This marks the first FDA approval for transcatheter aortic valve replacement (TAVR) in asymptomatic AS patients. Approval came on the back of data from the EARLY TAVR trial. EARLY TAVR demonstrated that asymptomatic severe AS patients randomized to Edwards TAVR experienced superior outcomes compared to guideline-recommended clinical surveillance (watchful waiting).

Edwards says EARLY TAVR marked the first randomized, controlled trial designed to evaluate TAVR compared to watchful waiting in asymptomatic severe AS. It had a median follow-up of 3.8 years. Investigators reported that 26.8% of the 455 patients in the TAVR arm experienced death, stroke or unplanned cardiovascular hospitalization. That compared to 45.3% of the 466 patients in the clinical surveillance arm.

Dr. Philippe Genereux serves as director of the structural heart program at Gagnon Cardiovascular Institute, Morristown Medical Center in New Jersey. Genereux called the need to change practice and TAVR guidelines for AS “urgent.” Additionally, Genereux said EARLY TAVR underscored the importance of early evaluation to benefit patient outcomes and the healthcare system.