Transcatheter Aortic Regurgitation – Trilogy Valve in the FDA – Pre-Approval Stage
Transcatheter Aortic Regurgitation – Trilogy Valve in the FDA – Pre-Approval Stage
Source: Medical News Update – TCTMD (2026)
Clinical Problem
• Transcatheter valves (TAVR) were historically designed for aortic stenosis (AS)
• These systems rely on annular and leaflet calcification for:
• Anchoring
• Stability
• In aortic regurgitation (AR):
• Often no calcification
• → Traditional TAVR valves fail to anchor properly
• → High risk of:
• Valve migration
• Paravalvular leak
Why AR Was Challenging
• Lack of calcified landing zone
• Dilated annulus and root
• Unpredictable fixation with standard devices
👉 → AR long considered unsuitable for transcatheter therapy
The Trilogy Valve – Key Innovation
• Specifically designed for native AR (not AS)
• Uses Locator Technology:
• Mechanically engages native leaflets
• Provides active anchoring (not calcification-dependent)
• Enables:
• Precise positioning
• Improved stability
Clinical Milestone
• ✅ The system is CE-marked in Europe and has been granted FDA “Breakthrough Device designation”
• Represents a paradigm shift:
• From “not feasible” → “treatable”
Clinical Implications
• Expands TAVR indications to:
• Patients with severe AR unsuitable for surgery
• ALIGN-AR (published in The Lancet): Trilogy demonstrates feasible and effective TAVR for severe AR.
ALIGN-AR (Lancet 2024; expanded 2025):
• Procedural success: ~95–97%
• 30-day mortality: ~1.6%
• 1-year mortality: ~7–8%
• Stroke: ~0.6%
• Moderate/severe PVL: very low (~1–2%)
👉 Conclusion: Safe, effective TAVR for severe AR in high-risk patients.
Reference (The Lancet)
