SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.

Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve))

Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve)).

HSVD is defined as hemodynamic mean gradient ≥ 20mmHg on any echocardiogram after implant procedure.

Mean aortic gradient as measured by echocardiogram at the 12-month visit.

Effective Orifice Area (EOA) as measured by echocardiogram at the 12-month visit.

Moderate or severe PPM will be defined as follows:

For subjects with BMI < 30 kg/m2

• Moderate PPM: EOAI = 0.85 - 0.65 cm2/m2
• Severe PPM: EOAI = ≤ 0.65 cm2/m2

For subjects with BMI ≥ 30 kg/m2

• Moderate PPM: EOAI = 0.70 - 0.55 cm2/m2
• Severe PPM: EOAI = ≤ 0.55 cm2/m2

Device Success is defined as meeting all of the following:

Freedom from mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch (PPM) and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s) AND No moderate or severe prosthetic valve regurgitation)

Incidence of an early safety composite 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, TAVR, or SAVR)

Incidence of clinical efficacy (after 30 days) at 12 months defined as a composite of:

• All-cause mortality
• All stroke (disabling and non-disabling)
• Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure
• NYHA class III or IV
• Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm2 and/or Doppler velocity index (DVI) <0. 35m/s, AND/OR moderate or severe prosthetic valve regurgitation)

Note: This section is excluding subjects with pacemaker or ICD at baseline.

Aortic valve re-intervention rate as measured as the percentage of patients that had a procedure to fix or replace their prosthetic valve at the 30 days, 12 months and 2 Year visit.

EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided. The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine).

Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, selfefficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Note: This is the overall summary score for KCCQ.

Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve))

Effective Orifice Area (EOA) as measured by echocardiogram at the following intervals: Discharge, 30 Days, 12 Months and 2 Years

Mean aortic gradient as measured by echocardiogram at the following intervals: Discharge, 30 Days, 12 Months and 2 Years

Paravalvular Leak as measured by the percentage of participants that had none, trace, mild, moderate and severe, at Discharge, 30 Days, 12 Months and 2 Years

Mean gradient ≥ 20 mmHg based on stress echocardiogram at select sites.