Hemodynamic Comparison of Tissue Aortic Valves

Inclusion Criteria

• Age ≥ 18 years.
• Severe aortic stenosis (AS) based on overall clinical impression, with or without aortic valve mean gradient ≥ 40 mm Hg, EOA < 1.0 cm2, or EOA index < 0.6 cm2/m2.
• Scheduled for clinically indicated elective aortic valve replacement for a primary diagnosis of severe AS.
• Less than moderate aortic regurgitation on preoperative testing.
• Isolated aortic valve replacement; or aortic valve replacement with concomitant coronary artery bypass grafting, ascending aorta repair, or mitral and/or tricuspid annuloplasty for functional mitral regurgitation / tricuspid regurgitation.
• Left ventricular ejection fraction ≥ 40% on preoperative testing.
• Physically able and willing to pedal a recumbent bicycle.
• Patient and surgeon agree that the patient will undergo valve replacement with a bioprosthesis.
• Patient and surgeon agree that the use of one specific bioprosthesis manufacturer / model is not indicated based on clinical criteria.
• Willing to undergo randomization to have implanted one of three bioprosthesis at the time of aortic valve replacement.
• Willing and able to undergo preoperative echocardiography/Doppler for purposes of the research study.
• Willing and able to undergo post-operative exercise stress echocardiography/Doppler 5 to 7 months after valve replacement for purposes of the research protocol.

Exclusion Criteria

• Age < 18 years.
• AS felt by overall clinical impression to be less than severe.
• Aortic valve replacement is urgent or emergent.
• Moderate of more aortic regurgitation on preoperative testing.
• Concomitant mitral or tricuspid valve replacement.
• Left ventricular ejection fraction < 40% on preoperative testing.
• Physically unable or unwilling to pedal a recumbent bicycle.
• Planned aortic valve replacement with a mechanical prosthesis.
• Operating surgeon believes that any one of the three protocol bioprosthetic devices is contraindicated based on clinical criteria.
• Not willing to undergo randomization to have implanted one of three bioprosthesis.
• Unwilling or unable to undergo preoperative echocardiography/Doppler for purposes of the research protocol.
• Unwilling or unable to undergo post-operative exercise stress echocardiography/Doppler 5 to 7 months after valve replacement for purposes of the research protocol.