TAVR for pure aortic regurgitation performs well.
TAVR for pure aortic regurgitation performs well.
Align-AR Trial Summary – Key Points(presented as a Kate-breaking study at the American College of Cardiology (ACC) 2025 annual meeting).
1. Trial Focus: First 500 patients with pure aortic regurgitation (AR) treated with the JenaValve TAVR system showed highly encouraging results.
2. Clinical Challenge: Pure AR lacks calcification, making standard TAVR devices (designed for aortic stenosis) prone to migration or embolization. This late-breaking clinical trial marks a significant step forward for a population long underserved by current transcatheter options. Unlike aortic stenosis, pure AR presents unique challenges due to the absence of valve calcification, making standard TAVR devices more likely to embolize. The JenaValve, was designed specifically for non-calcified anatomy and has received FDA Breakthrough Device designation. The prognosis in patients who have symptomatic aortic regurgitation, especially when they have NYHA Class III or IV heart failure symptoms is pretty dismal. Almost half the patients may be dead at the end of five years. The only approved treatment is surgery, but a lot of patients are not treated because they’re high-risk surgical candidates.
3. Device Advantage: The JenaValve uses leaflet-locating clips to anchor the valve without needing calcium, minimizing valve displacement and leakage.
4. Clinical Results:
• Zero intraprocedural deaths.
• 30-day mortality: 1.6% (vs. 4% expected).
• One-year mortality: 8% (vs. 25% performance goal).
• Stroke rate: 0.8% disabling strokes at 30 days.
• Paravalvular leak: Moderate or greater in only 0.3%.
• Symptom improvement: Over 90% reached NYHA Class I or II by 30 days.
• Sustained valve performance and quality of life up to 2 years.
• Cardiac remodeling: Reduced LV volume and mass.
• KCCQ scores improved by ~20 points at 1 and 2 years.
5. Limitation: High new pacemaker implantation rate (23%), especially with larger valves:
• 16.8% (23 mm valve) vs. 28.9% (27 mm valve).
• Predictors include baseline heart failure, large annulus, RBBB.
6. Regulatory Status:
• FDA premarket approval is underway.
• Supported by 2-year follow-up data on >200 patients.
7. Next Step: ARtist Trial – randomized study comparing TAVR vs. surgery in >1,000 non-high-risk surgical patients, with up to 10 years of follow-up.