PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry

total aortic regurgitation post procedure, at 7 days or discharge, 30 days and 12 months follow-up

Incidence of all-cause mortality at 30 days post index procedure

Clinical events as defined per VARC-2 consensus document

Procedural success is defined as

Absence of intra-procedure mortality and complications arising during implantation of the prosthetic valve such as:

• inability to properly seat the valve in the annulus
• need for more than one implanted aortic bioprosthesis (valve-in-valve or ectopic deployment)
• surgical aortic valve replacement required to correct a severe aortic regurgitation or procedure complication The procedure can be considered as success despite the presence of residual aortic regurgitation which may be due to the anatomic configuration of the annulus or a calcific valvular annulus.

Device success is defined as:

• Absence of intra-procedure mortality (procedure to 24H) AND,
• Correct positioning (placement in the annulus with no impairment of aortic bioprosthesis function) of a single prosthetic heart valve into the proper anatomical location AND,
• Intended performance of the prosthetic heart valve:

• No prosthesis-patient mismatch (EAOi >0.85 cm2/m2) AND,
• Mean aortic valve gradient <20mmHg or peak velocity < 3 m/s AND,
• No moderate or severe prosthetic valve regurgitation.

In evaluating echo parameters, values at 7D/Discharge (whichever occurs first) will be used for each of the echo parameters above. If any of echo parameters is missing at 7-days or discharge, post-procedure data may be used for the missing values. If device success or failure cannot be determined due to missing of parameters listed above or un-evaluable echocardiography assessment, device success will be considered not obtainable.

VARC-2 Composite Safety at 30 days defined as:

• All-cause mortality
• All stroke (disabling and non-disabling)
• Life-threatening bleeding
• Acute kidney injury - Stage 2 or 3 (including renal replacement therapy)
• Coronary artery obstruction requiring intervention
• Major vascular complication
• Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVI)

Functional improvement from baseline as per NYHA Functional Classification

Improvement from baseline of the hemodynamic function: effective orifice area and mean transprosthetic gradient

Valve related dysfunction defined as: mean aortic valve gradient ≥ 20mmHg, EOA ≤0.9-1.1 cm2, and/or DVI< 0.35, and/or moderate or severe prosthetic valve regurgitation (See VARC-2 and Figure 4 from VARC manuscript)