAVR in these patients.
The PARTNER 3 trial found that patients receiving the Sapien 3 valve had a lower composite rate of death, stroke or rehospitalization at 1 year than surgical patients. The Evolut trial found that patients receiving the Evolut valve had results that were noninferior to SAVR patients with respect to the composite endpoint of death or disabling stroke at 24 months.