The U.S. Food and Drug Administration (FDA) has granted approval to Edwards Lifesciences’ SAPIEN 3 platform, a transcatheter aortic valve replacement (TAVR) therapy. This marks the first FDA approval of TAVR for patients with severe aortic stenosis who do not yet show symptoms.
Results from the EARLY TAVR Trial
The approval stems from findings of the EARLY TAVR trial, in which researchers randomly assigned patients with asymptomatic severe aortic stenosis to either receive the TAVR procedure or undergo watchful waiting.
Over a median follow-up period of 3.8 years, 26.8% of the 455 patients treated with TAVR experienced death, stroke, or unplanned cardiovascular hospitalization. In contrast, 45.3% of the 446 patients in the surveillance group encountered similar outcomes. These results demonstrate a significant advantage for early intervention.
Call to Rethink Current Guidelines
As per Medical Xpress, these findings have prompted renewed calls for changes in clinical practice. Philippe Genereux, M.D., of the Gagnon Cardiovascular Institute at Morristown Medical Center, emphasized the urgency of updating TAVR treatment guidelines.
Dr. Genereux stated, “There is an urgent need to change practice and TAVR guidelines for treating aortic stenosis patients. Currently, the guidelines recommend ‘watchful waiting’ until symptoms develop.”
Importance of Early Evaluation
Dr. Genereux further noted that many patients initially considered asymptomatic eventually developed symptoms suddenly and unpredictably. This highlights the critical need for early evaluation by a specialized heart team to improve patient outcomes and reduce the burden on the healthcare system.