Stages of Structural Valve Deterioration

Stage 1: Morphological valve deterioration

Ÿ Intrinsic permanent changes to the prosthetic valve, including leaflet tear, disruption, flail leaflet, leaflet fibrosis and/or calcification without significant hemodynamic changes.

Stage 2: Moderate hemodynamic valve deterioration^†

Ÿ Morphological valve deterioration (See Stage 1) AND:

Ÿ Increase in mean transvalvular gradient ≥ 10 mmHg resulting in mean gradient ≥ 20 mmHg^‡ with concomitant decrease in aortic valve area (AVA) ≥ 0.3 cm² or ≥25% and/or decrease in Doppler velocity index ≥ 0.1 or ≥20% compared to echocardiographic assessment performed 1 to 3 months post-procedure (or discharge if not available), OR new occurrence or increase of ≥1 grade of transvalvular aortic regurgitation (AR) resulting in moderate transvalvular AR.

Stage 3: Severe hemodynamic valve deterioration^†

Ÿ Morphological valve deterioration (See Stage 1) AND:

Ÿ Increase in mean transvalvular gradient ≥ 20 mmHg resulting in mean gradient ≥ 30 mmHg^‡ with concomitant decrease in AVA ≥ 0.6 cm² or ≥50% and/or decrease in Doppler velocity index ≥ 0.2 or ≥40% compared to echocardiographic assessment performed 1 to 3 months post-procedure (or discharge if not available), OR new occurrence, or increase of ≥2 grades, of transvalvular AR resulting in severe AR.