A victory for early treatment: FDA Approves First TAVR Valves for Asymptomatic Severe Aortic Stenosis
A victory for early treatment: FDA Approves First TAVR Valves for Asymptomatic Severe Aortic Stenosis
Source: Cardiovascular Business
Author: Michael Walter
Date: May 1, 2025
Key Points:
1. Historic FDA Approval:
• The FDA approved the Sapien 3, 3 Ultra, and 3 Ultra Resilia TAVR valves (balloon-expandable) from Edwards Lifesciences for asymptomatic severe aortic stenosis (AS).
• This marks the first-ever approval of TAVR for asymptomatic patients.
2. Trial That Led to Approval – EARLY TAVR:
• Included 901 patients ≥65 years old with asymptomatic severe AS.
• Patients were randomized to TAVR vs. clinical surveillance.
• Primary outcome (mortality, stroke, or unplanned cardiovascular hospitalization):
• 26.8% in TAVR group vs. 45.3% in surveillance group.
• Driven mainly by lower hospitalization: 20.9% (TAVR) vs. 41.7% (surveillance).
• TAVR group also had fewer deaths (8.4% vs. 9.2%) and strokes (4.2% vs. 6.7%).
3. Patient Quality of Life (KCCQ score):
• At 2 years, 86.8% of TAVR patients had favorable health status vs. 68% in surveillance group.
• Mean KCCQ score at baseline: 92.7, reflecting a symptom-free cohort.
4. Delayed Intervention in Watchful Waiting:
• 87% of surveillance group eventually underwent TAVR after median follow-up of 3.8 years.
5. Expert Reactions:
• Prof. Bernard Prendergast called this a “major reset” in how cardiologists approach asymptomatic AS.
• Criticized current guidelines promoting “watchful waiting”, advocating instead for early diagnosis and intervention.
6. Regulatory and Practice Impact:
• Dr. Philippe Généreux (lead investigator): Urged a change in guidelines to replace “wait for symptoms” with proactive evaluation and intervention.
• Emphasized unpredictable progression from asymptomatic to symptomatic status.
7. Implications:
• Early TAVR may soon become standard of care for selected patients with severe asymptomatic AS.
• May reduce mortality, stroke, hospitalization, and preserve long-term quality of life.
