Subjects who were treated with the INSPIRIS RESILIA Aortic Valve

Surgical replacement of the aortic valve with the Edwards INSPIRIS RESILIA Aortic Valve

Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.

Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.

Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed by four categories, which are "no/trace leak", "a mild leak", "a moderate leak", and "a severe leak". A severe leak indicates a worsening outcome.

Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.

Paravalvular leak is evaluated by echocardiography over time. It is assessed by four categories, which are "no/trace leak", "a mild leak", "a moderate leak", and "a severe leak". A severe leak indicates a worsening outcome.

The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.

Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.