, 2025-05-01 15:27:00
Key takeaways:
- A transcatheter aortic valve replacement platform was approved for severe asymptomatic aortic stenosis.
- Edwards Lifesciences’ TAVR platform is the first to be approved in this population.
Edwards Lifesciences announced the FDA approved its transcatheter aortic valve replacement platform for treatment of severe asymptomatic aortic stenosis, the first in this patient population.
Approval of this platform (SAPIEN 3, SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA) was based on the results of the EARLY TAVR trial which were presented at TCT 2024 and simultaneously published in The New England Journal of Medicine. The trial was designed to evaluate TAVR compared with watchful waiting for patients with severe asymptomatic aortic stenosis.
As Healio previously reported, over a median follow-up of nearly 4 years, 26.8% of patients with severe asymptomatic aortic stenosis assigned to TAVR experienced death, stroke or unplanned CV hospitalization, compared with 45.3% of patients assigned to watchful waiting.
Philippe Généreux
“There is an urgent need to change practice and TAVR guidelines for the treatment of aortic stenosis patients, which currently recommend ‘watchful waiting’ until symptoms develop,” Philippe Généreux, MD, director of the structural heart program at Gagnon Cardiovascular Institute, Morristown Medical Center, said in a press release. “As we saw in the EARLY TAVR trial, patients originally designated as asymptomatic became symptomatic in sudden and unpredictable ways, underscoring the importance of early evaluation by a heart team to improve patient outcomes and benefit the healthcare system.”
Editor’s note: This is a developing news story. Please check back soon for updates.
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Sources/Disclosures
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Disclosures:
Généreux reports consulting for Edwards Lifesciences and serving as principal investigator on the EARLY TAVR trial sponsored by Edwards Lifesciences.
