Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis

Summary

The purpose of this study is to examine the impact of early surgery in patients with asymptomatic severe aortic valve stenosis with signs of subclinical LV dysfunction despite preserved LVEF, with a watchfull waiting approach.

Eligibility

Inclusion Criteria:

* 1\. Severe AS defined as

  1. aortic valve area (AVA) ≤1 cm2, AND
  2. Transvalvular maximum velocity (Vmax) ≥3.5 m/s AND
  3. AS severity evaluated severe by a heart valve team conference. In cases where severity is not unambiguous an integrative approach will be utilized combining echocardiographic markers of valve severity and LV function, and if necessary aortic valve calcification estimated by non-contrast CT.

     2\. Considered to be asymptomatic (estimated by a consultant in cardiology) 3. Considered to be candidate for AVR (transcatheter AVR/surgical AVR) 4. Sign of increased LV filling pressures18 or reduced longitudinal LV systolic function

  <!-- -->

  1. Left atrial volume index (LAVi) \> 34 ml/m2; OR
  2. ratio of early diastolic peak mitral inflow velocity (E) to early mitral annulus diastolic velocity (e') ratio E/e'avg\>13; OR
  3. Threefold elevation in NT-proBNP compared to the upper expected age and gender value. OR
  4. GLS\>-15 5. Age ≥18 years 6. Signed informed consent

Exclusion Criteria:

1. LVEF\<50%
2. Very severe AS defined as Vmax\>5 m/s.
3. Concomitant severe valvular disease other than AS
4. Previous valvular surgery
5. Estimated glomerular filtration rate\<30 ml/min/m2
6. Dementia
7. Women of childbearing potential
8. Inability to provide informed consent
9. Age\>85 years.
10. Supravalvular or subvalvular AS

Conditions3

Browse More Trials