Hemal Gada, MD reacting to the FDA’s approval of TAVR for asymptomatic AS.

Surgeries & Interventions

FDA Approves TAVR for Asymptomatic AS

TAVR will officially be an option for asymptomatic patients with severe aortic stenosis following the FDA’s approval of Edwards Lifesciences’ SAPIEN 3 platform for the patient group. 

• This is the first approval for TAVR in asymptomatic patients and stems from the EARLY TAVR trial, which suggested that TAVR led to better outcomes than to watchful waiting.
• Up until now, only patients at a high risk of surgery were eligible to have their aortic valves replaced via TAVR, with younger, healthier patients recommended for SAVR.

EARLY TAVR was the first RCT designed to evaluate TAVR compared to watchful waiting for patients with asymptomatic severe AS.

• Over a median of 3.8 years, 26.8% of TAVR patients experienced death, stroke, or unplanned CV hospitalization, compared with 45.3% of clinical surveillance patients.

These results helped inform the FDA’s decision, but the debate is only getting hotter on whether younger AS patients really benefit from the convenience of TAVR given its durability tradeoffs.

• Some more pro-TAVR physicians highlighted that patients originally designated as asymptomatic can become symptomatic in sudden and unpredictable ways.
• Meanwhile, other physicians focused on the shorter durability, suggesting that TAVR valves aren’t intended for patients who may live 30 years with the replacement valve.
• Depending on how you interpret EARLY TAVR’s stroke results, it’s somewhat unclear if TAVR actually impacted stroke rates in asymptomatic patients.

A durability solution could be in the works, with the Edwards’ SAPIEN 3 RESILIA valves that come with improved leaflet tissue, but data is limited on how long those valves will last before needing re-replacement.

The Takeaway

TAVR’s FDA approval for asymptomatic AS patients is undoubtedly exciting, but just because TAVR is easier to implant doesn’t mean it’s the right solution for everyone. Heart anatomy and health varies from patient to patient, and we still have a ways to go before “one valve fits all.”

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